Federal Register Vol. 83, No.110,

Federal Register Volume 83, Issue 110 (June 7, 2018)

Page Range26347-26546
FR Document

83_FR_110
Current View
Page and SubjectPDF
83 FR 26456 - Public Water System Supervision Program Revision for the State of NevadaPDF
83 FR 26497 - Government in the Sunshine Act Meeting NoticePDF
83 FR 26457 - Sunshine Act Meeting; Farm Credit Administration BoardPDF
83 FR 26533 - Delmarva Central Railroad Company-Change in Operator Exemption-Cassatt Management, LLC d/b/a Bay Coast RailroadPDF
83 FR 26463 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
83 FR 26367 - Safety Zone; Blazing Paddles 2018 SUP Race; Cuyahoga River, Cleveland, OH &PDF
83 FR 26538 - Agency Information Collection Activities: Requests for Comments Approval of Information Collection: Organization Designation AuthorizationPDF
83 FR 26537 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Dealer's Aircraft Registration Certificate ApplicationPDF
83 FR 26369 - Acequinocyl; Pesticide TolerancesPDF
83 FR 26537 - Agency Information Collection Activities: Requests for Comments; Clearance of Reinstate Approval of Information Collection: Aviation InsurancePDF
83 FR 26438 - Applications for New Awards; Gaining Early Awareness and Readiness for Undergraduate Programs (Partnership Grants)PDF
83 FR 26539 - Notice of Public Meeting: National Dialogue on Highway AutomationPDF
83 FR 26445 - Applications for New Awards; Gaining Early Awareness and Readiness for Undergraduate Programs (State Grants)PDF
83 FR 26499 - Agency Information Collection Activities: Proposed Collection; Comments Requested; Request for Registration Under the Gambling Devices Act of 1962PDF
83 FR 26432 - Pacific Fishery Management Council; Public MeetingPDF
83 FR 26490 - Certificate of Alternative Compliance for the M/V SAMANTHA SPDF
83 FR 26364 - Drawbridge Operation Regulation; Hutchinson River, New York, NYPDF
83 FR 26496 - Agency Information Collection Activities: Homeland Security Acquisition Regulation (HSAR) Regulation on Agency ProtestsPDF
83 FR 26365 - Drawbridge Operation Regulation; Snohomish River and Steamboat Slough, Everett and Marysville, WAPDF
83 FR 26365 - Safety Zone; Ohio River, Mile Marker 27.8 to Mile Marker 28.2, Vanport, PAPDF
83 FR 26364 - Drawbridge Operation Regulation; Willamette River at Portland, ORPDF
83 FR 26361 - Special Local Regulation; Tred Avon River, Between Bellevue, MD and Oxford, MDPDF
83 FR 26458 - Information Collection Being Submitted for Review and Approval to the Office of Management and BudgetPDF
83 FR 26436 - Agency Information Collection Activities: Notice of Intent To Renew Collection 3038-0093, Part 40, Provisions Common to Registered EntitiesPDF
83 FR 26437 - Agency Information Collection Activities: Notice of Intent To Renew Collection Number 3038-0007, Regulation of Domestic Exchange-Traded OptionsPDF
83 FR 26503 - Draft Letter to the Nuclear Energy Institute Regarding the Clarification of Regulatory Paths for Lead Test AssembliesPDF
83 FR 26432 - Schedules for Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification WorkshopsPDF
83 FR 26359 - Removal of Cross References to Previously Removed Appendices and SubpartPDF
83 FR 26489 - End of the Call for Participation for Computational Photography Project for Pill Identification (C3PI)PDF
83 FR 26415 - Glycine From India, the People's Republic of China, and Thailand: Postponement of Preliminary Determinations of Countervailing Duty InvestigationsPDF
83 FR 26414 - Certain Folding Gift Boxes From the People's Republic of China: Final Results of Expedited Third Sunset Review and Continuation of the Antidumping Duty OrderPDF
83 FR 26503 - Advisory Committee on the Medical Uses of Isotopes: Meeting NoticePDF
83 FR 26347 - Securities Transaction Settlement CyclePDF
83 FR 26413 - Agenda and Notice of Public Meetings of the South Dakota Advisory CommitteePDF
83 FR 26457 - Notice of Issuance of Statement of Federal Financial Accounting Standards 55, Amending Inter-Entity Cost ProvisionsPDF
83 FR 26452 - Application To Export Electric Energy; ALLETE, Inc., d/b/a Minnesota PowerPDF
83 FR 26452 - Certification Notice-253; Notice of Filing of Self-Certification of Coal Capability Under the Powerplant and Industrial Fuel Use ActPDF
83 FR 26453 - Notice of Intent To Grant an Exclusive Copyright LicensePDF
83 FR 26434 - Multistakeholder Process on Promoting Software Component TransparencyPDF
83 FR 26354 - Regulatory Program Fees and Water Charges RatesPDF
83 FR 26377 - Hours of Service of Drivers of Commercial Motor Vehicles: Regulatory Guidance Concerning the Use of a Commercial Motor Vehicle for Personal ConveyancePDF
83 FR 26505 - Product Change-Priority Mail Negotiated Service AgreementPDF
83 FR 26505 - Product Change-Priority Mail Express Negotiated Service AgreementPDF
83 FR 26464 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
83 FR 26374 - Hours of Service of Drivers of Commercial Motor Vehicles; Regulatory Guidance Concerning the Transportation of Agricultural CommoditiesPDF
83 FR 26501 - Pacific Gas and Electric Company Diablo Canyon Independent Spent Fuel Storage InstallationPDF
83 FR 26491 - Changes in Flood Hazard DeterminationsPDF
83 FR 26495 - Ohio; Amendment No. 1 to Notice of a Major Disaster DeclarationPDF
83 FR 26494 - Proposed Flood Hazard DeterminationsPDF
83 FR 26453 - Stoneray Power Partners, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 26454 - Copenhagen Wind Farm, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 26456 - Montauk Energy Storage Center, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 26454 - East Hampton Energy Storage Center, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 26454 - Combined Notice of Filings #1PDF
83 FR 26541 - Pipeline Safety: Information Collection ActivitiesPDF
83 FR 26541 - Limitation on Claims Against Proposed Public Transportation ProjectsPDF
83 FR 26361 - Air Force Freedom of Information Act ProgramPDF
83 FR 26534 - Cumberland Fossil Plant Coal Combustion Residuals Management Operations Final Environmental Impact StatementPDF
83 FR 26539 - Notice of Final Federal Agency Actions on Proposed Highway in CaliforniaPDF
83 FR 26485 - Facilitation of Public-Private Dialogue to Increase Innovation and Investment in the Healthcare SectorPDF
83 FR 26499 - Notice of Intent To Grant Partially Exclusive LicensePDF
83 FR 26500 - Notice of Intent To Grant Partially Exclusive Patent LicensePDF
83 FR 26387 - Airworthiness Directives; Airbus Helicopters Deutschland GmbH HelicoptersPDF
83 FR 26483 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
83 FR 26416 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Marine Site Characterization Surveys off of DelawarePDF
83 FR 26540 - Petition for Waiver of CompliancePDF
83 FR 26482 - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
83 FR 26465 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 049PDF
83 FR 26477 - Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact ConsiderationsPDF
83 FR 26481 - Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications; CorrectionPDF
83 FR 26481 - Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee, RenewalPDF
83 FR 26356 - Listing of Color Additives Subject to Certification; D&C Black No. 4PDF
83 FR 26475 - Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief; Draft Guidance for Industry; AvailabilityPDF
83 FR 26477 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health ClaimPDF
83 FR 26497 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Federal Explosives License/Permit (FEL) Renewal Application-ATF Form 5400.14/5400.15 Part IIIPDF
83 FR 26498 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Firearms Disabilities for Nonimmigrant AliensPDF
83 FR 26413 - Agenda and Notice of Public Meeting of the Massachusetts Advisory CommitteePDF
83 FR 26546 - Open Meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project CommitteePDF
83 FR 26544 - Open Meeting of the Taxpayer Advocacy Panel Special Projects CommitteePDF
83 FR 26546 - Open Meeting of the Taxpayer Advocacy Panel Joint CommitteePDF
83 FR 26498 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-DVD Copy Control AssociationPDF
83 FR 26546 - Open Meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project CommitteePDF
83 FR 26544 - Electronic Tax Administration Advisory Committee (ETAAC); Notice of MeetingPDF
83 FR 26499 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Heterogeneous System Architecture FoundationPDF
83 FR 26545 - Open Meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project CommitteePDF
83 FR 26545 - Open Meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project CommitteePDF
83 FR 26545 - Open Meeting of the Taxpayer Advocacy Panel Toll-Free Phone Line Project CommitteePDF
83 FR 26392 - Product Jurisdiction; CorrectionPDF
83 FR 26392 - Periodic ReportingPDF
83 FR 26412 - Notice of Public Meeting of the Idaho Advisory CommitteePDF
83 FR 26416 - Marine Fisheries Advisory Committee; Charter RenewalPDF
83 FR 26416 - Marine Fisheries Advisory Committee MeetingPDF
83 FR 26531 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Amend a Representation Made in a Proposed Rule Change Previously Approved by the Commission Relating to the Listing and Trading of the iShares Inflation Hedged Corporate Bond ETFPDF
83 FR 26514 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To Implement Changes to the Required Fund Deposit Calculation in the Government Securities Division RulebookPDF
83 FR 26511 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE Proprietary Market Data Fee Schedule Regarding the NYSE Best Quote and Trades Market Data FeedPDF
83 FR 26507 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Content of the NYSE Best Quote & Trades Data FeedPDF
83 FR 26510 - Submission for OMB Review; Comment RequestPDF
83 FR 26506 - Sprott ETF Trust and Sprott Asset Management USA Inc.PDF
83 FR 26542 - Notice of OFAC Sanctions ActionsPDF
83 FR 26410 - Bayer CropScience LP; Availability of a Preliminary Plant Pest Risk Assessment, Draft Environmental Assessment, Preliminary Finding of No Significant Impact, and Preliminary Determination of Nonregulated Status for Cotton Genetically Engineered For Resistance to HPPD-Inhibitor Herbicides (e.g., Isoxaflutole) and GlyphosatePDF
83 FR 26410 - Notice of a Determination Regarding the Classical Swine Fever and Swine Vesicular Disease Status of JapanPDF
83 FR 26533 - Administrative Declaration of a Disaster for the Commonwealth of VIRGINIAPDF
83 FR 26461 - Open Commission Meeting, Thursday, June 7, 2018PDF
83 FR 26396 - Transforming the 2.5 GHz BandPDF
83 FR 26463 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
83 FR 26457 - Information Collection Being Submitted for Review and Approval to the Office of Management and BudgetPDF
83 FR 26460 - Information Collection Being Submitted for Review and Approval to the Office of Management and BudgetPDF
83 FR 26487 - Prospective Grant of an Exclusive Patent License: The Development of an Anti-BCMA Immunotoxin for the Treatment of Human CancerPDF
83 FR 26488 - National Institute of Nursing Research; Notice to Close MeetingPDF
83 FR 26489 - National Institute of Nursing Research; Notice to Close MeetingPDF
83 FR 26489 - National Institute of Mental Health; Notice of Closed MeetingPDF
83 FR 26486 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed MeetingsPDF
83 FR 26489 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 26389 - Airworthiness Directives; 328 Support Services GmbH (Type Certificate Previously Held by AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) AirplanesPDF
83 FR 26383 - Airworthiness Directives; The Boeing Company AirplanesPDF
83 FR 26381 - Airworthiness Directives; Honda Aircraft Company LLCPDF
83 FR 26374 - General Technical, Organizational, Conforming, and Correcting Amendments to the Federal Motor Carrier Safety Regulations; CorrectionPDF
83 FR 26349 - Airworthiness Directives; Aircraft Industries a.s. AirplanesPDF
83 FR 26352 - Airworthiness Directives; Bombardier, Inc., AirplanesPDF

Issue

83 110 Thursday, June 7, 2018 Contents Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

AIRFORCE Air Force Department RULES Freedom of Information Act Program, 26361 2018-12237 Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Explosives License/Permit Renewal Application, 26497-26498 2018-12215 Firearms Disabilities for Nonimmigrant Aliens, 26498 2018-12214 Animal Animal and Plant Health Inspection Service NOTICES Determinations: Classical Swine Fever and Swine Vesicular Disease Status of Japan, 26410 2018-12186 Environmental Assessments; Availability, etc.: Bayer CropScience LP; Cotton Genetically Engineered for Resistance to HPPD-Inhibitor Herbicides (e.g., Isoxaflutole) and Glyphosate, 26410-26412 2018-12187 Antitrust Division Antitrust Division NOTICES Changes Under the National Cooperative Research and Production Act of 1993: DVD Copy Control Assn., 26498-26499 2018-12209 Heterogeneous System Architecture Foundation, 26499 2018-12206 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26464-26465 2018-12251 Civil Rights Civil Rights Commission NOTICES Meetings: Idaho Advisory Committee, 26412-26413 2018-12199 Massachusetts Advisory Committee, 26413 2018-12213 South Dakota Advisory Committee, 26413-26414 2018-12266 Coast Guard Coast Guard RULES Drawbridge Operations: Hutchinson River, New York, NY, 26364-26365 2018-12287 Snohomish River and Steamboat Slough, Everett and Marysville, WA, 26365 2018-12284 Willamette River at Portland, OR, 26364 2018-12282 Safety Zones: Blazing Paddles 2018 Stand Up Paddleboard Race, Cuyahoga River, Cleveland, OH, 26367-26369 2018-12301 Ohio River, Mile Marker 27.8 to Mile Marker 28.2, Vanport, PA, 26365-26367 2018-12283 Special Local Regulations: Tred Avon River, Between Bellevue, MD and Oxford, MD, 26361-26364 2018-12281 NOTICES Certificates of Alternative Compliance: M/V SAMANTHA S, 26490 2018-12288 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

National Telecommunications and Information Administration

Commodity Futures Commodity Futures Trading Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Provisions Common to Registered Entities, 26436-26437 2018-12278 Regulation of Domestic Exchange-Traded Options, 26437-26438 2018-12277 Comptroller Comptroller of the Currency RULES Securities Transaction Settlement Cycle, 26347-26349 2018-12267 Defense Department Defense Department See

Air Force Department

Delaware Delaware River Basin Commission RULES Regulatory Program Fees and Water Charges Rates, 26354-26356 2018-12258 Education Department Education Department NOTICES Applications for New Awards: Gaining Early Awareness and Readiness for Undergraduate Programs (Partnership Grants), 26438-26445 2018-12294 Gaining Early Awareness and Readiness for Undergraduate Programs (State Grants), 26445-26452 2018-12291 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Applications to Export Electric Energy: ALLETE, Inc., d/b/a Minnesota Power, 26452 2018-12264 Exclusive Copyright Licenses: VariGrid Explorations, Inc., 26453 2018-12262 Self-Certifications of Coal Capability Under Powerplant and Industrial Fuel Use Act; Filings, 26452-26453 2018-12263
Environmental Protection Environmental Protection Agency RULES Pesticide Tolerances: Acequinocyl, 26369-26374 2018-12297 NOTICES Public Water System Supervision Program; Revisions: Nevada, 26456-26457 2018-12376 Farm Credit Farm Credit Administration NOTICES Meetings; Sunshine Act, 26457 2018-12352 Federal Accounting Federal Accounting Standards Advisory Board NOTICES Statement of Federal Financial Accounting Standards 55: Amending Inter-Entity Cost Provisions, 26457 2018-12265 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Aircraft Industries a.s. Airplanes, 26349-26352 2018-11930 Bombardier, Inc., Airplanes, 26352-26354 2018-11827 PROPOSED RULES Airworthiness Directives: 328 Support Services GmbH (Type Certificate Previously Held by AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) Airplanes, 26389-26391 2018-12135 Airbus Helicopters Deutschland GmbH Helicopters, 26387-26389 2018-12227 Honda Aircraft Company LLC, 26381-26383 2018-12127 The Boeing Company Airplanes, 26383-26387 2018-12128 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Aviation Insurance, 26537 2018-12296 Dealer's Aircraft Registration Certificate Application, 26537-26538 2018-12298 Organization Designation Authorization, 26538-26539 2018-12299 Federal Communications Federal Communications Commission PROPOSED RULES Transforming the 2.5 GHz Band, 26396-26409 2018-12183 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26457-26461, 26463 2018-12180 2018-12181 2018-12182 2018-12280 Meetings: Open Commission Meeting, 26461-26462 2018-12184 Federal Deposit Federal Deposit Insurance Corporation RULES Securities Transaction Settlement Cycle, 26347-26349 2018-12267 Federal Emergency Federal Emergency Management Agency NOTICES Flood Hazard Determinations; Changes, 26491-26494 2018-12248 Flood Hazard Determinations; Proposals, 26494-26495 2018-12246 Major Disaster Declarations: Ohio; Amendment No. 1, 26495-26496 2018-12247 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 26454-26456 2018-12240 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Copenhagen Wind Farm, LLC, 26454 2018-12243 East Hampton Energy Storage Center, LLC, 26454 2018-12241 Montauk Energy Storage Center, LLC, 26456 2018-12242 Stoneray Power Partners, LLC, 26453-26454 2018-12244 Federal Highway Federal Highway Administration NOTICES Final Federal Agency Actions: California; Proposed Highway, 26539-26540 2018-12235 Meetings: National Dialogue on Highway Automation, 26539 2018-12292 Federal Motor Federal Motor Carrier Safety Administration RULES General Technical, Organizational, Conforming, and Correcting Amendments to Federal Motor Carrier Safety Regulations: Correction, 26374 2018-12032 Hours of Service of Drivers of Commercial Motor Vehicles: Regulatory Guidance Concerning Transportation of Agricultural Commodities, 26374-26377 2018-12250 Regulatory Guidance Concerning Use of Commercial Motor Vehicle for Personal Conveyance, 26377-26380 2018-12256 Federal Railroad Federal Railroad Administration NOTICES Petitions for Waivers of Compliance, 26540-26541 2018-12224 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 26463 2018-12302 Federal Transit Federal Transit Administration NOTICES Limitations on Claims Against Proposed Public Transportation Projects, 26541 2018-12238 Food and Drug Food and Drug Administration RULES Listing of Color Additives Subject to Certification; D and C Black No. 4, 26356-26359 2018-12218 PROPOSED RULES Product Jurisdiction: Correction, 26392 2018-12201 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Environmental Impact Considerations, 26477-26481 2018-12221 Record Retention Requirements for Soy Protein and Risk of Coronary Heart Disease Health Claim, 26477 2018-12216 Charter Renewals: Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee, 26481 2018-12219 Food and Drug Administration Modernization Act of 1997: Modifications to List of Recognized Standards, Recognition List Number: 049, 26465-26475 2018-12222 Guidance: Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for President's Emergency Plan for AIDS Relief, 26475-26477 2018-12217 Requests for Feedback and Meetings for Medical Device Submissions: Q-Submission Program, 26482-26483 2018-12223 Meetings: Pulmonary-Allergy Drugs Advisory Committee; Establishment of Public Docket, 26483-26485 2018-12226 New Drug Applications: Sebela Ireland, Ltd., et al.; Withdrawal of Approval; Correction, 26481-26482 2018-12220 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 26542-26544 2018-12189 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 Requests for Information: Facilitation of Public-Private Dialogue To Increase Innovation and Investment in Healthcare Sector, 26485-26486 2018-12234
Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Homeland Security Acquisition Regulation on Agency Protests, 26496-26497 2018-12286
Housing Housing and Urban Development Department RULES Removal of Cross References to Previously Removed Appendices and Subpart, 26359-26361 2018-12274 Internal Revenue Internal Revenue Service NOTICES Meetings: Electronic Tax Administration Advisory Committee, 26544 2018-12207 Taxpayer Advocacy Panel Joint Committee, 26546 2018-12210 Taxpayer Advocacy Panel Notices and Correspondence Project Committee, 26545 2018-12204 Taxpayer Advocacy Panel Special Projects Committee, 26544-26545 2018-12211 Taxpayer Advocacy Panel Tax Forms and Publications Project Committee, 26545 2018-12205 Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee, 26546 2018-12208 Taxpayer Advocacy Panel Taxpayer Communications Project Committee, 26546 2018-12212 Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee, 26545 2018-12203 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Folding Gift Boxes From the People's Republic of China; Final Results of Expedited Third Sunset Review and Continuation of Antiumping Duty Order, 26414-26415 2018-12271 Glycine From India, the People's Republic of China, and Thailand; Postponement of Preliminary Determinations, 26415-26416 2018-12272 International Trade Com International Trade Commission NOTICES Meetings; Sunshine Act, 26497 2018-12363 Justice Department Justice Department See

Alcohol, Tobacco, Firearms, and Explosives Bureau

See

Antitrust Division

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Request for Registration Under Gambling Devices Act of 1962, 26499 2018-12290
NASA National Aeronautics and Space Administration NOTICES Intents To Grant Partially Exclusive Patent Licenses, 26499-26501 2018-12231 2018-12232 National Institute National Institutes of Health NOTICES End of Call for Participation for Computational Photography Project for Pill Identification, 26489 2018-12273 Meetings: Center for Scientific Review, 26489-26490 2018-12174 National Institute of Arthritis and Musculoskeletal and Skin Diseases, 26486-26487 2018-12175 National Institute of Mental Health, 26489 2018-12176 National Institute of Nursing Research, 26488-26489 2018-12177 2018-12178 Prospective Grants of Exclusive Patent Licenses: Development of Anti-BCMA Immunotoxin for Treatment of Human Cancer, 26487-26488 2018-12179 National Oceanic National Oceanic and Atmospheric Administration NOTICES Charter Renewals: Marine Fisheries Advisory Committee, 26416 2018-12198 Meetings: Marine Fisheries Advisory Committee, 26416 2018-12197 Pacific Fishery Management Council, 26432 2018-12289 Schedules for Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops, 26432-26434 2018-12275 Takes of Marine Mammals Incidental to Specified Activities: Marine Site Characterization Surveys Off of Delaware, 26416-26432 2018-12225 National Telecommunications National Telecommunications and Information Administration NOTICES Meetings: Multistakeholder Process on Promoting Software Component Transparency, 26434-26436 2018-12261 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Draft Letter to Nuclear Energy Institute Regarding Clarification of Regulatory Paths for Lead Test Assemblies, 26503-26505 2018-12276 Environmental Assessments; Availability, etc.: Pacific Gas and Electric Co. Diablo Canyon Independent Spent Fuel Storage Installation, 26501-26503 2018-12249 Meetings: Advisory Committee on Medical Uses of Isotopes, 26503 2018-12269 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Pipeline Safety, 26541-26542 2018-12239 Postal Regulatory Postal Regulatory Commission PROPOSED RULES Periodic Reporting, 26392-26396 2018-12200 Postal Service Postal Service NOTICES Product Changes: Priority Mail Express Negotiated Service Agreement, 26505 2018-12252 Priority Mail Negotiated Service Agreement, 26505-26506 2018-12253 2018-12254 2018-12255 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26510-26511 2018-12192 Applications: Sprott ETF Trust and Sprott Asset Management USA, Inc., 26506-26507 2018-12191 Self-Regulatory Organizations; Proposed Rule Changes: Cboe BZX Exchange, Inc., 26531-26533 2018-12196 Fixed Income Clearing Corp., 26514-26530 2018-12195 New York Stock Exchange, LLC, 26507-26514 2018-12193 2018-12194 Small Business Small Business Administration NOTICES Disaster Declarations: Virginia; Administrative Declaration, 26533 2018-12185 Surface Transportation Surface Transportation Board NOTICES Changes in Operator Exemptions: Delmarva Central Railroad Co.; Cassatt Management, LLC d/b/a Bay Coast Railroad, 26533 2018-12308 Tennessee Tennessee Valley Authority NOTICES Environmental Impact Statements; Availability, etc.: Cumberland Fossil Plant Coal Combustion Residuals Management Operations, 26534-26537 2018-12236 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Motor Carrier Safety Administration

See

Federal Railroad Administration

See

Federal Transit Administration

See

Pipeline and Hazardous Materials Safety Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Foreign Assets Control Office

See

Internal Revenue Service

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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83 110 Thursday, June 7, 2018 Rules and Regulations DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency 12 CFR Parts 12 and 151 [Docket ID OCC-2017-0013] RIN 1557-AE24 FEDERAL DEPOSIT INSURANCE CORPORATION 12 CFR Part 344 RIN 3064-AE64 Securities Transaction Settlement Cycle AGENCY:

Office of the Comptroller of the Currency, Treasury (“OCC”); and Federal Deposit Insurance Corporation (“FDIC”).

ACTION:

Final rule.

SUMMARY:

The OCC and the FDIC (“Agencies”) are adopting a final rule to shorten the standard settlement cycle for securities purchased or sold by national banks, federal savings associations, and FDIC-supervised institutions. The Agencies' final rule is consistent with an industry-wide transition to a two business-day settlement cycle, which is designed to reduce settlement exposure and align settlement practices across all market participants.

DATES:

This final rule is effective October 1, 2018.

FOR FURTHER INFORMATION CONTACT:

OCC: David Stankiewicz, Special Counsel, Securities and Corporate Practices Division, (202) 649-5510; Daniel Perez, Attorney, Legislative and Regulatory Activities Division, (202) 649-5490 or, for persons who are deaf or hearing-impaired, TTY, (202) 649-5597; or Patricia Dalton, Technical Expert, Asset Management Group, Market Risk, at (202) 649-6360.

FDIC: Thomas F. Lyons, Chief, (202) 898-6850; Michael W. Orange, Senior Trust Examination Specialist, (678) 916-2289, Policy & Program Development, Risk Management Policy Branch, Division of Risk Management Supervision; Annmarie H. Boyd, Counsel, (202) 898-3714; Benjamin J. Klein, Counsel, (202) 898-7027, Bank Activities Unit, Supervision and Legislation Branch, Legal Division.

SUPPLEMENTARY INFORMATION: I. Background

On September 5, 2017, the securities industry in the United States transitioned from a standard securities settlement cycle of three business days after the date of the contract, commonly known as “T+3,” to a two-business day standard, or “T+2.” The transition was the culmination of a multi-year securities industry initiative and rule changes implemented by the U.S. Securities and Exchange Commission and securities self-regulatory organizations (such as the Financial Industry Regulatory Authority and the Municipal Securities Rulemaking Board). In connection with the transition to T+2, on June 9, 2017, the OCC issued Bulletin 2017-22, which notified national banks, federal savings associations (“FSAs”), federal branches, and federal agencies (together, “OCC-supervised institutions”) that they should be in compliance with T+2 as of September 5, 2017. The FDIC issued similar guidance applicable to FDIC-supervised institutions 1 through Financial Institution Letter 32-2017 on July 26, 2017.

1 “FDIC-supervised institution” means any insured depository institution for which the FDIC is the appropriate Federal banking agency pursuant to section 3(q) of the Federal Deposit Insurance Act, 12 U.S.C. 1813(q). 12 CFR 344.3(h). Pursuant to section 3(q), the FDIC is the appropriate Federal banking agency with respect to: (1) Any State nonmember insured bank; (2) any foreign bank having an insured branch; and (3) any State savings association. 12 U.S.C. 1813(q)(2).

Regulations governing recordkeeping and confirmation requirements for the securities transactions of national banks and FSAs, both for the bank's own account and for customers, are set out in parts 12 and 151 of the OCC's regulations, respectively. Regulations governing the same for FDIC-supervised institutions are set out in part 344 of the FDIC's regulations. These regulations require that banks generally not effect or enter into a contract for the purchase or sale of a security that provides for payment of funds and delivery of securities later than the third business day after the date of the contract, unless otherwise expressly agreed to by the parties at the time of the transaction.

II. Notice of Proposed Rulemaking

On September 11, 2017, the Agencies published in the Federal Register a notice of proposed rulemaking that would amend regulations applicable to OCC-supervised institutions and FDIC-supervised institutions (together, “banks”) by aligning those regulations with T+2.2 In the notice of proposed rulemaking, the Agencies proposed to amend their respective regulations by directly changing the settlement period applicable to banks from three business days to two. The Agencies also proposed an alternative approach, which would achieve the same immediate result but operate by tying the settlement period applicable to banks to the “standard settlement cycle followed by registered broker dealers in the United States.”

2 82 FR 42619 (Sep. 11, 2017).

The Agencies received three responses to their request for comment. The Investment Company Institute (“ICI”) and the Securities Industry and Financial Markets Association (“SIFMA”) both “strongly” supported the proposal as a path to aligning the Agencies' regulations with those applicable to other market participants in the United States. A third commenter, an individual, also expressed support for the final rule. Both ICI and SIFMA expressed a preference for the alternative approach. After considering these comments, the Agencies decided to adopt the alternative approach in order to maintain alignment more readily between the settlement period applicable to banks and the standard settlement cycle followed by registered broker dealers in the United States.

III. Description of the Final Rule

The final rule will require banks to settle most securities transactions within the number of business days in the “standard settlement cycle followed by registered broker dealers in the United States” unless otherwise agreed to by the parties at the time of the transaction. Banks will be able to determine the number of business days in the standard settlement cycle followed by registered broker dealers in the United States by referencing SEC Rule 15c6-1, 17 CFR 240.15c6-1(a). Effective September 5, 2017, and as of the date of publication of this final rule, the standard settlement cycle followed by registered broker dealers in the United States is two business days after the date of the contract.

The final rule amends the OCC and FDIC regulations at parts 12, 151, and 344, which govern the recordkeeping and confirmation requirements for bank securities transactions. In order to accommodate the change described above, the Agencies made certain additional, purely editorial changes to the language of these parts. The additional changes were intended to make the regulations easier to follow and understand in light of the revisions necessary to implement the alternative approach.

The effective date for this final rule is October 1, 2018. The Agencies understand that, consistent with the industry's transition to T+2, banks are already in compliance with a two-day settlement standard as a practical matter.

IV. Regulatory Analysis Paperwork Reduction Act

Under the Paperwork Reduction Act (“PRA”), 44 U.S.C. 3501-3520, the Agencies may not conduct or sponsor, and a person is not required to respond to, an information collection unless the information collection displays a valid Office of Management and Budget (“OMB”) control number. This final rule does not introduce or change any collections of information; therefore, it does not require a submission to OMB. The Agencies invited comment on their PRA determination when issuing the proposed rule, and no responsive comments were received.

Regulatory Flexibility Act

The Regulatory Flexibility Act, 5 U.S.C. 601 et seq. (“RFA”), requires an agency, in connection with a final rule, to prepare a Final Regulatory Flexibility Analysis describing the impact of the rule on small entities (defined by the Small Business Administration (“SBA”) for purposes of the RFA to include banking entities with total assets of $550 million or less) or to certify that the rule would not have a significant economic impact on a substantial number of small entities.

FDIC: For the reasons described below and pursuant to section 605(b) of the RFA, the FDIC certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

As of December 31, 2017, the FDIC supervises 3,643 depository institutions, of which 2,924 are defined as small banking entities by the terms of the RFA. The transition of the standard settlement cycle to two days will reduce by one day the settlement time of transactions for equities, corporate bonds, municipal bonds, unit investment trusts, mutual funds, exchange-traded funds, exchange-traded products, American depository receipts, options, rights, and warrants. According to recent Call Report data, 2,565 FDIC-supervised small entities reported holding some volume of equities that are likely to be affected by the new securities settlement cycle, provide custodial banking services, or possess a subsidiary classified as a securities dealer.

The effects on small entities will vary according to the degree of participation in securities transactions. According to recent Call Report data one small entity identified itself as providing custodial banking services, while seven small entities have a subsidiary classified as a securities dealer according to data from the Federal Reserve's National Information Center.

As discussed above, because the industry has already implemented the practice of a standard settlement cycle, currently consisting of two days, and because the final rule does not contain any new recordkeeping, reporting, or compliance requirements, the FDIC anticipates that it will not impose any significant additional costs on FDIC-supervised institutions. Thus, the final rule will not have a substantial impact on any FDIC-supervised small entities. Therefore, the FDIC certifies that the final rule would not have a significant economic impact on a substantial number of FDIC-supervised small entities.

OCC: As of December 31, 2017, the OCC supervised approximately 886 small entities.3 Because the final rule does not contain any new recordkeeping, reporting, or compliance requirements, the OCC anticipates that it will not impose costs on any OCC-supervised institutions. Further, OCC-supervised institutions were required to comply with the substance of the rule before the proposed rule was published in the Federal Register. Thus, the final rule will not have a substantial impact on any OCC-supervised small entities. Therefore, the OCC certifies that the final rule would not have a significant economic impact on a substantial number of OCC-supervised small entities.

3 The OCC calculated the number of small entities using the SBA's size thresholds for commercial banks and savings institutions, and trust companies, which are $550 million and $38.5 million, respectively. Consistent with the General Principles of Affiliation, 13 CFR 121.103(a), the OCC counted the assets of affiliated financial institutions when determining whether to classify a national bank or federal savings association as a small entity. The OCC used December 31, 2017, to determine size because a “financial institution's assets are determined by averaging the assets reported on its four quarterly financial statements for the preceding year.” See footnote 8 of the SBA's Table of Size Standards.

Unfunded Mandates Reform Act of 1995 Determination

The OCC analyzed the final rule under the factors set forth in the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532). Under this analysis, the OCC considered whether the final rule includes a federal mandate 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 in any one year (adjusted annually for inflation).

The rule does not impose new mandates. Therefore, the OCC concludes that implementation of the rule will not result in an expenditure of $100 million or more annually by state, local, and tribal governments, or by the private sector.

Riegle Community Development and Regulatory Improvement Act

The Riegle Community Development and Regulatory Improvement Act (“RCDRIA”) requires that the Agencies, in determining the effective date and administrative compliance requirements of new regulations that impose additional reporting, disclosure, or other requirements on insured depository institutions (“IDIs”), consider, consistent with principles of safety and soundness and the public interest, any administrative burdens that such regulations would place on depository institutions, including small depository institutions, and customers of depository institutions, as well as the benefits of such regulations. 12 U.S.C. 4802. In addition, in order to provide an adequate transition period, new regulations that impose additional reporting, disclosures, or other new requirements on IDIs generally must take effect on the first day of a calendar quarter that begins on or after the date on which the regulations are published in final form.

The final rule includes no additional reporting, disclosure, or other requirements on IDIs, including small depository institutions, nor on the customers of depository institutions. Therefore, the requirements of RCDRIA do not apply. Nonetheless, the Agencies invited comment on any administrative burdens that the final rule would place on depository institutions, including small depository institutions, and customers of depository institutions. The Agencies did not receive any comments responsive to this issue.

Plain Language

Section 722 of the Gramm-Leach-Bliley Act requires the Agencies to use plain language in all proposed and final rules published after January 1, 2000. When issuing a proposed rule, the Agencies invited comment on how to make this rule easier to understand. No comments responsive to this issue were received.

List of Subjects 12 CFR Parts 12 and 151

Banks, Banking, Federal savings associations, National banks, Reporting and recordkeeping requirements, Securities.

12 CFR Part 344

Banks, Banking, Reporting and recordkeeping requirements, Savings associations.

OCC amends 12 CFR parts 12 and 151 and FDIC amends 12 CFR part 344 as follows:

DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency PART 12—RECORDKEEPING AND CONFIRMATION REQUIREMENTS FOR SECURITIES TRANSACTIONS 1. The authority citation for part 12 continues to read as follows: Authority:

12 U.S.C. 24, 92a, and 93a.

2. Section 12.9 is amended by revising paragraph (a) to read as follows:
§ 12.9 Settlement of securities transactions.

(a) All contracts effected or entered into by a national bank for the purchase or sale of a security (other than an exempted security as defined in 15 U.S.C. 78c(a)(12), government security, municipal security, commercial paper, bankers' acceptances, or commercial bills) shall provide for completion of the transaction within the number of business days in the standard settlement cycle followed by registered broker dealers in the United States, unless otherwise agreed to by the parties at the time of the transaction. The number of business days in the standard settlement cycle shall be determined by reference to paragraph (a) of SEC Rule 15c6-1, 17 CFR 240.15c6-1(a).

PART 151—RECORDKEEPING AND CONFIRMATION REQUIREMENTS FOR SECURITIES TRANSACTIONS 3. The authority citation for part 151 continues to read as follows: Authority:

12 U.S.C. 1462a, 1463, 1464, 5412(b)(2)(B).

4. Section 151.130 is amended by: a. Republishing paragraph (a) introductory text. b. Revising paragraphs (a)(1) and (a)(2); c. Redesignating paragraph (a)(3) as (a)(4); and d. Adding a new paragraph (a)(3).

The revisions and addition are set forth below.

§ 151.130 When must I settle a securities transaction?

(a) You may not effect or enter into a contract for the purchase or sale of a security that provides for payment of funds and delivery of securities later than the latest of:

(1) The number of business days in the standard settlement cycle followed by registered broker dealers in the United States after the date of the contract. The number of business days in the standard settlement cycle shall be determined by reference to paragraph (a) of SEC Rule 15c6-1, 17 CFR 240.15c6-1(a);

(2) The fourth business day after the contract, if the contract involves the sale for cash of securities that are priced after 4:30 p.m. Eastern Standard Time on the date the securities are priced and are sold by an issuer to an underwriter under a firm commitment underwritten offering registered under the Securities Act of 1933, 15 U.S.C. 77a, et seq., or are sold by you to an initial purchaser participating in the offering;

(3) Such time as the SEC may specify pursuant to an order of exemption in accordance with paragraph (b)(2) of SEC Rule 15c6-1; or

FEDERAL DEPOSIT INSURANCE CORPORATION PART 344—RECORDKEEPING AND CONFIRMATION REQUIREMENTS FOR SECURITIES TRANSACTIONS 5. The authority citation for part 344 continues to read as follows: Authority:

12 U.S.C. 1817, 1818, 1819, and 5412.

6. Section 344.7 is amended by revising paragraph (a) to read as follows:
§ 344.7 Settlement of securities transactions.

(a) All contracts effected or entered into by an FDIC-supervised institution that provide for the purchase or sale of a security (other than an exempted security as defined in 15 U.S.C. 78c(a)(12), government security, municipal security, commercial paper, bankers' acceptances, or commercial bills) shall provide for completion of the transaction within the number of business days in the standard settlement cycle followed by registered broker dealers in the United States, unless otherwise agreed to by the parties at the time of the transaction. The number of business days in the standard settlement cycle shall be determined by reference to paragraph (a) of SEC Rule 15c6-1, 17 CFR 240.15c6-1(a).

Dated: May 29, 2018. Joseph M. Otting, Comptroller of the Currency. Dated at Washington, DC, this 31st of May 2018.

By order of the Board of Directors.

Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
[FR Doc. 2018-12267 Filed 6-6-18; 8:45 am] BILLING CODE 4810-33-P; 6714-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0462; Product Identifier 2018-CE-017-AD; Amendment 39-19292; AD 2018-11-04] RIN 2120-AA64 Airworthiness Directives; Aircraft Industries a.s. Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; request for comments.

SUMMARY:

We are adopting a new airworthiness directive (AD) for Aircraft Industries a.s. Models L 410 UVP-E20 and L 410 UVP-E20 CARGO airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as un-commanded negative thrust mode activated on an engine. We are issuing this AD to require actions to address the unsafe condition on these products.

DATES:

This AD is effective June 27, 2018.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of June 27, 2018.

We must receive comments on this AD by July 23, 2018.

ADDRESSES:

You may send comments by any of the following methods:

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

Fax: (202) 493-2251.

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

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

For service information identified in this AD, contact Aircraft Industries, a.s., 686 04 Kunovice 1177, Czech Republic; phone: +420 572 817 664; fax: +420 572 816 112; email: [email protected]; internet: http://www.let.cz/clanek_267_objednavka-bulletinove-sluzby.html. You may review copies of the referenced service information at the FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the internet at http://www.regulations.gov by searching for locating Docket No. FAA-2018-0462.

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-2018-0462; 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 regulatory 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 FURTHER INFORMATION CONTACT:

Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4059; fax: (816) 329-4090; email: [email protected].

SUPPLEMENTARY INFORMATION: Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued AD No. 2018-0057, dated March 14, 2018 (referred to after this as “the MCAI”), to correct an unsafe condition for Aircraft Industries a.s. Models L 410 UVP-E20 and L 410 UVP-E20 CARGO airplanes and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

The investigation results of an L 410 UVP-E20 accident identified that, during final approach, an un-commanded negative thrust mode was activated on the right-hand engine. Pending the investigation results of the accident, as a preliminary measure, EASA issued SIB 2017-21, recommending operators to check the components of engine and propeller control system, including the beta switch, in accordance with the instructions of Revision 1 of AI SB L410UVP-E/492b.

This condition, if not corrected, could lead to reduced or loss of control of an aeroplane.

To address this unsafe condition, AI issued the MB, providing modification instructions, and issued the DB, amending the Aircraft Flight Manual (AFM), providing instructions for the flight crew in case of inadvertent beta range cell activation in flight and introducing instructions for the flight crew to check the function of pitch lock system before each flight.

For the reasons described above, this [EASA] AD requires modification of the electrical testing circuit of the propeller pitch lock system and amendment of the applicable AFM.

EASA SIB 2017-21 has been withdrawn accordingly. You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0462.

Related Service Information Under 1 CFR Part 51

Aircraft Industries a.s. has issued LET Aircraft Industries Mandatory Bulletin MB No. L410UVP-E/143a, Revision 2, dated March 7, 2018; and LET Aircraft Industries Documentation Bulletin DB No. L410UVP-E/268d, dated May 9, 2018. Mandatory Bulletin MB No. L410UVP-E/143a describes procedures for modifying the electrical circuit of the propeller pitch lock system function test. Documentation Bulletin DB No. L410UVP-E/268d provides instructions for flight crew in case of inadvertent beta range cell activation in flight and instructions for a pre-flight check of the function of the pitch lock system. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of the AD

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

FAA's Determination of the Effective Date

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because there are no airplanes currently on the U.S. registry and thus, does not have any impact upon the public. Therefore, we find good cause that notice and opportunity for prior public comment are unnecessary. In addition, for the reason(s) stated above, we find that good cause exists for making this amendment effective in less than 30 days.

Difference Between the MCAI and This AD

The MCAI requires the AFM changes in accordance with DB No.: L410UVP-E/247d and DB No.: L410UVP-E/259d, both dated March 3, 2018. These documents only apply to airplanes operated under the European type certificate and do not apply to those airplanes operating under the FAA type certificate. Therefore, Aircraft Industries a.s. developed DB No.: L410UVP-E/268d, dated May 9, 2018, and this AD requires the AFM changes in accordance with this document.

Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0462; Product Identifier 2018-CE-017-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

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

Costs of Compliance

We estimate that this AD will affect 0 products of U.S. registry. We also estimate that it would take about 9 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $2,000 per product.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $0 fleet cost, but $2,765 per product if a product is registered on the U.S. registry.

According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

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.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes, gliders, balloons, airships, domestic business jet transport airplanes, and associated appliances to the Director of the Policy and Innovation Division.

Regulatory Findings

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

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

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

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

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

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new AD: 2018-11-04 Aircraft Industries a.s.: Amendment 39-19292; Docket No. FAA-2018-0462; Product Identifier 2018-CE-017-AD. (a) Effective Date

This airworthiness directive (AD) becomes effective June 27, 2018.

(b) Affected ADs

None.

(c) Applicability

This AD applies to the following Aircraft Industries a.s. Models L 410 UVP-E20 and L 410 UVP-E20 CARGO airplanes, manufacturer serial numbers 2904 through 3114, that are:

(1) Equipped with GE Aviation H80-200 engines and Avia Propeller AV 725 propellers; and

(2) certificated in any category.

(d) Subject

Air Transport Association of America (ATA) Code 61: Propellers/Propulsors.

(e) Reason

This AD was prompted by mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as un-commanded negative thrust mode activated on an engine. We are issuing this AD to provide guidance to the flight crew in the event of un-commanded negative thrust mode activated on an engine, which could lead to loss of control.

(f) Actions and Compliance

Unless already done, do the following actions.

(1) Within the next 25 hours time-in-service (TIS) after the effective date of this AD or within the next 30 days after the effective date of this, whichever occurs first, modify the electrical testing circuit of the propeller pitch lock system following the Instructions for Implementation in LET Aircraft Industries Mandatory Bulletin MB No. L410UVP-E/143a, Revision 2, dated March 7, 2018.

(2) Within the next 25 hours TIS after the effective date of this AD or within the next 30 days after the effective date of this, whichever occurs first, incorporate airplane flight manual (AFM) changes following the Measures specified in LET Aircraft Industries Documentation Bulletin DB No. L410UVP-E/268d, dated May 9, 2018. After incorporating the AFM changes, operate the airplane accordingly.

(3) If any discrepancies are found during any pitch lock system pre-flight check required in the AFM changes specified in paragraph (f)(2) of this AD, before further flight, contact the manufacturer for FAA-approved repair instructions approved specifically for this AD. You may use the contact information found in paragraph (i)(3) of this AD.

(g) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, Small Airplane Standards Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4059; fax: (816) 329-4090; email: [email protected] Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.

(2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, Small Airplane Standards Branch, FAA; or the European Aviation Safety Agency (EASA).

(h) Related Information

Refer to MCAI EASA AD No. 2018-0057, dated March 14, 2018, for related information. You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0462.

(i) Material Incorporated by Reference

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

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

(i) LET Aircraft Industries Mandatory Bulletin MB No. L410UVP-E/143a, Revision 2, dated March 7, 2018.

(ii) LET Aircraft Industries Documentation Bulletin DB No. L410UVP-E/268d, dated May 9, 2018.

(3) For service information identified in this AD, contact Aircraft Industries, a.s., 686 04 Kunovice 1177, Czech Republic; phone: +420 572 817 664; fax: +420 572 816 112; email: [email protected]; internet: http://www.let.cz/clanek_267_objednavka-bulletinove-sluzby.html.

(4) You may view this service information at FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the internet at http://www.regulations.gov by searching for locating Docket No. FAA-2018-0462.

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

Issued in Kansas City, Missouri, on May 11, 2018. Melvin J. Johnson, Aircraft Certification Service, Deputy Director, Policy and Innovation Division, AIR-601.
[FR Doc. 2018-11930 Filed 6-6-18; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-1175; Product Identifier 2017-NM-087-AD; Amendment 39-19300; AD 2018-11-12] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc., Airplanes AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for all Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. This AD was prompted by a report that Belleville washers installed on the shimmy damper of the main landing gear (MLG) may fail due to fatigue. This AD requires revising the maintenance or inspection program, as applicable, to incorporate a repetitive task specified in the maintenance review board (MRB) report. We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD is effective July 12, 2018.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of July 12, 2018.

ADDRESSES:

For service information identified in this final rule, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email [email protected]; internet http://www.bombardier.com. You may view this referenced service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1175.

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-2017-1175; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Cesar Gomez, Aerospace Engineer, Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7318; fax 516-794-5531.

SUPPLEMENTARY INFORMATION: Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The NPRM published in the Federal Register on January 2, 2018 (83 FR 83) (“the NPRM”).

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2017-14, dated April 21, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The MCAI states:

It has been found that Belleville washers installed on the Main Landing Gear (MLG) Shimmy Damper may fail in fatigue. A failed washer segment migrating into the piston cavity may interfere with piston travel. As a result, shimmy damper performance would be compromised, MLG shimmy could occur and potentially lead to a MLG failure.

As a result of this investigation, a restoration task has been added for Belleville washers' replacement at 20,000 flight cycles, during MLG overhaul. For aeroplanes that have passed the 20,000 flight cycle threshold, a phase-in period is defined.

This [Canadian] AD is issued to mandate the Maintenance Review Board (MRB) revised task for the affected aeroplanes models.

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1175. Comments

We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the NPRM and the FAA's response to that comment.

Request to the Contact Manufacturer for Service Information

Bombardier stated that task number 320100-229, Restoration (Belleville Washer Replacement) of the MLG Shimmy Damper, of the MRB Report of the Bombardier CRJ700/900/1000 Maintenance Requirements Manual (MRM)—Part 1, Volume 1, CSP B-053, Revision 17, dated June 25, 2017, is currently specified in paragraph (g) of the proposed AD. Bombardier commented that it is planning to issue Revision 18 of the service information by June 25, 2018. Bombardier stated to contact Bombardier for the latest service information should the AD be published after June 25, 2018.

We expect to issue this AD prior to the anticipated date of release of new service information, and we do not agree to delay issuance of this AD until new service information is released. However, if new service information is released after this AD is issued, operators may request approval of an alternative method of compliance (AMOC) under the provisions of paragraph (j)(1) of this AD. We have not changed this AD regarding this issue.

Conclusion

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

Bombardier has issued MRB report task number 320100-229, Restoration (Belleville Washer Replacement) of the MLG Shimmy Damper, of the MRB Report of the Bombardier CRJ700/900/1000 Maintenance Requirements Manual (MRM)—Part 1, Volume 1, CSP B-053, Revision 17, dated June 25, 2017. This service information describes the restoration (Belleville Washer Replacement) of the MLG shimmy damper. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

We estimate that this AD affects 544 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We have determined that revising the maintenance or inspection program takes an average of 90 work-hours per operator, although we recognize that this number may vary from operator to operator. In the past, we have estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), we have determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, we estimate the total cost per operator to be $7,650 (90 work-hours x $85 per work-hour).

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.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

Regulatory Findings

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

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

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

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

3. Will not affect intrastate aviation in Alaska, and

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2018-11-12 Bombardier, Inc., Airplanes: Amendment 39-19300; Docket No. FAA-2017-1175; Product Identifier 2017-NM-087-AD. (a) Effective Date

This AD is effective July 12, 2018.

(b) Affected ADs

None.

(c) Applicability

This AD applies to all Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes, certificated in any category.

(d) Subject

Air Transport Association (ATA) of America Code 32, Landing gear.

(e) Reason

This AD was prompted by a report indicating that Belleville washers installed on the shimmy damper of the main landing gear (MLG) may fail due to fatigue. We are issuing this AD to prevent a failed washer segment migrating into the piston cavity and interfering with piston travel. As a result, the shimmy damper performance could be compromised, and an MLG shimmy could occur, potentially leading to an MLG failure and affecting the airplane's safe flight and landing.

(f) Compliance

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

(g) Maintenance or Inspection Program Revision

Within 30 days after the effective date of this AD, revise the airplane maintenance or inspection program, as applicable, by incorporating maintenance review board (MRB) report task number 320100-229, Restoration (Belleville Washer Replacement) of the MLG Shimmy Damper, of the MRB Report of the Bombardier CRJ700/900/1000 Maintenance Requirements Manual (MRM)—Part 1, Volume 1, CSP B-053, Revision 17, dated June 25, 2017. The initial compliance time for MRB report task number 320100-229 is specified in paragraphs (g)(1) and (g)(2) of this AD, as applicable.

(1) For any shimmy damper with 20,000 total accumulated flight cycles or fewer as of the effective date of this AD, the initial compliance time is before the accumulation of 26,000 total flight cycles.

(2) For any shimmy damper with 20,000 total accumulated flight cycles or more as of the effective date of this AD, the initial compliance time is specified in paragraph (g)(2)(i) or (g)(2)(ii), whichever occurs later.

(i) Within 6,000 flight cycles after the effective date of this AD, but prior to the accumulation of 30,000 total flight cycles.

(ii) Within 30 days after effective date of this AD.

(h) Credit for Previous Actions

This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Bombardier Temporary Revision MRB-0070, dated October 20, 2015.

(i) No Alternative Actions and/or Intervals

After the airplane maintenance or inspection program has been revised, as required by paragraph (g) of this AD, no alternative actions (e.g., inspections) and/or intervals may be used unless the actions and/or intervals are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (j)(1) of this AD.

(j) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, New York ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; fax 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

(2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO Branch, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier Inc.'s TCCA Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.

(k) Related Information

(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2017-14, dated April 21, 2017, for related information. This MCAI may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1175.

(2) For more information about this AD, contact Cesar Gomez, Aerospace Engineer, Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7318; fax 516-794-5531.

(3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (l)(3) and (l)(4) of this AD.

(l) Material Incorporated by Reference

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

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

(i) Maintenance review board (MRB) report task number 320100-229, Restoration (Belleville Washer Replacement) of the MLG Shimmy Damper, of the MRB Report of the Bombardier CRJ700/900/1000 Maintenance Requirements Manual (MRM)—Part 1, Volume 1, CSP B-053, Revision 17, dated June 25, 2017.

(ii) Reserved.

(3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email [email protected]; internet http://www.bombardier.com.

(4) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

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

Issued in Des Moines, Washington, on May 21, 2018. James Cashdollar, Acting Director, System Oversight Division, Aircraft Certification Service.
[FR Doc. 2018-11827 Filed 6-6-18; 8:45 am] BILLING CODE 4910-13-P
DELAWARE RIVER BASIN COMMISSION 18 CFR Parts 401 and 420 Regulatory Program Fees and Water Charges Rates AGENCY:

Delaware River Basin Commission.

ACTION:

Final rule.

SUMMARY:

Notice is provided of the Commission's regulatory program fees and schedule of water charges for the fiscal year beginning July 1, 2018.

DATES:

This final rule is effective July 1, 2018.

FOR FURTHER INFORMATION CONTACT:

Elba L. Deck, CPA, Director of Administration and Finance, 609-883-9500, ext. 201.

SUPPLEMENTARY INFORMATION:

The Delaware River Basin Commission (“DRBC” or “Commission”) is a Federal-interstate compact agency charged with managing the water resources of the Delaware River Basin on a regional basis without regard to political boundaries. Its members are the governors of the four basin states—Delaware, New Jersey, New York and Pennsylvania—and on behalf of the federal government, the North Atlantic Division Commander of the U.S. Army Corps of Engineers.

In accordance with 18 CFR 401.43(c), on July 1 of every year beginning July 1, 2017, the Commission's regulatory program fees as set forth in Tables 1, 2 and 3 of that section are subject to an annual adjustment, commensurate with any increase in the annual April 12-month Consumer Price Index (CPI) for Philadelphia published by the U.S. Bureau of Labor Statistics during that year. Pursuant to 18 CFR 420.43(c), the same indexed adjustment applies to the Commission's schedule of water charges for consumptive and non-consumptive withdrawals of surface water within the basin. The referenced April 12-month CPI for 2018 showed an increase of 1.38%. Commensurate adjustments are thus required.

This notification is made in accordance with 18 CFR 401.42(c) and 18 CFR 420.42(c), which provide that a revised fee schedule will be published in the Federal Register by July 1. The revised fees also may be obtained by contacting the Commission during business hours or by checking the Commission's website.

List of Subjects 18 CFR Part 401

Administrative practice and procedure, Project review, Water pollution control, Water resources.

18 CFR Part 420

Water supply.

For the reasons set forth in the preamble, the Delaware River Basin Commission amends parts 401 and 420 of title 18 of the Code of Federal Regulations as set forth below:

PART 401—RULES OF PRACTICE AND PROCEDURE 1. The authority citation for part 401 continues to read as follows: Authority:

Delaware River Basin Compact (75 Stat. 688), unless otherwise noted.

Subpart C—Project Review Under Section 3.8 of the Compact 2. In § 401.43, revise Tables 1, 2 and 3 to read as follows:
§ 401.43 Regulatory program fees. Table 1 To § 401.43—Docket Application Filing Fee Project type Docket application fee Fee maximum Water Allocation $411 per million gallons/month of allocation 1, not to exceed $15,401 1.
  • Fee is doubled for any portion to be exported from the basin.
  • Greater of: $15,401 1 or Alternative Review Fee.
    Wastewater Discharge Private projects: $1,027 1
  • Public projects: $513 1
  • Alternative Review Fee.
    Other 0.4% of project cost up to $10,000,000 plus 0.12% of project cost above $10,000,000 (if applicable), not to exceed $77,003 1 Greater of: $77,003 1 or Alternative Review Fee. 1 Subject to annual adjustment in accordance with paragraph (c) of this section.
    Table 2 to § 401.43—Annual Monitoring and Coordination Fee Annual fee Allocation Water Allocation 1 $308 <4.99 mgm. 1 $462 5.00 to 49.99 mgm. 1 $667 50.00 to 499.99 mgm. 1 $847 500.00 to 9,999.99 mgm. 1 $1,027 > or = to 10,000 mgm. Annual fee Discharge design capacity Wastewater Discharge 1 $308 <0.05 mgd. 1 $626 0.05 to 1 mgd. 1 $842 1 to 10 mgd. 1 $1,027 >10 mgd. 1 Subject to annual adjustment in accordance with paragraph (c) of this section. Table 3 to § 401.43—Additional Fees Proposed action Fee Fee maximum Emergency Approval Under 18 CFR 401.40 $5,000 Alternative Review Fee. Late Filed Renewal Surcharge $2,000. Modification of a DRBC Approval At Executive Director's discretion, Docket Application Fee for the appropriate project type Alternative Review Fee. Name change $1,027 1. Change of Ownership $1,540 1 1 Subject to annual adjustment in accordance with paragraph (c) of this section.
    PART 420—BASIN REGULATIONS—WATER SUPPLY CHARGES 3. The authority citation for part 420 continues to read as follows: Authority:

    Delaware River Basin Compact, 75 Stat. 688.

    4. In § 420.41, revise paragraphs (a) and (b) to read as follows:
    § 420.41 Schedule of water charges.

    (a) $82.14 per million gallons for consumptive use, subject to paragraph (c) of this section; and

    (b) $0.82 per million gallons for non-consumptive use, subject to paragraph (c) of this section.

    Dated: June 1, 2018. Pamela M. Bush, Commission Secretary.
    [FR Doc. 2018-12258 Filed 6-6-18; 8:45 am] BILLING CODE 6360-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 74 [Docket No. FDA-2017-C-0935] Listing of Color Additives Subject to Certification; D&C Black No. 4 AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non-absorbable sutures for use in general surgery. This action is in response to a color additive petition (CAP) submitted by DSM Biomedical.

    DATES:

    This rule is effective July 10, 2018. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by July 9, 2018.

    ADDRESSES:

    You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. Electronic objections must be submitted on or before July 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 9, 2018. Objections 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 objections in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection 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 objection, that information will be posted on https://www.regulations.gov.

    • If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection 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 objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2017-C-0935 for “Listing of Color Additives Subject to Certification; D&C Black No. 4.” Received objections, 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 an objection with confidential information that you do not wish to be made publicly available, submit your objections 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.” We will review this copy, including the claimed confidential information, in our 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:

    Joseph M. Thomas, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 301-796-9465.

    SUPPLEMENTARY INFORMATION: I. Introduction

    In the Federal Register on March 6, 2017 (82 FR 12531), we announced that we filed a color additive petition (CAP 7C0310) submitted by DSM Biomedical (petitioner), 735 Pennsylvania Dr., Exton, PA 19341. The petition proposed to amend the color additive regulations in part 73 (21 CFR part 73), Listing of Color Additives Exempt from Certification, to provide for the safe use of high-purity carbon black for coloring UHMWPE non-absorbable sutures for use in general surgery.1 After the petition was filed and during our review, we determined that the color additive will require batch certification by FDA. We intend to give each certified batch of the subject color additive the name D&C Black No. 4. Therefore, this color additive will be identified as D&C Black No. 4 and will be listed in part 74 (21 CFR part 74), Listing of Color Additives Subject to Certification.

    1 The original petition did not specify that the color additive is to be used in sutures that are non-absorbable. Therefore, our March 6, 2017, notice of filing did not specify that the color additive is intended for use in non-absorbable sutures. However, petitioner's subsequent submissions to FDA indicated that the intended use of the additive is for sutures that are non-absorbable.

    II. Identity and Specifications

    D&C Black No. 4 is a high-purity carbon black prepared by the oil furnace process. It is manufactured by injecting a heated aromatic petroleum feedstock into the combustion zone of a natural gas-fired furnace to produce carbon black. The reaction is quenched with water and the carbon particles are further cooled and separated by a filter. The recovered high-purity carbon black is dried and pelletized to produce the final D&C Black No. 4 commercial product, consisting of aggregated particles with a surface area ranging from 50 to 260 meters squared per gram (m2/g). D&C Black No. 4 is mechanically mixed at a maximum level of 1 percent by weight with the UHMWPE suture raw materials to form a homogenous suspension, absent of chemical reaction between components, and extruded to form black colored sutures.

    As explained in section III, the color additive D&C Black No. 4 may contain low levels of potentially carcinogenic polycyclic aromatic hydrocarbon (PAH) contaminants. To limit the amounts of these contaminants in the color additive, FDA is setting specifications for total PAHs, as well as for the individual PAH species benzo[a]pyrene (B[a]P) and dibenz[a,h]anthracene. These specifications are consistent with specifications for other high-purity carbon blacks approved by FDA, including the color additive D&C Black No. 2 (§ 74.2052 (21 CFR 74.2052)), which is approved for use in certain cosmetics, including cosmetics for use in the area of the eye (i.e., eyeliner, brush-on-brow, eye shadow, mascara), and high-purity furnace black, which is approved for use in food-contact polymers (§ 178.3297 (21 CFR 178.3297)). These specifications are also supported by the safety information reviewed as a part of this petition (see section III). In addition, to ensure compliance with these specifications, FDA is requiring that D&C Black No. 4 for use in UHMWPE non-absorbable sutures be from a batch of the color additive certified by FDA.

    The identity for D&C Black No. 4 is the same as D&C Black No. 2, except for the surface area. For D&C Black No. 2, we set specifications for arsenic, lead, and mercury, total color (as carbon), total sulfur, ash content, surface area, and weight loss on heating, in addition to the specifications for total PAHs, benzo[a]pyrene (B[a]P), and dibenz[a,h]anthracene. We are setting the same specifications that were established for D&C Black No. 2 for D&C Black No. 4 for these parameters with the exception of surface area specification, which is broader for D&C Black No. 4.

    III. Safety Evaluation A. Determination of Safety

    Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be listed for a particular use unless a fair evaluation of the data and information available to FDA establish that the color additive is safe under the intended conditions of use. Furthermore, under 21 CFR 70.5(c), a color additive intended for use in a surgical suture must have a listing specifically providing for this use. FDA's color additive regulations in 21 CFR 70.3(i) define “safe” to mean that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.

    Section 721(b)(5)(B)(ii) of the FD&C Act provides that for any use of a color additive that will not result in ingestion of any part of such additive, the color additive shall be deemed to be unsafe and shall not be listed if, after tests that are appropriate for the evaluation of the safety of additives for such use, or after other relevant exposure of man or animal to such additive, it is found to induce cancer in man or animal. Importantly, however, section 721(b)(5)(B) of the FD&C Act applies to the additive itself and not to impurities in the additive. That is, where an additive itself has not been shown to cause cancer, but contains a carcinogenic impurity, the additive is properly evaluated under the general safety standard using risk assessment procedures to determine whether there is a reasonable certainty that no harm will result from the intended use of the additive (Scott v. FDA, 728 F.2d 322 (6th Cir. 1984)).

    B. Safety of the Petitioned Use of D&C Black No. 4

    In evaluating the safety of a color additive, FDA customarily reviews the available data on each relevant chemical impurity to determine whether the chemical induces tumors in animals or humans. If FDA concludes that the chemical impurity causes cancer in animals or humans, the Agency calculates the unit cancer risk for the chemical and the upper bound limit of lifetime human cancer risk from the chemical's presence in the additive. To establish with reasonable certainty that D&C Black No. 4 intended to color UHMWPE non-absorbable sutures is not harmful under the intended conditions of use, we have considered the exposure to the color additive and its impurities, the additive's toxicological data, and other relevant information (such as published literature) available to us.

    The petitioner incorporated safety information that was previously submitted to FDA on behalf of Cabot Corp. in Food Additive Petition 5B4464 by reference to support the safety of high-purity furnace black as a colorant for polymers in food-contact applications. D&C Black No. 4 is manufactured in the same manner as the referenced high-purity furnace black.

    The petitioner also submitted data from an extraction study testing the migration of D&C Black No. 4 from UHMWPE sutures and provided data from two studies demonstrating biocompatibility of UHMWPE sutures along with other information. The petitioner's data from the extraction study indicated that D&C Black No. 4, when added to UHMWPE non-absorbable sutures at the maximum level of 1 percent, remains physically embedded in the suture matrix resulting in the color additive not being detected in the extracts at the limit of quantitation. This study evaluated the amount of non-volatile residue (NVR) and any extractables that could migrate from the suture. The study was performed with water, hexane, and ethanol at 50 °C for 24 hours and demonstrated that D&C Black No. 4 does not migrate from the suture following exposure to solvents with varying polarities and exposure to heat. The study also yielded NVRs not able to be analyzed. To estimate potential exposure from D&C Black No. 4, the petitioner used data from the extraction study and the conservative assumption that all of the NVR that was extracted and not able to be analyzed was D&C Black No. 4. The petitioner derived an estimate for the mass amount of D&C Black No. 4 expected to migrate over a lifetime, expressed as the mean daily exposure, based on its proposed use level in surgical sutures, and using data for the maximum NVR extracted and the surface area of the tested sutures.

