Federal Register Vol. 83, No.233,

Federal Register Volume 83, Issue 233 (December 4, 2018)

Page Range62449-62688
FR Document

83_FR_233
Current View
Page and SubjectPDF
83 FR 62687 - Providing for the Closing of Executive Departments and Agencies of the Federal Government on December 5, 2018PDF
83 FR 62685 - World AIDS Day, 2018PDF
83 FR 62683 - National Impaired Driving Prevention Month, 2018PDF
83 FR 62679 - Delegation of Authority Contained in Condition 23 of the Resolution of Advice and Consent to Ratification of the Chemical Weapons ConventionPDF
83 FR 62609 - Sunshine Act MeetingsPDF
83 FR 62656 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “Lucio Fontana: On the Threshold” ExhibitionPDF
83 FR 62641 - Sunshine Act MeetingsPDF
83 FR 62656 - Sunshine Act MeetingPDF
83 FR 62463 - Significant New Use Rules on Certain Chemical Substances; WithdrawalPDF
83 FR 62573 - Interim Registration Review Decisions and Case Closures for Several Pesticides; Notice of AvailabilityPDF
83 FR 62475 - Calcium Formate; Exemption From the Requirement of a TolerancePDF
83 FR 62479 - Bixafen; Pesticide TolerancesPDF
83 FR 62486 - 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer; Tolerance ExemptionPDF
83 FR 62571 - Registration Review Proposed Interim Decisions for Several Pesticides; Notice of AvailabilityPDF
83 FR 62489 - Oxytetracycline; Pesticide TolerancesPDF
83 FR 62574 - Relocation Allowances: Taxes on Travel, Transportation, and Relocation ExpensesPDF
83 FR 62562 - Intent To Prepare a Draft Supplemental Environmental Impact Statement (DSEIS) for the Haile Gold Mine in Lancaster County, South CarolinaPDF
83 FR 62601 - HEARTH Act Approval of Prairie Band Potawatomi Nation RegulationsPDF
83 FR 62598 - 30-Day Notice of Proposed Information Collection: HUD Acquisition RegulationPDF
83 FR 62599 - 60-Day Notice of Proposed Information Collection: Comment Request: Agency Information Collection Activities: Race and Ethnic Data CollectionPDF
83 FR 62656 - Notice of Public MeetingPDF
83 FR 62454 - Form N-1A; CorrectionPDF
83 FR 62577 - Medicare Program; Extension of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance TransportsPDF
83 FR 62582 - Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment; Draft Guidance for Industry; AvailabilityPDF
83 FR 62496 - Patient Protection and Affordable Care Act; Elimination of Internal Agency Process for Implementation of the Federally-Facilitated User Fee AdjustmentPDF
83 FR 62569 - Combined Notice of FilingsPDF
83 FR 62570 - Combined Notice of Filings #1PDF
83 FR 62657 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Training and Qualification Requirements for Check Airmen and Flight InstructorsPDF
83 FR 62574 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
83 FR 62632 - Proposed Collection; Comment RequestPDF
83 FR 62642 - Proposed Collection; Comment RequestPDF
83 FR 62512 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna FisheriesPDF
83 FR 62603 - Polytetrafluoroethylene (PTFE) Resin From China and India; DeterminationPDF
83 FR 62569 - Extension of the Public Comment Period for the U.S. Department of Energy Interpretation of High-Level Radioactive WastePDF
83 FR 62561 - Light-Walled Rectangular Pipe and Tube From Turkey: Rescission of Antidumping Duty Administrative Review; 2017-2018PDF
83 FR 62508 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery off the Southern Atlantic Region; Regulatory Amendment 28PDF
83 FR 62560 - Refillable Stainless Steel Kegs From the People's Republic of China: Postponement of Preliminary Determination in the Countervailing Duty InvestigationPDF
83 FR 62577 - Final National Occupational Research Agenda for Oil and Gas ExtractionPDF
83 FR 62563 - 2018-2019 Award Year Deadline Dates for Reports and Other Records Associated With the Free Application for Federal Student Aid (FAFSA), the Federal Supplemental Educational Opportunity Grant Program (FSEOG), the Federal Work-Study (FWS) Programs, the Federal Pell Grant (Pell Grant) Program, the William D. Ford Federal Direct Loan (Direct Loan) Program, the Teacher Education Assistance for College and Higher Education (TEACH) Grant Program, and the Iraq and Afghanistan Service Grant ProgramPDF
83 FR 62568 - Privacy Act of 1974; Matching ProgramPDF
83 FR 62449 - Pears Grown in Oregon and Washington; Decreased Assessment Rate for Processed PearsPDF
83 FR 62631 - Privacy Act of 1974; System of RecordsPDF
83 FR 62501 - Defense Federal Acquisition Regulation Supplement: Documentation for Interagency Contracts (DFARS Case 2018-D073)PDF
83 FR 62554 - Defense Federal Acquisition Regulation Supplement: Small Business Set-Asides for Architect-Engineer and Construction Design Contracts (DFARS Case 2018-D057)PDF
83 FR 62502 - Defense Federal Acquisition Regulation Supplement: Modification of DFARS Clause “Surge Option” (DFARS Case 2018-D025)PDF
83 FR 62550 - Defense Federal Acquisition Regulation Supplement: Restrictions on Use of Lowest Priced Technically Acceptable Source Selection Process (DFARS Case 2018-D010)PDF
83 FR 62498 - Defense Federal Acquisition Regulation Supplement: Sunset of Provision Relating to the Procurement of Certain Goods (DFARS Case 2018-D007)PDF
83 FR 62575 - Supplemental Evidence and Data Request on Interventions for Substance Use Disorders in Adolescents: A Systematic ReviewPDF
83 FR 62583 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Medical Device Registration and ListingPDF
83 FR 62514 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher Vessels Less Than 50 Feet Length Overall Using Hook-and-Line Gear in the Central Regulatory Area of the Gulf of AlaskaPDF
83 FR 62560 - Submission for OMB Review; Comment RequestPDF
83 FR 62595 - Solicitation for Written Comments on Proposed Objectives for Healthy People 2030; CorrectionPDF
83 FR 62601 - Indian Gaming; Approval of Tribal-State Class III Gaming Compact Amendment in the State of OklahomaPDF
83 FR 62532 - Air Plan Approval; Texas; Emission StatementsPDF
83 FR 62585 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Drug Supply Chain Security Act Implementation: Identification of Suspect Product and NotificationPDF
83 FR 62468 - Air Plan Approval; Texas; Emission StatementsPDF
83 FR 62657 - Petition for Waiver of CompliancePDF
83 FR 62658 - Petition for Waiver of CompliancePDF
83 FR 62658 - Petition for Special Approval of Alternate StandardPDF
83 FR 62580 - Determination of Regulatory Review Period for Purposes of Patent Extension; ASPIRE ASSISTPDF
83 FR 62590 - Determination of Regulatory Review Period for Purposes of Patent Extension; TRULANCEPDF
83 FR 62591 - Determination of Regulatory Review Period for Purposes of Patent Extension; OCALIVAPDF
83 FR 62466 - Air Plan Approval; Connecticut; Volatile Organic Compound Emissions From Consumer Products and Architectural and Industrial Maintenance Coatings; CorrectionPDF
83 FR 62589 - Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under Generic Drug User Fee Amendments; Guidance for Industry; AvailabilityPDF
83 FR 62464 - Air Plan Approval; New Hampshire; Infrastructure State Implementation Plan Requirements for the 2012 PM2.5PDF
83 FR 62532 - Air Plan Approval; Massachusetts; Air Emissions Inventory, Emissions Statements, Source Registration, and Emergency Episode Planning ProvisionsPDF
83 FR 62593 - Determination of Regulatory Review Period for Purposes of Patent Extension; EXABLATE NEURO MODEL 4000 TYPE 1.0 SYSTEMPDF
83 FR 62595 - National Institute of General Medical Sciences; Notice of Closed MeetingPDF
83 FR 62597 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0001PDF
83 FR 62595 - Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal AgenciesPDF
83 FR 62629 - Proposed Submission of Information Collection for OMB Review; Comment Request; Request for Coverage DeterminationPDF
83 FR 62627 - Privacy Act of 1974; System of RecordsPDF
83 FR 62603 - Certain Thermoplastic-Encapsulated Electric Motors, Components Thereof, and Products and Vehicles Containing Same II; Notice of Request for Statements on the Public InterestPDF
83 FR 62651 - Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 4756(c)(2)PDF
83 FR 62644 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Change To Amend Certain of Its Listing FeesPDF
83 FR 62653 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 3306(c)(2)PDF
83 FR 62633 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 4756(c)(2)PDF
83 FR 62646 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing of Amendment No. 2 To Proposed Rule Change To Introduce Cboe Market Close, a Closing Match Process for Non-BZX Listed Securities Under New Exchange Rule 11.28PDF
83 FR 62642 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change, Relating to Amendments to Futures and Options Risk Procedures (the “F&O Risk Procedures”) 1PDF
83 FR 62648 - Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange's Transaction Fees at Equity 7, Section 118PDF
83 FR 62638 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change Relating to Amendments to the ICE Clear Europe CDS Risk Policy (the “CDS Risk Policy”), CDS Clearing Back-Testing Policy (the “Back-Testing Policy”) and CDS Stress-Testing Policy (the “Stress-Testing Policy”) (Collectively, the “CDS Policies”)PDF
83 FR 62636 - Apollo Management, L.P.PDF
83 FR 62630 - Submission for Review: Health Benefits Election Form, SF 2809PDF
83 FR 62630 - Submission for Review: Rollover Election (RI 38-117), Rollover Information (RI 38-118), and Special Tax Notice Regarding Rollovers (RI 37-22), 3206-0212PDF
83 FR 62608 - Advisory Council on Employee Welfare and Pension Benefit Plans; Notice of Charter RenewalPDF
83 FR 62561 - Notice of Availability: Table Saw Blade-Contact Injuries Special Study Report, 2017PDF
83 FR 62673 - Proposed Extension of Information Collection Request Submitted for Public Comment; Comment Request for Disclosure of Returns and Return Information to Designee of TaxpayerPDF
83 FR 62673 - Proposed Extension of Information Collection Request Submitted for Public Comment; Comment Request for Tests for Determining Whether an Obligation is Principally SecuredPDF
83 FR 62674 - Proposed Extension of Information Collection Request Submitted for Public Comment; Comment Request for Form 8918PDF
83 FR 62659 - Limitation on Claims Against Proposed Public Transportation ProjectsPDF
83 FR 62670 - Agency Information Collection Activities; Information Collection Renewal; Comment Request; LeasingPDF
83 FR 62671 - Agency Information Collection Activities; Information Collection Renewal; Comment Request; Funding and Liquidity Risk ManagementPDF
83 FR 62503 - Limitations on the Issuance of Commercial Driver's Licenses With a Hazardous Materials EndorsementPDF
83 FR 62505 - Lease and Interchange of Vehicles; Motor Carriers of Passengers; Extension of Compliance DatePDF
83 FR 62603 - Filing of Plats of Survey; NVPDF
83 FR 62466 - Air Plan Approval; Georgia; Revisions To VOC Definitions and Ambient Air Quality StandardsPDF
83 FR 62470 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Revisions to Regulation for Control of Ozone Season Nitrogen Oxide EmissionsPDF
83 FR 62661 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel VIANA 42′ Cruising Catamaran With Fixed Keels; Invitation for Public CommentsPDF
83 FR 62667 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel TORTOISE; Invitation for Public CommentsPDF
83 FR 62665 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel RIPPLE EFFECT II 46′ Sailing Catamaran; Invitation for Public CommentsPDF
83 FR 62662 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel NEVER MONDAY 34′ Twin Engine Powerboat; Invitation for Public CommentsPDF
83 FR 62663 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MISS MARIE; Invitation for Public CommentsPDF
83 FR 62666 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MABUHAY; Invitation for Public CommentsPDF
83 FR 62660 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel LOKI 42′ Cruising Catamaran With Fixed Keels; Invitation for Public CommentsPDF
83 FR 62668 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel LILIKOI; Invitation for Public CommentsPDF
83 FR 62664 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel DIMINUENDO 43′ Fixed Keel Sloop Sailing Vessel; Invitation for Public CommentsPDF
83 FR 62669 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel CHICANE; Invitation for Public CommentsPDF
83 FR 62660 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ALYOSHA; Invitation for Public CommentsPDF
83 FR 62455 - Removal of Alternate Participant ProgramPDF
83 FR 62626 - Meeting of the Advisory Committee on Reactor Safeguards (ACRS) Subcommittee on Planning and ProceduresPDF
83 FR 62617 - Fuel Cycle Safety, Safeguards, and Environmental Review Interim Staff GuidancePDF
83 FR 62604 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved CollectionPDF
83 FR 62606 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved CollectionPDF
83 FR 62605 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved CollectionPDF
83 FR 62607 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved CollectionPDF
83 FR 62607 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension, Without Change, of a Currently Approved Collection; National Motor Vehicle Title Information System (NMVTIS)PDF
83 FR 62672 - Notice of OFAC Sanctions Actions.PDF
83 FR 62600 - Foreign Endangered Species; Marine Mammals; Receipt of Permit ApplicationsPDF
83 FR 62453 - Revocation of Class E Airspace; Sunol, CAPDF
83 FR 62555 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Revisions to Red Snapper and Hogfish Management MeasuresPDF
83 FR 62451 - Establishment of Class E Airspace; Kemmerer, WYPDF
83 FR 62494 - Suspension of Community EligibilityPDF
83 FR 62536 - State of North Dakota Underground Injection Control Program; Class I, III, IV, and V Primacy RevisionsPDF
83 FR 62618 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards ConsiderationsPDF
83 FR 62516 - National Defense Authorization Acts of 2016 and 2017, Recovery Improvements for Small Entities After Disaster Act of 2015, and Other Small Business Government ContractingPDF
83 FR 62540 - Federal Acquisition Regulation: Revision of Limitations on SubcontractingPDF
83 FR 62609 - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving Proposed No Significant Hazards Considerations and Containing Sensitive Unclassified Non-Safeguards Information and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards InformationPDF

Issue

83 233 Tuesday, December 4, 2018 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Requests for Supplemental Evidence and Data Submissions: Interventions for Substance Use Disorders in Adolescents: A Systematic Review, 62575-62577 2018-26304 Agricultural Marketing Agricultural Marketing Service RULES Decreased Assessment Rate: Pears Grown in Oregon and Washington, 62449-62451 2018-26311 Agriculture Agriculture Department See

Agricultural Marketing Service

Census Bureau Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 62560 2018-26300 Centers Disease Centers for Disease Control and Prevention NOTICES Final National Occupational Research Agenda for Oil and Gas Extraction, 62577 2018-26315 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Medicare Program: Extension of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports, 62577-62580 2018-26334 Coast Guard Coast Guard NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 62597 2018-26280 Commerce Commerce Department See

Census Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Funding and Liquidity Risk Management, 62671-62672 2018-26251 Leasing, 62670-62671 2018-26252 Consumer Product Consumer Product Safety Commission NOTICES Table Saw Blade-Contact Injuries Special Study Report, 2017, 62561-62562 2018-26260 Defense Acquisition Defense Acquisition Regulations System RULES Defense Federal Acquisition Regulation Supplement: Documentation for Interagency Contracts, 62501-62502 2018-26309 Modification of DFARS Clause “Surge Option”, 62502-62503 2018-26307 Sunset of Provision Relating to the Procurement of Certain Goods, 62498-62501 2018-26305 PROPOSED RULES Defense Federal Acquisition Regulation Supplement: Restrictions on Use of Lowest Priced Technically Acceptable Source Selection Process, 62550-62554 2018-26306 Small Business Set-Asides for Architect-Engineer and Construction Design Contracts, 62554-62555 2018-26308 Defense Department Defense Department See

Defense Acquisition Regulations System

See

Engineers Corps

PROPOSED RULES Federal Acquisition Regulation: Limitations on Subcontracting, 62540-62550 2018-25506
Education Department Education Department NOTICES 2018-2019 Award Year Deadline Dates for Reports and Other Records Associated With the Free Application for Federal Student Aid, the Federal Supplemental Educational Opportunity Grant Program, the Federal Work-Study Programs, the Federal Pell Grant Program, the William D. Ford Federal Direct Loan Program, the Teacher Education Assistance for College and Higher Education Grant Program, and the Iraq and Afghanistan Service Grant Program, 62563-62568 2018-26313 Privacy Act; Matching Program, 62568-62569 2018-26312 Employee Benefits Employee Benefits Security Administration NOTICES Charter Renewals: Advisory Council on Employee Welfare and Pension Benefit Plans, 62608-62609 2018-26261 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Department of Energy Interpretation of High-Level Radioactive Waste, 62569 2018-26319
Engineers Engineers Corps NOTICES Environmental Impact Statements; Availability, etc.: Haile Gold Mine in Lancaster County, SC, 62562-62563 2018-26341 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Connecticut; Volatile Organic Compound Emissions from Consumer Products and Architectural and Industrial Maintenance Coatings; Correction, 62466 2018-26286 Georgia; Revisions to VOC Definitions and Ambient Air Quality Standards, 62466-62468 2018-26245 New Hampshire; Infrastructure State Implementation Plan Requirements for the 2012 Fine Particle National Ambient Air Quality Standards, 62464-62466 2018-26284 Texas; Emission Statements, 62468-62470 2018-26294 West Virginia; Revisions to Regulation for Control of Ozone Season Nitrogen Oxide Emissions, 62470-62474 2018-26243 Pesticide Tolerances: Bixafen, 62479-62485 2018-26348 Oxytetracycline, 62489-62494 2018-26343 Significant New Use Rules on Certain Chemical Substances; Withdrawal, 62463-62464 2018-26358 Tolerance Exemptions: 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer, 62486-62489 2018-26347 Calcium Formate, 62475-62479 2018-26353 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Massachusetts; Air Emissions Inventory, Emissions Statements, Source Registration, and Emergency Episode Planning Provisions, 62532-62536 2018-26283 Texas; Emission Statements, 62532 2018-26297 North Dakota Underground Injection Control Program; Class I, III, IV, and V Primacy Revisions, 62536-62540 2018-25893 NOTICES Interim Registration Review Decisions and Case Closures for Several Pesticides, 62573-62574 2018-26354 Registration Review Proposed Interim Decisions for Several Pesticides, 62571-62573 2018-26344 Federal Aviation Federal Aviation Administration RULES Establishment of Class E Airspace: Kemmerer, WY, 62451-62452 2018-26195 Revocation of Class E Airspace: Sunol, CA, 62453 2018-26209 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Training and Qualification Requirements for Check Airmen and Flight Instructors, 62657 2018-26329 Federal Emergency Federal Emergency Management Agency RULES Suspension of Community Eligibility, 62494-62496 2018-26132 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 62569-62571 2018-26330 2018-26331 Federal Motor Federal Motor Carrier Safety Administration RULES Lease and Interchange of Vehicles; Motor Carriers of Passengers, 62505-62508 2018-26249 Limitations on the Issuance of Commercial Driver's Licenses With a Hazardous Materials Endorsement, 62503-62505 2018-26250 Federal Railroad Federal Railroad Administration NOTICES Petitions for Special Approval of Alternate Standard, 62658-62659 2018-26291 Petitions for Waivers of Compliance, 62657-62658 2018-26292 2018-26293 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 62574 2018-26328 Federal Transit Federal Transit Administration NOTICES Limitation on Claims Against Proposed Public Transportation Projects, 62659-62660 2018-26254 Fish Fish and Wildlife Service NOTICES Permit Applications: Foreign Endangered Species; Marine Mammals, 62600-62601 2018-26215 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, 62585-62589 2018-26295 Electronic Submission of Medical Device Registration and Listing, 62583-62585 2018-26303 Determination of Regulatory Review Period for Purposes of Patent Extension: EXABLATE NEURO MODEL 4000 TYPE 1.0 SYSTEM, 62593-62595 2018-26282 Determination of Regulatory Review Periods for Purposes of Patent Extensions: ASPIRE ASSIST, 62580-62582 2018-26290 OCALIVA, 62591-62593 2018-26288 TRULANCE, 62590-62591 2018-26289 Guidance: Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment, 62582-62583 2018-26333 Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under Generic Drug User Fee Amendments, 62589-62590 2018-26285 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 62672-62673 2018-26216 General Services General Services Administration PROPOSED RULES Federal Acquisition Regulation: Limitations on Subcontracting, 62540-62550 2018-25506 NOTICES Relocation Allowances: Taxes on Travel, Transportation, and Relocation Expenses, 62574-62575 2018-26342 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

RULES Patient Protection and Affordable Care Act: Elimination of Internal Agency Process for Implementation of the Federally-Facilitated User Fee Adjustment, 62496-62498 2018-26332 NOTICES Proposed Objectives for Healthy People 2030; Correction, 62595 2018-26299
Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: HUD Acquisition Regulation, 62598-62599 2018-26339 Race and Ethnic Data Collection, 62599-62600 2018-26338 Indian Affairs Indian Affairs Bureau NOTICES HEARTH Act Approvals: Prairie Band Potawatomi Nation Regulations, 62601-62602 2018-26340 Indian Gaming: Approval of Tribal-State Class III Gaming Compact Amendment in Oklahoma, 62601 2018-26298 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Land Management Bureau

Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 62673-62675 2018-26256 2018-26258 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Disclosure of Returns and Return Information to Designee of Taxpayer, 62673-62674 2018-26259 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Light-Walled Rectangular Pipe and Tube from Turkey, 62561 2018-26318 Refillable Stainless Steel Kegs from the People's Republic of China, 62560-62561 2018-26316 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Thermoplastic-Encapsulated Electric Motors, Components Thereof, and Products and Vehicles Containing Same II, 62603-62604 2018-26274 Polytetrafluoroethylene Resin from China and India, 62603 2018-26324 Justice Department Justice Department See

Justice Programs Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 62604-62607 2018-26218 2018-26219 2018-26220 2018-26221
Justice Programs Justice Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 62607-62608 2018-26217 Labor Department Labor Department See