    While FDA agrees with using the conservative assumption that all NVR extracted was D&C Black No. 4, the petitioner's exposure estimate represents the scenario where D&C Black No. 4 would migrate from the sutures 1 day post-implantation. However, since non-absorbable sutures are intended to be left in the body indefinitely post-implantation, it is necessary to average the petitioner's exposure estimate over an individual's lifetime post-implantation (assumed to be 70 years) to estimate the lifetime average exposure to D&C Black No. 4. In this manner, we estimated the lifetime average exposure to D&C Black No. 4 to be 15.3 nanograms per person per day (ng/p/d). However, as carbon black is known to be thermally stable, inert, and insoluble in water and common solvents, we agree with the petitioner's conclusion that D&C Black No. 4 is firmly embedded and does not migrate from the suture matrix, resulting in no potential exposure to D&C Black No. 4 from sutures that are in contact with the body (Ref. 1).

    As discussed in section II, D&C Black No. 4 has been shown to contain low levels of PAH impurities, some of which are carcinogenic. We have previously considered the safe use of high-purity carbon black as a color additive in cosmetics (D&C Black No. 2; § 74.2052) and as a colorant in food-contact polymers (high-purity furnace black; § 178.3297) and set limits for PAHs in these high-purity carbon blacks to minimize exposure. We are setting similar limits for PAHs in D&C Black No. 4 as those established for D&C Black No. 2: Total PAHs (not more than 0.5 milligrams per kilogram (mg/kg) (500 parts per billion)); B[a]P (not more than 0.005 mg/kg (5 parts per billion)); and dibenz[a,h]anthracene (not more than 0.005 mg/kg (5 parts per billion)).

    There were no detectable PAHs at the limit of quantitation resulting from the petitioner's extraction study. The petitioner stated that the trace levels of PAHs in the color additive, as limited by specifications, are strongly bound to the surface of D&C Black No. 4 carbon particles due to the powerful adsorption capabilities of the color additive. FDA concurs that any PAH impurities are not expected to migrate under the proposed specifications and conditions of use (Ref. 1). In calculating the lifetime average exposure to PAHs from the use of D&C Black No. 4 in sutures, we used the conservative assumption that total PAHs, B[a]P, and dibenz[a,h]anthracene are present in the color additive at their specification limits. These assumptions, along with the assumption that all NVR extracted from the sutures is D&C Black No. 4, calculated over a 70-year lifespan, results in a conservative estimated lifetime average exposure of total PAHs of 7.7 × 10 6 ng/p/d, B[a]P of 7.7 × 10 8 ng/p/d, and dibenz[a,h]anthracene of 7.7 × 10 8 ng/p/d (Ref. 1).

    Current data have shown B[a]P to be a high contributor to the total carcinogenic potential for the PAH family (Ref. 2). To assess the risk from exposure to PAHs, FDA has used a worst-case assumption that all PAHs are present in D&C Black No. 4 as B[a]P. We used data from a carcinogenesis bioassay on B[a]P, conducted by H. Brune, et al., to estimate the upper-bound limit of lifetime human risk from exposure to B[a]P equivalents resulting from the petitioned use of the color additive (Ref. 3). The authors reported treatment-related benign forestomach tumors or esophageal tumors in male rats exposed to B[a]P. Using a linear-at-low-dose extrapolation method and tumor incidence data from the H. Brune, et al. study, we estimated the unit cancer risk (UCR) for B[a]P to be 1.75 (milligrams per kilogram bodyweight per day (mg/kg bw/day)) 1 (Ref. 4). The UCR represents the derived cancer risk calculated per unit dose of the additive. This same UCR was used to assess the risk from exposure to PAHs for D&C Black No. 2 (69 FR 44927, July 28, 2004) and high-purity furnace black (Ref. 5). The lifetime cancer risk (LCR) was calculated by multiplying the UCR for B[a]P by the estimated lifetime average exposures. This results in LCRs of 2.24 × 10 15 and 2.24 × 10 13 for B[a]P and total PAHs, respectively. Because of the conservative assumptions we used to calculate the exposure estimate and the carcinogenic potency of PAHs in the color additive, and the fact that PAHs bind tightly to carbon black and are not expected to migrate, the lifetime-averaged individual exposure to PAHs is likely to be substantially less than our worst-case exposure estimate. Thus, the probable lifetime human risk would be less than the estimated LCR. Therefore, we conclude that there is reasonable certainty that no harm from exposure to PAHs will result from the petitioned use of the additive (Refs. 1 and 3).

    IV. Conclusion

    Based on the data and information in the petition and other available relevant material, FDA concludes that the petitioned use of D&C Black No. 4 for coloring UHMWPE non-absorbable sutures for use in general surgery is safe. We further conclude that the additive will achieve its intended technical effect and is suitable for the petitioned uses. Based on the available information, we are amending the color additive regulations in part 74 as set forth in this document. In addition, in accordance with 21 CFR 71.20(b), we conclude that batch certification of D&C Black No. 4 is necessary for the protection of public health because of the need to limit the levels of PAHs, some of which have been shown to be carcinogenic. Therefore, part 74 should be amended as set forth in this document.

    V. Public Disclosure

    In accordance with §  71.15 (21 CFR 71.15), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in §  71.15, we will delete from the documents any materials that are not available for public disclosure.

    VI. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as stated in the notice of petition published in the Federal Register of March 6, 2017. We stated that we had determined, under 21 CFR 25.32(l), that this action “is of a type that does not individually or cumulatively have a significant effect on the human environment” such that neither an environmental assessment nor an environmental impact statement is required. We have not received any new information or comments that would affect our previous determination.

    VII. Paperwork Reduction Act of 1995

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

    VIII. Objections

    This rule is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see ADDRESSES) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

    Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register.

    IX. References

    The following references are on display with the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References that are published articles and books are not on display.

    1. Memorandum from H. Lee, Division of Petition Review, Office of Food Additive Safety (OFAS), CFSAN, FDA to J. Thomas, Division of Petition Review, OFAS, CFSAN, FDA, dated April 27, 2018. 2. Choi H, R. Harrison, H. Komulainen, et al., “Polycyclic Aromatic Hydrocarbons.” WHO Guidelines for Indoor Air Quality: Selected Pollutants. Geneva: World Health Organization; 2010. 3. Brune H., R. P. Deutsch-Wenzel, M. Habs, et al., “Investigation of the Tumorigenic Response to Benzo(a)pyrene in Aqueous Caffeine Solution Applied Orally to Sprague-Dawley Rats,” Journal of Cancer Research and Clinical Oncology, 102(2):153-157, 1981. 4. Memorandum from N. Anyangwe, Division of Petition Review, OFAS, CFSAN, FDA to J. Thomas, Division of Petition Review, OFAS, CFSAN, FDA, dated April 27, 2018. 5. Memorandum from the Indirect Additives Branch, FDA, to the Executive Secretary, Quantitative Risk Assessment Committee, FDA, concerning “Estimation of the Upper-bound Lifetime Risk from Polynuclear Aromatic Hydrocarbons (PAH's) in High-Purity Furnace Black (HPFB): subject of Food Additive Petition No. 5B4464 (Cabot Corp.),” dated May 9, 1996. List of Subjects in 21 CFR Part 74

    Color additives, Cosmetics, Drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 74 is amended as follows:

    PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION 1. The authority citation for part 74 continues to read as follows: Authority:

    21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

    2. Section 74.3054 is added to subpart D to read as follows:
    § 74.3054 D&C Black No. 4.

    (a) Identity. The color additive D&C Black No. 4 is a high-purity carbon black prepared by the oil furnace process. It is manufactured by the combustion of aromatic petroleum oil feedstock and consists essentially of pure carbon, formed as aggregated fine particles with a surface area range of 50 to 260 meters (m)2/gram.

    (b) Specifications. D&C Black No. 4 must conform to the following specifications and must be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:

    (1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 50 to 260 m2/gram.

    (2) Weight loss on heating at 950 °C for 7 minutes (predried for 1 hour at 125 °C), not more than 2 percent.

    (3) Ash content, not more than 0.15 percent.

    (4) Arsenic (total), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million).

    (5) Lead (total), not more than 10 mg/kg (10 parts per million).

    (6) Mercury (total), not more than 1 mg/kg (1 part per million).

    (7) Total sulfur, not more than 0.65 percent.

    (8) Total polycyclic aromatic hydrocarbons (PAHs), not more than 0.5 mg/kg (500 parts per billion).

    (9) Benzo[a]pyrene, not more than 0.005 mg/kg (5 parts per billion).

    (10) Dibenz[a,h]anthracene, not more than 0.005 mg/kg (5 parts per billion).

    (11) Total color (as carbon), not less than 95 percent.

    (c) Uses and restrictions. (1) D&C Black No. 4 may be safely used at a level not to exceed 1.0 percent by weight of the suture material for coloring ultra-high molecular weight polyethylene non-absorbable sutures for general surgical use.

    (2) Authorization and compliance with this use must not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the ultra-high molecular weight polyethylene surgical sutures in which D&C Black No. 4 is used.

    (d) Labeling. The label of the color additive must conform to the requirements of § 70.25 of this chapter.

    (e) Certification. All batches of D&C Black No. 4 must be certified in accordance with regulations in part 80 of this chapter.

    Dated: June 1, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-12218 Filed 6-6-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Parts 1, 8, 16, and 40 [Docket No. FR-6102-F-01] RIN 2501-AD88 Removal of Cross References to Previously Removed Appendices and Subpart AGENCY:

    Office of General Counsel, HUD.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule corrects HUD's regulations by removing cross references to appendices and a subpart that were removed by earlier rulemakings. In 1995, HUD removed several appendices throughout HUD's regulations deemed unnecessary or obsolete. In 1996, HUD consolidated its hearing procedures for nondiscrimination and equal opportunity matters in a new CFR part and removed the subpart of another. Cross-references to the removed appendices and subpart were not removed, however. This final rule corrects HUD's regulations by removing cross references to these nonexistent appendices and subpart.

    DATES:

    Effective July 9, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Ariel Pereira, Associate General Counsel, Office of Legislation and Regulations, Department of Housing and Urban Development, 451 7th Street SW, Room 10282, Washington, DC 20410; telephone number 202-402-5138 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).

    SUPPLEMENTARY INFORMATION: I. Background

    On September 11, 1995 (60 FR 47260), HUD published a final rule entitled, “Elimination of Obsolete Parts” which removed from 24 CFR several appendices deemed obsolete and unnecessary. HUD undertook the regulation consistent with the “Regulatory Reinvention Initiative,” which required federal agencies to eliminate outdated regulations and modify others to reduce regulatory burden. Among the provisions removed were appendix A in 24 CFR part 1, appendices A and B in 24 CFR part 8, appendix A in 24 CFR part 16, and appendix A in 24 CFR part 40.

    On October 4, 1996 (61 FR 52216), HUD published a final rule entitled, “Consolidated HUD Hearing Procedures for Civil Rights Matters,” which revised HUD's regulations by removing descriptions of nondiscrimination and equal opportunity hearing procedures from individual sections and consolidating those descriptions in a new part, 24 CFR part 180. As part of the 1996 final rule, HUD removed subpart E of 24 CFR part 8.

    HUD has determined that while these 1995 and 1996 rules removed the above-mentioned appendices and subpart, cross references to these nonexistent appendices and subpart remain in title 24.

    II. This Final Rule

    This final rule removes cross references in title 24 to the nonexistent appendices and subpart. In 24 CFR part 16, however, removing the references to the nonexistent appendices requires that HUD revise § 16.3 to keep the meaning of the regulation the same. The deleted appendix in 24 CFR part 16 contained the address for Privacy Act inquiries, and this rule replaces the reference to the removed appendix with the current contact address for HUD's Privacy Act Officer. In removing 24 CFR part 40, appendix A, HUD decided to no longer provide a copy of the Uniform Federal Accessibility Standards text in its regulation, given that the information is publicly available and HUD's appendix would be outdated every time the United States Access Board updated the standards. HUD is not providing an updated cross-reference in 24 CFR part 40 but notes in this final rule that the public may access the most current Uniform Federal Accessibility Standards by visiting the website for the United States Access Board at www.access-board.gov.

    III. Justification for Final Rulemaking

    HUD generally publishes a rule for public comment before issuing a rule for effect, in accordance with its own regulations on rulemaking at 24 CFR part 10. Part 10 provides for exceptions to the general rule if the agency finds good cause to omit advance notice and public participation. The good cause requirement is satisfied when prior public procedure is “impracticable, unnecessary, or contrary to the public interest” (24 CFR 10.1; see also 5 U.S.C. 553(b)). HUD finds that public notice and comment are unnecessary for this rulemaking because this rule removes cross references to appendices and to a subpart which have already been removed by previous rulemaking, and, as such, this rule does not establish or affect substantive policy. This rule corrects HUD's regulations and eliminates confusion resulting from having cross references to appendices and to a subpart that no longer exist. For these reasons, HUD has determined that it is unnecessary to delay the effectiveness of this rule to solicit prior public comment.

    IV. Findings and Certification Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Because HUD has determined that good cause exists to issue this rule without prior public comment, this rule is not subject to the requirement to publish an initial or final regulatory flexibility analysis under the RFA as part of such action.

    Unfunded Mandates Reform

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 1 requires that an agency prepare a budgetary impact statement before promulgating a rule that includes a Federal mandate 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 in any one year. If a budgetary impact statement is required, section 205 of UMRA also requires an agency to identity and consider a reasonable number of regulatory alternatives before promulgating a rule.2 However, the UMRA applies only to rules for which an agency publishes a general notice of proposed rulemaking. As discussed above, HUD has determined, for good cause, that prior notice and public comment is not required on this rule and, therefore, the UMRA does not apply to this final rule.

    1 2 U.S.C. 1532.

    2 2 U.S.C. 1534.

    Executive Order 13132, Federalism

    Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments and is not required by statute, or the rule preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. This rule will not have federalism implications and would not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.

    Environmental Review

    This final rule does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise or provide for standards for construction or construction materials, manufactured housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this final rule is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).

    List of Subjects 24 CFR Part 1

    Administrative practice and procedure, Civil rights, Reporting and recordkeeping requirements.

    24 CFR Part 8

    Administrative practice and procedure, Civil rights, Equal employment opportunity, Grant programs—housing and community development, Individuals with disabilities, Loan programs—housing and community development, Reporting and recordkeeping requirements.

    24 CFR Part 16

    Privacy.

    24 CFR Part 40

    Individuals with disabilities, Public housing, Reporting and recordkeeping requirements.

    Accordingly, for the reasons discussed in this preamble, HUD amends 24 CFR parts 1, 8, 16, and 40 as follows:

    PART 1—NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OF THE DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT—EFFECTUATION OF TITLE VI OF THE CIVIL RIGHTS ACT OF 1964 1. The authority citation for part 1 continues to read as follows: Authority:

    42 U.S.C. 2000d-1 and 3535(d).

    § 1.3 [Amended]
    2. Amend § 1.3 by removing “, including any program or activity assisted under the statutes listed in appendix A of this part 1” from the first sentence and by removing the last two sentences of the section. PART 8—NONDISCRIMINATION BASED ON HANDICAP IN FEDERALLY ASSISTED PROGRAMS AND ACTIVITIES OF THE DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 3. The authority citation for part 8 continues to read as follows: Authority:

    29 U.S.C. 794; 42 U.S.C. 3535(d) and 5309.

    § 8.1 [Amended]
    4. In § 8.1, amend paragraph (b) by removing the reference “subparts D and E” and adding in its place “subpart D”.
    § 8.2 [Amended]
    5. Amend § 8.2 by removing the last sentence of the section.
    § 8.4 [Amended]
    6. In § 8.4, amend paragraph (c)(2) by removing the parenthetical “(see appendix B)”. PART 16—IMPLEMENTATION OF THE PRIVACY ACT OF 1974 7. The authority citation for part 16 continues to read as follows: Authority:

    5 U.S.C. 552(a); 42 U.S.C. 3535(d).

    § 16.2 [Amended]
    8. In § 16.2, amend paragraph (b)(2) by removing the phrase “, identified in Appendix A to this part,”.
    § 16.3 [Amended]
    9. In § 16.3, amend paragraph (a) by removing the phrase “first address listed in Appendix A to this part” and adding in its place “following address: Privacy Act Officer, Department of Housing and Urban Development, 451 7th St. SW, Room 10139, Washington, DC 20410”.
    § 16.4 [Amended]
    10. In § 16.4, amend paragraph (a) by removing the phrase “identified in Appendix A to this part”. PART 40—ACCESSIBILITY STANDARDS FOR DESIGN, CONSTRUCTION, AND ALTERATION OF PUBLICLY OWNED RESIDENTIAL STRUCTURES 11. The authority citation for part 40 continues to read as follows: Authority:

    42 U.S.C. 3535(d), 4153.

    § 40.2 [Amended]
    12. In § 40.2, amend paragraph (b)(3) by removing “contained in appendix A to this part”.
    § 40.4 [Amended]
    13. Amend § 40.4 by removing “the specifications contained in appendix A to this part,”. Dated: May 30, 2018. J. Paul Compton, Jr., General Counsel.
    [FR Doc. 2018-12274 Filed 6-6-18; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF DEFENSE Department of the Air Force 32 CFR Part 806 [Docket ID: USAF-2017-HQ-0001] RIN 0701-AA76 Air Force Freedom of Information Act Program AGENCY:

    Department of the Air Force, DoD.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule removes the Department of the Air Force's regulation concerning the Freedom of Information Act program. On February 6, 2018, the DoD published a revised FOIA program rule as a result of the FOIA Improvement Act of 2016. When the DoD FOIA program rule was revised, it included DoD component information and removed the requirement for component supplementary rules. The DoD now has one DoD-level rule for the FOIA program at 32 CFR part 286 that contains all the codified information required for the Department. Therefore, this part can be removed from the CFR.

    DATES:

    This rule is effective on June 7, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Bao-Anh Trinh at 703-614-8500.

    SUPPLEMENTARY INFORMATION:

    It has been determined that publication of this CFR part removal for public comment is impracticable, unnecessary, and contrary to public interest since it is based on removing the Air Force's internal policies and procedures that are publically available on the Air Force's website.

    The Department of the Air Force's internal guidance concerning the implementation of the FOIA within the Department of the Air Force will continue to be published in Air Force Manual 33-302 (available at http://static.e-publishing.af.mil/production/1/saf_cio_a6/publication/dodm5400.07_afman33-302/dodm5400.07_afman33-302.pdf).

    This rule is one of 14 separate DoD FOIA rules. With the finalization of the DoD-level FOIA rule at 32 CFR part 286, the Department is eliminating the need for this separate FOIA rule and reducing costs to the public as explained in the preamble of the DoD-level FOIA rule published at 83 FR 5196-5197.

    This rule is not significant under Executive Order (E.O.) 12866, “Regulatory Planning and Review,” therefore, E.O. 13771, “Reducing Regulation and Controlling Regulatory Costs” does not apply.

    List of Subjects in 32 CFR Part 806

    Freedom of information.

    PART 806—[REMOVED] Accordingly, by the authority of 5 U.S.C. 301, 32 CFR part 806 is removed. Bao-Anh Trinh, Air Force Federal Register Liaison Officer.
    [FR Doc. 2018-12237 Filed 6-6-18; 8:45 am] BILLING CODE 5001-10-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2018-0088] RIN 1625-AA08 Special Local Regulation; Tred Avon River, Between Bellevue, MD and Oxford, MD AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing special local regulations for certain waters of the Tred Avon River. This action is necessary to provide for the safety of life on these navigable waters located between Bellevue, MD, and Oxford, MD, during a swim event on June 9, 2018. If necessary, due to inclement weather, the event will be rescheduled to June 10, 2018. This action will prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Maryland—National Capital Region or Coast Guard Patrol Commander.

    DATES:

    This rule is effective from 8:30 a.m. on June 9, 2018 through 11 a.m. on June 10, 2018.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0088 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email Mr. Ronald Houck, U.S. Coast Guard Sector Maryland—National Capital Region; telephone 410-576-2674, email [email protected].

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

    On June 13, 2017, Charcot-Marie-Tooth Association of Trappe, MD, notified the Coast Guard that from 9:15 a.m. until 10:15 a.m. on June 9, 2018, and if necessary, due to inclement weather, from 9:15 a.m. until 10:15 a.m. on June 10, 2018, it will be conducting the swim portion of the Oxford Biathlon in the Tred Avon River that starts at Bellevue, MD and finishes at Oxford, MD. In response, on April 4, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) entitled “Special Local Regulation; Tred Avon River, between Bellevue, MD and Oxford, MD” (83 FR 14381). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended May 4, 2018, we received one comment.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Due to the date of the event, it would be impracticable and contrary to the public interest to make the regulation effective 30 days after publication in the Federal Register. The regulation must be in place by June 9th in order to protect the public from the hazards associated with this swim event.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233, which authorizes the Coast Guard to establish and define special local regulations. The Captain of the Port (COTP) Maryland—National Capital Region has determined that potential hazards associated with the swim would be a safety concern for anyone intending to operate within certain waters of the Tred Avon River between Bellevue, MD, and Oxford, MD. The purpose of this rulemaking is to protect event participants, spectators and transiting vessels on specified waters of the Tred Avon River before, during, and after the scheduled event.

    IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received one comment on our NPRM published April 4, 2018. The comment addressed issues not related to this rulemaking. Therefore, there are no substantive changes in the regulatory text of this rule from the proposed rule in the NPRM.

    This rule establishes a special local regulation to be enforced from 8:30 a.m. until 11 a.m. on June 9, 2018, and if necessary, due to inclement weather, from 8:30 a.m. until 11 a.m. on June 10, 2018. The regulated area covers all navigable waters of the Tred Avon River, from shoreline to shoreline, within an area bounded on the east by a line drawn from latitude 38°42′25″ N, longitude 076°10′45″ W, thence south to latitude 38°41′37″ N, longitude 076°10′26″ W, and bounded on the west by a line drawn from latitude 38°41′58″ N, longitude 076°11′04″ W, thence south to latitude 38°41′25″ N, longitude 076°10′49″ W, thence east to latitude 38°41′25″ N, longitude 076°10′30″ W, located at Oxford, MD. The enforcement and duration of the regulated area is intended to ensure the safety of event participants and vessels within the specified navigable waters before, during, and after the 9:15 a.m. to 10:15 a.m. swim. Except for Oxford Biathlon participants, no vessel or person will be permitted to enter the regulated area without obtaining permission from the COTP Maryland—National Capital Region or Coast Guard Patrol Commander.

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

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

    This regulatory action determination is based on the size and duration of the regulated area, which would impact a small designated area of the Tred Avon River for 21/2 hours. The Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the status of the regulated area. Moreover, the rule will allow vessels to request permission to enter the regulated area, and vessel traffic will be able to safely transit the regulated area once the Coast Guard Patrol Commander deems it safe to do so.

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Directive 023-01, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves implementation of regulations within 33 CFR part 100 applicable to organized marine events on the navigable waters of the United States that could negatively impact the safety of waterway users and shore side activities in the event area lasting 21/2 hours. It is categorically excluded from further review under paragraph L[61] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Memorandum For Record for Categorically Excluded Actions supporting this determination is available in the docket where indicated under ADDRESSES.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 100

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

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

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

    33 U.S.C. 1233; 33 CFR 1.05-1.

    2. Add § 100.501T05-0088 to read as follows:
    § 100.501T05-0088 Special Local Regulation; Tred Avon River, between Bellevue, MD and Oxford, MD.

    (a) Definitions—(1) Captain of the Port (COTP) Maryland—National Capital Region means the Commander, U.S. Coast Guard Sector Maryland—National Capital Region or any Coast Guard commissioned, warrant or petty officer who has been authorized by the COTP to act on his behalf.

    (2) Coast Guard Patrol Commander means a commissioned, warrant, or petty officer of the U.S. Coast Guard who has been designated by the Commander, Coast Guard Sector Maryland—National Capital Region.

    (3) Official Patrol means any vessel assigned or approved by Commander, Coast Guard Sector Maryland—National Capital Region with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.

    (4) Participant means all persons and vessels registered with the event sponsor as participating in the Oxford Biathlon event or otherwise designated by event sponsor as having a function tied to the event.

    (b) Location. The following location is a regulated area: All navigable waters of the Tred Avon River, from shoreline to shoreline, within an area bounded on the east by a line drawn from latitude 38°42′25″ N, longitude 076°10′45″ W, thence south to latitude 38°41′37″ N, longitude 076°10′26″ W, and bounded on the west by a line drawn from latitude 38°41′58″ N, longitude 076°11′04″ W, thence south to latitude 38°41′25″ N, longitude 076°10′49″ W, thence east to latitude 38°41′25″ N, longitude 076°10′30″ W, located at Oxford, MD. All coordinates reference Datum NAD 1983.

    (c) Special local regulations. (1) The COTP or Coast Guard Patrol Commander may forbid and control the movement of all vessels and persons, including event participants, in the regulated area. When hailed or signaled by an official patrol, a vessel or person in the regulated area shall immediately comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both. The Coast Guard Patrol Commander may terminate the event, or the operation of any support vessel participating in the event, at any time it is deemed necessary for the protection of life or property.

    (2) Except for participants and vessels already at berth, all persons and vessels within the regulated area at the time it is activated are to depart the regulated area.

    (3) Persons and vessels desiring to transit, moor, or anchor within the regulated area must obtain authorization from the COTP Maryland—National Capital Region or Coast Guard Patrol Commander. During the enforcement period, persons or vessel operators may request permission to transit, moor, or anchor within the regulated area from the Coast Guard Patrol Commander on Marine Band Radio, VHF-FM channel 16 (156.8 MHz). The Coast Guard Patrol Commander and official patrol vessels enforcing this regulated area can be contacted on marine band radio VHF-FM channel 16 (156.8 MHz) and channel 22A (157.1 MHz).

    (4) The Coast Guard will publish a notice in the Fifth Coast Guard District Local Notice to Mariners and issue a marine information broadcast on VHF-FM marine band radio.

    (d) Enforcement officials. The Coast Guard may be assisted with the marine event patrol and enforcement of the regulated area by other Federal, State, and local agencies.

    (e) Enforcement period. This section will be enforced from 8:30 a.m. until 11 a.m. on June 9, 2018, and if necessary, due to inclement weather, from 8:30 a.m. until 11 a.m. on June 10, 2018.

    Dated: June 4, 2018. Joseph B. Loring, Captain, U.S. Coast Guard, Captain of the Port Maryland—National Capital Region.
    [FR Doc. 2018-12281 Filed 6-6-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0300] Drawbridge Operation Regulation; Willamette River at Portland, OR AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Burnside Bridge across the Willamette River, mile 12.4, at Portland, OR. The deviation is necessary to accommodate bridge repairs and upgrades. This deviation allows the double bascule bridge to operate one side only in single leaf mode.

    DATES:

    This deviation is effective from 7 a.m. on July 1, 2018 to 4 p.m. on October 13, 2018.

    ADDRESSES:

    The docket for this deviation, USCG-2018-0300 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email [email protected].

    SUPPLEMENTARY INFORMATION:

    Multnomah County, Oregon owns the Burnside Bridge, crossing the Willamette River, mile 12.4, at Portland, OR, and has requested a temporary deviation from the operating schedule. The requested deviation is to accommodate bridge repairs and upgrades. To facilitate this maintenance, the draw of the subject bridge will be authorized to operate in single leaf and open the east leaf of the span only. The bridge is also authorized to maintain the west leaf in the closed-to-navigation position to marine traffic, and reduce the vertical clearance up to ten feet. This deviation period is from 7 a.m. on July 1, 2018 to 4 p.m. on October 13, 2018.

    The Burnside Bridge provides a vertical clearance of 41 feet in the closed-to-navigation position referenced to Columbia River Datum 0.0, and the west leaf will be reduced to 31 feet with scaffolding installed. The horizontal clearance for an east leaf opening will be 100 feet. The normal operating schedule is in 33 CFR 117.897. Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. The Coast Guard contacted all known users of the Willamette River for comment, and we received no objections for this deviation.

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

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

    Dated: May 23, 2018. Steven M. Fischer, Bridge Administrator, Thirteenth Coast Guard District.
    [FR Doc. 2018-12282 Filed 6-6-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0440] Drawbridge Operation Regulation; Hutchinson River, New York, NY AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Hutchinson River Parkway Bridge across the Hutchinson River, mile 0.9 at New York, New York. This deviation is necessary to allow the bridge to remain in the closed-to-navigation position to facilitate structural repairs.

    DATES:

    This deviation is effective from 12:01 a.m. on July 16, 2018 to 11:59 p.m. on September 16, 2018.

    ADDRESSES:

    The docket for this deviation, USCG-2018-0440 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Judy Leung-Yee, Bridge Management Specialist, First District Bridge Branch, U.S. Coast Guard; telephone 212-514-4336, email [email protected].

    SUPPLEMENTARY INFORMATION:

    The New York City Department of Transportation, the bridge owner, requested a temporary deviation from the normal operating schedule to facilitate structural repairs. The Hutchinson River Parkway Bridge, across the Hutchinson River, mile 0.9 at New York, New York has a vertical clearance of 30 feet at mean high water and 38 feet at mean low water in the closed position. The existing drawbridge operating regulations are listed at 33 CFR 117.793(b).

    Under this temporary deviation, from 12:01 a.m. on July 16, 2018 to 11:59 p.m. on September 16, 2018 the draw of the Hutchinson River Parkway Bridge will be closed to navigation for a period not to exceed 14 days; the draw will then open for vessels in accordance with established operating regulations for a period not to exceed another 7 days, after which the cycle will repeat.

    The waterway is transited by commercial and recreational traffic. The bridge owner notified known commercial vessel operators that transit the waterway and there were no objections to this temporary deviation. Vessels able to pass under the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.

    The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

    Dated: May 24, 2018. C.J. Bisignano, Supervisory Bridge Management Specialist, First Coast Guard District.
    [FR Doc. 2018-12287 Filed 6-6-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0428] Drawbridge Operation Regulation; Snohomish River and Steamboat Slough, Everett and Marysville, WA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the twin, SR 529 Highway Bridge, north bound, across Steamboat Slough, mile 1.2, near Marysville, WA. The deviation is necessary to accommodate painting and preservation. This deviation allows the bridge to remain in the closed-to-navigation position during the maintenance period to allow safe movement of the work crew.

    DATES:

    This deviation is effective from 12:01 a.m. on July 2, 2018 to 11:59 p.m. on September 30, 2018.

    ADDRESSES:

    The docket for this deviation, USCG-2018-0428 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email [email protected].

    SUPPLEMENTARY INFORMATION:

    The Washington State Department of Transportation, the bridge owner, has requested that the twin, SR 529, Highway Bridge, north bound, across Steamboat Slough, mile 1.2, near Marysville, WA, remain in the closed-to-navigation position, which will reduce the lift span's vertical clearance by three feet. This request is to facilitate safe, uninterrupted bridge work for painting and preservation. The SR 529 highway bridge across Steamboat Slough, mile 1.2, provides 10 feet of vertical clearance above mean high water elevation while in the closed-to-navigation position; and this bridge operates in accordance with 33 CFR 117.1059(g).

    The twin, SR 529, Highway Bridge, north bound, across Steamboat Slough, mile 1.2, is authorized to remain in the closed-to navigation position, and need not open for maritime traffic from 12:01 a.m. on July 2, 2018 to 11:59 p.m. on September 30, 2018. The subject bridge's lift span vertical clearance is also authorized to be reduced from ten feet to seven feet except for a 50 foot wide section that shall not be reduced for maritime passage. The bridge shall operate in accordance to 33 CFR 117.1059(g) at all other times.

    Waterway usage on this part of the Snohomish River and Steamboat Slough includes vessels ranging from commercial tug and barge to small pleasure craft. Vessels able to pass under the subject bridge in the closed-to-navigation position may do so at any time. The subject bridge will not be able to open for vessels engaged in emergency response during the closure period. An alternate route for vessels to pass is available through Ebey Slough and Union Slough near the entrance of Steamboat Slough at high tide. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridges so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

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

    Dated: May 23, 2018. Steven M. Fischer, Bridge Administrator, Thirteenth Coast Guard District.
    [FR Doc. 2018-12284 Filed 6-6-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2018-0308] RIN 1625-AA00 Safety Zone; Ohio River, Mile Marker 27.8 to Mile Marker 28.2, Vanport, PA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone for the navigable waters of the Ohio River from mile marker 27.8 to mile marker 28.2 near the Vanport Highway Bridge. The safety zone is necessary to protect personnel, vessels, and the marine environment from potential hazards created by a cargo movement near the Vanport Highway Bridge in Vanport, PA. Entry of vessels or persons into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.

    DATES:

    This rule is effective without actual notice from June 7, 2018 through 6 p.m. on June 16, 2018. For the purposes of enforcement, actual notice will be used from 8 a.m. on June 2, 2018 through June 7, 2018.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0308 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email Petty Officer Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard, at telephone 412-221-0807, email [email protected].

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

    The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. We must establish this safety zone by June 2, 2018, and we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this rule. The NPRM process would delay the establishment of the safety zone until after the date of the cargo operation and compromise public safety.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is needed to respond to the potential safety hazards associated with the cargo movement.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Marine Safety Unit Pittsburgh (COTP) has determined that potential hazards associated with a cargo movement operation on a day between June 2, 2018 and June 16, 2018 will be a safety concern for anyone within a half-mile stretch of the Ohio River. This rule is necessary to protect personnel, vessels, and the marine environment in the navigable waters before, during, and after the cargo movement.

    IV. Discussion of the Rule

    This rule establishes a temporary safety zone from 8 a.m. on June 2, 2018 through 6 p.m. on June 16, 2018 for all navigable waters of the Ohio River from mile marker 27.8 to mile marker 28.2. Entry into this safety zone during the enforcement period is prohibited, unless authorized by the COTP or a designated representative. Subject to the cargo delivery intervals and potential inclement weather, the enforcement period will be 30 minutes prior to, during, and 1 hour after any cargo movement near the Vanport Highway Bridge. The Coast Guard was informed that the operation would take place during daylight hours only and last approximately 4 hours. A safety vessel will coordinate all vessel traffic during the enforcement period. The COTP or a designated representative will inform the public through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), or through other means of public notice as appropriate at least 3 hours in advance of the enforcement period.

    The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during cargo movement operations. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of Marine Safety Unit Pittsburgh. They may be contacted on VHF-FM Channel 16 or 67. Persons and vessels permitted to enter this regulated area must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative. The COTP or a designated representative will inform the public of the effective period for the safety zone as well as any changes in the dates and times of enforcement through Local Notice to Mariners (LNMs), Broadcast Notices to Mariners (BNMs), and/or Marine Safety Information Bulletins (MSIBs) as appropriate.

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

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

    This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. This safety zone will be enforced for a period of four hours on one day on less than a half mile of the Ohio River. The Coast Guard will issue LNMs and BNMs via VHF-FM marine channel 16 about the temporary safety zone, and the rule allows vessels to seek permission from the COTP or a designated representative to enter the safety zone.

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security 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 determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone lasting only 4 hours that prohibits entry on a half-mile stretch of the Ohio River for 4 hours on one day from June 2, 2016 through June 16, 2018. It is 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 Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 165

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

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

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

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

    2. Add § 165.T08-0308 to read as follows:
    § 165.T08-0308 Safety Zone; Ohio River, mile marker 27.8 to mile marker 28.2, Vanport, PA.

    (a) Location. The following area is a safety zone: All navigable waters of the Ohio River from mile marker 27.8 to mile marker 28.2.

    (b) Effective period. This section is effective from 8 a.m. on June 2, 2018 through 6 p.m. on June 16, 2018.

    (c) Enforcement period. This section will be enforced from June 2, 2018 through June 16, 2018, subject to cargo delivery intervals and potential inclement weather, 30 minutes prior to, during, and 1 hour after any cargo movement in the vicinity of the Vanport Highway Bridge. The Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative will inform the public of the enforcement period through BNMs, LNMs, and/or Marine Safety Information Bulletins (MSIBs) or through other means of public notice at least 3 hours in advance of the enforcement period. A safety vessel will coordinate all vessel traffic during the enforcement of this safety zone.

    (d) Regulations. (1) In accordance with the general regulations in § 165.23, entry into this zone is prohibited unless authorized by the COTP or designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Marine Safety Unit Pittsburgh.

    (2) Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16 or 67.

    (3) All persons and vessels permitted to enter this safety zone must transit at the slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative.

    (e) Informational broadcasts. The COTP or a designated representative will inform the public of the effective period for the safety zone as well as any changes in the dates and times of enforcement through Local Notices to Mariners (LNMs), Broadcast Notices to Mariners (BNMs), and/or Marine Safety Information Bulletins (MSIBs) as appropriate.

    Dated: June 1, 2018. L. McClain, Jr., Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit Pittsburgh.
    [FR Doc. 2018-12283 Filed 6-6-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2018-0242] RIN 1625-AA00 Safety Zone; Blazing Paddles 2018 SUP Race; Cuyahoga River, Cleveland, OH& AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone for certain waters of the Cuyahoga River during the Blazing Paddles Stand Up Paddleboard Race. This safety zone is intended to restrict vessels from a portion of the Cuyahoga River during the Blazing Paddles Stand Up Paddleboard Race. This temporary safety zone is necessary to protect mariners and racers from the navigational hazards associated with the Stand Up Paddleboard Race.

    DATES:

    This rule is effective from 8:30 a.m. through 11:30 a.m. on June 23, 2018.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0242 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email LT Michael Collet, Chief of Waterways Management, U.S. Coast Guard Sector Buffalo; telephone 716-843-9322, email [email protected].

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

    On April 20, 2018 the Coast Guard published a Notice of Proposed Rulemaking (NPRM) titled Blazing Paddles 2018 SUP Race; Cuyahoga River, Cleveland, OH § 165.T09-0242. In that we discussed why we issued the NPRM and invited comments on our proposed regulatory action related to this Standup Paddleboard race. The comment period ended May 30, 2018; we received one comment relating to the event. The comment makes note of a Memorandum of Understanding that had been agreed upon by the Lake Carriers' Association and Share the River. The Lake Carriers Association have no objection to the proposed rule. There was nothing further that needed to be addressed regarding the Temporary Final Rule.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register because doing so would be impracticable and contrary to the public interest. Delaying the effective date would be contrary to the rule's objectives of ensuring safety of life on the navigable waters and protection of persons and vessels near the event.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Buffalo (COTP) has determined that a large-scale paddle craft event on a navigable waterway will pose a significant risk to participants and the boating public. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the Blazing Paddles Race is happening.

    IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received one comment on our NPRM published April 30, 2018, and there was no objection to the proposed rule. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

    This rule establishes a safety zone from 8:30 a.m. through 11:30 a.m. on June 23, 2018. The safety zone will cover all navigable waters at the start point at position 41°29′36″ N and 081°42′13″ W to the turnaround point at position 41°28′52″ N and 081°40′33″ W on the Cuyahoga River in Cleveland, OH. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 9 to 11 a.m. Paddleboard Race.

    Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the COTP Buffalo or his designated on-scene representative. The COTP or his designated on-scene representative may be contacted via VHF Channel 16.

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

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

    This regulatory action determination is based on the characteristics of the safety zone. The safety zone created by this rule will be relatively small and is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. In addition, the safety zone will designate times when races are not occurring; allowing vessels to travel through the safety zone. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the COTP.

    B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received 00 comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishment of a safety zone. It is 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 Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 165

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

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

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

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

    2. Add § 165.T09-0242 to read as follows:
    § 165.T09-0242 Safety Zone; Blazing Paddles 2018 SUP Race; Cuyahoga River, Cleveland, OH.

    (a) Location. The safety zone will encompass all waters of the Cuyahoga River in Cleveland OH, beginning at position 41°29′36″ N and 081°42′13″ W to the turnaround point at position 41°28′52″ N and 081°40′33″ (NAD 83).

    (b) Enforcement period. This rule will be enforced from 8:30 a.m. through 11:30 a.m. on June 23, 2018.

    (c) Regulations. (1) In accordance with the general regulations in § 165.23, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Buffalo (COTP) or his designated on-scene representative.

    (2) This safety zone is closed to all vessel traffic, except as may be permitted by the COTP or his designated on-scene representative.

    (3) The “on-scene representative” of the COTP is any Coast Guard commissioned, warrant or petty officer who has been designated by the COTP to act on his behalf.

    (4) Vessel operators desiring to enter or operate within the safety zone must contact the COTP Buffalo or his on-scene representative to obtain permission to do so. The COTP or his on-scene representative may be contacted via VHF Channel 16 or at (716) 843-9322. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP or his on-scene representative.

    Dated: June 4, 2018. Joseph S. Dufresne, Captain, U.S. Coast Guard, Captain of the Port Buffalo.
    [FR Doc. 2018-12301 Filed 6-6-18; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0376; FRL-9978-20] Acequinocyl; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of acequinocyl in or on guava and the tropical and subtropical, small fruit, inedible peel, subgroup 24A. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective June 7, 2018. Objections and requests for hearings must be received on or before August 6, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0376, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected].

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

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

    C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0376 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 6, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0376, 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 CBI or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 23, 2017 (82 FR 49020) (FRL-9967-37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7E8579) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide acequinocyl, 2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione, and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone (acequinocyl-OH), expressed as acequinocyl equivalents in or on guava at 0.9 ppm and the tropical and subtropical, small fruit, inedible peel, subgroup 24A at 2 ppm. That document referenced a summary of the petition prepared by Arysta LifeScience, the registrant, which is available in the docket, http://www.regulations.gov. A comment expressing concern about the effects of wind turbines on bats was received on the notice of filing, but it is not relevant to this action.

    EPA is establishing the requested tolerances with additional significant figures in conformity with Agency policy.

    III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

    Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for acequinocyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with acequinocyl follows.

    A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

    The target organs of acequinocyl are the liver (hepatocyte vacuolization, brown pigmented cells and perivascular inflammatory cells in liver) and hematopoietic system (hemorrhage, increased clotting factor times and increased platelet counts). There was no evidence of neurotoxicity or immunotoxicity. There was no evidence of carcinogenic potential in either the rat or mouse and there was no concern for genotoxicity or mutagenicity.

    In rats and rabbits, there was no evidence of increased quantitative or qualitative fetal susceptibility. For both species, maternal effects (clinical signs and gross necropsy findings) were observed at similar or lower doses than those producing fetal effects. In rabbits, there were increased incidences of late resorptions at the highest dose tested. Since it is unknown whether resorptions occurred from toxicity to maternal animals or the fetuses, the resorptions are considered maternal and developmental adverse effects. In the rat two-generation reproduction toxicity study, there was increased quantitative offspring susceptibility. Offspring effects consisted of hemorrhagic effects, swollen body parts (head and extremities), protruding eyes, clinical signs (bloody encrusted nose, cold to touch, red urine, blue colored eyes and extremities, paleness), delays in pupil development, and increased mortality occurring mainly after weaning. The increased incidences of hemorrhagic effects post-weaning indicate toxicity to the hematopoietic system. While there were no parental effects up to the highest dose tested, hematological effects (changes in partial and activated partial thromboplastin times) were observed in adult animals in other studies at the same dose causing the offspring effects, but were not measured in the two-generation reproduction toxicity study. As a result, using a weight-of-evidence approach that considers the findings from the two-generation reproduction toxicity study in context of the full toxicological database, parental toxicity would be anticipated at the same doses as offspring effects if additional evaluations had been performed, particularly hematological measurements. There were no effects on reproductive parameters.

    Specific information on the studies received and the nature of the adverse effects caused by acequinocyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Acequinocyl. Human Health Risk Assessment to Support the Petition for Tolerance for Residues in/on Guava and Tropical and Subtropical, Small Fruit, Inedible Peel, Subgroup 24A” on page numbers 29-31 in docket ID number EPA-HQ-OPP-2017-0376.

    B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

    A summary of the toxicological endpoints for acequinocyl used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of January 18, 2017 (82 FR 5409) (FRL-9956-85).

    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to acequinocyl, EPA considered exposure under the petitioned-for tolerances as well as all existing acequinocyl tolerances in 40 CFR 180.599. EPA assessed dietary exposures from acequinocyl in food as follows:

    i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

    Such effects were identified for acequinocyl. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all proposed and registered uses.

    ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level residues and 100 PCT for all proposed and registered uses.

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that acequinocyl does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

    iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for acequinocyl. Tolerance-level residues and 100 PCT were assumed for all food commodities.

    2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for acequinocyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of acequinocyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), Provisional Cranberry Model, and Screening Concentration in Ground Water (SCI-GROW) Model, the estimated drinking water concentrations (EDWCs) of acequinocyl for acute exposures are estimated to be 6.69 parts per billion (ppb) for surface water and 3.6 × 10−3 ppb for ground water, and for chronic exposures are estimated to be 6.69 ppb for surface water and 3.6 × 10−3 ppb for ground water.

    Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For both the acute and chronic dietary risk assessments, the water concentration value of 6.69 ppb was used to assess the contribution to drinking water.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

    Acequinocyl is currently registered for the following uses that could result in residential exposures: Use on ornamentals for landscapes, gardens, and trees. EPA assessed residential exposure using the following assumptions: Residential handler exposures are not expected since all registered acequinocyl product labels with residential use sites (e.g., ornamentals for landscapes, gardens, and trees) require that handlers wear specific clothing (e.g., long-sleeve shirt/long pants) and/or use personal protective equipment (PPE). As a result, a residential handler assessment was not conducted.

    Only short-term post-application dermal exposure is anticipated for the registered residential uses. The quantitative exposure/risk assessment for residential post-application exposures assessed dermal exposures to adults for activities associated with gardening, dermal exposures to children (6 to <11 years old) for activities associated with playing in and around gardens and gardening, dermal exposures to adults associated with handling trees and retail plants, and dermal exposures to children (6 to <11 years old) for activities associated with playing in and around trees and retail plants.

    Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

    4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

    EPA has not found acequinocyl to share a common mechanism of toxicity with any other substances, and acequinocyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that acequinocyl does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

    D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

    2. Prenatal and postnatal sensitivity. There is no evidence of an increased quantitative or qualitative fetal susceptibility in rats or rabbits. In isolation, there was evidence of increased quantitative offspring susceptibility in the two-generation reproductive study; however, the concern is low since:

    i. The effects in pups are well characterized with a clear NOAEL and

    ii. The effects are protected for by the selected endpoints.

    Therefore, there are no residual uncertainties for pre-/post-natal toxicity. Additionally, hematological parameters were not measured for the parental animals in the two-generation reproductive study; however, hematological effects were observed in adult animals in other oral rat studies at the same doses eliciting offspring effects. Therefore, considering the offspring findings in the two-generation reproductive toxicity study in context with the full toxicological database, there is no concern for offspring susceptibility since parental toxicity would be anticipated at the same dose as offspring effects.

    3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings:

    i. The toxicity database for acequinocyl is complete.

    ii. There is no indication that acequinocyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

    iii. There is no evidence of an increased quantitative or qualitative fetal susceptibility in rats or rabbits, but in isolation there was evidence of increased quantitative offspring susceptibility in the two-generation reproductive study. However, the concern is low for the reasons outlined above in section III.D.2.

    iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to acequinocyl in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children. These assessments will not underestimate the exposure and risks posed by acequinocyl.

    E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

    1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to acequinocyl will occupy 71% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to acequinocyl from food and water will utilize 71% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of acequinocyl is not expected.

    3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Acequinocyl is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to acequinocyl.

    Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1140 for adults and 910 for children 6-11 years old. Because EPA's level of concern for acequinocyl is a MOE of 100 or below, these MOEs are not of concern.

    4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

    An intermediate-term adverse effect was identified; however, acequinocyl is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for acequinocyl.

    5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, acequinocyl is not expected to pose a cancer risk to humans.

    6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to acequinocyl residues.

    IV. Other Considerations A. Analytical Enforcement Methodology

    Adequate enforcement methodology (two high-performance liquid chromatography methods with tandem mass-spectroscopy detection (HPLC/MS/MS) for determining residues in/on fruit and nut commodities (Morse Methods Meth-133, Revision #4 and Meth-135, Revision #3)) is available to enforce the tolerance expression.

    The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]

    B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

    The Codex has not established any MRLs for acequinocyl on the crops cited in this document.

    V. Conclusion

    Therefore, tolerances are established for residues of acequinocyl, including its metabolites and degradates, in or on guava at 0.90 ppm and the tropical and subtropical, small fruit, inedible peel, subgroup 24A at 2.0 ppm.

    VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

    This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

    VII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: May 25, 2018. Michael Goodis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority:

    21 U.S.C. 321(q), 346a and 371.

    2. In § 180.599, add alphabetically the entries “Guava” and “Tropical and subtropical, small fruit, inedible peel, subgroup 24A” to the table in paragraph (a) to read as follows:
    § 180.599 Acequinocyl; tolerances for residues.

    (a) * * *

    Commodity Parts per
  • million
  • *    *    *    *    * Guava 0.90 *    *    *    *    * Tropical and subtropical, small fruit, inedible peel, subgroup 24A 2.0 *    *    *    *    *
    [FR Doc. 2018-12297 Filed 6-6-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 373 RIN 2126-AC06 General Technical, Organizational, Conforming, and Correcting Amendments to the Federal Motor Carrier Safety Regulations; Correction AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Final rule; correction.

    SUMMARY:

    FMCSA corrects the technical corrections final rule published on May 17, 2018, that amended FMCSA regulations to make minor changes to correct inadvertent errors and omissions, remove or update obsolete references, ensure conformity with Office of the Federal Register style guidelines, and improve the clarity and consistency of certain regulatory provisions. This document corrects an amendatory instruction.

    DATES:

    Effective June 18, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Mr. David Miller, Federal Motor Carrier Safety Administration, Regulatory Development Division, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, by telephone at (202) 366-5370 or via email at [email protected] Office hours are from 9 a.m. to 5 p.m. e.t., Monday through Friday, except Federal holidays.

    SUPPLEMENTARY INFORMATION:

    In FR Doc. 2018-10437, appearing on page 22873 in the Federal Register of Thursday, May 17, 2018, the following correction is made:

    § 373.103 [Corrected]
    1. On page 22873, in the third column, in amendment 10a., the instruction “Withdraw the amendments to § 373.103 published April 16, 2018, at 83 FR 16224” is withdrawn. Issued under the authority delegated in 49 CFR 1.87 on: May 30, 2018. Larry W. Minor, Associate Administrator for Policy.
    [FR Doc. 2018-12032 Filed 6-6-18; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 395 [Docket No. FMCSA-2017-0360] Hours of Service of Drivers of Commercial Motor Vehicles; Regulatory Guidance Concerning the Transportation of Agricultural Commodities AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT

    ACTION:

    Announcement of regulatory guidance

    SUMMARY:

    FMCSA announces regulatory guidance to clarify the applicability of the “Agricultural commodity” exception in the “Hours of Service (HOS) of Drivers” regulations. This regulatory guidance clarifies the exception with regard to: drivers operating unladen vehicles traveling either to pick up an agricultural commodity or returning from a delivery point; drivers engaged in trips beyond 150 air-miles from the source of the agricultural commodity; determining the “source” of agricultural commodities under the exemptions; and how the exception applies when agricultural commodities are loaded at multiple sources during a trip. This regulatory guidance is issued to ensure consistent understanding and application of the exception by motor carriers and State officials enforcing HOS rules identical to or compatible with FMCSA's requirements.

    DATES:

    This guidance is applicable on June 7, 2018 and expires June 7, 2023.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Thomas Yager, Chief, Driver and Carrier Operations Division, Federal Motor Carrier Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, phone (202) 366-4325, email [email protected].

    SUPPLEMENTARY INFORMATION: I. Public Participation Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble as being available in the docket, go to www.regulations.gov and insert the docket number, “FMCSA-2017-0360” in the “Keyword” box and click “Search.” Next, click the “Open Docket Folder” button and choose the document to review. If you do not have access to the internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays.

    II. Legal Basis

    The National Highway System Designation Act of 1995, Public Law 104-59, sec. 345, 109 Stat. 568. 613 (Nov. 28, 1995) (the Act), provided the initial exception for drivers transporting agricultural commodities or farm supplies for agricultural purposes. The Act limited the exception to a 100 air-mile radius from the source of the commodities or distribution point for the farm supplies and during the planting and harvesting seasons as determined by the applicable State.

    The Safe, Accountable, Flexible, Efficient Transportation Act: A Legacy for Users (SAFETEA-LU) revised this provision, redesignated it as new section 229 of Title II of the Motor Carrier Safety Improvement Act of 1999, and defined the terms “agricultural commodity” and “farm supplies for agricultural purposes.” Public Law 109-59, sections 4115 and 4130, 119 Stat. 1144, 1726, 1743 (Aug. 10, 2005). These terms are now defined in 49 CFR 395.2.

    Most recently, the statute was amended by section 32101(d) of the Moving Ahead for Progress in the 21st Century Act (MAP-21), Public Law 112-141, 126 Stat. 405, 778 (July 6, 2012). This provision revised the description of the exception's scope and extended the applicable distance from 100 air-miles to 150 air-miles from the source.

    III. Background

    The focus of today's guidance is limited to the application of the 150 air-mile exception for the transportation of “agricultural commodities,” 49 CFR 395.1(k)(1). It does not address “farm supplies for agricultural purposes” under § 395.1(k)(2) or (3), since few questions have been raised about their applicability, nor does it address the specifics of the definition of an agricultural commodity as defined in § 395.2. While the regulatory provision governing the agricultural commodity exception closely tracks the statutory provisions discussed above, the language is susceptible to multiple interpretations, and the Agency acknowledges that various stakeholders and enforcement officials in different States have expressed inconsistent understandings of the exception from time to time.

    IV. Public Comments and Responses

    On December 20, 2017, FMCSA published a Federal Register notice proposing regulatory guidance concerning the transportation of agricultural commodities and requested public comment on the proposals (82 FR 60360). The comment period ended on January 19, 2018, but was extended to February 20, 2018 (83 FR 2765, Jan. 19, 2018). There were 566 comments submitted to the docket. Approximately one-half of them addressed issues other than this regulatory guidance, such as electronic logging devices (ELDs), other aspects of the HOS rules, and other provisions of the Federal Motor Carrier Safety Regulations (FMCSRs). Some commenters suggested specific revisions to the FMCSRs, which are beyond the scope of regulatory guidance. Of the remaining comments, most were supportive of the proposed guidance and suggested only minor revisions. Many were from umbrella agricultural associations, some representing as many as 15 other associations. Additional details regarding the public comments are provided under the topical headings below.

    1. Unladen Vehicles (Question 34)

    Interpreted literally, the agricultural commodity exception could be read as applicable only during the period during which the commodity is being transported, and not to movements of an unladen commercial motor vehicle (CMV) either traveling to pick up a load or returning after a delivery. The Agency does not consider that view consistent with the de-regulatory purpose of the exception since applying HOS rules on these unladen trips would limit the relief that Congress intended to grant, while needlessly complicating the regulatory monitoring task that enforcement officials are asked to perform. It is unreasonable to assume that the 1995 statute intended to exempt, for example, farmers hauling soy beans from the field to an elevator, while subjecting them to the full extent of the HOS regulations during the empty return trip to the field to pick up the next load. The Agency has therefore informally advised stakeholders that both legs of a trip are covered. In the proposed guidance (Question 34), FMCSA sought to clarify how the agricultural commodity exception applies to someone driving an unladen CMV either to a source to pick up an agricultural commodity or on a return trip following delivery of an agricultural commodity. The proposed Guidance to Question 34 stated that the agricultural commodity exception (§ 395.1(k)(1)) does apply while driving unloaded to a source where an agricultural commodity will be loaded, and to an unloaded return trip after delivering an agricultural commodity, provided that the trip does not involve transporting other cargo and the sole purpose of the trip is to complete the delivery or pick up of of agricultural commodities, as defined in § 395.2.

    Comments: All comments on this issue were supportive. The American Farm Bureau Federation (Farm Bureau) agrees with the Agency's interpretation that unladen vehicles traveling to and from a source of an agricultural commodity should be able to take advantage of the agricultural commodity exception. The Oregon Cattleman's Association supports FMCSA's view that time spent driving an unladen or empty vehicle to or from a source of an agricultural commodity should be exempt from the hours-of-service (HOS) provisions. The New Mexico Farm and Livestock Bureau agrees, commenting that unladen vehicles hauling to and from an agricultural source or multiple sources should fall under the exception. A number of multiple-group filers commented that the Agency must clearly define that unladen trucks are covered under the agricultural exception. The Owner-Operator Independent Drivers Association (OOIDA) supports the revised guidance that would allow the exception for drivers while driving unloaded to a source where an agricultural commodity will be loaded, and to an unloaded return trip after delivering an agricultural commodity. The Agricultural and Food Transporters Conference, an affiliate of the American Trucking Associations (ATA), commented that the Question 34 guidance is crucial for the movement of agricultural commodities and farm supplies. When a carrier is delivering an agricultural commodity, it must have the ability to unload and travel back to reload, all while under the exception. Not only does this minimize confusion for the carrier in having to travel exempt and non-exempt over and over, but it also significantly minimizes confusion for enforcement officials who are working with the carriers.

    FMCSA Response: The Agency agrees that the § 395.1(k)(1) exception should apply to all portions of a round-trip involving agricultural commodities that occur within the 150 air-mile radius of the source, regardless of whether the CMV is loaded or empty or whether the destination is outside the 150 air-mile radius. The Guidance in Question 34 to § 395.1 is revised to this effect.

    2. Loads Beyond a 150 Air-Mile Radius (Question 35)

    The Agency recognizes that some enforcement personnel and other stakeholders have interpreted the agricultural commodity exception as inapplicable to any portion of a trip if the destination exceeds 150 air-miles from the source. Under that reading, the word “location” in § 395.1(k)(1) is interpreted as reflecting only the final destination of the load. FMCSA considers the statutory language, as amended,1 and the implementing regulation 2 to be ambiguous, given the legislative intent to create an exempt zone with a radius of 150 air miles. The Agency believes that a narrow interpretation is unwarranted. In the proposed regulatory guidance (Question 35), the Agency stated that “location” means the outer limit of the exception distance, i.e., 150 air-miles from the source. Thus, the Agency proposed to interpret the exception as available to a driver transporting agricultural commodities for a distance up to 150 air-miles from the source, regardless of the distance between the source and final destination or place of delivery. Upon crossing the 150 air-mile point, however, the driver would be subject to the HOS rules for the remainder of the trip to the destination. The hours accumulated within the 150-mile radius are not counted toward the driver's hours of service. Returning empty, the driver would be subject to the HOS rules until returning within the 150 air-mile radius in which the trip began.

    1 As amended by MAP-21, Public Law 112-141, 32101(d), 126 Stat. 778 (July 6, 2012), this statute reads:

    (1) Transportation of agricultural commodities and farm supplies.—Regulations prescribed by the Secretary under sections 31136 and 31502 regarding maximum driving and on-duty time for drivers used by motor carriers shall not apply during planting and harvest periods, as determined by each State, to—

    (A) Drivers transporting agricultural commodities from the source of the agricultural commodities to a location within a 150-air-mile radius from the source; . . .

    2 The regulatory exception reads:

    Agricultural operations. The provisions of this part shall not apply during planting and harvesting periods, as determined by each State, to drivers transporting

    (1) Agricultural commodities from the source of the agricultural commodities to a location within a 150 air-mile radius from the source;

    . . . 49 CFR 395.1(k)(1). The term “agricultural commodity” is defined in 49 CFR 395.2.

    Comments: Most commenters supported Question 35 as proposed, and one commenter was completely opposed. The Farm Bureau requested the Agency to modify Question 35 to simply state: “The exception applies to transportation during the initial 150-air miles from the source of the commodity. Starting at zero from that point, the driver must then begin recording his or her duty time, and the limits under the 11-hour, 14-hour, and 60/70-hour rules apply.” The Florida Fruit and Vegetable Association commented that the agricultural exception is unclear on how it is to be applied beyond the 150 air-miles, and does not encompass trucks returning once they have been assigned a specific pick-up. Additionally, it is not clear how hours would be recorded if multiple pickup points are involved. An individual commenter stated that the proposed guidance is unreasonable and is likely to create unsafe conditions where fatigued drivers are operating on the highway. According to him, the term “location” in the phrase, “from the source of the agricultural commodities to a location within a 150 air-mile radius from the source,” can only mean the delivery location. He states that under the proposed guidance, if a person is stopped outside the 150 air-mile radius of the source, neither the motor carrier nor an enforcement officer will be able to determine compliance with the law. If a driver is exempt from part 395 some of the time, but has to comply with all of part 395 at other times, it would be impossible to determine compliance with HOS when the driver is not exempt. The National Grain and Feed Association asked FMCSA to apply the HOS regulations only to situations in which a driver operates beyond the 150-air mile radius. Therefore, starting at the time and location where the vehicle goes past the 150-air mile distance, the driver must maintain logs.

    FMCSA Response: FMCSA believes it would be contrary to the purpose of the exception to apply it to only one portion of the trip within the 150 air-mile radius. The Agency disagrees that it would be impossible to determine HOS compliance outside the 150 air-mile radius. Transporters are required to maintain records of duty status (paper or AOBRD/ELD) and supporting documents when not operating under an exception. Commercial vehicle inspectors are trained to ascertain compliance with the HOS regulations, and would be able to do so as with any other transporters who are not under an HOS exception at the time of inspection.

    3. Sources (Question 36)

    Several agricultural transporters have requested guidance on the extent to which grain elevators or livestock sale barns, for example, should be considered a “source” of agricultural commodities under § 395.1(k)(1). Historically, the nature of the commodities included in the definition led to an informal conclusion that the “source” was the location where the crops were grown or the animals raised. That concept does not adequately address the aggregation and interim storage of commodities. The identification of the source is more reasonably defined by factors that include more than a farm or ranch.

    As long as the commodity retains its original form, a place where the commodity is aggregated and stored may be treated as a “source” from which the 150 air-mile radius is measured.

    Comments: Those persons who commented on the issue agreed that elevators and livestock markets are examples of “sources” other than the original farm or field. Many suggested other broad examples that they believe should be included. No one specifically objected to the proposal. The Farm Bureau believes that logic and common sense dictate that grain elevators and livestock markets are “sources” of agricultural commodities. The Oregon Cattleman's Association agrees with this position, and cites the dictionary definition of “source” as “a point of origin” and describes the challenges of loading at such locations as virtually identical to loading at a farm or ranch. Other commenters point out that feed mills and barns, as well as processing plants that produce bulk animal feed, are often legitimately viewed as sources. The Midwest Shipper's Association states that grain elevators are often a source, and that other facilities are closely related to elevators. These include facilities that clean and process grain, soybeans and oilseed, as well as ethanol plants that ship distiller grains.

    FMCSA Response: While an agricultural commodity may have several “sources” under Question 36 (e.g., for grain, both a field and an elevator), the “source” necessarily excludes the point at which the commodity is processed to such an extent that it is no longer in its original form or does not otherwise meet the definition of an agricultural commodity in 49 CFR 395.2. Question 36 to § 395.1 has been added to clarify that the source of an agricultural commodity includes more than just the original location at the farm or field. The Agency recognizes that further regulatory guidance may be necessary as the industry and enforcement communities adjust to these clarifications of § 395.1.

    4. Multiple Sources (Question 37)

    Many transporters have also asked how the agricultural commodity exception would apply if the driver were to pick up partial loads at two or more locations. Specifically, they asked whether a pick-up at a subsequent source has the effect of extending the 150 air-mile radius, i.e., restarting the calculation of the 150 air-mile distance. Previous informal guidance has been that the 150 air-mile radius is based on the first source of an agricultural commodity on a particular trip, and that additional stops to load additional agricultural commodities do not extend the 150-mile radius.

    Comments: Most commenters agreed that multiple pick-ups and deliveries should be allowed, but that the 150 air-mile radius should be measured from the last pick-up point, not the first point as proposed. Other than the disagreement with that part of the proposal, no one objected to allowing multiple pick-ups and deliveries. The Farm Bureau believes that the exception should not be limited to one “use” each day, and all locations at which agricultural commodities are loaded for shipment should qualify as a source. The Oregon Cattleman's Association agrees, and points out that the alternative—limiting a vehicle or driver to a single “trip”—adds unnecessary complexity to the analysis. Each of several loading stops during the duty day takes place at what the industry views as a “source”—the industry does not think in terms of a single daily “trip.” The New Mexico Farm and Livestock Bureau concurs that livestock markets and elevators are properly viewed as the source of the commodity. The Colorado Farm Bureau states that Congress did not intend to limit a driver or vehicle to a single “source” each calendar day. The Iowa Cattlemen's Association supports the Farm Bureau position.

    Commenters explained that drivers often must pick up agricultural commodities at several locations to fill their vehicle. This is the only reasonable approach to making a living hauling agricultural products. It would be inefficient to operate below capacity, and one stop may not have enough product to fill a truck.

    CVSA applauded efforts to update Agency guidance. It believes greater clarity is needed regarding the loading of agricultural commodities at multiple sources. It states that the exception should begin with the first source, and that stopping after that initial source should not restart the exception. In its view, the exception and the 150 air-mile radius should be applied from the original source only.

    FMCSA Response: Question 37 to § 395.1 has been added to clarify that multiple pick-ups are permissible but that the 150 air-mile radius continues to be measured from the first pick-up point regardless of the number of times commodities are loaded or offloaded. The Agency agrees with CVSA's position that the exception should begin with the first source only. FMCSA notes in the interest of safety that, under a contrary interpretation that restarts the 150-mile exception with each new source, a motor carrier could effectively extend the exception indefinitely. The Agency did not intend to imply that a carrier would be limited to one “trip” per day. A trip terminates when all of the commodity has been offloaded or non-exempt freight or products are added to the load. Thereafter, a new trip under the agricultural exception could be started the same day by loading a shipment of agricultural commodities at a different source. The 150 air-mile radius would then be measured from this new trip initiation point.