Employee Benefits Security Administration

Land Land Management Bureau NOTICES Plats of Surveys: Nevada, 62603 2018-26248 Maritime Maritime Administration NOTICES Requests for Administrative Waivers of the Coastwise Trade Laws: Vessel ALYOSHA, 62660-62661 2018-26232 Vessel CHICANE, 62669-62670 2018-26233 Vessel DIMINUENDO, 62664-62665 2018-26234 Vessel LILIKOI, 62668-62669 2018-26235 Vessel LOKI, 62660 2018-26236 Vessel MABUHAY, 62666-62667 2018-26237 Vessel MISS MARIE, 62663-62664 2018-26238 Vessel NEVER MONDAY, 62662-62663 2018-26239 Vessel RIPPLE EFFECT II, 62665-62666 2018-26240 Vessel TORTOISE, 62667-62668 2018-26241 Vessel VIANA, 62661-62662 2018-26242 NASA National Aeronautics and Space Administration PROPOSED RULES Federal Acquisition Regulation: Limitations on Subcontracting, 62540-62550 2018-25506 National Institute National Institutes of Health NOTICES Meetings: National Institute of General Medical Sciences, 62595 2018-26281 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: Atlantic Bluefin Tuna Fisheries, 62512-62514 2018-26325 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Snapper-Grouper Fishery off the Southern Atlantic Region; Regulatory Amendment 28, 62508-62512 2018-26317 Fisheries of the Exclusive Economic Zone Off Alaska: Pacific Cod by Catcher Vessels Less than 50 Feet Length Overall Using Hook-and-Line Gear in the Central Regulatory Area of the Gulf of Alaska, 62514-62515 2018-26302 PROPOSED RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Reef Fish Fishery of the Gulf of Mexico; Revisions to Red Snapper and Hogfish Management Measures, 62555-62559 2018-26196 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Applications and Amendments Involving Proposed No Significant Hazards Considerations, etc., 62609-62617 2018-25452 Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations: Biweekly Notice, 62618-62626 2018-25728 Guidance: Fuel Cycle Safety, Safeguards, and Environmental Review, 62617-62618 2018-26225 Meetings: Advisory Committee on Reactor Safeguards Subcommittee on Planning and Procedures, 62626 2018-26226 Meetings; Sunshine Act, 62609 2018-26454 Occupational Safety Health Rev Occupational Safety and Health Review Commission NOTICES Privacy Act; Systems of Records, 62627-62629 2018-26276 Pension Benefit Pension Benefit Guaranty Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Request for Coverage Determination, 62629-62630 2018-26278 Personnel Personnel Management Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Health Benefits Election Form, 62630-62631 2018-26263 Rollover Election, Rollover Information, and Special Tax Notice Regarding Rollovers, 62630 2018-26262 Postal Service Postal Service NOTICES Privacy Act; Systems of Records, 62631-62632 2018-26310 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: National Impaired Driving Prevention Month (Proc. 9828), 62681-62684 2018-26540 World AIDS Day (Proc. 9829), 62685-62686 2018-26543 EXECUTIVE ORDERS Government Agencies and Employees: Closing of Executive Departments and Agencies on December 5, 2018 (EO 13852), 62687-62688 2018-26552 ADMINISTRATIVE ORDERS Chemical Weapons Convention, Resolution of Advice and Consent to Ratification; Delegation of Authority (Memorandum of November 5, 2018), 62677-62679 2018-26528 Securities Securities and Exchange Commission RULES Form N-1A; Correction, 62454-62455 2018-26335 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 62632-62633, 62642 2018-26326 2018-26327 Applications: Apollo Management, LP, 62636-62637 2018-26264 Meetings; Sunshine Act, 62641-62642, 62656 2018-26401 2018-26402 Self-Regulatory Organizations; Proposed Rule Changes: Bats BZX Exchange, Inc., 62646-62648 2018-26269 ICE Clear Europe, Ltd., 62638-62644 2018-26266 2018-26268 Nasdaq BX, Inc., 62648-62653 2018-26267 2018-26273 Nasdaq PHLX, LLC, 62653-62655 2018-26271 NYSE American, LLC, 62644-62646 2018-26272 The Nasdaq Stock Market, LLC, 62633-62635 2018-26270 Small Business Small Business Administration PROPOSED RULES Small Business Government Contracting: National Defense Authorization Acts, Recovery Improvements for Small Entities After Disaster Act, 62516-62532 2018-25705 Social Social Security Administration RULES Removal of Alternate Participant Program, 62455-62463 2018-26231 State Department State Department NOTICES Culturally Significant Objects Imported for Exhibition: Lucio Fontana—On the Threshold, 62656-62657 2018-26407 Meetings: Sixth Session of the International Maritime Organization's Sub-Committee on Ship Design and Construction, 62656 2018-26336 Substance Substance Abuse and Mental Health Services Administration NOTICES Certified Laboratories and Instrumented Initial Testing Facilities: Urine Drug Testing for Federal Agencies, 62595-62596 2018-26279 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

Federal Railroad Administration

See

Federal Transit Administration

See

Maritime Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Foreign Assets Control Office

See

Internal Revenue Service

Separate Parts In This Issue Part II Presidential Documents, 62677-62679 2018-26528 Part III Presidential Documents, 62681-62688 2018-26540 2018-26543 2018-26552 Reader Aids

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83 233 Tuesday, December 4, 2018 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 927 [Doc. No. AMS-SC-18-0049; SC18-927-2 FR] Pears Grown in Oregon and Washington; Decreased Assessment Rate for Processed Pears AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule.

SUMMARY:

This final rule implements a recommendation from the Processed Pear Committee (Committee) to decrease the assessment rate established for “summer/fall” varieties of pears for canning for the 2018-2019 and subsequent fiscal periods. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.

DATES:

Effective January 3, 2019.

FOR FURTHER INFORMATION CONTACT:

Dale Novotny, Marketing Specialist, or Gary Olson, Regional Director, Northwest Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (503) 326-2724, Fax: (503) 326-7440, or Email: [email protected] or [email protected] Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202)720-8938, or Email: [email protected]

SUPPLEMENTARY INFORMATION:

This action, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This rule is issued under Marketing Order No. 927, as amended (7 CFR part 927), regulating the handling of pears grown in Oregon and Washington. Part 927, (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of growers, handlers, and processors operating within the area of production, and a public member.

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 13563 and 13175. This rule falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the Order now in effect, Oregon and Washington pear handlers are subject to assessments. Funds to administer the Order are derived from such assessments. The assessment rate established by this rule will be applicable to all “summer/fall” varieties of pears specifically used for canning for the 2018-2019 fiscal period, and continue until amended, suspended, or terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

The Order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The Committee members are familiar with the Committee's needs and with the costs of goods and services in their local area and can formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting where all directly affected persons have an opportunity to participate and provide input.

This final rule decreases the assessment rate from $8.00 per ton, the rate that was established for the 2017-2018 and subsequent fiscal periods, to $7.15 per ton of “summer/fall” varieties of pears for canning handled for the 2018-2019 and subsequent fiscal periods. The assessment rate for “winter” and “other” pears for processing will remain unchanged at $0.00. The Committee met on May 30, 2018, and unanimously recommended 2018-2019 fiscal period expenditures of $693,472. In comparison, last year's budgeted expenditures were $800,150. The Committee also unanimously recommended an assessment rate of $7.15 per ton of “summer/fall” varieties of pears for canning handled. The new assessment rate of $7.15 per ton is $0.85 lower than the previous $8.00 per ton rate. The Committee recommended the lower assessment rate to balance assessment revenue with its budgeted expenditures and to maintain its monetary reserve at levels authorized by the Order.

The major expenditures recommended by the Committee for the 2018-2019 fiscal period include $495,000 for promotion and paid advertising, $136,172 for research, $15,000 for market access programs, $25,000 for administrative and management services, and $22,300 for Committee expenses. In comparison, these major expense categories for the 2017-2018 fiscal period were budgeted at $591,030, $147,694, $14,576, $25,000, and $21,850; respectively.

The assessment rate recommended by the Committee was derived by considering anticipated expenses, expected shipments, and the amount of funds available in the authorized reserve. The quantity of assessable “summer/fall” pears for canning for the 2018-2019 fiscal period is estimated at 100,000 tons. Thus, the recommended $7.15 per ton assessment rate is expected to provide handler assessments of $715,000. This amount will be adequate to cover budgeted expenses of $693,472, with any excess funds used to make a small contribution to the Committee's monetary reserve. Funds in the reserve (currently $497,565) will be kept within the maximum permitted by § 927.42(a) of approximately one fiscal period's expenses.

The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee, or other available information.

Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's budget for subsequent fiscal periods will be reviewed and, as appropriate, approved by USDA.

Final Regulatory Flexibility Analysis

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 1,500 growers of pears for processing in the production area and approximately 43 handlers of processed pears subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

According to data from USDA National Agricultural Statistics Service (NASS), the Committee, and the industry for the 2016-2017 season (the most recent complete season of record) the average f.o.b. price for Oregon-Washington processed Bartlett pears (the only variety used for canning in the production area) was approximately $390.50 per ton. Total shipments for that period were approximately 103,020 tons. Using the number of handlers, and assuming a normal distribution, the majority of handlers may have average annual receipts of less than $7,500,000 ($390.50 per ton times 103,020 tons equals $40,229,310 divided by 43 handlers equals $935,565 per handler).

In addition, based on data from the Committee, the industry produced 103,020 tons of processed pears in the production area during the 2016-2017 season, with an average grower price of $360 per ton. Based on the average grower price, production, and the total number of Oregon-Washington processed pear growers reported by the Committee (1,500), and assuming a normal distribution, the average annual grower revenue is below $750,000 ($360 per ton times 103,020 tons equals $37,087,200 divided by 1,500 growers equals $24,725 per grower). Thus, the majority of Oregon and Washington processed pear handlers and growers may be classified as small entities.

This rule decreases the assessment rate collected from handlers for the 2018-2019 and subsequent fiscal periods from $8.00 per ton to $7.15 per ton of Oregon and Washington “summer/fall” pears for canning handled. The Committee unanimously recommended 2018-2019 fiscal period expenditures of $693,472 and the $7.15 per ton assessment rate. The assessment rate of $7.15 per ton is $0.85 lower than the previous rate in effect for the 2017-2018 fiscal period. The quantity of assessable “summer/fall” pears for canning for the 2018-2019 fiscal period is estimated at 100,000 tons. Thus, the $7.15 per ton rate should provide $715,000 in assessment income. Income derived from handler assessments should be adequate to cover budgeted expenses, with any excess funds to be carried over in the Committee's monetary reserve to be used in subsequent years.

The major expenditures recommended by the Committee for the 2018-2019 fiscal period include $495,000 for promotion and paid advertising, $136,172 for research, $15,000 for market access programs, $25,000 for administrative and management services, and $22,300 for Committee expenses. In comparison, these major expense categories for the 2017-2018 fiscal period were budgeted at $591,030, $147,694, $14,576, $25,000, and $21,850, respectively.

The new, lower assessment rate is necessary to balance assessment revenue with the Committee's 2018-2019 fiscal period budgeted expenditures and to maintain its monetary reserve at levels authorized in the Order.

Prior to arriving at this budget and assessment rate, the Committee considered the benefits and costs related to maintaining the previous assessment rate of $8.00 per ton and establishing other assessment rates. However, leaving the assessment rate unchanged would have generated more revenue than required to meet the Committee's 2018-2019 fiscal period budgeted expenses of $693,472, and would have added a large amount of excess funds to the Committee's already sufficient monetary reserve. Based on estimated shipments, the assessment rate of $7.15 per ton is expected to provide $715,000 in assessment income. The Committee determined assessment revenue will be adequate to fully cover budgeted expenditures for the 2018-2019 fiscal period, with a small amount of excess funds to be added to the Committee's monetary reserve. Reserve funds will be kept within the amount authorized by the Order.

A review of historical information and preliminary information pertaining to the upcoming fiscal year indicates that the average grower price for the 2018-2019 season should be approximately $296 per ton of pears for processing. Therefore, the estimated assessment revenue for the 2018-2019 fiscal period as a percentage of total grower revenue is about 2.4 percent ($7.15 per ton assessment divided by $296 per ton grower price).

This action decreases the assessment obligation imposed on handlers for the 2018-2019 and subsequent fiscal periods. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate will reduce the burden on handlers, and may reduce the burden on producers.

The Committee's meetings were widely publicized throughout the Oregon and Washington processed pear industry. All interested persons were invited to attend the meetings and participate in Committee deliberations on all issues. Like all Committee meetings, the May 30, 2018, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189, Fruit Crops. No changes in those requirements are necessary because of this action. Should any changes become necessary, they will be submitted to OMB for approval.

This rule does not impose any additional reporting or recordkeeping requirements on either small or large Oregon and Washington processed pear handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.

AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

A proposed rule concerning this action was published in the Federal Register on September 12, 2018 (83 FR 46119). Copies of the proposed rule were also mailed or sent via facsimile to all Oregon and Washington fresh pear handlers. The proposal was made available through the internet by USDA and the Office of the Federal Register. A 30-day comment period ending October 12, 2018, was provided for interested persons to respond to the proposal. Two comments were received during the comment period. The first comment was in support of the action. The second comment was a negative opinion on marketing orders in general and did not address the specific proposed rulemaking action. Accordingly, no changes will be made to the rule as proposed, based on the comments received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, will tend to effectuate the declared policy of the Act.

List of Subjects in 7 CFR Part 927

Marketing agreements, Pears, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, 7 CFR part 927 is amended as follows:

PART 927—PEARS GROWN IN OREGON AND WASHINGTON 1. The authority citation for part 927 continues to read as follows: Authority:

7 U.S.C. 601-674.

2. Section 927.237 is amended by revising the introductory text and paragraph (a) to read as follows:
§ 927.237 Assessment rate.

On and after July 1, 2018, the following base rates of assessment for pears for processing are established for the Processed Pear Committee:

(a) $7.15 per ton for any or all varieties or subvarieties of pears for canning classified as “summer/fall” excluding pears for other methods of processing;

Dated: November 29, 2018. Bruce Summers, Administrator, Agricultural Marketing Service.
[FR Doc. 2018-26311 Filed 12-3-18; 8:45 am] BILLING CODE 3410-02-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0034; Airspace Docket No. 17-ANM-34] RIN 2120-AA66 Establishment of Class E Airspace; Kemmerer, WY AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action amends Class E surface area airspace at Kemmerer Municipal Airport, Kemmerer, WY, by enlarging the airspace area north of the airport and removing the Notice to Airmen (NOTAM) part-time status for the airspace. Also, this action reduces Class E airspace extending upward from 700 feet above the surface and removes Class E airspace extending upward from 1,200 feet above the surface.

DATES:

Effective 0901 UTC, February 28, 2019. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES:

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

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

FOR FURTHER INFORMATION CONTACT:

Bonnie Malgarini, Federal Aviation Administration, Operations Support Group, Western Service Center, 2200 S 216th Street, Des Moines, WA 98198; telephone (206) 231-2329.

SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace at Kemmerer Municipal Airport, Kemmerer, WY, to accommodate airspace redesign in support of IFR operations at the airport.

History

The FAA published a notice of proposed rulemaking in the Federal Register (83 FR 21970; May 11, 2018) for Docket No. FAA-2018-0034 to amend Class E airspace at Kemmerer Municipal Airport, Kemmerer, WY, to accommodate airspace redesign in support of IFR operations at the airport. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6002, and 6005, respectively, of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule

The FAA is amending Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying the north extension of the Class E surface area airspace at Kemmerer Municipal Airport, Kemmerer, WY, to within 1.8 miles (from 1 mile) each side of the 354° bearing (from the 360° bearing) from the airport extending from the 4.3-mile radius of the airport to 7.7 miles (from 7 miles) north of the airport. Also, the NOTAM part-time status for the airspace would be removed to make the airspace effective continuously.

The FAA also amends the Class E airspace extending upward from 700 feet above the surface to within a 4.3-mile radius of Kemmerer Municipal Airport from the airport 035° bearing clockwise to the airport 006° bearing, and within a 9.5 mile radius of the airport from the airport 006° bearing clockwise to the airport 035° bearing, and within 2.2 miles each side of the 354° bearing from the airport extending from the 4.3-mile radius of the airport to 15.9 miles north of the airport, and within 2.2 miles each side of the 172° bearing from the airport extending from the 4.3-mile radius of the airport to 7.4 miles south of the airport (from within the 8-mile radius of Kemmerer Municipal Airport, and within 4 miles each side of the 174° bearing from the airport extending from the airport 11 miles south of the airport, and within 3.6 miles each side of the 354° bearing from the airport extending from the airport to 16.1 miles northwest of the airport). Additionally, the Class E airspace extending upward from 1,200 feet above the surface is removed because sufficient airspace exists (Wasatch and Jackson Class E airspace areas) and duplication is not necessary. This airspace redesign is necessary for the safety and management of IFR operations at the airport.

Regulatory Notices and Analyses

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

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

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

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

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

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, is amended as follows: Paragraph 6002 Class E Airspace Areas Designated as Surface Areas. ANM WY E2 Kemmerer, WY [Amended] Kemmerer Municipal Airport, WY (Lat. 41°49′27″ N, long. 110°33′25″ W)

Within a 4.3-mile radius of Kemmerer Municipal Airport, and within 1.8-miles each side of the 354° bearing from the airport extending from the 4.3-mile radius of the airport to 7.7 miles north of the airport.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ANM WY E5 Kemmerer, WY [Amended] Kemmerer Municipal Airport, WY (Lat. 41°49′27″ N, long. 110°33′25″ W)

That airspace extending upward from 700 feet above the surface within a 4.3-mile radius of Kemmerer Municipal Airport from the airport 035° bearing clockwise to the airport 006° bearing, and within a 9.5-mile radius of the airport from the airport 006° bearing clockwise to the airport 035° bearing, and within 2.2 miles each side of the 354° bearing from the airport extending from the 4.3-mile radius of the airport to 15.9 miles north of the airport, and within 2.2 miles each side of the 172° bearing from the airport extending from the 4.3-mile radius of the airport to 7.4 miles south of the airport.

Issued in Seattle, Washington, on November 20, 2018. Shawn M. Kozica, Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2018-26195 Filed 12-3-18; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-1147; Airspace Docket No. 17-AWP-29] RIN 2120-AA66 Revocation of Class E Airspace; Sunol, CA AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action removes Class E airspace extending upward from 1,200 feet above the surface at Sunol, CA. This airspace is wholly contained within the Sacramento en route airspace area and duplication is not necessary.

DATES:

Effective 0901 UTC, February 28, 2019. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES:

FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA).

For information on the availability of this material at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

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

FOR FURTHER INFORMATION CONTACT:

Bonnie Malgarini, Federal Aviation Administration, Operations Support Group, Western Service Center, 2200 S 216th Street, Des Moines, WA 98198-6547; telephone (206) 231-2329.

SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it clarifies airspace designations by eliminating the redundancy.

History

The FAA published a notice of proposed rulemaking in the Federal Register (83 FR 7432; February 21, 2018) for Docket No. FAA-2017-1147 to remove Class E airspace extending upward from 1,200 feet above the surface at Sunol, CA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule

This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 removes Class E airspace extending upward from 1,200 feet above the surface at Sunol, CA. This airspace is wholly contained within the Sacramento en route airspace area and duplication is not necessary.

Regulatory Notices and Analyses

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

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

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

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

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

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11C,

Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth AWP CA E5 Sunol, CA [Removed]
Issued in Seattle, Washington, on November 20, 2018. Shawn M. Kozica, Manager, Operations Support Group, Western Service Center.
[FR Doc. 2018-26209 Filed 12-3-18; 8:45 am] BILLING CODE 4910-13-P
SECURITIES AND EXCHANGE COMMISSION 17 CFR Parts 239 and 274 [Release Nos. 33-10577, IC-33308; File Nos. S7-08-15; S7-04-18] Form N-1A; Correction AGENCY:

Securities and Exchange Commission.

ACTION:

Final rule; technical correction.

SUMMARY:

This document makes technical corrections to several amendments to Form N-1A, which the Commission adopted as part of three rulemakings: Investment Company Reporting Modernization, which was published in the Federal Register on November 18, 2016; Optional Internet Availability of Investment Company Shareholder Reports, which was published in the Federal Register on June 22, 2018; and Investment Company Liquidity Disclosure, which was published in the Federal Register on July 10, 2018. This document is being published to correct the paragraph designations that appeared in the amendatory instructions preceding certain of the form amendments that the Commission adopted as part of each of these rulemakings. This document makes technical corrections only to the paragraph designations that appear in the amendatory instructions preceding these form amendments. This document does not make any substantive changes (i.e., changes except corrections to typographical errors) to the text of the form amendments themselves.

DATES:

Effective December 4, 2018, except:

• The revisions to Item 27(d)(3) of Form N-1A are effective May 1, 2020;

• Item 27(d)(7) of Form N-1A (referenced in 17 CFR 239.15A and 274.11A) is effective January 1, 2019, through December 31, 2021; and

• Item 27(d)(7) is removed effective January 1, 2022.

FOR FURTHER INFORMATION CONTACT:

James Maclean, Senior Counsel, or Amanda Hollander Wagner, Branch Chief, Investment Company Regulation Office, at (202) 551-6792, Division of Investment Management, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-8549.

SUPPLEMENTARY INFORMATION:

We are making a technical amendment to Item 27 of Form N-1A under 17 CFR 239.15A and 274.11A.

List of Subjects 17 CFR Part 239

Reporting and recordkeeping requirements, Securities.

17 CFR Part 274

Investment companies, Reporting and recordkeeping requirements, Securities.

Statutory Authority and Text of Amendments

For the reasons set out above, title 17, chapter II of the Code of Federal Regulations is amended as follows:

PART 239—FORMS PRESCRIBED UNDER THE SECURITIES ACT OF 1933 1. The authority citation for part 239 continues to read in part as follows: Authority:

15 U.S.C. 77c, 77f, 77g, 77h, 77j, 77s, 77z-2, 77z-3, 77sss, 78c, 78l, 78m,78n, 78o(d), 78o-7 note, 78u-5, 78w(a), 78ll, 78mm, 80a-2(a), 80a-3, 80a-8, 80a-9, 80a-10, 80a-13, 80a-24, 80a-26, 80a-29, 80a-30, and 80a-37; and sec. 107, Pub. L. 112-106, 126 Stat. 312, unless otherwise noted.

PART 274—FORMS PRESCRIBED UNDER THE INVESTMENT COMPANY ACT OF 1940 2. The authority citation for part 274 continues to read in part as follows: Authority:

15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78l, 78m, 78n, 78o(d), 80a-8, 80a-24, 80a-26, 80a-29, and Pub. L. 111-203, sec. 939A, 124 Stat. 1376 (2010), unless otherwise noted.

3. Form N-1A (referenced in §§ 239.15A and 274.11A), Item 27, is amended by: a. Revising paragraph (d)(3); b. Redesignating paragraph (d)(6) as (d)(6)(i); c. Adding new paragraph (d)(6)(ii); d. Adding paragraph (d)(7); and e. Removing paragraph (d)(7).

The revisions and additions read as follows:

Note:

The text of Form N-1A does not, and this amendment will not, appear in the Code of Federal Regulations.

Form N-1A Item 27. Financial Statements

(d) * * *

(3) Statement Regarding Availability of Quarterly Portfolio Schedule. A statement that: (i) The Fund files its complete schedule of portfolio holdings with the Commission for the first and third quarters of each fiscal year as an exhibit to its reports on Form N-PORT; (ii) the Fund's Form N-PORT reports are available on the Commission's website at http://www.sec.gov; and (iii) if the Fund makes the information on Form N-PORT available to shareholders on its website or upon request, a description of how the information may be obtained from the Fund.

(6) Board Approvals and Liquidity Reviews.

(i) Statement Regarding Basis for Approval of Investment Advisory Contract. * * *

(ii) Statement Regarding Liquidity Risk Management Program. If the board of directors reviewed the Fund's liquidity risk management program pursuant to rule 22e-4(b)(2)(iii) of the Act [17 CFR 270.22e-4(b)(2)(iii)] during the Fund's most recent fiscal half-year, briefly discuss the operation and effectiveness of the Fund's liquidity risk management program over the past year.

Instruction

If the board reviews the liquidity risk management program more frequently than annually, a fund may choose to include the discussion of the program's operation and effectiveness over the past year in one of either the fund's annual or semi-annual reports, but does not need to include it in both reports.

(7) Front Cover Page or Beginning of Annual and Semi-Annual Report. Include on the front cover page or at the beginning of the annual or semi-annual report a statement to the following effect, if applicable:

Beginning on [date], as permitted by regulations adopted by the Securities and Exchange Commission, paper copies of the Fund's shareholder reports like this one will no longer be sent by mail, unless you specifically request paper copies of the reports from the Fund [or from your financial intermediary, such as a broker-dealer or bank]. Instead, the reports will be made available on a website, and you will be notified by mail each time a report is posted and provided with a website link to access the report.