    V. Regulatory Guidance

    FMCSA issues Regulatory Guidance, Questions 34, 35, 36, and 37 to 49 CFR 395.1 as follows:

    PART 395—Hours of Service of Drivers
    § 395.1 Scope of the rules in this part

    Question 34: Does the agricultural commodity exception (§ 395.1(k)(1)) apply to drivers while driving unloaded within 150 air-miles of the place where an agricultural commodity will be loaded, and to that portion of an unloaded return trip which occurs within a 150 air-mile radius of the place where the agricultural commodity was loaded?

    Guidance: Yes, provided that the trip does not involve transporting any non-agricultural cargo and the sole purpose of the trip is to make a pick-up or delivery of agricultural commodities, as defined in § 395.2. In that case, driving and on-duty time are not limited, nor do other requirements of 49 CFR part 395 apply.

    Question 35: Does the agricultural commodity exception (§ 395.1(k)(1)) apply if the destination for the commodity is beyond the 150 air-mile radius from the source?

    Guidance: Yes, the exception applies to transportation during the initial 150 air-miles from the source of the commodity, regardless of the distance to the final destination. Once a driver operates beyond the 150 air-mile radius of the source, 49 CFR part 395 applies. The driver is then subject to the limits under the hours-of-service rules and must record those hours. Once the hours-of-service rules begin to apply on a given trip, they continue to apply for the duration of that trip, until the driver crosses back into the area within 150 air-miles of the original source of the commodities.

    Question 36: How is the “source” of the agricultural commodities in § 395.1(k)(1) determined?

    Guidance: The “source” of an agricultural commodity, as the term is used in § 395.1(k)(1), is the point at which an agricultural commodity is loaded onto an unladen commercial motor vehicle. The location may be any intermediate storage or handling location away from the original source at the farm or field, provided the commodity retains its original form and is not significantly changed by any processing or packing. If a driver is making multiple trips, the first trip, and the 150 air-mile exception around that source, terminate once all agricultural products are offloaded at a delivery point. A new source for a new trip may then be identified, and the 150 air-mile radius for the exception will be around that source.

    For example, a sales barn where cattle are loaded may be treated as a “source,” in addition to the location at which they were raised, since cattle remain livestock. As another example, a place where heads of lettuce are stored may become a “source,” provided they retain their original form. An elevator where grain is collected and dried may be a new “source,” again assuming that the grain is not milled or similarly processed at the elevator.

    Question 37: How is the “source of the agricultural commodities” determined if the driver makes multiple pick-ups of the commodity en route to the final destination?

    Guidance: When a driver loads some of an agricultural commodity at a “source” and then loads more of that commodity at additional stops, the first place where the commodity was loaded is the measuring point for the 150 air-mile radius.

    VI. Review Date for the Regulatory Guidance

    In accordance with section 5203(a)(2)(A) and (a)(3) of the Fixing America's Surface Transportation (FAST) Act, Public Law 114-94, 129 Stat. 1312, 1535 (Dec. 4, 2015), this regulatory guidance will be posted on FMCSA's website, www.fmcsa.dot.gov. It expires June 7, 2023. The Agency will consider whether the guidance should be withdrawn, reissued for another period up to five years, or incorporated into the safety regulations.

    Issued on: May 31, 2018. Raymond P. Martinez, Administrator.
    [FR Doc. 2018-12250 Filed 6-6-18; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 395 [Docket No. FMCSA-2017-0108] Hours of Service of Drivers of Commercial Motor Vehicles: Regulatory Guidance Concerning the Use of a Commercial Motor Vehicle for Personal Conveyance AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Regulatory guidance.

    SUMMARY:

    On December 19, 2017, FMCSA proposed revisions to the regulatory guidance concerning driving a commercial motor vehicle (CMV) for personal use while off-duty, referred to as “personal conveyance.” Over 380 comments were received in response to the draft guidance. This document provides revised guidance and addresses issues raised by commenters. This guidance applies to all CMV drivers required to record their hours of service (HOS) who are permitted by their carrier to use the vehicle for personal use.

    DATES:

    This guidance is applicable on June 7, 2018 and expires June 7, 2023.

    FOR FURTHER INFORMATION CONTACT:

    For information concerning this notice contact Ms. LaTonya Mimms, Transportation Specialist, Enforcement Division, FMCSA. Ms. Mimms may be reached at 202-366-0991 and by email at [email protected]. If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION: Background

    The Federal Motor Carrier Safety Regulations (FMCSRs) require drivers to document their HOS on records of duty status (RODS), identifying one of four duty status options: (1) On-duty not driving, (2) driving, (3) sleeper berth, and (4) off-duty (49 CFR 395.8). The use of personal conveyance is a tool used to account for the movement of a CMV while the driver is off-duty.

    Motor carriers are responsible for ensuring that drivers are not operating while ill or fatigued. However, motor carriers, at their discretion, may authorize their drivers to use a CMV while off-duty for personal conveyance. When this occurs, drivers are required to document such use as off-duty on their RODS, irrespective of the method used to record the driver's HOS (e.g., paper logs, automatic on-board recording device, electronic logging devices (ELDs), etc.)

    The minimum performance and design standards for ELDs in the Agency's final rule on “Implementation of Electronic Logging Devices and Hours of Service Supporting Documents” (ELD rule) (80 FR 78292, December 15, 2015) include the automatic recording of data related to the off-duty movement and location of the CMV. As part of the ELD rule, ELD manufacturers are required to include a special driving category for personal conveyance. This may be used by drivers at the motor carriers' discretion.

    The previous guidance on personal conveyance (49 CFR 395.8, Question 26) was issued by the Federal Highway Administration (FHWA), FMCSA's predecessor agency, in a memorandum dated November 18, 1996, and later published in a compilation of guidance (62 FR 16370, 16426, April 4, 1997). The guidance reiterated the basic principle that a driver in off-duty status must be relieved from work and all responsibility for performing work. It highlighted the use of the CMV as a personal conveyance in traveling to and from the place of employment (e.g., the normal work reporting location). The 1997 guidance included discussion of CMVs used to travel short distances from a driver's en route lodgings to restaurants in the vicinity of such lodgings. In addition, the 1997 guidance explicitly excluded the use of laden vehicles as personal conveyance and the operation of the CMV as personal conveyance by drivers who have been placed out of service for HOS violations. The guidance has remained unchanged since 1997.

    On December 19, 2017. FMCSA issued revised guidance and requested comments. (82 FR 60269) In changing the guidance, the Agency focused on the reason the driver is operating a CMV while off-duty, without regard to whether the CMV is laden.

    This notice clarifies issues raised such as using personal conveyance to leave a shipper or receiver and travel to a safe location for rest, the fact that the use of personal conveyance does not impact on-duty time, and provides additional scenarios in the guidance as to when the use of personal conveyance is allowable, and, includes passenger carrier specific scenarios.

    Comments on the Proposed Guidance

    FMCSA received over 380 comments on the proposed guidance. Over 300 of the comments were from individuals, with approximately 240 representing drivers of property-carrying CMVs. The remaining comments came from companies, associations, safety organizations, and two States. Companies included Cowboy Up Transport, Boyle Transportation, Crete Carrier, C.H. Robinson, and Schneider National. The associations included the American Bus Association, the American Trucking Associations, the Owner Operator Independent Drivers Association, the Truckload Carriers Association, and Western States Trucking Association. The safety organizations included the Commercial Vehicle Safety Alliance, Advocates for Highway and Auto Safety (AHAS), the Truck Safety Coalition and Road Safe America.

    The majority of commenters supported expanding the definition to include laden vehicles. However, the Truck Safety Coalition and Road Safe America opposed this change, expressing concern that FMCSA was proposing to replace an objective standard with a subjective standard and that it would be difficult for law enforcement to assess a driver's intent to determine if the CMV is being used for personal conveyance. In addition, the Truck Safety Coalition and Road Safe America noted studies conducted by the FMCSA, National Institute of Occupational Safety and Health, Federal Highway Administration and National Highway Traffic Safety Administration, relating to the incidence of fatigue reported by long haul truck drivers and impact of pressures from the shipping community on fatigue.

    AHAS also opposed this change for similar reasons and questioned the disparate impact on drivers of single unit trucks that FMCSA noted in the December 2017 notice.

    Also, several motor carriers reiterated that the decision to allow the use of personal conveyance should remain with the company.

    FMCSA Response

    The purpose of the guidance is to provide additional clarity on the use of personal conveyance as a type of off-duty status. The guidance provides additional details to determine if a movement of the CMV is an appropriate off-duty use. The new guidance will improve uniformity for the industry and the enforcement communities. The clarity provided in this notice will lead to greater uniformity in the enforcement of the HOS rules.

    In response to concerns that this guidance will somehow increase fatigue, FMCSA notes that there are no changes to the HOS rules in this document. In fact, because the current requirement to record HOS using ELDs makes the time spent driving a CMV as personal conveyance transparent to the motor carrier and enforcement, the Agency believes that consistency and uniformity in the application of the guidance by both the industry and enforcement will be increased. FMCSA recognizes that much of the pressure on drivers referenced in the comments results from delays during the loading or unloading process causing a driver to run out of hours. This guidance will have a positive impact on the concerns expressed by the Truck Safety Coalition, Road Safe America, and AHAS by giving drivers the flexibility to locate and obtain adequate rest as this would be off-duty time in personal conveyance status. In addition, as described above, this guidance, used in conjunction with the ELD rule will lead to greater uniformity in enforcement.

    According to the FMCSA's records in the Motor Carrier Management Information System, there are approximately 2.3 million straight trucks that operate in interstate commerce. Under the previous guidance, the drivers of many straight trucks were not permitted to operate in an off-duty status for personal conveyance because they were laden. The revised guidance allows these vehicles, under the circumstances described in the guidance to be driven as a personal conveyance.

    Other recurring issues or questions raised are discussed individually below.

    Some commenters provided suggestions or requests that are outside of the scope of guidance. Those included modifying the HOS regulations so that there is a definition of personal conveyance consistent with the Canadian HOS regulation and establishing mileage or time limits for the use of personal conveyance.

    In addition, some motor carriers and drivers questioned who would be liable in a crash when the driver is operating in the personal conveyance mode. FMCSA notes that this issue is outside of its authority and would be determined based on the contract or agreement between the motor carrier or owner of the commercial motor vehicle and the liability insurance provider as well as principles of State tort law.

    Clarification of Impact to On-Duty Hours

    Numerous commenters asked for clarification on how the use of personal conveyance impacts on-duty hours.

    FMCSA Response

    Personal conveyance is an off-duty status. Therefore, there are no impacts to the 11- or 14-hour limitations for truck drivers, the 10- or 15-hour limitations for bus drivers, the 60/70-hour limitations, the 34-hour restart provisions, or any other on-duty status.

    Leaving a Shipper or Receiver to go to a Safe Place for Required Rest

    Crete Carrier, Vilma Kuprescenko, Desiree Wood, Paul Tyler and many others suggested that a driver should be allowed to identify movement from a receiver or shipper, after exhausting his or her HOS, as personal conveyance, if that movement is to allow the driver to arrive at a safe location to obtain the required rest. Crete Carrier believes that not allowing the driver to identify such a movement as personal conveyance would be contrary to the coercion rule (49 CFR 390.6), as the shipper is forcing a driver to leave the premises even after exhausting his or her hours of service limits. Schneider National also asked for clarification on this issue.

    FMCSA Response

    The movement from a shipper or receiver to the nearest safe resting area may be identified as personal conveyance, regardless of whether the driver exhausted his or her HOS, as long as the CMV is being moved solely to enable the driver to obtain the required rest at a safe location. The Agency recognizes that the driver may not be aware of the direction of the next dispatch and that in some instances the nearest safe resting location may be in the direction of that dispatch. If the driver proceeds to the nearest reasonable and safe location and takes the required rest, this would qualify as personal conveyance. FMCSA recommends that the driver annotate on the log if he/she cannot park at the nearest location and must proceed to another location.

    FMCSA also notes that the Coercion Rule is intended to protect drivers from motor carriers, shippers, receivers, or transportation intermediaries who threaten to withhold work from, take employment action against, or punish a driver for refusing to operate in violation the FMCSRs, Hazardous Materials Regulations, and the Federal Motor Carrier Commercial Regulations. Crete Carrier's reference to the coercion rule in the context of having to leave a shipper's/receiver's property is not accurate, provided that the shipper or receiver does not threaten to retaliate or take adverse action against the driver in violation of the rule.

    Movement Required by Safety Officials

    Jeff Muzik asked about the impacts to the 10-hour break if a safety official requires the driver to move the CMV.

    FMCSA Response

    If a Federal, State or local law enforcement official requires a driver to relocate the CMV during the 10-hour break period for truck drivers or the 8-hour break period for bus drivers, personal conveyance may be used to document the movement. Again, as this is off-duty time, this does not require a restart of the rest period. However, the CMV must be moved no farther than the nearest reasonable and safe area to complete the rest period.

    Returning to the Last On-Duty Location

    Schneider National noted that the draft scenarios in section (a) of the guidance to Question 26 implied that the driver must return to the last on-duty location but that other scenarios in the same section indicate otherwise. Allen England and Billy Barnes Enterprises expressed disagreement with any requirement to return to the last on-duty location.

    FMCSA Response

    The driver is not required to return to the previous on-duty location. A driver may resume on-duty status immediately after an off-duty status regardless of the location of the CMV.

    Enhancing Operational Readiness

    Danny Schnautz, Brian Ausloos, and Doug Pope questioned FMCSA's description of “enhancing operational readiness.” Other carriers also provided examples of movements that they believed are personal conveyance but enhance operational readiness.

    FMCSA Response

    Enhancing operational readiness includes on-duty movement of a CMV that provides a commercial benefit to the motor carrier. For example, if the movement places the load closer to the destination, it may not be considered personal conveyance, except under circumstances outlined specifically in the examples provided in the guidance. Additionally, if a driver who is under dispatch stops at a location such as his/her home, because the driver's home is closer to the next destination or pick up location, then this would not be personal conveyance.

    Application of Guidance to Passenger Carrying Vehicles

    The American Bus Association (ABA) stated that the proposed guidance did not mention motorcoaches. ABA and others requested examples that specifically reference motorcoach operations. The United Motorcoach Association provided examples of personal conveyance, including use of a motorcoach to reach restaurants or pursue personal activities after dropping off passengers at a hotel or when a driver is using a motorcoach to transport drivers who are off-duty to pursue personal activities.

    In addition, Michael Letlow requested confirmation that motorcoaches with luggage only are not considered laden.

    FMCSA Response

    Examples have been added to the final guidance that make clear that drivers of passenger-carrying operations may also use their vehicles for personal conveyance in appropriate circumstances. In addition, FMCSA reminds commenters that this guidance now applies regardless of whether the vehicle is laden. However, the requirement for the driver to be off-duty still exists. Therefore, if a driver is taking luggage to a hotel and is on-duty, personal conveyance would not apply. However, if the driver is off-duty and using a motorcoach with luggage on board to get lunch, personal conveyance would be appropriate.

    New Guidance Language

    FMCSA replaces Question 26 as noted below. In accordance with the requirement in Section 5203(a)(2)(A) of the Fixing America's Surface Transportation (FAST) Act, Public Law 114-94, 129 Stat. 1312, 1535, Dec. 4, 2015, the guidance above will be posted on FMCSA's website, http://www.fmcsa.dot.gov and expires no later than June 7, 2023. The Agency will then consider whether the guidance should be withdrawn, reissued for another period of up to five years, or incorporated into the safety regulations at that time.

    FMCSA reminds motor carriers and drivers that additional information about ELDs is available at www.fmcsa.dot.gov/eld.

    FMCSA updates the guidance for § 395.8 Driver's Record of Duty Status to read as follows:

    Question 26: Under what circumstances may a driver operate a commercial motor vehicle (CMV) as a personal conveyance?

    Guidance: A driver may record time operating a CMV for personal conveyance (i.e., for personal use or reasons) as off-duty only when the driver is relieved from work and all responsibility for performing work by the motor carrier. The CMV may be used for personal conveyance even if it is laden, since the load is not being transported for the commercial benefit of the carrier at that time. Personal conveyance does not reduce a driver's or motor carrier's responsibility to operate a CMV safely. Motor carriers can establish personal conveyance limitations either within the scope of, or more restrictive than, this guidance, such as banning use of a CMV for personal conveyance purposes, imposing a distance limitation on personal conveyance, or prohibiting personal conveyance while the CMV is laden.

    (a) Examples of appropriate uses of a CMV while off-duty for personal conveyance include, but are not limited to:

    1. Time spent traveling from a driver's en route lodging (such as a motel or truck stop) to restaurants and entertainment facilities.

    2. Commuting between the driver's terminal and his or her residence, between trailer-drop lots and the driver's residence, and between work sites and his or her residence. In these scenarios, the commuting distance combined with the release from work and start to work times must allow the driver enough time to obtain the required restorative rest as to ensure the driver is not fatigued.

    3. Time spent traveling to a nearby, reasonable, safe location to obtain required rest after loading or unloading. The time driving under personal conveyance must allow the driver adequate time to obtain the required rest in accordance with minimum off-duty periods under 49 CFR 395.3(a)(1) (property-carrying vehicles) or 395.5(a) (passenger-carrying vehicles) before returning to on-duty driving, and the resting location must be the first such location reasonably available.

    4. Moving a CMV at the request of a safety official during the driver's off-duty time

    5. Time spent traveling in a motorcoach without passengers to en route lodging (such as motel or truck stop), or to restaurants and entertainment facilities and back to the lodging. In this scenario, the driver of the motorcoach can claim personal conveyance provided the driver is off-duty. Other off-duty drivers may be on board the vehicle, and are not considered passengers.

    6. Time spent transporting personal property while off-duty.

    7. Authorized use of a CMV to travel home after working at an offsite location.

    (b) Examples of uses of a CMV that would not qualify as personal conveyance include, but are not limited to, the following:

    1. The movement of a CMV in order to enhance the operational readiness of a motor carrier. For example, bypassing available resting locations in order to get closer to the next loading or unloading point or other scheduled motor carrier destination.

    2. After delivering a towed unit, and the towing unit no longer meets the definition of a CMV, the driver returns to the point of origin under the direction of the motor carrier to pick up another towed unit.

    3. Continuation of a CMV trip in interstate commerce in order to fulfill a business purpose, including bobtailing or operating with an empty trailer in order to retrieve another load or repositioning a CMV (tractor or trailer) at the direction of the motor carrier.

    4. Time spent driving a passenger-carrying CMV while passenger(s) are on board. Off-duty drivers are not considered passengers when traveling to a common destination of their own choice within the scope of this guidance.

    5. Time spent transporting a CMV to a facility to have vehicle maintenance performed.

    6. After being placed out of service for exceeding the maximum periods permitted under part 395, time spent driving to a location to obtain required rest, unless so directed by an enforcement officer at the scene.

    7. Time spent traveling to a motor carrier's terminal after loading or unloading from a shipper or a receiver.

    8. Time spent operating a motorcoach when luggage is stowed, the passengers have disembarked and the driver has been directed to deliver the luggage.

    Issued on: May 31, 2018. Raymond P. Martinez, Administrator.
    [FR Doc. 2018-12256 Filed 6-6-18; 8:45 am] BILLING CODE 4910-EX-P
    83 110 Thursday, June 7, 2018 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0513; Product Identifier 2018-CE-013-AD] RIN 2120-AA64 Airworthiness Directives; Honda Aircraft Company LLC AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to supersede Airworthiness Directive (AD) 2018-11-05, which applies to certain Honda Aircraft Company (Honda) LLC Model HA-420 airplanes. AD 2018-11-05 requires incorporating a temporary revision into the airplane flight manual and replacing the faulty power brake valve (PBV) upon condition. Since AD 2018-11-05 was issued as an interim action in order to address the need for the immediate detection of a faulty PBV, we are issuing this proposed AD to address the long-term corrective action. This proposed AD would retain the actions required in AD 2018-11-05, would require replacing the faulty PBV with an improved design part at a specified time, and would prohibit future installations of the faulty PBVs on all Honda Model HA-420 airplanes. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by July 23, 2018.

    ADDRESSES:

    You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Honda Aircraft Company LLC, 6430 Ballinger Road, Greensboro, North Carolina 27410; telephone (336) 662-0246; internet: http://www.hondajet.com. You may view this service information at the FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    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-2018-0513; 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 NPRM, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations (phone: 800-647-5527) is listed above. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Samuel Kovitch, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia 30337; phone: (404) 474-5570; fax: (404) 474-5605; email: [email protected].

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0513; Product Identifier 2018-CE-013-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

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

    Discussion

    We issued AD 2018-11-05, Amendment 39-19293 (83 FR 24016, May 24, 2018), (“AD 2018-11-05), for certain Honda Aircraft Company LLC (Honda) Model HA-420 airplanes. AD 2018-11-05 requires inserting a temporary revision into the airplane flight manual (AFM), which may be performed by the owner/operator (pilot) holding at least a private pilot certificate and must be entered into the airplane records showing compliance with the AD in accordance with 14 CFR 43.9 (a)(1)-(4) and 14 CFR 91.417(a)(2)(v). AD 2018-11-05 also requires a conditional replacement of the installed power brake valve (PBV), P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007, with an improved PBV, P/N HJ1-13243-101-009, if any of the procedures listed in the AFM temporary revision reveals a leaking PBV. In addition, AD 2018-11-05 provides an optional terminating action for inserting the temporary revision into the AFM by replacing the installed P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007 with the improved P/N HJ1-13243-101-009. AD 2018-11-05 resulted from reports of unannunciated asymmetric braking during ground operations and landing deceleration.

    We issued AD 2018-11-05 to prevent failure of the PBV, which could cause degraded braking performance and reduced directional control during ground operations and landing deceleration.

    Actions Since AD 2018-11-05 Was Issued

    Since AD 2018-11-05 was issued as an interim action in order to address the need for the immediate detection of a faulty PBV (the short-term action of inserting the temporary revision into the AFM), we are issuing this proposed AD to address the long-term corrective action (replacing the PBV).

    Related Service Information Under 1 CFR Part 51

    We reviewed Honda Aircraft Company Temporary Revision TR 01.1, dated February 16, 2018, to the Honda Aircraft Company HA-420 Airplane Flight Manual and Service Bulletin SB-420-32-001, dated January 8, 2018, and Revision B, dated April 16, 2018. Temporary Revision TR 01.1, dated February 16, 2018, to the HA-420 Airplane Flight Manual (AFM) describes procedures for performing pilot checks of the braking system during ground operations before every flight and before every landing and includes instructions for corrective actions if any indication of a leaking PBV is found. Service Bulletin SB-420-32-001, dated January 8, 2018, and Revision B, dated April 16, 2018, describes procedures for replacing a defective PBV with an improved design PBV. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination

    We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

    Proposed AD Requirements

    This proposed AD would retain the requirements of AD 2018-11-05. This proposed AD would also require replacing the installed PBV, P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007, with the improved design PBV, P/N HJ1-13243-101-009, at a specified time.

    Differences Between This Proposed AD and the Service Information

    Honda Service Bulletin SB-420-32-001, dated January 8, 2018, and Revision B, dated April 16, 2018, specify submitting certain information to the manufacturer. This AD does not require that action.

    Costs of Compliance

    We estimate that this proposed AD affects 72 airplanes of U.S. registry.

    We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Insert temporary revision into the airplane flight manual 1 work-hour × $85 per hour = $85 Not applicable $85 $6,120 Replace the power brake valve (PBV) 20 work-hours × $85 per hour = $1,700 $21,878 23,578 1,697,616

    Replacing the PBV was provided as an on-condition cost and an optional terminating action in AD 2018-11-05. We have no way of determining how many owner/operators of the affected airplanes may have already done this proposed replacement. Therefore, we have included a total cost for all affected airplanes.

    The difference in the Cost of Compliance between AD 2018-11-05 and this proposed AD is the proposed requirement to replace the power brake valve at a specified time.

    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.

    This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes, gliders, balloons, airships, domestic business jet transport airplanes, and associated appliances to the Director of the Policy and Innovation Division.

    Regulatory Findings

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

    For the reasons discussed above, I certify that the proposed regulation:

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2018-11-05, Amendment 39-19293 (83 FR 24016, May 24, 2018), and adding the following new AD: Honda Aircraft Company LLC: Docket No. FAA-2018-0513; Product Identifier 2018-CE-013-AD. (a) Comments Due Date

    The FAA must receive comments on this AD action by July 23, 2018.

    (b) Affected ADs

    This AD replaces AD 2018-11-05, Amendment 39-19293 (83 FR 24016, May 24, 2018).

    (c) Applicability

    This AD applies to Honda Aircraft Company LLC Model HA-420 airplanes, all serial numbers, that:

    (1) Have power brake valve, part number (P/N) HJ1-13243-101-005 or HJ1-13243-101-007, installed; and

    (2) are certificated in any category.

    (d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 32, Landing Gear.

    (e) Unsafe Condition

    This AD was prompted by reports of unannunciated asymmetric braking during ground operations and landing deceleration. We are issuing this AD to detect failure of the power brake valve (PBV). The unsafe condition, if not addressed, could result in degraded braking performance and reduced directional control during ground operations and landing deceleration.

    (f) Compliance

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

    (g) Insert Temporary Revision Into the Airplane Flight Manual (AFM)

    Before further flight after May 29, 2018 (the effective date retained from AD 2018-11-05) insert Honda Aircraft Company Temporary Revision TR 01.1, dated February 16, 2018, into the Honda Aircraft Company (Honda) HA-420 Airplane Flight Manual (AFM) (“the temporary revision”). The procedures listed in the temporary revision are required while operating with PBV P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007 installed. This insertion and the steps therein may be performed by the owner/operator (pilot) holding at least a private pilot certificate and must be entered into the airplane records showing compliance with this AD in accordance with 14 CFR 43.9(a)(1)-(4) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417, 121.380, or 135.439.

    (h) No Reporting Requirement

    Although Honda Service Bulletin SB-420-32-001, dated January 8, 2018, and Revision B, dated April 16, 2018, specify submitting certain information to the manufacturer, this AD does not require that action.

    (i) Replace the Power Brake Valve

    As of and at any time after May 29, 2018 (the effective date retained from AD 2018-11-05), if any of the procedures listed in the temporary revision referenced in paragraph (g) of this AD reveal a leaking PBV, before further flight, replace the installed PBV, P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007, with the improved design PBV, P/N HJ1-13243-101-009. The replacement must be done using the Accomplishment Instructions in either Honda Service Bulletin SB-420-32-001, dated January 8, 2018, or Revision B, dated April 16, 2018. Before further flight after installing P/N HJ1-13243-101-009, remove the temporary revision from the Honda HA-420 AFM.

    (j) Optional Terminating Action for Inserting the AFM Temporary Revision/Pilot Checks

    (1) Instead of inserting the temporary revision or at any time after inserting the temporary revision required by paragraph (g) of this AD and before the mandatory replacement required in paragraph (j) of this AD, you may replace the installed PBV, P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007, with the improved design PBV, P/N HJ1-13243-101-009. The replacement must be done using the Accomplishment Instructions in either Honda Service Bulletin SB-420-32-001, dated January 8, 2018, or Revision B, dated April 16, 2018. Before further flight after installing P/N HJ1-13243-101-009, remove the temporary revision from the Honda HA-420 AFM.

    (2) The on-condition replacement required by paragraph (h) of this AD is still required before further flight.

    (k) Mandatory Replacement

    Within the next 12 months after the effective date of this AD, replace the installed PBV, P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007, with the improved design PBV, P/N HJ1-13243-101-009. The replacement must be done using the Accomplishment Instructions in either Honda Service Bulletin SB-420-32-001, dated January 8, 2018, or Revision B, dated April 16, 2018. Before further flight after installing P/N HJ1-13243-101-009, remove the temporary revision from the Honda HA-420 AFM.

    (l) Special Flight Permit

    Special flight permits for the AFM Limitations portion of this AD are prohibited. Special flight permits for the PBV replacement required in this AD are permitted with the following limitations: One ferry flight, including fuel stops, to service center with Honda Aircraft Company Temporary Revision TR 01.1, dated February 16, 2018, incorporated into the Honda HA-420 AFM.

    (m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (n) of this AD.

    (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (3) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (h) through (j) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

    (ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

    (n) Related Information

    (1) For more information about this AD, contact Samuel Kovitch, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia 30337; phone: (404) 474-5570; fax: (404) 474-5605; email: [email protected]

    (2) For service information identified in this AD, contact Honda Aircraft Company LLC, 6430 Ballinger Road, Greensboro, North Carolina 27410; telephone (336) 662-0246; internet: http://www.hondajet.com. FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    Issued in Kansas City, Missouri, on May 29, 2018. Melvin J. Johnson, Aircraft Certification Service, Deputy Director, Policy and Innovation Division, AIR-601.
    [FR Doc. 2018-12127 Filed 6-6-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0504; Product Identifier 2018-NM-046-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 707 series airplanes and Model 720 and 720B series airplanes. This proposed AD was prompted by a report indicating that a fracture of the midspar fitting resulted in the separation of the inboard strut and engine from the airplane, and a determination that existing inspections are not sufficient for timely detection of cracking. This proposed AD would require repetitive inspections of certain nacelle strut spar and overwing fittings, and diagonal braces and associated fittings; replacement of the diagonal brace assembly on certain airplanes; and applicable related investigative and corrective actions. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by July 23, 2018.

    ADDRESSES:

    You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet https://www.myboeingfleet.com. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0504.

    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-2018-0504; 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 NPRM, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey Chang, Aerospace Engineer, Propulsion Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5263; fax: 562-627-5210; email: [email protected] or George Garrido, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5232; fax: 562-627-5210; email [email protected].

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0504; Product Identifier 2018-NM-046-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

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

    Discussion

    We have received reports of cracking of the midspar fittings and of the engine and nacelle strut separating from the airplane. We issued AD 2012-16-12, Amendment 39-16159 (77 FR 49708, August 17, 2012) to require inspection of the inboard and outboard strut midspar fittings and AD 2015-11-04, Amendment 39-18167 (80 FR 30605, May 29, 2015) to require replacement of all engine strut midspar fittings and to initiate a life limit program. Since that time, we have determined that inspections of other strut fittings are needed for timely detection of cracking. Cracks have been reported in the diagonal brace end fittings, forward mating fittings, aft mating fittings, overwing support fittings, and the upper surface and the aft lug(s) of the front spar fittings on the nacelle struts, numbers 1, 2, 3 and 4. This cracking is attributed to fatigue in the end fittings and stress corrosion or fatigue in the mating fittings. This condition, if not addressed, could result in cracks that grow beyond a critical length, allowing strut fittings to fail and reducing the structural integrity of the nacelle. This, in combination with damage to adjacent attachment structure, could result in the loss of an engine from the airplane.

    Related Service Information Under 1 CFR Part 51

    We reviewed the following service information.

    • Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017. The service information describes procedures for repetitive detailed inspections of the diagonal brace tube for any crack; repetitive detailed inspections and high frequency eddy current (HFEC) inspections of the nacelle strut diagonal brace end fittings, forward mating fitting, and aft mating fitting for any crack; an alternative dye penetrant inspection of vertical webs on aft mating fitting for any crack; an HFEC inspection of the diagonal brace tube for any crack; and corrective actions.

    • Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017. The service information describes procedures for repetitive detailed, HFEC, and ultrasonic inspections of the overwing support fittings for any crack at the bolt hole forward of the wing front spar and at the holes for the four fasteners attaching the fitting to the spar, and related investigative and corrective actions.

    • Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016. The service information describes procedures for repetitive detailed and surface HFEC inspections of the front spar fittings at nacelle struts numbers 1, 2, 3, and 4 for cracks, and replacement of cracked front spar fittings.

    This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination

    We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs.

    Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between this Proposed AD and the Service Information.” For information on the procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0504.

    The phrase “related investigative actions” is used in this proposed AD. Related investigative actions are follow-on actions that (1) are related to the primary action, and (2) further investigate the nature of any condition found. Related investigative actions in an AD could include, for example, inspections.

    The phrase “corrective actions” is used in this proposed AD. Corrective actions correct or address any condition found. Corrective actions in an AD could include, for example, repairs.

    Differences Between This Proposed AD and the Service Information

    Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017; Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017; and Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016; specify to contact the manufacturer for certain instructions, but this proposed AD would require using repair methods, modification deviations, replacement deviations, and alteration deviations in one of the following ways:

    • In accordance with a method that we approve; or

    • Using data that meet the certification basis of the airplane, and that have been approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) whom we have authorized to make those findings.

    Costs of Compliance

    We estimate that this proposed AD affects 65 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Detailed inspections per Service Bulletin A3364, Revision 4 36 work-hours × $85 per hour = $3,060 per inspection cycle $0 $3,060 per inspection cycle $198,900 per inspection cycle. HFEC inspections per Service Bulletin A3364, Revision 4 128 work-hours × $85 per hour = $10,880 per inspection cycle 0 $10,880 per inspection cycle $707,200 per inspection cycle. Inspections per Service Bulletin A3365, Revision 3 20 work-hours × $85 per hour = $1,700 per inspection cycle 0 $1,700 per inspection cycle $110,500 per inspection cycle. Detailed inspections per Service Bulletin A3514, Revision 1 12 work-hours × $85 per hour = $1,020 per inspection cycle 0 $1,020 per inspection cycle $66,300 per inspection cycle. HFEC inspections per Service Bulletin A3514, Revision 1 32 work-hours × $85 per hour = $2,720 per inspection cycle 0 $2,720 per inspection cycle $176,800 per inspection cycle.

    We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.

    We estimate that any necessary proposed replacement of affected fittings would take about 96 work-hours for a cost of $8,160 per fitting. We have received no definitive data on the parts costs of the affected fittings. We have no way of determining the number of aircraft that might need this replacement.

    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.

    This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

    Regulatory Findings

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

    For the reasons discussed above, I certify this proposed regulation:

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 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): The Boeing Company: Docket No. FAA-2018-0504; Product Identifier 2018-NM-046-AD. (a) Comments Due Date

    We must receive comments by July 23, 2018.

    (b) Affected ADs

    This AD affects AD 82-24-03, Amendment 39-4496 (47 FR 51099, November 12, 1982) (“AD 82-24-03”) and AD 2005-08-15, Amendment 39-14067 (70 FR 21136, April 25, 2005) (“AD 2005-08-15”).

    (c) Applicability

    This AD applies to all The Boeing Company Model 707-100 Long Body, -200, -100B Long Body, and -100B Short Body series airplanes; Model 707-300, -300B, -300C, and -400 series airplanes; and Model 720 and 720B series airplanes; certificated in any category.

    (d) Subject

    Air Transport Association (ATA) of America Code 54, Nacelles/pylons.

    (e) Unsafe Condition

    This AD was prompted by a report indicating that a fracture of the midspar fitting resulted in the separation of the inboard strut and engine from the airplane, and a determination that existing inspections for other nacelle strut fittings are not sufficient for timely detection of cracking. We are issuing this AD to address cracks, which if not detected and corrected, could grow beyond a critical length, allowing the strut fitting to fail and reducing the structural integrity of the nacelle. This, in combination with damage to adjacent attachment structure, could result in the loss of an engine from the airplane.

    (f) Compliance

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

    (g) Repetitive Detailed Inspections of the Front Spar Fittings at Nacelle Struts Numbers 1, 2, 3, and 4

    Prior to the accumulation of 3,500 total flight hours; within 700 flight hours after the most recent inspection specified in Boeing 707 Alert Service Bulletin A3514, dated July 29, 2004, was done; or within three months after the effective date of this AD; whichever occurs later: Do a detailed inspection for cracking of the front spar fittings at nacelle struts numbers 1, 2, 3, and 4, in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016. If any cracking is found, before further flight, replace the affected fitting, in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016. Repeat the inspections thereafter at intervals not to exceed 700 flight hours.

    (h) Repetitive Surface High Frequency Eddy Current (HFEC) Inspections of the Aft Lugs on the Front Spar Fittings at Nacelle Struts Numbers 1, 2, 3, and 4

    Within 1,500 flight cycles or 48 months after the most recent detailed inspection required by paragraph (g) of this AD was done, whichever occurs first, do a surface HFEC inspection for cracking of the aft lugs on the front spar fittings at nacelle struts numbers 1, 2, 3, and 4, and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016, except as required by paragraph (l)(4) of this AD. Do all applicable corrective actions before further flight. Repeat the inspection thereafter at intervals not to exceed 1,500 flight cycles or 48 months, whichever occurs first.

    (i) Repetitive Inspections of the Overwing Support Fitting at Nacelle Struts Numbers 1, 2, 3, and 4

    At the times specified in paragraph 1.E., “Compliance,” of Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017, except as required by paragraph (l)(1) of this AD: Do the inspections specified in paragraphs (i)(1) through (i)(3) of this AD and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017, except as required by paragraph (l)(3) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the inspections thereafter at the applicable time specified in paragraph 1.E., “Compliance,” of Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017.

    (1) Do a detailed inspection for any crack at all five holes in the overwing support fitting, and at the flange radii.

    (2) Do the inspection specified in paragraph (i)(2)(i) or (i)(2)(ii) of this AD.

    (i) Do a surface HFEC inspection for any crack in the overwing support fitting around the hole immediately forward of the spar chord, with the bolt in place, and at the flange radii.

    (ii) Do an open hole HFEC inspection for any crack in the overwing support fitting at the hole immediately forward of the spar chord.

    (3) Do the inspection specified in paragraph (i)(3)(i) or (i)(3)(ii) of this AD.

    (i) Do an ultrasonic inspection for any crack in the overwing support fitting around the four holes common to the fitting and the spar chord, with the bolts in place.

    (ii) Do a surface HFEC inspection for any crack in the overwing support fitting around the four holes common to the fitting and the spar chord, with the bolts in place.

    (j) Inspections of the Nacelle Strut Diagonal Braces and Associated Fittings

    For airplanes with nacelle strut diagonal braces and associated fittings which have accumulated 7,500 flight cycles or more: At the applicable times specified in paragraph 1.E., “Compliance” of Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017, except as required by paragraph (l)(2) of this AD, do the inspections specified in paragraphs (j)(1) through (j)(3) of this AD. Repeat the inspections thereafter at the applicable intervals specified in tables 1, 2, 3, and 4 of paragraph 1.E., “Compliance,” of Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017. If any crack is found during any inspection required by this paragraph, before further flight, do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017, except as required by paragraph (l)(3) of this AD.

    (1) Do a detailed inspection of the nacelle strut diagonal brace end fittings, diagonal brace tube, forward mating fitting, and aft mating fitting for any crack.

    (2) Do HFEC inspections of the nacelle strut diagonal brace end fittings, forward mating fitting, and aft mating fitting for any crack. As an alternative for the aft mating fitting, do a dye penetrant inspection of vertical webs on aft mating fitting for any crack.

    (3) Do an HFEC inspection of the diagonal brace tube for any crack.

    (k) Replacement

    For Group 3, 4, and 6 airplanes as identified in Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017, on which the outboard diagonal brace end fitting (forward or aft) attach holes have been oversized as specified in Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017: Within 1,000 flight cycles after the effective date of this AD, replace the diagonal brace assembly, in accordance with Figure 3 of Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017.

    (l) Exceptions to Service Information Specifications

    (1) For purposes of determining compliance with the requirements of this AD: Where Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017, uses the phrase “the Revision 3 date of this service bulletin,” this AD requires using “the effective date of this AD.”

    (2) For purposes of determining compliance with the requirements of this AD: Where Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017, uses the phrase “the Revision 4 date of this service bulletin,” this AD requires using “the effective date of this AD.”

    (3) Where Boeing 707 Alert Service Bulletin A3364, Revision 4, dated February 21, 2017; and Boeing 707 Alert Service Bulletin A3365, Revision 3, dated March 9, 2017; specify contacting Boeing: This AD requires repair using a method approved in accordance with the procedures specified in paragraph (o) of this AD.

    (4) Where Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016, specifies contacting Boeing: This AD requires replacement using a method approved in accordance with the procedures specified in paragraph (o) of this AD.

    (m) Terminating Action for Other ADs

    (1) Accomplishing the initial inspections required by paragraph (j) of this AD terminates all requirements of AD 82-24-03.

    (2) Accomplishing the initial inspections required by paragraph (g) of this AD, terminates all requirements of AD 2005-08-15.

    (n) Parts Installation Prohibition

    As of the effective date of this AD, no person may install, on any airplane, a front spar fitting having a part number other than the part numbers specified in paragraph 2.C.2. of Boeing 707 Alert Service Bulletin A3514, Revision 1, dated November 9, 2016.

    (o) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person(s) identified in paragraph (p)(1) of this AD. Information may be emailed to: [email protected].

    (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, replacement, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Los Angeles ACO Branch, to make those findings. To be approved, the repair method, modification deviation, replacement deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.

    (p) Related Information

    (1) For more information about this AD, contact Jeffrey Chang, Aerospace Engineer, Propulsion Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5263; fax: 562-627-5210; email: [email protected] or George Garrido, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5232; fax: 562-627-5210; email [email protected].

    (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet https://www.myboeingfleet.com. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    Issued in Des Moines, Washington, on May 24, 2018. James Cashdollar, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-12128 Filed 6-6-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0517; Product Identifier 2017-SW-098-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Helicopters Deutschland GmbH Helicopters AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for Airbus Helicopters Deutschland GmbH (Airbus Helicopters) Model MBB-BK 117 C-2 and MBB-BK 117 D-2 helicopters. This proposed AD would require altering and re-identifying the overhead panel shock mount assembly (shock mount). This proposed AD is prompted by the manufacturer's stress recalculations. The actions of this proposed AD are intended to correct an unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by August 6, 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-2018-0517; 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 proposed AD, the European Aviation Safety Agency (EASA) 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 proposed rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.helicopters.airbus.com/website/en/ref/Technical-Support_73.html. 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

    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 might result from adopting the proposals in this document. 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.

    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 proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.

    Discussion

    EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD No. 2017-0026, dated February 14, 2017, to correct an unsafe condition for Airbus Helicopters Model MBB-BK 117 C-2, MBB-BK117 C-2e, MBB-BK 117 D-2, and MBB-BK117 D-2m helicopters. EASA advises that a recent stress calculation identified that the shock mount may not withstand certification crash loads. EASA states that this condition, if not corrected, could lead to the overhead panel disconnecting during an emergency landing and injuring occupants. Accordingly, the EASA AD requires modifying and re-identifying the shock mounts.

    FAA's Determination

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

    Related Service Information Under 1 CFR Part 51

    We reviewed Airbus Helicopters Alert Service Bulletin (ASB) MBB-BK117 C-2-24A-015 for Model MBB-BK117 C-2 helicopters and ASB MBB-BK117 D-2-24A-004 for Model MBB-BK117 D‐2 helicopters, both Revision 0 and dated September 14, 2016. This service information contains procedures for altering the shock mounts by installing retaining plates and re-identifying the shock mounts by changing the last three digits of the part number (P/N) to -966.

    This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    Proposed AD Requirements

    This proposed AD would require installing a retaining plate on the shock mount and re-identifying the shock mount by changing the last three digits of the P/N to -966.

    This proposed AD would also prohibit installing shock mount P/N B246M2035102 and P/N B246M2036101 on any helicopter.

    Differences Between This Proposed AD and the EASA AD

    The EASA AD applies to Model MBB-BK117 D-2m helicopters, whereas this proposed AD would not since the Model MBB-BK117 D-2m is not FAA type-certificated. This proposed AD would also not include the Model MBB-BK117 C-2(e) in the applicability section because it is a marketing designation and not an FAA type-certificated model. However, this proposed AD would apply to those helicopters, as they are Model MBB-BK117 C-2 helicopters. The EASA AD specifies particular helicopter serial numbers (S/Ns) that may not be required to complete some of the requirements of the AD since the specified S/Ns were manufactured with shock mounts not affected by the unsafe condition. This proposed AD does not specify particular S/Ns.

    Costs of Compliance

    We estimate that this proposed AD would affect 144 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 per work-hour.

    Installing retaining plates and re-identifying the four shock mounts would take about 3 work-hours and parts would cost about $184 for a total estimated cost of $439 per helicopter and $63,216 for the U.S. fleet.

    According to Airbus Helicopter's service information, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage by Airbus. Accordingly, we have included all costs in our cost estimate.

    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 proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 this proposed regulation:

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

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

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

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

    We prepared an economic evaluation of the estimated costs to comply with this proposed 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.

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 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): Airbus Helicopters Deutschland GmbH: Docket No. FAA-2018-0517; Product Identifier 2017-SW-098-AD. (a) Applicability

    This AD applies to Model MBB-BK 117 C-2 and Model MBB-BK 117 D-2 helicopters, certificated in any category, with an overhead panel shock mount assembly part number (P/N) B246M2035102 or P/N B246M2036101 installed.

    Note 1 to paragraph (a) of this AD: Helicopters with an MBB-BK117 C-2e designation are Model MBB-BK117 C-2 helicopters.

    (b) Unsafe Condition

    This AD defines the unsafe condition as failure of an overhead panel shock mount assembly (shock mount). This condition could result in detachment of the overhead panel and injury to occupants during an emergency landing.

    (c) Comments Due Date

    We must receive comments by August 6, 2018.

    (d) 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.

    (e) Required Actions

    (1) Within 300 hours time-in-service:

    (i) Install a retaining plate on each shock mount by following the Accomplishment Instructions, paragraphs 3.B.2.1. through 3.B.2.4, of Airbus Helicopters Alert Service Bulletin (ASB) MBB-BK117 C-2-24A-015, Revision 0, dated September 14, 2016 (ASB MBB-BK117 C-2-24A-015), or ASB MBB-BK117 D-2-24A-004, Revision 0, dated September 14, 2016 (ASB MBB-BK117 D-2-24A-004), as applicable to your model helicopter.

    (ii) Re-identify shock mount P/N B246M2035102 as P/N B246M2035966 and shock mount P/N B246M2036101 as P/N B246M2036966 using permanent ink. When the ink is dry, apply varnish over the P/N.

    (iii) Re-install each shock mount.

    (2) After the effective date of this AD, do not install a shock mount P/N B246M2035102 or P/N B246M2036101 on any helicopter.

    (f) 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.

    (g) Additional Information

    The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2017-0026, dated February 14, 2017. You may view the EASA AD on the internet at http://www.regulations.gov in the AD Docket.

    (h) Subject

    Joint Aircraft Service Component (JASC) Code: 2400, Electrical Power System.

    Issued in Fort Worth, Texas, on May 31, 2018. James A. Grigg, Acting Director, Compliance & Airworthiness Division, Aircraft Certification Service.
    [FR Doc. 2018-12227 Filed 6-6-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0503; Product Identifier 2018-NM-048-AD] RIN 2120-AA64 Airworthiness Directives; 328 Support Services GmbH (Type Certificate Previously Held by AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all 328 Support Services GmbH Model 328-100 and -300 airplanes. This proposed AD was prompted by reports indicating corrosion on the horizontal stabilizer bearing supports at the contact surface to the horizontal stabilizer rear spar. This proposed AD would require inspections for corrosion and any other damage (i.e., cracking and chafing) of the horizontal stabilizer rear bearing supports, replacement of the affected horizontal stabilizer rear bearing supports if necessary, and modification of the horizontal stabilizer rear spar. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by July 23, 2018.

    ADDRESSES:

    You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact 328 Support Services GmbH, Global Support Center, P.O. Box 1252, D-82231 Wessling, Federal Republic of Germany; telephone +49 8153 88111 6666; fax +49 8153 88111 6565; email [email protected]; internet http://www.328support.de. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    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-2018-0503; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Todd Thompson, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3228.

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0503; Product Identifier 2018-NM-048-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM based on those comments.

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

    Discussion

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2017-0239, dated November 30, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all 328 Support Services GmbH Model 328-100 and -300 airplanes. The MCAI states:

    Occurrences were reported on horizontal stabilizer bearing supports being found corroded at the contact surface to the horizontal stabilizer rear spar. The corroded area was at the lower flange position, which is connected to the stabilizer rear spar and not visible without detachment of the fitting. Investigation determined that the corrosion is triggered by galvanic effect, due to a direct contact between the horizontal stabilizer rear spar, made from CFRP (carbon fibre reinforced plastic), and the aluminium rear attachment fitting.

    This condition, if not detected and corrected, could lead to failure of the fitting and loss of one load path of the horizontal stabilizer attachment, possibly resulting in reduced control of the aeroplane.

    To address this potential unsafe condition, 328 Support Services GmbH (328 SSG) issued Service Bulletin (SB) SB-328-55-557 and SB-328J-55-324 to provide instructions for inspection of the affected area, replacement of the parts, and modification to improve corrosion behaviour by incorporating of glass fibre layer.

    For the reasons described above, this [EASA] AD requires a one-time inspection [detailed visual inspection and an eddy current inspection for chafing and corrosion] of the horizontal stabilizer rear bearing supports, and, depending on findings, accomplishment of applicable corrective action(s) [replacement of the affected horizontal stabilizer rear bearing supports]. This [EASA] AD also requires a modification of the horizontal stabilizer rear spar, irrespective of findings.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0503.

    Related Service Information Under 1 CFR Part 51

    328 Support Services GmbH has issued Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018; and Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018. This service information describes a detailed visual inspection and an eddy current inspection for corrosion and any other damage (i.e., cracking and chafing) of the horizontal stabilizer rear bearing supports, modification of the horizontal stabilizer rear spar, and replacement of the affected horizontal stabilizer rear bearing supports if necessary. These documents are distinct since they apply to different airplane models. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

    Costs of Compliance

    We estimate that this proposed AD affects 27 airplanes of U.S. registry.

    We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Detailed visual inspection and eddy current inspection 4 work-hours × $85 per hour = $340 $0 $340 $9,180 Modification 16 work-hours × $85 per hour = $1,360 0 1,360 36,720

    We estimate the following costs to do any necessary replacement that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need this replacement:

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Replacement 24 work-hours × $85 per hour = $2,040 (*) $2,040 * We have received no definitive data that would enable us to provide part cost estimates for the on-condition action specified in this proposed AD.
    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.

    This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

    Regulatory Findings

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

    For the reasons discussed above, I certify this proposed regulation:

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 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):

    328 Support Services GmbH (Type Certificate Previously Held by AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH): Docket No. FAA-2018-0503; Product Identifier 2018-NM-048-AD. (a) Comments Due Date

    We must receive comments by July 23, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all 328 Support Services GmbH (Type Certificate previously held by AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) Model 328-100 and -300 airplanes, certificated in any category.

    (d) Subject

    Air Transport Association (ATA) of America Code 55, Stabilizers.

    (e) Reason

    This AD was prompted by reports indicating corrosion on the horizontal stabilizer bearing supports at the contact surface to the horizontal stabilizer rear spar. We are issuing this AD to address corrosion on the horizontal stabilizer bearing supports and rear spar, which could lead to failure of the fitting and loss of one load path of the horizontal stabilizer attachment, and possibly result in reduced controllability of the airplane.

    (f) Compliance

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

    (g) Inspection and Modification

    (1) At the applicable time specified in paragraph (g)(3)(i) or (g)(3)(ii) of this AD, do a detailed visual inspection and an eddy current inspection for corrosion and any other damage (i.e., cracking and chafing) of the horizontal stabilizer rear bearing supports in accordance with the Accomplishment Instructions of 328 Support Services GmbH Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018 (for Model 328-300 airplanes); as applicable.

    (2) At the applicable time specified in paragraph (g)(3)(i) or (g)(3)(ii) of this AD, modify the horizontal stabilizer rear spar in accordance with the Accomplishment Instructions of 328 Support Services GmbH Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018 (for Model 328-300 airplanes); as applicable.

    (3) Do the actions in paragraphs (g)(1) and (g)(2) at the applicable compliance time specified in paragraph (g)(3)(i) or (g)(3)(ii) of this AD.

    (i) For Group 1 airplanes as identified in 328 Support Services GmbH Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018 (for Model 328-300 airplanes); as applicable: Within 1,000 flight cycles or 8 months, whichever occurs first after the effective date of this AD.

    (ii) For Group 2 airplanes as identified in 328 Support Services GmbH Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018 (for Model 328-300 airplanes); as applicable: Within 5,000 flight hours or 30 months, whichever occurs first after the effective date of this AD.

    (h) Corrective Action

    If, during the inspections required by paragraph (g) of this AD, corrosion or any other damage (i.e., cracking and chafing) is detected, before further flight, replace the affected horizontal stabilizer rear bearing supports in accordance with the Accomplishment Instructions of 328 Support Services GmbH Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018 (for Model 328-300 airplanes); as applicable.

    (i) Parts Installation Prohibition

    As of the applicable time specified in paragraph (i)(1) or (i)(2) of this AD, no person may install a horizontal stabilizer rear bearing support, part number 001B551A1441000, on any airplane.

    (1) For Group 1 airplanes as identified in 328 Support Services GmbH Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018 (for Model 328-300 airplanes); as applicable: After replacement of the horizontal stabilizer rear bearing supports as required by paragraph (h) of this AD.

    (2) For Group 2 airplanes as identified in 328 Support Services GmbH Service Bulletin SB-328-55-557, Revision 1, dated February 1, 2018 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, Revision 1, dated February 1, 2018 (for Model 328-300 airplanes); as applicable: As of the effective date of this AD.

    (j) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using 328 Support Services GmbH Service Bulletin SB-328-55-557, dated September 1, 2017 (for Model 328-100 airplanes); or 328 Support Services GmbH Service Bulletin SB-328J-55-324, dated September 1, 2017 (for Model 328-300 airplanes).

    (k) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Section, Transport Standards Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Section, send it to the attention of the person identified in paragraph (l)(2) of this AD. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or the European Aviation Safety Agency (EASA); or 328 Support Services GmbH's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

    (l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2017-0239, dated November 30, 2017, for related information. This MCAI may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0503.

    (2) For more information about this AD, contact Todd Thompson, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th Street, Des Moines, WA 98198; telephone and fax 206-231-3228.

    (3) For service information identified in this AD, contact 328 Support Services GmbH, Global Support Center, P.O. Box 1252, D-82231 Wessling, Federal Republic of Germany; telephone +49 8153 88111 6666; fax +49 8153 88111 6565; email [email protected]; internet http://www.328support.de. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    Issued in Des Moines, Washington, on May 24, 2018. James Cashdollar, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-12135 Filed 6-6-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 3 [Docket No. FDA-2004-N-0191] Product Jurisdiction; Correction AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule; correction.

    SUMMARY:

    The Food and Drug Administration is correcting a proposed rule to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to Agency components for premarket review and regulation that appeared in the Federal Register of May 15, 2018. The document was published with an error in the discussion of the preliminary economic analysis impact. This document corrects that error.

    DATES:

    Submit either electronic or written comments on the proposed rule by July 16, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Melissa Burns, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20933, 301-796-8930, [email protected]

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of Tuesday, May 15, 2018, beginning on page 22428 for FR Doc. 2018-10321, table 1 on page 22433 is corrected to read:

    Table 1—Benefits, Costs, and Distributional Effects of the Proposed Rule 1 2 Category Primary
  • estimate
  • Low
  • estimate
  • High
  • estimate
  • Units Year
  • dollars
  • Discount rate
  • (%)
  • Period
  • covered
  • (years)
  • Notes
    Costs: Annualized $17,000 $12,000 $27,000 2016 7 10 Monetized $/year 15,000 10,000 23,000 2016 3 10 Annualized 7 Quantified 3 Qualitative Benefits: Annualized 28,000 25,000 89,000 2016 7 10 Monetized $/year 28,000 25,000 89,000 2016 3 10 Annualized 7 Quantified 3 Qualitative Firms and FDA may realize savings from sponsors choosing to submit electronic RFDs Transfers: Federal 7 Annualized Monetized $millions/year 3 From/To From: To: Other 7 Annualized Monetized $millions/year 3 From/To From: To: Effects: State, Local or Tribal Government: Small Business: Will not have a significant impact on a substantial number of small entities. Wages: Growth: 1 We use a 10-year time horizon for this rule with payments occurring at the end of each period. 2 All dollar values are rounded to the nearest $1,000.
    Dated: June 1, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-12201 Filed 6-6-18; 8:45 am] BILLING CODE 4164-01-P
    POSTAL REGULATORY COMMISSION 39 CFR Part 3050 [Docket No. RM2018-5; Order No. 4630] Periodic Reporting AGENCY:

    Postal Regulatory Commission.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Commission is noticing a recent filing requesting that the Commission initiate an informal rulemaking proceeding to consider changes to an analytical method for use in periodic reporting (Proposal Two). This document informs the public of the filing, invites public comment, and takes other administrative steps.

    DATES:

    Comments are due: July 16, 2018.

    ADDRESSES:

    Submit comments electronically via the Commission's Filing Online system at http://www.prc.gov. Those who cannot submit comments electronically should contact the person identified in the FOR FURTHER INFORMATION CONTACT section by telephone for advice on filing alternatives.

    FOR FURTHER INFORMATION CONTACT:

    David A. Trissell, General Counsel, at 202-789-6820.

    SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Proposal Two III. Notice and Comment IV. Ordering Paragraphs I. Introduction

    On May 25, 2018, the Postal Service filed a petition pursuant to 39 CFR 3050.11 requesting that the Commission initiate a rulemaking proceeding to consider changes to analytical principles relating to periodic reports.1 The Petition identifies the proposed analytical changes filed in this docket as Proposal Two.

    1 Petition of the United States Postal Service for the Initiation of a Proceeding to Consider Proposed Changes in Analytical Principles (Proposal Two), May 25, 2018 (Petition).

    II. Proposal Two

    Background. Proposal Two relates to new sampling and weighting procedures for the city carrier portion of the In-Office Cost System (IOCS).2 The current IOCS design uses a multi-stage probability sample to randomly select city carriers, then an interval of work time from the city carrier's tour, resulting in an observation (“reading”) that represents a “snapshot” of work activity in a sampled interval.3 Under the current IOCS design, data collection for city carriers is widely dispersed in both time and location, so the Postal Service conducts most city carrier readings by telephone. The Postal Service states that the availability of detailed clock ring data from the Time and Attendance Collection System (TACS) and Delivery Operations Information System (DOIS) data now allows for a change to the current IOCS sampling design for city carriers. Id. at 1-2.

    2 Petition at 1. The IOCS “is a continuous, ongoing probability sample of work time to estimate costs of various activities performed by clerks, mail handlers, city carriers, and supervisors.” See Docket No. ACR2017, Library Reference USPS-FY17-37, file “USPS-FY17-37.Preface.pdf,” at 2.

    3 Petition, Proposal Two at 1. The Postal Service currently uses cost estimates from the IOCS to develop total accrued costs for both city carrier in-office and street time. Id.

    Proposal. The Postal Service proposes to change the current IOCS sample design for city carriers to a cluster sampling approach that would include using TACS workhours to weight the sampling data. Id. at 3-4. In the morning, on-site clustered city carrier readings would be conducted by an IOCS data collector, rather than with telephone respondents in sampled delivery zones.4 In zones with six or more routes (sampling mode 1), a maximum of six carriers would be randomly selected to represent the zone and morning readings would be taken on-site by the IOCS data collector once every 30 minutes.5 In zones with fewer than six city carriers working the selected zone (sampling mode 2), morning readings would be taken on-site by the IOCS data collector on all carriers once every 15 minutes.6 In the afternoon (sampling mode 3), all city carrier readings would be conducted by telephone and clustered into one-hour intervals.7

    4Id. at 2, 4. “Zone is defined by both ZIP Code and finance number.” Id. at 4 n.5.

    5Id. at 5. All morning readings would begin when carriers start their workday and would continue until 11 a.m. Id. at 6.

    6 The Postal Service plans to synchronize IOCS-Cluster readings with City Carrier Cost System (CCCS) tests when a data collector is already scheduled to be at a delivery unit.

    7 All afternoon readings would be conducted between 11:00 and 19:00 hours. Id. at 6.

    Under the cluster sampling design, the Postal Service proposes to use TACS workhours to weight sampling data by zone, and to provide cost controls for city carriers by time-of-day (morning and afternoon) and day-of-week group (weekday/Saturday group and Sunday/Holiday group). Id. at 4-5. Additionally, the Postal Service states that it will use DOIS and TACS data for the sampled zone to weight the readings for each test relative to other tests within the same Cost Ascertainment Group (CAG) strata, and to post-stratify readings by route group and city carrier craft group. Id. at 4, 7. However, the Postal Service states that all afternoon readings are scaled to the total hours in the afternoon and not estimated by CAG separately because it asserts that “there are insufficient afternoon tallies” and “no significant difference [for in-office cost] is expected” because carriers would be on the street. Id. at 7.

    The Postal Service asserts that the proposal adopts the approach suggested by the Commission in Order No. 4399 for developing route group weighting factors when there were “empty cells” within the combination of route group and carrier group. Id. at 12.

    Proposal Two would also “[u]se TACS data to provide control totals for the portion of supervisor costs incurred by employees whose base craft is carrier, but who have clocked as supervisor.” Id. at 4. Additionally, unlike the current IOCS methodology, under the Proposal Two methodology, no IOCS readings would be conducted on Sundays and Holidays.8 However, for purposes of evaluating and presenting the estimated impact on FY 2017 costs, the Postal Service “shows the effects of attributing all Sunday/Holiday costs” to Parcel Select. Id. at 9.

    8Id. at 5. Instead, the Postal Service states that it will develop control total costs for Sunday/Holiday from TACS hours and distribute costs using scanning data from Product Tracking and Reporting (PTR). Id. at 5, 9. The Postal Service explains that it intends to file a separate proposal outlining the use of the PTR data for Sunday/Holiday costs. Id. at 5.

    Rationale and impact. The Postal Service states that the primary objective of Proposal Two is to replace telephone readings with on-site readings, particularly while carriers are on the premises and handling mail. Id. at 10.

    The Postal Service projects that the IOCS-Cluster system will obtain twice as much on-premises data as the current system, but “due to the improvement in sampling efficiency, will not require additional data collection resources.” Id. at 8. Further, the Postal Service asserts that “[t]he new design improves data quality by obtaining far more data from on-site rather than telephone readings, while simultaneously improving data collection efficiency.” Id. at 1.

    The Postal Service lists several benefits of the proposal including the ability to scan barcodes, providing feedback at the time of the reading for less-common products and assisting with “back-end processing of tallies.” Id. at 10. Additionally, the Postal Service states that on-site data collectors may do a better job than a telephone respondent of recognizing some of the mailpiece markings that are less common and more obscure. Id. Further, unlike city carrier telephone respondents, under Proposal Two, on-site IOCS data collectors would not have other duties that may affect and constrain participating in a reading under the current IOCS sampling system. Id.

    The Postal Service states that the proposal will result in a significant increase in the percentage of direct tallies where the carrier is handling the mailpiece, and decreases in tallies for support and administrative activities, training, and mixed mail. Id. at 12. The Postal Service also anticipates a significant increase in tallies in the parking area, potentially making it possible to distribute mixed mail tallies separately from in-facility. Id. at 13.

    The Postal Service states that the pilot data indicate some significant shifts in product costs, including a decrease in costs for First-Class letters, and increases in costs for a number of products including parcel-shaped products, carrier route bundled products, Periodicals, and International Mail. Id. at 14-15. The Postal Service asserts that the shifts in product costs are most likely due to the use of on-site data collectors rather than telephone respondents. Id. at 15. The proposal would also impact costs associated with supervising city carriers.9

    9Id. at 14. The pilot data showed a 9.1-percent increase in supervisor city carrier costs, which resulted in a slight increase in piggyback factors on city carrier costs. Id.

    The Postal Service's estimate of the effect on product unit costs is presented in Table 5 of Proposal Two, which is reproduced here. Id. at 16.

    BILLING CODE 7710-FW-P EP07JN18.004 BILLING CODE 7710-FW-C III. Notice and Comment

    The Commission establishes Docket No. RM2018-5 for consideration of matters raised by the Petition. More information on the Petition may be accessed via the Commission's website at http://www.prc.gov. Interested persons may submit comments on the Petition and Proposal Two no later than July 16, 2018. Pursuant to 39 U.S.C. 505, Lyudmila Y. Bzhilyanskaya is designated as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.

    IV. Ordering Paragraphs

    It is ordered:

    1. The Commission establishes Docket No. RM2018-5 for consideration of the matters raised by the Petition of the United States Postal Service for the Initiation of a Proceeding to Consider Proposed Changes in Analytical Principles (Proposal Two), filed May 25, 2018.

    2. Comments by interested persons in this proceeding are due no later than July 16, 2018.

    3. Pursuant to 39 U.S.C. 505, the Commission appoints Lyudmila Y. Bzhilyanskaya to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this docket.

    4. The Secretary shall arrange for publication of this order in the Federal Register.

    By the Commission.

    Ruth Ann Abrams, Acting Secretary.
    [FR Doc. 2018-12200 Filed 6-6-18; 8:45 am] BILLING CODE 7710-FW-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 1 and 27 [WT Docket No. 18-120; FCC 18-59] Transforming the 2.5 GHz Band AGENCY:

    Federal Communications Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    In this document, the Federal Communications Commission (Commission or FCC) seeks comment on proposed service rules on the 2.5 GHz band and on refinements to the adopted rules in this document.