If you already elected to receive shareholder reports electronically, you will not be affected by this change and you need not take any action. You may elect to receive shareholder reports and other communications from the Fund [or your financial intermediary] electronically by [insert instructions].

You may elect to receive all future reports in paper free of charge. You can inform the Fund [or your financial intermediary] that you wish to continue receiving paper copies of your shareholder reports by [insert instructions]. Your election to receive reports in paper will apply to all funds held with [the fund complex/your financial intermediary].

Dated: November 29, 2018. Brent J. Fields, Secretary.
[FR Doc. 2018-26335 Filed 12-3-18; 8:45 am] BILLING CODE 8011-01-P
SOCIAL SECURITY ADMINISTRATION 20 CFR Parts 404, 411 and 416 [Docket No. SSA-2017-0071] RIN 0960-AI24 Removal of Alternate Participant Program AGENCY:

Social Security Administration.

ACTION:

Final rule.

SUMMARY:

We are removing from the Code of Federal Regulations (CFR) our “Alternate Participant Program” rules because they are obsolete. We are removing these rules in accordance with the requirements of Executive Order (E.O.) 13777.

DATES:

Effective Date: December 4, 2018.

FOR FURTHER INFORMATION CONTACT:

Cara Caplan, Social Security Administration, 6401 Security Boulevard, Baltimore, MD 21235-6401, 410-966-0586. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our internet site, Social Security Online, at http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

We are removing our Alternate Participant Program rules in accordance with E.O. 13777 (“Enforcing the Regulatory Reform Agenda”).1 The E.O. requires agencies to identify rules that, among other things, are outdated or unnecessary, and repeal, replace, or modify them, consistent with applicable law. These rules, found in 20 CFR Chapter III Part 411, Subpart J, describe how the Alternate Participant Program was affected by the Ticket to Work and Self-Sufficiency Program (Ticket Program),2 and procedures related to phasing it out.

1 82 FR 12285 (March 1, 2017).

2 66 FR 67369 (December 28, 2001).

Under the Social Security Act (Act), the Commissioner of Social Security is authorized to reimburse States for reasonable and necessary costs of vocational rehabilitation (VR) services furnished to certain disabled individuals under a State VR plan that meets specific requirements.3 If a State is unwilling to participate or does not have a plan meeting the specified requirements, we can enter into agreements or contracts with alternative VR service providers under the same conditions that apply to a State VR agency.4 In 1994, we created the Alternate Participant Program, which was intended to provide more VR service options to beneficiaries.5 These alternate VR service providers, referred to as “alternate participants,” could be organizations, institutions, individuals, or other public or private agencies.

3 Section 222(d)(1) of the Act, 42 U.S.C. 422(d)(1).

4 Section 222(d)(2) of the Act, 42 U.S.C. 422(d)(2).

5 59 FR 11899 (March 15, 1994).

Our procedures changed when we published final rules implementing the Ticket Program 6 in 2001. The Ticket Program, authorized by the Ticket to Work and Work Incentives Improvement Act of 1999 (TWWIIA),7 expanded the universe of service providers available to beneficiaries with disabilities who are seeking employment services, VR services, and other support services. Under the Ticket Program, beneficiaries have the option of obtaining services from providers known as employment networks (ENs). As we implemented the Ticket Program and began using ENs, we phased out the use of alternate participants, as authorized by section 101(d)(5) of the TWWIIA.8

6 66 FR 67369 (December 28, 2001).

7 Public Law 106-170, 113 Stat. 1860.

8 Section 105(d)(5) of Public Law 106-170, 113 Stat. 1860, 1877.

Under current rules, we cannot pay an alternate participant for services provided after December 31, 2003. There are no outstanding Alternate Participant Program payments and no entity could become eligible for these payments in the future. Because we no longer use the Alternate Participant Program, the rules associated with that program are obsolete and no longer necessary. In alignment with this rule removal, we are also removing references to the program found in Subparts A and E of 20 CFR part 411, sections in Subparts A and V of 20 CFR part 404, and sections in Subpart A and V of 20 CFR part 416.

Regulatory Procedures Justification for Issuing a Final Rule Without Notice and Comment

We follow the Administrative Procedure Act (APA) rulemaking procedures specified in 5 U.S.C. 553 when we develop regulations. Generally, the APA requires that an agency provide prior notice and opportunity for public comment before issuing a final rule. The APA provides exceptions to its notice and public comment procedures when an agency finds there is good cause for dispensing with such procedures because they are impracticable, unnecessary, or contrary to the public interest.

We find that there is good cause under 5 U.S.C. 553(b)(B) to issue this regulatory change as a final rule without prior notice or public comment. We find that prior notice and public comment are unnecessary because this final rule only removes from the CFR obsolete and unnecessary rules that do not affect any current beneficiaries.

In addition, we find good cause for dispensing with the 30-day delay in the effective date of this rule provided for in 5 U.S.C. 553(d)(3). For the reasons stated above, we find it unnecessary to delay the effective date of the changes we are making in this final rule. Accordingly, we are making them effective upon publication.

Executive Order 12866 as Supplemented by Executive Order 13563

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

Executive Order 13132 (Federalism)

We analyzed this final rule in accordance with the principles and criteria established by Executive Order 13132 and determined that the rule will not have sufficient Federalism implications to warrant the preparation of a Federalism assessment. We also determined that this rule will not preempt any State law or State regulation or affect the States' abilities to discharge traditional State governmental functions.

E.O. 13771

This regulation codifies legislative changes that already took place. Accordingly, the regulation does not have any financial impact on the public, and as such is an exempt regulatory action under E.O. 13771.

Regulatory Flexibility Act

We certify that this final rule will not have a significant economic impact on a substantial number of small entities because there are no current participants of the Alternate Participant Program. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

Paperwork Reduction Act

This rule does not create any new or affect any existing collections and, therefore, does not require Office of Management and Budget approval under the Paperwork Reduction Act.

(Catalog of Federal Domestic Assistance Program Social Security—Retirement Insurance; and 96.004, Social Security—Survivors Insurance) List of Subjects 20 CFR Part 404

Administrative practice and procedure, Blind, Disability benefits, Old-age, Survivors, and Disability Insurance, Reporting and recordkeeping requirements, Social Security.

20 CFR Part 411

Administrative practice and procedure, Blind, Disability benefits, Public assistance programs, Reporting and recordkeeping requirements, Social Security, Supplemental Security Income (SSI), Vocational rehabilitation.

20 CFR Part 416

Administrative practice and procedure, Alcoholism, Drug abuse, Investigations, Medicaid, Penalties, Reporting and recordkeeping requirements, Social Security, Supplemental Security Income (SSI), Travel and transportation expenses, Vocational rehabilitation.

Nancy A. Berryhill, Acting Commissioner of Social Security.

For the reasons set out in the preamble, we amend 20 CFR parts 404, 411, and 416 as set forth below:

PART 404—FEDERAL OLD AGE, SURVIVORS AND DISABILITY INSURANCE (1950-  ) Subpart A—Introduction, General Provisions and Definitions 1. The authority citation for subpart A of part 404 continues to read as follows: Authority:

Secs. 203, 205(a), 216(j), and 702(a)(5) of the Social Security Act (42 U.S.C. 403, 405(a), 416(j), and 902(a)(5)) and 48 U.S.C. 1801.

2. Amend § 404.1 by revising paragraph (v) to read as follows:
§ 404.1 Introduction

(v) Subpart V relates to payments to State vocational rehabilitative agencies for vocational rehabilitation services.

Subpart V—Payments for Vocational Rehabilitation Services 3. The authority citation for subpart V of part 404 continues to read as follows: Authority:

Secs. 205(a), 222, and 702(a)(5) of the Social Security Act (42 U.S.C. 405(a), 422, and 902(a)(5)).

4. Amend § 404.2102 as follows: a. Remove and reserve paragraphs (c) and (j); b. Revise the introductory text and paragraphs (b), (d), (f), and (k).

The revisions read as follows:

§ 404.2102 Purpose and scope.

This subpart describes the rules under which the Commissioner will pay the State VR agencies for VR services. Payment will be provided for VR services provided on behalf of disabled individuals under one or more of the provisions discussed in § 404.2101.

(b) Section 404.2104 explains how State VR agencies may participate in the payment program under this subpart.

(c) [Reserved]

(d) Sections 404.2108 through 404.2109 describe the requirements and conditions under which we will pay a State VR agency under this subpart.

(f) Section 404.2112 describes when payment will be made to a VR agency because an individual's disability benefits are continued based on his or her participation in a VR program which we have determined will increase the likelihood that he or she will not return to the disability rolls.

(j) [Reserved]

(k) Section 404.2119 describes how we will make payment to State VR agencies for rehabilitation services.

§ 404.2103 [Amended]
5. Amend § 404.2103 by removing the definition of Alternate participants. 6. Amend § 404.2104 as follows: a. Remove paragraphs (b)(3) and (f); b. Remove and reserve paragraph (e)(2); and c. Revise the heading of the section and paragraphs (a), (b)(2), (c)(2), and (e)(3).

The revisions read as follows:

§ 404.2104 Participation by State VR agencies.

(a) General. In order to participate in the payment program under this subpart through its VR agency(ies), a State must have a plan which meets the requirements of title I of the Rehabilitation Act of 1973, as amended.

(b) * * *

(2) A State with one or more approved VR agencies may choose to limit participation of those agencies to a certain class(es) of disability beneficiaries. For example, a State with separate VR agencies for the blind and disabled may choose to limit participation to the VR agency for the blind. In such a case, we would give the State, through its VR agency for the blind, the opportunity to participate with respect to blind disability beneficiaries in the State in accordance with paragraph (d) of this section. A State that chooses to limit participation of its VR agency(ies) must notify us in advance under paragraph (e)(1) of this section of its decision to limit such participation.

(c) * * *

(2)(i) In order for the State to participate with respect to a disability beneficiary whom we referred to a State VR agency, the State VR agency must notify the appropriate Regional Commissioner (SSA) in writing or through electronic notification of its decision either to accept the beneficiary as a client for VR services or to place the beneficiary into an extended evaluation process. The notice must be received by the appropriate Regional Commissioner (SSA) no later than the close of the fourth month following the month in which we referred the beneficiary to the State VR agency.

(ii) In any case in which a State VR agency notifies the appropriate Regional Commissioner (SSA) in writing within the stated time period under paragraph (c)(2)(i) of this section of its decision to place the beneficiary into an extended evaluation process, the State VR agency also must notify that Regional Commissioner in writing upon completion of the evaluation of its decision whether or not to accept the beneficiary as a client for VR services. If we receive a notice of a decision by the State VR agency to accept the beneficiary as a client for VR services following the completion of the extended evaluation, the State may continue to participate with respect to such beneficiary.

(e) * * *

(2) [Reserved]

(3) A State which has decided not to participate or to limit participation may participate later through its VR agency(ies) in accordance with paragraph (c) of this section. A State which decides to resume participation under paragraph (c) of this section must provide advance written notice of that decision to the appropriate Regional Commissioner (SSA). A decision of a State to resume participation under paragraph (c) of this section will be effective beginning with the third month following the month in which the notice of the decision is received by the appropriate Regional Commissioner (SSA) or, if later, with a month specified by the State. The notice of the State decision must be submitted by an official authorized to act for the State as explained in paragraph (e)(1) of this section.

§ 404.2106 [Removed and Reserved]
7. Remove and reserve § 404.2106. 8. Amend § 404.2108 by revising paragraphs (a), (d), and (f) to read as follows:
§ 404.2108 Requirements for payment.

(a) The State VR agency must file a claim for payment in each individual case within the time periods specified in § 404.2116;

(d) The VR services for which payment is being requested must have been provided under a State plan for VR services approved under title I of the Rehabilitation Act of 1973, as amended, and must be services that are described in § 404.2114;

(f) The State VR agency must maintain, and provide as we may require, adequate documentation of all services and costs for all disability beneficiaries with respect to whom a State VR agency could potentially request payment for services and costs under this subpart; and

9. Amend § 404.2111 by revising the introductory text and paragraphs (b)(1)(i) and (b)(2) to read as follows:
§ 404.2111 Criteria for determining when VR services will be considered to have contributed to a continuous period of 9 months.

The State VR agency may be paid for VR services if such services contribute to the individual's performance of a continuous 9-month period of SGA. The following criteria apply to individuals who received more than just evaluation services. If a State VR agency claims payment for services to an individual who received only evaluation services, it must establish that the individual's continuous period or medical recovery (if medical recovery occurred before completion of a continuous period) would not have occurred without the services provided. In applying the criteria below, we will consider services described in § 404.2114 that were initiated, coordinated or provided, including services before October 1, 1981.

(b) * * *

(1) * * *

(i) The individualized written rehabilitation program (IWRP) included medical services; and

(2) In some instances, the State VR agency will not have provided, initiated, or coordinated medical services. If this happens, payment for VR services may still be possible under paragraph (a) of this section if:

(i) The medical recovery was not expected by us; and

(ii) The individual's impairment is determined by us to be of such a nature that any medical services provided would not ordinarily have resulted in, or contributed to, the medical cessation.

10. Revise § 404.2112 to read as follows:
§ 404.2112 Payment for VR services in a case where an individual continues to receive disability payments based on participation in an approved VR program.

Sections 404.1586(g), 404.316(c), 404.337(c), and 404.352(c) explain the criteria we will use in determining if an individual whose disability has ceased should continue to receive disability benefits from us because of his or her continued participation in a VR program. A VR agency can be paid for the cost of VR services provided to an individual if the individual was receiving benefits in a month or months, after October 1984, based on § 404.316(c), § 404.337(c), or § 404.352(c). If this requirement is met, a VR agency can be paid for the costs of VR services provided within the period specified in § 404.2115, subject to the other payment and administrative provisions of this subpart.

11. Amend § 404.2114 by revising paragraphs (a) introductory text, (a)(2), and (b)(4) to read as follows:
§ 404.2114 Services for which payment may be made.

(a) General. Payment may be made for VR services provided by a State VR agency in accordance with title I of the Rehabilitation Act of 1973, as amended, subject to the limitations and conditions in this subpart. VR services for which payment may be made under this subpart include only those services described in paragraph (b) of this section which are—

(2) Provided by a State VR agency under an IWRP, but only if the services could reasonably be expected to motivate or assist the individual in returning to, or continuing in, SGA.

(b) * * *

(4) Vocational and other training services, including personal and vocational adjustment, books, tools, and other training materials, except that training or training services in institutions of higher education will be covered under this section only if maximum efforts have been made by the State VR agency to secure grant assistance in whole or in part from other sources;

12. Amend § 404.2115 by revising paragraphs (a) introductory text and (b) to read as follows:
§ 404.2115 When services must have been provided.

(a) In order for the VR agency to be paid, the services must have been provided—

(b) If an individual who is entitled to disability benefits under this part also is or has been receiving disability or blindness benefits under part 416 of this chapter, the determination as to when services must have been provided may be made under this section or § 416.2215 of this chapter, whichever is advantageous to the State VR agency that is participating in both VR programs.

13. Amend § 404.2116 by revising the introductory text and paragraphs (b)(1) and (b)(2) to read as follows:
§ 404.2116 When claims for payment for VR services must be made (filing deadlines).

The State VR agency must file a claim for payment in each individual case within the following time periods:

(b) * * *

(1) If a written notice requesting that a claim be filed was sent to the State VR agency, a claim must be filed within 90 days following the month in which VR services end, or if later, within 90 days after receipt of the notice.

(2) If no written notice was sent to the State VR agency, a claim must be filed within 12 months after the month in which VR services end.

14. Amend § 404.2117 by revising the introductory text and paragraphs (a), (b), (c)(1) introductory text, (c)(2), (d), and (e) to read as follows:
§ 404.2117 What costs will be paid.

In accordance with section 222(d) of the Social Security Act, the Commissioner will pay the State VR agency for the VR services described in § 404.2114 which were provided during the period described in § 404.2115 and which meet the criteria in § 404.2111 or § 404.2112, but subject to the following limitations:

(a) The cost must have been incurred by the State VR agency;

(b) The cost must not have been paid or be payable from some other source. For this purpose, State VR agencies will be required to seek payment or services from other sources in accordance with the “similar benefit” provisions under 34 CFR part 361, including making maximum efforts to secure grant assistance in whole or part from other sources for training or training services in institutions of higher education.

(c)(1) The cost must be reasonable and necessary, in that it complies with the written cost-containment policies of the State VR agency. A cost which complies with these policies will be considered necessary only if the cost is for a VR service described in § 404.2114. The State VR agency must maintain and use these cost-containment policies, including any reasonable and appropriate fee schedules, to govern the costs incurred for all VR services, including the rates of payment for all purchased services, for which payment will be requested under this subpart. For the purpose of this subpart, the written cost-containment policies must provide guidelines designed to ensure—

(2) The State VR agency shall submit to us before the end of the first calendar quarter of each year a written statement certifying that cost-containment policies are in effect and are adhered to in procuring and providing goods and services for which the State VR agency requests payment under this subpart. Such certification must be signed by the State's chief financial official or the head of the VR agency. Each certification must specify the basis upon which it is made, e.g., a recent audit by an authorized State, Federal or private auditor (or other independent compliance review) and the date of such audit (or compliance review). We may request the State VR agency to submit to us a copy(ies) of its specific written cost-containment policies and procedures (e.g., any guidelines and fee schedules for a given year) if we determine that such additional information is necessary to ensure compliance with the requirements of this subpart. The State VR agency must provide such information when requested by us.

(d) The total payment in each case, including any prior payments related to earlier continuous 9-month periods of SGA made under this subpart, must not be so high as to preclude a “net saving” to the trust funds (a “net saving” is the difference between the estimated saving to the trust funds, if disability benefits eventually terminate, and the total amount we pay to the State VR agency);

(e) Any payment to the State VR agency for either direct or indirect VR expenses must be consistent with the cost principles described in OMB Circular No. A-87, as revised;

§ 404.2118 [Removed and Reserved]
15. Remove and reserve § 404.2118. 16. Revise § 404.2119 to read as follows:
§ 404.2119 Method of payment.

Payment to the State VR agencies pursuant to this subpart will be made either by advancement of funds or by payment for services provided (with necessary adjustments for any overpayments and underpayments), as decided by the Commissioner.

17. Revise § 404.2120 to read as follows:
§ 404.2120 Audits.

(a) General. The State shall permit us and the Comptroller General of the United States (including duly authorized representatives) access to and the right to examine records relating to the services and costs for which payment was requested or made under these regulations. These records shall be retained by the State for the periods of time specified for retention of records in the Federal Acquisition Regulations (48 CFR part 4, subpart 4.7).

(b) Audit basis. Auditing will be based on cost principles and written guidelines in effect at the time services were provided and costs were incurred. The State VR agency will be informed and given a full explanation of any questioned items. It will be given a reasonable time to explain questioned items. Any explanation furnished by the State VR agency will be given full consideration before a final determination is made on questioned items in the audit report.

(c) Appeal of audit determinations. The appropriate SSA Regional Commissioner will notify the State VR agency in writing of his or her final determination on the audit report. If the State VR agency disagrees with that determination, it may request reconsideration in writing within 60 days after receiving the Regional Commissioner's notice of the determination. The Commissioner will make a determination and notify the State VR agency of that decision in writing, usually, no later than 45 days from the date of appeal. The decision by the Commissioner will be final and conclusive unless the State VR agency appeals that decision in writing in accordance with 45 CFR part 16 to the Department of Health and Human Services' Departmental Appeals Board within 30 days after receiving it.

18. Amend § 404.2121 by revising paragraphs (a), (b)(3), (c), and (d) to read as follows:
§ 404.2121 Validation reviews.

(a) General. We will conduct a validation review of a sample of the claims for payment filed by each State VR agency. We will conduct some of these reviews on a prepayment basis and some on a postpayment basis. We may review a specific claim, a sample of the claims, or all the claims filed by any State VR agency, if we determine that such review is necessary to ensure compliance with the requirements of this subpart. For each claim selected for review, the State VR agency must submit such records of the VR services and costs for which payment has been requested or made under this subpart, or copies of such records, as we may require to ensure that the services and costs meet the requirements for payment. For claims for cases described in § 404.2101(a), a clear explanation or existing documentation which demonstrates how the service contributed to the individual's performance of a continuous 9-month period of SGA must be provided. For claims for cases described in § 404.2101(b) or (c), a clear explanation or existing documentation which demonstrates how the service was reasonably expected to motivate or assist the individual to return to or continue in SGA must be provided. If we find in any prepayment validation review, that the scope or content of the information is inadequate, we will request additional information and will withhold payment until adequate information has been provided. The State VR agency shall permit us (including duly authorized representatives) access to, and the right to examine, any records relating to such services and costs. Any review performed under this section will not be considered an audit for purposes of this subpart.

(b) * * *

(3) To assess the need for additional validation reviews or additional documentation requirements for any State VR agency to ensure compliance with the requirements under this subpart.

(c) Determinations. In any validation review, we will determine whether the VR services and costs meet the requirements for payment and determine the amount of payment. We will notify in writing the State VR agency of our determination. If we find in any postpayment validation review that more or less than the correct amount of payment was made for a claim, we will determine that an overpayment or underpayment has occurred and will notify the State VR agency that we will make the appropriate adjustment.

(d) Appeals. If the State VR agency disagrees with our determination under this section, it may appeal that determination in accordance with § 404.2127. For purposes of this section, an appeal must be filed within 60 days after receiving the notice of our determination.

19. Revise § 404.2122 to read as follows:
§ 404.2122 Confidentiality of information and records.

The State shall comply with the provisions for confidentiality of information, including the security of systems, and records requirements described in 20 CFR part 401 and pertinent written guidelines (see § 404.2123).

20. Revise § 404.2123 to read as follows:
§ 404.2123 Other Federal laws and regulations.

Each State VR agency shall comply with the provisions of other Federal laws and regulations that directly affect its responsibilities in carrying out the vocational rehabilitation function.

21. Amend § 404.2127 by revising paragraphs (a) and (c) to read as follows:
§ 404.2127 Resolution of disputes.

(a) Disputes on the amount to be paid. The appropriate SSA official will notify the State VR agency in writing of his or her determination concerning the amount to be paid. If the State VR agency disagrees with that determination, the State VR agency may request reconsideration in writing within 60 days after receiving the notice of determination. The Commissioner will make a determination and notify the State VR agency of that decision in writing, usually no later than 45 days from the date of the State VR agency's appeal. The decision by the Commissioner will be final and conclusive upon the State VR agency unless the State VR agency appeals that decision in writing in accordance with 45 CFR part 16 to the Department of Health and Human Services' Departmental Appeals Board within 30 days after receiving the Commissioner's decision.

(c) Disputes on determinations made by the Commissioner which affect a disability beneficiary's rights to benefits. Determinations made by the Commissioner which affect an individual's right to benefits (e.g., determinations that disability benefits should be terminated, denied, suspended, continued or begun at a different date than alleged) cannot be appealed by a State VR agency. Because these determinations are an integral part of the disability benefits claims process, they can only be appealed by the beneficiary or applicant whose rights are affected or by his or her authorized representative. However, if an appeal of an unfavorable determination is made by the individual and is successful, the new determination would also apply for purposes of this subpart. While a VR agency cannot appeal a determination made by the Commissioner which affects a beneficiary's or applicant's rights, the VR agency can furnish any evidence it may have which would support a revision of a determination.

PART 411—THE TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM 22. The authority citation for part 411 continues to read as follows: Authority:

Secs. 702(a)(5) and 1148 of the Social Security Act (42 U.S.C. 902(a)(5) and 1320b-19); sec. 101(b)-(e), Public Law 106-170, 113 Stat. 1860, 1873 (42 U.S.C. 1320b-19 note).

Subpart A—Introduction
§ 411.100 [Amended]
23. Amend § 411.100 by removing paragraph (j). 24. Amend § 411.115 by revising paragraph (f) to read as follows:
§ 411.115 Definitions of terms used in this part.

(f) Employment plan means an individual work plan described in paragraph (i) of this section, or an individualized plan for employment described in paragraph (j) of this section.

Subpart E—Employment Networks
§ 411.305 [Amended]
25. Amend § 411.305 by removing and reserving paragraph (d). Subpart J—[Removed] 26. Remove subpart J, consisting of §§ 411.700 through 411.730. PART 416—SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Subpart A—Introduction, General Provisions and Definitions 27. The authority citation for subpart A of part 416 is revised to read as follows: Authority:

Secs. 702(a)(5) and 1601-1635 of the Social Security Act (42 U.S.C. 902(a)(5) and 1381-1383d); sec. 212, Pub. L. 93-66, 87 Stat. 155 (42 U.S.C. 1382 note); sec. 502(a), Pub. L. 94-241, 90 Stat. 268 (48 U.S.C. 1681 note).

28. Amend § 416.101 by revising paragraph (v) to read as follows:
§ 416.101 Introduction.

(v) Subpart V of this part explains when payments are made to State vocational rehabilitation agencies for vocational rehabilitation services.

Subpart V—Payments for Vocational Rehabilitation Services 29. The authority citation for subpart V of part 416 continues to read as follows: Authority:

Secs. 702(a)(5), 1615, 1631(d)(1) and (e), and 1633(a) of the Social Security Act (42 U.S.C. 902(a)(5), 1382d, 1383(d)(1) and (e), and 1383b(a)).

30. Amend § 416.2201 introductory text to read as follows:
§ 416.2201 General.

In general, sections 1615(d) and (e) of the Social Security Act (the Act) authorize payment from the general fund for the reasonable and necessary costs of vocational rehabilitation (VR) services provided certain disabled or blind individuals who are eligible for supplemental security income (SSI) benefits, special SSI eligibility status, or federally administered State supplementary payments. In this subpart, such benefits, status, or payments are referred to as disability or blindness benefits (see § 416.2203). Subject to the provisions of this subpart, payment may be made for VR services provided an individual during a month(s) for which the individual is eligible for disability or blindness benefits, including the continuation of such benefits under section 1631(a)(6) of the Act, or for which the individual's disability or blindness benefits are suspended (see § 416.2215). Paragraphs (a) and (b) of this section describe the cases in which the State VR agencies can be paid for the VR services provided such an individual under this subpart. The purpose of sections 1615(d) and (e) of the Act is to make VR services more readily available to disabled or blind individuals and ensure that savings accrue to the general fund. Payment will be made for VR services provided on behalf of such an individual in cases where—

31. Amend § 416.2202 as follows: a. Remove and reserve paragraphs (c) and (j); and b. Revise the introductory text and paragraphs (b), (d), (f), and (k).

The revisions read as follows:

§ 416.2202 Purpose and scope.

This subpart describes the rules under which the Commissioner will pay the State VR agencies for VR services. Payment will be provided for VR services provided on behalf of disabled or blind individuals under one or more of the provisions discussed in § 416.2201.

(b) Section 416.2204 explains how State VR agencies may participate in the payment program under this subpart.

(c) [Reserved]

(d) Sections 416.2208 through 416.2209 describe the requirements and conditions under which we will pay a State VR agency under this subpart.

(f) Section 416.2212 describes when payment will be made to a VR agency because an individual's disability or blindness benefits are continued based on his or her participation in a VR program which we have determined will increase the likelihood that he or she will not return to the disability rolls.

(j) [Reserved]

(k) Section 416.2219 describes how we will make payment to State VR agencies for rehabilitation services.

§ 416.2203 [Amended]
32. Amend § 416.2203 by removing the definition of Alternate participants. 33. Amend § 416.2204 as follows: a. Remove paragraphs (b)(3) and (f); b. Remove and reserve paragraph (e)(2); c. Revise the heading of the section and paragraphs (a), (b)(2), (c)(2), and (e)(3).

The revisions read as follows:

§ 416.2204 Participation by State VR agencies.

(a) General. In order to participate in the payment program under this subpart through its VR agency(ies), a State must have a plan which meets the requirements of title I of the Rehabilitation Act of 1973, as amended.

(b) * * *

(2) A State with one or more approved VR agencies may choose to limit participation of those agencies to a certain class(es) of disabled or blind recipients. For example, a State with separate VR agencies for the blind and disabled may choose to limit participation to the VR agency for the blind. In such a case, we would give the State, through its VR agency for the blind, the opportunity to participate with respect to blind recipients in the State in accordance with paragraph (d) of this section. A State that chooses to limit participation of its VR agency(ies) must notify us in advance under paragraph (e)(1) of this section of its decision to limit such participation.

(c) * * *

(2)(i) In order for the State to participate with respect to a disabled or blind recipient whom we referred to a State VR agency, the State VR agency must notify the appropriate Regional Commissioner (SSA) in writing or through electronic notification of its decision either to accept the recipient as a client for VR services or to place the recipient into an extended evaluation process. The notice must be received by the appropriate Regional Commissioner (SSA) no later than the close of the fourth month following the month in which we referred the recipient to the State VR agency.

(ii) In any case in which a State VR agency notifies the appropriate Regional Commissioner (SSA) in writing within the stated time period under paragraph (c)(2)(i) of this section of its decision to place the recipient into an extended evaluation process, the State VR agency also must notify that Regional Commissioner in writing upon completion of the evaluation of its decision whether or not to accept the recipient as a client for VR services. If we receive a notice of a decision by the State VR agency to accept the recipient as a client for VR services following the completion of the extended evaluation, the State may continue to participate with respect to such recipient.

(e) * * *

(2) [Reserved]

(3) A State which has decided not to participate or to limit participation may participate later through its VR agency(ies) in accordance with paragraph (c) of this section. A State that decides to resume participation under paragraph (c) of this section must provide advance written notice of that decision to the appropriate Regional Commissioner (SSA). A decision of a State to resume participation under paragraph (c) of this section will be effective beginning with the third month following the month in which the notice of the decision is received by the appropriate Regional Commissioner (SSA) or, if later, with a month specified by the State. The notice of the State decision must be submitted by an official authorized to act for the State as explained in paragraph (e)(1) of this section.

§ 416.2206 [Removed and Reserved]
34. Remove and reserve § 416.2206. 35. Amend § 416.2208 by revising paragraphs (a), (d), and (f) as follows:
§ 416.2208 Requirements for payment.

(a) The State VR agency must file a claim for payment in each individual case within the time periods specified in § 416.2216;

(d) The VR services for which payment is being requested must have been provided under a State plan for VR services approved under title I of the Rehabilitation Act of 1973, as amended, and must be services that are described in § 416.2214;

(f) The State VR agency must maintain, and provide as we may require, adequate documentation of all services and costs for all disabled or blind recipients with respect to whom a State VR agency could potentially request payment for services and costs under this subpart; and

36. Amend § 416.2211 by revising the introductory text and paragraphs (b)(1)(i), and (b)(2) to read as follows:
§ 416.2211 Criteria for determining when VR services will be considered to have contributed to a continuous period of 9 months.

The State VR agency may be paid for VR services if such services contribute to the individual's performance of a continuous 9-month period of SGA. The following criteria apply to individuals who received more than just evaluation services. If a State VR agency claims payment for services to an individual who received only evaluation services, it must establish that the individual's continuous period or medical recovery (if medical recovery occurred before completion of a continuous period) would not have occurred without the services provided. In applying the criteria below, we will consider services described in § 416.2214 that were initiated, coordinated or provided, including services before October 1, 1981.

(b) * * *

(1) * * *

(i) The individualized written rehabilitation program (IWRP), included medical services; and

(2) In some instances, the State VR agency will not have provided, initiated, or coordinated medical services. If this happens, payment for VR services may still be possible under paragraph (a) of this section if:

(i) The medical recovery was not expected by us; and

(ii) The individual's impairment is determined by us to be of such a nature that any medical services provided would not ordinarily have resulted in, or contributed to, the medical cessation.

37. Revise § 416.2212 to read as follows:
§ 416.2212 Payment for VR services in a case where an individual continues to receive disability or blindness benefits based on participation in an approved VR program.

Section 1631(a)(6) of the Act contains the criteria we will use in determining if an individual whose disability or blindness has ceased should continue to receive disability or blindness benefits because of his or her continued participation in an approved VR program. A VR agency can be paid for the cost of VR services provided to an individual if the individual was receiving benefits based on this provision in a month(s) after October 1984 or, in the case of a blindness recipient, in a month(s) after March 1988. If this requirement is met, a VR agency can be paid for the costs of VR services provided within the period specified in § 416.2215, subject to the other payment and administrative provisions of this subpart.

38. Amend § 416.2214 by revising paragraph (a) introductory text, (a)(2), and (b)(4) to read as follows:
§ 416.2214 Services for which payment may be made.

(a) General. Payment may be made for VR services provided by a State VR agency in accordance with title I of the Rehabilitation Act of 1973, as amended, subject to the limitations and conditions in this subpart. VR services for which payment may be made under this subpart include only those services described in paragraph (b) of this section which are—

(2) Provided by a State VR agency under an IWRP, but only if the services could reasonably be expected to motivate or assist the individual in returning to, or continuing in, SGA.

(b) * * *

(4) Vocational and other training services, including personal and vocational adjustment, books, tools, and other training materials, except that training or training services in institutions of higher education will be covered under this section only if maximum efforts have been made by the State VR agency to secure grant assistance in whole or in part from other sources;

39. Amend § 416.2215 by revising paragraphs (a) introductory text and (b) to read as follows:
§ 416.2215 When services must have been provided.

(a) In order for the VR agency to be paid, the services must have been provided—

(b) If an individual who is receiving disability or blindness benefits under this part, or whose benefits under this part are suspended, also is entitled to disability benefits under part 404 of this chapter, the determination as to when services must have been provided may be made under this section or § 404.2115 of this chapter, whichever is advantageous to the State VR agency that is participating in both VR programs.

40. Amend § 416.2216 by revising the introductory text and paragraphs (b)(1) and (b)(2) to read as follows:
§ 416.2216 When claims for payment for VR services must be made (filing deadlines).

The State VR agency must file a claim for payment in each individual case within the following time periods:

(b) * * *

(1) If a written notice requesting that a claim be filed was sent to the State VR agency, a claim must be filed within 90 days following the month in which VR services end, or if later, within 90 days after receipt of the notice.

(2) If no written notice was sent to the State VR agency, a claim must be filed within 12 months after the month in which VR services end.

41. Amend § 416.2217 by revising the introductory text and paragraphs (a), (b), (c)(1) introductory text, (c)(2), (d), and (e) as follows:
§ 416.2217 What costs will be paid.

In accordance with section 1615(d) and (e) of the Social Security Act, the Commissioner will pay the State VR agency for the VR services described in § 416.2214 which were provided during the period described in § 416.2215 and which meet the criteria in § 416.2211 or § 416.2212, but subject to the following limitations:

(a) The cost must have been incurred by the State VR agency;

(b) The cost must not have been paid or be payable from some other source. For this purpose, State VR agencies will be required to seek payment or services from other sources in accordance with the “similar benefit” provisions under 34 CFR part 361, including making maximum efforts to secure grant assistance in whole or part from other sources for training or training services in institutions of higher education.

(c)(1) The cost must be reasonable and necessary, in that it complies with the written cost-containment policies of the State VR agency. A cost which complies with these policies will be considered necessary only if the cost is for a VR service described in § 416.2214. The State VR agency must maintain and use these cost-containment policies, including any reasonable and appropriate fee schedules, to govern the costs incurred for all VR services, including the rates of payment for all purchased services, for which payment will be requested under this subpart. For the purpose of this subpart, the written cost-containment policies must provide guidelines designed to ensure—

(2) The State VR agency shall submit to us before the end of the first calendar quarter of each year a written statement certifying that cost-containment policies are in effect and are adhered to in procuring and providing goods and services for which the State VR agency requests payment under this subpart. Such certification must be signed by the State's chief financial official or the head of the VR agency. Each certification must specify the basis upon which it is made, e.g., a recent audit by an authorized State, Federal or private auditor (or other independent compliance review) and the date of such audit (or compliance review). We may request the State VR agency to submit to us a copy(ies) of its specific written cost-containment policies and procedures (e.g., any guidelines and fee schedules for a given year), if we determine that such additional information is necessary to ensure compliance with the requirements of this subpart. The State VR agency shall provide such information when requested by us.

(d) The total payment in each case, including any prior payments related to earlier continuous 9-month periods of SGA made under this subpart, must not be so high as to preclude a “net saving” to the general funds (a “net saving” is the difference between the estimated savings to the general fund, if payments for disability or blindness remain reduced or eventually terminate, and the total amount we pay to the State VR agency);

(e) Any payment to the State VR agency for either direct or indirect VR expenses must be consistent with the cost principles described in OMB Circular No. A-87, as revised;

§ 416.2218 [Removed and Reserved]
42. Remove and reserve § 416.2218. 43. Revise § 416.2219 to read as follows:
§ 416.2219 Method of payment.

Payment to the State VR agencies pursuant to this subpart will be made either by advancement of funds or by payment for services provided (with necessary adjustments for any overpayments and underpayments), as decided by the Commissioner.

44. Revise § 416.2220 to read as follows:
§ 416.2220 Audits.

(a) General. The State shall permit us and the Comptroller General of the United States (including duly authorized representatives) access to and the right to examine records relating to the services and costs for which payment was requested or made under these regulations. These records shall be retained by the State for the periods of time specified for retention of records in the Federal Acquisition Regulations (48 CFR part 4, subpart 4.7).

(b) Audit basis. Auditing will be based on cost principles and written guidelines in effect at the time services were provided and costs were incurred. The State VR agency will be informed and given a full explanation of any questioned items. They will be given a reasonable time to explain questioned items. Any explanation furnished by the State VR agency will be given full consideration before a final determination is made on questioned items in the audit report.

(c) Appeal of audit determinations. The appropriate SSA Regional Commissioner will notify the State VR agency in writing of his or her final determination on the audit report. If the State VR agency disagrees with that determination, it may request reconsideration in writing within 60 days after receiving the Regional Commissioner's notice of the determination. The Commissioner will make a determination and notify the State VR agency of that decision in writing, usually, no later than 45 days from the date of the appeal. The decision by the Commissioner will be final and conclusive unless the State VR agency appeals that decision in writing in accordance with 45 CFR part 16 to the Department of Health and Human Services' Departmental Appeals Board within 30 days after receiving it.

45. Amend § 416.2221 by revising paragraphs (a), (b)(3), (c), and (d) to read as follows:
§ 416.2221 Validation reviews.

(a) General. We will conduct a validation review of a sample of the claims for payment filed by each State VR agency. We will conduct some of these reviews on a prepayment basis and some on a postpayment basis. We may review a specific claim, a sample of the claims, or all the claims filed by any State VR agency, if we determine that such review is necessary to ensure compliance with the requirements of this subpart. For each claim selected for review, the State VR agency must submit such records of the VR services and costs for which payment has been requested or made under this subpart, or copies of such records, as we may require to ensure that the services and costs meet the requirements for payment. For claims for cases described in § 416.2201(a), a clear explanation or existing documentation which demonstrates how the service contributed to the individual's performance of a continuous 9-month period of SGA must be provided. For claims for cases described in § 416.2201(b) or (c), a clear explanation or existing documentation which demonstrates how the service was reasonably expected to motivate or assist the individual to return to or continue in SGA must be provided. If we find in any prepayment validation review that the scope or content of the information is inadequate, we will request additional information and will withhold payment until adequate information has been provided. The State VR agency shall permit us (including duly authorized representatives) access to, and the right to examine, any records relating to such services and costs. Any review performed under this section will not be considered an audit for purposes of this subpart.

(b) * * *

(3) To assess the need for additional validation reviews or additional documentation requirements for any State VR agency to ensure compliance with the requirements under this subpart.

(c) Determinations. In any validation review, we will determine whether the VR services and costs meet the requirements for payment and determine the amount of payment. We will notify in writing the State VR agency of our determination. If we find in any postpayment validation review that more or less than the correct amount of payment was made for a claim, we will determine that an overpayment or underpayment has occurred and will notify the State VR agency that we will make the appropriate adjustment.

(d) Appeals. If the State VR agency disagrees with our determination under this section, it may appeal that determination in accordance with § 416.2227. For purposes of this section, an appeal must be filed within 60 days after receiving the notice of our determination.

46. Revise § 416.2222 to read as follows:
§ 416.2222 Confidentiality of information and records.

The State shall comply with the provisions for confidentiality of information, including the security of systems, and records requirements described in 20 CFR part 401 and pertinent written guidelines (see § 416.2223).

47. Revise § 416.2223 to read as follows:
§ 416.2223 Other Federal laws and regulations.

Each State VR agency shall comply with the provisions of other Federal laws and regulations that directly affect its responsibilities in carrying out the vocational rehabilitation function.

48. Amend § 416.2227 by revising paragraphs (a) and (c) to read as follows:
§ 416.2227 Resolution of disputes.

(a) Disputes on the amount to be paid. The appropriate SSA official will notify the State VR agency in writing of his or her determination concerning the amount to be paid. If the State VR agency disagrees with that determination, the State VR agency may request reconsideration in writing within 60 days after receiving the notice of determination. The Commissioner will make a determination and notify the State VR agency of that decision in writing, usually, no later than 45 days from the date of the State VR agency's appeal. The decision by the Commissioner will be final and conclusive upon the State VR agency unless the State VR agency appeals that decision in writing in accordance with 45 CFR part 16 to the Department of Health and Human Services' Departmental Appeals Board within 30 days after receiving the Commissioner's decision.

(c) Disputes on determinations made by the Commissioner which affect a disabled or blind beneficiary's rights to benefits. Determinations made by the Commissioner which affect an individual's right to benefits (e.g., determinations that disability or blindness benefits should be terminated, denied, suspended, continued or begun at a different date than alleged) cannot be appealed by a State VR agency. Because these determinations are an integral part of the disability or blindness benefits claims process, they can only be appealed by the beneficiary or applicant whose rights are affected or by his or her authorized representative. However, if an appeal of an unfavorable determination is made by the individual and is successful, the new determination would also apply for purposes of this subpart. While a VR agency cannot appeal a determination made by the Commissioner which affects a beneficiary's or applicant's rights, the VR agency can furnish any evidence it may have which would support a revision of a determination.

[FR Doc. 2018-26231 Filed 12-3-18; 8:45 am] BILLING CODE 4191-02-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2018-0627; FRL-9986-74] RIN 2070-AB27 Significant New Use Rules on Certain Chemical Substances; Withdrawal AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Withdrawal of direct final rule.

SUMMARY:

EPA is withdrawing significant new use rules (SNURs) promulgated under the Toxic Substances Control Act (TSCA) for 26 chemical substances, which were the subject of premanufacture notices (PMNs). EPA published these SNURs using direct final rulemaking procedures, which requires EPA to take certain actions if an adverse comment is received. EPA received adverse comments regarding the SNURs identified in the direct final rule. Therefore, the Agency is withdrawing the direct final rule SNURs identified in this document, as required under the direct final rulemaking procedures.

DATES:

The direct final rule published at 83 FR 49806 on October 3, 2018 (FRL-9983-82) is withdrawn effective December 3, 2018.

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0627, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. 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 OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

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

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

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

A list of potentially affected entities is provided in the Federal Register of October 3, 2018 (83 FR 49806) (FRL-9983-82). If you have questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

II. What direct final SNURs are being withdrawn?

In the Federal Register of October 3, 2018 (83 FR 49806) (FRL-9983-82), EPA issued direct final SNURs for 26 chemical substances that are identified in the document. Because the Agency received adverse comments regarding the SNURs identified in the document, EPA is withdrawing the direct final SNURs issued for these 26 chemical substances, which were the subject of PMNs. In addition to the Direct Final SNURs, elsewhere in the same issue of the Federal Register of October 3, 2018 (83 FR 49903) (FRL-9983-81), EPA issued proposed SNURs covering these 26 chemical substances. EPA will address all adverse public comments in a subsequent final rule, based on the proposed rule.

III. Good Cause Finding

EPA determined that this document is not subject to the 30-day delay of effective date generally required by the Administrative Procedure Act (APA) (5 U.S.C. 553(d)) because of the time limitations for publication in the Federal Register. This document must publish on or before the effective date of the direct final rule containing the direct final SNURs being withdrawn.

IV. Statutory and Executive Order Reviews

This action withdraws regulatory requirements that have not gone into effect and which contain no new or amended requirements and reopens a comment period. As such, the Agency has determined that this action will not have any adverse impacts, economic or otherwise. The statutory and Executive Order review requirements applicable to the direct final rules were discussed in the October 3, 2018 Federal Register (83 FR 49806). Those review requirements do not apply to this action because it is a withdrawal and does not contain any new or amended requirements.

V. Congressional Review Act (CRA)

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). Section 808 of the CRA allows the issuing agency to make a rule effective sooner than otherwise provided by CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary, or contrary to the public interest. As required by 5 U.S.C. 808(2), this determination is supported by a brief statement in Unit III.

List of Subjects 40 CFR Part 9

Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

Dated: November 19, 2018. Lance Wormell, Acting Director, Chemical Control Division, Office of Pollution Prevention and Toxics. Accordingly, the amendments to 40 CFR parts 9 and 721 published on October 3, 2018 (83 FR 49806), are withdrawn effective December 3, 2018.
[FR Doc. 2018-26358 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R01-OAR-2017-0344; FRL-9986-82-Region 1] Air Plan Approval; New Hampshire; Infrastructure State Implementation Plan Requirements for the 2012 PM2.5 NAAQS AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is approving two State Implementation Plan (SIP) submissions from New Hampshire that address the infrastructure SIP requirements, including the interstate transport requirements, of the Clean Air Act (CAA or Act) for the 2012 fine particle (PM2.5) National Ambient Air Quality Standards (NAAQS). The approval does not address CAA section 110(a)(2)(K) (regarding air quality modeling and data), which EPA will address in a later rulemaking. The infrastructure SIP requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities with respect to this NAAQS under the CAA, including the obligations related to transport. The EPA is taking this action under the Clean Air Act.

DATES:

This rule is effective on January 3, 2019.

ADDRESSES:

EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2017-0344. All documents in the docket are listed on the https://www.regulations.gov website. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available at https://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA New England Regional Office, Office of Ecosystem Protection, Air Quality Planning Unit, 5 Post Office Square-Suite 100, Boston, MA. EPA requests that if at all possible, you contact the contact listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays.