    DATES:

    Comments are due on or before July 9, 2018; reply comments are due on or before August 6, 2018.

    ADDRESSES:

    You may submit comments, identified by WT Docket No. 18-120, by any of the following methods:

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

    Federal Communications Commission's Website: https://www.fcc.gov/ecfs/filings. Follow the instructions for submitting comments.

    People With Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email: [email protected], phone: 202-418-0530 or TTY: 202-418-0432.

    For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    John J. Schauble of the Wireless Telecommunications Bureau, Broadband Division, at 202-418-0797 or by email to [email protected]. For information regarding the PRA information collection requirements contained in this PRA, contact Cathy Williams, Office of Managing Director, at (202) 418-2918 or [email protected].

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's Notice of Proposed Rulemaking, WT Docket No. 18-120, FCC 18-59, adopted and released on May 10, 2018. The complete text of this document is available for public inspection and copying from 8 a.m. to 4:30 p.m. Eastern Time (ET) Monday through Thursday or from 8 a.m. to 11:30 a.m. ET on Fridays in the FCC Reference Information Center, 445 12th Street SW, Room CY-A257, Washington, DC 20554. The complete text is available on the Commission's website at http://wireless.fcc.gov, or by using the search function on the ECFS web page at http://www.fcc.gov/cgb/ecfs/. Alternative formats are available to persons with disabilities by sending an email to [email protected] or by calling the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (tty).

    Comment Filing Procedures

    Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

    Electronic Filers: Comments may be filed electronically using the internet by accessing the ECFS: https://www.fcc.gov/ecfs/filings. Filers should follow the instructions provided on the website for submitting comments. In completing the transmittal screen, filers should include their full name, U.S. Postal Service mailing address, and the applicable docket number, WT Docket No. 18-120.

    Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

    Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

    • All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW, Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.

    • Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Dr., Annapolis Junction, Annapolis, MD 20701.

    • U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington, DC 20554.

    People With Disabilities: 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 & Governmental Affairs Bureau at 202-418-0530 (voice), 888-835-5322 (tty).

    Ex Parte Rules—Permit-But-Disclose

    Pursuant to § 1.1200(a) of the Commission's rules, this NPRM shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with § 1.1206(b). In proceedings governed by § 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

    Initial Regulatory Flexibility Analysis

    As required by the Regulatory Flexibility Act of 1980 (“RFA”), the Commission has prepared an Initial Regulatory Flexibility Analysis (“IRFA”) of the possible significant economic impact on a substantial number of small entities of the policies and rules proposed in the NPRM. The Commission requests written public comment on the analysis. Comments must be filed in accordance with the same deadlines as comments filed in response to the NRPM and must have a separate and distinct heading designating them as responses to the IRFA.

    Paperwork Reduction Act

    This document contains proposed new or modified information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget (OMB) to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the Commission seeks specific comment on how it might further reduce the information collection burden for small business concerns with fewer than 25 employees.

    Synopsis I. Introduction

    1. The 2.5 GHz band (2496-2690 MHz) constitutes the single largest band of contiguous spectrum below 3 gigahertz and has been identified as prime spectrum for next generation mobile operations, including 5G uses. Significant portions of this band, however, currently lie fallow across approximately one-half of the United States, primarily in rural areas. Moreover, access to the Educational Broadband Service (EBS) has been strictly limited since 1995, and current licensees are subject to a regulatory regime largely unchanged from the days when educational TV was the only use envisioned for this spectrum. The Commission proposes to allow more efficient and effective use of this spectrum band by providing greater flexibility to current EBS licensees as well as providing new opportunities for additional entities to obtain unused 2.5 GHz spectrum to facilitate improved access to next generation wireless broadband, including 5G. The Commission also seeks comment on additional approaches for transforming the 2.5 GHz band, including by moving directly to an auction for some or all of the spectrum.

    II. Background

    2. EBS, formerly known as ITFS (Instructional Television Fixed Service), permits the transmission of instructional material for the formal education of students by accredited public and private schools, colleges, and universities.

    3. Currently, eligibility to hold an EBS license is limited to (1) accredited public and private educational institutions, (2) governmental organizations engaged in the formal education of enrolled students, and (3) nonprofit organizations whose purposes are educational and include providing educational and instructional television materials to accredited institutions and governmental organizations. EBS licenses generally are held by state government agencies, state universities and university systems, public community and technical colleges, private universities and colleges, public elementary and secondary school districts, private schools (including Catholic school systems and other religious schools), public television and radio stations, hospitals and hospital associations, and other non-profit educational entities.

    4. EBS licensees operate in 114 megahertz of the 2.5 GHz band; the remaining 80 megahertz is assigned to the Broadband Radio Service (BRS). EBS licensees are authorized to operate on the A, B, C, D, and G channel groups, with each group comprised of three 5.5 MHz channels in the lower or upper band segment and one 6 MHz channel in the mid-band segment. Since 1983 the Commission has allowed EBS licensees to lease their excess capacity to commercial providers, but it has required EBS licensees to retain five percent of their capacity for educational use, and it further has required that they use each channel at least 20 hours per week for educational purposes.

    5. Currently, there are 1,300 EBS licensees holding over 2,190 licenses. EBS licenses generally are based on a 35-mile radius circular Geographic Service Area (GSA) (with an area of 1934 square miles), although due to a historical license modification process the Commission adopted in 2005, many EBS licenses have much smaller, irregular GSAs. Incumbent EBS licenses cover only about one half of the geographic area of the United States in any given channel. In the rest of the country, mostly rural areas west of the Mississippi River, the 2.5 GHz spectrum remains unassigned. There is some EBS spectrum unassigned in urban areas as well, but such spectrum generally is only available in small, irregularly shaped areas between GSAs that are considerably smaller than the area of a 35-mile radius circle.

    6. The Commission suspended the processing of EBS applications in 1993. Only twice since then has the Commission opened filing windows for EBS applications. In 1995, the Commission provided a five-day window for the filing of applications for new construction permits and for major changes to existing EBS facilities. And in 1996, the Mass Media Bureau announced a sixty-day window for the filing of a limited class of applications, but during that window, it only permitted the filing of EBS modification applications and amendments to pending EBS applications proposing to co-locate with an authorized wireless cable facility.

    7. During the past 20 years, the Commission, on several occasions, has considered assigning EBS spectrum licenses by auction. Most recently, the Commission in 2008 decided to use competitive bidding to license unassigned BRS spectrum but held that a “broader record should be developed on how to distribute licenses for unassigned EBS spectrum,” and it sought further comment on how to license unassigned EBS spectrum in the BRS/EBS Second FNPRM.

    8. In response to the BRS/EBS Second FNPRM, commenters proposed various alternative licensing schemes, including awarding licenses through a comparative point system; permitting only consortia to apply for a Basic Trading Area (BTA) license (an area consisting of several counties surrounding a common commercial center); permitting existing licensees to expand their respective GSAs to the borders of the BTA, which would eliminate all white space and in turn, eliminate the need to file applications for new licenses (“GSA maximization”); and permitting licensees to expand their respective GSAs to the borders of the BTA after accepting applications for new stations (reverse GSA maximization). Subsequently, on June 6, 2014, the Catholic Technology Network, the National EBS Association, the Wireless Communications Association International, and the Hispanic Information and Telecommunications Network, Inc. proposed a multi-step process for licensing unassigned EBS spectrum. Unused EBS spectrum, however, has remained generally unavailable since 1995.

    III. Discussion

    9. In accordance with the Commission's goal of making additional spectrum available for flexible use, and to promote use of 2.5 GHz frequencies that have been unassigned for far too long, the Commission proposes and seeks comment on a number of steps to encourage and facilitate more efficient use of this spectrum. First, given the irregularity of current EBS geographic service areas (as well as outdated regulatory requirements), the Commission proposes to rationalize existing EBS holdings so that existing licensees have new opportunities to put 2.5 GHz spectrum to its highest and best use. Second, the Commission seeks comment on whether to open one or more local priority filing windows so that existing licensees, Tribal Nations, and educational entities could get access to unassigned spectrum in the 2.5 GHz band. Third, the Commission proposes to use geographic area licensing to assign any remaining spectrum, which may result in the auction of any licenses for 2.5 GHz spectrum still unassigned after rationalizing holdings and any new filing windows. Finally, the Commission seeks comment on additional approaches for transforming the 2.5 GHz band, including by moving directly to an auction for some or all of the spectrum. The Commission believes the proposed changes discussed herein will reduce unnecessary regulatory burdens on licensees, promote greater spectrum efficiency, and facilitate the full use of EBS spectrum to provide advanced mobile broadband services, particularly in rural areas where this spectrum sits idle today.

    A. Rationalizing Existing 2.5 GHz Holdings

    10. Ensuring that the radio spectrum is used efficiently and intensively is an important public interest goal—a goal that also serves the interests of the existing licensees. The Commission traditionally has recognized that a spectrum policy based on flexible use in regular geographic areas has several advantages. Such flexible use licensing can promote broadband deployment, ensure the spectrum is put to its most beneficial use, allow licensees to respond to consumer demand for new services, and maximize the probability of success for new services.

    1. Regular Geographic License Areas

    11. As an initial step, the Commission proposes to rationalize the GSAs of existing EBS licensees, except grandfathered licensees in the E and F Channel groups, to a defined geographic area, namely, the sum of census tracts that are covered by, or that intersect, a licensee's existing GSA. The Commission proposes that such rationalization should occur automatically (i.e., the Commission would update our licensing records to reflect the change), so existing licensees would not be required to file applications with the Commission or otherwise notify the Commission to effectuate this change.1

    1 The Commission notes that it followed a similar automatic process when ITFS licensees were awarded a protected service area (“PSA”), the precursor to a GSA, and when the PSA was expanded from 15 miles to 35 miles. The Commission also notes that pursuant to our existing rules, grandfathered EBS licensees on the E and F channel groups would not be permitted to expand their GSAs. 47 CFR 27.1216. Pursuant to 47 CFR 27.1216, because there may be both EBS and BRS stations on the same channels in the same market, grandfathered E and F group EBS channels have previously been limited in their ability to expand their GSAs. This may still be the case. The Commission seeks comment on whether rationalizing the holdings of grandfathered EBS licensees on the E and F channel groups would be feasible, whether the Commission could use a similar rationalization scheme as proposed herein for EBS generally, and whether doing so would facilitate more intensive use of 2.5 GHz spectrum.

    12. The Commission seeks comment on whether such expansion should include every census tract that is covered by or that intersects the licensee's existing GSA. Alternatively, should a census tract be included only if a minimum percentage of that census tract overlaps the GSA, and, if so, what should that minimum percentage threshold be (e.g., 10 percent, 25 percent, 50 percent)? The Commission also seeks comment on whether, if the Commission adopts a minimum percentage overlap threshold, that minimum percentage should be a percentage of the census tract's geography or of the census tract's population.

    13. Second, the Commission proposes that, in this rationalization process, each current EBS GSA will be converted to a single license made up of all the census tracts it covers or intersects, rather than converted to a collection of separate licenses, each the size of a single census tract. The Commission seeks comment on this proposal.

    14. Finally, the Commission seeks comment on how to resolve situations in which two or more co-channel GSAs overlap the same census tract(s), and whether simply setting the threshold for required overlap at 50 percent in order to include the census tract in the GSA is the best way to address such a situation. Are there other ways to address situations in which co-channel GSAs overlap the same census tracts?

    15. Modifying EBS licenses to GSAs based on census tracts should generate two particular benefits. First, since census tract boundaries are pre-determined and follow regular geographic separation patterns (e.g., divisions based on streets), the boundaries of census tract-based GSAs should be easier to determine than a circular GSA that cuts across regular geographic boundaries.

    16. Second, rationalizing incumbent EBS licenses based on census tracts would yield white spaces that also are based on the boundaries of census tracts and/or counties (since census tracts nest into counties), rather than irregular shapes and slivers. This regularity in the shape and size of white spaces would facilitate new entry into the 2.5 GHz band. The Commission seeks comment on these views. Commenters should discuss the costs and benefits of such a license area change.

    17. As an alternative to basing GSAs on census tracts, the Commission seeks comment on whether the Commission should expand existing GSAs to include the counties covered by or that intersect the GSA. Under this alternative, the Commission seeks comment on whether to include a county only if a minimum percentage of the county overlaps the GSA and, if so, what that minimum percentage should be (e.g., 50 percent, 75 percent). The Commission also seeks comment on whether, if it adopts a minimum percentage overlap threshold, that the minimum percentage should be a percentage of the county's geography or of the county's population. In addition, the Commission seeks comment on how to resolve situations where more than one EBS licensee is in the same county, and whether and to what extent automatic expansion on a county basis will result in inefficient use of spectrum.

    18. The Commission also seeks comment on any other issue that may arise from rationalizing existing EBS holdings and allowing EBS licensees to apply to expand their GSA boundaries. In addition to the criteria stated above, are there any other requirements that existing licensees should satisfy in order to be permitted to expand into the vacant area of a county? For instance, should the right to expand to county boundaries be limited to licensees that provide service to a given percentage of that county? If so, what should the minimum percentage be? Should the minimum percentage be a percentage of the county's geography or of the county's population? Should the Commission establish a requirement that the incumbent licensee's GSA cover a minimum percentage of the area in a county before it is allowed to expand into the remainder of the county? In the alternative, should the Commission simply have existing licensees maintain their current contours, rather than rationalizing existing holdings? Commenters should discuss cost and benefits of any advocated approach and support their position with quantitative and qualitative data.

    2. Additional Flexibility for EBS Licenses

    19. Granting additional flexibility to EBS licensees has been an effective means of allowing better use of the 2.5 GHz band. In 1983, when the Commission allowed 2.5 GHz licensees to lease excess capacity, it provided educators with another means of acquiring the resources needed to operate Instructional Television Fixed Source (ITFS) facilities for education. In 2004, when the Commission created BRS and EBS, the more flexible technical rules allowed the bands to be used for broadband services. Now, significant amounts of commercial broadband data flow through the 2.5 GHz band. The Commission believes subsequent events have confirmed the Commission's prediction that “consumer benefits will be maximized if BRS/EBS licensees are able to take advantage of the flexible use standard in Part 27.” The Commission now seeks comment on granting additional flexibility to EBS licensees in order to promote more intensive and efficient spectrum use.

    20. First, the Commission proposes to provide EBS licensees with the flexibility to assign or transfer control of their licenses to entities that are not EBS-eligible. Specifically, the Commission proposes to eliminate the limit on what entities can hold EBS licenses (rule 27.1201) and make clear that licensees may assign or transfer control of their licenses to other entities. The Commission notes that the existing licensees have built out their systems since 2011 and understand how they use their EBS licenses as well as the availability of wireless broadband in their area. Under this proposal, the decision whether to lease or transfer a license would rest with the EBS licensee.2 There is little reason to think that, at this point in time, the Commission is better positioned than licensees themselves to determine how to maximize the use of 2.5 GHz spectrum for licensees and their communities. And there is little reason to think that licensees should not be allowed to decide for themselves whether to continue to hold their licenses or to transfer their licenses to a third party in the secondary market. The Commission seeks comment on this proposal.

    2 If the EBS licensee's lease provides for an option or right or right of first refusal with respect to a license, the provisions of the contract would apply, subject to the requirement that all assignments and transfers of Commissions licenses are subject to Commission consent.

    21. EBS licensees whose licenses were granted via waiver since the EBS filing freeze was instituted are currently prohibited from leasing the spectrum. Consistent with our consideration of providing additional secondary-markets flexibility to existing EBS licensees, the Commission proposes to eliminate any special restrictions on such licensees; accordingly, those whose licenses were granted via waiver would have the same flexibility to lease their spectrum or to transfer or assign their licenses as the Commission proposes for other EBS licensees. The Commission seeks comment on this proposal.

    22. The Commission also seeks comment on eliminating the educational use requirements for EBS licensees. The educational use requirements, which have not been updated since 1998 were based on the use of analog video and permitted many administrative uses to fulfill the educational requirement. However, most EBS licensees or their commercial lessees are providing digital broadband service, offered 24/7, at the school itself, at home, or anywhere within the licensee's GSA. It appears the existing educational use requirements are out of date and do not fit the actual use of the spectrum. Given the additional flexibility the Commission is granting EBS licensees, the Commission seeks comment on whether there is value in attempting to update the educational use requirements—who is better positioned to determine the highest and best use of 2.5 GHz spectrum, the Commission or licensees? Commenters should explain and quantify the benefits and costs of these regulatory requirements, including whether to update them (and if so, how).

    23. The Commission also proposes to eliminate the current restrictions on EBS lease terms. Under existing rules, EBS licensees are prohibited from leasing their facilities for a term longer than 30 years and lessees are required to provide EBS lessors with the opportunity to revisit their lease terms at years 15, 20, and 25 to review their “educational use requirements in light of changes in educational needs, technology, and other relevant factors and to obtain access to such additional services, capacity, support, and/or equipment as the parties shall agree upon in the spectrum leasing arrangement to advance the EBS licensee's educational mission.” To that end, the Commission proposes to eliminate these lease restrictions on a going-forward basis.3 The Commission also seeks comment on any other revisions needed to fully rationalize our rules for the transferability, leasing, and use of EBS spectrum. Are there other restrictions that unnecessarily reduce the ability of licensees to put this spectrum to its highest and best use?

    3 While the Commission proposes to eliminate EBS-specific term-related restrictions for leases, the Commission does not propose to eliminate the requirement that lease notifications must be refiled for each new license term.

    24. Finally, the Commission asks whether, in light of the actions the Commission takes in this proceeding, it should modify our treatment of EBS in the spectrum screen. In the Mobile Spectrum Holdings Report and Order, the Commission concluded that it was necessary to include most EBS spectrum into the spectrum screen “to reflect today's marketplace realities.” While the Commission found that EBS spectrum generally was suitable and available for the provision of mobile telephony/mobile broadband services, it did apply a discount. Specifically, the Commission first excluded the five percent of the EBS capacity that is reserved for educational uses because it remains committed to EBS spectrum serving educational purposes. Second, it excluded the EBS white space. After taking these discounts into consideration, the Commission, in 2014, included 89 megahertz of EBS spectrum in the screen. Are any changes to this treatment warranted? Should the Commission reconsider the spectrum aggregation screen?

    B. Opportunities To Acquire New 2.5 GHz Licenses

    25. Once the Commission has rationalized the holdings of existing EBS licensees, unassigned portions of the 2.5 GHz band will be ready for new assignment—bringing new opportunities to rural communities that have lacked access to this spectrum before. The Commission proposes to use geographic area licensing to assign any remaining spectrum, which should result in the auction of licenses for unassigned portions of the 2.5 GHz band and seek comment on whether it should first open up to three new local priority filing windows to give existing licensees, Tribal Nations, and educational entities an opening to access 2.5 GHz spectrum to serve their local communities. The Commission also proposes build-out requirements for these new licenses to ensure that all Americans have the opportunity to benefit from the 2.5 GHz band.

    1. New Local Priority Filing Windows

    26. When the Commission reopened applications for the 2.5 GHz band in 1985, it expressed a “strong preference” for local applicants in the licensing process. The Commission found then that local applicants were “convincingly demonstrated . . . to be the best authorities for evaluating their educational needs and the needs of others they propose to serve in their communities,” to “best understand the educational needs . . . of their communities,” and to “act most responsibly in designing and developing [2.5 GHz] systems.” It thus opened a “local priority period” to give “more local entities . . . the opportunity to fill more channels as financial support from non-[instructional] use becomes more widespread.”

    27. Now that the Commission is again opening the 2.5 GHz band for additional licensing, the Commission starts by seeking comment on whether the Commission should open up to three new filing windows for qualifying applicants that want to use currently unassigned 2.5 GHz spectrum to serve their local communities. In each filing window, qualifying applicants would have the opportunity to apply for one or more vacant channels of EBS spectrum in areas where the applicant can show it has a local presence. The first filing window would be for existing EBS licensees, the second for Tribal Nations, and the third for other educational entities. The Commission seeks comment on whether the Commission should open any new local priority filing windows, if any, as well as the details of such windows in turn.

    28. In responding, commenters should discuss whether such priority filing windows to assign licenses is consistent with our statutory authority to assign licenses that could be used for telecommunications, and Commission policy and precedent regarding use of competitive bidding. Also, should these entities be given preference over others, in light of other benefits provided to these entities, such as various Universal Service programs, including E-Rate and the Connect America Fund? The Commission also seeks comment on whether such filing windows can be misused and result in unjust enrichment, with licenses being sold or leased to ineligible entities for profit. What effect might these priority windows have on the attractiveness of the remaining spectrum for other applicants? Should the Commission have one combined priority window for these entities, or the three the Commission seeks comment on below?

    29. Local Presence. When the Commission previously created a local priority period, it defined as “local” those “institutions and organizations that are physically located in the community, or metropolitan area, where service is proposed.” The Commission proposes for any new local priority filing window, should the Commission choose to implement this approach, to similarly require an applicant to demonstrate, as part of the application process, that it is physically located within the license area applied for. The Commission seeks comment on this requirement and what it would mean in practice. For example, should a college or university be considered to be physically located in any area in which it has a campus? Should an entity created by a state or local government for the purpose of serving formal educational needs, such as a public school or a school district, be considered to be physically located in every area where it has a school building? Should having a physical or mailing address within a particular area, be sufficient to demonstrate that the applicant has a local presence within that area? Are there any situations in which simply having some sort of physical address is not indicative of the local presence of an applicant? Commenters should discuss whether the proposed definition of local presence would serve the public interest and provide any relevant qualitative and quantitative data to support their positions.

    30. Commenters also should address what documentation applicants must provide to make such a demonstration. Should the determination of whether an applicant is considered to have a local presence be based solely on an applicant's physical location(s) and/or physical address(es)? Commenters should discuss other factors that should be considered and explain how any factors that they suggest will ensure that the local priority filing window is available only to local applicants. The Commission also seeks comment any other issues that it may need to address to implement a local presence requirement.

    31. The Commission notes that the majority of current EBS licensees, such as school districts, schools, colleges and universities, appear to have a local presence where they have licenses. It also appears that the entities most likely to be affected by a local presence requirement are the “national” licensees. Although national licensees serve a purpose in providing educational services to educational institutions and students, educational entities with a local presence have a closer understanding of the needs of their local communities and are more likely to use 2.5 GHz spectrum to meet such needs, especially in rural areas. Entities with a local presence are part of the communities they wish to serve, and requiring local presence would increase the likelihood that the EBS spectrum would be put to beneficial use for local communities. The Commission seeks comment on these views.

    32. Local Priority Filing Window 1: Existing Licensees. If the Commission decides to use priority filing windows, the Commission seeks comment on whether it should open a window for existing EBS licensees. Opening such a window would allow existing licensees that are already providing service in a significant portion of a county (and have a local presence in that county) to expand their service to the county border.4 Existing licensees have already deployed service throughout a portion may be best positioned to quickly put the white-spaces in their local area to use through an edging-out strategy. In addition, since a number of school districts are based on county boundaries, allowing county expansion could allow county-based school districts to better provide services to the students within their districts, and in many cases, to provide services to those students at home, as well as on school premises. Alternatively, such a window would preclude other applicants from accessing 2.5 GHz white spaces, including new entrants long excluded from the band. The Commission seeks comment on opening such a local priority filing window.

    4 To be clear, should another licensee already hold licenses for census tracts in that county, the Commission would not intend the county-expansion to encompass those areas.

    33. Were the Commission to open such a window, it would propose to limit participation to existing licensees as of the adoption of this NPRM. 5 Setting a firm, fixed date allows all commenters and the Commission to easily discern what entities would be potential applicants for this window should the Commission adopt it. Furthermore, applicants in this window would be limited to seeking county-based licenses only in counties where they have a local presence. And finally, applicants in this window would be limited to seeking county-based licenses only where they hold, after the rationalization of existing license areas, licenses on a particular channel that cover at least 25 percent of census tracts in a county. The Commission seeks comment on these conditions. In particular, what adjustments to these conditions, if any, would be appropriate to ensure that the goals of such a window would be met? For example, should the Commission require licensees to hold licenses covering even more of a county (say 50 percent of census tracts)? Or should the Commission require that a local presence of the licensee lie inside the county but outside the already-licensed area of the licensee (under a theory that licensees should be permitted to expand to cover areas where they have a physical presence but otherwise restricted so that new licensees have the opportunity to participate in the 2.5 GHz band)?

    5 The Commission seeks comment on whether holders of special temporary authority (an STA) who are not full-fledged licensees should qualify for such a window. Should the Commission expect them to have the permanent facilities in place to quickly expand service to the county edge?

    34. What other conditions, if any, should the Commission adopt on participants in such a window? For example, should the Commission exclude channels in counties in which more than one existing licensee would qualify for expansion on a single channel? If so, how would the Commission determine all counties in which existing licensees meet the local presence requirement? Alternatively, should the Commission only exclude channels in counties in which more than one licensee holds licenses covering at least 25 percent of the census tracts in the county? Should the Commission exclude tribal areas that are contained within a county that would be subject to the Tribal Nations window discussed below? The Commission seeks comment on these and any other issues related to opening a new local priority filing window for existing licensees.

    35. Local Priority Filing Window 2: Rural Tribal Nations. The Commission seeks comment on whether the Commission, if it decides to pursue this approach, should open a new local priority filing window for rural Tribal Nations. The Commission has recognized that “members of federally-recognized American Indian Tribes and Alaska Native Villages and other residents of Tribal lands have lacked meaningful access to wired and wireless communications services.” Opening such a window would allow rural Tribal Nations an opportunity to access 2.5 GHz spectrum to address educational and communications needs of their communities and residents on rural Tribal lands, including the deployment of advanced wireless services to areas that have too long been without. Alternatively, such a window would preclude other applicants from accessing 2.5 GHz white spaces. The Commission seeks comment on opening such a local priority filing window.

    36. Were the Commission to open such a window, it would propose to limit participation to federally-recognized American Indian Tribes and Alaska Native Villages located in rural areas.6 Such a request would appear to comport with Native Public Media's request to open the 2.5 GHz band to Indian Tribes and Tribal Governments to account for the special trust relationship between Tribal Nations and the Federal Government and the fact that Native Americans are acutely underrepresented in communications media. Furthermore, applicants in this window would be limited to seeking new licenses only in rural areas where they have a local presence—that would include rural Tribal lands associated with the Tribal Nation itself. The Commission seeks comment on how much of the license area would need to be Tribal lands to qualify. Would 25 percent be sufficient? 50 percent? The Commission further seeks comment on how to define rural Tribal lands for these purposes. Should the Commission use the definition of rural Tribal lands used for E-rate program and Lifeline; i.e., Tribal Lands that are not part of “an urbanized area or urban cluster area with a population equal to or greater than 25,000”? The Commission asks commenters to discuss any issues that may arise out of a particular definition of Tribal Lands. The Commission seeks comment on whether to exclude lands that currently are not inhabited by members of the Tribal Nations and/or are held as private property from the definition. To this end, the Commission requests comment on how to ensure that the only entities eligible to participate in this filing window are entities that meet our definition of a Tribal Nation, and whose Tribal lands are lands where tribal members reside as a group and are not used for purely commercial purposes. The Commission seeks comment on these conditions. In particular, what adjustments to these conditions, if any, would be appropriate to ensure that the goals of such a window would be met?

    6 Alternatively, should the Commission authorize any “Native American Tribal entity” to participate, including any entity that is listed on the U.S. Secretary of the Interior's currently published list of Indian Tribes recognized to be eligible for the special programs and services provided by the United States to Indians because of their status as Indians? See The Federally Recognized Indian Tribe List Act of 1994 (Indian Tribe Act, Pub. L. 103-154, 108 Stat. 4791 (1994)) (Indian Tribe Act).

    37. The Commission next seeks comment on whether licenses granted for white spaces in such a local priority window should be at the county level or on a census-tract-by-census-tract basis. Commenters should discuss why a particular geographic area size would be appropriate taking into account all relevant information, including border interference coordination needs, propagation characteristics of the band, and the services that will be offered. The Commission notes that using a smaller license area (census tracts) would increase the fit between areas licensed to Tribal Nations and Tribal lands, but may have offsetting efficiency losses. Commenters should discuss the costs and benefits of any advocated approach and support their position with quantitative and qualitative data.

    38. The Commission also proposes that, if it were to adopt such a local priority filing window, it would not limit the number of channels that a Tribal Nation could acquire. Given the state of wireless technologies (including the use of progressively wider channels), the Commission believes that allowing access to contiguous spectrum on any number of available channels would more efficiently accommodate varying business models and spectrum needs for wireless broadband. The Commission seeks comment on this proposal.

    39. Finally, the Commission seeks comment on any other ways by which it could encourage the use of 2.5 GHz spectrum on Tribal Lands. Should the Commission impose any additional obligations to ensure that Tribal Nations hold 2.5 GHz licenses for the benefit of their Tribal community? The Commission seeks comment on these and any other issues related to opening a new local priority filing window for Tribal Nations, and in particular it seeks government-to-government consultation and coordination with federally recognized Tribes on these issues and the input of inter-Tribal government associations and Native representative organizations.

    40. Local Priority Filing Window 3: New Educational Entities. To the extent that the Commission implements any filing windows, it seeks comment on whether the Commission should open a new local priority filing window for educational entities that do not currently hold any 2.5 GHz licenses. Opening such a window would allow new educational entities that have never had the opportunity to benefit from holding and using 2.5 GHz spectrum (and that have a local presence in a particular area) the opportunity to access this spectrum for the first time. The Commission notes that the majority of requests for waiver of the current filing freeze have come from educators with a local presence in the communities that they wish to serve. Alternatively, such a window would preclude the auction of any licenses for remaining 2.5 GHz white spaces. The Commission seeks comment on opening such a local priority filing window.

    41. Were the Commission to open such a window, it would propose to limit participation to accredited institutions as well as governmental organizations engaged in the formal education of enrolled students who are not 2.5 GHz licensees as of the adoption of this NPRM. 7 Setting a firm, fixed date allows all commenters and the Commission to easily discern what entities would be potential applicants for this window should it adopt it. Furthermore, applicants in this window would be limited to seeking licenses only in areas where they have a local presence. The Commission seeks comment on these conditions. In particular, what adjustments to these conditions, if any, would be appropriate to ensure that the goals of such a window would be met?

    7 As before, the Commission seeks comment on whether holders of special temporary authority (an STA) who are not full-fledged licensees should qualify for such a window.

    42. The Commission next seeks comment on whether licenses granted for white spaces in such a local priority window should be at the county level or on a census-tract-by-census-tract basis. Commenters should discuss why a particular geographic area size would be appropriate taking into account all relevant information, including border interference coordination needs, propagation characteristics of the band, and the services that will be offered. Since a number of school districts are based on county boundaries, would allowing county-based licenses allow county-based school districts to better provide services to the students within their districts, and in many cases, to provide services to those students at home, as well as on school premises? Commenters should discuss the costs and benefits of any advocated approach and support their position with quantitative and qualitative data.

    43. The Commission also proposes that, if it were to adopt such a local priority filing window, it would not limit the number of channels that a new educational entity could acquire. Given the state of wireless technologies (including the use of progressively wider channels), the Commission believes that allowing access to contiguous spectrum on any number of available channels would more efficiently accommodate varying business models and spectrum needs for wireless broadband. The Commission seeks comment on this proposal.

    44. Local Priority Filing Process. The Commission seeks comment on the appropriate time frame for any new local priority filing windows. How long should the Commission keep this window open, and how much notice should be given to applicants before the filing window opens? For example, should each such filing window last 30 days with at least 90 days' notice to potential applicants of the licenses available? The Commission asks entities that are interested in participating in the application window and obtaining 2.5 GHz licenses to indicate their interests and the difficulties that they may face to help us evaluate any possible technical and process issues that may arise in implementing one or more new local priority filing windows for applicants and processing such applications. Given technical limitations of the Universal Licensing System (ULS), the Commission notes that it may not be able to accept applications for all available EBS licenses in one general filing window. If that is the case, and the Commission divides the available licenses among multiple filing windows, how should such division be implemented: by region; by population, with the most populous States first or last; alphabetically; or by some other method? The Commission seeks comment on these and related issues.

    45. Resolving Mutually Exclusive Applications. The Act requires that, if the Commission accepts mutually exclusive applications for initial spectrum licenses, the Commission “shall grant the license . . . through a system of competitive bidding.” The Commission assigns licenses for commercial and private internal use through competitive bidding in order to place the licenses in the hands of the parties that value them most highly and that are able to use them most effectively. If the Commission decides to create one or more local priority filing windows, as discussed here, it would result in relatively few mutually exclusive applications, but such a result is not precluded. Therefore, should the Commission receive mutually exclusive applications, it must use competitive bidding to assign initial licenses subject to mutually exclusive applications. The Commission seeks comment on limiting such competitive bidding to the mutually exclusive applicants in that particular filing window, however. In addition, the Commission proposes to employ the part 1 rules governing competitive bidding design, unjust enrichment, application and payment procedures, reporting requirements, and the prohibition on certain communications between auction applicants. The Commission does not propose to adopt designated entity provisions. Under this proposal, such rules would be subject to any further modifications that the Commission may adopt for its part 1 general competitive bidding rules in the future. The Commission seeks comment on this proposal.

    46. The also seeks comment on whether to allow a settlement window for the filers to resolve any mutual exclusivity before the Commission accept any application for a 2.5 GHz license. The Commission also seeks comment on any alternative “engineering solutions, negotiation, threshold qualifications, service regulations, and other means” 8 of avoiding mutually exclusive applications for new licenses that might further the public interest and comply with the Act.

    8 47 U.S.C. 309(j)(6)(E).

    47. Holding Periods for Licenses Acquired through a Local Priority Filing Window. The Commission seeks comment on whether to impose a special holding period on any license acquired through a local priority filing window, if any. Although the Commission generally seeks to facilitate the free transfer of licenses among parties, granting certain entities local priority filing windows is premised on the idea that such entities are uniquely qualified to hold spectrum licenses and ensures that the licenses are put to their highest and best use—something that could not occur if such an entity quickly flipped that license to another, nonqualifying entity. Should the Commission expect that these licenses are likely to be used by the licensee, or that they ultimately will be leased or sold to others who are not eligible for the priority preference? Should the Commission implement a holding period that deters the lease or sale of spectrum to ineligible entities? What factors should the Commission consider in establishing a holding period? What is the most appropriate length for a holding period so as to alleviate concerns involving any potential for speculative behavior or acquisition of 2.5 GHz licenses by entities that do not have a bona fide interest in providing service? Would a three, five, or seven-year or more holding period be most appropriate for these circumstances? In determining the appropriate length of holding period, should the Commission consider the chances for and mitigate the potential unjust enrichment by those receiving a priority preference? Are there additional steps that should be taken to ensure that entities are not unjustly enriched? Should the Commission require the licensee to demonstrate completion of certain buildout requirements before allowing a transfer of control? Should the Commission prohibit an EBS licensee that is granted a license during one of the local priority windows proposed herein from leasing 100 percent or some other percentage of their capacity to a commercial entity during the holding period? The Commission seeks comment on these issues.

    48. For EBS licenses granted via the local priority windows proposed above, the Commission proposes to require that licensees must reserve a minimum of 20 percent of the capacity of their channels for educational uses that “further the educational mission of accredited public and private schools” consistent with paragraphs (b) and (c) of § 27.1203 of the Commission's rules and may not enter into spectrum leasing arrangements involving this reserved capacity. For EBS licensees that choose to provide a broadcast-type service, the Commission proposes to require such licensees to offer 20 hours per channel, per week of educational programming. The Commission seeks comment on these proposals.

    2. Licensing White Spaces

    49. The Commission proposes, after any new licenses have been assigned through one or more local priority filing windows should the Commission choose to implement that approach, that any remaining 2.5 GHz spectrum 9 be made available for commercial use via competitive bidding. The Commission proposes that it would conduct an auction for licenses of EBS spectrum in conformity with the general competitive bidding rules set forth in part 1, subpart Q, of the Commission's rules. As proposed above for mutually exclusive applications filed in the three EBS filing windows, the Commission proposes to employ the part 1 rules governing competitive bidding design, unjust enrichment, application and payment procedures, reporting requirements, and the prohibition on certain communications between auction applicants. The Commission also proposes not to apply designated entity preferences in this auction. The Commission seeks comment on this proposal.

    9 In the BRS/EBS Second FNPRM, the Commission sought comment on a variety of issues related to licensing EBS spectrum in the Gulf of Mexico. The Commission need not address whether to eliminate restrictions on EBS spectrum in the Gulf of Mexico because, as explained herein, the Commission proposes to eliminate restrictions on all remaining “white space” EBS spectrum and make it available for commercial use via competitive bidding.

    50. The Commission seeks comment on the appropriate geographic size of new 2.5 GHz white space licenses (e.g., county, census tract, or something else) and the size of the channel blocks (e.g., existing channels or the entire available band). Commenters should discuss the costs and benefits of adopting their proposed geographic area size and channel block size and why such area and channel block sizes would serve the public interest taking into account all the characteristics of this band.

    51. Consistent with our longstanding approach, the Commission would initiate a public notice process to solicit public input on certain details of auction design and the auction procedures. This public notice process would address auction-specific matters such as the competitive bidding design and mechanisms, minimum opening bids and/or reserve prices, caps on bidding credits, and payment procedures. In advance of the auction, another public notice would announce the auction procedures and provide detailed instructions for potential auction participants. The Commission also seeks comment on whether any of our part 1 rules should be modified for an auction of licenses in these frequency bands.

    3. Requirements for New 2.5 GHz Licenses

    52. The current performance requirements for licensees in the 2.5 GHz band were set forth in 2006, as part of the ongoing efforts to transition the band to the new band plan established in 2004. The 2006 BRS/EBS Second Report and Order established a substantial service regime for BRS and EBS licensees and required licensees to demonstrate compliance by May 1, 2011. The 2006 BRS/EBS Second Report and Order also established specific safe harbors, including 30 percent population coverage for mobile or point-to-multipoint use, or six permanent links per million for fixed point-to-point services. The 2006 BRS/EBS Second Report and Order also established an educational safe harbor for EBS licensees, consisting of 20 hours of educational use per channel, per week. In 2010, the Commission established a new requirement for new BRS licenses issued after November 6, 2009: The licensee must make a showing of substantial service within four years from the date of issue of the license. The Commission seeks comment on how effective these performance requirements have been.

    53. Last year, the Commission adopted a unified regulatory framework for the Wireless Radio Services (WRS) that replaced the existing patchwork of service-specific rules regarding renewal, comparative renewal, continuity of service, and partitioning and disaggregation, with clear, consistent rules of the road for WRS licensees. The Commission included BRS in the new WRS framework, but excluded EBS from the WRS framework on the ground that “this service presents unique issues that are under consideration in” this present proceeding.

    54. Performance Requirements for New 2.5 GHz Licenses. The Commission proposes more robust performance requirements for any new 2.5 GHz licenses granted through a local priority filing window or a system of competitive bidding. For mobile and fixed point-to-multipoint services, the Commission proposes an interim benchmark of 50 percent population coverage and a final benchmark of 80 percent population coverage. For fixed point-to-point services, the Commission proposes an interim benchmark of 20 point-to-point links per million persons (one link per 50,000 persons) in a license area, and a final benchmark of 40 point-to-point links per million persons (one link per 25,000 persons) in a licensed area. These benchmarks are slightly higher than those for the AWS-3 and WCS bands (which have similar propagation characteristics) given the maturity of technologies already developed and deployed in the 2.5 GHz band. For educational broadcast services, the Commission seeks comment on an interim benchmark of 50 percent population coverage and a final benchmark of 80 percent population coverage. The Commission seeks comment on these performance benchmarks and on any other requirements that may be more appropriate for this band. Are there considerations specific to this band that would warrant a different approach? Are there new technological developments, or issues specific to the 2.5 GHz band, that render a usage-based approach or any other approach suitable here? When should the interim benchmark showing be required? What penalty should apply to licensees that do not meet it? In addition, because the Commission seeks comment on whether to adopt a licensing framework based on census tracts, the Commission also seeks comment on how such a framework would affect performance requirements. Is there some other method of evaluating meaningful service, beyond traditional metrics, that might be more appropriate considering the size of license areas? The Commission also seeks comment on whether there are other more appropriate construction requirements for educational services.

    55. Renewal Standards. The Commission also proposes to bring any new 2.5 GHz licenses granted through a local priority filing window or a system of competitive bidding into the unified regulatory renewal framework for WRS. The Commission believes that updating the renewal standards in this manner will encourage rapid deployment of next generation wireless services, including 5G. The Commission also seeks comment on bringing existing EBS licensees, once their licenses have been rationalized as discussed earlier, into the WRS framework for license renewal. What are the costs and benefits of each approach?

    C. Cleaning Up the 2.5 GHz Rules

    56. The process for transitioning BRS and EBS licensees to the new band plan was completed in 2011. While a few Multichannel Video Programming Distributors have received waivers to opt out of the transition so that they can continue providing service, all other licensees have transitioned to the new band plan. It therefore appears that the transition rules are no longer necessary.10 The Commission believes it is in the public interest to eliminate regulations that are out of date and no longer necessary. The Commission therefore proposes to eliminate the BRS/EBS transition rules.

    10 Should an MVPD operator decide that it wishes to discontinue video service and transition to the new band plan, it can follow the process established by the Wireless Telecommunications Bureau in Antilles Wireless, LLC d/b/a USA Digital, et al., Order on Reconsideration, 25 FCC Rcd 8052, 8058, paras. 13-14 (WTB 2010).

    57. The Commission also proposes to make various non-substantive, clarifying amendments to § 27.1206. The proposed changes are contained in the Proposed Rules. The changes are designed to make the rules easier to understand without changing the substantive requirements for BRS. The Commission seeks comment on these proposed changes.

    D. Additional Approaches for Transforming the 2.5 GHz Band

    58. The Commission seeks comment on other approaches to rationalizing and opening up the 2.5 GHz band for more productive and intensive use. Generally, are there better ways to restructure the 2.5 GHz band that will ensure that it is put to its highest and best use? In particular, the Commission seeks comment on other licensing and auction ideas and alternatives to the local priority filing window approach. Commenters should provide information about the costs and benefits of any approach suggested.

    59. For instance, should the Commission, regardless of the scope of incumbent operations, create new geographic area licenses? If so, what types of geographic area licenses should the FCC create? Should the Commission license the spectrum based on census tracts or counties or some other size? Commenters should discuss whether their view of the appropriate geographic area size changes if the Commission is considering licenses that encompass more than the white spaces previously discussed, and if so why. Additionally, what channel size or sizes should the Commission use in licensing this spectrum?

    60. If the FCC were to adopt this approach, how would the Commission account for reasonable investment-backed expectations and incumbent operations? Would a different approach than those considered in section III.A. above be preferable, and if so why? For example, should the Commission convert incumbent licenses into new, flexible use spectrum licenses that would be subject to its secondary market rules? If so, how? Should our approach to incumbent licensees depend on or consider the existing and/or historic use of the spectrum by those incumbent licensees, including, for instance, the construction of facilities or degree to which the spectrum has consistently been put to use?

    61. Should the Commission consider moving directly to auction for this spectrum, rather than open priority filing windows for certain entities? In section III.B.2, the Commission seeks comment on auctioning the white spaces, but, instead, should the Commission consider other auction options, such as an incentive auction of this spectrum in order to provide incentives for incumbents to make underutilized spectrum available for commercial use? In particular, should the Commission rely on § 6402 of the Spectrum Act, now codified at 47 U.S.C. 309(j)(8)(G) (or some other source of authority) to encourage incumbent licensees to relinquish voluntarily some or all of their spectrum usage rights to permit the assignment of new initial licenses subject to flexible-use service rules? Are there other means of assigning licenses and promoting more efficient uses that the Commission should consider, such as an overlay auction 11 or other auction mechanisms? The Commission seeks comment on the implications of moving directly to auction.

    11 In an overlay auction, the auction winner acquires spectrum rights “subject to the exclusion of overlapping, co-channel incumbent” licensees. Typically, if an incumbent license cancels or is forfeited, the overlay licensee automatically acquires the right to operate in the area formerly covered by the incumbent license.

    62. Regardless of the particular approach the Commission takes to facilitate more intensive use of the 2.5 GHz spectrum, should the Commission allow all entities that are interested in using this spectrum the same opportunity to acquire licenses in this band? In other words, should the Commission not adopt local priority filing windows or otherwise grant preferential treatment to potential licensees based on their identity or other criteria?

    IV. Initial Regulatory Flexibility Analysis

    63. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the NPRM. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments provided on the first page of the NPRM. The Commission will send a copy of this NPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In addition, the NPRM and IRFA (or summaries thereof) will be published in the Federal Register.

    A. A. Need for, and Objectives of, the Proposed Rules

    64. In the NPRM, the Commission take steps to permit more flexible use of the 2496-2690 MHz (2.5 GHz) band by current EBS licensees and to provide new opportunities for EBS eligible entities, Tribal Nations, and commercial entities to obtain unused 2.5 GHz spectrum to facilitate improved access to next generation wireless broadband, including 5G, for both educational and commercial uses. As mentioned in the NPRM, roughly half of EBS spectrum currently is unassigned, while the other half is assigned in geographic areas of various sizes and shapes and is subject to unique use and transfer restrictions. The irregularity in the current geographic service areas, combined in some cases with outdated regulatory requirements has impeded the efficient deployment of services, such as mobile broadband, in this spectrum band. Consistent with the Commission's goal of making additional spectrum available for flexible use, and to promote use of EBS frequencies that have been unassigned for far too long, the Commission proposes and seeks comment on a number of steps to encourage and facilitate more efficient use of the 2.5 GHz band. Additionally, since the process for transitioning BRS and EBS licensees to the new band plan was completed in 2011, the Commission proposes to eliminate the BRS/EBS transition rules. The Commission believes it is in the public interest to eliminate these regulations that are out of date and no longer necessary.

    B. B. Legal Basis

    65. The proposed actions are authorized pursuant to Sections 1, 2, 3, 4(i), 7, 201, 301, 302, 303, 304, 307, 308, 309, and 310 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 157, 201, 301, 302, 303, 304, 307, 308, 309, 310 and Section 706 of the Telecommunications Act of 1996, as amended, 47 U.S.C. 1302.

    C. C. Description and Estimate of the Number of Small Entities to Which the Proposed Rules Will Apply

    66. The RFA directs agencies to provide a description of, and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules and policies, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.

    67. Small Businesses, Small Organizations, Small Governmental Jurisdictions. Our actions, over time, may affect small entities that are not easily categorized at present. The Commission therefore describes here, at the outset, three broad groups of small entities that could be directly affected herein. First, while there are industry specific size standards for small businesses that are used in the regulatory flexibility analysis, according to data from the SBA's Office of Advocacy, in general a small business is an independent business having fewer than 500 employees. These types of small businesses represent 99.9 percent of all businesses in the United States which translates to 28.8 million businesses.

    68. Next, the type of small entity described as a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, as of August 2016, there were approximately 356,494 small organizations based on registration and tax data filed by nonprofits with the Internal Revenue Service (IRS).

    69. Finally, the small entity described as a “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” U.S. Census Bureau data from the 2012 Census of Governments indicate that there were 90,056 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number there were 37,132 General purpose governments (county, municipal and town or township) with populations of less than 50,000 and 12,184 Special purpose governments (independent school districts and special districts) with populations of less than 50,000. The 2012 U.S. Census Bureau data for most types of governments in the local government category show that the majority of these governments have populations of less than 50,000. Based on this data the Commission estimates that at least 49,316 local government jurisdictions fall in the category of “small governmental jurisdictions.”

    70. Wireless Telecommunications Carriers (except Satellite). This industry comprises establishments engaged in operating and maintaining switching and transmission facilities to provide communications via the airwaves. Establishments in this industry have spectrum licenses and provide services using that spectrum, such as cellular services, paging services, wireless internet access, and wireless video services. The appropriate size standard under SBA rules is that such a business is small if it has 1,500 or fewer employees. For this industry, U.S. Census Bureau data for 2012 show that there were 967 firms that operated for the entire year. Of this total, 955 firms had employment of 999 or fewer employees and 12 had employment of 1,000 employees or more. Thus under this category and the associated size standard, the Commission estimates that the majority of wireless telecommunications carriers (except satellite) are small entities.

    71. Broadband Radio Service and Educational Broadband Service. Broadband Radio Service systems, previously referred to as Multipoint Distribution Service (MDS) and Multichannel Multipoint Distribution Service (MMDS) systems, and “wireless cable,” transmit video programming to subscribers and provide two-way high-speed data operations using the microwave frequencies of the BRS and EBS (previously referred to as the Instructional Television Fixed Service (ITFS)).

    72. BRS—In connection with the 1996 BRS auction, the Commission established a small business size standard as an entity that had annual average gross revenues of no more than $40 million in the previous three calendar years. The BRS auctions resulted in 67 successful bidders obtaining licensing opportunities for 493 Basic Trading Areas (BTAs). Of the 67 auction winners, 61 met the definition of a small business. BRS also includes licensees of stations authorized prior to the auction. At this time, based on our review of licensing records, the Commission estimates that of the 61-small business BRS auction winners, based on our review of licensing records, 48 remain small business licensees. In addition to the 48 small businesses that hold BTA authorizations, there are approximately 86 incumbent BRS licensees that are considered small entities (18 incumbent BRS licensees do not meet the small business size standard). After adding the number of small business auction licensees to the number of incumbent licensees not already counted, there are currently approximately 133 BRS licensees that are defined as small businesses under either the SBA or the Commission's rules.

    73. In 2009, the Commission conducted Auction 86, the sale of 78 licenses in the BRS areas. The Commission offered three levels of bidding credits: (i) A bidder with attributed average annual gross revenues that exceed $15 million and do not exceed $40 million for the preceding three years (small business) received a 15 percent discount on its winning bid; (ii) a bidder with attributed average annual gross revenues that exceed $3 million and do not exceed $15 million for the preceding three years (very small business) received a 25 percent discount on its winning bid; and (iii) a bidder with attributed average annual gross revenues that do not exceed $3 million for the preceding three years (entrepreneur) received a 35 percent discount on its winning bid. Auction 86 concluded in 2009 with the sale of 61 licenses. Of the ten winning bidders, two bidders that claimed small business status won 4 licenses; one bidder that claimed very small business status won three licenses; and two bidders that claimed entrepreneur status won six licenses.

    74. EBS—Educational Broadband Service has been included within the broad economic census category and SBA size standard for Wired Telecommunications Carriers since 2007. Wired Telecommunications Carriers are comprised of establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies.” The SBA's small business size standard for this category is all such firms having 1,500 or fewer employees. U.S. Census Bureau data for 2012 show that there were 3,117 firms that operated that year. Of this total, 3,083 operated with fewer than 1,000 employees. Thus, under this size standard, the majority of firms in this industry can be considered small.

    75. In addition to Census data, the Commission's Universal Licensing System indicates that as of March 2018 there are 1,300 licensees holding over 2,190 active EBS licenses. The Commission estimates that of these 2,190 licenses, the majority are held by non-profit educational institutions and school districts, which are by statute defined as small businesses.

    D. D. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements

    76. The Commission expects the rules proposed in the NPRM will impose new or additional reporting or recordkeeping and/or other compliance obligations on small entities as well as other EBS licensees and EBS eligible entities. The Commission discusses it proposals and the obligations that would result below, and seeks comment on these matters, including cost and benefit analyses supported by quantitative and qualitative data from the parties in the proceeding.

    77. Rationalizing the GSAs of incumbent EBS Licensees. The Commission proposes to rationalize the GSAs of incumbent EBS licensees, except grandfathered licensees in the E and F Channel groups, to a defined geographic area, namely, the sum of census tracts that are covered by, or that intersect with, a licensee's existing GSA. The Commission proposes that, in this rationalization process, each current EBS GSA will be converted to a single license made up of all the census tracts it covers, rather than converted to a collection of separate census tract-sized licenses. The Commission also proposes that EBS licensees with a local presence in a county be given the opportunity to apply to expand their GSA to the boundaries of a county where they have a local presence. Licensees who take advantage of that option would be subject to new performance requirements. As an alternative to basing GSAs on census tracts, the Commission seeks comment on whether it should expand existing GSAs to include the county (or counties) covered by or that intersect the GSA.

    78. Additional Flexibility for EBS Licenses. The Commission proposes to provide EBS licensees with the flexibility to assign or transfer control of their licenses to entities that are not EBS-eligible. To provide additional flexibility and to facilitate the most efficient use of the EBS spectrum through a market-based mechanism, the Commission proposes to allow an incumbent EBS licensee, in addition to leasing a portion of its license, to assign or transfer control of its entire license to entities that do not meet the eligibility criteria contained in § 27.1201 of the Commission's rules. If the incumbent EBS licensee were to choose to assign or transfer its license, the new licensee would not be required to comply with the educational use requirements in § 27.1203 of the Commission's rules. The Commission seeks comment on whether licensees whose license were granted via waiver, should be given additional flexibility to lease their spectrum or to transfer or assign their licenses freely. Given this flexibility to transfer or assign an entire EBS license to non-eligible entities, free of educational use requirements, the Commission also proposes to eliminate the educational use requirements in § 27.1203 for all EBS licensees. The Commission also proposes to eliminate restrictions on EBS lease terms on a going forward basis and ask whether additional revisions are necessary to fully rationalize our rules for the transferability, leasing and use of EBS spectrum.

    79. Opportunities to Acquire New 2.5 GHz Licenses. The Commission proposes to auction off licenses for unassigned portions of the 2.5 GHZ band and seek comment on whether it should first open up to three new local priority filing windows to give existing licensees, Tribal Nations and educational entities an opportunity to access 2.5 GHz spectrum to serve their local communities. The Commission also proposes build-out requirements for these new licenses to ensure that all Americans have the opportunity to benefit from the 2.5 GHz band.

    80. New Local Priority Filing Window—Local Presence. The Commission proposes to require an applicant to demonstrate as part of the application process that it has a local presence, and that an EBS-eligible entity should be considered to have a “local presence” when it is physically located within the license area where service is proposed. The Commission seeks comment on what documentation applicants must provide to demonstrate that they have a local presence.

    81. Local Priority Filing Window 1: Existing Licensees. The Commission seeks comment on opening a window that would permit existing 2.5 GHz licensees to expand their service to the county border if they were able to demonstrate that they had a local presence in that county, and if they covered at least 25 percent of census tracts in that county. Such a window would allow existing licensees to quickly put white space to use, but it would also preclude new entrants.

    82. Local Priority Filing Window 2: Tribal Nations. The Commission seeks comment on opening a new filing priority filing window for Tribal Nations. The Commission proposes to limit participation to federally-recognized American Indian Tribes and Alaska Native Villages that also have a local presence. The Commission also proposes not to limit the number of channels that a Tribal Nations could apply for as EBS-eligible entities for the purposes of participating in the Native National entity filing window. The Commission asks commenters to propose other ways by which it could encourage the use of EBS spectrum on Tribal Lands and in Native communities.

    83. Local Priority Filing Window 3: New Educational Entities. The Commission seeks comment on opening a new local priority filing window for educational entities that do not hold any 2.5 GHz spectrum. The Commission would propose to limit participation in such a window to accredited institutions as well as governmental organizations engaged in the formal education of enrolled students who are not 2.5 GHz licensees as of the adoption of this NPRM and only in areas in which they have a local presence. The Commission seeks comment on whether to assign new EBS licenses on a county-wide or census tract basis.

    84. Local Priority Filing Process. The Commission seeks comment on the appropriate time frame for any of the new local priority filing windows, how long the windows should be open, and how much notice to give. The Commission asks entities that are interested in participating in the application window and obtaining 2.5 GHz licenses to indicate their interests and the difficulties that they may face to help us evaluate any possible technical and process issues that may arise in implementing one or more new local priority filing windows for applicants and processing such applications.

    85. Resolving Mutually Exclusive Applications. While the Commission does not anticipate many mutually exclusive applications based on the local priority filing windows, it notes that the Communications Act requires that assign initial licenses subject to mutually exclusive applications through competitive bidding. The Commission proposes to limit such competitive bidding to the mutually exclusive applications filed during a particular window, and ask for comment on that. The Commission asks for comment on whether the Commission should permit a settlement window to resolve such mutual exclusivity. The Commission also proposes to employ the part 1 rules governing competitive bidding design, unjust enrichment, application and payment procedures, reporting requirements, and the prohibition on certain communications between auction applicants, and seeks comment on this proposal.

    86. Holding Periods for Licenses Acquired Through a Local Priority Filing Window. The Commission seeks comment on whether to impose a special holding period, and for how long, on any license acquired through a local priority filing window in order to ensure that licenses are not immediately flipped to a nonqualifying entity. The Commission asks whether a three, five, or seven-year holding period would be most appropriate for these circumstances. The Commission also asks whether licensees should be required to meet certain buildout requirements before allowing a transfer.

    87. Licensing White Spaces. The Commission proposes that after any new licenses have been assigned through one or more local priority filing windows, any remaining 2.5 GHz spectrum would be made available for commercial use via competitive bidding using our general part 1 competitive bidding rules. The Commission seeks comment on this proposal and on the appropriate size of such licenses and the size of channel blocks. The Commission also proposes to apply designated entity preferences in this auction, and to eliminate the EBS eligibility criteria contained in § 27.1201 of the rules with respect to unassigned spectrum and ask for comment on these proposals.

    88. Requirements for New 2.5 GHz Licenses. The Commission proposes more robust construction requirements for new 2.5 GHz licenses granted based on the proposed local priority filing window in the NPRM or a system of competitive bidding. For mobile and fixed point-to-multipoint services, the Commission proposes an interim benchmark of 50 percent population coverage and a final benchmark of 80 percent population coverage. For fixed point-to-point services, the Commission proposes an interim benchmark of 20 point-to-point links per million persons (one link per 50,000 persons) in a license area, and 40 point-to-point links per million persons (one link per 25,000 persons) in a licensed area. For educational broadcast services that provide least 20 hours of educational use per channel per week, the Commission seeks comment on an interim benchmark of 50 percent population coverage and a final benchmark of 80 percent population coverage. The Commission also proposes to bring any new 2.5 GHz licenses granted through a local priority filing window or a system of competitive bidding into the unified regulatory renewal framework for WRS. The Commission seeks comment on bringing existing EBS licensees into the WRS framework for license renewal once their licenses have been rationalized.

    89. Cleaning Up the 2.5 GHz Rules. The Commission proposes to eliminate the BRS/EBS transition rules since the process for transitioning BRS and EBS licensees to the new band plan was completed in 2011 and the rules no longer appear necessary. The Commission also proposes to make various non-substantive, clarifying amendments to § 27.1206 to make the rules easier to understand without changing the substantive requirements for BRS. The proposed changes are contained in the Proposed Rules of the NRPM, and the Commission seeks comment on these proposed changes.

    E. E. Steps Taken To Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered

    90. The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use or performance rather than design standards; and (4) an exemption from coverage of the rules, or any part thereof, for such small entities.”

    91. The Commission does not believe that its proposed changes will have a significant economic impact on small entities however, to get a better understanding costs and benefits associated with proposals and any alternatives raised in this proceeding as mentioned above in the previous section, the Commission has requested that commenters discuss the costs and benefits supported by quantitative and qualitative data of any approach advocated. The proposed changes expanding the use of the 2.5 GHz band will benefit small entities as well as entities of other sizes by reducing unnecessary regulatory burdens on licensees, promoting greater spectrum efficiency, and facilitating the full use of EBS spectrum to provide advanced mobile broadband services, particularly in rural areas where this spectrum sits idle today. Moreover, the proposed reforms will permit more flexible use of this spectrum by small and other sized entities that currently hold EBS licenses and will provide new opportunities for EBS eligible entities, Tribal Nations, and commercial entities to obtain unused 2.5 GHz spectrum to facilitate improved access to next generation wireless broadband, including 5G, for both educational and commercial uses.

    92. More specifically, the Commission's proposed rationalization process for incumbent EBS licensees that would occur automatically allowing incumbent licensees to avoid a requirement to file applications with the Commission or to otherwise notify the Commission to effectuate this change would minimize some costs and/or administrative burdens on small entities associated with the rule, if adopted. Small entities should also benefit from removal of the filing freeze for new EBS licenses and the requirement that EBS eligible entities applying for a new license must have a local presence in the areas in which they wish to provide service, which will provide them greater opportunity to obtain EBS spectrum to meet the needs of their communities. In addition, small entities should benefit from the increased flexibility of our proposal to allow EBS licensees with the flexibility to assign or transfer control of their licenses to entities that are not EBS-eligible. The Commission believes that, at this point in time, licensees are in the best position to determine how to use their licenses, or, alternatively, whether to transfer their licenses to a third party in the secondary market.

    93. For existing EBS licenses the Commission's action declining to issue proposals creating new performance or renewal requirements will spare small entities and other existing EBS licensees the costs of new compliance requirements in these areas. With respect to performance requirements adopted for all new EBS licenses, the Commission believes such requirements are necessary to ensure that spectrum is being put into use and has proposed a variety of metrics to provide small entities as well as other licensees with a variety of means by which they may demonstrate compliance. The Commission anticipates that updating the performance requirements in this manner will encourage rapid deployment of next generation wireless services, including 5G, which will benefit small entities and the industry as a whole.

    F. F. Federal Rules That May Duplicate, Overlap, or Conflict With the Proposed Rules

    94. None.

    V. Ordering Clauses

    95. It is ordered, pursuant to the authority found in Sections 1, 2, 3, 4(i), 7, 201, 301, 302, 303, 304, 307, 308, 309, and 310 of the Communications Act of 1934, 47 U.S.C. 151, 152, 153, 154(i), 157, 201, 301, 302, 303, 304, 307, 308, 309, 310, and Section 706 of the Telecommunications Act of 1996, as amended, 47 U.S.C. 1302, and Section 1.411 of the Commission's Rules, 47 CFR 1.411, that this Notice of Proposed Rulemaking is hereby adopted.

    96. It is further ordered that notice is hereby given of the proposed regulatory changes described in this Notice of Proposed Rulemaking, and that comment is sought on these proposals.

    97. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Notice of Proposed Rulemaking, including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

    List of Subjects in 47 CFR Parts 1 and 27

    Communications common carriers, Communications equipment, Reporting and recordkeeping requirements.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary. Proposed Rules

    For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR parts 1 and 27 as follows:

    PART 1—PRACTICE AND PROCEDURE 1. The authority citation for part 1 continues to read as follows: Authority:

    47 U.S.C. 151, 154(i), 155, 157, 160, 201, 225, 227, 303, 309, 332, 1403, 1404, 1451, 1452, and 1455, unless otherwise noted.

    2. Amend § 1.949 by revising paragraph (c) to read as follows:
    § 1.949 Application for renewal of authorization.

    (c) Implementation. Covered Site-based Licenses, except Common Carrier Fixed Point-to-Point Microwave Service (part 101, subpart I of this chapter), and Covered Geographic Licenses in the 600 MHz Service (part 27, subpart N); 700 MHz Commercial Services (part 27, subpart F); Advanced Wireless Services (part 27, subpart L) (AWS-3 (1695-1710 MHz, 1755-1780 MHz, and 2155-2180 MHz) and AWS-4 (2000-2020 MHz and 2180-2200 MHz) only); and H Block Service (part 27, subpart K) must comply with paragraphs (d) through (h) of this section. Broadband Radio Service and Educational Broadband Service licenses (part 27, subpart M) initially issued after [effective date of final rule] must comply with paragraphs (d) through (h) of this section. All other Covered Geographic Licenses must comply with paragraphs (d) through (h) of this section beginning on January 1, 2023. Common Carrier Fixed Point-to-Point Microwave Service (part 101, subpart I) must comply with paragraphs (d) through (h) of this section beginning on October 1, 2018.

    PART 27—MISCELLANEOUS WIRELESS COMMUNICATIONS SERVICES 3. The authority citation for part 27 continues to read as follows: Authority:

    47 U.S.C. 154, 301, 302a, 303, 307, 309, 332, 336, 337, 1403, 1404, 1451, and 1452, unless otherwise noted.

    4. Amend § 27.14 by revising paragraph (o) to read as follows:
    § 27.14 Construction Requirements.

    (o)(1) All BRS and EBS licensees issued after [effective date of final rule], must demonstrate compliance with the performance requirements described in this paragraph. All equipment used to demonstrate compliance must be in use and actually providing service, either for internal use or to unaffiliated customers, as of the interim deadline or the end of the license term, whichever is applicable.

    (2) Licensees relying on mobile service must demonstrate reliable signal coverage of 50% of the population of the geographic service area by the interim deadline, and 80% of the population of the geographic service area by the end of the license term.

    (3) Licensees relying on fixed service must demonstrate operation of one link for each 50,000 persons in the geographic service area by the interim deadline, and one link for each 25,000 persons in the geographic service area by the end of the license term.

    § 27.1201 [Removed and Reserved]
    5. Remove and reserve § 27.1201. 6. Revise § 27.1206 to read as follows:
    § 27.1206 Geographic Service Area.

    (a) BRS:

    (1) For BRS incumbent licenses granted before September 15, 1995, the GSA for a channel is the GSA as created on January 10, 2005.

    (2) For BRS BTA authorization holders, the GSA for a channel is the BTA, subject to the exclusion of overlapping, co-channel incumbent GSAs created on January 10, 2005.