FOR FURTHER INFORMATION CONTACT:

Alison C. Simcox, Air Quality Unit, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square-Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912, tel. (617) 918-1684; [email protected]

SUPPLEMENTARY INFORMATION:

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

Table of Contents I. Background and Purpose II. Response to Comments III. Final Action IV. Statutory and Executive Order Reviews I. Background and Purpose

On April 10, 2018 (83 FR 15343), EPA published a Notice of Proposed Rulemaking (NPRM) for the State of New Hampshire. The NPRM proposed approval of two SIP submissions from the New Hampshire Department of Environmental Services (NHDES), which included an infrastructure SIP submission for the 2012 fine particle (PM2.5 1 ) National Ambient Air Quality Standard (NAAQS) submitted by the state on December 22, 2015, and a separate SIP submission addressing the “Good Neighbor” (or “transport”) provisions for the 2012 PM2.5 NAAQS (Section 110(a)(2)(D)(i)(I) of the CAA) submitted by the state on June 8, 2016.

1 PM2.5 refers to particulate matter of 2.5 microns or less in diameter, often referred to as “fine” particles.

This rulemaking does not cover three substantive areas that are not integral to acting on a state's infrastructure SIP submission: (i) Existing provisions related to excess emissions during periods of start-up, shutdown, or malfunction at sources (“SSM” emissions) that may be contrary to the CAA and EPA's policies addressing such excess emissions; (ii) existing provisions related to “director's variance” or “director's discretion” that purport to permit revisions to SIP-approved emissions limits with limited public process or without requiring further approval by EPA, that may be contrary to the CAA (“director's discretion”); and, (iii) existing provisions for Prevention of Significant Deterioration (PSD) programs that may be inconsistent with current requirements of EPA's “Final New Source Review (NSR) Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”). Instead, EPA has the authority to address each of these substantive areas separately. A detailed history, interpretation, and rationale for EPA's approach to infrastructure SIP requirements can be found in EPA's May 13, 2014, proposed rule entitled, “Infrastructure SIP Requirements for the 2008 Lead NAAQS” in the section, “What is the scope of this rulemaking?” See 79 FR 27241 at 27242-45.

The rationale for EPA's proposed action is explained in the NPRM and will not be restated here.

II. Response to Comments

EPA received six sets of comments during the comment period. Only one set includes significant, adverse comment, and it relates solely to section 110(a)(2)(K) of the Act (regarding air quality modeling and data). In the NPRM, EPA proposed to approve NHDES' submissions for the 2012 PM2.5 NAAQS for the infrastructure requirements of Section 110(a)(2)(A) through (M), including (K). In this rulemaking, EPA is finalizing the approval of New Hampshire's submissions for the infrastructure requirements of section 110(a)(2)(A) through (M), except (K). EPA will take separate action at a later date addressing these comments and the section 110(a)(2)(K) requirements for New Hampshire's infrastructure SIP submissions for the 2012 PM2.5 NAAQS.

The other five sets of comments we received all discuss subjects outside the scope of an infrastructure SIP action, do not explain (or provide a legal basis for) how the proposed action should differ in any way, and, indeed, make no specific mention of the proposed action. Consequently, those five sets of comments are not germane to this rulemaking and require no further response.

III. Final Action

EPA is approving New Hampshire's December 2015 and June 2016 infrastructure SIP submissions for the 2012 PM2.5 NAAQS, except for Section 110(a)(2)(K) (regarding air quality modeling and data), which EPA will address in a later rulemaking.

IV. Statutory and Executive Order Reviews

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

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

• This action is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866;

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

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

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

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

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

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

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

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 4, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

Dated: November 28, 2018. Alexandra Dunn, Regional Administrator, EPA Region 1.

Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

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

42 U.S.C. 7401 et seq.

Subpart EE—New Hampshire 2. Amend § 52.1520 in the table in paragraph (e) by adding an entry for “Submittals to meet Section 110(a)(2) Infrastructure Requirements for the 2012 PM2.5 NAAQS” at the end of the table to read as follows:
§ 52.1520 Identification of plan.

(e) * * *

New Hampshire NonRegulatory Name of nonregulatory SIP provision Applicable geographic or nonattainment area State submittal date/
  • effective date
  • EPA approved date Explanations
    *         *         *         *         *         *         * Submittals to meet Section 110(a)(2) Infrastructure Requirements for the 2012 PM2.5 NAAQS Statewide 12/22/2015; supplement submitted 6/8/2016 12/4/2018, [Insert Federal Register citation] These submittals are approved with respect to the following CAA requirements: 110(a)(2)(A), (B), (C), (D), (E), (F), (G), (H), (J), (L), and (M).
    [FR Doc. 2018-26284 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R01-OAR-2018-0099; FRL-9986-97-Region 1] Air Plan Approval; Connecticut; Volatile Organic Compound Emissions From Consumer Products and Architectural and Industrial Maintenance Coatings; Correction AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule; correction.

    SUMMARY:

    This document corrects the preamble in the DATES section to a final rule published in the Federal Register on November 19, 2018. The Environmental Protection Agency (EPA) published a final rule approving Connecticut's State Implementation Plan (SIP) revision that amended requirements for controlling volatile organic compound (VOC) emissions from consumer products and architectural and industrial maintenance (AIM) coatings by revising Regulations of Connecticut State Agencies (RCSA) sections 22a-174-40, 22a-174-41, and adding section 22a-174-41a.

    DATES:

    This final rule correction is effective on December 4, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Ariel Garcia, Air Quality Planning Unit, U.S. Environmental Protection Agency, EPA Region 1 Regional Office, 5 Post Office Square, Suite 100 (Mail code: OEP05-2), Boston, MA 02109-3912, telephone number: (617) 918-1660, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The EPA issued a final rule in the Federal Register on November 19, 2018 (83 FR 58188). An error occurred in the DATES section where it erroneously stated that “Written comments must be received on or before December 19, 2018.” The EPA previously provided an opportunity for written comments, on our proposed approval of Connecticut's SIP revision, in a proposed rule issued in the Federal Register on June 4, 2018 (83 FR 25615). Therefore, this corrective action merely designates the Final rule as being effective on December 19, 2018.

    Correction

    In FR Doc. 2018-24895 appearing on page 58188 in the Federal Register of Monday, November 19, 2018, the following correction is made:

    On page 58188, in the second column, under the heading entitled DATES remove the text “Written comments must be received on or before December 19, 2018.” and add in its place the text “This final rule is effective on December 19, 2018.”.

    Dated: November 28, 2018. Alexandra Dunn, Regional Administrator, EPA Region 1.
    [FR Doc. 2018-26286 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2018-0116; FRL-9987-12-Region 4] Air Plan Approval; Georgia; Revisions To VOC Definitions and Ambient Air Quality Standards AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    On November 13, 2017, the State of Georgia through the Georgia Environmental Protection Division (EPD), submitted a revision to the Georgia State Implementation Plan (SIP). The Environmental Protection Agency (EPA) is approving changes to several portions of the revision that modifies the State's air quality regulations as incorporated into the SIP. Specifically, the revision pertains to definition changes, including the modification of the definition of “volatile organic compounds” (VOC) and changes to the State's air quality standards for sulfur dioxide, particulate matter, carbon monoxide, ozone, lead and nitrogen dioxide to be consistent with the National Ambient Air Quality Standard (NAAQS). EPA is approving these provisions of the SIP revision because the State has demonstrated that the changes are consistent with the Clean Air Act (CAA or Act).

    DATES:

    This rule will be effective January 3, 2019.

    ADDRESSES:

    EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2018-0116. All documents in the docket are listed on the www.regulations.gov website. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Tiereny Bell, Air Regulatory Management Section, Air Planning and Implementation Branch, Pesticides and Toxics Management Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9088. Ms. Bell can also be reached via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    On July 17, 2018 (83 FR 33168), EPA proposed to approve into the Georgia SIP changes to Georgia's air quality rule 391-3-1-.01, “Definitions” and rule 391-3-1-.02(4), “Ambient Air Standards” submitted by the State of Georgia through the Georgia EPD on November 13, 2017. EPA's July 17, 2018, rulemaking did not propose action on Georgia's air quality rules 391-3-1-.03(6), “Exemption” under permits and rule 391-3-1-.0(7)(a)(1), “General Requirements” under Prevention of Significant Deterioration (PSD). EPA will address these changes in a separate notice. Additionally, EPA's July 17, 2018, rulemaking did not propose action on Georgia's air quality rule 391-3-1-.02(7)(a)2(ix), “Regulated NSR pollutant” under PSD, and rule 391-3-1-.03(8)(c)(16), “Additional Provisions for PM2.5 Non-attainment Areas” under permits.1

    1 The State withdrew Rule 391-3-1-.02(7)(a)2(ix), “Regulated NSR pollutant” and Rule 391-3-1-.03(8)(c)(16), “Additional Provisions for PM2.5 Non-Attainment Areas” on December 1, 2016, and July 26, 2017, respectively. The State also acknowledges this in the response to comment of the pre-hearing in the November 13, 2017, submittal. The information is in the Docket.

    The November 13, 2017, SIP revision changes Rule 391-3-1-.01, “Definitions” by adding t-Butyl acetate (also known as tertiary butyl acetate or TBAC) and 1,1,2,2-Tetrafluoro-1-(2,2,2-trifluoroethoxy) ethane to the list of organic compounds having negligible photochemical reactivity. The definition of VOC is also being updated by removing the recordkeeping requirements for t-Butyl acetate. Additionally, the definition of VOC is being revised to include chemical names to clarify previous exemptions. Lastly, the submission revises Rule 391-3-1-.02(4), “Ambient Air Standards” by updating Georgia's air quality standard to be consistent with the NAAQS. The details of the Georgia submission and the rationale for EPA's action are explained in the proposed rulemaking. Comments on the proposed rulemaking were due on or before August 20, 2018. EPA did not receive any adverse comments on the proposed action. EPA is now taking final action to approve the above-referenced revisions.

    II. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of Georgia Rule 391-3-1-.01 entitled “Definitions,” effective July 20, 2017, which revises the VOC definition and removes the recordkeeping requirements for t-Butyl acetate. Rule 391-3-1-.02(4) entitled “Ambient Air Standards,” effective July 20, 2017, updates Georgia's air quality standard to be consistent with the NAAQS. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 Office (please contact the person identified in the For Further Information Contact section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.2

    2See 62 FR 27968 (May 22, 1997).

    III. Final Action

    EPA is taking final action to approve Georgia's November 13, 2017, SIP revision which amends the VOC definition in rule 391-3-1-.01, and updates Georgia's air quality standards to be consistent with the NAAQS in rule 391-3-1-.02(4). EPA has evaluated the relevant portions of Georgia's November 13, 2017, SIP revision and has determined that it meets the applicable requirements of the CAA and EPA regulations.

    IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. This action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

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

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

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

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

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

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

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

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

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

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

    The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

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

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 4, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: November 15, 2018. Onis “Trey” Glenn, III, Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

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

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

    Subpart L—Georgia 2. In § 52.570, the table in paragraph (c) is amended by revising the entries “391-3-1-.01” and “391-3-1-.02(4)” to read as follows:
    § 52.570 Identification of plan.

    (c)* * *

    EPA-Approved Georgia Regulations State citation Title/subject State effective date EPA approval date Explanation 391-3-1-.01 Definitions 7/20/2017 12/4/2018, [insert Federal Register citation] *         *         *         *         *         *         * Emission Standards *         *         *         *         *         *         * 391-3-1-.02(4) Ambient Air Standards 7/20/2017 12/4/2018 [insert Federal Register citation] *         *         *         *         *         *         *
    [FR Doc. 2018-26245 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2018-0676; FRL-9986-66-Region 6] Air Plan Approval; Texas; Emission Statements AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule.

    SUMMARY:

    Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving a portion of a State Implementation Plan (SIP) revision submitted by the State of Texas for the 2008 8-hour ozone national ambient air quality standards (NAAQS). The portion of the SIP revision being approved pertains to CAA 2008 ozone NAAQS requirement for emission statements in the Dallas/Fort Worth ozone nonattainment area (DFW area).

    DATES:

    This rule is effective on March 4, 2019 without further notice, unless the EPA receives relevant adverse comment by January 3, 2019. If the EPA receives such comment, the EPA will publish a timely withdrawal in the Federal Register informing the public that this rule will not take effect.

    ADDRESSES:

    Submit your comments, identified by Docket No. EPA-R06-OAR-2018-0676, at https://www.regulations.gov or via email to [email protected] Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, please contact Ms. Karolina Ruan Lei, 214-665-7346, [email protected] For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

    Docket: The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available at either location (e.g., CBI).

    FOR FURTHER INFORMATION CONTACT:

    Ms. Karolina Ruan Lei, 214-665-7346, [email protected] To inspect the hard copy materials, please schedule an appointment with Ms. Karolina Ruan Lei or Mr. Bill Deese at 214-665-7253.

    SUPPLEMENTARY INFORMATION:

    Throughout this document “we,” “us,” and “our” means the EPA.

    I. Background

    Section 110 of the CAA requires states to develop and submit to the EPA a SIP to ensure that state air quality meets the NAAQS. These ambient standards currently address six criteria pollutants: Carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide. Each federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin through air pollution regulations and control strategies. The EPA approved SIP regulations and control strategies are federally enforceable.

    In 2008, we revised the 8-hour ozone primary and secondary NAAQS to a level of 0.075 parts per million (ppm) to provide increased protection of public health and the environment (73 FR 16436, March 27, 2008). The 2008 8-hour ozone NAAQS revised the 1997 8-hour ozone NAAQS of 0.08 ppm. The DFW area was classified as a “Moderate” ozone nonattainment area for the 2008 8-hour ozone NAAQS (77 FR 30088, May 21, 2012). The DFW 2008 ozone nonattainment area consists of Collin, Dallas, Denton, Ellis, Johnson, Kaufman, Parker, Rockwall, Tarrant, and Wise counties.

    On August 21, 2018, Texas submitted a SIP revision addressing oxides of nitrogen (NOx) reasonably available control technology (RACT) for a cement manufacturing plant in Ellis County as a part of its DFW 2008 8-hour ozone NAAQS SIP update. That SIP revision also included a description of how the CAA Section 182(a)(3)(B) requirement for emission statements from stationary point sources are met in the DFW area for the 2008 ozone NAAQS, using already-existing measures previously approved by EPA.1 EPA is only evaluating the emission statements portion of the August 21, 2018 SIP submittal in this action.2 A copy of the SIP revision submittal that includes the emission statement requirement is included in the docket to this rulemaking and is available online at www.regulations.gov, Docket number EPA-R06-OAR-2018-0676. In the SIP revision submittal, Texas noted that the SIP revision pertaining to emissions inventory requirements approved by EPA on August 26, 1994 (59 FR 44036) meets the CAA requirement for emission statements. The codification of the Texas SIP approved by EPA can be found at 40 CFR 52.2270(c).

    1 See page 4-4 of the adopted SIP revision submittal by Texas that is included in the docket to this action.

    2 In a separate action we proposed to approve the remainder of the August 21, 2018 SIP submittal. See Docket number EPA-R06-OAR-2018-0675 online at www.regulations.gov.

    II. The EPA's Evaluation

    CAA section 182(a)(3)(B) calls for SIPs for all ozone nonattainment areas to require that the owner or operator of each stationary source of nitrogen oxides or volatile organic compounds (ozone precursors) provide the State with an annual statement of emissions along with a certification that this information is accurate to the best knowledge of the individual certifying the statement.

    The Texas SIP includes 30 TAC Section 101.10 (Emissions Inventory Requirements). The certification for emission statements is found at 30 TAC Section 101.10(d) (Certifying statement). We initially approved this certification as meeting the CAA emission statement requirement on August 26, 1994 (59 FR 44036).3 Most recently we approved revisions to 30 TAC Section 101.10 (Emissions Inventory Requirements) on June 8, 2017 (82 FR 26598). The most recently EPA approved Texas regulation continues to include appropriate provisions so that the owner or operator of each stationary source must provide the State with a statement with each emissions inventory attesting that the information contained in the inventory is true and accurate to the best knowledge of the certifying official (30 TAC Section 101.10(d)(1)). We find that the SIP revision submittal that is the subject of this action continues to be consistent with those requirements. Therefore, since the Texas SIP already includes an approved CAA emission statement requirement, we are approving this portion of the SIP revision as it pertains to the 2008 ozone standard.

    3 In that action, we approved revisions to 30 TAC Section 101.10: Emissions Inventory Requirements and the emission statement program for stationary sources within ozone nonattainment areas as the revisions satisfied CAA Section 182(a)(3)(B) requirements and was consistent with EPA's draft Guidance on the Implementation of an Emission Statement Program (July 1992).

    III. Final Action

    We are approving the revision to the Texas SIP submitted on August 21, 2018, that pertains to the 2008 ozone NAAQS requirement for emission statements for large stationary sources in the DFW area.

    The EPA is publishing this rule without prior proposal because we view this as a non-controversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the SIP revision if relevant adverse comments are received. This rule will be effective on March 4, 2019 without further notice unless we receive relevant adverse comment by January 3, 2019. If we receive relevant adverse comments, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so now. Please note that if we receive relevant adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

    IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

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

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

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

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

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

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

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

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

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

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

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 4, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

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

    Dated: November 26, 2018. Anne Idsal, Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart SS—Texas 2. In §  52.2270(e), the second table titled “EPA Approved Nonregulatory Provisions and Quasi-Regulatory Measures in the Texas SIP” is amended by adding an entry at the end for “Emission Statement Requirements for the 2008 Ozone NAAQS”.

    The revision reads as follows:

    § 52.2270 Identification of plan.

    (e) * * *

    EPA Approved Nonregulatory Provisions and Quasi-Regulatory Measures in the Texas SIP Name of SIP provision Applicable geographic or non-
  • attainment area
  • State submittal/
  • effective date
  • EPA approval date Comments
    *         *         *         *         *         *         * Emission Statement Requirements for the 2008 Ozone NAAQS Dallas-Fort Worth, TX 8/21/2018 12/4/2018, [Insert Federal Register citation]
    [FR Doc. 2018-26294 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2017-0633; FRL-9986-89-Region 3] Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Revisions to Regulation for Control of Ozone Season Nitrogen Oxide Emissions AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving two state implementation plan (SIP) revisions submitted by the State of West Virginia. The revisions pertain to a West Virginia regulation that established the nitrogen oxides (NOX) ozone season trading program under the Clean Air Interstate Rule (CAIR), which implemented requirements for NOX reductions necessary to reduce interstate transport of pollution. The EPA-administered trading programs under CAIR were discontinued upon the implementation of the Cross-State Air Pollution Rule (CSAPR), which was promulgated by EPA to replace CAIR. CSAPR established Federal implementation plans (FIPs) for 28 states, including West Virginia, and applied to electric generating units (EGUs). The SIP submittals are comprised of revisions to the West Virginia regulation that implemented the CAIR ozone season NOX trading program that had previously been included in the West Virginia SIP. The revised West Virginia regulation removed the CAIR ozone season NOX trading program provisions, which also addressed certain large non-electric generating units (non-EGUs), established new requirements for these large non-EGUs, included a state-wide NOX emissions cap, and recodified certain other provisions that address the NOX emission reductions required for cement kilns and internal combustion engines. EPA is approving these SIP revisions to West Virginia's ozone season NOX regulation in accordance with the requirements of the Clean Air Act (CAA).

    DATES:

    This final rule is effective on January 3, 2019.

    ADDRESSES:

    EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2017-0633. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., confidential business information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available through http://www.regulations.gov, or please contact the person identified in the FOR FURTHER INFORMATION CONTACT section for additional availability information.

    FOR FURTHER INFORMATION CONTACT:

    Marilyn Powers, (215) 814-2308, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    On August 28, 2018 (82 FR 43836), EPA published a notice of proposed rulemaking (NPRM) which proposed approval of the SIP revisions submitted by the State of West Virginia for revisions to Regulation 45CSR40. The first formal SIP revision was submitted by West Virginia through the West Virginia Department of Environmental Protection (WVDEP) on July 13, 2016. On October 10, 2017, WVDEP provided a supplemental SIP submission comprised of a demonstration showing that NOX emissions from applicable non-EGUs do not exceed the West Virginia NOX budget under EPA's NOX SIP Call.1 The NOX SIP Call, issued pursuant to Section 110 of the CAA and codified at 40 CFR 51.121 and 51.122, was designed to mitigate significant transport of NOX, one of the precursors of ozone. At the same time, EPA developed the NOX Budget Trading Program, an EPA-administered allowance trading program that states could adopt to meet their obligations under the NOX SIP Call. The NOX Budget Trading Program allowed EGUs greater than 25 megawatts and industrial non-EGUs, such as boilers and turbines, with a rated heat input greater than 250 million British thermal units per hour (MMBtu/hr), referred to as “large non-EGUs,” to participate in a regional NOX cap and trade program. West Virginia complied with the NOX SIP Call by participation of its large EGUs and large non-EGUs in the NOX Budget Trading Program. EPA discontinued administration of the NOX Budget Trading Program in 2009 upon the start of the CAIR trading programs (70 FR 25162, May 12, 2005). The NOX SIP Call requirements continued to apply, however, and EGUs in most states (including West Virginia) that formerly participated in the NOX Budget Trading Program continued to meet their NOX SIP Call requirements under the generally more stringent requirements of the CAIR NOX Ozone Season Trading Program, either pursuant to CAIR FIPs (71 FR 25328, April 28, 2006) or pursuant to approved CAIR SIP revisions.2 For the large non-EGUs, states needed to take regulatory action to ensure that their obligations under the NOX SIP Call continued to be met, either through an option to submit a CAIR SIP revision that allowed the non-EGUs to participate in the CAIR NOX Ozone Season Trading Program or through adoption of other replacement regulations. West Virginia chose to include the large non-EGUs as CAIR trading sources, and submitted, for inclusion in the SIP, Regulation 40CSR40 which implemented the CAIR NOX Ozone Season Trading Program and included the non-EGUs as trading sources. EPA approved Regulation 45CSR40 into the West Virginia SIP on August 4, 2009 (74 FR 38536). 45CSR40 also included requirements for stationary internal combustion engines and cement manufacturing kilns that are subject to the NOX SIP Call.

    1 In October 1998 (63 FR 57356), EPA finalized the “Finding of Significant Contribution and Rulemaking for Certain States in the Ozone Transport Assessment Group Region for Purposes of Reducing Regional Transport of Ozone”—commonly called the NOX SIP Call.

    2 EPA approved a CAIR SIP revision replacing the CAIR FIP for West Virginia on August 4, 2009 (74 FR 38536).

    When CSAPR replaced CAIR starting on January 1, 2015,3 the CSAPR FIP trading programs for annual NOX, ozone season NOX and annual SO2 were applicable in West Virginia. Thus, since January 1, 2015, the provisions related to implementation of the CAIR Ozone Season Trading Program in West Virginia regulation 45CSR40 were obsolete. Initially, the CSAPR FIP trading programs applied only to EGUs and, unlike CAIR, did not provide for expansion of the ozone season trading program to include the NOX SIP Call large non-EGUs. States, like West Virginia, whose large non-EGUs had previously traded in the CAIR NOX Ozone Season Trading Program, were therefore required to address the non-EGU reduction requirements of the NOX SIP Call outside of a regional trading program.4

    3See NPRM for this action, page 43837, for details on the remand of CAIR.