    (3) If an incumbent BRS license is cancelled or is forfeited, the GSA area of the incumbent station shall dissolve and the right to operate in that area automatically reverts to the GSA licensee that held the corresponding BTA.

    (b) For EBS:

    (1) Incumbent EBS licensees. (i) The GSA of EBS licenses on the E and F channel groups is defined in § 27.1216. EBS licensees on the E and F channel groups are prohibited from expanding their GSAs.

    (ii) For EBS licenses not in the E and F channel groups in effect as of [effective date of final rule], the GSA for a channel consists of all census tracts which are covered by or intersect its GSA existing as of [effective date of final rule].

    (2) New initial EBS licenses. The GSA for a channel for new initial licenses issued after [effective date of final rule], is the county [census tract] for which the license is issued, subject to the exclusion of overlapping, co-channel incumbent GSAs.

    7. Revise § 27.1214 to read as follows:
    § 27.1214 EBS spectrum leasing arrangements and grandfathered leases.

    (a) All leases of current EBS spectrum entered into prior to January 10, 2005 and in compliance with leasing rules formerly contained in part 74 of this chapter may continue in force and effect, notwithstanding any inconsistency between such leases and the rules applicable to spectrum leasing arrangements set forth in this chapter. Such leases entered into pursuant to the former part 74 rules of this chapter may be renewed and assigned in accordance with the terms of such lease. All spectrum leasing arrangements leases entered into after January 10, 2005, pursuant to the rules set forth in part 1 and part 27 of this chapter, must comply with the rules in those parts.

    (b) For leasing arrangements entered into between July 19, 2006 and [effective date of final rule], the maximum permissible term of an EBS spectrum leasing arrangement (including the initial term and all renewal terms that commence automatically or at the sole option of the lessee) shall be 30 years. Any spectrum leasing arrangement in excess of 15 years that is entered into on or after July 19, 2006 and before [effective date of final rule] must include terms which provide the EBS licensee on the 15th year and every 5 years thereafter, with an opportunity to review its educational use requirements in light of changes in educational needs, technology, and other relevant factors and to obtain access to such additional services, capacity, support, and/or equipment as the parties shall agree upon in the spectrum leasing arrangement to advance the EBS licensee's educational mission.

    8. Revise § 27.1217 to read as follows:
    § 27.1217 Competitive bidding procedures for the Broadband Radio Service and the Educational Broadband Service.

    Mutually exclusive initial applications for BRS and EBS licenses are subject to competitive bidding. The designated entity provisions in § 27.1218 shall not apply to auctions held after [effective date of final rule]. The general competitive bidding procedures set forth in part 1, subpart Q of this chapter will apply unless otherwise provided in this subpart.

    § § 27.1230 through 27.1239 [Removed]
    9. Remove §§ 27.1230 through 27.1239.
    [FR Doc. 2018-12183 Filed 6-6-18; 8:45 am] BILLING CODE 6712-01-P
    83 110 Thursday, June 7, 2018 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2017-0098] Notice of a Determination Regarding the Classical Swine Fever and Swine Vesicular Disease Status of Japan AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Notice.

    SUMMARY:

    We are advising the public of our determination that Japan is free of classical swine fever (CSF) and swine vesicular disease (SVD). Based on an evaluation of the CSF and SVD status of Japan, which we made available to the public for review and comment through a previous notice, the Administrator has determined that CSF and SVD are not present in Japan and that live swine, pork, and pork products may safely be imported into the United States from Japan subject to conditions in the regulations.

    DATES:

    This change in Japan's CSF and SVD status will be recognized on July 9, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Kelly Rhodes, Senior Staff Veterinarian, Regionalization Evaluation Services, National Import Export Services, VS, APHIS, USDA, 4700 River Road Unit 38, Riverdale, MD 20737-1231; email: [email protected]; (301) 851-3315.

    SUPPLEMENTARY INFORMATION:

    The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of certain animals and animal products into the United States in order to prevent the introduction of various animal diseases, including classical swine fever (CSF) and swine vesicular disease (SVD). These are dangerous and communicable diseases of swine.

    Within part 94, § 94.9 contains requirements governing the importation of pork and pork products from regions where CSF exists. Section 94.10 contains importation requirements for swine from regions where CSF is considered to exist. Section 94.12 contains requirements governing the importation of pork or pork products from regions where SVD exists. Section 94.14 prohibits the importation of domestic swine which are moved from or transit any region in which SVD is known to exist.

    In accordance with §§ 94.9(a)(1) and 94.10(a)(1), the Animal and Plant Health Inspection Service (APHIS) maintains a web-based list of regions which the Agency considers free of CSF. Sections 94.9(a)(2) and 94.10(a)(2) state that APHIS will add a region to this list after it conducts an evaluation of the region and finds that CSF is not present.

    Similarly, in accordance with § 94.12(a)(1), APHIS maintains a web-based list of regions which the Agency considers free of SVD. Paragraph (a)(2) of this section states that APHIS will add a region to this list after it conducts an evaluation of the region and finds that SVD is not present.

    The regulations in § 92.2 contain requirements for requesting the recognition of the animal health status of a region (as well as for the approval of the export of a particular type of animal or animal product to the United States from a foreign region). If, after review and evaluation of the information submitted in support of the request, APHIS believes the request can be safely granted, APHIS will make its evaluation available for public comment through a document published in the Federal Register. Following the close of the comment period, APHIS will review all comments received and will make a final determination regarding the request that will be detailed in another document published in the Federal Register.

    In accordance with that process, Japan requested that APHIS evaluate the CSF and SVD disease status of the country. Based on our evaluation, we determined that Japan is free of both CSF and SVD and that the surveillance, prevention, and control measures implemented by Japan are sufficient to minimize the likelihood of introducing CSF and SVD into the United States via imports of species or products susceptible to these diseases.

    On February 20, 2018, we published in the Federal Register (83 FR 7138, Docket No. APHIS-2017-0098) a notice 1 in which we announced the availability for review and comment of our evaluation of the CSF and SVD status of Japan. We solicited comments on the notice for 30 days ending on March 22, 2018. We received no comments on our evaluation.

    1 To view the notice and the supporting documents, go to https://www.regulations.gov/docket?D=APHIS20170098.

    Therefore, based on the findings of our evaluation and the absence of comments that would lead us to reconsider those findings, we are announcing our determination to add Japan to the list of regions declared free of CSF and the list of regions declared free of SVD. These lists are available on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/ct_animal_disease_status.

    Authority:

    7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 1st day of June 2018. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2018-12186 Filed 6-6-18; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2017-0073] Bayer CropScience LP; Availability of a Preliminary Plant Pest Risk Assessment, Draft Environmental Assessment, Preliminary Finding of No Significant Impact, and Preliminary Determination of Nonregulated Status for Cotton Genetically Engineered For Resistance to HPPD-Inhibitor Herbicides (e.g., Isoxaflutole) and Glyphosate AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Notice.

    SUMMARY:

    We are advising the public that the Animal and Plant Health Inspection Service has prepared a preliminary determination regarding a request from Bayer CropScience LP seeking a determination of nonregulated status for cotton designated as event GHB811, which has been genetically engineered for dual resistance to HPPD-inhibitor herbicides (e.g., isoxaflutole) and the herbicide glyphosate. We are also making available for public review and comment our preliminary plant pest risk assessment, draft environmental assessment, and preliminary finding of no significant impact for the preliminary determination of nonregulated status.

    DATES:

    We will consider all comments that we receive on or before July 9, 2018.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0073.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2017-0073, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

    The draft environmental assessment, preliminary regulatory determination, preliminary finding of no significant impact, preliminary plant pest risk assessment, and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0073 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

    Supporting documents for this petition are also available on the APHIS website at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition Number 17-138-01p.

    FOR FURTHER INFORMATION CONTACT:

    Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email: [email protected]. To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851-3892, email: [email protected].

    SUPPLEMENTARY INFORMATION:

    Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), the regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered “regulated articles.”

    The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. APHIS received a petition (APHIS Petition Number 17-138-01p) from Bayer CropScience LP (Bayer) of Research Triangle Park, NC, seeking a determination of nonregulated status of cotton (Gossypium spp.) designated as event GHB811, which has been genetically engineered for dual resistance to HPPD-inhibitor herbicides (e.g., isoxaflutole) and the herbicide glyphosate. The Bayer petition states that information collected during field trials and laboratory analyses indicates that GHB811 cotton is not likely to be a plant pest and therefore should not be a regulated article under APHIS' regulations in 7 CFR part 340.

    According to our process 1 for soliciting public comment when considering petitions for determinations of nonregulated status of GE organisms, APHIS accepts written comments regarding a petition once APHIS deems it complete. In a notice 2 published in the Federal Register on October 27, 2017 (82 FR 49782-49783, Docket No. APHIS-2017-0073), APHIS announced the availability of the Bayer petition for public comment. APHIS solicited comments on the petition for 60 days ending on December 26, 2017, in order to help identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. APHIS received eight comments on the petition. One submission was in favor of the GHB811 cotton determination. Seven of the comments expressed a general disapproval of the planting and use of GE crops. Of the seven comments in opposition, two submissions contained attached comments by organizations. APHIS has evaluated the issues raised during the comment period and, where appropriate, has provided a discussion of these issues in our draft environmental assessment (EA).

    1 On March 6, 2012, APHIS published in the Federal Register (77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing our public review process for soliciting public comments and information when considering petitions for determinations of nonregulated status for GE organisms. To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.

    2 To view the notice, the petition, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0073.

    After public comments are received on a completed petition, APHIS evaluates those comments and then provides a second opportunity for public involvement in our decisionmaking process. According to our public review process (see footnote 1), the second opportunity for public involvement follows one of two approaches, as described below.

    If APHIS decides, based on its review of the petition and its evaluation and analysis of comments received during the 60-day public comment period on the petition, that the petition involves a GE organism that raises no substantive new issues, APHIS will follow Approach 1 for public involvement. Under Approach 1, APHIS announces in the Federal Register the availability of APHIS' preliminary regulatory determination along with its draft EA, preliminary finding of no significant impact (FONSI), and its preliminary plant pest risk assessment (PPRA) for a 30-day public review period. APHIS will evaluate any information received related to the petition and its supporting documents during the 30-day public review period. For this petition, we are using Approach 1.

    Had APHIS decided, based on its review of the petition and its evaluation and analysis of comments received during the 60-day public comment period on the petition, that the petition involves a GE organism that raises substantive new issues, APHIS would follow Approach 2. Under Approach 2, APHIS first solicits written comments from the public on a draft EA and preliminary PPRA for a 30-day comment period through the publication of a Federal Register notice. Then, after reviewing and evaluating the comments on the draft EA and preliminary PPRA and other information, APHIS would revise the preliminary PPRA as necessary and prepare a final EA and, based on the final EA, a National Environmental Policy Act (NEPA) decision document (either a FONSI or a notice of intent to prepare an environmental impact statement).

    As part of our decisionmaking process regarding a GE organism's regulatory status, APHIS prepares a PPRA to assess the plant pest risk of the article. APHIS also prepares the appropriate environmental documentation—either an EA or an environmental impact statement—in accordance with NEPA, to provide the Agency and the public with a review and analysis of any potential environmental impacts that may result if the petition request is approved.

    APHIS has prepared a preliminary PPRA and has concluded that cotton designated as event GHB811, which has been genetically engineered for dual herbicides resistance, is unlikely to pose a plant pest risk. In section 403 of the Plant Protection Act, “plant pest” is defined as any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an infectious agent or other pathogen, or any article similar to or allied with any of the foregoing.

    APHIS has also prepared a draft EA in which we present two alternatives based on our analysis of data submitted by Bayer, a review of other scientific data, field tests conducted under APHIS oversight, and comments received on the petition. APHIS is considering the following alternatives: (1) Take no action, i.e., APHIS would not change the regulatory status of cotton designated as event GHB811, or (2) make a determination of nonregulated status of cotton designated as event GHB811.

    The draft EA was prepared in accordance with (1) NEPA, as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372). Based on our draft EA and other pertinent scientific data, APHIS has prepared a preliminary FONSI with regard to the preferred alternative identified in the draft EA.

    Based on APHIS' analysis of field and laboratory data submitted by Bayer, references provided in the petition, peer-reviewed publications, information analyzed in the draft EA, the preliminary PPRA, comments provided by the public on the petition, and discussion of issues in the draft EA, APHIS has determined that cotton designated as event GHB811 is unlikely to pose a plant pest risk. We have therefore reached a decision to make a preliminary determination of nonregulated status of cotton designated as event GHB811, whereby cotton designated as event GHB811 would no longer be subject to our regulations governing the introduction of certain GE organisms.

    We are making available for a 30-day review period APHIS' preliminary regulatory determination of cotton designated as event GHB811, along with our preliminary PPRA, draft EA, and preliminary FONSI for the preliminary determination of nonregulated status. The draft EA, preliminary FONSI, preliminary PPRA, and our preliminary determination for cotton designated as event GHB811, as well as the Bayer petition and the comments received on the petition, are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. Copies of these documents may also be obtained from the person listed under FOR FURTHER INFORMATION CONTACT.

    After the 30-day review period closes, APHIS will review and evaluate any information received during the 30-day review period. If, after evaluating the information received, APHIS determines that we have not received substantive new information that would warrant APHIS altering our preliminary regulatory determination or preliminary FONSI, substantially changing the proposed action identified in the draft EA, or substantially changing the analysis of impacts in the draft EA, APHIS will notify the public through an announcement on our website of our final regulatory determination. If, however, APHIS determines that we have received substantive new information that would warrant APHIS altering our preliminary regulatory determination or preliminary FONSI, substantially changing the proposed action identified in the draft EA, or substantially changing the analysis of impacts in the draft EA, then APHIS will conduct the additional analysis and prepare an amended EA, a new FONSI, and/or a revised PPRA, which would be made available for public review in a subsequent notice in the Federal Register, similar to an Approach 2 petition. APHIS will also notify the petitioner.

    Authority:

    7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 1st day of June 2018. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2018-12187 Filed 6-6-18; 8:45 am] BILLING CODE 3410-34-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Idaho 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 (FACA) that a meeting of the Idaho Advisory Committee (Committee) to the Commission will be held at 1:00 p.m. (Mountain Time) Wednesday, June 20, 2018, for the purpose of discussing potential civil rights topics of study.

    DATES:

    The meeting will be held on Wednesday, June 20, 2018, at 1:00 p.m. MT.

    Public Call Information:

    Dial: 877-675-4751.

    Conference ID: 5522721.

    FOR FURTHER INFORMATION CONTACT:

    Angelica Trevino at [email protected] or (213) 894-3437.

    SUPPLEMENTARY INFORMATION:

    This meeting is available to the public through the following toll-free call-in number: 877-675-4751, conference ID number: 5522721. Any interested member of the public may call this number and listen to the meeting. 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. 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 entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Angelica Trevino at [email protected] Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at http://facadatabase.gov/committee/meetings.aspx?cid=245. Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. 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 Unit at the above email or street address.

    Agenda I. Welcome II. Discuss Civil Rights Issues in Idaho III. Public Comment IV. Adjournment Dated: June 1, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-12199 Filed 6-6-18; 8:45 am] BILLING CODE 6335-01-P
    COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meeting of the Massachusetts Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of monthly planning meetings.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Massachusetts Advisory Committee to the Commission will convene on Thursday, June 28, 2017 at 1:00 p.m. (EDT) at McCarter & English, LLP, 265 Franklin Street, Boston, MA 02110. The purpose of the meeting is project planning so that members can begin discussing potential topics for its civil rights project.

    DATES:

    Thursday, June 28, 2018 (EDT) at 1:00 p.m. (EDT).

    ADDRESSES:

    McCarter & English, LLP, 265 Franklin Street, Boston, MA 02110.

    FOR FURTHER INFORMATION CONTACT:

    Evelyn Bohor, at [email protected] or by phone at 303-866-1040.

    SUPPLEMENTARY INFORMATION:

    If other persons who plan to attend the meeting require other accommodations, please contact Evelyn Bohor at [email protected] at the Eastern Regional Office at least ten (10) working days before the scheduled date of the meeting. Time will be set aside at the end of the meeting so that members of the public may address the Committee after the planning meeting. Persons interested in the issue are also invited to submit written comments; the comments must be received in the regional office by Monday, July 30, 2018. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at [email protected]. Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://facadatabase.gov/committee/meetings.aspx?cid=254 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Eastern Regional Office at the above phone number, email or street address.

    Agenda Thursday, June 28, 2018 at 1:00 p.m. (EDT) I. Roll Call II. Planning to Discussion Potential Civil Rights Topics III. Other Business IV. Open Comment V. Adjournment Dated: June 1, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-12213 Filed 6-6-18; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meetings of the South Dakota 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 planning meetings of the South Dakota Advisory Committee to the Commission will convene at 5:00 p.m. (MDT) on Tuesday, June 26, 2018 via teleconference. The purpose of the meeting is to review logistics and possible presenters at two community briefings to be held in Pine Ridge and Pierre, South Dakota in July 2018.

    DATES:

    Tuesday, June 26, 2018, at 5:00 p.m. (MDT).

    ADDRESSES:

    To be held via teleconference:

    Conference Call Toll-Free Number for Both Meetings: 1-800-310-7032, Conference ID: 3590626.

    TDD: Dial Federal Relay Service 1-800-877-8339 and give the operator the above conference call number and conference ID.

    FOR FURTHER INFORMATION CONTACT:

    Evelyn Bohor, [email protected], 303-866-1040.

    SUPPLEMENTARY INFORMATION:

    Members of the public may listen to the discussion by dialing the following Conference Call Toll-Free Number: 1-800-310-7032; Conference ID: 3590626. Please be advised that before being placed into the conference call, the operator will ask callers to provide their names, their organizational affiliations (if any), and an email address (if available) prior to placing callers into the conference room. 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 phone number.

    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service (FRS) at 1-800-877-8339 and provide the FRS operator with Conference Call Toll-Free Number: 1-800-310-7032; Conference ID: 3590626. Members of the public are invited to submit written comments; the comments must be received in the regional office by Thursday, July 26, 2018. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1050, or emailed to Evelyn Bohor at [email protected]. Persons who desire additional information may contact the Rocky Mountain Regional Office at (303) 866-1040.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=274 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Rocky Mountain 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 Rocky Mountain Regional Office at the above phone number, email or street address.

    Tuesday, June 26, 2018 (5:00 p.m.-MDT) Agenda • Welcome and Roll-call • Review and Discuss Logistics and Possible Presenters at Two Upcoming Briefings • Public Comment • Adjourn Dated: June 4, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-12266 Filed 6-6-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-866] Certain Folding Gift Boxes From the People's Republic of China: Final Results of Expedited Third Sunset Review and Continuation of the Antidumping Duty Order AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) order on certain folding gift boxes from the People's Republic of China (China) would likely lead to continuation or recurrence of dumping at the dumping margins identified in the “Final Results of Review” section of this notice.

    DATES:

    Applicable June 7, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Keith Haynes, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5139.

    SUPPLEMENTARY INFORMATION: Background

    On February 1, 2018, Commerce published the notice of initiation of the third sunset review of the antidumping duty order 1 on certain folding gift boxes from China, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).2 On February 16, 2018, Commerce received a notice of intent to participate from Harvard Folding Box Company, Inc. (Harvard) and P.S. Greetings, Inc. doing business as (d.b.a.) Fantus Paper Products (P.S. Greetings), hereinafter referred to as Domestic Interested Parties, within the deadline specified in 19 CFR 351.218(d)(1)(i).3 Domestic Interested Parties claimed interested party status under section 771(9)(C) of the Act, as producers of the domestic like product.4 On November 3, 2017, Commerce received complete substantive responses from Domestic Interested Parties within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i).5 We received no substantive response from any other domestic or respondent interested parties in this proceeding, nor was a hearing requested. As a result, pursuant to 19 CFR 351.218(e)(1)(ii)(C), Commerce conducted an expedited (120-day) sunset review of the Order.

    1See Notice of Antidumping Duty Order: Certain Folding Gift Boxes from the People's Republic of China, 67 FR 864 (January 8, 2002) (Order).

    2See Initiation of Five-Year (Sunset) Reviews, 83 FR 4641 (February 1, 2018).

    3See Domestic Interested Parties' letter, “Third Five-Year (Sunset) Review of Antidumping Duty Order on Folding Gift Boxes from the People's Republic of China/The Domestic Industry's Notice of Intent to Participate,” dated February 16, 2018.

    4Id. at 2. Harvard was a petitioner in the underlying investigation of this proceeding. See Notice of Preliminary Determination of Sales at Less Than Fair Value: Certain Folding Gift Boxes from the People's Republic of China, 66 FR 40973 (August 6, 2001); unchanged in Notice of Final Determination of Sales at Less Than Fair Value: Certain Folding Gift Boxes from the People's Republic of China, 66 FR 58115 (November 20, 2001) (Final Determination).

    5See Domestic Interested Parties' letter, “Third Five-Year (Sunset) Review of the Antidumping Duty Order on Folding Gift Boxes from the People's Republic of China/Substantive Response to the Notice of Initiation,” dated March 5, 2018 (Substantive Response).

    Scope of the Order

    The products covered by the Order are certain folding gift boxes. Folding gift boxes are a type of folding or knock-down carton manufactured from paper or paperboard. Folding gift boxes are produced from a variety of recycled and virgin paper or paperboard materials, including, but not limited to, clay-coated paper or paperboard and kraft (bleached or unbleached) paper or paperboard. The scope of the Order excludes gift boxes manufactured from paper or paperboard of a thickness of more than 0.8 millimeters, corrugated paperboard, or paper mache. The scope also excludes those gift boxes for which no side of the box, when assembled, is at least nine inches in length.

    Folding gift boxes included in the scope are typically decorated with a holiday motif using various processes, including printing, embossing, debossing, and foil stamping, but may also be plain white or printed with a single color. The subject merchandise includes folding gift boxes, with or without handles, whether finished or unfinished, and whether in one-piece or multi-piece configuration. One-piece gift boxes are die-cut or otherwise formed so that the top, bottom, and sides form a single, contiguous unit. Two-piece gift boxes are those with a folded bottom and a folded top as separate pieces. Folding gift boxes are generally packaged in shrink-wrap, cellophane, or other packaging materials, in single or multi-box packs for sale to the retail customer. The scope excludes folding gift boxes that have a retailer's name, logo, trademark or similar company information printed prominently on the box's top exterior (such folding gift boxes are often known as “not-for-resale” gift boxes or “give-away” gift boxes and may be provided by department and specialty stores at no charge to their retail customers). The scope of the Order also excludes folding gift boxes where both the outside of the box is a single color and the box is not packaged in shrink-wrap, cellophane, other resin-based packaging films, or paperboard.

    Imports of the subject merchandise are classified under Harmonized Tariff Schedules of the United States (HTSUS) subheadings 4819.20.0040 and 4819.50.4060. These subheadings also cover products that are outside the scope of the Order. Furthermore, although the HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of the Order is dispositive.

    Analysis of Comments Received

    All issues raised in this sunset review, including the likelihood of continuation or recurrence of dumping and the magnitude of the margins likely to prevail if the Order were revoked, are addressed in the Issues and Decision Memorandum,6 dated concurrently with, and hereby adopted by this notice. The Issues and Decision Memorandum is a public document and is on file 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 to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed at http://enforcement.trade.gov/frn/. The signed Issues and Decision Memorandum and the electronic version of the Issues and Decision Memorandum are identical in content.

    6See Memorandum, “Issues and Decision Memorandum for the Final Results of the Expedited Third Sunset Review of the Antidumping Duty Order on Certain Folding Gift Boxes from the People's Republic of China” dated concurrently with this notice (Issues and Decision Memorandum).

    Final Results of Review

    Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, we determine that revocation of the Order on folding gift boxes from China would be likely to lead to continuation or recurrence of dumping, and that the magnitude of the dumping margins likely to prevail would be weighted-average dumping margins above de minimis.

    Manufacturers,
  • Producers,
  • and Exporters
  • Weighted-Average
  • Margin
  • (percent)
  • All Manufacturers, Producers, and Exporters 7 Above de minimis.
    Notification Regarding Administrative Protective Order

    This notice also serves as the only reminder to parties subject to an 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. Timely 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.

    7 Max Fortune Industrial Ltd. was excluded from the order. See Order, 67 FR at 865.

    We are issuing and publishing these results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CR 351.218.

    Dated: June 1, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2018-12271 Filed 6-6-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-533-884, C-570-081, C-549-838] Glycine From India, the People's Republic of China, and Thailand: Postponement of Preliminary Determinations of Countervailing Duty Investigations AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    DATES:

    Applicable June 7, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Chelsey Simonovich at 202-482-1979 (India); Tyler Weinhold at 202-482-1121 (the People's Republic of China (China)); George Ayache at 202-482-2623 (Thailand), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.

    SUPPLEMENTARY INFORMATION: Background

    On April 25, 2018, the Department of Commerce (Commerce) initiated countervailing duty (CVD) investigations on glycine from India, China, and Thailand.1 Currently, the preliminary determinations of these investigations are due no later than June 21, 2018.

    1See Glycine from India, the People's Republic of China, and Thailand: Initiation of Countervailing Duty Investigations, 83 FR 18002 (April 25, 2018) (Initiation Notice).

    Postponement of Preliminary Determination

    Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in a CVD investigation within 65 days after the date on which Commerce initiated the investigation. However, if the petitioner makes a timely request for a postponement, section 703(c)(1)(A) of the Act allows Commerce to postpone making the preliminary determination until no later than 130 days after the date on which Commerce initiated the investigation. Under 19 CFR 351.205(e), a petitioner must submit a request for postponement 25 days or more before the scheduled date of the preliminary determination and must state the reason for the request. Commerce will grant the request unless it finds compelling reasons to deny the request.

    On May 22, 2018, GEO Specialty Chemicals, Inc. and Chattem Chemicals, Inc. (collectively, the petitioners) submitted timely requests, pursuant to section 703(c)(1)(A) of the Act and 19 CFR 351.205(e), to postpone the preliminary determinations.2 The petitioners state that the current investigation schedule does not provide adequate time to develop the record prior to the preliminary determination. The petitioners, therefore, request postponement of the preliminary determination to allow parties sufficient time to develop the record, including analyzing questionnaire responses and permit the issuance of supplemental questionnaires, if necessary. According to petitioners, postponement of the preliminary determination by the maximum extension of 65 additional days in this case would allow sufficient time for Commerce to develop the record in this investigation.

    2See the petitioners' letter re: Glycine from the People's Republic of China, India and Thailand: Request to Extend Deadline for Preliminary Determinations, dated May 22, 2018.

    In accordance with 19 CFR 351.205(e), the petitioners have stated the reasons for requesting a postponement of the preliminary determination, and Commerce finds there are no compelling reasons to deny the requests. Therefore, in accordance with section 703(c)(1)(A) of the Act, Commerce is postponing the deadline for the preliminary determinations to no later than 130 days after the day on which the investigations were initiated, i.e., April 17, 2018. Accordingly, Commerce will issue the preliminary determinations no later than August 27, 2018.3 In accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(1), the deadline for the final determinations of these investigations will continue to be 75 days after the date of the preliminary determinations, unless postponed at a later date.

    3See 19 CFR 351.303(b)(1) and (2). Postponing the preliminary determination to 130 days after initiation would place the deadline on Saturday, August 25, 2018. Commerce's practice dictates that where a deadline falls on a weekend or a federal holiday, the appropriate deadline is the next business day. This date reflects the next business day after the deadline of August 25, 2018. See Notice of Clarification: Application of “Next Business Day” Rule for Administrative Determination Deadlines Pursuant to the Tariff Act of 1930, As Amended, 70 FR 24533 (May 10, 2005).

    This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).

    Dated: June 1, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2018-12272 Filed 6-6-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG258 Marine Fisheries Advisory Committee Meeting AGENCY:

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

    ACTION:

    Notice of open public meeting.

    SUMMARY:

    This notice sets forth the proposed schedule and agenda of a forthcoming meeting of the Marine Fisheries Advisory Committee (MAFAC). The members will discuss and provide advice on issues outlined under SUPPLEMENTARY INFORMATION below.

    DATES:

    The meeting will be held June 26, 2018, from 8:30 a.m. to 12 p.m. and 2 p.m. to 5:15 p.m., and June 27, from 8:30 a.m. to 12 p.m.

    ADDRESSES:

    The meeting will be held at the Port of Portland, 7200 NE Airport Way, Portland, OR 97218; 503-415-6000.

    FOR FURTHER INFORMATION CONTACT:

    Heidi Lovett, MAFAC Assistant Director; 301-427-8034; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    As required by section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, notice is hereby given of a meeting of MAFAC. The MAFAC was established by the Secretary of Commerce (Secretary), and, since 1971, advises the Secretary on all living marine resource matters that are the responsibility of the Department of Commerce. The complete charter and summaries of prior meetings are located online at https://www.fisheries.noaa.gov/topic/partners#marine-fisheries-advisory-committee.

    Matters To Be Considered

    This meeting time and agenda are subject to change.

    The meeting is convened to hear presentations and updates and to discuss policies and guidance on the following topics: Columbia Basin Partnership Task Force efforts on the conservation and restoration of salmon and steelhead; NMFS communications and outreach in support of U.S. seafood competitiveness; outcomes of the recreational fisheries summit; and the budget outlook for FY2018 and FY2019. MAFAC will discuss various administrative and organizational matters, Federal Advisory Committee Act ethics and general law, and meetings of subcommittees and working groups may be convened.

    Special Accommodations

    The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Heidi Lovett; 301-427-8034 by June 15, 2018.

    Dated: June 1, 2018. Jennifer L. Lukens, Federal Program Officer, Marine Fisheries Advisory Committee, National Marine Fisheries Service.
    [FR Doc. 2018-12197 Filed 6-6-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG259 Marine Fisheries Advisory Committee; Charter Renewal AGENCY:

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

    ACTION:

    Notice of renewed charter.

    SUMMARY:

    Notice is hereby given of the 2-year renewed charter for the Marine Fisheries Advisory Committee (MAFAC), signed on April 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Heidi Lovett, Assistant Federal Program Officer, MAFAC, 301-427-8034.

    SUPPLEMENTARY INFORMATION:

    As required by section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1982), notice is hereby given of the renewed charter for MAFAC. MAFAC was established by the Secretary of Commerce (Secretary) on February 17, 1972, to advise the Secretary on all living marine resource matters that are the responsibility of the Department of Commerce. This Committee advises and reviews the adequacy of living marine resources policies and programs to meet the needs of commercial and recreational fisheries, aquaculture, and environmental, consumer, academic, tribal, governmental, and other national interests. The Committee's charter must be renewed every 2 years from the date of the last renewal. The charter can be accessed online at https://www.fisheries.noaa.gov/national/partners/marine-fisheries-advisory-committee-charter.

    Dated: June 1, 2018. Jennifer L. Lukens, Federal Program Officer, Marine Fisheries Advisory Committee, National Marine Fisheries Service.
    [FR Doc. 2018-12198 Filed 6-6-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF991 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Marine Site Characterization Surveys off of Delaware AGENCY:

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

    ACTION:

    Notice; Issuance of an 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 Garden State Offshore Energy, LLC (GSOE), to incidentally harass, by Level B harassment only, marine mammals during marine site characterization surveys off the coast of Delaware as part of the Skipjack Wind Project in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS-A 0482) and along potential submarine cable routes to a landfall location in Maryland or Delaware.

    DATES:

    This Authorization is valid for one year from the date of issuance.

    FOR FURTHER INFORMATION CONTACT:

    Jordan Carduner, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the applications and supporting documents, as well as a list of the references cited in this document, may be obtained by visiting the internet at: www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-other-energy-activities-renewable. In case of problems accessing these documents, please call the contact listed above.

    SUPPLEMENTARY INFORMATION: Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce (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 a proposed authorization is provided to the public for review.

    An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.

    NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

    The MMPA states that the term “take” means to harass, hunt, capture, or kill, or attempt to harass, hunt, capture, or kill any marine mammal.

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

    Summary of Request

    On November 22, 2017, NMFS received a request from GSOE for an IHA to take marine mammals incidental to marine site characterization surveys off the coast of Delaware in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS-A 0482) (Lease Area) and along potential submarine cable routes to a landfall location in Maryland or Delaware. GSOE has designated Skipjack Offshore Energy, LLC (Skipjack), a wholly-owned indirect subsidiary of Deepwater Wind Holdings, LLC (Deepwater Wind), and an affiliate of GSOE, to perform the activities described in the IHA application. A revised application was received on March 19, 2018. NMFS deemed that request to be adequate and complete. GSOE's request is for take of 14 marine mammal species by Level B harassment. Neither GSOE nor NMFS expects serious injury or mortality to result from this activity, and the activity is expected to last no more than one year Therefore, an IHA is appropriate.

    Description of the Activity Overview

    GSOE plans to conduct marine site characterization surveys, including high-resolution geophysical (HRG) and geotechnical surveys, in the Lease Area and along potential submarine cable routes to landfall locations in either the state of Maryland or Delaware. Surveys would occur from approximately May 2018 through December 2018.

    The purpose of the marine site characterization surveys is to obtain a baseline assessment of seabed/sub-surface soil conditions in the Lease Area and cable route corridors to support the siting of the proposed Skipjack wind farm. Underwater sound resulting from GSOE's site characterization surveys have the potential to result in incidental take of marine mammals in the form of behavioral harassment. Geophysical surveys would be conducted for up to 183 days and geotechnical surveys would be conducted for up to 72 days. This schedule is based on 24-hour operations and includes potential down time due to inclement weather.

    Geotechnical surveys would entail the use of core penetration testing, deep boring cores and vibracores. Geotechnical surveys are not expected to result in the take of marine mammals and are not analyzed further in this document. Geophysical surveys would entail the use of a multibeam depth sounder, shallow penetration sub-bottom profiler (chirp), medium penetration sub-bottom profiler (boomer and sparker or bubble gun), sidescan sonar and marine magnetometer. The deployment of geophysical survey equipment, including the equipment planned for use during GSOE's planned activity, produces sound in the marine environment that has the potential to result in harassment of marine mammals.

    A detailed description of the planned survey activities, including types of survey equipment planned for use, is provided in the Federal Register notice of the proposed IHA (83 FR 14417; April 4, 2018). Since that time, no changes have been made to the planned activities. Therefore, a detailed description is not repeated here. Please refer to that Federal Register notice for the description of the specific activity.

    Comments and Responses

    NMFS published a notice of proposed IHA in the Federal Register on April 4, 2018 (83 FR 14417). During the 30-day public comment period, NMFS received comment letters from the Marine Mammal Commission (Commission), from a group of non-governmental organizations (NGOs) including Natural Resources Defense Council, National Wildlife Federation, Conservation Law Foundation, Defenders of Wildlife, Southern Environmental Law Center, Surfrider Foundation, Sierra Club, International Fund for Animal Welfare, and Wildlife Conservation Society, and from a member of the general public. NMFS has posted the comments online at: www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-other-energy-activities-renewable. The following is a summary of the public comments received and NMFS' responses.

    Comment 1: The Commission expressed concern that the method used to estimate the numbers of takes, which summed fractions of takes for each species across project days, does not account for and negates the intent of NMFS' 24-hour reset policy and recommended that NMFS share the rounding criteria with the Commission in an expeditious manner.

    NMFS Response: NMFS appreciates the Commission's ongoing concern in this matter. Calculating predicted takes is not an exact science and there are arguments for taking different mathematical approaches in different situations, and for making qualitative adjustments in other situations. We believe, however, that the methodology used for take calculation in this IHA remains appropriate and is not at odds with the 24-hour reset policy the Commission references. We look forward to continued discussion with the Commission on this matter and will share the rounding guidance as soon as it is ready for public review.

    Comment 2: The Commission recommended that, until behavioral thresholds are updated, NMFS require applicants to use the 120-decibel (dB) re 1 micropascal (μPa), rather than 160- dB re 1μPa, threshold for acoustic, non-impulsive sources (e.g., sub-bottom profilers/chirps, echosounders, and other sonars including side-scan and fish-finding).

    NMFS Response: Certain sub-bottom profiling systems are appropriately considered to be impulsive sources (e.g., boomers, sparkers); therefore, the threshold of 160 dB re 1μPa will continue to be used for those sources. Other source types referenced by the Commission (e.g., chirp sub-bottom profilers, echosounders, and other sonars including side-scan and fish-finding) produce signals that are not necessarily strictly impulsive; however, NMFS finds that the 160-dB rms threshold is most appropriate for use in evaluating potential behavioral impacts to marine mammals because the temporal characteristics (i.e., intermittency) of these sources are better captured by this threshold. The 120-dB threshold is associated with continuous sources and was derived based on studies examining behavioral responses to drilling and dredging. Continuous sounds are those whose sound pressure level remains above that of the ambient sound, with negligibly small fluctuations in level (NIOSH, 1998; ANSI, 2005). Examples of sounds that NMFS would categorize as continuous are those associated with drilling or vibratory pile driving activities. Intermittent sounds are defined as sounds with interrupted levels of low or no sound (NIOSH, 1998). Thus, signals produced by these source types are not continuous but rather intermittent sounds. With regard to behavioral thresholds, we consider the temporal and spectral characteristics of signals produced by these source types to more closely resemble those of an impulse sound rather than a continuous sound. The threshold of 160 dB re 1μPa is typically associated with impulsive sources, which are inherently intermittent. Therefore, the 160 dB threshold (typically associated with impulsive sources) is more appropriate than the 120 dB threshold (typically associated with continuous sources) for estimating takes by behavioral harassment incidental to use of such sources.

    Comment 3: The Commission requested clarification regarding certain issues associated with NMFS' notice that one-year renewals could be issued in certain limited circumstances and expressed concern that the process would bypass the public notice and comment requirements. The Commission also suggested that NMFS should discuss the possibility of renewals through a more general route, such as a rulemaking, instead of notice in a specific authorization. The Commission further recommended that if NMFS did not pursue a more general route, that the agency provide the Commission and the public with a legal analysis supporting our conclusion that this process is consistent with the requirements of section 101(a)(5)(D) of the MMPA.

    NMFS Response: The process of issuing a renewal IHA does not bypass the public notice and comment requirements of the MMPA. 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. Importantly, such renewals would be limited to circumstances 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 they are for all IHAs. Last, NMFS will publish on our website a description of the renewal process before any renewal is issued utilizing the new process.

    Comment 4: The NGOs expressed concern regarding the marine mammal density estimates used to calculate take. Specifically, the commenters stated the estimates derived from models presented in Roberts et al. (2016) may underrepresent density and seasonal presence of large whales in the survey area, and recommended that NMFS consider additional data sources in density modeling for future analyses of estimated take, including initial data from state monitoring efforts, existing passive acoustic monitoring data, opportunistic marine mammal sightings data, and other data sources.

    NMFS Response: NMFS has determined that the data provided by Roberts et al. (2016) represents the best available information concerning marine mammal density in the survey area and has used it accordingly. NMFS has considered other available information, including that cited by the commenters, and determined that it does not contradict the information provided by Roberts et al. (2016). The information discussed by the commenters does not provide data in a format that is directly usable in an acoustic exposure analysis and the commenters make no useful recommendation regarding how to do so. We will review the data sources recommended by the commenters and will consider their suitability for inclusion in future analyses, as requested by the commenters.

    Comment 5: The NGOs recommended that NMFS should analyze levels of take for the entire duration of the activities specified in the proposed IHA (i.e., May 15th to December 31st, 2018).

    NMFS Response: We agree with the commenters. As noted in the IHA application, density data for the months May through December (i.e., the entire duration of the survey including May 15th to December 31st, 2018) were, in fact, analyzed in the take estimate. The statement in the Federal Register notice of the proposed IHA (83 FR 14417; April 4, 2018) that the NGOs refer to in this comment, that density data for the months of May and December were not included in the take analysis, was incorrect, and has been corrected in this document. The potential for analyzing only certain months of density data, based on anticipated months that the survey would most likely be active, had been discussed previously but this approach was not ultimately followed, thus this statement should not have appeared in the Federal Register notice of the proposed IHA. We regret any confusion this may have caused.

    Comment 6: Regarding mitigation measures, the NGOs recommended NMFS impose a restriction on site assessment and characterization activities that have the potential to injure or harass the North Atlantic right whale from November 1st to April 30th.

    NMFS Response: In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, 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; and (2) the practicability of the measures for applicant implementation, which may consider such things as relative cost and impact on operations.

    GSOE determined the planned duration of the survey based on their data acquisition needs, which are largely driven by the Bureau of Ocean Energy Management's (BOEM) data acquisition requirements prior to required submission of a construction and operations plan (COP). Any effort on the part of NMFS to restrict the months during which the survey could operate would likely have the effect of forcing the applicant to conduct additional months of surveys the following year, resulting in increased costs incurred by the applicant and additional time on the water with associated additional production of underwater noise which could have further potential impacts to marine mammals. Thus the time and area restrictions recommended by the commenters would not be practicable for the applicant to implement and would to some degree offset the benefit of the recommended measure. In addition, our analysis of the potential impacts of the survey on right whales does not indicate that such closures are warranted, as potential impacts to right whales from the survey activities would be limited to short-term behavioral responses; no marine mammal injury is expected as a result of the survey, nor is injury authorized in the IHA. Thus, in consideration of the limited potential benefits of time and area restrictions, in concert with the impracticability and increased cost on the part of the applicant that would result from such restrictions, NMFS has determined that time and area restrictions are not warranted in this case. Existing mitigation measures, including exclusion zones, ramp-up of survey equipment, and vessel strike avoidance measures, are sufficiently protective to ensure the least practicable adverse impact on species or stocks and their habitat.

    Comment 7: Regarding mitigation measures, the NGOs recommended that NMFS require that geophysical surveys commence, with ramp-up, during daylight hours only to maximize the probability that North Atlantic right whales are detected and confirmed clear of the exclusion zone, and that, if a right whale were detected in the exclusion zone during nighttime hours and the survey is shut down, developers should be required to wait until daylight hours for ramp-up to commence.

    NMFS Response: We acknowledge the limitations inherent in detection of marine mammals at night. However, similar to the discussion above regarding time and area closures, restricting the ability of the applicant to ramp-up surveys only during daylight hours would have the potential to result in lengthy shutdowns of the survey equipment, which could result in the applicant failing to collect the data they have determined is necessary, which could result in the need to conduct additional surveys the following year. This would result in significantly increased costs incurred by the applicant. Thus the restriction suggested by the commenters would not be practicable for the applicant to implement. In addition, as described above, potential impacts to marine mammals from the survey activities would be limited to short-term behavioral responses. Restricting surveys in the manner suggested by the commenters may reduce marine mammal exposures by some degree in the short term, but would not result in any significant reduction in either intensity or duration of noise exposure. No injury is expected to result even in the absence of mitigation, given the very small estimated Level A harassment zones. In the event that NMFS imposed the restriction suggested by the commenters, potentially resulting in a second survey season of surveys required for the applicant, vessels would be on the water introducing noise into the marine environment for an extended period of time. Therefore, in addition to practicability concerns for the applicant, the restrictions recommended by the commenters could result in the surveys spending increased time on the water, which may result in greater overall exposure to sound for marine mammals; thus the commenters have failed to demonstrate that such a requirement would result in a net benefit for affected marine mammals. Therefore, in consideration of potential effectiveness of the recommended measure and its practicability for the applicant, NMFS has determined that restricting survey start-ups to daylight hours is not warranted in this case.

    However, in recognition of the concerns raised by the commenters, we have added a mitigation requirement to the IHA that shutdown of geophysical survey equipment is required upon confirmed passive acoustic monitoring (PAM) detection of a North Atlantic right whale at night, even in the absence of visual confirmation, except in cases where the acoustic detection can be localized and the right whale can be confirmed as being beyond the 500 m exclusion zone (EZ); equipment may be re-started no sooner than 30 minutes after the last confirmed acoustic detection.

    Comment 8: The NGOs recommended that NMFS require a 500 m EZ for marine mammals and sea turtles (with the exception of dolphins that voluntarily approach the vessel). Additionally, the NGOs recommended that protected species observers (PSOs) monitor to an extended 1,000 m EZ for North Atlantic right whales.

    NMFS Response: Regarding the recommendation for a 1,000 m EZ specifically for North Atlantic right whales, we have determined that the 500 m EZ, as required in the IHA, is sufficiently protective. We note that the 500 m EZ exceeds the modeled distance to the Level B harassment isopleth (447 m) thus for North Atlantic right whales detected by PSOs this EZ would be expected to effectively minimize potential instances of injury and harassment.

    Regarding the commenters' recommendation to require a 500 m EZ for all marine mammals (except dolphins that approach the vessel) we have determined the EZs as currently required in the IHA (described in Mitigation Measures, below) are sufficient to ensure the least practicable adverse impact on species or stocks and their habitat. The EZs would prevent all potential instances of marine mammal injury (though in this instance, injury would not be an expected outcome even in the absence of mitigation due to very small predicted isopleths corresponding to the Level A harassment threshold (Table 5) and would further prevent some instances of behavioral harassment, as well as limiting the intensity and/or duration of behavioral harassment that does occur. As NMFS has determined the EZs currently required in the IHA to be sufficiently protective, we do not think expanded EZs, beyond what is required in the IHA, are warranted. With respect to EZs for sea turtles, we do not have the statutory authority under the MMPA to require mitigation measures specific to sea turtles.

    Comment 9: The NGOs recommended that NMFS should not allow modifications of the radii of the EZs based on sound source validation data, except in the event that sound source validation data support the extension of the EZs.

    NMFS Response: While NMFS disagrees that modifications should not be made on the basis of empirical data, this comment is not relevant to this action. The potential for modification of the radii of the EZs has not been proposed by NMFS in this IHA and is not included in the issued IHA.

    Comment 10: The NGOs recommended that a combination of visual monitoring by PSOs and PAM should be required 24 hours per day, and that a combination of PAM and continual visual monitoring using night vision and infra-red should be required at night.

    NMFS Response: The PAM requirement has been included in the IHA because PAM was proposed by the applicant, and PAM is required in BOEM lease stipulations. We do not think the use of PAM is necessarily warranted for surveys using the sound sources proposed for use by GSOE, due to relatively small areas that are expected to be ensonified to the Level A harassment threshold (Table 5). As we are not convinced that PAM is necessarily warranted for this type of survey, we do not think a requirement to expand the use of PAM to 24 hours a day during the planned survey is warranted. Expanding the PAM requirement to 24 hours a day may also result in increased costs on the part of the applicant. When the potential benefits of a 24 hour PAM requirement are considered in concert with the potential increased costs on the part of the applicant that would result from such a requirement, we determined a requirement for 24 hour PAM operation is not warranted in this case. We have determined the current requirements for visual and acoustic monitoring are sufficient to ensure the EZs and Watch Zone are adequately monitored.

    Comment 11: The NGOs recommended that NMFS require a 10 knot speed restriction on all project-related vessels transiting to/from the survey area from November 1st through April 30th and that all project vessels operating within the survey area should be required to maintain a speed of 10 knots or less during the entire survey period.

    NMFS Response: NMFS has analyzed the potential for ship strike resulting from GSOE's activity and has determined that the mitigation measures specific to ship strike avoidance are sufficient to avoid the potential for ship strike. These include: A requirement that all vessel operators comply with 10 knot (18.5 kilometer (km)/hr) or less speed restrictions in any Seasonal Management Area (SMA) or Dynamic Management Area (DMA); a requirement that all vessel operators reduce vessel speed to 10 knots (18.5 km/hr) or less when any large whale, any mother/calf pairs, pods, or large assemblages of non-delphinoid cetaceans are observed within 100 m of an underway vessel; a requirement that all survey vessels maintain a separation distance of 500 m or greater from any sighted North Atlantic right whale; a requirement that, if underway, vessels must steer a course away from any sighted North Atlantic right whale at 10 knots or less until the 500 m minimum separation distance has been established; and a requirement that, if a North Atlantic right whale is sighted in a vessel's path, or within 500 m of an underway vessel, the underway vessel must reduce speed and shift the engine to neutral. Additional measures to prevent the potential for ship strike are discussed in more detail below (see the Mitigation section). We have determined that the ship strike avoidance measures are sufficient to ensure the least practicable adverse impact on species or stocks and their habitat. We also note that vessel strike during surveys is extremely unlikely based on the low vessel speed; the survey vessel would maintain a speed of approximately 4 knots (7.4 kilometers per hour) while transiting survey lines.

    Comment 12: The NGOs recommended that NMFS account for the potential for indirect ship strike risk resulting from habitat displacement in our analyses.

    NMFS Response: NMFS determined that habitat displacement was not an expected outcome of the specified activity, therefore an analysis of potential impacts to marine mammals from habitat displacement is not warranted in this case.

    Comment 13: The NGOs recommended that NMFS fund analyses of recently collected marine mammal sighting and acoustic data from 2016 and continue to fund and expand surveys and studies to (i) improve our understanding of distribution and habitat use of marine mammals off Delaware and the broader mid-Atlantic region, and (ii) enhance the resolution of population genetic structure for humpback and fin whales. The NGOs also recommended that NMFS support an expert workshop to consider any existing data and any new information necessary to inform seasonal restrictions and mitigation measures in time for the November 2018 North Atlantic right whale migration period.

    NMFS Response: We agree with the NGOs that analyses of recently collected sighting and acoustic data, as well as continued marine mammal surveys, are warranted, and we welcome the opportunity to participate in fora where implications of such data for potential mitigation measures would be discussed; however, we have no statutory authority or ability to require funding of such analyses and surveys, nor do we have the ability to fund such a workshop. We note that NMFS is undertaking numerous efforts relative to recovering right whales; these include expert working groups focused on specific aspects of recovery such as ship strike mitigation and entanglement mitigation, including two subgroups under the Atlantic Large Whale Take Reduction Plan which both met within the last two months, with a further full team meeting planned for fall 2018.

    Comment 14: The NGOs recommended that NMFS incentivize offshore wind developers to partner with scientists to collect data that would increase the understanding of the effectiveness of night vision and infra-red technologies off Delaware and the broader region, with a view towards greater reliance on these technologies to commence surveys during nighttime hours in the future.

    NMFS Response: NMFS agrees with the NGOs that improved data on relative effectiveness of night vision and infra-red technologies would be beneficial and could help to inform future efforts at detection of marine mammals during nighttime activities. We have no authority to incentivize such partnerships under the MMPA and the commenters have not provided us with any specific recommendations to evaluate beyond a broad recommendation. However, we will encourage coordination and communication between offshore wind developers and researchers on effectiveness of night vision and infra-red technologies, to the extent possible. In recognition of the commenters' concerns, we have also added a requirement that the final report submitted to NMFS must include an assessment of the effectiveness of night vision equipment used during nighttime surveys, including comparisons of relative effectiveness among the different types of night vision equipment used.

    Comment 15: The comment letter from a member of the general public recommended the IHA be issued to GSOE.

    NMFS Response: We have issued the IHA to GSOE.

    Description of Marine Mammals in the Area of Specified Activity

    Sections 3 and 4 of GSOE's IHA application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history, of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SAR; www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports-region) and more general information about these species (e.g., physical and behavioral descriptions) may be found on NMFS' website (www.fisheries.noaa.gov/species-directory). All species that could potentially occur in the proposed survey area are included in Table 5 of the IHA application. However, the temporal and/or spatial occurrence of several species listed in Table 5 of the IHA application is such that take of these species is not expected to occur, and they are not discussed further beyond the explanation provided here. Take of these species is not anticipated either because they have very low densities in the project area, are known to occur further offshore than the project area, or are considered very unlikely to occur in the project area during the survey due to the species' seasonal occurrence in the area.

    Table 1 lists all species with expected potential for occurrence in the survey area and with the potential to be taken as a result of the survey 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 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' SARs). While no mortality is anticipated or authorized here, PBR is included here as a gross indicator 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' 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' U.S. 2017 draft SARs (e.g., Hayes et al., 2018). All values presented in Table 1 are the most recent available at the time of publication and are available in the 2017 draft Atlantic SARs (Hayes et al., 2018).

    Table 1—Marine Mammals Known To Occur in the Survey Area Common name Stock NMFS MMPA and ESA status; strategic (Y/N) 1 Stock
  • Abundance (CV,Nmin, most recent abundance survey) 2
  • Predicted abundance (CV) 3 PBR 4 Occurrence and seasonality in the survey area
    Toothed whales (Odontoceti) Sperm whale (Physeter macrocephalus) North Atlantic E; Y 2,288 (0.28; 1,815; n/a) 5,353 (0.12) 3.6 Rare. Long-finned pilot whale (Globicephala melas) W. North Atlantic -; Y 5,636 (0.63; 3,464; n/a) 18,977 (0.11) 6 35 Rare. Atlantic white-sided dolphin (Lagenorhynchus acutus) W. North Atlantic -; N 48,819 (0.61; 30,403; n/a) 37,180 (0.07) 304 Rare. Atlantic spotted dolphin (Stenella frontalis) W. North Atlantic -; N 44,715 (0.43; 31,610; n/a) 55,436 (0.32) 316 Rare. Bottlenose dolphin (Tursiops truncatus) W. North Atlantic, Offshore -; N 77,532 (0.40; 56,053; 2011) 97,476 (0.06) 5 561 Common year round. W. North Atlantic, Northern Migratory Coastal -; N 6,639 (0.41; 4,759; 2015) 48 Common in summer; rare in winter. Common dolphin 6 (Delphinus delphis) W. North Atlantic -; N 173,486 (0.28; 55,690; 2011) 86,098 (0.12) 557 Common year round. Harbor porpoise (Phocoena phocoena) Gulf of Maine/Bay of Fundy -; N 79,833 (0.32; 61,415; 2011) 45,089 (0.12) * 706 Common year round. Baleen whales (Mysticeti) North Atlantic right whale (Eubalaena glacialis) W. North Atlantic E; Y 458 (0; 455; n/a) 535 (0.45) * 1.4 Year round in continental shelf and slope waters, occur seasonally to forage. Humpback whale 7 Megaptera novaeangliae) Gulf of Maine -; N 335 (0.42; 239; n/a) 1,637 (0.07) * 3.7 Common year round. Fin whale (Balaenoptera physalus) W. North Atlantic E; Y 1,618 (0.33; 1,234; n/a) 4,633 (0.08) 2.5 Year round in continental shelf and slope waters, occur seasonally to forage. Sei whale (Balaenoptera borealis) Nova Scotia E; Y 357 (0.52; 236; n/a) 717 (0.3) 0.5 Year round in continental shelf and slope waters, occur seasonally to forage. Minke whale 6 (Balaenoptera acutorostrata) Canadian East Coast -; N 20,741 (0.81; 1,425; n/a) 2,112 (0.05)* 162 Year round in continental shelf and slope waters, occur seasonally to forage. Earless seals (Phocidae) Gray seal 8 (Halichoerus grypus) W. North Atlantic -; N 27,131 (0.10; 25,908; n/a) 1,554 Rare. Harbor seal (Phoca vitulina) W. North Atlantic -; N 75,834 (0.15; 66,884; 2012) 2,006 Common year round. 1 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 (see footnote 3) 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 Based on NMFS SARs except where noted otherwise. NMFS SARs online at: www.nmfs.noaa.gov/pr/sars. CV is coefficient of variation; Nmin is the minimum estimate of stock abundance. In some cases, CV is not applicable. For certain stocks, abundance estimates are actual counts of animals and there is no associated CV. The most recent abundance survey that is reflected in the abundance estimate is presented; there may be more recent surveys that have not yet been incorporated into the estimate. All values presented here are from the 2017 draft Atlantic SARs (Hayes et al., 2018). 3 This information represents species- or guild-specific abundance predicted by recent habitat-based cetacean density models (Roberts et al., 2016). These models provide the best available scientific information regarding predicted density patterns of cetaceans in the U.S. Atlantic Ocean, and we provide the corresponding abundance predictions as a point of reference. Total abundance estimates were produced by computing the mean density of all pixels in the modeled area and multiplying by its area. For those species marked with an asterisk, the available information supported development of either two or four seasonal models; each model has an associated abundance prediction. Here, we report the maximum predicted abundance. 4 Potential biological removal, 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 size (OSP). 5 Abundance estimates are in some cases reported for a guild or group of species when those species are difficult to differentiate at sea. Similarly, the habitat-based cetacean density models produced by Roberts et al. (2016) are based in part on available observational data which, in some cases, is limited to genus or guild in terms of taxonomic definition. Roberts et al. (2016) produced density models to genus level for Globicephala spp. and produced a density model for bottlenose dolphins that does not differentiate between offshore and coastal stocks. 6 Abundance as reported in the 2007 Canadian Trans-North Atlantic Sighting Survey (TNASS), which provided full coverage of the Atlantic Canadian coast (Lawson and Gosselin, 2009). Abundance estimates from TNASS were corrected for perception and availability bias, when possible. In general, where the TNASS survey effort provided superior coverage of a stock's range (as compared with NOAA shipboard survey effort), the resulting abundance estimate is considered more accurate than the current NMFS abundance estimate (derived from survey effort with inferior coverage of the stock range). NMFS stock abundance estimate for the common dolphin is 70,184. NMFS stock abundance estimate for the sei whale is 356. 7 NMFS stock abundance estimate applies to Gulf of Maine feeding population. Actual humpback whale population in survey area is likely to be larger and to include humpback whales from additional feeding populations in unknown numbers. 8 NMFS stock abundance estimate applies to U.S. population only, actual abundance is believed to be much larger.

    Four marine mammal species that are listed under the Endangered Species Act (ESA) may be present in the survey area and are included in the take request: North Atlantic right whale, fin whale, sei whale and sperm whale.

    Though other marine mammal species are known to occur in the Northwest Atlantic Ocean, the temporal and/or spatial occurrence of several of these species is such that take of these species is not expected to occur, and they are therefore not discussed further beyond the explanation provided here. Take of these species is not anticipated either because they have very low densities in the project area (e.g., blue whale, Clymene dolphin, pantropical spotted dolphin, striped dolphin, spinner dolphin, killer whale, false killer whale, pygmy killer whale,), or, are known to occur further offshore than the project area (e.g., beaked whales, short-finned pilot whale, rough toothed dolphin, Kogia spp.).

    For the majority of species potentially present in the specific geographic region, NMFS has designated only a single generic stock (e.g., “western North Atlantic”) for management purposes. This includes the “Canadian east coast” stock of minke whales, which includes all minke whales found in U.S. waters. For humpback and sei whales, NMFS defines stocks on the basis of feeding locations, i.e., Gulf of Maine and Nova Scotia, respectively. However, our reference to humpback whales and sei whales in this document refers to any individuals of the species that are found in the specific geographic region.

    A detailed description of the species likely to be affected by GSOE's survey, 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 of the proposed IHA (83 FR 14417; April 4, 2018); since that time, we are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not repeated here. Please refer to that Federal Register notice for these descriptions. Please also refer to NMFS' website (www.fisheries.noaa.gov/species-directory) for generalized species accounts.

    Information concerning marine mammal hearing, including marine mammal functional hearing groups, was provided in the Federal Register notice of the proposed IHA (83 FR 14417; April 4, 2018), therefore that information is not repeated here; please refer to that Federal Register notice for this information. For further information about marine mammal functional hearing groups and associated frequency ranges, please see NMFS (2016) for a review of available information. Fourteen marine mammal species (twelve cetacean and two pinniped (both phocid) species) have the reasonable potential to co-occur with the survey activities. Please refer to Table 1. Of the cetacean species that may be present, five are classified as low-frequency cetaceans (i.e., all mysticete species), six are classified as mid-frequency cetaceans (i.e., all delphinid species and the sperm whale), and one is classified as a high-frequency cetacean (i.e., harbor porpoise).

    Potential Effects of Specified Activities on Marine Mammals and Their Habitat

    The effects of underwater noise from GSOE's survey activities have the potential to result in behavioral harassment of marine mammals in the vicinity of the survey area. The Federal Register notice of the proposed IHA (83 FR 14417; April 4, 2018) included a discussion of the effects of anthropogenic noise on marine mammals and their habitat, therefore that information is not repeated here; please refer to that Federal Register notice for that information. No instances of hearing threshold shifts, injury, serious injury, or mortality are expected as a result of the planned activities.

    Estimated Take

    This section provides an estimate of the number of incidental takes authorized through this IHA, which will inform both NMFS' consideration of “small numbers” and the negligible impact determination.

    Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

    Authorized takes are by Level B harassment, as use of the survey equipment has the potential to result in disruption of behavioral patterns for individual marine mammals. NMFS has determined take by Level A harassment is not an expected outcome of the activity and thus we do not authorize the take of any marine mammals by Level A harassment. This is discussed in greater detail below. As described previously, no mortality or serious injury is anticipated or authorized for this activity. Below we describe how the take is estimated for this project.

    Described in the most basic way, 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. Below, we describe these components in more detail and present the take estimate.

    Acoustic Thresholds

    NMFS uses 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—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 sound source (e.g., frequency, predictability, duty cycle); the environment (e.g., bathymetry); and the receiving animals (hearing, motivation, experience, demography, behavioral context) and therefore can be difficult to predict (Southall et al., 2007, Ellison et al. 2011). NMFS uses a generalized acoustic threshold based on received level to estimate the onset of Level B (behavioral) harassment. NMFS predicts that marine mammals may be behaviorally harassed when exposed to underwater anthropogenic noise above received levels 160 dB re 1 μPa (rms) for non-explosive impulsive (e.g., seismic HRG equipment) or intermittent (e.g., scientific sonar) sources. GSOE's activity includes the use of impulsive sources. Therefore, the 160 dB re 1 μPa (rms) criteria is applicable for analysis of Level B harassment.

    Level A harassment—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (NMFS 2016) 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 Technical Guidance identifies the received levels, or thresholds, above which individual marine mammals are predicted to experience changes in their hearing sensitivity for all underwater anthropogenic sound sources, reflects the best available science, and better predicts the potential for auditory injury than does NMFS' historical criteria.

    These thresholds were developed by compiling and synthesizing the best available science and soliciting input multiple times from both the public and peer reviewers to inform the final product, and are provided in Table 2 below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2016 Technical Guidance, which may be accessed at: www.nmfs.noaa.gov/pr/acoustics/guidelines.htm. As described above, GSOE's activity includes the use of intermittent and impulsive sources

    Table 2—Thresholds Identifying the Onset of Permanent Threshold Shift in Marine Mammals Hearing group PTS onset thresholds Impulsive* Non-impulsive Low-Frequency (LF) Cetaceans L pk,flat: 219 dB; L E,LF,24h: 183 dB L E,LF,24h: 199 dB. Mid-Frequency (MF) Cetaceans L pk,flat: 230 dB; L E,MF,24h: 185 dB L E,MF,24h: 198 dB. High-Frequency (HF) Cetaceans L pk,flat: 202 dB; L E,HF,24h: 155 dB L E,HF,24h: 173 dB. Phocid Pinnipeds (PW) (Underwater) L pk,flat: 218 dB; L E,PW,24h: 185 dB L E,PW,24h: 201 dB. Otariid Pinnipeds (OW) (Underwater) L pk,flat: 232 dB; L E,OW,24h: 203 dB L E,OW,24h: 219 dB. Note:

    *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 (Lpk) has a reference value of 1 μPa, and cumulative sound exposure level (LE) has a reference value of 1μPa2s. 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 estimating the area ensonified above the acoustic thresholds.

    The survey would entail the use of HRG survey equipment. The distance to the isopleth corresponding to the threshold for Level B harassment was calculated for all HRG survey equipment with the potential to result in harassment of marine mammals using the spherical transmission loss (TL) equation: TL=20log10. Results of acoustic modeling indicated that, of the HRG survey equipment planned for use that has the potential to result in harassment of marine mammals, the AA Dura Spark would be expected to produce sound that would propagate the furthest in the water (Table 3); therefore, for the purposes of the take calculation, it was assumed the AA Dura Spark would be active during the entirety of the survey. Thus the distance to the isopleth corresponding to the threshold for Level B harassment for the AA Dura Spark (estimated at 447 m; Table 3) was used as the basis of the Level B take calculation for all marine mammals.

    Table 3—Modeled Radial Distances From HRG Survey Equipment to Isopleth Corresponding to Level B Harassment Threshold HRG system Radial distance (m) to level B harassment threshold (160 dB re 1 μPa) TB Chirp 70.79 EdgeTech Chirp 6.31 AA Boomer 5.62 AA S-Boom 141.25 Bubble Gun 63.1 800J Spark 141.25 AA Dura Spark 446.69

    Predicted distances to Level A harassment isopleths, which vary based on marine mammal functional hearing groups (Table 2), were also calculated. The updated acoustic thresholds for impulsive sounds (such as HRG survey equipment) contained in the Technical Guidance (NMFS, 2016) were presented as dual metric acoustic thresholds using both SELcum and peak sound pressure level metrics. As dual metrics, NMFS considers onset of PTS (Level A harassment) to have occurred when either one of the two metrics is exceeded (i.e., metric resulting in the largest isopleth). The SELcum metric considers both level and duration of exposure, as well as auditory weighting functions by marine mammal hearing group. In recognition of the fact that calculating Level A harassment ensonified areas could be more technically challenging to predict due to the duration component and the use of weighting functions in the new SELcum thresholds, NMFS developed an optional User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to facilitate the estimation of take numbers. GSOE used the NMFS optional User Spreadsheet to calculate distances to Level A harassment isopleths based on SELcum and used the spherical spreading loss model (similar to the method used to calculate Level B isopleths as described above) to calculate distances to Level A harassment isopleths based on peak pressure.