    4 Subsequent to West Virginia's July 13, 2016 submission, EPA finalized the CSAPR Update Rule to address transport related to the 2008 ozone NAAQS. It is noted that CSAPR Update included flexibility for states to submit SIPs that expand the CSAPR ozone season trading program to include the large non-EGUs. West Virginia has not submitted a SIP that includes the non-EGUs as participants in the CSAPR trading program.

    The CSAPR FIPs which replaced CAIR only applied to EGUs, and, at the time West Virginia developed its SIP submittal, states did not have an option under CSAPR to bring their non-EGUs into the CSAPR NOX Ozone Season Trading Program. So, while EGU compliance with CSAPR satisfied the EGUs' NOX SIP Call requirements, West Virginia needed to modify its ozone season NOX regulation to address the NOX SIP Call requirements for the non-EGUs that were formerly trading in the CAIR NOX ozone season trading program. 40 CFR 51.121(f) sets forth alternatives for states to address NOX SIP Call reduction obligations for large non-EGUs including (1) imposing a NOX mass emissions cap on each source, (2) imposing a NOX emissions rate limit on each source and assuming maximum operating capacity for every such source for purposes of estimating NOX mass emissions, or (3) imposing other regulatory requirements that the state has demonstrated to EPA provide equivalent or greater assurance that the state will comply with its ozone season NOX budget.

    II. Summary of SIP Revision and EPA Analysis

    Former Regulation 45CSR40 (effective in West Virginia on July 1, 2016), which was approved into the West Virginia SIP, was originally adopted by WVDEP to implement the ozone season trading program under CAIR and to address NOX SIP Call requirements. The July 13, 2016 West Virginia SIP submittal is comprised of a revised 45CSR40 which removed the CAIR Ozone Season Trading Program provisions, retained the definitions, applicability, and other provisions responding to the NOX SIP Call (including monitoring under 40 CFR part 75), added new requirements to address its NOX SIP Call obligations for sources that were trading under CAIR but are no longer part of a trading program, and retained and recodified the limits on NOX emissions that applied to stationary internal combustion engines and cement kilns previously in the former version of 45CSR40 (with a State effective date of May 1, 2008) which EPA had approved into the West Virginia SIP. As the CAIR trading program has been replaced by the trading programs under CSAPR, as described previously, these revisions removing references to CAIR are consistent with the requirements for CAA 110(l) as CAIR was replaced by CSAPR and thus no longer yielded reductions in pollutants nor presently applied to any sources.

    On February 8, 2018, WVDEP provided a letter clarifying an applicability exclusion specified in section 4 of 45CSR40 of the July 13, 2016 SIP submittal. The letter clarifies that the West Virginia regulation was intended to refer to current provisions of CSAPR, and thus is intended to refer to updated CSAPR provisions. The letter states that West Virginia will work towards revising 45CSR40 as expeditiously as possible to conform the regulation to refer to currently enforceable CSAPR provisions and will submit the revised 45CSR40 as a SIP revision to EPA for approval once the regulation correctly refers to 40 CFR part 97, subpart EEEEE.

    Other specific requirements of revised West Virginia regulation 45CSR40 and the rationale for EPA's proposed approval are explained in the NPRM and will not be restated here. However, EPA provides two clarifications on the NPRM—one pertains to an aspect of EPA's summary of the new sections in 45CSR40 that address ozone season NOX emissions, and the second pertains to the date of West Virginia's supplemental SIP submission.

    EPA's summary of section 4 (Applicability) explained that any unit that is already subject to the CSAPR NOX Ozone Season Trading Program FIP established under 40 CFR part 97, subpart BBBBB is exempt from the ozone season NOX emission limits, monitoring, recordkeeping, and reporting requirements established in sections 5 and 6 of 45CSR40.5 Section 4 of 45CSR40 also exempts from applicability any units subject to a CSAPR-equivalent trading program established under regulations approved as a SIP revision pursuant to 40 CFR 52.38(b)(5).6 Thus, while West Virginia presently does not have a CSAPR-equivalent program in its SIP, if West Virginia submits a SIP revision for a CSAPR-equivalent trading program in the future, and EPA approves the submittal into the State's SIP, sections 5 and 6 of 45CSR40-4 would not apply to such units. EPA's intent, as stated in the NPRM, is to approve the State submission in full, including the entirety of section 4. Thus, our approval of 45CSR40 is not affected; we are providing this clarification to explain the breadth of 45CSR40.

    5 As noted in section I of this document, West Virginia intends to update the existing reference to 40 CFR part 97, subpart BBBBB to cross-reference the currently applicable CFR provisions at 40 CFR part 97, subpart EEEEE, after which West Virginia will submit the updated regulation to EPA for approval into the SIP.

    6 Consistent with the State's clarification that the existing reference to 40 CFR part 97, subpart BBBBB, is intended to cross-reference the currently applicable CFR provisions at 40 CFR part 97, subpart EEEEE, the existing reference to 40 CFR 52.38(b)(5) should be understood as referring to the currently applicable CFR provision at 40 CFR 52.38(b)(9).

    Also, EPA clarifies that the October 10, 2017 SIP submission, which West Virginia submitted to demonstrate compliance with its NOX SIP Call non-EGU NOX emissions budget, was the only supplemental submission from West Virginia. The references to an October 11, 2017 and an October 13, 2017 supplemental submission were in error and should have instead referred to the October 10, 2017 submittal, which is included in the docket for this rulemaking action.

    III. Public Comments and EPA's Responses

    EPA received three anonymous comments on the NPRM, all of which are in the docket for this rulemaking at www.regulations.gov. One of the comments did not concern any of the specific issues raised in the NPRM, nor did they address EPA's rationale for the proposed approval of WVDEP's submittal. Therefore, EPA is not responding to this comment. The remaining two comments are addressed as follows:

    Comment 1: A commenter noted that the NPRM made reference to an October 11, 2017 and an October 13, 2017 supplemental submission from West Virginia, and asked where these submissions were as the docket only included a supplemental submission dated October 10, 2017.

    EPA Response: The references to the October 11, 2017 and October 13, 2017 submittals were in error as EPA intended to refer instead to the October 10, 2017 supplemental submission. There was only one supplemental submission from West Virginia—the October 10, 2017 submittal, which provided the demonstration that West Virginia's NOX budget was being met. The docket included this submittal, and the preamble to this final rulemaking notice explains that the NPRM inadvertently cited the two incorrect dates that were both intended to refer to the October 10, 2017 submittal.

    Comment 2: A commenter made a general comment that, because of the large coal mining industry in West Virginia, air pollution should be taken seriously to ensure good air quality.

    EPA Response: As explained in this document and in the NPRM, this action establishes new requirements for large non-EGUs to meet West Virginia's obligations under the NOX SIP Call. Total NOX emissions from all affected units may not exceed West Virginia's statewide NOX budget, or cap, established by EPA under the NOX SIP Call. Continuous emissions monitoring, recordkeeping, and reporting are required to assure NOX emissions do not exceed the State cap. Thus, the 45CSR40 in the West Virginia SIP will not interfere with the air quality or CAA requirements, as EPA explained in the NPRM.

    IV. Final Action

    EPA is approving West Virginia's July 13, 2016 SIP revision submittal as supplemented on October 10, 2017 and clarified on February 8, 2018. Amended regulation 45CSR40 removes the obsolete provisions that implemented the CAIR NOX Ozone Season Trading Program, establishes new requirements to address the NOX SIP Call obligations for large non-EGUs in the State that were trading under CAIR but are no longer part of a trading program, establishes an enforceable statewide cap on ozone season NOX emissions for these non-EGUs in accordance with West Virginia's state budget under the NOX SIP Call, and recodifies previously SIP-approved provisions that apply to internal combustion engines and cement kilns. The October 10, 2017 supplemental submission demonstrates that the total NOX emissions from all affected large non-EGUs in West Virginia do not exceed the State cap previously established for West Virginia under the NOX SIP Call. The February 8, 2018 letter clarified West Virginia's intent to refer specifically to provisions of CSAPR presently enforceable and its intent to address the minor citation cross reference expeditiously with a future SIP revision submittal. The revisions are in accordance with section 110 of the CAA as the SIP submittal meets requirements in the CAA and in 40 CFR 51.121 related to the NOX SIP Call requirements.

    V. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of West Virginia regulation 45CSR40—Control of Ozone Season Nitrogen Oxides Emissions. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region III Office (please contact the person identified in the For Further Information Contact section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.7

    7 62 FR 27968 (May 22, 1997).

    VI. Statutory and Executive Order Reviews A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

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

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because

    SIP approvals are exempted under Executive Order 12866.

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

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

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

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

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

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

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

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

    In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

    B. Submission to Congress and the Comptroller General

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

    C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 4, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action approving West Virginia revised regulation 45CSR40 into the West Virginia SIP may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Sulfur oxides.

    Dated: November 13, 2018. Cosmo Servidio, Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart XX—West Virginia 2. In § 52.2520, the table in paragraph (c) is amended by: a. Revising the heading “[45 CSR] Series 40 Control of Ozone Season Nitrogen Oxide Emissions to Mitigate Interstate Transport of Ozone and Nitrogen Oxides” to read “[45 CSR] Series 40 Control of Ozone Season Nitrogen Oxides Emissions”; b. Revising “Section 45-40-1” through “Section 45-40-11”; c. Adding “Section 45-40-9” in numerical order; d. Removing “Section 45-40-12” through “Section 45-40-110”;

    The addition and revisions read as follows:

    § 52.2520 Identification of plan.

    (c) * * *

    EPA-Approved Regulations In the West Virginia SIP State citation
  • [chapter 16-20 or 45 CSR ]
  • Title/subject State
  • effective
  • date
  • EPA approval date Additional explanation/
  • citation at 40 CFR 52.2565
  • *         *         *         *         *         *         * [45 CSR] Series 40 Control of Ozone Season Nitrogen Oxides Emissions Section 45-40-1 General 7/1/16 12/4/2018, [insert Federal Register citation] Revising 1.1.a, 1.1.b, and 1.1.c.
  • Removing 1.2 and 1.3.
  • Recodifying 1.4 and 1.5 to 1.2 and 1.3, respectively.
  • Revising 1.7 and recodifying as 1.5.
  • Prior approval of this section was 74 FR 38536 on 8/4/09.
  • Section 45-40-2 Definitions 7/1/16 12/4/2018, [insert Federal Register citation] Removing 2.1, 2.2, 2.3, 2.5-2.8, 2.10-2.28, 2.31-2.34, 2.36-2.39, 2.41, 2.42, 2.46-2.52, 2.54, 2.58, 2.59, 2.62-2.66, 2.68-2.70, 2.72, 2.75, 2.78-2.82, 2.84-2.87, 2.89, 2.90, 2.92, 2.93, 2.95-2.97, and 2.99-2.103.
  • Revising 2.35 and recodifying as 2.5.
  • Revising 2.40 and recodifying as 2.6.
  • Revising 2.43 and recodifying as 2.7.
  • Revising 2.45 and recodifying as 2.8.
  • Revising 2.45 and recodifying as 2.9.
  • Revising 2.60 and recodifying as 2.14.
  • Revising 2.61 and recodifying as 2.15.
  • Revising 2.71 and recodifying as 2.17.
  • Revising 2.88 and recodifying as 2.23.
  • Revising 2.94 and recodifying as 2.25.
  • Revising 2.98 and recodifying as 2.26.
  • Recodifying 2.4 as 2.1, 2.9 as 2.2, 2.29 as 2.3,
  • 2.30 as 2.4, 2.40 as 2.6, 2.44 as 2.8, 2.53 as 2.10, 2.55 as 2.11, 2.56 as 2.12, 2.57 as 2.13, 2.60 as 2.14, 2.67 as 2.16, 2.73 as 2.18, 2.74 as 2.19, 2.76 as 2.20, 2.77 as 2.21,
  • 2.83 as 2.22, 2.91 as 2.24, and 2.104 as 2.27.
  • Prior approval of this section was 74 FR 38536 on 8/4/09.
  • Section 45-40-3 Measurements, Abbreviations and Acronyms 7/1/16 12/4/2018, [insert Federal Register citation] Removed definitions for Hg, kW, kWh, MWw, MWh, O2, ppm, lb, scfh, SO2, and H2O.
  • Prior approval of this section was 74 FR 38536 on 8/4/09.
  • Section 45-40-4 Applicability 7/1/16 12/4/2018, [insert Federal Register citation] Remove preamble, 4.1, 4.2, 4.3, 4.4, and 4.5.
  • Add new 4.1, 4.2, and 4.3.
  • Prior approval of this section was 74 FR 38536 on 8/4/09.
  • Section 45-40-5 Ozone Season NOX Emission Limitations 7/1/16 12/4/2018, [insert Federal Register citation] Prior approval of this section was 74 FR 38536 on 8/4/09. Section 45-40-6 Monitoring, Recordkeeping and Reporting Requirements 7/1/16 12/4/2018, [insert Federal Register citation] Prior approval of this section was 74 FR 38536 on 8/4/09. Section 45-40-7 Violation 7/1/16 12/4/2018, [insert Federal Register citation] Prior approval of this section was 74 FR 38536 on 8/4/09. Section 45-40-8 Ozone Season NOX Budget Demonstration 7/1/16 12/4/2018, [insert Federal Register citation] Prior approval of this section was 74 FR 38536 on 8/4/09. Section 45-40-9 Ozone Season NOX Reduction Requirements for Stationary Internal Combusion Engines 7/1/16 12/4/2018, [insert Federal Register citation] Prior approval of this section was 74 FR 38536 on 8/4/09. Section 45-40-10 Ozone Season NOX Reduction Requirements for Emissions of NOX from Cement Manufacturing Kilns 7/1/16 12/4/2018, [insert Federal Register citation] Prior approval of this section was 74 FR 38536 on 8/4/09. Section 45-40-11 Inconsistency Between Rules 7/1/16 12/4/2018, [insert Federal Register citation] Prior approval of this section was 74 FR 38536 on 8/4/09. *         *         *         *         *         *         *
    [FR Doc. 2018-26243 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2018-0091; FRL-9986-06] Calcium Formate; Exemption From the Requirement of a Tolerance AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes an exemption from the requirement of a tolerance for residues of calcium formate (CAS Reg. No. 544-17-2) when used as an inert ingredient (carrier) in pesticide formulations applied to growing crops only. ADAMA Agan, Ltd. c/o Makhteshim Agan of North America, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of calcium formate.

    DATES:

    This regulation is effective December 4, 2018. Objections and requests for hearings must be received on or before February 4, 2019, 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-2018-0091, 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 L. Goodis, Director, 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 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. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

    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-2018-0091 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 February 4, 2019. 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-2018-0091, 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. Petition for Exemption

    In the Federal Register of April 11, 2018 (83 FR 15528) (FRL-9975-57), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11075) by ADAMA Agan, Ltd. c/o Makhteshim Agan of North America, Inc., 3120 Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of calcium formate (CAS Reg. No. 544-17-2) when used as an inert ingredient (carrier) in pesticide formulations applied to growing crops only. That document referenced a summary of the petition prepared by ADAMA Agan, LTD, the petitioner, which is available in the docket, http://www.regulations.gov.

    This is based on the Agency's risk assessment which can be found at http://www.regulations.gov in document: Calcium Formate; Human Health Risk Assessment in docket ID number EPA-HQ-OPP-2018-0091. No comments were received in response to the notice published by EPA.

    III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

    IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for 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 . . . .”

    EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

    Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), 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 calcium formate including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with calcium formate follows.

    A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 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 toxicity database on calcium formate is somewhat limited. Consequently, studies on appropriate surrogates were used to supplement the database on calcium formate. Formic acid, sodium formate, potassium formate and ammonium formate were selected as appropriate surrogates since they are either the acid form of calcium formate or other salts of formic acid.

    Calcium formate is not expected to be acutely toxic based on acute toxicity data. There are no subchronic or chronic studies on calcium formate, although there are studies on potassium formate. These studies show effects based on reduced body weight gain. A two-year study with potassium formate indicates the compound is not carcinogenic to Wistar rats.

    In mutagenicity studies with calcium formate, sodium formate and methyl formate, results of the test were negative for all chemicals. The weight-of-evidence suggests that calcium is not expected to be mutagenic.

    There are no available developmental toxicity studies on calcium formate; however, both a rat and rabbit developmental toxicity study have been conducted on sodium formate. In the rat study, the maternal and developmental no-observed-adverse-effect-level (NOAEL) was considered the highest dose tested at 945 milligram/kilogram/day (mg/kg/day). In the rabbit study, the maternal and developmental toxicity NOAEL was also the highest dose tested at 1,000 mg/kg/day. A five-generation rat reproductive toxicity study on calcium formate has been conducted with a NOAEL of >200 mg/kg/day (only dose tested). In a three-generation reproduction study in rats via drinking water, no treatment related effects were observed in the parental animals and off springs at doses up to 200 mg/kg/day.

    No studies were submitted for immunotoxicity. However, the toxicity studies available did not show any signs of immunotoxicity up to limit doses. Therefore, immunotoxicity is not of concern.

    There are no available studies for neurotoxicity. However, the functional observation battery performed in the 90-day oral toxicity study did not show any signs of neurotoxicity up to limit doses. Therefore, neurotoxicity is not of concern.

    A metabolism study is available in the toxicity database. Calcium formate breaks down into calcium and formate ions. Calcium ions are ubiquitous in the natural environment and can be considered as having little toxicity or hazard. Formate ions are readily converted to carbon dioxide in the environment by biodegradation or photooxidation.

    Specific information on the studies received and the nature of the adverse effects caused by calcium formate as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document Calcium Formate Risk Assessment at page 7 in docket ID number EPA-HQ-OPP-2018-0091.

    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://www.epa.gov/pesticides/factsheets/riskassess.htm.

    No toxicological endpoints of concern were identified for calcium formate based on available toxicity studies on surrogate chemicals. Formic acid, sodium formate, potassium formate and ammonium formate were selected as appropriate surrogates since they are either the acid form of calcium formate or other salts of formic acid. Most of the available studies on these substances were not conducted up to the limit dose. The highest dose of 200 mg/kg/day in a lifelong study in rats via drinking water did not produce any systemic toxicity (IUCLID, Calcium formate, 2001). Therefore, a conservative risk assessment was conducted using a NOAEL of 200 mg/kg/day for chronic dietary and short- and intermediate-term dermal exposure risk estimates. An uncertainty/safety factor of 100X (10X for interspecies variability and 10X for interspecies extrapolation) was used. The Food Quality Protection Act (FQPA) factor of 10X was reduced to 1X, therefore, the chronic Reference Dose (cRfD) of 2 mg/kg/day is equal to the chronic Population Adjusted Dose (cPAD). A 100% dermal absorption factor is assumed for converting oral to dermal equivalent doses in the absence of dermal toxicity or dermal absorption studies.

    For short and intermediate term inhalation exposure, the route specific study was used. The NOAEL of 0.62 mg/l (32 parts per million (ppm)) was observed in a 90-day inhalation toxicity study in rats (IUCLID, Formic acid, 2000). The uncertainty factor is 100X (10X for interspecies variability and IOX for interspecies extrapolation). The FQPA factor of 10 X was reduced to 1X.

    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to calcium formate, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from calcium formate in food as follows:

    Because no endpoint was identified for acute exposure, an acute exposure assessment was not conducted.

    In conducting the chronic dietary exposure assessment using the Dietary Exposure Evaluation Model DEEM-FCIDTM, EPA used food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, what we eat in America, (NHANES/WWEIA). This dietary survey was conducted from 1994-98. As to residue levels in food, no residue data were submitted. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

    In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient.

    The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. The concentration of active ingredients in agricultural products is generally at least 50 percent of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient.

    Second, the conservatism of this methodology is compounded by EPA's decision to assume that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity.

    Finally, a third compounding conservatism is EPA's assumption that all foods contain the inert ingredient at the highest tolerance level. In other words, EPA assumed 100 percent of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient.

    In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, and then used this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders of magnitude higher than actual residues in food when distributed in commerce.

    Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data.

    2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for calcium formate, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

    There are no known or anticipated residential uses for calcium formate and therefore, residential exposure is not expected.

    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 calcium formate to share a common mechanism of toxicity with any other substances, and calcium formate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that calcium formate 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://www.epa.gov/pesticides/cumulative.

    D. Safety Factor for Infants and Children

    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 pre-natal and post-natal 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 FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data is available to EPA to support the choice of a different factor.

    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:

    1. Toxicological studies were identified for calcium formate in the publicly available databases. However, calcium formate breaks down into calcium and formate ions. Calcium ions are ubiquitous in the natural environment and can be considered as having little toxicity or hazard risk. The toxicological database for calcium formate is limited. There is available data on formic acid and related formate compounds (such as ammonium, sodium and methyl formate), which can serve as suitable surrogates for calcium formate. Studies conducted with methanol are also applicable to formate compounds, since methanol is metabolized into formic acid. Therefore, the database is considered adequate for FQPA assessment.

    2. There is no evidence of increased susceptibility of infants and children in the available reproduction and developmental toxicity studies with calcium formate and/or sodium formate. No developmental or maternal systemic toxicity was observed in rats at doses up to 200 mg/kg/day when calcium format was administered via drinking water. No developmental or maternal toxicity was observed in mice at doses up to 750 mg/kg gavage dose of sodium formate on gestation day 8. No evidence of increased susceptibility was observed following pre- and post-natal exposure to calcium formate. In a multigeneration reproduction study (three to five generations), no parental, reproductive or offspring toxicity was observed at doses up to 200 mg/kg/day.

    3. No neurotoxicity studies are available in the database. However, there is no evidence of clinical signs of neurotoxicity in the database, nor evidence of susceptibility in the young in the database. Therefore, EPA concluded that the developmental neurotoxicity study is not required. There is no evidence of immunotoxicity in the available database.

    4. The dietary food exposure assessment utilizes highly conservative default assumptions that would not under estimate the dietary risk to all populations. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for ammonium formate, a value of 100 ppb for drinking water based on screening level modeling was used for the chronic dietary risk assessment. The value of 100 ppb is considered to be a high end, conservative assumption that is not likely to underestimate drinking water risks.

    Taking into consideration the available information, EPA concludes the additional 10X FQPA safety factor can be reduced to 1X. These assessments will not underestimate the exposure and risks posed by calcium formate.

    E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on calcium. EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to calcium formate under reasonable foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.920 for residues of calcium formate when used as an inert ingredient in pesticide formulations applied is safe under FFDCA section 408.

    1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, calcium formate is not expected to pose an acute risk.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure analysis, EPA has concluded that risk estimates for chronic exposure to calcium formate from food and water are not of concern (<100% cPAD with a risk estimate at 31.2% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for calcuim formate.

    3. Short-and intermediate term risk. Short- and intermediate-term toxicological endpoints were established; however, calcium formate is not registered for any use patterns that would result in short- or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- or 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 short-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for calcium formate.

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

    5. 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 calcium formate residues.

    V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

    VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for calcium formate (CAS Reg. No. 544-17-2) when used as an inert ingredient (carrier) in pesticide formulations applied to growing crops only.

    VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a tolerance 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), or 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 exemption 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).

    VIII. 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: November 14, 2018. Donna Davis, Acting 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 § 180.920, add alphabetically the inert ingredient to the table to read as follows:
    § 180.920 Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance. Inert ingredients Limits Uses *         *         *         *         *         *         * Calcium formate (CAS Reg. No. 544-17-2) Carrier *         *         *         *         *         *         *
    [FR Doc. 2018-26353 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0538; FRL-9982-42] Bixafen; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of bixafen in or on multiple commodities which are identified and discussed later in this document. FMC Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective December 4, 2018. Objections and requests for hearings must be received on or before February 4, 2019 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-2016-0538, 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-2016-0538 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 February 4, 2019. 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-2016-0538, 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 November 30, 2016 (81 FR 86312) (FRL-9954-06), 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 6F8475) by FMC Corporation. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide bixafen, N-(3′,4′-dichloro-5-fluoro[1,1′-biphenyl]-2-yl)-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide, in or on cattle, fat at 0.5 parts per million (ppm); cattle, kidney at 0.3 ppm; cattle, liver at 1.5 ppm; cattle, muscle at 0.15 ppm; grain, aspirated fractions at 80 ppm; grain, cereal, forage, fodder and straw, group 16 (except rice), forage at 4.0 ppm; grain, cereal, forage, fodder and straw, group 16 (except rice), hay at 5.0 ppm; grain, cereal, forage, fodder and straw, group 16 (except rice), stover at 6.0 ppm; grain, cereal, forage, fodder and straw, group 16 (except rice), straw at 7.0 ppm; grain, cereal, group 15 (except rice and sorghum) at 0.15 ppm; milk at 0.1 ppm; oilseed, rapeseed subgroup 20A at 0.15 ppm; peanut, hay at 10.0 ppm; peanut, nutmeat at 0.02 ppm; peanut, refined oil at 0.04 ppm; poultry, eggs at 0.02 ppm; poultry, fat at 0.02 ppm; poultry, liver at 0.02 ppm; poultry, muscle at 0.02 ppm; sorghum, grain at 3.0 ppm; soybean, hulls at 0.15 ppm; soybean, seed at 0.06 ppm; sugar beet, dried pulp at 1.0 ppm; vegetable, root subgroup 1A at 0.2 ppm and vegetable, tuberous and corm subgroup 1C at 0.02 ppm. That document referenced a summary of the petition prepared by FMC Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    Based upon review of the data supporting the petition, EPA is establishing tolerances that vary from those proposed. The reason for these changes are explained in Unit IV.D.

    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 bixafen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with bixafen 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.

    Following repeated oral administration of bixafen, the liver was the primary target organ in mice, rats and dogs. Increased liver weights and hepatocellular hypertrophy were observed in all species tested and were considered to reflect hepatic microsomal enzyme induction. Also, in several studies, there was evidence for liver toxicity based on clinical chemistry changes (increased serum alkaline phosphatase and cholesterol, decreased serum albumin) and histopathological changes (hepatocellular pigmentation, degeneration and necrosis). In mice and rats, the thyroid was an additional target in the subchronic and chronic studies, with effects such as increased thyroid weight, follicular cell hypertrophy and follicular cell hyperplasia observed. Thyroid toxicity was seen only in the presence of liver effects, either adverse effects (such as hepatocellular single-cell degeneration/necrosis) or adaptive effects (such as increased liver weights with enzyme changes, hepatocellular hypertrophy). This correlation suggested they thyroid effects are secondary to the liver effects via enhanced hepatic clearance of thyroid hormones. This suggestion was supported by a 14-day mechanistic study in rats in which a marked induction of phase I and II hepatic enzymes, a slight reduction of thyroid hormone (T3, T4) levels and a significant increase of TSH levels were observed at 150 mg/kg bodyweight per day, the only dose tested. Since thyroid toxicity was seen in the absence of adverse liver effects in studies such as the subchronic and chronic rat studies, a primary adverse effect on the thyroid cannot be ruled out. However, no studies are available to address potential susceptibility in the young to potential thyroid toxicity. As a result, the need for a Comparative Thyroid Assay (CTA) was considered. However, given risk estimates are well below the Agency's level of concern (LOC) even when using conservative exposure assumptions, the Agency concluded that a CTA is not required at this time. This conclusion, however, may be revisited should the use pattern change or if updated risk estimates reach a point where the PODs used in the risk assessment are no longer protective of potential life-stage susceptibility.

    From the prenatal developmental studies, it is apparent that evidence of increased quantitative susceptibility in offspring was observed in the database. The prenatal developmental study in the rat showed decreased fetal body weights at a dose that produced no adverse effects in the dam. Similarly, the prenatal developmental study in the rabbit showed decreased fetal body weight in the absence of maternal toxicity. In the rat 2-generation reproduction study, however, parental toxicity (decreased body weight and increased liver weight with centrilobular and diffuse hypertrophy) and offspring toxicity (decreased F1 and F2 pup body weights) occurred at the same dose level.

    An acute neurotoxicity study in the adult rat indicated decreased motor activity in both sexes and decreased rearing counts in females at a high dose level (1,000 mg/kg/day). A subchronic neurotoxicity study was not available, and no evidence of neurotoxicity was observed in other studies in the database.

    Bixafen did not produce evidence of mutagenicity or clastogenicity in the required battery of studies. The available mouse carcinogenicity study produced no treatment-related tumors in the presence of other toxicity such as organ weight changes with histopathology in both the liver and thyroid. Thus, bixafen is classified as “not likely to be carcinogenic to humans.”

    Bixafen has low acute oral, dermal, and inhalation toxicity. Bixafen is not an acute eye irritant and is neither a dermal irritant nor a dermal sensitizer. Specific information on the studies received and the nature of the adverse effects caused by bixafen 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 Bixafen. Human Health Risk Assessment for Section 3 Registration and Tolerance Requests for a New Active Ingredient Proposed for Use on Cereal Grains, Group 15 (Except Rice); Forage, Fodder and Straw of Cereal Grains, Group 16 (Except Rice); Peanut; Soybean; Root Vegetable Subgroup 1A; and Tuberous and Corm Vegetable Subgroup 1C at pages 14—23 in docket ID number EPA-HQ-OPP-2016-0538.

    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 bixafen used for human risk assessment is shown in Table 1 of this unit.

    Table 1—Summary of Toxicological Doses and Endpoints for Bixafen for Use in Human Health Risk Assessment Exposure/scenario Point of departure and uncertainty/
  • safety factors
  • RfD, PAD, LOC for risk assessment Study and toxicological effects
    Acute dietary (General population including infants and children) NOAEL = 250 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Acute RfD = 2.5 mg/kg/day
  • aPAD = 2.5 mg/kg/day
  • Acute Neurotoxicity Study in rats; MRID 49877279.
  • LOAEL = 1,000 mg/kg/day based on statistically significant decreases in motor activity in both sexes and decreased rearing counts in females approximately 4 hours following a single oral dose.
  • Chronic dietary (All populations) NOAEL = 2.8 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Chronic RfD = 0.03 mg/kg/day
  • cPAD = 0.03 mg/kg/day
  • Chronic/Carcinogenicity Studies in Rats; MRIDs 49877272, 49877273.
  • LOAEL = 17.4 mg/kg/day based on thyroid effects (follicular cell hypertrophy, alteration of the thyroid colloid at interim and terminal sacrifice).
  • Cancer (Oral, dermal, inhalation) Classification: “Not likely to be carcinogenic to humans” based on an absence of tumors in the rat chronic/oncogenicity and mouse carcinogenicity studies. FQPA SF = Food Quality Protection Act Safety Factor. mg/kg/day = milligram/kilogram/day. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to bixafen, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from bixafen 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 bixafen. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) Nationwide Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, the acute dietary analysis was obtained from the Dietary Exposure Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; version 3.16). The assessment is based on tolerance-level residues and 100% crop treated (100 PCT) estimates for all commodities.

    ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WWEIA conducted from 2003-2008. As to residue levels in food, the chronic dietary analysis was obtained from the Dietary Exposure Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; version 3.16). The assessment is based on tolerance-level residues and 100 PCT estimates for all commodities.

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that bixafen 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 percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for bixafen. 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 bixafen in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of bixafen. 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.

    The Tier II Pesticide in Water Calculator (PWC version 1.52) and Tier I Pesticide Root Zone Model Ground Water (PRZM GW) was used for calculating surface water and ground water EDWCs respectively. The driver for drinking water exposure is from surface water and the EDWC of bixafen for acute exposure is estimated to be 16.3 parts per billion (ppb). For chronic exposure for non-cancer assessment, it is estimated to be 15.2 ppb for surface water.

    Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 16.3 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 15.2 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).

    Bixafen is not proposed nor is it registered for any specific use patterns that would result in residential exposure.

    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 bixafen to share a common mechanism of toxicity with any other substances, and bixafen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that bixafen 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 FQPA Safety Factor (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. The prenatal developmental toxicity studies showed effects in the fetus (decreased body weights) at dose levels that were lower than that of the observed maternal toxicity (decreased body weights). However, concerns for potential pre- and postnatal susceptibility from the developmental and reproduction studies are low because clear NOAELs and LOAELs exist for these developmental effects, and the PODs and endpoints selected for risk assessment are protective of potential toxicity in offspring.

    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 bixafen is considered complete at this time. The following acceptable studies are available to support this determination: A prenatal developmental toxicity study in rabbits, a prenatal developmental toxicity study in rats, a two-generation reproduction study in rats and an acute neurotoxicity study. The following study waivers were accepted, and it was determined that these studies are not required at this time: subchronic inhalation, subchronic neurotoxicity, and an immunotoxicity study. As summarized in Unit III.A., EPA determined that the CTA study is not required at this time.

    ii. An acute neurotoxicity study in the adult rat indicated decreased motor activity in both sexes and decreased rearing counts in females at a high dose level (1,000 mg/kg/day). A subchronic neurotoxicity study was not available, and no evidence of neurotoxicity was observed in other studies in the database. Concern for neurotoxicity is low, and thus no developmental neurotoxicity study or FQPA 10X SF is necessary, because (1) signs of neurotoxicity in the database occur only at a high dose level, do not include neuropathology; (2) a clear and well-defined NOAEL has been established; and (3) the PODs used for risk assessment are protective of neurotoxicity seen in the database.

    iii. There is evidence of increased prenatal quantitative susceptibility of the developing offspring in the toxicology database for bixafen. Developmental toxicity (reduced fetal body weight) was seen at doses that caused no maternal toxicity in both rats and rabbits. However, clear NOAELs and LOAELs exist for these developmental effects, and the endpoints and PODs selected for risk assessment are protective of these effects. In the 2-generation reproduction toxicity study, toxicity in the offspring (decreased F1 and F2 pup body weights) occurred at the same level where parental toxicity (decreased body weight) was observed, and susceptibility was not demonstrated. The subchronic and chronic rat studies in the database indicate thyroid toxicity (epithelial cell hypertrophy) at the LOAELs, and no studies are available to address potential susceptibility in the young to potential thyroid toxicity. As a result, the need for a CTA was considered. However, given risk estimates are well below the Agency's level of concern even when using conservative exposure assumptions and that further refinement of exposure estimates would yield even greater margins of safety, the Agency concluded that a CTA is not required at this time.

    iv. There are no residual uncertainties identified in the exposure databases. The unrefined dietary risk assessments are based on high-end assumptions such as tolerance-level residues, 100PCT assumptions, and modeled, high-end estimates of residues in drinking water. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to bixafen in drinking water. These assessments will not underestimate the exposure and risks posed by bixafen.

    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 bixafen will occupy <1% of the aPAD for children 1-2 years of age, 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 bixafen from food and water will utilize 20% of the cPAD for children 1-2 years of age the population group receiving the greatest exposure.

    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). A short-term adverse effect was identified; however, bixafen is not proposed for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-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 short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for bixafen.

    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, bixafen is not proposed 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 bixafen.

    5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, bixafen 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 bixafen residues.

    IV. Other Considerations A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Analytical Methods 00983 and 01063, high- performance liquid chromatography methods with tandem mass spectrometry detection (LC/MS/MS)) is available as an enforcement method for determination of residues of bixafen and its metabolite bixafen-desmethyl.

    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 established MRLs for bixafen in or on barley and oats at 0.4 ppm; the U.S. tolerance for grain, cereal, group 15, except rice and grain sorghum at 0.40 ppm is harmonized with those MRLs. Codex has also established MRLs for rye, wheat, and wheat bran at 0.05 ppm, which is not harmonized with the U.S. tolerances for group 15 because use consistent with approved labeling could result in exceedances. Codex has also established MRLs for barley straw and fodder, dry at 20 ppm; oat straw and fodder, dry at 20 ppm; rye straw and fodder, dry at 20 ppm; and wheat straw and fodder, dry at 20 ppm. The U.S. tolerance for grain, cereal, forage, fodder and straw, group 16, except rice at 20 ppm is harmonized with those Codex MRLs.

    Additionally, the Codex has established MRLs for bixafen in or on cattle, fat at 2 ppm; cattle, meat byproducts at 4 ppm; cattle, muscle at 2 ppm; goat, fat at 2 ppm; goat, meat byproducts at 4 ppm; goat, muscle at 2 ppm; horse, fat at 2 ppm; horse, meat byproducts at 4 ppm; horse, muscle at 2 ppm; milk at 0.2 ppm; sheep, fat at 2 ppm; sheep, meat byproducts at 4 ppm; and sheep, muscle at 2 ppm. These MRLs are significantly higher than the tolerances being established for bixafen on the same commodities in the United States. The U.S. tolerances are based on calculated dietary burden that supports a lower residue level in fat, muscle, and meat byproducts commodities. Therefore, these tolerances are not harmonized because such high tolerances could mask instances of misuse by U.S. growers. As noted in the next section, the Agency is not establishing tolerances for milk fats and poultry commodities in harmony with Codex MRLs for milk fats, poultry, edible offal, poultry fats, and poultry meat because the Agency has determined that use consistent with the approved pesticide will not result in residues in milk fats and poultry commodities.

    C. Revisions to Petitioned-For Tolerances

    Several proposed tolerances requested by the petitioner are different from those being established by EPA. For soybean seed; peanut; peanut, hay; vegetable, tuberous and corm (subgroup 1C); and vegetable, root, subgroup 1A, tolerance values were calculated using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures and field trial residue data. The combination provided a different tolerance value than the proposed values. EPA is establishing a tolerance for grain, cereal, group 15, except rice and grain sorghum at 0.40 ppm instead of 0.15 ppm and for grain, cereal, forage, fodder and straw, group 16, except rice at 20 ppm, rather than the requested tolerances for forage at 4.0 ppm, hay at 5.0 ppm, stover at 6.0 ppm, straw at 7.0 ppm in order to harmonize with Codex MRLs. Since the tolerance of 20 ppm for group 16 covers the residues on forage, hay, stover, and straw forms of the group 16 commodities, EPA has determined that separate tolerances are unnecessary.

    Additionally, while tolerances were proposed on liver and kidney for livestock commodities, EPA is establishing tolerances on meat byproducts, which are inclusive of kidney and liver. EPA is further establishing lower tolerances for residues in fat, muscle and meat byproducts in cattle, based on the calculated dietary burdens paired with low residue transfer rates into ruminant commodities. The tolerance on milk is also established at a lower level (0.04 ppm versus the 0.10 ppm proposed tolerance). This recommendation is also based on the calculated dietary burdens paired with low residue transfer rates into ruminant commodities.

    Under EPA's regulations (40 CFR 180.6), EPA assessed whether residues on raw agricultural commodities would result in possible residues entering the diet of man through the ingestion of milk, eggs, meat, and/or poultry produced by animals fed agricultural products bearing such residues. As a result of that assessment, EPA determined that quantifiable residues are expected in commodities from cattle, horses, goats, and sheep and is establishing tolerances for residues in fat, muscle and meat byproducts in horse, goat and sheep. EPA also determined that there is no reasonable expectation of residues in or on milk fats and poultry products; therefore, no tolerances on milk fats and poultry commodities are needed.

    Additionally, the proposed use and associated tolerance on Rapeseed subgroup 20A (canola) was subsequently withdrawn by the petitioner; therefore, the Agency is not establishing a tolerance on that subgroup because it is not needed.

    The Agency is not establishing a tolerance for peanut, refined oil as requested because the residue data indicate that anticipated residues in the peanut, refined oil are lower than, and will be covered by, the tolerance for peanut.

    Finally, the Agency is establishing a tolerance for radish, tops, even though it was not requested by the petitioner. Under EPA's regulations (40 CFR 180.40(f)(1)(i)(B)), EPA will not establish a crop group tolerance unless all necessary tolerances are established, including tolerances for raw commodities not covered by the crop group and derivative of commodities in the group. In this case, EPA is establishing a tolerance for root vegetables, subgroup 1A, which includes radish. Due to the presence of residues on radish tops, EPA is establishing a necessary tolerance on radish tops to facilitate the establishment of the subgroup 1A tolerance.

    V. Conclusion

    Therefore, tolerances are established for residues of bixafen in or on beet, sugar, dried pulp at 1.0 ppm; cattle, fat at 0.08 ppm; cattle, meat byproducts at 0.40 ppm; cattle, muscle at 0.08 ppm; goat, fat at 0.08 ppm; goat, meat byproducts at 0.40 ppm; goat, muscle at 0.08 ppm; grain, aspirated grain fractions at 80 ppm; grain, cereal, forage, fodder, and straw, group 16, except rice at 20 ppm; grain, cereal, group 15, except rice and grain sorghum at 0.40 ppm; horse, fat at 0.08 ppm; horse, meat byproducts at 0.40 ppm; horse, muscle at 0.08 ppm; milk at 0.04 ppm; peanut at 0.01 ppm; peanut, hay at 8.0 ppm; radish, tops at 3.0 ppm; sheep, fat at 0.08 ppm; sheep, meat byproducts at 0.40 ppm; sheep, muscle at 0.08 ppm; sorghum, grain, grain at 3.0 ppm; soybean, hulls at 0.15 ppm; soybean, seed at 0.04 ppm; vegetable, root subgroup 1A at 0.30 ppm; and vegetable, tuberous and corm subgroup 1C at 0.01 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 tolerances 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: November 13, 2018. Donna Davis, Acting 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. Add § 180.702 to subpart C to read as follows:
    § 180.702 Bixafen; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the fungicide bixafen, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only bixafen, N-(3,4-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide, in or on the commodity.

    Commodity Parts per million Beet, sugar, dried pulp 1.0 Grain, aspirated grain fractions 80 Grain, cereal, forage, fodder, and straw, group 16, except rice 20 Grain, cereal, group 15, except rice and grain sorghum 0.40 Peanut 0.01 Peanut, hay 8.0 Radish, tops 3.0 Sorghum, grain, grain 3.0 Soybean, hulls 0.15 Soybean, seed 0.04 Vegetable, root, subgroup 1A 0.30 Vegetable, tuberous and corm, subgroup 1C 0.01

    (2) Tolerances are established for residues of the fungicide bixafen, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of bixafen, N-(3,4-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide, and its desmethyl metabolite, N-(3′,4′-dichloro-5-fluoro[1,1′-biphenyl]-2-yl)-3-(difluoromethyl)-1H-pyrazole-4-carboxamide, calculated as the stoichiometric equivalent of bixafen, in or on the commodity.

    Commodity Parts per million Cattle, fat 0.08 Cattle, meat byproducts 0.40 Cattle, muscle 0.08 Goat, fat 0.08 Goat, meat byproducts 0.40 Goat, muscle 0.08 Horse, fat 0.08 Horse, meat byproducts 0.40 Horse, muscle 0.08 Milk 0.04 Sheep, fat 0.08 Sheep, meat byproducts 0.40 Sheep, muscle 0.08

    (b) Section 18 emergency exemptions. [Reserved]

    (c) Tolerances with regional registrations. [Reserved]

    (d) Indirect or inadvertent residues. [Reserved]

    [FR Doc. 2018-26348 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2018-0290; FRL-9985-99] 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer; Tolerance Exemption AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes an exemption from the requirement of a tolerance for residues of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt (CAS Reg. No. 55141-01-0), and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer (CAS Reg. No. 35641-59-9); when used as inert ingredients in a pesticide chemical formulation. BASF Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt) and 1-propanesulfonic acid, 2-methyl-2[(1oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer on food or feed commodities.

    DATES:

    This regulation is effective December 4, 2018. Objections and requests for hearings must be received on or before February 4, 2019, 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-2018-0290, 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 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. 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-2018-0290 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 February 4, 2019. 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-2018-0290, 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. Background and Statutory Findings

    In the Federal Register of June 14, 2018 (83 FR 27743) (FRL-9978-41), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-11148) filed by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 277709-3528. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt (CAS Reg. No. 55141-01-0), and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer (CAS Reg. Reg. No. 35641-59-9). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request.

    There were no comments received in response to the notice of filling.

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(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 use 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 an exemption from the requirement of 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 . . . ” and specifies factors EPA is to consider in establishing an exemption.

    III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information 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. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer both conform to the definition of a polymer given in 40 CFR 723.250(b) and meet the following criteria that are used to identify low-risk polymers.

    1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

    2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

    3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

    4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

    5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

    6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

    7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250(d)(6).

    Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

    8. The polymer's number average MW of 14,000 is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000.

    Thus, 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer meet the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on their conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer.

    IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this exemption, EPA considered that 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer are greater than 14,000 daltons. Generally, polymers of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

    V. 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 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer to share a common mechanism of toxicity with any other substances, and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer do 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://www.epa.gov/pesticides/cumulative.

    VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold 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 data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

    VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer.

    VIII. Other Considerations A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

    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 a MRL for 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt or 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer.

    IX. Conclusion

    Accordingly, EPA finds that exempting residues of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer from the requirement of a tolerance will be safe.

    X. Statutory and Executive Order Reviews

    This action establishes a tolerance 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). 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).

    XI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This 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: November 14, 2018. Donna Davis, Acting 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 § 180.960, alphabetically add the polymers in the table to read as follows:
    § 180.960 Polymers; exemptions from the requirement of a tolerance. Polymer CAS No. *         *         *         *         *         *         * Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt, minimum number average molecular weight (in amu) 14,000 55141-01-0 *         *         *         *         *         *         * 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer, minimum number average molecular weight (in amu) 14,000 35641-59-9 *         *         *         *         *         *         *
    [FR Doc. 2018-26347 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0820; FRL-9986-87] Oxytetracycline; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of oxytetracycline in or on fruit, citrus, crop group 10-10. Geo Logic Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective December 4, 2018. Objections and requests for hearings must be received on or before February 4, 2019 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-2015-0820, 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-2015-0820 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 February 4, 2019. 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-2015-0820, 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 March 16, 2016 (81 FR 14030) (FRL-9942-86), 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 5F8415) by Geo Logic Corporation, P.O. Box 3091, Tequesta, FL 33469. The petition requested that 40 CFR 180.337 be amended by establishing tolerances for residues of the bactericide oxytetracycline, (4S,4aR,5S,5aR,6S,12aS)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, in or on fruit, citrus, crop group 10-10 at 0.01 parts per million (ppm).

    That document referenced a summary of the petition prepared by Geo Logic Corporation, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.

    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 oxytetracycline including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with oxytetracycline 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.