    Modeling of distances to isopleths corresponding to Level A harassment was performed for all types of HRG equipment planned for use with the potential to result in harassment of marine mammals. Of the HRG equipment types modeled, the AA Dura Spark resulted in the largest distances to isopleths corresponding to Level A harassment for all marine mammal functional hearing groups; therefore, to be conservative, the isopleths modeled for the AA Dura Spark were used to estimate potential Level A take. Based on a conservative assumption that the AA Dura Spark would be operated at 1,000 joules during the survey, a peak source level of 223 dB re 1μPa was used for modeling Level A harassment isopleths based on peak pressure (Crocker & Fratantonio, 2016). Inputs to the NMFS optional User Spreadsheet for the AA Dura Spark are shown in Table 4. Modeled distances to isopleths corresponding to Level A harassment thresholds for the AA Dura Spark are shown in Table 5 (modeled distances to Level A harassment isopleths for all other types of HRG equipment planned for use are shown in Table 6 of the IHA application). As described above, NMFS considers onset of PTS (Level A harassment) to have occurred when either one of the two metrics is exceeded (i.e., metric resulting in the largest isopleth). In this case, modeled distances to isopleths corresponding to the Level A harassment threshold were greater based on the peak SPL metric than the SELcum metric for all marine mammal functional hearing groups (Table 5). We note that Table 5 in the Federal Register notice of the proposed IHA (83 FR 14417; April 4, 2018) contained errors that reflected errors in Table 6 of the IHA application (an incorrect weighting factor adjustment was used in the optional User Spreadsheet which resulted in incorrect Level A isopleths for the SELcum metric). The correct inputs are shown in Table 4 below and the correct distances to Level A isopleths are shown in Table 5 below. Note that where distances to isopleths corresponding to the Level A harassment threshold have changed in comparison to those shown and analyzed in the proposed IHA, they are less than those that were presented in the proposed IHA.

    Table 4—Inputs to the NMFS Optional User Spreadsheet for the AA Dura Spark Source Level (RMS SPL) 1 213 dB re 1μPa Source Level (peak) 1 223 dB re 1μPa Weighting Factor Adjustment (kHz) 1 3.2 Source Velocity (meters/second) 2.07 Pulse Duration (seconds) 0.0021 1/Repetition rate (seconds) 2.42 Duty Cycle 0.00 1 Derived from Crocker & Fratantonio (2016), based on operation at 1,000 joules. Table 5—Modeled Radial Distances to Isopleths Corresponding to Level A Harassment Thresholds Functional hearing group
  • (Level A harassment thresholds)
  • Radial distance (m) to Level A
  • harassment
  • threshold
  • (SELcum)
  • Radial distance (m) to Level A
  • harassment
  • threshold
  • (Peak SPLflat)
  • Low frequency cetaceans (L pk,flat: 219 dB; L E,LF,24h: 183 dB) 1.3 1.6 Mid frequency cetaceans (L pk,flat: 230 dB; LE,MF,24h: 185 dB) 0.0 0.0 High frequency cetaceans (L pk,flat: 202 dB; L E,HF,24h: 155 dB) 8.6 11.2 Phocid Pinnipeds (Underwater) (L pk,flat: 218 dB; L E,HF,24h: 185 dB) 0.7 1.8

    Due to the small estimated distances to Level A harassment thresholds for all marine mammal functional hearing groups, based on both SELcum and peak SPL (Table 5), and in consideration of the mitigation measures (see the Mitigation section for more detail), NMFS has determined that the likelihood of Level A take of marine mammals occurring as a result of the survey is so low as to be discountable.

    We note that because of some of the assumptions included in the methods used, isopleths produced may be overestimates to some degree. Most of the acoustic sources planned for use in GSOE's survey (including the AA Dura Spark) do not radiate sound equally in all directions but were designed instead to focus acoustic energy directly toward the sea floor. Therefore, the acoustic energy produced by these sources is not received equally in all directions around the source but is instead concentrated along some narrower plane depending on the beamwidth of the source. However, the calculated distances to isopleths do not account for this directionality of the sound source and are therefore conservative. Two types of geophysical survey equipment planned for use in the planned survey are omni-directional, however the modeled distances to isopleths corresponding to the Level B harassment threshold for these sources are smaller than that for the Dura Spark, and the Dura Spark was used to conservatively estimate take for the duration of the survey. For mobile sources, such as the planned survey, the User Spreadsheet predicts the closest distance at which a stationary animal would not incur PTS if the sound source traveled by the animal in a straight line at a constant speed.

    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.

    The best available scientific information was considered in calculating marine mammal exposure estimates (the basis for estimating take). For cetacean species, densities calculated by Roberts et al. (2016) were used. The density data presented by Roberts et al. (2016) incorporates aerial and shipboard line-transect survey data from NMFS and from other organizations collected over the period 1992-2014. Roberts et al. (2016) modeled density from 8 physiographic and 16 dynamic oceanographic and biological covariates, and controlled for the influence of sea state, group size, availability bias, and perception bias on the probability of making a sighting. NMFS considers the models produced by Roberts et al. (2016) to be the best available source of data regarding cetacean densities for this project. More information, including the model results and supplementary information for each model, is available online at: seamap.env.duke.edu/models/Duke-EC-GOM-2015/.

    For the purposes of the take calculations, density data from Roberts et al. (2016) were mapped using a geographic information system (GIS), using density data for the months May through December. Mean density per month for each species within the survey area was calculated by selecting 11 random raster cells selected from 100 km2 grid cells that were inside the Delaware Wind Energy Area (WEA) and an additional buffer of 10 km outside the WEA boundary (see Figure 1 in the IHA application). Estimates provided by the models are based on a grid cell size of 100 km2; therefore, model grid cell values were then divided by 100 to determine animals per square km. We note that the Federal Register notice of the proposed IHA (83 FR 14417; April 4, 2018) contained an incorrect statement that density data for the months of May and December were not included in the take estimates, however, this statement was incorrect; density data for all months during which the survey may occur (i.e., May through December) were included in the take analysis.

    Systematic, offshore, at-sea survey data for pinnipeds are more limited than those for cetaceans. The best available information concerning pinniped densities in the survey area is the U.S. Navy's Operating Area (OPAREA) Density Estimates (NODEs) (DoN, 2007). These density models utilized vessel-based and aerial survey data collected by NMFS from 1998-2005 during broad-scale abundance studies. Modeling methodology is detailed in DoN (2007). For the purposes of the take calculations, NODEs Density Estimates (DoN, 2007) as reported for the summer and fall seasons in the “Mid Atlantic” area were used to estimate harbor seal densities. NODEs reports a density value of 0 for gray seals throughout the year in the “Mid Atlantic” area; however, the survey data used to develop the OPAREA Density Estimates for gray seal are nearly 20 years old; and, based on the best available information (Hayes et al., 2018), gray seals are expected to occur in the survey area, especially during the fall months. Therefore, density data for harbor seals for the summer and fall seasons in the “Mid Atlantic” area were used to estimate gray seal density in the survey area. We acknowledge that this probably represents a conservative approach to estimating gray seal density in the survey area, however this approach is based on the best available information.

    Take Calculation and Estimation

    Here we describe how the information provided above is brought together to produce a quantitative take estimate.

    In order to estimate the number of marine mammals predicted to be exposed to sound levels that would result in harassment, radial distances to predicted isopleths corresponding to harassment thresholds are calculated, as described above. Those distances are then used to calculate the area(s) around the HRG survey equipment predicted to be ensonified to sound levels that exceed harassment thresholds. The area estimated to be ensonified to relevant thresholds in a single day of the survey is then calculated, based on areas predicted to be ensonified around the HRG survey equipment and the estimated trackline distance traveled per day by the survey vessel. GSOE estimates a daily track line distance of 110 km per day during HRG surveys. Based on the maximum estimated distance to the Level B harassment threshold of 447 m (Table 3) and the estimated daily track line distance of 110 km, an area of 98.9 km2 would be ensonified to the Level B harassment threshold per day during HRG surveys.

    The number of marine mammals expected to be incidentally taken per day is then calculated by estimating the number of each species predicted to occur within the daily ensonified area, using estimated marine mammal densities as described above. Estimated numbers of each species taken per day are then multiplied by the number of survey days, and the product is then rounded, to generate an estimate of the total number of each species expected to be taken over the duration of the survey (Table 6).

    Takes of bottlenose dolphins could be from either the Western North Atlantic Offshore or Western North Atlantic Northern Migratory Coastal stocks. For purposes of calculating takes as a percentage of population, we assume 50 percent of bottlenose dolphins taken will be from the Western North Atlantic Offshore stock and 50 percent will be from the Western North Atlantic Northern Migratory Coastal stock.

    The applicant estimated a total of 4 takes by Level A harassment of harbor porpoises and 3 takes each by Level A harassment for harbor seals and gray seals would occur, in the absence of mitigation. However, as described above, due to the very small estimated distances to Level A harassment thresholds (Table 5), and in consideration of the planned mitigation measures, the likelihood of the planned survey resulting in take in the form of Level A harassment is considered so low as to be discountable; therefore, we do not authorize take of any marine mammals by Level A harassment. Take numbers are shown in Table 6.

    Table 6—Total Numbers of Potential Incidental Take of Marine Mammals Authorized and Takes as a Percentage of Population Species Density
  • (#/100 km2)
  • Level A takes
  • authorized
  • Estimated Level B takes Level B takes authorized Total takes
  • authorized
  • Total takes
  • authorized as a
  • percentage of
  • population 1
  • North Atlantic right whale 0.0078 0 1 1 1 0.2 Humpback whale 0.0344 0 6 6 6 0.4 Fin whale 0.1004 0 18 18 18 0.4 Sei whale 2 0.0036 0 1 2 2 <0.1 Minke whale 3 0.0244 0 4 4 4 <0.1 Sperm whale 0.0053 0 1 1 1 <0.1 Long-finned pilot whale 2 0.0507 0 9 32 32 0.2 Bottlenose dolphin 4 6.3438 0 1148 1148 1148 1.18 (W. North Atlantic Offshore stock) 3 17.3 (W. North Atlantic Northern Migratory Coastal stock) Atlantic Spotted dolphin 0.1323 0 24 24 24 <0.1 Common dolphin 3 2.9574 0 535 535 535 0.3 Atlantic white-sided dolphin 0.4342 0 79 79 79 0.2 Harbor porpoise 0.5625 0 102 102 102 0.2 Harbor seal 6.4933 0 1175 1175 1175 1.6 Gray seal 6.4933 0 1175 1175 1175 4.3 1 Estimates of total takes as a percentage of population are based on marine mammal abundance estimates provided by Roberts et al. (2016), when available, to maintain consistency with density estimates which are derived from data provided by Roberts et al. (2016). In cases where abundances are not provided by Roberts et al. (2016), total takes as a percentage of population are based on abundance estimates in the NMFS Atlantic SARs (Hayes et al., 2018). 2 The number of authorized takes (Level B harassment only) for these species has been increased from the estimated take to mean group size. Source for sei whale group size estimate is: Schilling et al. (1992). Source for long-finned pilot whale group size estimate is: Augusto et al. (2017). 3 Estimates of total authorized takes as a percentage of population are based on marine mammal abundance estimates as reported in the 2007 TNASS (Lawson and Gosselin, 2009) (Table 1). Abundance estimates from TNASS were corrected for perception and availability bias, when possible. In general, where the TNASS survey effort provided superior coverage of a stock's range (as compared with NOAA shipboard survey effort), the resulting abundance estimate is considered more accurate than abundance estimates based on NMFS surveys. 4 A total of 1,148 takes of bottlenose dolphins are authorized. Takes could be from either the Western North Atlantic Offshore or Western North Atlantic Northern Migratory Coastal stocks. For purposes of calculating takes as a percentage of population we assume 50 percent of bottlenose dolphins taken will be from the Western North Atlantic Offshore stock and 50 percent will be from the Western North Atlantic Northern Migratory Coastal stock.

    Species with Take Estimates Less than Mean Group Size: Using the approach described above to estimate take, the take estimates for the sei whale and long-finned pilot whale were less than the average group sizes estimated for these species (Table 6). However, information on the social structures and life histories of these species indicates these species are often encountered in groups. The results of take calculations support the likelihood that the planned survey is expected to encounter and to incidentally take these species, and we believe it is likely that these species may be encountered in groups. Therefore it is reasonable to conservatively assume that one group of each of these species will be taken during the planned survey. We authorize the take of the average group size for these species and stocks to account for the possibility that the planned survey encounters a group of any of these species or stocks (Table 6). We note that the average group size estimate for sei whales in the Federal Register notice of the proposed IHA was incorrectly stated as 6 when in fact Schilling et al. (1992) report an average group size of 2; therefore, the number of authorized takes of sei whales has been revised downward from the number of takes proposed in the proposed IHA (from 6 takes proposed to 2 takes authorized). Note that the take estimate for the North Atlantic right whale was not increased to average group size because the exclusion zone for right whales (500 m) (see the Mitigation section), which exceeds the estimated isopleth corresponding to the Level B harassment threshold, is expected to avoid the potential for takes that exceed the take estimate. Also, the take estimate for the sperm whale was not increased to average group size because, based on water depths in the survey area (16 to 28 m (52 to 92 ft)), it is very unlikely that groups of sperm whales, which tend to prefer deeper depths, would be encountered by the planned survey.

    Mitigation

    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 relative cost and impact on operations.

    Mitigation Measures

    Based on the applicant's request, which includes requirements relating to the BOEM Lease stipulations associated with ESA-listed marine mammals, and specific information regarding the zones ensonified above NMFS thresholds, NMFS is requiring the following mitigation measures during the marine site characterization surveys.

    Marine Mammal Exclusion Zones and Watch Zone

    Marine mammal EZs would be established around the HRG survey equipment and monitored by protected species observers (PSO) during HRG surveys, as follows:

    • 500 m EZ for North Atlantic right whales;

    • 200 m EZ for all other ESA-listed cetaceans (including fin whale, sei whale and sperm whale); and

    • 25 m EZ for harbor porpoises.

    The applicant proposed a 500 m EZ for North Atlantic right whales and 200 m EZ for all other marine mammals; however, for non-ESA-listed marine mammals, based on estimated distances to isopleths corresponding with Level A harassment thresholds (Table 5), we determined EZs for species other than those described above were not warranted. If HRG survey equipment is shut down (as described below) due to a marine mammal being observed within or approaching the relevant EZs, ramp up of survey equipment may not commence until the animal(s) has been observed exiting the relevant EZ, or until an additional time period has elapsed with no further sighting of the animal (e.g., 15 minutes for harbor porpoises and 30 minutes for all large whale species). In addition to the EZs described above, PSOs will visually monitor and record the presence of all marine mammals within 500 m. Marine mammals observed by PSOs within 447 m of geophysical survey equipment will be documented as takes by Level B harassment.

    Visual Monitoring

    As per the BOEM lease, visual and acoustic monitoring of the established exclusion and monitoring zones will be performed by qualified and NMFS-approved PSOs. It will be the responsibility of the Lead PSO on duty to communicate the presence of marine mammals as well as to communicate the action(s) that are necessary to ensure mitigation and monitoring requirements are implemented as appropriate. PSOs will be equipped with binoculars and would estimate distances to marine mammals located in proximity to the vessel and/or exclusion zone using range finders. Reticulated binoculars will also be available to PSOs for use as appropriate based on conditions and visibility to support the siting and monitoring of marine species. Position data will be recorded using hand-held or vessel global positioning system (GPS) units for each sighting. Observations will take place from the highest available vantage point on the survey vessel. During surveys conducted at night, night-vision equipment with infrared light-emitting diodes spotlights and/or infrared video monitoring will be available for PSO use, and passive acoustic monitoring (described below) will be used.

    Pre-Clearance of the Exclusion Zone

    Prior to initiating HRG survey activities, GSOE will implement a 30-minute pre-clearance period. During this period, the PSOs will ensure that no North Atlantic right whales are observed within 500 m of geophysical survey equipment, and that no other marine mammal species are observed within 200 m of geophysical survey equipment. Surveys may not begin until these zones have been clear of the relevant marine mammal species for 30 minutes. This pre-clearance requirement would include small delphinoids that approach the vessel (e.g., bow ride). PSOs would also continue to monitor the zone for 30 minutes after survey equipment is shut down or survey activity has concluded.

    Passive Acoustic Monitoring

    As proposed by the applicant and required by BOEM lease stipulations, PAM will be used to support monitoring during night time operations to provide for optimal acquisition of species detections at night. The PAM system will consist of an array of hydrophones with both broadband (sampling mid-range frequencies of 2 kHz to 200 kHz) and at least one low-frequency hydrophone (sampling range frequencies of 75 Hz to 30 kHz). The PAM operator(s) will monitor acoustic signals in real time both aurally (using headphones) and visually (via sound analysis software). PAM operators will communicate nighttime detections to the lead PSO on duty who will ensure the implementation of the appropriate mitigation measure.

    Shutdown of geophysical survey equipment is required upon confirmed PAM detection of a North Atlantic right whale at night, even in the absence of visual confirmation, except in cases where the acoustic detection can be localized and the right whale can be confirmed as being beyond the 500 m EZ; equipment may be re-started no sooner than 30 minutes after the last confirmed acoustic detection. However, aside from the required shutdown for right whales as described above, PAM detection alone would not trigger a requirement for any mitigation action to be taken upon acoustic detection of marine mammals.

    Ramp-Up of Survey Equipment

    As proposed by the applicant, where technically feasible, a ramp-up procedure will be used for geophysical survey equipment capable of adjusting energy levels at the start or re-start of survey activities. The ramp-up procedure will be used at the beginning of HRG survey activities in order to provide additional protection to marine mammals near the survey area by allowing them to detect the presence of the survey and vacate the area prior to the commencement of survey equipment use at full energy. Ramp-up of the survey equipment will not begin until the relevant EZs have been cleared by the PSOs, as described above. Systems will be initiated at their lowest power output and will be incrementally increased to full power. If any marine mammals are detected within the EZ prior to or during the ramp-up, HRG equipment will be shut down (as described below).

    Shutdown Procedures

    If a marine mammal is observed within or approaching the relevant EZ (as described above) an immediate shutdown of the survey equipment is required. Subsequent restart of the survey equipment may only occur after the animal(s) has either been observed exiting the relevant EZ or until an additional time period has elapsed with no further sighting of the animal (e.g., 15 minutes for delphinoid cetaceans and pinnipeds and 30 minutes for all other species).

    In addition, shutdown of geophysical survey equipment is required upon confirmed PAM detection of a North Atlantic right whale at night, even in the absence of visual confirmation, except in cases where the acoustic detection can be localized and the right whale can be confirmed as being beyond the 500 m EZ; equipment may be re-started no sooner than 30 minutes after the last confirmed acoustic detection.

    As required in the BOEM lease, if the HRG equipment shuts down for reasons other than mitigation (i.e., mechanical or electronic failure) resulting in the cessation of the survey equipment for a period greater than 20 minutes, a 30 minute pre-clearance period (as described above) will precede the restart of the HRG survey equipment. If the pause is less than 20 minutes, the equipment may be restarted as soon as practicable at its full operational level only if visual surveys were continued diligently throughout the silent period and the EZs remained clear of marine mammals during that entire period. If visual surveys were not continued diligently during the pause of 20 minutes or less, a 30-minute pre-clearance period (as described above) will precede the re-start of the HRG survey equipment. Following a shutdown, HRG survey equipment may be restarted following pre-clearance of the zones as described above.

    If a species for which authorization has not been granted, or, a species for which authorization has been granted but the authorized number of takes have been met, approaches or is observed within an EZ or within the watch zone, shutdown will occur.

    Vessel Strike Avoidance

    Vessel strike avoidance measures will include, but are not limited to, the following, as required in the BOEM lease, except under circumstances when complying with these requirements would put the safety of the vessel or crew at risk:

    • All vessel operators and crew will maintain vigilant watch for cetaceans and pinnipeds, and slow down or stop their vessel to avoid striking these protected species;

    • All survey vessels greater than or equal to 65 ft (19.8 m) in overall length will comply with 10 knot (18.5 km/hr) or less speed restriction in any SMAper the NOAA ship strike reduction rule (73 FR 60173; October 10, 2008);

    • All vessel operators will reduce vessel speed to 10 knots (18.5 km/hr) or less when any large whale, any mother/calf pairs, pods, or large assemblages of non-delphinoid cetaceans are observed near (within 100 m (330 ft)) an underway vessel;

    • All survey vessels will maintain a separation distance of 500 m (1640 ft) or greater from any sighted North Atlantic right whale;

    • If underway, vessels must steer a course away from any sighted North Atlantic right whale at 10 knots (18.5 km/hr) or less until the 500 m (1640 ft) minimum separation distance has been established. If a North Atlantic right whale is sighted in a vessel's path, or within 500 m (330 ft) to an underway vessel, the underway vessel must reduce speed and shift the engine to neutral. Engines will not be engaged until the North Atlantic right whale has moved outside of the vessel's path and beyond 500 m. If stationary, the vessel must not engage engines until the North Atlantic right whale has moved beyond 500 m;

    • All vessels will maintain a separation distance of 100 m (330 ft) or greater from any sighted non-delphinoid cetacean. If sighted, the vessel underway must reduce speed and shift the engine to neutral, and must not engage the engines until the non-delphinoid cetacean has moved outside of the vessel's path and beyond 100 m. If a survey vessel is stationary, the vessel will not engage engines until the non-delphinoid cetacean has moved out of the vessel's path and beyond 100 m;

    • All vessels will maintain a separation distance of 50 m (164 ft) or greater from any sighted delphinoid cetacean. Any vessel underway remain parallel to a sighted delphinoid cetacean's course whenever possible, and avoid excessive speed or abrupt changes in direction. Any vessel underway reduces vessel speed to 10 knots (18.5 km/hr) or less when pods (including mother/calf pairs) or large assemblages of delphinoid cetaceans are observed. Vessels may not adjust course and speed until the delphinoid cetaceans have moved beyond 50 m and/or the abeam of the underway vessel;

    • All vessels will maintain a separation distance of 50 m (164 ft) or greater from any sighted pinniped; and

    • All vessels underway will not divert or alter course in order to approach any whale, delphinoid cetacean, or pinniped. Any vessel underway will avoid excessive speed or abrupt changes in direction to avoid injury to the sighted cetacean or pinniped.

    GSOE will ensure that vessel operators and crew maintain a vigilant watch for cetaceans and pinnipeds by slowing down or stopping the vessel to avoid striking marine mammals. Project-specific training will be conducted for all vessel crew prior to the start of the site characterization survey activities. Confirmation of the training and understanding of the requirements will be documented on a training course log sheet. Signing the log sheet will certify that the crew members understand and will comply with the necessary requirements throughout the survey activities.

    Seasonal Operating Requirements

    As described above, the northern section of the survey area partially overlaps with a portion of one North Atlantic right whale SMA which occurs off the mouth of the Delaware Bay. This SMA is active from November 1 through April 30 of each year. Survey vessels that are 65 ft (19.8 m) or greater in overall length will be required to adhere to the mandatory vessel speed restrictions (<10 kn) when operating within the SMA during times when the SMA is active. In addition, between watch shifts, members of the monitoring team will consult NMFS' North Atlantic right whale reporting systems for the presence of North Atlantic right whales throughout survey operations. Members of the monitoring team will monitor the NMFS North Atlantic right whale reporting systems for the establishment of a Dynamic Management Area (DMA). If NMFS should establish a DMA in the survey area, within 24 hours of the establishment of the DMA, GSOE will coordinate with NMFS to alter the survey activities as needed to avoid right whales to the extent possible.

    The mitigation measures are designed to avoid the already low potential for injury in addition to some Level B harassment, and to minimize the potential for vessel strikes. There are no known marine mammal feeding areas, rookeries, or mating grounds in the survey area that would otherwise potentially warrant increased mitigation measures for marine mammals or their habitat (or both). The survey would occur in an area that has been identified as a biologically important area for migration for North Atlantic right whales. However, given the small spatial extent of the survey area relative to the substantially larger spatial extent of the right whale migratory area, and the relatively limited temporal overlap of the survey with the months that the migratory area is considered biologically important (March, April, November and December), the survey is not expected to appreciably reduce migratory habitat nor to negatively impact the migration of North Atlantic right whales. Thus additional mitigation to address the survey's occurrence in North Atlantic right whale migratory habitat is not warranted. Further, we believe the mitigation measures are practicable for the applicant to implement.

    Based on our evaluation of the applicant's measures, NMFS has determined that the mitigation measures provide the means of 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

    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.

    Monitoring Measures

    As described above, visual monitoring of the EZs and monitoring zone will be performed by qualified and NMFS-approved PSOs. Per the applicant's proposal, PSO qualifications will include completion of a PSO training course and documented field experience conducting similar surveys. As proposed by the applicant and required by BOEM, an observer team comprising a minimum of four NMFS-approved PSOs and a minimum of two certified PAM operator(s), operating in shifts, will be employed by GSOE during the planned surveys. PSOs and PAM operators would work in shifts such that no one monitor will work more than 4 consecutive hours without a 2-hour break or longer than 12 hours during any 24-hour period. During daylight hours the PSOs will rotate in shifts of one on and three off, while during nighttime operations PSOs will work in pairs. The PAM operators will also be on call as necessary during daytime operations should visual observations become impaired. Each PSO will monitor 360 degrees of the field of vision.

    Also as described above, PSOs will be equipped with binoculars and have the ability to estimate distances to marine mammals located in proximity to the vessel and/or exclusion zone using range finders. Reticulated binoculars will also be available to PSOs for use as appropriate based on conditions and visibility to support the siting and monitoring of marine species. During night operations, PAM and night-vision equipment with infrared light-emitting diode spotlights and/or infrared video monitoring will be used to increase the ability to detect marine mammals. Position data will be recorded using hand-held or vessel global positioning system (GPS) units for each sighting. Observations will take place from the highest available vantage point on the survey vessel. General 360-degree scanning will occur during the monitoring periods, and target scanning by the PSO will occur when alerted of a marine mammal presence.

    Data on all PAM/PSO observations will be recorded, including dates, times, and locations of survey operations; time of observation, location and weather; details of marine mammal sightings (e.g., species, numbers, behavior); and details of any observed taking (e.g., behavioral disturbances or injury/mortality).

    Reporting Measures

    Within 90 days after completion of survey activities, a final technical report will be provided to NMFS that fully documents the methods and monitoring protocols, summarizes the data recorded during monitoring, summarizes the number of marine mammals estimated to have been taken during survey activities (by species, when known), summarizes the mitigation actions taken during surveys (including what type of mitigation and the species and number of animals that prompted the mitigation action, when known), includes an assessment of the effectiveness of night vision equipment used during nighttime surveys (including comparisons of relative effectiveness among the different types of night vision equipment used), and provides an interpretation of the results and effectiveness of all mitigation and monitoring. Any recommendations made by NMFS must be addressed in the final report prior to acceptance by NMFS.

    In addition to the final technical report, GSOE will provide the reports described below as necessary during survey activities. In the unanticipated event that GSOE's survey activities lead to an injury (Level A harassment) or mortality (e.g., ship-strike, gear interaction, and/or entanglement) of a marine mammal, DWW would immediately cease the specified activities and report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources and the NMFS Greater Atlantic Stranding Coordinator. The report would include the following information:

    Time, date, and location (latitude/longitude) of the incident;

    • Name and type of vessel involved;

    • Vessel's speed during and leading up to the incident;

    • Description of the incident;

    • Status of all sound source use in the 24 hours preceding the incident;

    • Water depth;

    • Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

    • Description of all marine mammal observations in the 24 hours preceding the incident;

    • Species identification or description of the animal(s) involved;

    • Fate of the animal(s); and

    • Photographs or video footage of the animal(s) (if equipment is available).

    Activities would not resume until NMFS is able to review the circumstances of the event. NMFS would work with GSOE to minimize reoccurrence of such an event in the future. GSOE would not resume activities until notified by NMFS.

    In the event that GSOE discovers an injured or dead marine mammal and determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition), GSOE would immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources and the NMFS Greater Atlantic Stranding Coordinator. The report would include the same information identified in the paragraph above. Activities would be able to continue while NMFS reviews the circumstances of the incident. NMFS would work with GSOE to determine if modifications in the activities are appropriate.

    In the event that GSOE discovers an injured or dead marine mammal and determines that the injury or death is not associated with or related to the activities authorized in the IHA (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), GSOE would report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, and the NMFS Greater Atlantic Regional Stranding Coordinator, within 24 hours of the discovery. GSOE would provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS. GSOE may continue its operations under such a case.

    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. 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' 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).

    To avoid repetition, our analysis applies to all the species listed in Table 6, given that NMFS expects the anticipated effects of the planned survey to be similar in nature.

    NMFS does not anticipate that serious injury or mortality would occur as a result of GSOE's planned survey, even in the absence of mitigation. Thus this authorization does not authorize any serious injury or mortality. As discussed in the Potential Effects section, non-auditory physical effects and vessel strike are not expected to occur.

    We expect that all potential takes would be in the form of short-term Level B behavioral harassment in the form of temporary avoidance of the area, a reaction that is considered to be of low severity and with no lasting biological consequences (e.g., Ellison et al., 2007). Potential impacts to marine mammal habitat were discussed in the Federal Register notice of the proposed IHA (83 FR 14417; April 4, 2018) (see Potential Effects of the Specified Activity on Marine Mammals and their Habitat). Marine mammal habitat may be impacted by elevated sound levels, but these impacts would be temporary. In addition to being temporary and short in overall duration, the acoustic footprint of the planned survey is small relative to the overall distribution of the animals in the area and their use of the area. Feeding behavior is not likely to be significantly impacted, as no areas of biological significance for marine mammal feeding are known to exist in the survey area. Prey species are mobile and are broadly distributed throughout the project area; therefore, marine mammals that may be temporarily displaced during survey activities are expected to be able to resume foraging once they have moved away from areas with disturbing levels of underwater noise. Because of the temporary nature of the disturbance and the availability of similar habitat and resources in the surrounding area, the impacts to marine mammals and the food sources that they utilize are not expected to cause significant or long-term consequences for individual marine mammals or their populations. In addition, there are no rookeries or mating or calving areas known to be biologically important to marine mammals within the project area. The planned survey area is within a biologically important migratory area for North Atlantic right whales (effective March-April and November-December) that extends from Massachusetts to Florida (LaBrecque, et al., 2015). Off the coast of Delaware, this biologically important migratory area extends from the coast to beyond the shelf break. Due to the fact that the planned survey is temporary and short in overall duration, the majority of the survey would occur outside the months when the BIA is considered important for right whale migration, and the acoustic footprint of the planned survey is very small relative to the spatial extent of the available migratory habitat in the area, right whale migration is not expected to be impacted by the planned survey.

    The mitigation measures are expected to reduce the number and/or severity of takes by (1) giving animals the opportunity to move away from the sound source before HRG survey equipment reaches full energy; and (2) preventing animals from being exposed to sound levels that may otherwise result in injury. Additional vessel strike avoidance requirements will further mitigate potential impacts to marine mammals during vessel transit to and within the survey area.

    NMFS concludes that exposures to marine mammal species and stocks due to GSOE's planned survey would result in only short-term (temporary and short in duration) effects to individuals exposed. Marine mammals may temporarily avoid the immediate area but are not expected to permanently abandon the area. Impacts to breeding, feeding, sheltering, resting, or migration are not expected, nor are shifts in habitat use, distribution, or foraging success. NMFS does not anticipate the marine mammal takes that would result from the planned survey would impact annual rates of recruitment or survival.

    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:

    • No mortality, serious injury, or Level A harassment is anticipated or authorized;

    • The anticipated impacts of the activity on marine mammals would be temporary behavioral changes due to avoidance of the area around the survey vessel;

    • The availability of alternate areas of similar habitat value for marine mammals to temporarily vacate the survey area during the planned survey to avoid exposure to sounds from the activity;

    • The project area does not contain areas of significance for feeding, mating or calving;

    • Effects on species that serve as prey species for marine mammals from the survey are not expected;

    • The mitigation measures, including visual and acoustic monitoring, exclusion zones, and shutdown measures, are expected to minimize potential impacts to marine mammals.

    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.

    The numbers of marine mammals that we authorize to be taken, for all species and stocks, would be considered small relative to the relevant stocks or populations (less than 17 percent for the Western North Atlantic Northern Migratory Coastal stock of bottlenose dolphins, and less than 5 percent for all other species and stocks) (Table 6). Bottlenose dolphins taken by the survey could originate from either the Western North Atlantic Offshore or Western North Atlantic Northern Migratory Coastal stocks, based on water depths and distances to shore in the survey area. For purposes of calculating takes as a percentage of population we assume 50 percent of bottlenose dolphins taken will originate from the Western North Atlantic Offshore stock and 50 percent will originate from the Western North Atlantic Northern Migratory Coastal stock. Based on the analysis contained herein of the activity (including the 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.

    Endangered Species Act

    Section 7(a)(2) of the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.) requires that each Federal agency insure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of IHAs, NMFS consults internally, in this case with the NMFS Greater Atlantic Regional Fisheries Office (GARFO), whenever we propose to authorize take for endangered or threatened species.

    The NMFS Office of Protected Resources Permits and Conservation Division is authorizing the incidental take of four species of marine mammals which are listed under the ESA: The North Atlantic right, fin, sei and sperm whale. Under Section 7 of the ESA, we requested initiation of consultation with the NMFS Greater Atlantic Regional Fisheries Office (GARFO) on March 19, 2018, for the issuance of this IHA. In May, 2018, NMFS GARFO determined our issuance of the IHA to GSOE was not likely to adversely affect the North Atlantic right, fin, sei and sperm whale or the critical habitat of any ESA-listed species.

    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 proposed action (i.e., the issuance of an incidental harassment authorization) with respect to potential impacts on the human environment.

    Accordingly, NMFS prepared an Environmental Assessment (EA) and analyzed the potential impacts to marine mammals that would result from the project, as well as from a similar project proposed by Deepwater Wind New England LLC off the coasts of Rhode Island and Massachusetts. A Finding of No Significant Impact (FONSI) was signed on May 15, 2018. A copy of the EA and FONSI is available on the internet at: www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-other-energy-activities-renewable.

    Authorization

    NMFS has issued an IHA to GSOE for conducting marine site characterization surveys offshore of Delaware and along potential submarine cable routes for a period of one year, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.

    Dated: June 1, 2018. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-12225 Filed 6-6-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG278 Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of public meetings.

    SUMMARY:

    The Pacific Fishery Management Council's (Pacific Council) Salmon Technical Team (STT) will hold a series of meetings to initiate the development of salmon rebuilding plans for Klamath River fall Chinook, Sacramento River fall Chinook, Strait of Juan de Fuca natural coho, Queets River natural coho, and Snohomish River natural coho. These meetings are open to the public.

    DATES:

    The meetings will be held June 20, 2018 through June 28, 2018. See SUPPLEMENTARY INFORMATION for specific dates and times.

    ADDRESSES:

    The STT meetings for Klamath River fall Chinook and Sacramento River fall Chinook will be held in the Siskiyou Room at the Red Lion Hotel, 1830 Hilltop Drive, Redding, CA 96002; telephone: (530) 221-8700.

    The STT meeting for Strait of Juan de Fuca natural coho will be held in Room 261 at the National Oceanic and Atmospheric Administration West Coast Region Office, 510 Desmond Drive SE, Lacy, WA 98503; telephone: (360) 753-9530. Please check-in at the U.S. Fish and Wildlife's reception desk for security clearance.

    The STT meetings for Queets River natural coho and Snohomish River natural coho will be held in the large conference room at the Northwest Indian Fisheries Commission, 6730 Martin Way East, Olympia, WA 98516; telephone: (360) 438-1180.

    Council address: Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Robin Ehlke, Pacific Council; telephone: (503) 820-2410.

    SUPPLEMENTARY INFORMATION:

    The STT meeting for Klamath River fall Chinook will be held Wednesday, June 20, 2018, from 10 a.m. to 5 p.m., or until business for the day has been completed.

    The STT meeting for Sacramento River fall Chinook will be held Thursday, June 21, 2018, from 10 a.m. to 5 p.m., or until business for the day has been completed.

    The STT meeting for Strait of Juan de Fuca natural coho will be held Tuesday, June 26, 2018, from 10 a.m. to 5 p.m., or until business for the day has been completed.

    The STT meeting for Queets River natural coho will be held Wednesday, June 27, 2018, from 10 a.m. to 5 p.m., or until business for the day has been completed.

    The STT meeting for Snohomish River natural coho will be held Thursday, June 28, 2018, from 10 a.m. to 5 p.m., or until business for the day has been completed.

    Three natural coho stocks (Queets coho, Strait of Juan de Fuca coho, and Snohomish coho) and two Chinook stocks (Sacramento River fall Chinook and Klamath River fall Chinook) were found to meet the criteria for being classified as overfished in the PFMC Review of 2017 Ocean Salmon Fisheries. Under the tenets of the Salmon Fishery Management Plan (FMP), the STT is required to develop a salmon rebuilding plan for each of these stocks and propose them to the Council within one year.

    The STT will meet with tribal, state, and other management entities who will work with the STT to provide data and expertise on pertinent topics to be included in each rebuilding plan, consistent with the FMP. Discussions may include, but are not limited to, work flow, document structure, and timeline. One meeting will occur for each of the five stocks; additional meetings will be scheduled as needed. These work sessions are open to the public.

    Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

    Special Accommodations

    The meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at [email protected] or (503) 820-2411 at least 10 days prior to the meeting date.

    Dated: June 4, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-12289 Filed 6-6-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG217 Schedules for Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops AGENCY:

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

    ACTION:

    Notice of public workshops.

    SUMMARY:

    Free Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops will be held in July, August, and September of 2018. Certain fishermen and shark dealers are required to attend a workshop to meet regulatory requirements and to maintain valid permits. Specifically, the Atlantic Shark Identification Workshop is mandatory for all federally permitted Atlantic shark dealers. The Safe Handling, Release, and Identification Workshop is mandatory for vessel owners and operators who use bottom longline, pelagic longline, or gillnet gear, and who have also been issued shark or swordfish limited access permits. Additional free workshops will be conducted during 2018 and will be announced in a future notice.

    DATES:

    The Atlantic Shark Identification Workshops will be held on July 26, August 23, and September 20, 2018. The Safe Handling, Release, and Identification Workshops will be held on July 3, July 23, August 14, August 21, September 5, and September 19, 2018. See SUPPLEMENTARY INFORMATION for further details.

    ADDRESSES:

    The Atlantic Shark Identification Workshops will be held in Wilmington, NC; Ronkonkoma, NY; and Panama City Beach, FL. The Safe Handling, Release, and Identification Workshops will be held in Port St. Lucie, FL; Ocean City, MD; Ronkonkoma, NY; Galveston, TX; Panama City, FL; and Warwick, RI. See SUPPLEMENTARY INFORMATION for further details on workshop locations.

    FOR FURTHER INFORMATION CONTACT:

    Rick Pearson by phone: (727) 824-5399.

    SUPPLEMENTARY INFORMATION:

    The workshop schedules, registration information, and a list of frequently asked questions regarding the Atlantic Shark ID and Safe Handling, Release, and ID workshops are posted on the internet at: https://www.fisheries.noaa.gov/atlantic-highly-migratory-species/atlantic-shark-identification-workshops, and https://www.fisheries.noaa.gov/atlantic-highly-migratory-species/atlantic-protected-species-safe-handling-release-and.

    Atlantic Shark Identification Workshops

    Since January 1, 2008, Atlantic shark dealers have been prohibited from receiving, purchasing, trading, or bartering for Atlantic sharks unless a valid Atlantic Shark Identification Workshop certificate is on the premises of each business listed under the shark dealer permit that first receives Atlantic sharks (71 FR 58057; October 2, 2006). Dealers who attend and successfully complete a workshop are issued a certificate for each place of business that is permitted to receive sharks. These certificate(s) are valid for 3 years. Thus, certificates that were initially issued in 2015 will be expiring in 2018. Approximately 145 free Atlantic Shark Identification Workshops have been conducted since January 2008.

    Currently, permitted dealers may send a proxy to an Atlantic Shark Identification Workshop. However, if a dealer opts to send a proxy, the dealer must designate a proxy for each place of business covered by the dealer's permit which first receives Atlantic sharks. Only one certificate will be issued to each proxy. A proxy must be a person who is currently employed by a place of business covered by the dealer's permit; is a primary participant in the identification, weighing, and/or first receipt of fish as they are offloaded from a vessel; and who fills out dealer reports. Atlantic shark dealers are prohibited from renewing a Federal shark dealer permit unless a valid Atlantic Shark Identification Workshop certificate for each business location that first receives Atlantic sharks has been submitted with the permit renewal application. Additionally, trucks or other conveyances that are extensions of a dealer's place of business must possess a copy of a valid dealer or proxy Atlantic Shark Identification Workshop certificate.

    Workshop Dates, Times, and Locations

    1. July 26, 2018, 12 p.m.-4 p.m., Hampton Inn, 124 Old Eastwood Road, Wilmington, NC 28403.

    2. August 23, 2018, 12 p.m.-4 p.m., Hilton Garden Inn, 3485 Veterans Memorial Highway, Ronkonkoma, NY 11779.

    3. September 20, 2018, 12 p.m.-4 p.m., Hampton Inn, 13505 Panama City Beach Parkway, Panama City Beach, FL 32407.

    Registration

    To register for a scheduled Atlantic Shark Identification Workshop, please contact Eric Sander at [email protected] or at (386) 852-8588. Pre-registration is highly recommended, but not required.

    Registration Materials

    To ensure that workshop certificates are linked to the correct permits, participants will need to bring the following specific items to the workshop:

    • Atlantic shark dealer permit holders must bring proof that the attendee is an owner or agent of the business (such as articles of incorporation), a copy of the applicable permit, and proof of identification.

    • Atlantic shark dealer proxies must bring documentation from the permitted dealer acknowledging that the proxy is attending the workshop on behalf of the permitted Atlantic shark dealer for a specific business location, a copy of the appropriate valid permit, and proof of identification.

    Workshop Objectives

    The Atlantic Shark Identification Workshops are designed to reduce the number of unknown and improperly identified sharks reported in the dealer reporting form and increase the accuracy of species-specific dealer-reported information. Reducing the number of unknown and improperly identified sharks will improve quota monitoring and the data used in stock assessments. These workshops will train shark dealer permit holders or their proxies to properly identify Atlantic shark carcasses.

    Safe Handling, Release, and Identification Workshops

    Since January 1, 2007, shark limited-access and swordfish limited-access permit holders who fish with longline or gillnet gear have been required to submit a copy of their Safe Handling, Release, and Identification Workshop certificate in order to renew either permit (71 FR 58057; October 2, 2006). These certificate(s) are valid for 3 years. Certificates issued in 2015 will be expiring in 2018. As such, vessel owners who have not already attended a workshop and received a NMFS certificate, or vessel owners whose certificate(s) will expire prior to the next permit renewal, must attend a workshop to fish with, or renew, their swordfish and shark limited-access permits. Additionally, new shark and swordfish limited-access permit applicants who intend to fish with longline or gillnet gear must attend a Safe Handling, Release, and Identification Workshop and submit a copy of their workshop certificate before either of the permits will be issued. Approximately 280 free Safe Handling, Release, and Identification Workshops have been conducted since 2006.

    In addition to certifying vessel owners, at least one operator on board vessels issued a limited-access swordfish or shark permit that uses longline or gillnet gear is required to attend a Safe Handling, Release, and Identification Workshop and receive a certificate. Vessels that have been issued a limited-access swordfish or shark permit and that use longline or gillnet gear may not fish unless both the vessel owner and operator have valid workshop certificates onboard at all times. Vessel operators who have not already attended a workshop and received a NMFS certificate, or vessel operators whose certificate(s) will expire prior to their next fishing trip, must attend a workshop to operate a vessel with swordfish and shark limited-access permits that uses longline or gillnet gear.

    Workshop Dates, Times, and Locations

    1. July 3, 2018, 9 a.m.-5 p.m., Holiday Inn, 10120 South US Highway 1, Port St Lucie, FL 34952.

    2. July 23, 2018, 9 a.m.-5 p.m., Marriott Courtyard, 2 15th Street, Ocean City, MD 21842.

    3. August 14, 2018, 9 a.m.-5 p.m., Marriott Courtyard, 5000 Express Drive South, Ronkonkoma, NY 11779.

    4. August 21, 2018, 9 a.m.-5 p.m., DoubleTree Hotel, 1702 Seawall Boulevard, Galveston, TX 77550.

    5. September 5, 2018, 9 a.m.-5 p.m., Hilton Garden Inn, 1101 US Highway 231, Panama City, FL 32405.

    6. September 19, 2018, 9 a.m.-5 p.m., Hilton Garden Inn, 1 Thurber Street, Warwick, RI 02886.

    Registration

    To register for a scheduled Safe Handling, Release, and Identification Workshop, please contact Angler Conservation Education at (386) 682-0158. Pre-registration is highly recommended, but not required.

    Registration Materials

    To ensure that workshop certificates are linked to the correct permits, participants will need to bring the following specific items with them to the workshop:

    • Individual vessel owners must bring a copy of the appropriate swordfish and/or shark permit(s), a copy of the vessel registration or documentation, and proof of identification.

    • Representatives of a business-owned or co-owned vessel must bring proof that the individual is an agent of the business (such as articles of incorporation), a copy of the applicable swordfish and/or shark permit(s), and proof of identification.

    • Vessel operators must bring proof of identification.

    Workshop Objectives

    The Safe Handling, Release, and Identification Workshops are designed to teach longline and gillnet fishermen the required techniques for the safe handling and release of entangled and/or hooked protected species, such as sea turtles, marine mammals, and smalltooth sawfish, and prohibited sharks. In an effort to improve reporting, the proper identification of protected species and prohibited sharks will also be taught at these workshops. Additionally, individuals attending these workshops will gain a better understanding of the requirements for participating in these fisheries. The overall goal of these workshops is to provide participants with the skills needed to reduce the mortality of protected species and prohibited sharks, which may prevent additional regulations on these fisheries in the future.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: June 4, 2018. Jennifer M. Wallace, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-12275 Filed 6-6-18; 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 meetings of a multistakeholder process on promoting software component transparency. This Notice announces the first meeting, which is scheduled for July 19, 2018.

    DATES:

    The meeting will be held on July 19, 2018, from 10:00 a.m. to 4:00 p.m., Eastern Daylight 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: Since 2015, the National Telecommunications and Information Administration has sought public comment on several matters around information and cyber policy and security, the Internet of Things (IoT), and the health of the digital ecosystem. In 2015, NTIA issued a Request for Comment to “identify substantive cybersecurity issues that affect the digital ecosystem and digital economic growth where broad consensus, coordinated action, and the development of best practices could substantially improve security for organizations and consumers.” 1 In a separate but related matter in April 2016, NTIA, along with the Department's internet Policy Task Force, sought comments on the “benefits, challenges, and potential roles for the government in fostering the advancement of the Internet of Things.” 2 Lastly, as part of Executive Order 13800, NTIA requested comments on “Promoting Stakeholder Action Against Botnets and Other Automated Threats.” 3

    1 U.S. Department of Commerce, internet Policy Task Force, Request for Public Comment, Stakeholder Engagement on Cybersecurity in the Digital Ecosystem, 80 FR 14360, Docket No. 150312253-5253-01 (Mar. 19, 2015), available at: https://www.ntia.doc.gov/files/ntia/publications/cybersecurity_rfc_03192015.pdf.

    2 U.S. Department of Commerce, internet Policy Task Force, Request for Public Comment, Benefits, Challenges, and Potential Roles for the Government in Fostering the Advancement of the Internet of Things, 81 FR 19956, Docket No 160331306-6306-01 (Apr. 5, 2016), available at: https://www.ntia.doc.gov/federal-register-notice/2016/rfc-potential-roles-government-fostering-advancement-internet-of-things.

    3 U.S. Department of Commerce, internet Policy Task Force, Request for Public Comment, Promoting Stakeholder Action Against Botnets and Other Automated Threats, 82 FR 27042, Docket No. 170602536-7536-01 (Mar. 19, 2015), available at: https://www.ntia.doc.gov/files/ntia/publications/fr-ntia-cyber-eo-rfc-06132017.pdf.

    Several themes emerged from these three public consultations. Many stakeholders emphasized the importance of community-led, consensus-driven, and risk-based solutions to address information security challenges, highlighting the role NTIA should play in convening multistakeholder processes. In the digital ecosystem, particular challenges were identified: Understanding and handling vulnerability information, addressing the insecurities in the growing IoT marketplace, and fostering a secure development lifecycle. NTIA has convened two multistakeholder processes to address these policy and market challenges. The first focused on how to promote collaboration around communicating vulnerability information, and the second helped vendors and consumers understand policy and market concerns related to patching vulnerabilities.

    The next initiative will focus on promoting software component transparency. Stakeholders will engage in an open and transparent process to explore the benefits and any potential risks of greater transparency. They may focus on incentives and barriers to adoption of transparency practices. The scope could include policy and international components. Transparency-driven solutions need not be prescriptive or regulatory, and can accommodate an ecosystem without a one-size-fits-all approach. The goal of this initiative is to foster a market that offers greater transparency on software components.

    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. While the majority of libraries and components do not have known vulnerabilities, many do, and the sheer quantity of software means that some software products ship with vulnerable or out-of-date components. Many technical solutions to aid in this have already been developed by industry and the standards community.

    Vendors and developers also would find software component data useful. Cataloging the inputs to a software product is recognized as an important part of a secure development life cycle.4 Indeed, many organizations have developed internal processes to capture and manage this data for security purposes. Many others do so to manage licensing issues around third-party software components and intellectual property rights. Communicating information about the underlying components can be a strong security signifier, while still protecting the valuable intellectual property and source code in software and devices.

    4 The Software Assurance Forum for Excellence in Code (SAFECode), an industry consortium, has released a report on third party components that cites a range of standards. Managing Security Risks Inherent in the Use of Third-party Components, SAFECode (May 2017), available at https://www.safecode.org/wp-content/uploads/2017/05/SAFECode_TPC_Whitepaper.pdf.

    The importance of transparency in information security is widely recognized, and the notion of transparency around components of software and connected devices is not new. Academics identified the potential value of a “software bill of materials” as far back as 1995,5 and there are a growing number of commercial solutions for security, licensing, and asset management. The International Standards Organization (ISO) first standardized software identification (SWID) tags in 2009.6 In 2015, NIST published Guidelines for the Creation of Interoperable Software Identification (SWID) Tags,7 and their use has been slowly increasing. The open source community has also developed the Software Package Data Exchange.8 This process will explore successful examples of use, and market barriers to increased adoption. From the perspective of the enterprise customer, it is hard to defend what one does not know. Transparency itself is not sufficient; the data must be useful and actionable. Understanding what is on an enterprise network is a key part of a security program. Having data about software components allows the enterprise customer to better understand the risks of potentially vulnerable software and devices.

    5 Leblang D.B., Levine P.H., Software configuration management: Why is it needed and what should it do? In: Estublier J. (eds) Software Configuration Management Lecture Notes in Computer Science, vol. 1005, Springer, Berlin, Heidelberg (1995).

    6 ISO/IEC 19770 “Software Identification Tag,” originally published in 2009, updated in 2015, https://www.iso.org/standard/65666.html.

    7 U.S. Department of Commerce, Guidelines for the Creation of Interoperable Software Identification (SWID) Tags, National Institute of Standards and Technology Internal Report 8060 (Dec. 2015), available at: https://csrc.nist.gov/csrc/media/publications/nistir/8060/final/documents/nistir_8060_draft_fourth.pdf.

    8 More information on the Software Package Data Exchange project is available at https://spdx.org.

    Any conversation around transparency must include a discussion of the needs of the diverse set of enterprise software users. Data about the underlying code can help both the customer and the vendor. It should be incorporated into a security-mature organization's existing vulnerability management solutions, and can help foster further innovation. Having access to this data can help organizations mitigate concerns around orphaned devices and products, and lower the risks of investing in new products by increasing capabilities to deal with future security issues.

    NTIA will act as the convener, but stakeholders will drive the outcomes. Stakeholders will determine how to scope and organize the work through subgroups or other means. Success of the process will be evaluated by the extent to which broader findings on software component transparency are implemented across the ecosystem.

    This multistakeholder process is not a standards development process and will not supplant ongoing standards efforts or discussions. NTIA will frame the initial conversation around the policy and market considerations for greater software component transparency. NTIA encourages cross-sector participation as this will help to prevent sector-specific solutions that could fragment the marketplace. NTIA encourages discussion of approaches and considerations from diverse sectors such as the medical device community, where the applicability of a “bill of materials” has garnered increased discussion and interest.9 This approach can promote a more efficient and adaptive marketplace for new products.

    Matters to Be Considered: The July 19, 2018, meeting will be the first in a series of NTIA-convened multistakeholder discussions on promoting software component transparency. Subsequent meetings will follow on a schedule determined by those participating in the first meeting. Stakeholders will engage in an open, transparent, and consensus-driven process to understand the range of issues involved. The multistakeholder process will involve hearing and understanding the perspectives of diverse stakeholders, explicitly sharing the perspectives of a range of software and IoT vendors and enterprise customers from across the digital economy.

    The July 19, 2018, meeting is intended to bring stakeholders together to share the range of views on software component transparency, and to establish more concrete goals and structure of the process. The objectives of this first meeting are to: (1) Share the perspectives and concerns of both the vendor and enterprise customer communities; (2) discuss and acknowledge what is already working; (3) explore obstacles and challenges for greater transparency and better risk decisions; (4) identify promising areas of potential collaboration; (5) engage stakeholders in a discussion of logistical issues, including internal structures such as a small drafting committee or various working groups, and the location and frequency of future meetings; and (6) identify concrete goals and stakeholder work following the first meeting. These topics could include, but are in no way limited to, an inventory of existing statutory, policy, regulatory, and market efforts to increase software component transparency; identification of incentives and disincentives for market adoption of approaches for software component transparency; exploration of statutory, policy, and regulatory activities that may inhibit adoption; accessible high-level guidance for strategic decision-makers; and review of international approaches to understand statutory, policy, and regulatory environments to understand effects on market adoption.

    The main objective of further meetings will be to encourage and facilitate continued discussion among stakeholders to map the range of issues, and develop a consensus view for some determined aspects of transparency. This discussion may include the appropriate scope of the initiative and circulation of stakeholder-developed drafts. Stakeholders may also agree on procedural work plans for the group, including additional meetings or modified logistics for future meetings. NTIA suggests that stakeholders consider setting clear deadlines for working drafts and a phase for external review of such drafts, before reconvening to take account of external feedback.

    More information about stakeholders' work will be available at: https://www.ntia.doc.gov/other-publication/2018/SoftwareTransparency.

    Time and Date: NTIA will convene the first meeting of the multistakeholder process on Software Component Transparency on July 19, 2018, from 10:00 a.m. to 4:00 p.m. Eastern Daylight Time. Please refer to NTIA's website, https://www.ntia.doc.gov/other-publication/2018/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/other-publication/2018/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/other-publication/2018/SoftwareTransparency, for the most current information.

    Dated: June 4, 2018. David J. Redl, Assistant Secretary for Communication and Information, National Telecommunications and Information Administration.
    [FR Doc. 2018-12261 Filed 6-6-18; 8:45 am] BILLING CODE 3510-60-P
    COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities: Notice of Intent To Renew Collection 3038-0093, Part 40, Provisions Common to Registered Entities AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commodity Futures Trading Commission (“Commission” or “CFTC”) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (“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, and to allow 60 days for public comment. This notice solicits comments on collections of information provided for by Part 40, Provisions Common to Registered Entities.

    DATES:

    Comments must be submitted on or before August 6, 2018.

    ADDRESSES:

    You may submit comments, identified by OMB Control No. 3038-0093 by any of the following methods:

    • The Agency's website, at http://comments.cftc.gov/. Follow the instructions for submitting comments through the website.

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

    Hand Delivery/Courier: Same as Mail above.

    Please submit your comments using only one method and identify that it is for the renewal of Collection Number 3038-0093.

    All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov. You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.1

    1 17 CFR 145.9.

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

    FOR FURTHER INFORMATION CONTACT:

    Lois J. Gregory, Associate Director, Division of Market Oversight, Commodity Futures Trading Commission, (202) 418-5092; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA, 44 U.S.C. 3501 et seq., 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 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 before submitting the collection to OMB for approval. To comply with this requirement, the CFTC is publishing notice of the proposed collection of information listed below.

    Title: Part 40, Provisions Common to Registered Entities (OMB Control No. 3038-0093). This is a request for extension of a currently approved information collection.

    Abstract: This collection of information involves the collection and submission to the Commission of information from registered entities concerning new products, rules, and rule amendments pursuant to the procedures outlined in §§ 40.2, 40.3, 40.5, 40.6, and 40.10 found in 17 CFR part 40.

    With respect to the collection of information, the CFTC invites comments on:

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

    • The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Ways to enhance the quality, usefulness, and clarity of the information to be collected; and

    • Ways to minimize the burden of 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.

    Burden Statement: Registered entities must comply with certification and approval requirements which include an explanation and analysis when seeking to implement new products, rules, and rule amendments, including changes to product terms and conditions. The Commission's regulations §§ 40.2, 40.3, 40.5, 40.6 and 40.10 provide procedures for the submission of rules and rule amendments by designated contract markets, swap execution facilities, derivatives clearing organizations, and swap data repositories. They establish the procedures for submitting the “written certification” required by Section 5c of the Act. In connection with a product or rule certification, the registered entity must provide a concise explanation and analysis of the submission and its compliance with statutory provisions of the Act. Accordingly, new rules or rule amendments must be accompanied by concise explanations and analyses of the purposes, operations, and effects of the submissions. This information may be submitted as part of the same submission containing the required “written certification.” The Commission estimates the average burden of this collection of information as follows:

    • Rules 40.2, 40.3, 40.5, and 40.6

    Estimated Number of Respondents: 70.

    Annual Responses by each Respondent: 100.

    Estimated Hours per Response: 2.

    Estimated Total Hours per Year: 14,000.

    • Rule 40.10

    Estimated Number of Respondents: 3.

    Annual Responses by each Respondent: 2.

    Estimated Hours per Response: 5.

    Estimated Total Hours per Year: 30.

    (Authority: 44 U.S.C. 3501 et seq.) Dated: June 4, 2018. Robert Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2018-12278 Filed 6-6-18; 8:45 am] BILLING CODE 6351-01-P
    COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities: Notice of Intent To Renew Collection Number 3038-0007, Regulation of Domestic Exchange-Traded Options AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice; Extension of an Existing Collection.

    SUMMARY:

    The Commodity Futures Trading Commission (CFTC) is announcing an opportunity for public comment on the proposed extension of a 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 rules related to risk disclosure concerning exchange-traded commodity options.

    DATES:

    Comments must be submitted on or before August 6, 2018.

    ADDRESSES:

    You may submit comments, identified by OMB Control No. 3038-0007 by any of the following methods:

    The Agency's website, via its Comments Online process: http://comments.cftc.gov. Follow the instructions for submitting comments through the website.

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

    Delivery/Courier: Same as Mail above.

    Please submit your comments using only one method and identify that it is for the renewal of Collection Number 3038-0007.

    All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov. You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.1

    1 17 CFR 145.9, 74 FR 17395, (Apr. 15, 2009).

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

    FOR FURTHER INFORMATION CONTACT:

    Commodity Futures Trading Commission, Three Lafayette Center, 1155 21st Street NW, Washington, DC 20581; Jacob Chachkin, Division of Swap Dealer and Intermediary Oversight, telephone: (202) 418-5496 and email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA, 44 U.S.C. 3501 et seq., 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, the CFTC is publishing notice of the proposed collection of information listed below. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the Commission's regulations were published on December 30, 1981.2

    2 46 FR 63035 (dec. 30, 1981).

    Title: Rules Relating to Regulation of Domestic Exchange-Traded Options, OMB Control Number 3038-0007—Extension.

    Abstract: The rules require futures commission merchants and introducing brokers: (1) To provide their customers with standard risk disclosure statements concerning the risk of trading commodity interests; and (2) to retain all promotional material and the source of authority for information contained therein. The purpose of these rules is to ensure that customers are advised of the risks of trading commodity interests and to avoid fraud and misrepresentation. This information collection contains the recordkeeping and reporting requirements needed to ensure regulatory compliance with Commission rules relating to this issue. The disclosure and recordkeeping requirements are necessary to monitor and to verify compliance by futures commission merchants (FCMs) and introducing brokers (IBs) with their obligations concerning disclosure and promotional material.

    With respect to the above collection of information, the CFTC invites comments on:

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

    • The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Ways to enhance the quality, usefulness, and clarity of the information to be collected; and

    • Ways to minimize the burden of 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.

    Burden Statement: The Commission estimates the burden of this collection of information as follows:

    Estimated Annual Reporting Burden Regulation Estimated number of respondents or recordkeepers per year Reports
  • annually
  • by each
  • respondent
  • Total annual
  • responses
  • Estimated average number of hours per
  • response
  • Estimated total number of hours of annual burden
  • in fiscal year
  • Reporting: 33.7—(Risk disclosure) 1,272.00 115.00 146,280.00 0.08 11,702.40 Recordkeeping: 33.8—(Retention of promotional material) 1,272.00 1.00 1,272.00 25.00 31,800.00 Grand total (reporting and recordkeeping) 147,552.00 43,502.40

    There are no capital costs or operating and maintenance costs associated with this collection.

    (Authority: 44 U.S.C. 3501 et seq.) Dated: June 4, 2018 Robert Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2018-12277 Filed 6-6-18; 8:45 am] BILLING CODE 6351-01-P
    DEPARTMENT OF EDUCATION Applications for New Awards; Gaining Early Awareness and Readiness for Undergraduate Programs (Partnership Grants) AGENCY:

    Office of Postsecondary Education, Department of Education.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Education is issuing a notice inviting applications for new awards for fiscal year (FY) 2018 for the Gaining Early Awareness and Readiness for Undergraduate Programs (GEAR UP) Partnership Grants, Catalog of Federal Domestic Assistance (CFDA) number 84.334A.

    DATES:

    Applications Available: June 7, 2018.

    Deadline for Transmittal of Applications: July 13, 2018.

    Deadline for Intergovernmental Review: September 11, 2018.

    ADDRESSES:

    For the addresses for obtaining and submitting an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the Federal Registeron February 12, 2018 (83 FR 6003) and available at www.thefederalregister.org/fdsys/pkg/FR-2018-02-12/pdf/2018-02558.pdf.

    FOR FURTHER INFORMATION CONTACT:

    Karmon Simms-Coates, U.S. Department of Education, 400 Maryland Avenue SW, room 278-54, Washington, DC 20202-6450. Telephone: (202) 453-7917. Email: [email protected].

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

    SUPPLEMENTARY INFORMATION:

    I. Funding Opportunity Description

    Purpose of Program: The GEAR UP program is a discretionary grant program that encourages eligible entities to provide support, and maintain a commitment, to eligible low-income students, including students with disabilities, to assist the students in obtaining a secondary school diploma (or its recognized equivalent) and to prepare for and succeed in postsecondary education. Under the GEAR UP program, the Department awards grants to two types of entities: (1) States and (2) partnerships consisting of at least one institution of higher education (IHE) and at least one local educational agency (LEA).

    In this notice, the Department invites applications for partnership grants only. We will invite applications for State grants in another notice published in the Federal Register. Required services under the GEAR UP program are specified in sections 404D(a) of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1070a-24(a)), and permissible services under the GEAR UP program are specified in section 404D(b) of the HEA (20 U.S.C. 1070a-24(b)). For partnership grantees, activities must include providing financial aid information for postsecondary education, encouraging enrollment in rigorous and challenging coursework in order to reduce the need for remediation at the postsecondary level, implementing activities to improve the number of participating students who obtain a secondary school diploma and who complete applications for and enroll in a program of postsecondary education. Activities may also include mentoring, tutoring, supporting dual or concurrent enrollment programs that support participating students in science, technology, engineering, or mathematics (STEM), academic and career counseling, financial and economic literacy education, and exposure to college campuses.

    Background: On March 2, 2018, the Secretary published in the Federal Register the Final Supplemental Priorities and Definitions for Discretionary Grant Programs (83 FR 9096) (Supplemental Priorities). In order to advance many of these priorities, this notice contains an absolute priority that encompasses several of the supplemental priorities. Because the absolute priority includes many categories from which an applicant may choose, and because projects occur over a period of many years, we believe applicants have ample opportunity to address these priorities in their projects.

    Priority: This notice contains one absolute priority with several categories. The absolute priority is from the Supplemental Priorities.

    Absolute Priority: For FY 2018 and any subsequent year in which we make awards from the list of unfunded applications from this competition, this priority is an absolute priority. Under 34 CFR 75.105(c)(3), we consider only applications that meet this priority. Applicants must address at least one priority area in at least three of the following four categories. Addressing additional activities or addressing all four categories will not increase an applicant's score, but applicants may choose to do so. Applicants must clearly indicate on their application the specific priority area and categories their project addresses.

    The four categories under this priority are:

    Category 1: Fostering Flexible and Affordable Paths To Obtaining Knowledge and Skills

    Projects that are designed to address one or more of the following priority areas:

    (a) Developing or implementing pathways to recognized postsecondary credentials (as defined in section 3(52) of the Workforce Innovation and Opportunity Act of 2014 (WIOA)) focused on career and technical skills that align with in-demand industry sectors or occupations (as defined in section 3(23) of WIOA). Students may obtain such credentials through a wide variety of education providers, such as: IHEs eligible for Federal student financial aid programs, nontraditional education providers (e.g., apprenticeship programs or computer coding boot camps), and providers of self-guided learning;

    (b) Providing work-based learning experiences (such as internships, apprenticeships, and fellowships) that align with in-demand industry sectors or occupations (as defined in section 3(23) of WIOA);

    (c) Creating or expanding innovative paths to a recognized postsecondary credential or obtainment of job-ready skills that align with in-demand industry sectors or occupations (as defined in section 3(23) of WIOA), such as through career pathways (as defined in section 3(7) of WIOA). Such credentials may be offered to students through a wide variety of education providers, such as providers eligible for Federal student financial aid programs, nontraditional education providers, and providers of self-guided learning; or

    (d) Creating or expanding opportunities for students to obtain recognized postsecondary credentials in science, technology, engineering, mathematics, or computer science (as defined in this notice).

    Category 2: Promoting Science, Technology, Engineering, or Math (STEM) Education, With a Particular Focus on Computer Science

    Projects designed to improve student achievement or other educational outcomes in one or more of the following areas: Science, technology, engineering, math, or computer science (as defined in this notice). These projects may address one or more of the following priority areas:

    (a) Supporting student mastery of key prerequisites (e.g., Algebra I) to ensure success in all STEM fields, including computer science (as defined in this notice); exposing children or students to building-block skills (such as critical thinking and problem-solving, gained through hands-on, inquiry-based learning); or supporting the development of proficiency in the use of computer applications necessary to transition from a user of technologies, particularly computer technologies, to a developer of them;

    (b) Increasing access to STEM coursework, including computer science (as defined in this notice), and hands-on learning opportunities, such as through expanded course offerings, dual-enrollment, high-quality online coursework, or other innovative delivery mechanisms;

    (c) Creating or expanding partnerships between schools, LEAs, State educational agencies, businesses, not-for-profit organizations, or IHEs to give students access to internships, apprenticeships, or other work-based learning experiences in STEM fields, including computer science (as defined in this notice);

    (d) Other evidence-based (as defined in 34 CFR 77.1 and in this notice) and innovative approaches to expanding access to high-quality STEM education, including computer science (as defined in this notice); or

    (e) Utilizing technology for educational purposes in communities served by rural local educational agencies (as defined in this notice) or other areas identified as lacking sufficient access to such tools and resources.

    Category 3: Protecting Freedom of Speech and Encouraging Respectful Interactions in a Safe Educational Environment, or Fostering Knowledge and Promoting the Development of Skills That Prepare Students To Be Informed, Thoughtful, and Productive Individuals and Citizens

    Projects that are designed to address one or more of the following priority areas:

    (a) Protecting free speech in order to allow for the discussion of diverse ideas or viewpoints; or

    (b) Fostering knowledge of the common rights and responsibilities of American citizenship and civic participation, such as through civics education consistent with section 203(12) of WIOA.

    Category 4: Fostering Knowledge and Promoting the Development of Skills That Prepare Students To Be Informed, Thoughtful, and Productive Individuals and Citizens

    Projects that are designed to address supporting instruction in personal financial literacy, knowledge of markets and economics, knowledge of higher education financing and repayment (e.g., college savings and student loans), or other skills aimed at building personal financial understanding and responsibility.

    Definitions: These definitions are from the Supplemental Priorities and 34 CFR 77.1(c).

    Computer Science means the study of computers and algorithmic processes and includes the study of computing principles and theories, computational thinking, computer hardware, software design, coding, analytics, and computer applications.

    Computer science often includes computer programming or coding as a tool to create software, including applications, games, websites, and tools to manage or manipulate data; or development and management of computer hardware and the other electronics related to sharing, securing, and using digital information.

    In addition to coding, the expanding field of computer science emphasizes computational thinking and interdisciplinary problem-solving to equip students with the skills and abilities necessary to apply computation in our digital world.

    Computer science does not include using a computer for everyday activities, such as browsing the internet; use of tools like word processing, spreadsheets, or presentation software; or using computers in the study and exploration of unrelated subjects.

    Demonstrates a rationale means a key project component included in the project's logic model is informed by research or evaluation findings that suggest the project component is likely to improve relevant outcomes.

    Evidence-based means the proposed project component is supported by one or more of strong evidence, moderate evidence, promising evidence, or evidence that demonstrates a rationale.

    Experimental study means a study that is designed to compare outcomes between two groups of individuals (such as students) that are otherwise equivalent except for their assignment to either a treatment group receiving a project component or a control group that does not. Randomized controlled trials, regression discontinuity design studies, and single-case design studies are the specific types of experimental studies that, depending on their design and implementation (e.g., sample attrition in randomized controlled trials and regression discontinuity design studies), can meet What Works Clearinghouse (WWC) standards without reservations as described in the WWC Handbook:

    (i) A randomized controlled trial employs random assignment of, for example, students, teachers, classrooms, or schools to receive the project component being evaluated (the treatment group) or not to receive the project component (the control group).

    (ii) A regression discontinuity design study assigns the project component being evaluated using a measured variable (e.g., assigning students reading below a cutoff score to tutoring or developmental education classes) and controls for that variable in the analysis of outcomes.

    (iii) A single-case design study uses observations of a single case (e.g., a student eligible for a behavioral intervention) over time in the absence and presence of a controlled treatment manipulation to determine whether the outcome is systematically related to the treatment.

    Logic model (also referred to as a theory of action) means a framework that identifies key project components of the proposed project (i.e., the active “ingredients” that are hypothesized to be critical to achieving the relevant outcomes) and describes the theoretical and operational relationships among the key project components and relevant outcomes.

    Moderate evidence means that there is evidence of effectiveness of a key project component in improving a relevant outcome for a sample that overlaps with the populations or settings proposed to receive that component, based on a relevant finding from one of the following:

    (i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;

    (ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” or “potentially positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or

    (iii) A single experimental study or quasi-experimental design study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—

    (A) Meets WWC standards with or without reservations;

    (B) Includes at least one statistically significant and positive (i.e., favorable) effect on a relevant outcome;

    (C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and

    (D) Is based on a sample from more than one site (e.g., State, county, city, school district, or postsecondary campus) and includes at least 350 students or other individuals across sites. Multiple studies of the same project component that each meet requirements in paragraphs (iii)(A), (B), and (C) of this definition may together satisfy this requirement.

    Project component means an activity, strategy, intervention, process, product, practice, or policy included in a project. Evidence may pertain to an individual project component or to a combination of project components (e.g., training teachers on instructional practices for English learners and follow-on coaching for these teachers).

    Promising evidence means that there is evidence of the effectiveness of a key project component in improving a relevant outcome, based on a relevant finding from one of the following:

    (i) A practice guide prepared by WWC reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;

    (ii) An intervention report prepared by the WWC reporting a “positive effect” or “potentially positive effect” on a relevant outcome with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or

    (iii) A single study assessed by the Department, as appropriate, that—

    (A) Is an experimental study, a quasi-experimental design study, or a well-designed and well-implemented correlational study with statistical controls for selection bias (e.g., a study using regression methods to account for differences between a treatment group and a comparison group); and

    (B) Includes at least one statistically significant and positive (i.e., favorable) effect on a relevant outcome.

    Quasi-experimental design study means a study using a design that attempts to approximate an experimental study by identifying a comparison group that is similar to the treatment group in important respects. This type of study, depending on design and implementation (e.g., establishment of baseline equivalence of the groups being compared), can meet WWC standards with reservations, but cannot meet WWC standards without reservations, as described in the WWC Handbook.

    Relevant outcome means the student outcome(s) or other outcome(s) the key project component is designed to improve, consistent with the specific goals of the program.

    Rural local educational agency means a local educational agency that is eligible under the Small Rural School Achievement (SRSA) program or the Rural and Low-Income School (RLIS) program authorized under Title V, Part B of the Elementary and Secondary Education Act of 1965, as amended. Eligible applicants may determine whether a particular district is eligible for these programs by referring to information on the Department's website at www2.ed.gov/nclb/freedom/local/reap.html.

    Strong evidence means that there is evidence of the effectiveness of a key project component in improving a relevant outcome for a sample that overlaps with the populations and settings proposed to receive that component, based on a relevant finding from one of the following:

    (i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” for the corresponding practice guide recommendation;

    (ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or

    (iii) A single experimental study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—

    (A) Meets WWC standards without reservations;

    (B) Includes at least one statistically significant and positive (i.e., favorable) effect on a relevant outcome;

    (C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and

    (D) Is based on a sample from more than one site (e.g., State, county, city, school district, or postsecondary campus) and includes at least 350 students or other individuals across sites. Multiple studies of the same project component that each meet requirements in paragraphs (iii)(A), (B), and (C) of this definition may together satisfy this requirement.

    What Works Clearinghouse Handbook (WWC Handbook) means the standards and procedures set forth in the WWC Procedures and Standards Handbook, Version 3.0 or Version 2.1 (incorporated by reference, see 34 CFR 77.2). Study findings eligible for review under WWC standards can meet WWC standards without reservations, meet WWC standards with reservations, or not meet WWC standards. WWC practice guides and intervention reports include findings from systematic reviews of evidence as described in the Handbook documentation.

    Program Authority: 20 U.S.C. 1070a-21—1070a-28.

    Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 75, 77, 79, 81, 82, 84, 86, 97, 98, and 99. (b) The Office of Management and Budget Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474. (d) The regulations for this program in 34 CFR part 694.

    Note:

    The regulations in 34 CFR part 86 apply to IHEs only.

    II. Award Information

    Type of Award: Discretionary grants.

    Estimated Available Funds: The Consolidated Appropriations Act, 2018 provided $350,000,000 for the GEAR UP program for FY 2018, of which we intend to use an estimated $129,666,000 for new GEAR UP awards. The estimated funding available for the new GEAR UP Partnership awards is $64,833,000.

    Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent years from the list of unfunded applications from this competition.

    Estimated Range of Awards: $100,000-$7,000,000.

    Estimated Average Size of Awards: $1,200,000.

    Maximum Award: We will not fund any application for a partnership grant above the maximum award of $800 per student for a single budget period of 12 months. Applications that request more than the maximum amount, except in the case of minimal technical or rounding errors, may be penalized. Additionally, no funding will be awarded for increases in an approved budget after the first 12-month budget period. As described in 34 CFR 694.1, the Assistant Secretary for Postsecondary Education may change the maximum amount through a notice published in the Federal Register.

    Estimated Number of Awards: 54.

    Note:

    The Department is not bound by any estimates in this notice.

    Project Period: Either 72 months or 84 months.

    Note:

    An applicant that wishes to seek funding for a seventh project year (i.e., for a project period greater than 72 months), in order to provide project services to GEAR UP students through their first year of attendance at an IHE, must propose to do so in the application provided in response to this notice.

    III. Eligibility Information

    1. Eligible Applicants: Partnerships consisting of (a) at least one LEA and (b) at least one degree-granting IHE. Partnerships may include not less than two other community organizations or entities, such as businesses, professional organizations, State agencies, institutions or agencies sponsoring programs authorized under the Leveraging Educational Assistance Partnership Program authorized in part A, subpart 4, of title IV of the HEA (20 U.S.C. 1070c et seq.), or other public or private agencies or organizations (20 U.S.C. 1070a-21(c)(2)).

    2. a. Cost Sharing or Matching: Section 404C(b)(1) of the HEA requires grantees under this program to provide from State, local, institutional, or private funds, not less than 50 percent of the cost of the program (or one dollar of non-Federal funds for every one dollar of Federal funds awarded), which may be provided in cash or in-kind. The provision also specifies that the match may be accrued over the full duration of the grant award period, except that the grantee must make substantial progress towards meeting the matching requirement in each year of the grant award period. Section 404C(c) of the HEA provides that in-kind contributions may include (1) the amount of the financial assistance obligated under GEAR UP to students from State, local, institutional, or private funds, (2) the amount of tuition, fees, room or board waived or reduced for recipients of financial assistance under GEAR UP, (3) the amount expended on documented, targeted, long-term mentoring and counseling provided by volunteers or paid staff of non-school organizations, including businesses, religious organizations, community groups, postsecondary educational institutions, nonprofit and philanthropic organizations, and other organizations, and (4) equipment and supplies, cash contributions from non-Federal sources, transportation expenses, in-kind or discounted program services, indirect costs, and facility usage.

    Section 404C(b)(2) further provides that the Secretary may approve a partnership's request for a reduced match percentage at the time of application if the partnership demonstrates significant economic hardship that precludes the partnership from meeting the matching requirement, or if the partnership requests that contributions to the scholarship fund be matched on the basis of two non-Federal dollars for every one Federal dollar of GEAR UP funds. GEAR UP program regulations in 34 CFR 694.8(a)-(c) address the content of an applicant's request for such a reduced match, and the maximum percentage match that the Secretary may waive. In addition, the Secretary may approve a reduction in match of up to 70 percent upon request from a partnership that (a) includes three or fewer IHEs as members (b) has a fiscal agent identified in 34 CFR 694.8(d)(1), and (c) serves students in schools and LEAs that meet the poverty criteria identified in 34 CFR 694.8(d)(2) and (3).

    b. Supplement-Not-Supplant: This program involves supplement, not supplant funding requirements. Under section 404B(e) of the HEA (20 U.S.C. 1070a-22(e)), grant funds awarded under this program must be used to supplement, and not supplant, other Federal, State, and local funds that would otherwise be expended to carry out activities assisted under this program.

    3. Other: General Application Requirements: All applicants must meet the following application requirements in order to be considered for funding. The application requirements are from section 404C(a) of the HEA (20 U.S.C. 1070a-23(a)).

    In order for an eligible entity to qualify for a grant under the GEAR UP program, the eligible entity shall submit to the Secretary an application for carrying out a GEAR UP program that—

    (a) Describes the activities for which assistance under this program is sought, including how the eligible entity will carry out the required activities described in section 404D(a) of the HEA;

    (b) Describes, in the case of an eligible entity described in section 404A(c)(2) of the HEA that chooses to provide scholarships, or an eligible entity described in section 404A(c)(1) of the HEA, how the eligible entity will meet the requirements of section 404E of the HEA;

    (c) Describes, in the case of an eligible entity described in section 404A(c)(2) of the HEA that requests a reduced match percentage under subsection (b)(2), how such reduction will assist the entity to provide the scholarships described in subsection (b)(2)(A)(ii);

    (d) Provides assurances that adequate administrative and support staff will be responsible for coordinating the activities described in section 404D of the HEA;

    (e) Provides assurances that activities assisted under this program will not displace an employee or eliminate a position at a school assisted under this program, including a partial displacement such as a reduction in hours, wages, or employment benefits;

    (f) Describes, in the case of an eligible entity described in section 404A(c)(1) of the HEA that chooses to use a cohort approach, or an eligible entity described in section 404A(c)(2) of the HEA, how the eligible entity will define the cohorts of the students served by the eligible entity pursuant to section 404B(d) of the HEA, and how the eligible entity will serve the cohorts through grade 12, including—

    (i) How vacancies in the program under this program will be filled; and

    (ii) How the eligible entity will serve students attending different secondary schools;

    (g) Describes how the eligible entity will coordinate programs under this program with other existing Federal, State, or local programs to avoid duplication and maximize the number of students served;

    (h) Provides such additional assurances as the Secretary determines necessary to ensure compliance with the requirements of this program;

    (i) Provides information about the activities that will be carried out by the eligible entity to support systemic changes from which future cohorts of students will benefit; and

    (j) Describes the sources of matching funds that will enable the eligible entity to meet the matching requirement described in subsection (b).

    4. Subgrantees: A grantee under this competition may not award subgrants to entities to directly carry out project activities described in its application.

    IV. Application and Submission Information

    1. Application Submission Instructions: For information on how to submit an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the Federal Register on February 12, 2018 (83 FR 6003) and available at www.thefederalregister.org/fdsys/pkg.FR-2018-02-12/pdf/2018-02558.pdf.

    2. Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this program.

    3. Funding Restrictions: We reference regulations outlining funding restrictions in the Applicable Regulations section of this notice.

    4. Content and Form of Application Submission: You must include your complete response to the selection criteria and absolute priority in the application narrative. Other requirements concerning the content of an application, together with the forms you must submit, are in the application package for this program.

    5. Recommended Page Limit: The application narrative is where you, the applicant, address the selection criteria that reviewers use to assess your application. There is no page limit for the application narrative; however, we recommend that you present your information clearly and concisely.

    Note:

    Applications that do not follow the formatting recommendations will not be penalized.

    We recommend the following standards:

    • A “page” is 8.5″ x 11″, on one side only, with 1″ margins.

    • Double-space all text in the application project narrative, and single-space titles, headings, footnotes, quotations, references, and captions.

    • Use a 12-point font.

    • Use an easily readable font such as Times New Roman, Courier, Courier New, or Arial.

    V. Application Review Information

    1. Selection Criteria: The selection criteria for this competition are from 34 CFR 75.210.

    a. Need for the project (15 points).

    (1) The Secretary considers the need for the proposed project.

    (2) In determining the need for the proposed project, the Secretary considers the following factors:

    (i) The magnitude or severity of the problem to be addressed by the proposed project; and

    (ii) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses.

    b. Quality of project design (15 points).

    (1) The Secretary considers the quality of the project design.

    (2) In determining the quality of project design, the Secretary considers the following factors:

    (i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable;

    (ii) The extent to which the project design reflects up-to-date research and the replication of effective practices; and

    (iii) The extent to which the project supports systemic changes from which future cohorts of students will benefit.

    (3) The extent to which the proposed project demonstrates a rationale (as defined in 34 CFR 77.1(c) and in this notice.

    c. Quality of project services (15 points).

    (1) The Secretary considers the quality of the services to be provided by the proposed project.

    (2) In determining the quality of project services provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.

    (3) In addition, the Secretary considers the following factors:

    (i) The extent to which the project services are likely to provide comprehensive mentoring, outreach, and supportive services to students, including the following activities: Information regarding financial aid for postsecondary education to participating students, encouraging student enrollment in rigorous and challenging curricula and coursework in order to reduce the need for remedial coursework at the postsecondary level, and improving the number of participating students who obtain a secondary school diploma and complete applications for and enroll in a program of postsecondary education; and

    (ii) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services.

    d. Quality of project personnel (10 points).

    (1) The Secretary considers the quality of the personnel who will carry out the proposed project.

    (2) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age or disability.

    (2) In addition, the Secretary considers the following factors:

    (i) The qualifications, including relevant training and experience, of the project director or principal investigator; and

    (ii) The qualifications, including relevant training and experience, of key personnel.

    e. Quality of the management plan (10 points).

    (1) The Secretary considers the quality of the management plan for the proposed project.

    (2) In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:

    (i) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks;

    (ii) The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project;

    (iii) The extent to which the time commitments of the project director and other key project personnel are appropriate and adequate to meet the objectives of the proposed project; and

    (iv) How the applicant will ensure that a diversity of perspectives are brought to bear in the operation of the proposed project, including those of parents, teachers, the business community, a variety of disciplinary and professional fields, recipients or beneficiaries of services, or others, as appropriate.

    f. Quality of the project evaluation (20 points).

    (1) The Secretary considers the quality of the evaluation to be conducted of the proposed project.

    (2) In determining the quality of the project evaluation, the Secretary considers the following factors:

    (i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project;

    (ii) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible;

    (iii) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes;

    (iv) The extent to which the evaluation will provide guidance about effective strategies suitable for replication or testing in other settings; and

    (v) The extent to which the methods of evaluation will, if well-implemented, produce promising evidence (as defined in 34 CFR 77.1(c)) about the projects effectiveness.

    g. Adequacy of resources (15 points).

    (1) The Secretary considers the adequacy of resources for the proposed project.

    (2) In determining the adequacy of resources for the proposed project, the Secretary considers the following factors:

    (i) The adequacy of support, including facilities, equipment, supplies and other resources from the applicant organization or the lead applicant organization;

    (ii) The relevance and demonstrated commitment of each partner in the proposed project to the implementation and success of the project;

    (iii) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits; and

    (iv) The potential for continued support of the project after Federal funding ends, including, as appropriate, the demonstrated commitment of appropriate entities to such support.

    2. Review and Selection Process: We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

    In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23) as well as all applicable requirements of all other Federal laws, executive orders, regulations, and policies governing this program.

    For this competition, a panel of non-Federal reviewers will review each application in accordance with the selection criteria in 34 CFR 75.217(d)(3) as required by 20 U.S.C. 1070-a23(d). The individual scores of the reviewers will be added and the sum divided by the number of reviewers to determine the peer review score received in the review process.

    If there are insufficient funds for all applications with the same total scores, to the extent practicable the Secretary will consider the distribution of grant awards based on the geographic distribution of such grant awards and the distribution between urban and rural applicants for the GEAR UP program consistent with 20 U.S.C. 1070a-22(a)(3).

    3. Risk Assessment and Special Conditions: Consistent with 2 CFR 200.205, before awarding grants under this competition the Department conducts a review of the risks posed by applicants. Under 2 CFR 3474.10, the Secretary may impose special conditions and, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

    4. Integrity and Performance System: If you are selected under this competition to receive an award that over the course of the project period may exceed the simplified acquisition threshold (currently $150,000), under 2 CFR 200.205(a)(2) we must make a judgment about your integrity, business ethics, and record of performance under Federal awards—that is, the risk posed by you as an applicant—before we make an award. In doing so, we must consider any information about you that is in the integrity and performance system (currently referred to as the Federal Awardee Performance and Integrity Information System (FAPIIS)), accessible through the System for Award Management. You may review and comment on any information about yourself that a Federal agency previously entered and that is currently in FAPIIS.

    Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.

    VI. Award Administration Information

    1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN), or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

    If your application is not evaluated or not selected for funding, we will notify you.

    2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

    We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

    3. Open Licensing Requirements: Unless an exception applies, if you are awarded a grant under this competition, you will be required to openly license to the public grant deliverables created in whole, or in part, with Department grant funds. When the deliverable consists of modifications to pre-existing works, the license extends only to those modifications that can be separately identified and only to the extent that open licensing is permitted under the terms of any licenses or other legal restrictions on the use of pre-existing works. For additional information on the open licensing requirements please refer to 2 CFR 3474.20(c).

    4. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

    (b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms/appforms.html.

    (c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.

    5. Performance Measures: The objectives of the GEAR UP program are (1) to increase the academic performance and preparation for postsecondary education of participating students; (2) to increase the rate of high school graduation and participation in postsecondary education of participating students; and (3) to increase educational expectations for participating students and increase student and family knowledge of postsecondary education options, preparation, and financing.

    The effectiveness of this program depends on the rate at which program participants complete high school and enroll in and complete a postsecondary education. Under the Government Performance and Results Modernization Act, we developed the following performance measures to track progress toward achieving the program's goals:

    1. The percentage of GEAR UP students who pass Pre-Algebra by the end of 8th grade.

    2. The percentage of GEAR UP students who pass Algebra 1 by the end of 9th grade.

    3. The percentage of GEAR UP students who take two years of mathematics beyond Algebra 1 by 12th grade.

    4. The percentage of GEAR UP students who are on track for graduation at the end of each grade.

    5. The percentage of GEAR UP students who are on track to apply for college as measured by completion of the SAT or ACT by the end of 11th grade.

    6. The percentage of GEAR UP students who graduate from high school.

    7. The percentage of GEAR UP students who complete the Free Application for Federal Student Aid.

    8. The percentage of GEAR UP students and former GEAR UP students who are enrolled at an IHE.

    9. The percentage of GEAR UP students who place into college-level math and English without need for remediation.

    10. The percentage of current GEAR UP students and former GEAR UP students who are on track to graduate from an IHE one year after enrolling in an IHE.

    In addition, to assess the efficiency of the program, we track the average cost, in Federal funds, of achieving a successful outcome, where success is defined as enrollment in a program of undergraduate instruction at an IHE of GEAR UP students immediately after high school graduation. These performance measures constitute GEAR UP's indicators of the success of the program. Accordingly, we request that applicants include these performance measures in conceptualizing the design, implementation, and evaluation of their proposed projects.

    6. Continuation Awards: In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: Whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance measurement requirements, the performance targets in the grantee's approved application.

    In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23) as well as all applicable requirements of all other Federal laws, executive orders, regulations, and policies governing this program.

    VII. Other Information

    Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to one of the program contact persons listed under FOR FURTHER INFORMATION CONTACT.

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

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

    Dated: June 4, 2018. Frank T. Brogan, Principal Deputy Assistant Secretary and Delegated the duties of the Assistant Secretary, Office of Planning, Evaluation and Policy Development, Delegated the duties of the Assistant Secretary, Office of Postsecondary Education.
    [FR Doc. 2018-12294 Filed 6-6-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION Applications for New Awards; Gaining Early Awareness and Readiness for Undergraduate Programs (State Grants) AGENCY:

    Office of Postsecondary Education, Department of Education.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Education is issuing a notice inviting applications for new awards for fiscal year (FY) 2018 for the Gaining Early Awareness and Readiness for Undergraduate Programs (GEAR UP) State Grants, Catalog of Federal Domestic Assistance (CFDA) number 84.334S.

    DATES:

    Applications Available: June 7, 2018.

    Deadline for Transmittal of Applications: July 13, 2018.

    Deadline for Intergovernmental Review: September 11, 2018.

    ADDRESSES:

    For the addresses for obtaining and submitting an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the Federal Register on February 12, 2018 (83 FR 6003) and available at www.thefederalregister.org/fdsys/pkg/FR-2018-02-12/pdf/2018-02558.pdf.

    FOR FURTHER INFORMATION CONTACT:

    Karmon Simms-Coates, U.S. Department of Education, 400 Maryland Avenue SW, room 278-54, Washington, DC 20202-6450. Telephone: (202) 453-7917. Email: [email protected]

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

    SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description

    Purpose of Program: The GEAR UP program is a discretionary grant program that encourages eligible entities to provide support, and maintain a commitment to eligible low-income students, including students with disabilities, to assist the students in obtaining a secondary school diploma (or its recognized equivalent) and to prepare for and succeed in postsecondary education. Under the GEAR UP program, the Department awards grants to two types of entities: (1) States and (2) eligible partnerships.

    In this notice, the Department invites applications for State grants only. We will invite applications for partnership grants in another notice published in the Federal Register. Required services under the GEAR UP program are specified in sections 404D(a) of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1070a-24(a)), and permissible services under the GEAR UP Program are specified in section 404D(b) and (c) of the HEA (20 U.S.C. 1070a-24(b) and (c)). For State grantees, activities must include providing financial aid information for postsecondary education, encouraging enrollment in rigorous and challenging coursework in order to reduce the need for remediation at the postsecondary level, implementing activities to improve the number of participating students who obtain a secondary school diploma and who complete applications for and enroll in a program of postsecondary education, and provision of scholarships as specified in section 404E of the HEA. Activities may also include mentoring, tutoring, supporting dual or concurrent enrollment programs that support participating students in science, technology, engineering, or mathematics (STEM), academic and career counseling, financial and economic literacy education, and exposure to college campuses.

    Background:

    On March 2, 2018, the Secretary published in the Federal Register the Final Supplemental Priorities and Definitions for Discretionary Grant Programs (83 FR 9096) (Supplemental Priorities). In order to advance many of these priorities, this notice contains an absolute priority that encompasses several of the supplemental priorities. Because the absolute priority includes many categories from which an applicant may choose, and because projects occur over a period of many years, we believe applicants have ample opportunity to address these priorities in their projects.

    Priorities: This notice contains one absolute priority and one competitive preference priority. The absolute priority has several categories. The absolute priority is from the Supplemental Priorities. This notice also contains one competitive preference priority. In accordance with 34 CFR 75.105(b)(2)(ii) and 34 CFR 75.105(b)(iv), the competitive preference priority is from section 404A(b)(3) of the HEA (20 U.S.C. 1070a-21(b)(3)) and the GEAR UP Program regulations (34 CFR 694.19).

    Absolute Priority: For FY 2018, and any subsequent year in which we make awards from the list of unfunded applications from this competition, this priority is an absolute priority. Under 34 CFR 75.105(c)(3), we consider only applications that meet this priority. Applicants must address at least one priority area in at least three of the following four categories. Addressing additional activities or addressing all four categories will not increase an applicant's score, but applicants may choose to do so.

    The four categories under this priority are:

    Category 1: Fostering Flexible and Affordable Paths To Obtaining Knowledge and Skills

    Projects that are designed to address one or more of the following priority areas:

    (a) Developing or implementing pathways to recognized postsecondary credentials (as defined in section 3(52) of the Workforce Innovation and Opportunity Act of 2014 (WIOA)) focused on career and technical skills that align with in-demand industry sectors or occupations (as defined in section 3(23) of WIOA). Students may obtain such credentials through a wide variety of education providers, such as: IHEs eligible for Federal student financial aid programs, nontraditional education providers (e.g., apprenticeship programs or computer coding boot camps), and providers of self-guided learning;

    (b) Providing work-based learning experiences (such as internships, apprenticeships, and fellowships) that align with in-demand industry sectors or occupations (as defined in section 3(23) of WIOA);

    (c) Creating or expanding innovative paths to a recognized postsecondary credential or obtainment of job-ready skills that align with in-demand industry sectors or occupations (as defined in section 3(23) of WIOA), such as through career pathways (as defined in section 3(7) of WIOA). Such credentials may be offered to students through a wide variety of education providers, such as providers eligible for Federal student financial aid programs, nontraditional education providers, and providers of self-guided learning; or

    (d) Creating or expanding opportunities for students to obtain recognized postsecondary credentials in science, technology, engineering, mathematics, or computer science (as defined in this notice).

    Category 2: Promoting Science, Technology, Engineering, or Math (STEM) Education, With a Particular Focus on Computer Science

    Projects designed to improve student achievement or other educational outcomes in one or more of the following areas: Science, technology, engineering, math, or computer science (as defined in this notice). These projects may address one or more of the following priority areas:

    (a) Supporting student mastery of key prerequisites (e.g., Algebra I) to ensure success in all STEM fields, including computer science (as defined in this notice); exposing children or students to building-block skills (such as critical thinking and problem-solving, gained through hands-on, inquiry-based learning); or supporting the development of proficiency in the use of computer applications necessary to transition from a user of technologies, particularly computer technologies, to a developer of them;

    (b) Increasing access to STEM coursework, including computer science (as defined in this notice), and hands-on learning opportunities, such as through expanded course offerings, dual-enrollment, high-quality online coursework, or other innovative delivery mechanisms;

    (c) Creating or expanding partnerships between schools, LEAs, State educational agencies, businesses, not-for-profit organizations, or IHEs to give students access to internships, apprenticeships, or other work-based learning experiences in STEM fields, including computer science (as defined in this notice);

    (d) Other evidence-based (as defined in 34 CFR 77.1 and in this notice) and innovative approaches to expanding access to high-quality STEM education, including computer science (as defined in this notice); or

    (e) Utilizing technology for educational purposes in communities served by rural local educational agencies (as defined in this notice) or other areas identified as lacking sufficient access to such tools and resources.

    Category 3: Protecting Freedom of Speech and Encouraging Respectful Interactions in a Safe Educational Environment, or Fostering Knowledge and Promoting the Development of Skills That Prepare Students To Be Informed, Thoughtful, and Productive Individuals and Citizens

    Projects that are designed to address one or more of the following priority areas:

    (a) Protecting free speech in order to allow for the discussion of diverse ideas or viewpoints; or

    (b) Fostering knowledge of the common rights and responsibilities of American citizenship and civic participation, such as through civics education consistent with section 203(12) of WIOA.

    Category 4: Fostering Knowledge and Promoting the Development of Skills That Prepare Students To Be Informed, Thoughtful, and Productive Individuals and Citizens.

    Projects that are designed to address supporting instruction in personal financial literacy, knowledge of markets and economics, knowledge of higher education financing and repayment (e.g., college savings and student loans), or other skills aimed at building personal financial understanding and responsibility.

    Competitive Preference Priority: For FY 2018, and any subsequent year in which we make awards from the list of unfunded applications from this competition, this priority is a competitive preference priority. Under 34 CFR 75.105(c)(2)(i), we award up to an additional two points, depending on how well the application meets this priority.

    This priority is:

    We give priority to an eligible applicant for a State GEAR UP grant that has: (a) Carried out a successful State GEAR UP grant prior to August 14, 2008, determined on the basis of data (including outcome data) submitted by the applicant as part of its annual and final performance reports from prior GEAR UP State grants administered by the applicant and the applicant's history of compliance with applicable statutory and regulatory requirements; and (b) a prior, demonstrated commitment to early intervention leading to college access through collaboration and replication of successful strategies.

    Definitions: These definitions are from the Supplemental Priorities and 34 CFR 77.1(c).

    Computer Science means the study of computers and algorithmic processes and includes the study of computing principles and theories, computational thinking, computer hardware, software design, coding, analytics, and computer applications.

    Computer science often includes computer programming or coding as a tool to create software, including applications, games, websites, and tools to manage or manipulate data; or development and management of computer hardware and the other electronics related to sharing, securing, and using digital information.

    In addition to coding, the expanding field of computer science emphasizes computational thinking and interdisciplinary problem-solving to equip students with the skills and abilities necessary to apply computation in our digital world.

    Computer science does not include using a computer for everyday activities, such as browsing the internet; use of tools like word processing, spreadsheets, or presentation software; or using computers in the study and exploration of unrelated subjects.

    Demonstrates a rationale means a key project component included in the project's logic model is informed by research or evaluation findings that suggest the project component is likely to improve relevant outcomes.

    Evidence-based means the proposed project component is supported by one or more of strong evidence, moderate evidence, promising evidence, or evidence that demonstrates a rationale.

    Experimental study means a study that is designed to compare outcomes between two groups of individuals (such as students) that are otherwise equivalent except for their assignment to either a treatment group receiving a project component or a control group that does not. Randomized controlled trials, regression discontinuity design studies, and single-case design studies are the specific types of experimental studies that, depending on their design and implementation (e.g., sample attrition in randomized controlled trials and regression discontinuity design studies), can meet What Works Clearinghouse (WWC) standards without reservations as described in the WWC Handbook:

    (i) A randomized controlled trial employs random assignment of, for example, students, teachers, classrooms, or schools to receive the project component being evaluated (the treatment group) or not to receive the project component (the control group).

    (ii) A regression discontinuity design study assigns the project component being evaluated using a measured variable (e.g., assigning students reading below a cutoff score to tutoring or developmental education classes) and controls for that variable in the analysis of outcomes.

    (iii) A single-case design study uses observations of a single case (e.g., a student eligible for a behavioral intervention) over time in the absence and presence of a controlled treatment manipulation to determine whether the outcome is systematically related to the treatment.

    Logic model (also referred to as a theory of action) means a framework that identifies key project components of the proposed project (i.e., the active “ingredients” that are hypothesized to be critical to achieving the relevant outcomes) and describes the theoretical and operational relationships among the key project components and relevant outcomes.

    Moderate evidence means that there is evidence of effectiveness of a key project component in improving a relevant outcome for a sample that overlaps with the populations or settings proposed to receive that component, based on a relevant finding from one of the following:

    (i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;

    (ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” or “potentially positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or

    (iii) A single experimental study or quasi-experimental design study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—

    (A) Meets WWC standards with or without reservations;

    (B) Includes at least one statistically significant and positive (i.e., favorable) effect on a relevant outcome;

    (C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and

    (D) Is based on a sample from more than one site (e.g., State, county, city, school district, or postsecondary campus) and includes at least 350 students or other individuals across sites. Multiple studies of the same project component that each meet requirements in paragraphs (iii)(A), (B), and (C) of this definition may together satisfy this requirement.

    Project component means an activity, strategy, intervention, process, product, practice, or policy included in a project. Evidence may pertain to an individual project component or to a combination of project components (e.g., training teachers on instructional practices for English learners and follow-on coaching for these teachers).

    Promising evidence means that there is evidence of the effectiveness of a key project component in improving a relevant outcome, based on a relevant finding from one of the following:

    (i) A practice guide prepared by WWC reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;

    (ii) An intervention report prepared by the WWC reporting a “positive effect” or “potentially positive effect” on a relevant outcome with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or

    (iii) A single study assessed by the Department, as appropriate, that—

    (A) Is an experimental study, a quasi-experimental design study, or a well-designed and well-implemented correlational study with statistical controls for selection bias (e.g., a study using regression methods to account for differences between a treatment group and a comparison group); and

    (B) Includes at least one statistically significant and positive (i.e., favorable) effect on a relevant outcome.

    Quasi-experimental design study means a study using a design that attempts to approximate an experimental study by identifying a comparison group that is similar to the treatment group in important respects. This type of study, depending on design and implementation (e.g., establishment of baseline equivalence of the groups being compared), can meet WWC standards with reservations, but cannot meet WWC standards without reservations, as described in the WWC Handbook.

    Relevant outcome means the student outcome(s) or other outcome(s) the key project component is designed to improve, consistent with the specific goals of the program.

    Rural local educational agency means a local educational agency that is eligible under the Small Rural School Achievement (SRSA) program or the Rural and Low-Income School (RLIS) program authorized under Title V, Part B of the Elementary and Secondary Education Act of 1965, as amended. Eligible applicants may determine whether a particular district is eligible for these programs by referring to information on the Department's website at www2.ed.gov/nclb/freedom/local/reap.html.

    Strong evidence means that there is evidence of the effectiveness of a key project component in improving a relevant outcome for a sample that overlaps with the populations and settings proposed to receive that component, based on a relevant finding from one of the following:

    (i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” for the corresponding practice guide recommendation;

    (ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or

    (iii) A single experimental study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—

    (A) Meets WWC standards without reservations;

    (B) Includes at least one statistically significant and positive (i.e., favorable) effect on a relevant outcome;

    (C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and

    (D) Is based on a sample from more than one site (e.g., State, county, city, school district, or postsecondary campus) and includes at least 350 students or other individuals across sites. Multiple studies of the same project component that each meet requirements in paragraphs (iii)(A), (B), and (C) of this definition may together satisfy this requirement.

    What Works Clearinghouse Handbook (WWC Handbook) means the standards and procedures set forth in the WWC Procedures and Standards Handbook, Version 3.0 or Version 2.1 (incorporated by reference, see 34 CFR 77.2). Study findings eligible for review under WWC standards can meet WWC standards without reservations, meet WWC standards with reservations, or not meet WWC standards. WWC practice guides and intervention reports include findings from systematic reviews of evidence as described in the Handbook documentation.

    Program Authority: 20 U.S.C. 1070a-21—1070a-28.

    Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 75, 77, 79, 81, 82, 84, 97, 98, and 99. (b) The Office of Management and Budget Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474. (d) The regulations for this program in 34 CFR part 694.

    II. Award Information

    Type of Award: Discretionary grants.

    Estimated Available Funds: The Consolidated Appropriations Act, 2018 provided $350,000,000 for the GEAR UP program for FY 2018, of which we intend to use an estimated $129,666,000 for new GEAR UP awards. The estimated funding available for the new GEAR UP State awards is $54,833,000.

    Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent years from the list of unfunded applications from this competition.

    Estimated Range of Awards: $2,500,000-$3,500,000.

    Estimated Average Size of Awards: $3,000,000.

    Maximum Award: We will not fund any application for a State grant above the maximum award of $3,500,000 for a single budget period of 12 months. Applications that request more than the maximum amount, except in the case of minimal technical or rounding errors, may be penalized. Additionally, no funding will be awarded for increases in budget after the first 12-month budget period. As described in 34 CFR 694.1, the Assistant Secretary for Postsecondary Education may change the maximum amount through a notice published in the Federal Register.

    Estimated Number of Awards: 18.

    Note:

    The Department is not bound by any estimates in this notice.

    Project Period: Either 72 months or 84 months.

    Note:

    An applicant that wishes to seek funding for a seventh project year (i.e., for a project period of greater than 72 months), in order to provide project services to GEAR UP students through their first year of attendance at an IHE, must propose to do so in the application provided in response to this notice.

    III. Eligibility Information

    1. Eligible Applicants: States as defined by section 103(21) of the HEA (20 U.S.C. 1003(21)), which includes in addition to the several States of the United States, the Commonwealth of Puerto Rico, the District of Columbia, Guam, American Samoa, the United States Virgin Islands, the Commonwealth of the Northern Mariana Islands, and the Freely Associated States. Per Congressional direction in the Explanatory Statement to the Consolidated Appropriations Act, 2018 (Pub. L. 115-141), States may only administer one active State GEAR UP grant at a time. Therefore, only States without an active State GEAR UP grant, or States that have an active State GEAR UP grant that is scheduled to end prior to October 1, 2018, are eligible to receive a new State GEAR UP award in this competition.

    2.a. Cost Sharing or Matching: Section 404C(b)(1) of the HEA requires grantees under this program to provide from State, local, institutional, or private funds, not less than 50 percent of the cost of the program (or one dollar of non-Federal funds for every one dollar of Federal funds awarded), which may be provided in cash or in-kind. The provision also specifies that the match may be accrued over the full duration of the grant award period, except that the grantee must make substantial progress towards meeting the matching requirement in each year of the grant award period. Section 404C(c) of the HEA provides that in-kind contributions may include (1) the amount of the financial assistance obligated under GEAR UP to students from State, local, institutional, or private funds, (2) the amount of tuition, fees, room or board waived or reduced for recipients of financial assistance under GEAR UP, (3) the amount expended on documented, targeted, long-term mentoring and counseling provided by volunteers or paid staff of non-school organizations, including businesses, religious organizations, community groups, postsecondary educational institutions, nonprofit and philanthropic organizations, and other organizations, and (4) equipment and supplies, cash contributions from non-Federal sources, transportation expenses, in-kind or discounted program services, indirect costs, and facility usage.

    b. Supplement-Not-Supplant: This program involves supplement, not supplant funding requirements. Under section 404B(e) of the HEA (20 U.S.C. 1070a-22(e)), grant funds awarded under this program must be used to supplement, and not supplant, other Federal, State, and local funds that would otherwise be expended to carry out activities assisted under this program.

    3. Other: General Application Requirements: All applicants must meet the following application requirements in order to be considered for funding. The application requirements are from section 404C(a) of the HEA (20 U.S.C. 1070a-23(a)).

    In order for an eligible entity to qualify for a grant under the GEAR UP program, the eligible entity shall submit to the Secretary an application for carrying out a GEAR UP program that—

    (a) Describes the activities for which assistance under this program is sought, including how the eligible entity will carry out the required activities described in section 404D(a) of the HEA;

    (b) Describes, in the case of an eligible entity described in section 404A(c)(2) of the HEA that chooses to provide scholarships, or an eligible entity described in section 404A(c)(1) of the HEA, how the eligible entity will meet the requirements of section 404E of the HEA;

    (c) Describes, in the case of an eligible entity described in section 404A(c)(2) of the HEA that requests a reduced match percentage under subsection (b)(2), how such reduction will assist the entity to provide the scholarships described in subsection (b)(2)(A)(ii);

    (d) Provides assurances that adequate administrative and support staff will be responsible for coordinating the activities described in section 404D of the HEA;

    (e) Provides assurances that activities assisted under this program will not displace an employee or eliminate a position at a school assisted under this program, including a partial displacement such as a reduction in hours, wages, or employment benefits;

    (f) Describes, in the case of an eligible entity described in section 404A(c)(1) of the HEA that chooses to use a cohort approach, or an eligible entity described in section 404A(c)(2) of the HEA, how the eligible entity will define the cohorts of the students served by the eligible entity pursuant to section 404B(d) of the HEA, and how the eligible entity will serve the cohorts through grade 12, including—

    (i) How vacancies in the program under this program will be filled; and

    (ii) How the eligible entity will serve students attending different secondary schools;

    (g) Describes how the eligible entity will coordinate programs under this program with other existing Federal, State, or local programs to avoid duplication and maximize the number of students served;

    (h) Provides such additional assurances as the Secretary determines necessary to ensure compliance with the requirements of this program;

    (i) Provides information about the activities that will be carried out by the eligible entity to support systemic changes from which future cohorts of students will benefit; and

    (j) Describes the sources of matching funds that will enable the eligible entity to meet the matching requirement described in subsection (b).

    4. Subgrantees: A grantee under this competition may not award subgrants to entities to directly carry out project activities described in its application.

    5. Other: Under Section 404E(b)(1) of the HEA (20 U.S.C. 1070a-25)(b)(1)), a State must use not less than 25 percent and not more than 50 percent of the grant funds for activities targeted at the school and LEA level as described in section 404D (20 U.S.C. 1070a-24) (excluding the provision of funds for postsecondary scholarships required by section 404D(a)(4) and with the remainder of grant funds spent on postsecondary scholarships to eligible GEAR UP students as described in section 404E). However, section 404E(b)(2) of the HEA permits the Secretary to allow a State to use more than 50 percent of grant funds received under this program for activities targeted at the LEA level if the State demonstrates in its grant application that it has another means of providing the students with the financial assistance described in HEA section 404E.

    IV. Application and Submission Information

    1. Application Submission Instructions: For information on how to submit an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the Federal Register on February 12, 2018 (83 FR 6003) and available at www.thefederalregister.org/fdsys/pkg.FR-2018-02-12/pdf/2018-02558.pdf.

    2. Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this program.

    3. Funding Restrictions: We reference regulations outlining funding restrictions in the Applicable Regulations section of this notice.

    4. Content and Form of Application Submission: You must include your complete response to the selection criteria, absolute priorities and competitive preference priority in the application narrative. Other requirements concerning the content of an application, together with the forms you must submit, are in the application package for this program.

    5. Recommended Page Limit and Format: The application narrative is where you, the applicant, address the selection criteria that reviewers use to assess your application. There is no page limit for the application narrative; however, we recommend that you present your information clearly and concisely.

    Note:

    Applications that do not follow the formatting recommendations will not be penalized.

    We recommend the following standards:

    • A “page” is 8.5″ x 11″, on one side only, with 1″ margins.

    • Double-space all text in the application narrative and single-space titles, headings, footnotes, quotations, references, and captions.

    • Use a 12 point font.

    • Use an easily readable font such as Times New Roman, Courier, Courier New, or Arial.

    V. Application Review Information

    1. Selection Criteria: The selection criteria for this competition are from 34 CFR 75.210.

    a. Need for the project (15 points).

    (1) The Secretary considers the need for the proposed project.

    (2) In determining the need for the proposed project, the Secretary considers the following factors:

    (i) The magnitude or severity of the problem to be addressed by the proposed project; and

    (ii) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses.

    b. Quality of project design (15 points).

    (1) The Secretary considers the quality of the project design.

    (2) In determining the quality of project design, the Secretary considers the following factors:

    (i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable;

    (ii) The extent to which the project design reflects up-to-date research and the replication of effective practices; and

    (iii) The extent to which the project supports systemic changes from which future cohorts of students will benefit.

    (3) The extent to which the proposed project demonstrates a rationale (as defined in 34 CFR 77.1(c) and in this Notice).

    c. Quality of project services (15 points).

    (1) The Secretary considers the quality of the services to be provided by the proposed project.

    (2) In determining the quality of project services provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.

    (3) In addition, the Secretary considers the following factors:

    (i) The extent to which the project services are likely to provide comprehensive mentoring, outreach, and supportive services to students, including the following activities: Information regarding financial aid for postsecondary education to participating students, encouraging student enrollment in rigorous and challenging curricula and coursework in order to reduce the need for remedial coursework at the postsecondary level, and improving the number of participating students who obtain a secondary school diploma and complete applications for and enroll in a program of postsecondary education; and

    (ii) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services.

    d. Quality of project personnel (10 points).

    (1) The Secretary considers the quality of the personnel who will carry out the proposed project.

    (2) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age or disability.

    (3) In addition, the Secretary considers the following factors:

    (i) The qualifications, including relevant training and experience, of the project director or principal investigator; and

    (ii) The qualifications, including relevant training and experience, of key personnel.

    e. Quality of the management plan (10 points).

    (1) The Secretary considers the quality of the management plan for the proposed project.

    (2) In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:

    (i) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks;

    (ii) The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project;

    (iii) The extent to which the time commitments of the project director and other key project personnel are appropriate and adequate to meet the objectives of the proposed project; and

    (iv) How the applicant will ensure that a diversity of perspectives are brought to bear in the operation of the proposed project, including those of parents, teachers, the business community, a variety of disciplinary and professional fields, recipients or beneficiaries of services, or others, as appropriate.

    f. Quality of the project evaluation (20 points).

    (1) The Secretary considers the quality of the evaluation to be conducted of the proposed project.

    (2) In determining the quality of the project evaluation, the Secretary considers the following factors:

    (i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project;

    (ii) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible;

    (iii) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes;

    (iv) The extent to which the evaluation will provide guidance about effective strategies suitable for replication or testing in other settings; and

    (v) The extent to which the methods of evaluation will, if well-implemented, produce promising evidence (as defined in 34 CFR 77.1(c)) about the project's effectiveness.

    g. Adequacy of resources (15 points).

    (1) The Secretary considers the adequacy of resources for the proposed project.

    (2) In determining the adequacy of resources for the proposed project, the Secretary considers the following factors:

    (i) The adequacy of support, including facilities, equipment, supplies and other resources from the applicant organization or the lead applicant organization;

    (ii) The relevance and demonstrated commitment of each partner in the proposed project to the implementation and success of the project;

    (iii) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits; and

    (iv) The potential for continued support of the project after Federal funding ends, including, as appropriate, the demonstrated commitment of appropriate entities to such support.

    2. Review and Selection Process: We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

    In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23) as well as all applicable requirements of all other Federal laws, executive orders, regulations, and policies governing this program.

    For this competition, a panel of non-Federal reviewers will review each application in accordance with the selection criteria in 34 CFR 75.217(d)(3), as required by 20 U.S.C. 1070-a23(d). The individual scores of the reviewers will be added and the sum divided by the number of reviewers to determine the peer review score received in the review process.

    If there are insufficient funds for all applications with the same total scores, to the extent practicable the Secretary will consider the distribution of grant awards based on the geographic distribution of such grant awards and the distribution between urban and rural applicants for the GEAR UP program consistent with 20 U.S.C. 1070a-22(a)(3).

    3. Risk Assessment and Special Conditions: Consistent with 2 CFR 200.205, before awarding grants under this competition the Department conducts a review of the risks posed by applicants. Under 2 CFR 3474.10, the Secretary may impose special conditions and, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

    4. Integrity and Performance System: If you are selected under this competition to receive an award that over the course of the project period may exceed the simplified acquisition threshold (currently $150,000), under 2 CFR 200.205(a)(2) we must make a judgment about your integrity, business ethics, and record of performance under Federal awards—that is, the risk posed by you as an applicant—before we make an award. In doing so, we must consider any information about you that is in the integrity and performance system (currently referred to as the Federal Awardee Performance and Integrity Information System (FAPIIS)), accessible through the System for Award Management. You may review and comment on any information about yourself that a Federal agency previously entered and that is currently in FAPIIS.

    Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.

    VI. Award Administration Information

    1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN), or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

    If your application is not evaluated or not selected for funding, we will notify you.

    2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

    We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

    3. Open Licensing Requirements: Unless an exception applies, if you are awarded a grant under this competition, you will be required to openly license to the public grant deliverables created in whole, or in part, with Department grant funds. When the deliverable consists of modifications to pre-existing works, the license extends only to those modifications that can be separately identified and only to the extent that open licensing is permitted under the terms of any licenses or other legal restrictions on the use of pre-existing works. For additional information on the open licensing requirements please refer to 2 CFR 3474.20(c).

    4. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

    (b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms/appforms.html.

    (c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.

    5. Performance Measures: The objectives of the GEAR UP program are (1) to increase the academic performance and preparation for postsecondary education of participating students; (2) to increase the rate of high school graduation and participation in postsecondary education of participating students; and (3) to increase educational expectations for participating students and increase student and family knowledge of postsecondary education options, preparation, and financing.

    The effectiveness of this program depends on the rate at which program participants complete high school and enroll in and complete a postsecondary education. Under the Government Performance and Results Act of 1993 (GPRA), we developed the following performance measures to track progress toward achieving the program's goals:

    1. The percentage of GEAR UP students who pass Pre-Algebra by the end of 8th grade.

    2. The percentage of GEAR UP students who pass Algebra 1 by the end of 9th grade.

    3. The percentage of GEAR UP students who take two years of mathematics beyond Algebra 1 by 12th grade.

    4. The percentage of GEAR UP students who are on track for graduation at the end of each grade.

    5. The percentage of GEAR UP students who are on track to apply for college as measured by completion of the SAT or ACT by the end of 11th grade.

    6. The percentage of GEAR UP students who graduate from high school.

    7. The percentage of GEAR UP students who complete the Free Application for Federal Student Aid.

    8. The percentage of GEAR UP students and former GEAR UP students who are enrolled at an IHE.

    9. The percentage of GEAR UP students who place into college-level math and English without need for remediation.

    10. The percentage of current GEAR UP students and former GEAR UP students who are on track to graduate from an IHE one year after enrolling in an IHE.

    In addition, to assess the efficiency of the program, we track the average cost, in Federal funds, of achieving a successful outcome, where success is defined as enrollment in a program of undergraduate instruction at an IHE of GEAR UP students immediately after high school graduation. These performance measures constitute GEAR UP's indicators of the success of the program. Accordingly, we request that applicants include these performance measures in conceptualizing the design, implementation, and evaluation of their proposed projects.

    6. Continuation Awards: In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: Whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance measurement requirements, the performance targets in the grantee's approved application.

    In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23) as well as all applicable requirements, and policies governing this program.

    VII. Other Information

    Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to one of the program contact persons listed under FOR FURTHER INFORMATION CONTACT.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. You may access the official edition of the Federal Register and the Code of Federal Regulations via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site. You may also access documents of the Department published in the Federal Register by using the article search feature at www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Dated: June 4, 2018. Frank T. Brogan, Principal Deputy Assistant Secretary and Delegated the duties of the Assistant Secretary, Office of Planning, Evaluation and Policy Development, Delegated the duties of the Assistant Secretary, Office of Postsecondary Education.
    [FR Doc. 2018-12291 Filed 6-6-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY [OE Docket No. EA-196-E] Application To Export Electric Energy; ALLETE, Inc., d/b/a Minnesota Power AGENCY:

    Office of Electricity Delivery and Energy Reliability, DOE.

    ACTION:

    Notice of Application.

    SUMMARY:

    ALLETE, Inc., d/b/a Minnesota Power (Applicant or Minnesota Power) has applied to renew its authority to transmit electric energy from the United States to Canada pursuant to the Federal Power Act.

    DATES:

    Comments, protests, or motions to intervene must be submitted on or before July 9, 2018.

    ADDRESSES:

    Comments, protests, motions to intervene, or requests for more information should be addressed to: Office of Electricity Delivery and Energy Reliability, Mail Code: OE-20, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585-0350. Because of delays in handling conventional mail, it is recommended that documents be transmitted by overnight mail, by electronic mail to [email protected], or by facsimile to 202-586-8008.

    SUPPLEMENTARY INFORMATION:

    Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b), 7172(f)) and require authorization under section 202(e) of the Federal Power Act (16 U.S.C. 824a(e)).

    On June 10, 2013, DOE issued Order No. EA-196-D to Minnesota Power, which authorized the Applicant to transmit electric energy from the United States to Canada as a power marketer for a five-year term using existing international transmission facilities. That authority expires on June 4, 2018. On April 23, 2018, Minnesota Power filed an application with DOE for renewal of the export authority contained in Order No. EA-196 for an additional five-year term.

    In its application, Minnesota Power states that it owns electric generation and transmission facilities and sells and distributes electricity within its northern Minnesota service territory. The electric energy that Minnesota Power proposes to export to Canada would be surplus energy purchased from third parties such as electric utilities and Federal power marketing agencies pursuant to voluntary agreements. The existing international transmission facilities to be utilized by Shell Energy have previously been authorized by Presidential Permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.

    Procedural Matters: Any person desiring to be heard in this proceeding should file a comment or protest to the application at the address provided above. Protests should be filed in accordance with Rule 211 of the Federal Energy Regulatory Commission's (FERC) Rules of Practice and Procedures (18 CFR 385.211). Any person desiring to become a party to these proceedings should file a motion to intervene at the above address in accordance with FERC Rule 214 (18 CFR 385.214). Five copies of such comments, protests, or motions to intervene should be sent to the address provided above on or before the date listed above.

    Comments and other filings concerning Minnesota Power's application to export electric energy to Canada should be clearly marked with OE Docket No. EA-196-E. An additional copy is to be provided directly to Christopher D. Anderson, ALLETE, Inc., 30 West Superior Street, Duluth, MN 55802.

    A final decision will be made on this application after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after a determination is made by DOE that the proposed action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system.

    Copies of this application will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program website at http://energy.gov/node/11845, or by emailing Angela Troy at [email protected]

    Issued in Washington, DC, on May 31, 2018. Brian Mills, Electricity Policy Analyst, Office of Electricity.
    [FR Doc. 2018-12264 Filed 6-6-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Certification Notice—253; Notice of Filing of Self-Certification of Coal Capability Under the Powerplant and Industrial Fuel Use Act AGENCY:

    Office of Electricity Delivery and Energy Reliability, DOE.

    ACTION:

    Notice of Filing.

    SUMMARY:

    On May 17, 2018, Clean Energy Future—Lordstown, LLC, as owner and operator of a new baseload electric generating powerplant, submitted a coal capability self-certification to the Department of Energy (DOE). The FUA and regulations thereunder require DOE to publish a notice of filing of self-certification in the Federal Register.

    ADDRESSES:

    Copies of coal capability self-certification filings are available for public inspection, upon request, in the Office of Electricity, Mail Code OE-20, Room 8G-024, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585.

    FOR FURTHER INFORMATION CONTACT:

    Christopher Lawrence at (202) 586-5260.

    SUPPLEMENTARY INFORMATION:

    On May 17, 2018, Clean Energy Future—Lordstown, LLC, as owner and operator of a new baseload electric generating powerplant, submitted a coal capability self-certification to the Department of Energy (DOE) pursuant to § 201(d) of the Powerplant and Industrial Fuel Use Act of 1978 (FUA), as amended, and DOE regulations in 10 CFR 501.60, 61. The FUA and regulations thereunder require DOE to publish a notice of filing of self-certification in the Federal Register. 42 U.S.C. 8311(d)(1) and 10 CFR 501.61(c). Title II of FUA, as amended (42 U.S.C. 8301 et seq.), provides that no new baseload powerplant may be constructed or operated without the capability to use coal or another alternate fuel as a primary energy source. Pursuant to the FUA, in order to meet the requirement of coal capability, the owner or operator of such a facility proposing to use natural gas or petroleum as its primary energy source shall certify to the Secretary of Energy (Secretary), prior to construction or prior to operation as a baseload powerplant, that such powerplant has the capability to use coal or another alternate fuel. Such certification establishes compliance with FUA section 201(a) as of the date it is filed with the Secretary. 42 U.S.C. 8311.

    The following owner of a proposed new baseload electric generating powerplant has filed a self-certification of coal-capability with DOE pursuant to FUA section 201(d) and in accordance with DOE regulations in 10 CFR 501.60, 61:

    Owner: Clean Energy Future—Lordstown, LLC. Capacity: 962 megawatts (MW). Plant Location: Lordstown, OH 44481. In-Service Date: June 1, 2018. Issued in Washington, DC, on May 31, 2018. Brian Mills, Electricity Policy Analyst, Office of Electricity.
    [FR Doc. 2018-12263 Filed 6-6-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Notice of Intent To Grant an Exclusive Copyright License AGENCY:

    National Energy Technology Laboratory, Department of Energy.

    ACTION:

    Notice of intent to grant an exclusive copyright license.

    SUMMARY:

    The National Energy Technology Laboratory (NETL) hereby gives notice that the Department of Energy (DOE) intends to grant an exclusive license to practice the copyrighted software titled “The Variable Grid Tool V.1,” to VariGrid Explorations, Inc., having its principal place of business in Missouri City, Texas. The copyright is owned by the United States of America, as represented by DOE, via copyright assignment.

    DATES:

    Written comments, objections, or nonexclusive license applications must be received at the ADDRESSES listed no later than June 22, 2018. Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

    ADDRESSES:

    Comments, applications for nonexclusive licenses, or objections relating to the prospective exclusive license should be submitted to Jessica Lamp, Technology Transfer Program Manager, U.S. Department of Energy, National Energy Technology Laboratory, P.O. Box 10940, Pittsburgh, PA 15236-0940 or via facsimile to (412) 386-4183.

    FOR FURTHER INFORMATION CONTACT:

    Jessica Lamp, Technology Transfer Program Manager, U.S. Department of Energy, National Energy Technology Laboratory, P.O. Box 10940, Pittsburgh, PA 15236; Telephone (412) 386-7417; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    VariGrid Explorations, Inc., has applied for an exclusive license to practice the copyrighted software and has a plan for commercialization of the software. DOE intends to grant the license, unless within 15 days of publication of this notice, NETL's Technology Transfer Program Manager (contact information listed) receives in writing any of the following, together with supporting documents:

    (i) A statement from any person setting forth reasons why it would not be in the best interest of the United States to grant the proposed license; or

    (ii) An application for a nonexclusive license to the copyrighted software, in which applicant states that it already has brought the software to practical application or is likely to bring the software to practical application expeditiously.

    The proposed license would be exclusive, subject to a license and other rights retained by the United States. DOE will review all timely written responses to this notice, and will grant the license if, after expiration of the 15-day notice period, and after consideration of any written responses to this notice, a determination is made that the license is in the public interest. Dated: May 18, 2018. Sean I. Plasynski, Director (Acting), National Energy Technology Laboratory.
    [FR Doc. 2018-12262 Filed 6-6-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-1709-000] Stoneray Power Partners, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Stoneray Power Partners, 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 June 21, 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: June 1, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-12244 Filed 6-6-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-1708-000] Copenhagen Wind Farm, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Copenhagen Wind Farm, 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 June 21, 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: June 1, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-12243 Filed 6-6-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-1534-000] East Hampton Energy Storage Center, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of East Hampton Energy Storage Center, 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 June 21, 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: June 1, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-12241 Filed 6-6-18; 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 rate filings:

    Docket Numbers: ER18-137-003.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Amendment: Amendment to ER18-137 re:MISO-PJM JOA and Overlapping Congestion Charges to be effective 8/1/2018.

    Filed Date: 5/31/18.

    Accession Number: 20180531-5371.

    Comments Due: 5 p.m. ET 6/21/18.

    Docket Numbers: ER18-1711-000.

    Applicants: Indiana Michigan Power Company, PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: AEP submits ILDSA, Service Agreement No. 1262 and Meridan Facilities Agreement to be effective 5/1/2018.

    Filed Date: 5/31/18.

    Accession Number: 20180531-5366.

    Comments Due: 5 p.m. ET 6/21/18.

    Docket Numbers: ER18-1712-000.

    Applicants: Pacific Gas and Electric Company.

    Description: § 205(d) Rate Filing: May 2018 Western Interconnection Agreement Biannual Filing to be effective 8/1/2018.

    Filed Date: 5/31/18.

    Accession Number: 20180531-5379.

    Comments Due: 5 p.m. ET 6/21/18.

    Docket Numbers: ER18-1713-000.

    Applicants: Pacific Gas and Electric Company.

    Description: § 205(d) Rate Filing: May 2018 Western WDT Service Agreement Biannual Filing to be effective 8/1/2018.

    Filed Date: 5/31/18.

    Accession Number: 20180531-5384.

    Comments Due: 5 p.m. ET 6/21/18.

    Docket Numbers: ER18-1714-000.

    Applicants: New England Power Pool Participants Committee.

    Description: § 205(d) Rate Filing: June 2018 Membership Filing to be effective 5/1/2018.

    Filed Date: 6/1/18.

    Accession Number: 20180601-5002.

    Comments Due: 5 p.m. ET 6/22/18.

    Docket Numbers: ER18-1715-000.

    Applicants: NorthWestern Corporation.

    Description: § 205(d) Rate Filing: SA 296 4th Rev—Unexecuted NITSA with Exxon Mobil Corporation to be effective 8/1/2018.

    Filed Date: 6/1/18.

    Accession Number: 20180601-5003.

    Comments Due: 5 p.m. ET 6/22/18.

    Docket Numbers: ER18-1717-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Original WMPA SA No. 5090; Queue No. AC1-209 to be effective 5/2/2018.

    Filed Date: 6/1/18.

    Accession Number: 20180601-5025.

    Comments Due: 5 p.m. ET 6/22/18.

    Docket Numbers: ER18-1718-000.

    Applicants: The United Illuminating Company.

    Description: Petition of The United Illuminating Company for Waiver of Tariff Provisions, et al.

    Filed Date: 5/31/18.

    Accession Number: 20180531-5406.

    Comments Due: 5 p.m. ET 6/7/18.

    Docket Numbers: ER18-1719-000.

    Applicants: Central Maine Power Company.

    Description: Petition of Central Maine Power Company for Waiver of Tariff Provisions, et al.

    Filed Date: 5/31/18.

    Accession Number: 20180531-5410.

    Comments Due: 5 p.m. ET 6/7/18.

    Docket Numbers: ER18-1720-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Notification of Tariff Discrepancy and Request for Limited Tariff Waiver of Midcontinent Independent System Operator, Inc.

    Filed Date: 5/31/18.

    Accession Number: 20180531-5418.

    Comments Due: 5 p.m. ET 6/21/18.

    Docket Numbers: ER18-1721-000.

    Applicants: Entergy Arkansas, Inc., Entergy Louisiana, LLC, Entergy New Orleans, LLC, Entergy Mississippi, Inc., Entergy Texas, Inc.

    Description: Request for Temporary and Limited Waiver of Tariff Provisions of Entergy Arkansas, Inc., et al.

    Filed Date: 5/31/18.

    Accession Number: 20180531-5419.

    Comments Due: 5 p.m. ET 6/21/18.

    Docket Numbers: ER18-1722-000.

    Applicants: Emera Maine, Central Maine Power Company, Maine Electric Power Company, New Hampshire Transmission, LLC, New England Power Company, The Connecticut Light and Power Company, NSTAR Electric Company, Public Service Company of New Hampshire, The United Illuminating Company, Unitil Energy Systems, Inc., Fitchburg Gas and Electric Light Company, Vermont Transco, LLC.

    Description: Petition of the Indentified Participating Transmission Owners for Limited Waiver of Tariff Provisions, et al.

    Filed Date: 5/31/18.

    Accession Number: 20180531-5420.

    Comments Due: 5 p.m. ET 6/7/18.

    Docket Numbers: ER18-1723-000.

    Applicants: New Hampshire Transmission, LLC.

    Description: Petition of New Hampshire Transmission, LLC for Waiver of Tariff Provisions, et al.

    Filed Date: 5/31/18.

    Accession Number: 20180531-5425.

    Comments Due: 5 p.m. ET 6/7/18.

    Docket Numbers: ER18-1724-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-06-01_SA 3116 ATC-Wisconsin Power and Light PCA (Hawk) to be effective 8/1/2018.

    Filed Date: 6/1/18.

    Accession Number: 20180601-5146.

    Comments Due: 5 p.m. ET 6/22/18.

    Docket Numbers: ER18-1725-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-06-01_SA 3117 ATC-Wisconsin Power and Light PCA (Schofield) to be effective 8/1/2018.

    Filed Date: 6/1/18.

    Accession Number: 20180601-5148.

    Comments Due: 5 p.m. ET 6/22/18.

    Docket Numbers: ER18-1726-000.

    Applicants: Mineral Point Energy LLC.

    Description: Tariff Cancellation: Mineral Point Energy LLC Cancellation of MBR Tariff to be effective 6/1/2018.

    Filed Date: 6/1/18.

    Accession Number: 20180601-5152.

    Comments Due: 5 p.m. ET 6/22/18.

    Docket Numbers: ER18-1727-000.

    Applicants: Niles Valley Energy LLC.

    Description: Tariff Cancellation: Niles Valley Energy LLC Cancellation of MBR Tariff to be effective 6/1/2018.

    Filed Date: 6/1/18.

    Accession Number: 20180601-5153.

    Comments Due: 5 p.m. ET 6/22/18.

    Docket Numbers: ER18-1730-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Revisions to the OATT and OA re: Overlapping Congestion Filing Phase II to be effective 8/1/2018.

    Filed Date: 6/1/18.

    Accession Number: 20180601-5216.

    Comments Due: 5 p.m. ET 6/22/18.

    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: June 1, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-12240 Filed 6-6-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-1535-000] Montauk Energy Storage Center, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Montauk Energy Storage Center, 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 June 21, 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: June 1, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-12242 Filed 6-6-18; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9978-84—Region 9] Public Water System Supervision Program Revision for the State of Nevada AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of tentative approval.

    SUMMARY:

    Notice is hereby given that the State of Nevada revised its approved Public Water System Supervision Program (PWSSP) under the federal Safe Drinking Water Act (SDWA) by adopting the Ground Water Rule, the Long Term 2 Enhanced Surface Water Treatment Rule, the Revised Total Coliform Rule, and the Stage 2 Disinfectants and Disinfection Byproducts Rule. The Environmental Protection Agency (EPA) has determined that these revisions by the State of Nevada are no less stringent than the corresponding Federal regulations and otherwise meet applicable SDWA primacy requirements. Therefore, EPA intends to approve these revisions to the State of Nevada's PWSSP.

    DATES:

    Request for a public hearing must be received on or before July 9, 2018.

    ADDRESSES:

    All documents relating to this determination are available for inspection between the hours of 8:30 a.m. and 4:00 p.m., Monday through Friday, except official State holidays and official Federal holidays, at the following offices: Nevada Department of Environmental Protection, Admin Office, 901 South Stewart Street, Suite 4001, Carson City, NV 89701; and United States Environmental Protection Agency, Region 9, Drinking Water Management Section, 75 Hawthorne Street (WTR-3-1), San Francisco, California 94105. Documents relating to this determination are also available online at https://ndep.nv.gov/posts/category/public-notices for inspection.

    FOR FURTHER INFORMATION CONTACT:

    Jacob Jenzen, EPA Region 9, Drinking Water Management Section, at the address given above; telephone number: (415) 972-3570; email address: [email protected].

    SUPPLEMENTARY INFORMATION: Background

    EPA approved the State of Nevada's original application for PWSSP primary enforcement authority which, following the public notice period, became effective on February 27, 1978 (43 FR 8030). EPA has approved various revisions to Nevada's primacy program since then.

    Public Process

    Any interested party may request a public hearing on this determination. A request for a public hearing must be submitted by July 9, 2018, to the Regional Administrator at the EPA Region 9 address shown above. Any request for a public hearing shall include the following information: 1. The name, address, and telephone number of the individual, organization, or other entity requesting a hearing; 2. A brief statement of the requesting person's interest in the Regional Administrator's determination and a brief statement of the information that the requesting person intends to submit at such hearing; and 3. The signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity. The Regional Administrator may deny frivolous or insubstantial requests for a hearing. If a valid request for a public hearing is made within the requested timeframe, a public hearing will be held and a notice of such hearing will be given in the Federal Register and a newspaper of general circulation.

    If EPA Region 9 does not receive a timely and appropriate request for a hearing and the Regional Administrator does not elect to hold a hearing, this determination shall become final and effective on July 9, 2018, and no further public notice will be issued.

    Authority:

    Section 1413 of the Safe Drinking Water Act, 42 U.S.C. 300g-2 (1996), and 40 CFR part 142 of the National Primary Drinking Water Regulations.

    Dated: May 18, 2018. Deborah Jordan, Acting Regional Administrator, EPA, Region 9.
    [FR Doc. 2018-12376 Filed 6-5-18; 4:15 pm] BILLING CODE 6560-50-P
    FARM CREDIT ADMINISTRATION Sunshine Act Meeting; Farm Credit Administration Board AGENCY:

    Farm Credit Administration.

    ACTION:

    Notice, regular meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the Government in the Sunshine Act, of the regular meeting of the Farm Credit Administration Board (Board).

    DATES:

    The regular meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on June 14, 2018, from 9:00 a.m. until such time as the Board concludes its business.

    ADDRESSES:

    Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102-5090. Submit attendance requests via email to [email protected] See SUPPLEMENTARY INFORMATION for further information about attendance requests.

    FOR FURTHER INFORMATION CONTACT:

    Dale L. Aultman, Secretary to the Farm Credit Administration Board, (703) 883-4009, TTY (703) 883-4056, [email protected]

    SUPPLEMENTARY INFORMATION:

    Parts of this meeting of the Board will be open to the public (limited space available) and parts will be closed to the public. Please send an email to [email protected] at least 24 hours before the meeting. In your email include: Name, postal address, entity you are representing (if applicable), and telephone number. You will receive an email confirmation from us. Please be prepared to show a photo identification when you arrive. If you need assistance for accessibility reasons, or if you have any questions, contact Dale L. Aultman, Secretary to the Farm Credit Administration Board, at (703) 883-4009. The matters to be considered at the meeting are:

    Open Session A. Approval of Minutes • May 10, 2018 B. Reports • Quarterly Report on Economic Conditions and FCS Conditions • Semi-Annual Report on Office of Examination Operations Closed Session *

    *Session Closed-Exempt pursuant to 5 U.S.C. 552b(c)(8) and (9).

    • Office of Examination Quarterly Report Dated: June 5, 2018. Dale L. Aultman, Secretary, Farm Credit Administration Board.
    [FR Doc. 2018-12352 Filed 6-5-18; 11:15 am] BILLING CODE 6705-01-P
    FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD Notice of Issuance of Statement of Federal Financial Accounting Standards 55, Amending Inter-Entity Cost Provisions AGENCY:

    Federal Accounting Standards Advisory Board.

    ACTION:

    Notice.

    Pursuant to 31 U.S.C. 3511(d), the Federal Advisory Committee Act (Pub. L. 92-463), as amended, and the FASAB Rules Of Procedure, as amended in October 2010, notice is hereby given that the Federal Accounting Standards Advisory Board (FASAB) has issued Statement of Federal Financial Accounting Standards 55, Amending Inter-entity Cost Provisions.

    The Statement is available on the FASAB website at http://www.fasab.gov/accounting-standards/. Copies can be obtained by contacting FASAB at (202) 512-7350.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Wendy M. Payne, Executive Director, 441 G Street NW, Suite 1155, Washington, DC 20548, or call (202) 512-7350.

    Authority:

    Federal Advisory Committee Act, Pub. L. 92-463.

    Dated: May 31, 2018. Wendy M. Payne, Executive Director.
    [FR Doc. 2018-12265 Filed 6-6-18; 8:45 am] BILLING CODE 1610-02-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1003] Information Collection Being Submitted for Review and Approval to the Office of Management and Budget AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before July 9, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicholas A. Fraser, OMB, via email [email protected]; and to Nicole Ongele, FCC, via email [email protected] and to [email protected] Include in the comments the OMB control number as shown in the SUPPLEMENTARY INFORMATION below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page <http://www.reginfo.gov/public/do/PRAMain>, (2) look for the section of the web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the OMB control number of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    SUPPLEMENTARY INFORMATION:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection.

    Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    OMB Control Number: 3060-1003.

    Title: Communications Disaster Information Reporting System (DIRS).

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities; Not-for-profit institutions; Federal Government; and/or State, Local or Tribal governments.

    Number of Respondents and Responses: 5,000 respondents; 40,900 responses.

    Estimated Time per Response: 0.10-0.50 hours.

    Frequency of Response: On occasion reporting requirement.

    Obligation to Respond: Voluntary. Statutory authority for this collection of information is contained in 47 U.S.C. 154(i), 218, 303(r) and 47 CFR Section 0.181(h).

    Total Annual Burden: 6,950 hours.

    Total Annual Cost: No Cost.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: DIRS filings consists of sensitive information that for national security and/or commercial reasons, the Commission will treat the filings at the time of receipt as non-public and presumptively confidential. However, DIRS filings will be shared with the Department of Homeland Security and the other Federal agencies authorized to participate in the National Response Framework Emergency Support Function-2 (ESF-2)(Communications). The Commission may publish or otherwise share anonymized summaries of DIRS filings at its discretion.

    Needs and Uses: In response to the events of September 11, 2001, the Federal Communications Commission (Commission or FCC) created an Emergency Contact Information System to assist the Commission in ensuring rapid restoration of communications capabilities after disruption by a terrorist threat or attack, and to ensure that public safety, public health, and other emergency and defense personnel have effective communications services available to them in the immediate aftermath of any terrorist attack within the United States. The Commission submitted, and OMB approved, a collection through which key communications providers could voluntarily provide contact information.

    The Commission's Public Safety and Homeland Security Bureau (PSHSB) developed the Disaster Information Reporting System (DIRS) that uses electronic forms to collect Emergency Contact Information forms and through which participants may inform the Commission of damage to communications infrastructure and facilities due to major emergencies and may request resources for restoration. The Commission updated the process by increasing the number of reporting entities to ensure inclusion of wireless, wireline, broadcast, cable, VoIP, and broadband internet access communications providers. The Commission is requesting a renewal of the currently approved collection. It is imperative that the Disaster Information Reporting System be in place so that the Commission has an accurate picture of the communications landscape during disasters.

    Federal Communications Commission. Marlene Dortch, Secretary.
    [FR Doc. 2018-12181 Filed 6-6-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-XXXX] Information Collection Being Submitted for Review and Approval to the Office of Management and Budget AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before July 9, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicholas A. Fraser, OMB, via email [email protected]; and to Nicole Ongele, FCC, via email [email protected] and to [email protected] Include in the comments the OMB control number as shown in the SUPPLEMENTARY INFORMATION below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page http://www.reginfo.gov/public/do/PRAMain, (2) look for the section of the web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the OMB control number of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    SUPPLEMENTARY INFORMATION:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection.

    Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    OMB Control Number: 3060-XXXX.

    Title: Application for Connect America Fund Phase II Auction Support—FCC Form 683.

    Form Number: FCC Form 683.

    Type of Review: New information collection.

    Respondents: Business or other for-Profit entities, Not-for-Profit institutions, and State, Local or Tribal Governments.

    Number of Respondents and Responses: 400 respondents; 800 responses.

    Estimated Time per Response: 2-12 hours (on average).

    Frequency of Response: Annual reporting requirements, on occasion reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection 47 U.S.C. 154, 254 and 303(r) of the Communications Act of 1934, as amended.

    Total Annual Burden: 5,600 hours.

    Total Annual Cost(s): No Cost.

    Nature and Extent of Confidentiality: Although most information collected in FCC Form 683 will be made available for public inspection, the Commission will withhold certain information collected in FCC Form 683 from routine public inspection. Specifically, the Commission will treat certain financial and technical information submitted in FCC Form 683 as confidential. In addition, an applicant may use the abbreviated process under 47 CFR 0.459(a)(4) to request confidential treatment of the audited financial statements that are submitted during the post-selection review process. However, if a request for public inspection for this technical or financial information is made under 47 CFR 0.461, and the applicant has any objections to disclosure, the applicant will be notified and will be required to justify continued confidential treatment. To the extent that an applicant seeks to have other information collected in FCC Form 683 or during the post-selection review process withheld from public inspection, the applicant may request confidential treatment pursuant to 47 CFR 0.459.

    Privacy Act Impact Assessment: No impact(s).

    Needs and Uses: In 2011, the Commission released the USF/ICC Transformation Order and Further Notice of Proposed Rulemaking, WC Docket No. 10-90 et al., FCC 11-161 (USF/ICC Transformation Order and/or FNPRM), which comprehensively reformed and modernized the high-cost program within the universal service fund to focus support on networks capable of providing voice and broadband services. Among other things, the Commission created the Connect America Fund (CAF) and concluded that support in price cap areas would be provided through a combination of “a new forward-looking model of the cost of constructing modern multi-purpose networks” and a competitive bidding process (the Connect America Fund Phase II auction or Phase II auction or Auction 903). The Commission also sought comment in the accompanying USF/ICC Transformation FNPRM on proposed rules governing the Phase II auction, including basic auction design and the application process.

    In the Phase II auction, service providers will compete to receive support of up to $1.98 billion over 10 years to offer voice and broadband service in unserved high-cost areas. The information collection requirements reported under this new collection are the result of several Commission decisions to implement reform adopted in the USF/ICC Transformation Order and move forward with conducting the Phase II auction. In the April 2014 Connect America Order, WC Docket No. 10-90 et al., FCC 14-54, the Commission adopted various rules regarding participation in the Phase II auction, the term of support, and the eligible telecommunications carrier (ETC) designation process. In the Phase II Auction Order, WC Docket No. 10-90 et al., FCC 16-64, the Commission adopted rules to govern the Phase II auction, including the adoption of a two-stage application process, which includes a pre-auction short-form application to be submitted by parties interested in bidding in the Phase II auction and a post-auction long-form application that must be submitted by winning bidders seeking to become authorized to receive Phase II auction support. The Commission concluded, based on its experience with auctions and consistent with the record, that this two-stage application process balances the need to collect information essential to conducting a successful auction and authorizing Phase II support with administrative efficiency.

    On January 30, 2018, the Commission adopted a public notice that established the final procedures for the Phase II auction, including the long-form application disclosure and certification requirements for winning bidders seeking to become authorized to receive Phase II auction support. See Phase II Auction Procedures Public Notice, WC Docket No. 17-182 et al., FCC 18-6. The Commission also adopted the Phase II Auction Order on Reconsideration, WC Docket No. 10-90 et al., FCC 18-5, which modified the Commission's letter of credit rules to provide some additional relief for Phase II auction support recipients by reducing the costs of maintaining a letter of credit.

    Under this information collection, the Commission will collect information from winning bidders to determine the recipients of Phase II auction support. To aid in collecting this information, the Commission has created FCC Form 683, which the public will use to provide the disclosures and certifications that must be made by Phase II auction winning bidders in the Connect America Fund Phase II auction seeking to become authorized for Phase II support.

    Federal Communications Commission. Marlene Dortch, Secretary.
    [FR Doc. 2018-12280 Filed 6-6-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0463] Information Collection Being Submitted for Review and Approval to the Office of Management and Budget AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before July 9, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicholas A. Fraser, OMB, via email [email protected]; and to Cathy Williams, FCC, via email [email protected] and to [email protected] Include in the comments the OMB control number as shown in the SUPPLEMENTARY INFORMATION below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page http://www.reginfo.gov/public/do/PRAMain, (2) look for the section of the web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the OMB control number of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    SUPPLEMENTARY INFORMATION:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    OMB Control Number: 3060-0463.

    Title: Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities, CG Docket No. 03-123, FCC 03-112, FCC 07-110, FCC 07-186.

    Form Number: N/A.

    Type of Review: Revision of a currently approved collection.

    Respondents: Business or other for-profit; Individuals or household; State, Local and Tribal Government.

    Number of Respondents and Responses: 5,072 respondents; 7,299 responses.

    Estimated Time per Response: 0.5 hours (30 minutes) to 50 hours.

    Frequency of Response: Annually, monthly, on occasion, and one-time reporting requirements; Recordkeeping and Third-Party Disclosure requirements.

    Obligation To Respond: Required to obtain or retain benefit. The statutory authority for the information collection requirements is found at section 225 of the Communications Act, 47 U.S.C. 225. The law was enacted on July 26, 1990, as Title IV of the ADA, Public Law 101-336, 104 Stat. 327, 366-69.

    Total Annual Burden: 10,822 hours.

    Total Annual Cost: $10,800.

    Nature and Extent of Confidentiality: Confidentiality is an issue to the extent that individuals and households provide personally identifiable information, which is covered under the FCC's updated system of records notice (SORN), FCC/CGB-1, “Informal Complaints, Inquiries, and Requests for Dispute Assistance.” As required by the Privacy Act, 5 U.S.C. 552a, the Commission also published a SORN, FCC/CGB-1 “Informal Complaints, Inquiries, and Requests for Dispute Assistance,” in the Federal Register on August 15, 2014 (79 FR 48152) which became effective on September 24, 2014.

    Privacy Impact Assessment: The FCC completed a Privacy Impact Assessment (PIA) on June 28, 2007. It may be reviewed at http://www.fcc.gov/omd/privacyact/Privacy-Impact-Assessment.html. The Commission is in the process of updating the PIA to incorporate various revisions to it as a result of revisions to the SORN.

    Needs and Uses: The Commission is submitting this modified information collection to the Office of Management and Budget (OMB) to transfer burden hours and costs associated with regulations under section 225 of the Communications Act (Act), which is currently approved under OMB control number 3060-1249, to this information collection. The Commission intends to discontinue information collection 3060-1249 once this information collection is approved.

    On December 21, 2001, the Commission released the 2001 TRS Cost Recovery Order, document FCC 01-371, published at 67 FR 4203, January 29, 2002, in which the Commission:

    (a) Directed the Interstate Telecommunications Relay Services (TRS) Fund (TRS Fund) administrator to continue to use the average cost per minute compensation methodology for the traditional TRS compensation rate;

    (b) required TRS providers to submit certain projected TRS-related cost and demand data to the TRS Fund administrator to be used to calculate the rate; and

    (c) directed the TRS Fund administrator to expand its form for providers to itemize their actual and projected costs and demand data, to include specific sections to capture speech-to-speech (STS) and video relay service (VRS) costs and minutes of use.

    In 2003, the Commission released the 2003 Second Improved TRS Order, published at 68 FR 50973, August 25, 2003, which among other things required that TRS providers offer certain local exchange carrier (LEC)-based improved services and features where technologically feasible, including a speed dialing requirement which may entail voluntary recordkeeping for TRS providers to maintain a list of telephone numbers. See also 47 CFR 64.604(a)(3)(vi)(B). In 2007, the Commission released the Section 225/255 VoIP Report and Order, published at 72 FR 43546, August 6, 2007, extending the disability access requirements that apply to telecommunications service providers and equipment manufacturers under 47 U.S.C. 225, 255 to interconnected voice over internet protocol (VoIP) service providers and equipment manufacturers. As a result, under rules implementing section 225 of the Act, interconnected VoIP service providers are required to publicize information about telecommunications relay services (TRS) and 711 abbreviated dialing access to TRS. See also 47 CFR 64.604(c)(3).

    In 2007, the Commission also released the 2007 Cost Recovery Report and Order and Declaratory Ruling, published at 73 FR 3197, January 17, 2008, in which the Commission:

    (a) Adopted a new cost recovery methodology for interstate traditional TRS and interstate STS based on the Multi-state Average Rate Structure (MARS) plan, under which interstate TRS compensation rates are determined by weighted average of the states' intrastate compensation rates, and which includes for STS additional compensation approved by the Commission for STS outreach;

    (b) requires STS providers to file a report annually with the TRS Fund administrator and the Commission on their specific outreach efforts directly attributable to the additional compensation approved by the Commission for STS outreach.

    (c) adopted a new cost recovery methodology for interstate captioned telephone service (CTS), as well as internet Protocol captioned telephone service (IP CTS), based on the MARS plan;

    (d) adopted a cost recovery methodology for internet Protocol (IP) Relay based on price caps;

    (e) adopted a cost recovery methodology for VRS that adopted tiered rates based on call volume;

    (f) clarified the nature and extent that certain categories of costs are compensable from the Fund; and

    (g) addressed certain issues concerning the management and oversight of the Fund, including prohibiting financial incentives offered to consumers to make relay calls.

    Federal Communications Commission.

    Marlene Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-12180 Filed 6-6-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION Open Commission Meeting, Thursday, June 7, 2018 May 31, 2018.

    The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, June 7, 2018. Please note the meeting is scheduled to commence at 11:30 a.m. in Room TW-C305, at 445 12th Street SW, Washington, DC. This is a change from the usual 10:30 a.m. Open Meeting start time.

    Item No. Bureau Subject 1 WIRELESS TELE-COMMUNICATIONS, INTERNATIONAL AND OFFICE OF ENGINEERING & TECHNOLOGY Title: Use of Spectrum Bands Above 24 GHz For Mobile Radio Services (GN Docket No. 14-177); Amendment of Parts 1, 22, 24, 27, 74, 80, 90, 95, and 101 To Establish Uniform License Renewal, Discontinuance of Operation, and Geographic Partitioning and Spectrum Disaggregation Rules and Policies for Certain Wireless Radio Services (WT Docket No. 10-112). Summary: The Commission will consider a Third Report and Order, Memorandum Opinion and Order, and Third Further Notice of Proposed Rulemaking that would continue efforts to make available millimeter wave spectrum, in bands at or above 24 GHz, for fifth-generation wireless, Internet of Things, and other advanced spectrum-based services. It would finalize rules for certain of these bands and seek comment on making additional spectrum available in the 26 GHz and 42 GHz bands for flexible terrestrial wireless use, sharing mechanisms in the Lower 37 GHz band, and earth station siting criteria for the 50 GHz band. 2 WIRELINE COMPETITION Title: Accelerating Wireline Broadband Deployment by Removing Barriers to Infrastructure Investment (WC Docket No. 17-84). Summary: The Commission will consider a Second Report and Order that will revise the Commission's section 214(a) discontinuance processes, network change disclosure processes, and Part 68 customer notification process to remove barriers to infrastructure investment and promote broadband deployment. 3 WIRELINE COMPETITION Title: Petition of NTCA—The Rural Broadband Association and the United States Telecom Association for Forbearance Pursuant to 47 U.S.C. § 160(c) from Application of Contribution Obligations on Broadband Internet Access Transmission Services (WC Docket No. 17-206). Summary: The Commission will consider an Order granting forbearance from applying Universal Service Fund contribution requirements to rural carriers' broadband Internet access transmission services. 4 INTERNATIONAL Title: Audacy Corporation Application for Authority to Launch and Operate a Non-Geostationary Medium Earth Orbit Satellite System in the Fixed-and Inter-Satellite Services (IBFS File No. SAT-LOA-20161115-00117). Summary: The Commission will consider an Order and Authorization that recommends granting Audacy's request to construct, deploy, and operate a proposed non-geostationary satellite (NGSO) constellation to provide continuous, high-speed, low-latency relay services to other NGSO spacecraft operators through Audacy's proposed satellites and gateway earth stations. 5 INTERNATIONAL Title: O3b Limited Request for Modification of U.S. Market Access for O3b Limited's Non-Geostationary Satellite Orbit System in the Fixed-Satellite Service and in the Mobile-Satellite Service (IBFS File Nos. SAT-MOD-20160624-00060, SAT-AMD-20161115-00116, SAT-AMD-20170301-00026, SAT-AMD-20171109-00154). Summary: The Commission will consider an Order and Declaratory Ruling that recommends granting a request to modify O3b's existing U.S. market access grant by adding new non-geostationary satellites and new frequency bands in order to provide broadband communication services in the United States. 6 WIRELINE COMPETITION Title: Updating the Intercarrier Compensation Regime to Eliminate Access Arbitrage (WC Docket No. 18-155). Summary: The Commission will consider a Notice of Proposed Rulemaking that proposes measures to eliminate access arbitrage in the intercarrier compensation regime. 7 WIRELINE COMPETITION Title: 8YY Access Charge Reform (WC Docket No. 18-156). Summary: The Commission will consider a Further Notice of Proposed Rulemaking that proposes taking further steps in reforming intercarrier compensation by transitioning interstate and intrastate originating 8YY end office and tandem switching and transport charges to bill-and-keep and capping and limiting 8YY database query rates. 8 WIRELINE COMPETITION Title: Text-Enabled Toll-Free Numbers (WC Docket No. 18-28); Toll Free Service Access Codes (CC Docket No. 95-155). Summary: The Commission will consider a Declaratory Ruling and Notice of Proposed Rulemaking that will clarify the Commission's rules regarding the authorization required to text-enable a toll-free number, and propose further safeguards to promote the innovative use of toll- free numbers while protecting the integrity of the toll-free numbering system. 9 CONSUMER & GOVERNMENTAL AFFAIRS Title: Protecting Consumers from Unauthorized Carrier Changes and Related Unauthorized Charges (CG Docket No. 17-169). Summary: The Commission will consider a Report and Order to protect consumers from slamming (the unauthorized change of a consumer's telephone provider) and cramming (the placement of unauthorized charges on a consumer's telephone bill), including rules to address sales call misrepresentations and abuses of the third-party verification procedures. 10 CONSUMER & GOVERNMENTAL AFFAIRS Title: Misuse of Internet Protocol (IP) Captioned Telephone Service (CG Docket No. 13-24); Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities (CG Docket No. 03-123). Summary: The Commission will consider a Report and Order, Declaratory Ruling, Further Notice of Proposed Rulemaking, and Notice of Inquiry to adopt measures, and seek comment on others, to ensure that Internet Protocol Captioned Telephone Service (IP CTS) remains sustainable for people with hearing loss who need it. 11 MEDIA Title: Leased Commercial Access (MB Docket No. 07-42); Modernization of Media Regulation Initiative (MB Docket No. 17-105). Summary: The Commission will consider a Further Notice of Proposed Rulemaking that tentatively concludes that the Commission should vacate its 2008 Leased Access Order, and invites comment on ways to modernize the existing leased access rules. 12 ENFORCEMENT Title: Enforcement Bureau Action. Summary: The Commission will consider an enforcement action.

    The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to: [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the internet from the FCC Live web page at www.fcc.gov/live.

    For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the internet. To purchase these services, call (703) 993-3100 or go to www.capitolconnection.gmu.edu.

    Federal Communications Commission. Marlene Dortch, Secretary.
    [FR Doc. 2018-12184 Filed 6-6-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-XXXX] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before August 6, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    OMB Control Number: 3060-XXXX.

    Title: Alternative Dispute Resolution Form Requests, FCC Form 5628.

    Form Number: FCC Form 5628.

    Type of Review: New information collection.

    Respondents: Individuals or Households.

    Number of Respondents and Responses: 5 respondents and 5 responses.

    Estimated Time per Response: 3 hours.

    Frequency of Response: One-time reporting requirement.

    Obligation to Respond: Voluntary. Statutory authority for these collections are contained in the Administrative Dispute Resolution Act, 5 U.S.C. 571 et seq.; Civil Justice Reform, Executive Order 12988; 29 CFR 1614.102(b)(2), 1614.105(f), 1614.108(b), and 1614.603.

    Total Annual Burden: 18 hours.

    Total Annual Cost: $3,750.

    Privacy Act Impact Assessment: The FCC is drafting a Privacy Impact Assessment to cover the personally identifiable information (PIA) that will be collected, used, and stored.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Needs and Uses: FCC employees who experience workplace conflict may explore dispute resolution alternatives by completing FCC Form 5628.

    Federal Communications Commission. Marlene Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-12182 Filed 6-6-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 2, 2018.

    A. Federal Reserve Bank of St. Louis (David L. Hubbard, Senior Manager) P.O. Box 442, St. Louis, Missouri 63166-2034. Comments can also be sent electronically to [email protected]:

    1. Stifel Financial Corp., St. Louis, Missouri; to acquire 100 percent of the voting shares of Business Bancshares, Inc., St. Louis, Missouri, and thereby indirectly acquire The Business Bank, Clayton, Missouri.

    Board of Governors of the Federal Reserve System, June 4, 2018. Ann Misback, Secretary of the Board.
    [FR Doc. 2018-12302 Filed 6-6-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-18-18AFX; Docket No. CDC-2018-0052] 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 Traumatic Brain Injury Disparities in Rural Areas (TBIDRA). This study will conduct a formative research to understand the challenges that rural healthcare providers face when diagnosing, treating, and managing traumatic brain injury (TBI) and develop a knowledge base to address gaps in services to improve clinical care and TBI outcomes in rural communities.

    DATES:

    CDC must receive written comments on or before August 6, 2018.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2018-0052 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 Jeffery 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

    Traumatic Brain Injury Disparities in Rural Areas (TBIDRA)—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Traumatic Brain Injury (TBI) is a significant public health concern in the United States, research indicates that residents of rural areas have both higher incidence and higher mortality rates from TBI than do residents of urban areas, and that the prevalence of TBI-related disability in rural geographical areas is higher than in urban and suburban areas. The obstacles healthcare providers and patients face in rural areas are vastly different than those in urban areas. There is little published research specifically related to the challenges rural providers face in TBI diagnosis and treatment, and even less examination into effective ways to address gaps in service and improve TBI outcomes. The National Center for Injury Prevention and Control at the CDC, in a 2015 “Report to Congress on TBI in the United States,” determined that certain population groups, including residents of rural geographic areas, require special consideration when it comes to researching TBI.

    This is a new Information Collection Request for 2 years to collect information on challenges that rural healthcare providers face in diagnosing, treating, and managing TBI of all severities and develop a knowledge base upon which we can begin to address gaps in services to improve clinical care and TBI outcomes in rural communities. The target population for the data collection effort includes physicians, nurse practitioners (NPs), and physician assistants (PAs) in selected specialties (general or family practice, emergency medicine, pediatrics) working in direct patient care in rural and urban areas. The focus of the study is rural healthcare providers; urban healthcare providers will be included in this study to allow for comparison in identifying the distinct challenges and opportunities for rural healthcare providers. This study has two data collection methods. A web survey to gather quantitative data on the unique challenges faced by rural clinicians, and focus groups to gain deeper insight into the context supporting and/or inhibiting access to comprehensive TBI evaluation and treatment, the study will collect qualitative data through focus groups with rural clinicians.

    The proposed information collection is authorized by the Public Health Services Act (PHS Act) which provides the legislative means for states to advance public health across the lifespan and to reduce health disparities.

    The total estimated annualized burden hours is 200. There are no costs to respondents other than their time.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden
  • (in hours)
  • Health care providers (Primary Care Physician, Emergency Physician, Nurse Practitioner and Physician Assistant) TBI Provider Survey 600 1 15/60 150 Focus group screener 36 1 5/60 3 Focus group questionnaire 31 1 5/60 3 Focus group discussion guide 31 1 85/60 44 Total 200
    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. 2018-12251 Filed 6-6-18; 8:45 am] BILLING CODE 4163-18-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: 049 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: 049” (Recognition List Number: 049), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

    DATES:

    These modifications to the list of recognized standards are applicable June 7, 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: 049.” 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: 049.

    • 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.

    An electronic copy of Recognition List Number: 049 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: 049 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: 049” 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. 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 (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 February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Recognition and Use of Consensus Standards.” The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. The guidance was updated in September 2007 and is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077274.htm.

    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: 049

    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: 049” 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 A. Anesthesiology 1-86 ISO 8185 Third edition 2008-06-15 (Corrected version), Respiratory tract humidifiers for medical use—Particular requirements for respiratory humidification systems Withdrawn. See 1-138. 1-95 ISO 5366-3 Second edition 2001-08-15 Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 3: Paediatric Tracheostomy Tubes [Including TECHNICAL CORRIGENDUM 1 (2003)] Withdrawn. See 1-117. 1-107 ANSI/AAMI/ISO 5356-1:2004 Anaesthetic and respiratory equipment—Conical connectors—Part 1: Cones and sockets Transferred. See 1-62. 1-109 ANSI/AAMI/ISO 5362:2006 Anaesthetic reservoir bags Transferred. See 1-75. 1-121 1-129 ISO 5359 Fourth edition 2014-10-01 Anaesthetic and respiratory equipment—Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)] Withdrawn and replaced with newer version including amendment. 1-128 1-130 ISO 18082 First edition 2014-06-15 Anaesthetic and respiratory equipment—Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)] Withdrawn and replaced with newer version including amendment. B. Biocompatibility 2-118 ANSI/AAMI/ISO 10993-11:2006/(R)2010 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity Transferred. See 2-176. 2-120 ANSI/AAMI/ISO 10993-6:2007/(R)2014 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation Withdrawn. 2-153 ANSI/AAMI/ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity Transferred. See 2-245. 2-156 ANSI/AAMI/ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process Transferred. See 2-220. 2-163 ANSI/AAMI/ISO 10993-9:2009/(R)2014 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products Transferred. See 2-168. 2-165 ANSI/AAMI/ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products form ceramics Transferred. See 2-170. 2-171 2-249 ISO 10993-16 Third edition 2017-05 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables Withdrawn and replaced with newer version. 2-172 ANSI/AAMI/TIR 10993-19:2006 Biological evaluation of medical devices—Part 19: Physicochemical, morphological, and topographical characterization of materials Transferred. See 2-167. 2-173 ANSI/AAMI/ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization Transferred. See 2-174. 2-180 ANSI/AAMI/ISO 10993-16:2010/(R)2014 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables from medical devices Withdrawn. 2-181 ANSI/AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects—Good clinical practice [Including: Technical Corrigendum 1 (2011)] Transferred. See 2-205. 2-190 ANSI/AAMI/ISO 10993-13:2010/(R)2014 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices Transferred. See 2-169. 2-198 ANSI/AAMI/ISO 10993-12:2012 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials Transferred. See 2-191. 2-207 2-250 ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials Withdrawn and replaced with newer version. 2-221 ANSI/AAMI/ISO 10993-2:2006 (R2014) Biological evaluation of medical devices—Part 2: Animal welfare requirements Transferred. See 2-222. 2-226 ANSI/AAMI/ISO 10993-3:2014 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity Transferred. See 2-228. 2-229 2-251 USP 40-NF35:2017 <87> Biological Reactivity Test, In Vitro—Direct Contact Test Withdrawn and replaced with newer version. 2-230 2-252 USP 40-NF35:2017 <87> Biological Reactivity Test, In Vitro—Elution Test Withdrawn and replaced with newer version. 2-231 2-253 USP 40-NF35:2017 <88> Biological Reactivity Tests, In Vivo Withdrawn and replaced with newer version. 2-232 2-254 USP 40-NF35:2017 <151> Pyrogen Test (USP Rabbit Test) Withdrawn and replaced with newer version. Extent of Recognition. 2-234 ANSI/AAMI/ISO 10993-4:2002/(R) 2013 & A1:2006/(R)2013 Biological evaluation of medical devices—Part 4: Selection of tests for interaction with blood [Including AMENDMENT 1 (2006)] Withdrawn. 2-236 ANSI/AAMI/ISO 10993-17:2002(R) 2012 Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substances Transferred. See 2-237. 2-239 ANSI/AAMI/ISO TIR 10993-20:2006 Biological Evaluation of Medical Devices—Part 20: Principles and methods for immunotoxicology testing of medical devices Transferred. See 2-240. 2-242 ANSI/AAMI/ISO TIR 37137:2014 Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants Transferred. See 2-241. C. Cardiovascular 3-80 ANSI/AAMI/ISO 81060-1:2007/(R)2013 Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement type Transferred. See 3-96. 3-83 ANSI/AAMI/ISO 14708-5:2010 Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devices Transferred. See 3-92. 3-101 ANSI/AAMI/IEC 60601-2-27:2011 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment Transferred. See 3-126. 3-106 ANSI/AAMI/IEC 60601-2-25:2011/(R)2016 Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs Transferred. See 3-105. 3-109 ANSI/AAMI/ISO 27186:2010 Active implantable medical devices—Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirements Transferred. See 3-89. 3-111 ANSI/AAMI/ISO 25539-3:2011 Cardiovascular implants—Endovascular devices—Part 3: Vena cava filters Transferred. See 3-103. 3-112 ANSI/AAMI/ISO 7199:2009 Cardiovascular implants and artificial organs—Blood gas exchangers (oxygenators) Transferred. See 3-124. 3-117 ANSI/AAMI/ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement type Transferred. See 3-122. 3-120 ANSI/AAMI/ISO 25539-2:2012 Cardiovascular implants—Endovascular devices—Part 2: Vascular stents Transferred. See 3-116. 3-124 3-150 ISO 7199 Third edition 2016-11-15 Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators) Withdrawn and replaced with newer version. 3-128 ANSI/AAMI/ISO 14117:2012 Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices Transferred. See 3-139. 3-130 3-151 ANSI/AAMI/IEC 80601-2-30:2009 & A1:2013/(R2016) Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers Reaffirmation. Extent of Recognition. Transferred. See 3-123. 3-131 ANSI/AAMI/ISO 27185:2012 Cardiac rhythm management devices—Symbols to be used with cardiac rhythm management device labels, and information to be supplied—General requirements Transferred. See 3-132. 3-140 ANSI/AAMI/ISO 5840-3:2013 Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques Transferred. See 3-133. 3-141 ANSI/AAMI/ISO 5841-3:2013 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors (IS-1) for implantable pacemakers Transferred. See 3-125. 3-146 ANSI/AAMI/ISO 5840-1:2015 Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements Transferred. See 3-145. 3-148 ANSI/AAMI/ISO 5840-2:2015 Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes Transferred. See 3-147. D. Dental/Ear, Nose, and Throat (ENT) 4-50 ADA Specification No. 18: 1992 Alginate Impression Materials Withdrawn. See 4-240. 4-89 ANSI/ADA Specification No. 53 Reaffirmed by ANSI: August 2013 Polymer-Based Crown and Bridge Materials Reaffirmation. 4-91 ANSI/ADA Standard No. 80/ISO 7491:2000 Reaffirmed by ANSI: May 2013 Dental Materials—Determination of Color Stability Transferred. See 4-241. 4-119 ANSI/ADA Specification No. 82:1998/ISO 13716:1999 Reaffirmed by ANSI: January 2009 Dental Reversible/Irreversible Hydrocolloid Impression Material Systems Withdrawn. See 4-240. 4-193 ANSI/ADA Standard No. 15-2008/ISO 22112:2005 Reaffirmed by ANSI: May 2013 Artificial Teeth for Dental Prostheses Transferred. See 4-151. 4-230 ANSI/ADA Standard No. 30/ISO 3107:2011 Approved by ANSI: February 2013 Dental Zinc Oxide/Eugenol & Zinc Oxide/Non-Eugenol Cements Transferred. See 4-198. 4-235 ANSI/ADA Standard No. 100/ISO 27020:2010 Approved by ANSI: November 2012 Orthodontic Brackets and Tubes Transferred. See 4-218. 4-237 ANSI/ADA Standard No.120-2009/ISO 20127:2005 Reaffirmed by ANSI: September 8, 2014 Powered Toothbrushes Transferred. See 4-238. E. General I (Quality Systems/Risk Management) (QS/RM) 5-65 ANSI/AAMI/ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications—Part 1: General requirements Transferred. See 5-63. 5-70 ANSI/AAMI/ISO 14971:2007/(R)2010 (Corrected 4 October 2007) Medical devices—Application of risk management to medical devices Transferred. See 5-40. 5-92 ANSI/AAMI/IEC 60601-1-8:2006 and A1:2012 Medical Electrical Equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Transferred. See 5-76. 5-96 ANSI/AAMI/IEC 62366-1:2015 Medical devices—Part 1: Application of usability engineering to medical devices Transferred. See 5-114. 5-100 ANSI/AAMI/ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications—Part 20: Common test methods Transferred. See 5-97. 5-118 ANSI/AAMI/ISO 15223-1:2016 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements Transferred. See 5-117. 5-119 ANSI/AAMI/ISO 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications Transferred. See 5-107. F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) 19-2 ANSI/AAMI/IEC 60601-1-2:2007 (R2012) Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests Transferred. See 19-1. 19-12 ANSI/AAMI/IEC 60601-1-2:2014 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and tests Transferred. See 19-8. G. General Hospital/General Plastic Surgery (GH/GPS) 6-149 6-401 ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves Withdrawn and replaced with newer version. 6-178 ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves Reaffirmation. 6-214 ASTM D6355-07 (Reapproved 2017) Standard Test Method for Human Repeat Insult Patch Testing of Medical Glove Reaffirmation. 6-217 6-402 ASTM F1670/F1670M-17 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Withdrawn and replaced with newer version. 6-227 ANSI/AAMI/IEC 60601-2-21:2009 Medical electrical equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers Transferred. See 6-388. 6-229 ANSI/AAMI/IEC 60601-2-2:2009 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment Transferred. See 6-389. 6-232 6-403 ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Withdrawn and replaced with newer version. 6-230 ANSI/AAMI/IEC 60601-2-19:2009 Medical electrical equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators Transferred. See 6-385. 6-235 ANSI/AAMI/IEC 60601-2-50:2009 Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment Transferred. See 6-387. 6-270 ASTM F1840-10 (Reapproved 2016) Standard Terminology for Surgical Suture Needles Reaffirmation. 6-304 6-404 ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use—Part 1: Syringes for manual use Withdrawn and replaced with newer version. 6-307 6-405 IEC 80601-2-59 Edition 2.0 2017-09 Medical electrical equipment—Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening Withdrawn and replaced with newer version. 6-323 6-406 ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) Withdrawn and replaced with newer version. 6-337 ANSI/AAMI/IEC 60601-2-20:2009 Medical electrical equipment—Part 2-20: Particular requirements for the basic safety and essential performance of transport incubators [Including AMENDMENT 1 (2016)] Transferred. See 6-386. H. In Vitro Diagnostics (IVD) 7-271 CLSI M100 27th Edition Performance Standards for Antimicrobial Susceptibility Testing Extent of recognition. I. Materials 8-113 ASTM F1147-05 (Reapproved 2017) ε1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings Reaffirmation. 8-337 ASTM F621-12 (Reapproved 2017) Standard Specification for Stainless Steel Forgings for Surgical Implants Reaffirmation. 8-356 ASTM F67-13 (Reapproved 2017) Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) Reaffirmation. 8-446 8-460 ASTM F2848-17 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns Withdrawn and replaced with newer version. Extent of recognition. J. Nanotechnology No new entries at this time K. Neurology 17-1 ANSI/AAMI NS28:1988/(R)2015 Intracranial pressure monitoring devices Reaffirmation. Extent of recognition. 17-8 17-15 ISO 14708-3 Second edition 2017-04 Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators Withdrawn and replaced with newer version. 17-10 ANSI/AAMI/ISO 14708-3:2008/(R)2011 Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators Withdrawn. 17-11 17-16 IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment—Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators Withdrawn and replaced with newer version. L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) 9-64 ANSI/AAMI/IEC 60601-2-2:2009 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories Withdrawn. Duplicate recognition. See 6-229. 9-66 ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters Transferred. See 9-89. 9-81 ANSI/AAMI/IEC 60601-2-16:2012 Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment Transferred. See 9-80 9-91 ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems—Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators [Including AMENDMENT 1 (2013)] Transferred. See 9-92. 9-91 9-114 IEC 60601-2-18: Edition 3.0 2009-08, medical electrical equipment—part 2-18: particular requirements for the basic safety and essential performance of endoscopic equipment Withdrawn and replaced with new recognition number. 9-93 9-115 ISO 25841 Third edition 2017-08 Female condoms—Requirements and test methods Withdrawn and replaced with newer version. 9-103 ANSI/AAMI/ISO 26722:2014 Water treatment equipment for haemodialysis applications and related therapies Transferred. See 9-101. 9-104 ANSI/AAMI/ISO 13958:2014 Concentrates for hemodialysis and related therapies Transferred. See 9-97. 9-105 ANSI/AAMI/ISO 13959:2014 Water for hemodialysis and related therapies Transferred. See 9-98. 9-106 ANSI/AAMI/ISO 11663:2014 Quality of dialysis fluid for hemodialysis and related therapies Transferred. See 9-100. 9-107 ANSI/AAMI/ISO 23500:2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies Transferred. See 9-99. M. Ophthalmic 10-43 10-105 ISO 11979-8 Third edition 2017-04 Ophthalmic Implants—Intraocular lenses—Part 8: Fundamental requirements Withdrawn and replaced with newer version. 10-46 10-106 ISO 18369-3 Second edition 2017-08 Ophthalmic optics—Contact lenses—Part 3: Measurement methods Withdrawn and replaced with newer version. 10-54 10-107 ISO 18369-4 Second edition 2017-08 Ophthalmic optics—Contact lenses—Part 4: Physicochemical properties of contact lens materials Withdrawn and replaced with newer version. 10-80 10-108 ISO 18369-2 Third edition 2017-08 Ophthalmic optics—Contact lenses—Part 2: Tolerances Withdrawn and replaced with newer version. 10-83 10-109 ISO 18369-1 Second edition 2017-08 Ophthalmic optics—Contact lenses—Part 1: Vocabulary, classification system and recommendations for labelling specifications Withdrawn and replaced with newer version. N. Orthopedic 11-259 ASTM F2887—12 Standard Specification for Total Elbow Prostheses Withdrawn. See 11-321. O. Physical Medicine 16-200 16-201 ISO 7176-19 Second edition 2008-07-15 AMENDMENT 1 2015-11-15. Wheelchairs—Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)] Withdrawn and replaced with a newer version including amendment. P. Radiology 12-139 NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3 Withdrawn. Duplicate recognition. See 12-105. 12-202 12-308 IEC 60601-2-43 Edition 2.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment—Part 2-43: Particular requirements for the safety and essential performance of X-Ray Equipment for interventional procedures Withdrawn and replaced with newer version. 12-204 12-309 IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis Withdrawn and replaced with newer version. 12-251 12-310 IEC 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION Medical electrical equipment—Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-Ray equipment Withdrawn and replaced with newer version. 12-252 12-311 IEC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment—Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-Ray equipment Withdrawn and replaced with newer version. 12-227 12-312 IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION Ultrasonics—Pulse-echo scanners—Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response Withdrawn and replaced with newer version. 12-276 12-313 IEC TS 62462 Edition 2.0 2017-07 Ultrasonics—Output test—Guidance for the maintenance of ultrasound physiotherapy systems Withdrawn and replaced with newer version. 12-155 12-314 ISO 11554 Fourth edition 2017-07 Optics and photonics—Lasers and laser-related equipment—Test methods for laser beam power, energy and temporal characteristics Withdrawn and replaced with newer version. 12-192 12-315 NEMA Standards Publication MS 8-2016 Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems Withdrawn and replaced with newer version. 12-258 12-316 IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields Withdrawn and replaced with newer version. Q. Software/Informatics 13-39 ANSI/AAMI/IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices—Part 1: Roles, responsibilities and activities Transferred. See 13-38. 13-41 ANSI/AAMI/IEC TIR80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices—Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples Transferred. See 13-40. 13-43 ANSI/AAMI/IEC TIR80001-2-2:2012 Technical Information Report Application of risk management for IT-networks incorporating medical devices—Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls Transferred. See 13-42. 13-45 ANSI/AAMI/IEC TIR80001-2-3:2012 Technical Information Report Application of risk management for IT-networks incorporating medical devices—Part 2-3: Guidance for wireless networks Transferred. See 13-44. 13-64 ANSI/AAMI/IEC TIR80001-2-4:2012 Technical Information Report Application of risk management for IT-networks incorporating medical devices—Part 2-4: General implementation guidance for healthcare delivery organizations Transferred. See 13-63. R. Sterility 14-221 ANSI/AAMI/ISO TIR 11139:2006 Sterilization of health care products—Vocabulary Transferred. See 14-325. 14-222 ANSI/AAMI/ISO 18472:2006/(R)2010 Sterilization of health care products—Biological and chemical indicators—Test equipment Transferred. See 14-354. 14-227 ANSI/AAMI/ISO 11737-1:2006 (R)2011 Sterilization of health care products—Microbiological methods—Part 1: Determination of the population of microorganisms on product Transferred. See 14-407. 14-238 ANSI/AAMI/ISO 11140-5:2007/(R)2012 Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs Transferred. See 14-332. 14-261 ANSI/AAMI/ISO 17665-1:2006/(R)2013 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices Transferred. See 14-333. 14-274 ANSI/AAMI/ISO 15882:2008/(R)2013 Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results Transferred. See 14-334. 14-278 ANSI/AAMI/ISO 10993-7:2008(R)2012 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals Transferred. See 14-408. 14-285 ANSI/AAMI/ISO 14161:2009/(R)2014 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results Transferred. See 14-336. 14-287 ANSI/AAMI/ISO 11737-2:2009/(R)2014 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process Transferred. See 14-327. 14-291 ANSI/AAMI/ISO 14937:2009/(R)2013 Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices Transferred. See 14-337. 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 Reaffirmation. 14-298 ANSI/AAMI/ISO 11137-3:2006/(R)2010 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects Withdrawn. See 14-510. 14-330 14-510 ISO 11137-3 Second edition 2017-06 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control Withdrawn and replaced with newer version. 14-339 ANSI/AAMI/ISO 20857:2010/(R)2015 Sterilization of health care products—Dry heat—Requirements for the development, validation and routine control of a sterilization process for medical devices Transferred. See 14-340. 14-348 ANSI/AAMI/ISO 13408-2:2003/(R)2013 Aseptic processing of health care products—Part 2: Filtration Transferred. See 14-138. 14-349 ANSI/AAMI/ISO 13408-3:2006/(R)2015 Aseptic processing of health care products—Part 3: Lyophilization Transferred. See 14-239. 14-350 ANSI/AAMI/ISO 13408-4:2005/(R)2014 Aseptic processing of health care products—Part 4: Clean-in-place technologies Transferred. See 14-191. 14-351 ANSI/AAMI/ISO 13408-5:2006/(R)2015 Aseptic processing of health care products—Part 5: Sterilization in place Transferred. See 14-240. 14-358 ANSI/AAMI/ISO 14160:2011/(R)2016 Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devices Transferred. See 14-361. 14-376 ANSI/AAMI/ISO TIR 17665-2:2009 Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1 Transferred. See 14-277. 14-387 ANSI/AAMI/ISO 13408-7:2012 Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination products Transferred. See 14-388. 14-425 ANSI/AAMI/ISO 13408-6:2005/(R) 2013 & A1:2013 Aseptic processing of health care products—Part 6: Isolator systems [Including AMENDMENT1 (2013)] Transferred. See 14-424. 14-426 ANSI/AAMI/ISO 13408-1:2008 (R2011) Aseptic processing of health care products—Part 1: General requirements [Including AMENDMENT1 (2013)] Transferred. See 14-427. 14-438 ANSI/AAMI/ISO 11137-2:2013 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose Transferred. See 14-409. 14-439 14-511 ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities Withdrawn and replaced with newer version. 14-457 ANSI/AAMI/ISO 11607-1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging [Including AMENDMENT 1 (2013)] Transferred. See 14-454. 14-458 ANSI/AAMI/ISO 11607-2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes [Including AMENDMENT 1 (2013)] Transferred. See 14-455. 14-459 ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products—Chemical indicators—Part 1: General requirements Transferred. See 14-460. 14-461 ANSI/AAMI/ISO 11137-1:2006/(R)2010 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including AMENDMENT 1 (2013)] Transferred. See 14-428. 14-479 ANSI/AAMI/ISO 11135:2014 Sterilization of health care products—Ethylene oxide—Requirements for development, validation and routine control of a sterilization process for medical devices Transferred. See 14-452. S. Tissue Engineering 15-17 ASTM F2311-08 Standard Guide for Classification of Therapeutic Skin Substitutes Withdrawn. 15-23 ASTM F2739-08 Standard Guide for Quantitating Cell Viability within Biomaterial Scaffolds Withdrawn. See 15-50. 15-37 15-51 ASTM F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications Withdrawn and replaced with newer version. 15-42 15-52 ASTM F2064-17 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications Withdrawn and replaced with newer version. 1 All standard titles in this table conform to the style requirements of the respective organizations. 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: 049.

    Table 2—New Entries to the List of Recognized Standards Recognition No. Title of standard 1 Reference No. and Date A. Anesthesiology 1-131 Medical suction equipment—Part 1: Electrically powered suction equipment ISO 10079-1 Third Edition 2015-11-01. 1-132 Medical suction equipment—Part 2: Manually powered suction equipment ISO 10079-2 Third Edition 2014-05-01. 1-133 Medical suction equipment—Part 3: Suction equipment powered from a vacuum or positive pressure gas source ISO 10079-3 Third Edition 2014-05-01. 1-134 Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 1: Evaluation and testing within a risk management process ISO 18562-1 First edition 2017-03. 1-135 Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 2: Tests for emissions of particulate matter ISO 18562-2 First edition 2017-03. 1-136 Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 3: Tests for emissions of volatile organic compounds ISO 18562-3 First edition 2017-03. 1-137 Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 4: Tests for leachables in condensate ISO 18562-4 First edition 2017-03. 1-138 Medical electrical equipment—Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment ISO 80601-2-74 First edition 2017-05. B. Biocompatibility No new entries at this time C. Cardiovascular No new entries at this time D. Dental/Ear, Nose, and Throat (ENT) 4-240 Dentistry—Hydrocolloid impression materials ISO 21563 First edition 2013-08-15. 4-241 Dental materials—Determination of colour stability ISO 7491 Second edition 2000-09-01. E. General I (Quality Systems/Risk Management) (QS/RM) No new entries at this time F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) No new entries at this time G. General Hospital/General Plastic Surgery (GH/GPS) 6-407 Standard Specification for Adult Portable Bed Rails and Related Products ASTM F3186-17. H. In Vitro Diagnostics (IVD) 7-274 Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline CLSI MM17-A Vol. 28 No. 9 (Replaces MM17-P Vol. 27 No. 21). I. Materials 8-461 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices ASTM F3208-17. 8-462 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles ASTM F3260-17. 8-463 Standard Guide for Additive Manufacturing—General Principles—Requirements for Purchased AM Parts ISO/ASTM 52901 First edition 2017-08. 8-464 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device ISO 10974 Second edition 2018. J. Nanotechnology 18-9 Nanotechnologies—Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)] ISO/TR 13014 First edition 2012-05-15. 18-10 Nanotechnologies—Endotoxin test on nanomaterial samples for in vitro systems—Limulus amebocyte lysate (LAL) test ISO 29701 First edition 2010-09-15. K. Neurology No new entries at this time L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) 9-115 Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies based on self-reports ISO 29943-1 First edition 2017-07. 9-116 Condoms—Guidance on clinical studies—Part 2: Female condoms, clinical function studies based on self-reports ISO 29943-2 First edition 2017-07. M. Ophthalmic 10-110 Ophthalmic implants—Ophthalmic viscosurgical devices [Including AMENDMENT 1 (2017)] ISO 15798 Third edition 2013-09-15 AMENDMENT 1 2017-05. N. Orthopedic No new entries at this time O. Physical Medicine 16-202 RESNA Standard for Wheelchairs Volume 4: Wheelchairs and Transportation RESNA WC-4:2017. P. Radiology No new entries at this time Q. Software/Informatics 13-104 Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems ANSI/UL 2900-2-1, First Edition September 1, 2017. R. Sterility No new entries at this time S. Tissue Engineering 15-53 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies ASTM F3206 -17. 15-54 Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model ASTM F3207-17. 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. FDA will be incorporating the modifications and revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will be announcing 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. Beginning with recognition list 049, FDA will no longer include in the database the CDRH Office and Division associated with recognized standards, Devices Affected, and Processes Affected. Beginning with recognition list 049 FDA will automatically incorporate, upon publication, a U.S. parallel adoption of an existing recognized international standard.

    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: May 31, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-12222 Filed 6-6-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1635] Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief.” This draft guidance describes circumstances under which an applicant may be eligible for a barrier-to-innovation waiver for some new drug applications (NDAs) for fixed-combination versions and single-entity versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV).

    DATES:

    Submit either electronic or written comments on the guidance August 6, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

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

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2018-D-1635 for “Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Ted Palat, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 2185, Silver Spring, MD 20993, 240-402-8739, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief.” The draft guidance describes the circumstances under which certain applications for fixed-combination and single-entity versions of previously approved antiretroviral therapies for the treatment of HIV under the President's Emergency Plan for AIDS Relief (PEPFAR) may be eligible for a barrier-to-innovation waiver.

    In October 2006, to encourage applicants to submit applications for HIV combination therapies that can be used in PEPFAR, FDA issued a final guidance entitled “Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV” (fixed-combination guidance). Attachments to the fixed-combination guidance describe some scenarios for approval of fixed-combination for the treatment of HIV and provide examples of drug combinations considered acceptable as fixed combinations and examples of those not considered acceptable as fixed combinations. Although the 2006 fixed-combination guidance focuses on fixed combinations, the scientific principles outlined in the guidance also apply to single ingredient versions of antiretroviral drugs that are components of regimens listed in Attachment B. The guidance also explains that the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides for certain circumstances in which FDA may grant a waiver or reduction in user fees.

    This draft guidance is a revision of the guidance for industry entitled “User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR,” issued February 2007. In this guidance, FDA provides information about the circumstances under which certain applications for fixed-combination and single-entity versions of previously approved antiretroviral therapies for the treatment of HIV under PEPFAR may be eligible for a barrier-to-innovation waiver.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The burden of information collection associated with requesting waivers of user fees (including PEPFAR waivers) was previously approved under OMB control number 0910-0693. The burden for completing and submitting Form FDA 3397 (Prescription Drug User Fee Coversheet) is not included in this analysis as the burden is already approved under OMB control number 0910-0297. The collections of information associated with submission of a new drug application or biologics license application are approved under OMB control numbers 0910-0001 and 0910-0338, respectively.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: June 1, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-12217 Filed 6-6-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0781] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

    DATES:

    Fax written comments on the collection of information by July 9, 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 0910-0428. 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.

    Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim—21 CFR 101.82 OMB Control Number 0910-0428—Extension

    Section 403(r)(3)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(3)(A)) provides for the use of food label statements characterizing a relationship of any nutrient of the type required to be in the label or labeling of the food to a disease or a health-related condition only where that statement meets the requirements of the regulations issued by the Secretary of Health and Human Services to authorize the use of such a health claim. Section 101.82 (21 CFR 101.82) of our regulations authorizes a health claim for food labels about soy protein and the risk of coronary heart disease. Accordingly, FDA established the previously referenced information collection in support of the regulation. In the Federal Register of October 31, 2017 (82 FR 50324), we published a proposed rule to revoke the underlying regulation found at § 101.82. We are taking this action based on our review of the totality of publicly available scientific evidence currently available and our tentative conclusion that such evidence does not support our previous determination that there is significant scientific agreement among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease. Upon finalization of the proposed rule, the associated information collection requirements under this OMB control number will be revoked. Until such time and in accordance with the PRA, we retain our currently approved burden estimate for the information collection displayed in table 1 of this notice.

    In the Federal Register of March 8, 2018 (83 FR 9856), 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 Recordkeeping Burden 1 21 CFR section Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total
  • annual
  • records
  • Average
  • burden per
  • recordkeeping
  • Total
  • hours
  • 101.82(c)(2)(ii)(B) 25 1 25 1 25 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on our current experience with the use of health claims, we estimate 25 firms market products bearing a soy protein/coronary heart disease health claim and that perhaps one of each firm's products might contain non-soy sources of protein along with soy protein. The records currently required to be retained under § 101.82(c)(2)(ii)(B) are the records, e.g., the formulation or recipe, that a manufacturer has and maintains as a normal course of its doing business. Thus, the burden to the food manufacturer is limited to assembling and retaining the records, which we estimate will take 1 hour annually.

    Dated: May 30, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-12216 Filed 6-6-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0961] Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations 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 reporting requirements contained in the FDA collection of information “Environmental Impact Considerations.”

    DATES:

    Submit either electronic or written comments on the collection of information by August 6, 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 August 6, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 6, 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-2012-N-0961 for “Environmental Impact Considerations.” 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.

    Environmental Impact Considerations—21 CFR Part 25 OMB Control Number 0910-0322—Extension I. Background

    FDA is requesting OMB approval for the reporting requirements contained in the FDA collection of information “Environmental Impact Considerations.” The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347) states national environmental objectives and imposes upon each Federal Agency the duty to consider the environmental effects of its actions. Section 102(2)(C) of NEPA requires the preparation of an environmental impact statement (EIS) for every major Federal action that will significantly affect the quality of the human environment.

    FDA's NEPA regulations are in part 25 (21 CFR part 25). All applications or petitions requesting Agency action require the submission of a claim for categorical exclusion or an environmental assessment (EA). A categorical exclusion applies to certain classes of FDA-regulated actions that usually have little or no potential to cause significant environmental effects and are excluded from the requirements to prepare an EA or EIS. Section 25.15(a) and (d) specifies the procedures for submitting to FDA a claim for a categorical exclusion. Extraordinary circumstances (§ 25.21), which may result in significant environmental impacts, may exist for some actions that are usually categorically excluded. An EA provides information that is used to determine whether an FDA action could result in a significant environmental impact. Section 25.40(a) and (c) specifies the content requirements for EAs for non-excluded actions.

    This collection of information is used by FDA to assess the environmental impact of Agency actions and to ensure that the public is informed of environmental analyses. Firms wishing to manufacture and market substances regulated under statutes for which FDA is responsible must, in most instances, submit applications requesting approval. Environmental information must be included in such applications for the purpose of determining whether the proposed action may have a significant impact on the environment. Where significant adverse events cannot be avoided, the Agency uses the submitted information as the basis for preparing and circulating to the public an EIS, made available through a Federal Register document also filed for comment at the Environmental Protection Agency. The final EIS, including the comments received, is reviewed by the Agency to weigh environmental costs and benefits in determining whether to pursue the proposed action or some alternative that would reduce expected environmental impact.

    Any final EIS would contain additional information gathered by the Agency after the publication of the draft EIS, a copy or a summary of the comments received on the draft EIS, and the Agency's responses to the comments, including any revisions resulting from the comments or other information. When the Agency finds that no significant environmental effects are expected, the Agency prepares a finding of no significant impact.

    FDA estimates the burden of this collection of information as follows:

    II. Estimated Annual Reporting Burden for Human Drugs (Including Biologics in the Center for Drug Evaluation and Research)

    Under §§ 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and 314.94(a)(9)(i) (21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and 314.94(a)(9)(i)), each investigational new drug application (IND), new drug application (NDA), and abbreviated new drug application (ANDA) must contain a claim for categorical exclusion under § 25.30 or § 25.31, or an EA under § 25.40. Annually, FDA receives approximately 3,687 INDs from 2,456 sponsors; 140 NDAs from 116 applicants; 3,192 supplements to NDAs from 443 applicants; 28 biologic license applications (BLAs) from 22 applicants; 464 supplements to BLAs from 52 applicants; 1,152 ANDAs from 248 applicants; and 6,774 supplements to ANDAs from 384 applicants. FDA estimates that it receives approximately 15,437 claims for categorical exclusions as required under § 25.15(a) and (d) and 10 EAs as required under § 25.40(a) and (c). Based on information provided by the pharmaceutical industry, FDA estimates that it takes sponsors or applicants approximately 8 hours to prepare a claim for a categorical exclusion and approximately 3,400 hours to prepare an EA.

    Table 1—Estimated Annual Reporting Burden for Human Drugs 1 21 CFR section Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Avera