    At high doses, the target organ of tetracycline toxicity is the liver. The most common effect in intermediate- or long-term oral exposures in rats and mice was a decrease in body weight. In the prenatal developmental study in rats, clinical signs included increased incidences of respiratory signs and rough hair coat in the dams, in addition to increased mortality and a decreased percentage of dams found pregnant. Also identified was a decrease in fetal body weight. In the mouse prenatal developmental study, there was no toxicity identified in the dams or fetuses. In all of the above animal studies, adverse effects were seen at doses that exceed the limit dose. There is no adequate reproductive toxicity study available in the database, however, the data requirement was waived based on the lack of reproductive effects reported during the history of use as a drug. No evidence of neurotoxicity was observed in any guideline study. A rat immunotoxicity study demonstrated immunosuppression at doses lower than those for systemic toxicity. Tetracyclines are known to inhibit bone growth in developing tissue. When oxytetracycline was administered orally as a single dose to two female infant rhesus monkeys, zygomatic arch bone (lateral surface of temporal bone) growth was inhibited for ~12.5 days with no recovery observed by 21 days. Effects on bone growth are consistent with oxytetracycline's ability to chelate calcium, and so are not unexpected. Bone developmental effects were also observed after administration of chlortetracycline and demethylchlortetracycline in adult rhesus monkeys highlighting the consistency of tetracycline treatment across this class of chemicals.

    The Agency has classified oxytetracycline as “Group D: Not Classifiable as to Human Carcinogenicity”. Oxytetracycline has low acute toxicity, being Toxicity Category IV for oral toxicity, the only acute lethality study available in the database.

    Specific information on the studies received and the nature of the adverse effects caused by oxytetracycline 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 document “Oxytetracycline/Oxytetracycline Hydrochloride/Oxytetracycline Calcium: Draft Human Health Risk Assessment in Support of Registration Review and Tolerance Establishment in/on Citrus Fruit Crop Group 10-10” in docket ID number EPA-HQ-OPP-2015-0820.

    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.

    Table 1—Summary of Toxicological Doses and Endpoints for Oxytetracycline for Use in Human Health Risk Assessment Exposure/scenario Point of departure and uncertainty/
  • safety factors
  • RfD, PAD, LOC for risk assessment Study and toxicological effects
    Acute dietary (All populations) None selected N/A No appropriate endpoint for females age 13-49 or for the general population attributable to a single exposure. Chronic dietary (All populations) NOAEL= 100 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 10x
  • Chronic RfD = 1 mg/kg/day
  • cPAD = 0.10 mg/kg/day
  • WOE from 3 rats and 2 dogs chronic studies.
  • The NOAEL of 100 mg/kg/day was derived from these studies and no specific LOAEL was established.
  • Cancer Classified as a Group D carcinogen—not classifiable as to human carcinogenicity. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. RfD = reference dose. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to oxytetracycline, EPA considered exposure under the petitioned-for tolerances as well as all existing oxytetracycline tolerances in 40 CFR 180.337. EPA assessed dietary exposures from oxytetracycline 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. No such effects were identified in the toxicological studies for oxytetracycline; therefore, a quantitative acute dietary exposure assessment is unnecessary.

    ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA 2003-2008 food consumption data from the USDA's National Health and Nutrition Examination Survey/What We Eat in America. As to residue levels in food, EPA used tolerance-level residues, default processing factors (PFs), and assumed 100 percent crop treated (PCT).

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that oxytetracycline 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 and/or PCT information in the dietary assessment for oxytetracycline. Tolerance-level residues and/or 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 oxytetracycline in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of oxytetracycline. 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 version 5.02/Variable Volume Water Body Model (VVWM V1.02) and Pesticide Root Zone Model Ground Water (PRZM GW), EDWCs of oxytetracycline for chronic exposures for non-cancer assessments are estimated to be 2.85 ppb for surface water and 0.323 ppb for ground water.

    Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 2.85 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). Oxytetracycline is not registered for any specific use patterns that would result in residential exposure.

    Tetracycline hydrochloride (97% chemical similarity to oxytetracycline) is approved by FDA for use as an oral antibiotic to treat certain bacterial and parasitic infections. EPA examined the impact that additional pesticide exposures to oxytetracycline would have on a person who has been prescribed the antibiotic. EPA determined that the additional pesticide exposure would not have more than a minimal impact on the total dose to the pharmaceutical patient, and thus concludes that there is a reasonable certainty that the additional exposure from pesticide uses of oxytetracycline would result in no harm finding to a user being treated therapeutically.

    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 assessed the potential for oxytetracycline to share a common mechanism of toxicity with any other substances. Based on its assessment of the available toxicological data, EPA has determined that oxytetracycline does not share a similar toxicological profile with other pesticides, and no further cumulative evaluation is necessary for oxytetracycline.

    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 FQPA Safety Factor (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. Considering the toxicity database for oxytetracycline, the mouse prenatal development study did not identify adverse effects up to the highest dose tested (HDT), 2,100 mg/kg/day. In addition, the effects seen in the rat prenatal development study occurred only at levels above the limit dose. Although guideline toxicity studies do not suggest an increased lifestage sensitivity/susceptibility (effects above the limit dose or no effects at the highest doses tested), data from the literature suggests that developing infants and children may be more susceptible to oxytetracycline side-effects than adults. When oxytetracycline was administered orally, as a single dose, to two female infant rhesus monkeys, zygomatic arch bone (lateral surface of temporal bone) growth was inhibited for ~12.5 days with no recovery observed by 21 days. The delayed bone growth occurs as a result of chelation of calcium, the mineral needed for bone growth. When the monkeys are treated with a very high dose of oxytetracycline (80 mg/kg), the calcium can be bound up for several days, leading to a delay in bone growth during that short time frame. However, once the oxytetracycline levels diminish, bone growth continues resulting in normal bones at maturity.

    3. Conclusion. The existing database, together with the extensive literature and study reports available on oxytetracycline, including studies submitted to and reviewed by the EPA, the National Toxicology Program, and World Health Organization, the FDA and open literature studies, is adequate for characterizing toxicity and quantification of risk from the proposed and existing uses of oxytetracycline. EPA is retaining the 10X FQPA SF because of the potential for pre-natal toxicity. The Agency concludes that this safety factor will be protective of potential toxicity to infants and children based on the following findings:

    i. The toxicity database for oxytetracycline is complete.

    ii. There is no indication that oxytetracycline 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 that oxytetracycline results in increased susceptibility in in utero rats in the prenatal developmental studies. Within the toxicity database, the mouse prenatal developmental study did not identify adverse effects up to the highest does tested (HDT), 2,100 mg/kg/day. Based on the adverse effects seen in infant rhesus monkeys after oral administration of oxytetracycline, the Food Quality Protection Act (FQPA) Safety Factor (SF) is being retained at 10X.

    iv. There are no residual uncertainties identified in the exposure databases. The dietary assessment overestimates actual exposures to oxytetracycline as it incorporated tolerance-level residues, default PFs, assumed that 100% of the proposed and existing crops are treated with oxytetracycline, and included high-end ground and surface drinking water modeling estimates. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to oxytetracycline in drinking water. These assessments will not underestimate the exposure and risks posed by oxytetracycline.

    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. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, oxytetracycline is not expected to pose an acute risk.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to oxytetracycline from food and water will utilize 33% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential pesticide uses for oxytetracycline.

    3. Short-term risk and Intermediate-term risk. Short-term and intermediate-term aggregate exposures take into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level) and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level), respectively. Short and intermediate-term adverse effects were identified; however, oxytetracycline is not registered for any residential pesticide uses that would result in short or intermediate-term residential exposures. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure and intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there are no short-term or intermediate-term residential exposures 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 short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for oxytetracycline.

    4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in adequate carcinogenicity studies in two animals, oxytetracycline is not expected to pose a cancer risk to humans and no cancer risk assessment was necessary.

    5. Pharmaceutical aggregate risk for U.S. population. Section 408 of the FFDCA requires EPA to consider potential sources of exposure to a pesticide and related substances in addition to the dietary sources expected to result from a pesticide use subject to the tolerance and determine that “there is a reasonable certainty of no harm” from those exposures. Because the Food and Drug Administration (FDA) may approve pharmaceutical drugs under FFDCA section 505, notwithstanding the possibility that some users may experience adverse side effects. EPA examines the impact that the additional pesticide exposures would have to a pharmaceutical user exposed to a related (or, in some cases, the same) compound in assessing the potential of harm to the pharmaceutical user. Where the additional pesticide exposure has no more than a minimal impact on the pharmaceutical user, EPA has concluded that it can make a reasonable certainty of no harm finding for the pesticide tolerances of that compound under section 408 of the FFDCA.

    For oxytetracycline, EPA's pesticide exposure assessment has taken into consideration the appropriate population, exposure route, and exposure duration for comparison with pharmaceutical exposure to oxytetracycline. EPA estimates that the pharmaceutical exposure a person is expected to receive from a typical therapeutic dose (25 mg/kg/day for children) is 750 to 2,800 times greater than the estimated dietary exposure from the pesticidal sources of oxytetracycline (0.0089334 mg/kg/day). Therefore, because the pesticide exposure has no more than a minimal impact on the total dose to a pharmaceutical user, EPA concludes that there is a reasonable certainty that the potential pesticide exposure will result in no harm to a person being treated therapeutically with oxytetracycline.

    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 oxytetracycline residues.

    IV. Other Considerations A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determining oxytetracycline residues in/on plant commodities. A high-performance liquid chromatography method with tandem mass spectrometry detection (LC/MS/MS) has been proposed for tolerance enforcement.

    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 a MRL for oxytetracycline.

    C. Response to Comments

    One comment was received generally opposing the use of any pesticides in or on food. The Agency recognizes that some individuals oppose the use of pesticides in or on food, but the FFDCA authorizes the Agency to establish tolerances for residues of pesticides in or on food if the Agency determines that the tolerance is safe. EPA has examined all the available data and determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. The commenter has provided no information to support a finding that the tolerances would not be safe.

    V. Conclusion

    Therefore, tolerances are established for residues of oxytetracycline, in or on fruit, citrus, group 10-10 at 0.01 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); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or 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: November 23, 2018. Michael Goodis, Director, Registration Division, Office of Pesticide Program.

    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 § 180.337, add alphabetically the entry for “Fruit, citrus, group 10-10” to the table in paragraph (a) to read as follows:
    § 180.337 Oxytetracycline; tolerances for residues.

    (a) * * *

    Commodity Parts per
  • million
  • *    *    *    *    *     Fruit, citrus, group 10-10 0.01 *    *    *    *    *    
    [FR Doc. 2018-26343 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket ID FEMA-2018-0002; Internal Agency Docket No. FEMA-8557] Suspension of Community Eligibility AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Final rule.

    SUMMARY:

    This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https://www.fema.gov/national-flood-insurance-program-community-status-book.

    DATES:

    The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables.

    FOR FURTHER INFORMATION CONTACT:

    If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Adrienne L. Sheldon, PE, CFM, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 400 C Street SW, Washington, DC 20472, (202) 212-3966.

    SUPPLEMENTARY INFORMATION:

    The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register.

    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

    Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

    National Environmental Policy Act. FEMA has determined that the community suspension(s) included in this rule is a non-discretionary action and therefore the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) does not apply.

    Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

    Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

    Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

    Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

    Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

    List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

    PART 64—[AMENDED] 1. The authority citation for part 64 continues to read as follows: Authority:

    42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp.; p. 376.

    § 64.6 [Amended]
    2. The tables published under the authority of § 64.6 are amended as follows: State and location Community No. Effective date authorization/cancellation of sale of flood insurance in community Current effective map date Date certain
  • Federal assistance
  • no longer available
  • in SFHAS
  • Region IV Florida: Fort Myers, City of, Lee County 125106 October 30, 1970, Emerg; April 16, 1979, Reg; December 7, 2018, Susp Dec. 7, 2018 Dec. 7, 2018. Georgia: Allenhurst, Town of, Liberty County 130350 May 6, 1975, Emerg; June 17, 1986, Reg; December 7, 2018, Susp ......do *   Do. Flemington, City of, Liberty County 130124 November 27, 1974, Emerg; May 17, 1982, Reg; December 7, 2018, Susp ......do   Do. Hinesville, City of, Liberty County 130125 June 13, 1975, Emerg; September 16, 1982, Reg; December 7, 2018, Susp ......do   Do. Liberty County, Unincorporated Areas 130123 January 22, 1975, Emerg; December 1, 1983, Reg; December 7, 2018, Susp ......do   Do. Midway, City of, Liberty County 130351 July 22, 1975, Emerg; September 30, 1981, Reg; December 7, 2018, Susp ......do   Do. Riceboro, City of, Liberty County 130126 June 26, 1975, Emerg; November 4, 1981, Reg; December 7, 2018, Susp ......do   Do. Walthourville, City of, Liberty County 130459 N/A, Emerg; October 29, 2008, Reg; December 7, 2018, Susp ......do   Do. South Carolina: Berkeley County, Unincorporated Areas 450029 October 13, 1978, Emerg; September 30, 1983, Reg; December 7, 2018, Susp ......do   Do. Goose Creek, City of, Berkeley County 450206 April 18, 1975, Emerg; February 17, 1982, Reg; December 7, 2018, Susp ......do   Do. Hanahan, City of, Berkeley County 450030 October 25, 1973, Emerg; June 15, 1981, Reg; December 7, 2018, Susp ......do   Do. Moncks Corner, Town of, Berkeley County 450031 July 1, 1975, Emerg; January 16, 1981, Reg; December 7, 2018, Susp ......do   Do. Region V Minnesota: Caledonia, City of, Houston County 270712 May 21, 2001, Emerg; N/A, Reg; December 7, 2018, Susp ......do   Do. Hokah, City of, Houston County 270192 November 29, 1974, Emerg; March 15, 1982, Reg; December 7, 2018, Susp December 7, 2018 December 7, 2018. Houston, City of, Houston County 270193 November 13, 1974, Emerg; July 16, 1979, Reg; December 7, 2018, Susp ......do   Do. Houston County, Unincorporated Areas 270190 April 30, 1974, Emerg; January 6, 1982, Reg; December 7, 2018, Susp ......do   Do. La Crescent, City of, Houston and Winona Counties 275237 February 11, 1972, Emerg; July 20, 1973, Reg; December 7, 2018, Susp ......do   Do. Region VII Iowa: Adel, City of, Dallas County 190103 July 30, 1975, Emerg; August 4, 1987, Reg; December 7, 2018, Susp ......do   Do. Dallas Center, City of, Dallas County 190564 N/A, Emerg; February 22, 2010, Reg; December 7, 2018, Susp ......do   Do. Dallas County, Unincorporated Areas 190860 December 14, 1992, Emerg; May 1, 1994, Reg; December 7, 2018, Susp ......do   Do. Dawson, City of, Dallas County 190358 N/A, Emerg; August 12, 2011, Reg; December 7, 2018, Susp ......do   Do. De Soto, City of, Dallas County 190359 September 1, 1979, Emerg; September 27, 1985, Reg; December 7, 2018, Susp ......do   Do. Granger, City of, Dallas County 190104 October 29, 1976, Emerg; June 1, 1987, Reg; December 7, 2018, Susp ......do   Do. Perry, City of, Dallas County 190105 June 10, 1975, Emerg; September 4, 1985, Reg; December 7, 2018, Susp ......do   Do. Redfield, City of, Dallas County 190361 October 26, 1976, Emerg; September 18, 1985, Reg; December 7, 2018, Susp ......do   Do. Van Meter, City of, Dallas County 190362 N/A, Emerg; January 26, 2009, Reg; December 7, 2018, Susp ......do   Do. Waukee, City of, Dallas County 190678 N/A, Emerg; May 3, 2001, Reg; December 7, 2018, Susp ......do   Do. Region VIII Colorado: Colorado Springs, City of, El Paso County 080060 March 30, 1973, Emerg; December 18, 1986, Reg; December 7, 2018, Susp ......do   Do. El Paso County, Unincorporated Areas 080059 March 9, 1973, Emerg; December 18, 1986, Reg; December 7, 2018, Susp ......do   Do. Fountain, City of, El Paso County 080061 October 2, 1974, Emerg; June 5, 1985, Reg; December 7, 2018, Susp ......do   Do. Green Mountain Falls, Town of, El Paso County 080062 March 18, 1975, Emerg; June 5, 1985, Reg; December 7, 2018, Susp ......do   Do. Manitou Springs, City of, El Paso County 080063 May 29, 1975, Emerg; February 1, 1984, Reg; December 7, 2018, Susp ......do   Do. Monument, Town of, El Paso County 080064 June 10, 1975, Emerg; December 18, 1986, Reg; December 7, 2018, Susp ......do   Do. Palmer Lake, Town of, El Paso County 080065 August 16, 1973, Emerg; July 3, 1978, Reg; December 7, 2018, Susp ......do   Do. Region X Oregon: Bandon, City of, Coos County 410043 October 11, 1974, Emerg; August 15, 1984, Reg; December 7, 2018, Susp ......do   Do. Coos Bay, City of, Coos County 410044 August 23, 1974, Emerg; August 1, 1984, Reg; December 7, 2018, Susp ......do   Do. Coos County, Unincorporated Areas 410042 July 7, 1975, Emerg; November 15, 1984, Reg; December 7, 2018, Susp ......do   Do. Coquille, City of, Coos County 410045 April 29, 1975, Emerg; September 28, 1984, Reg; December 7, 2018, Susp ......do   Do. Lakeside, City of, Coos County 410278 June 2, 1975, Emerg; August 1, 1984, Reg; December 7, 2018, Susp ......do   Do. Myrtle Point, City of, Coos County 410047 January 30, 1975, Emerg; July 16, 1984, Reg; December 7, 2018, Susp ......do   Do. North Bend, City of, Coos County 410048 June 4, 1975, Emerg; August 1, 1984, Reg; December 7, 2018, Susp ......do   Do. Powers, City of, Coos County 410049 August 6, 1975, Emerg; June 30, 1976, Reg; December 7, 2018, Susp ......do   Do. * ......do = Ditto. Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension.
    Dated: November 16, 2018. Eric Letvin, Deputy Assistant Administrator for Mitigation, Federal Insurance and Mitigation Administration—FEMA Resilience, Department of Homeland Security, Federal Emergency Management Agency.
    [FR Doc. 2018-26132 Filed 12-3-18; 8:45 am] BILLING CODE 9110-12-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 156 [CMS-9917-F] RIN 0938-AT93 Patient Protection and Affordable Care Act; Elimination of Internal Agency Process for Implementation of the Federally-Facilitated User Fee Adjustment AGENCY:

    Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).

    ACTION:

    Final rule.

    SUMMARY:

    The U.S. Department of Health and Human Services (HHS) is issuing this final rule to eliminate references to internal Executive Branch procedures provided for under Office of Management and Budget (OMB) circular A-25R in connection with an adjustment to the Federally-facilitated Exchange (FFE) user fee. HHS is amending these regulations because it has determined that an exception to OMB circular A-25R is not required to effectuate the FFE user fee adjustment. Thus, this final rule removes the language that refers to an exception under OMB circular A-25R as an aspect of reducing a participating issuer's FFE user fee obligation. This rule does not affect the ability of an issuer to obtain an applicable reduction in FFE user fee obligations, amend the calculation of the FFE user fee credit provided to a participating issuer, change the application of the monthly user fee adjustment, or alter any of the other standards that participating issuers must meet to qualify for the user fee adjustment.

    DATES:

    These regulations are effective on January 3, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Jaya Ghildiyal, (301) 492-5149, or Adrianne Patterson, (410) 786-0686.

    SUPPLEMENTARY INFORMATION: I. Background A. Determination To Issue a Final Rule

    The U.S. Department of Health and Human Services (HHS) is publishing this final rule without previously publishing a proposed rule because HHS has determined that the rule qualifies for exemption from notice-and-comment rulemaking under section 553 of the Administrative Procedures Act (Pub. L. 79-404, enacted June 11, 1946) (APA), both because it is a “matter relating to agency management” under section 553(a)(2) 1 and a “rule of agency organization, procedure or practice” under section 553(b)(3)(A). This rule eliminates an unnecessary reference to an internal inter-agency process, but makes no changes to the policy or operational processes set forth for participating FFE issuers or third parties subject to 45 CFR 156.50(d), and will have no effect on these entities or the other individuals and entities that were subjects of the July 2, 2013 final rule “Coverage of Certain Preventive Services Under the Affordable Care Act” (78 FR 39870), namely eligible organizations, self-insured plans of eligible organizations, and participants and beneficiaries of those plans.

    1 Although HHS's predecessor agency, the U.S. Department of Health, Education, and Welfare (HEW), waived the APA's exemption to the requirement for notice and comment rulemaking for “public property, loans, grants, benefits, or contracts” in section 553(a)(2), see “Public Participation in Rule Making,” 36 FR 2532 (Feb. 5, 1971), HEW did not waive the exemption in section 553(a)(2) for “matter[s] relating to agency management or personnel.”

    B. Legislative and Regulatory Overview

    The Patient Protection and Affordable Care Act (Pub. L. 111-148, enacted March 23, 2010) and the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152, enacted March 30, 2010) are collectively referred to as “PPACA” in this final rule. Section 1321(a) of the PPACA provides broad authority for the Secretary to establish standards and regulations to implement the statutory requirements related to Exchanges, qualified health plans (QHPs), and other components of title I of the PPACA. When operating an FFE under section 1321(c)(1) of the PPACA, HHS has the authority under sections 1321(c)(1) and 1311(d)(5)(A) of the PPACA to collect and spend user fees. OMB Circular A-25 Revised (OMB Circular A-25R) establishes federal policy regarding user fees and specifies that a user charge will be assessed against each identifiable recipient for special benefits derived from federal activities beyond those received by the general public.

    Section 2713(a)(4) of the Public Health Service Act, as added by the PPACA and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code, requires that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage provide certain women's preventive health services as a benefit without cost sharing, as provided for in comprehensive guidelines supported by the Health Resources and Services Administration. On July 2, 2013, the final rule “Coverage of Certain Preventive Services Under the Affordable Care Act” (78 FR 39870) published by HHS, the Department of the Treasury, and the Department of Labor, set forth regulations allowing eligible organizations to receive an accommodation relating to coverage of contraceptive services, so that they are not required to provide, arrange, or pay for these services. Those regulations at 45 CFR 147.131, 26 CFR 54.9815-2713A, and 29 CFR 2590.715-2713A were amended, but largely left in place, by interim final rules with requests for comments published in the Federal Register on October 13, 2017, Religious Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act (82 FR 47792) and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act (82 FR 47838) and final rules published in the Federal Register on November 15, 2018,with an effective date of January 14, 2019, Religious Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act (83 FR 57536) and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act (83 FR 57592). The 2013 final regulation also set forth processes and standards at § 156.50(c) and (d) to take into account the payments for the contraceptive services that are provided for participants and beneficiaries in self-insured plans of eligible organizations under the accommodation described in that final rule through an adjustment in the FFE user fee payable by an issuer participating in an FFE, at no cost to plan participants or beneficiaries, eligible organizations, third party administrators, or issuers.

    II. Provisions of the Final Regulations

    This final rule amends the regulations for adjustments of FFE user fees set forth at § 156.50, as established in the final rule published in the July 2, 2013 Federal Register. HHS is amending § 156.50(d)(3), to remove the current language providing that an authorizing exception under OMB Circular No. A-25R must be in effect in order for HHS to provide a participating issuer a reduction in its obligation to pay the FFE user fee. HHS will calculate the user fee reduction as the sum of the total dollar amount of the payments for contraceptive services submitted by applicable third party administrators, as described in paragraph (d)(2)(iii)(D), and an allowance, specified by HHS, for administrative costs and margin.

    HHS is also amending § 156.50(d)(4) to remove a corresponding requirement that an authorizing exception under OMB Circular No. A-25R be in effect. If the amount of the reduction under § 156.50(d)(3) is greater than the amount of the obligation to pay the FFE user fee in a particular month, the participating issuer will be provided a credit in succeeding months in the amount of the excess.

    HHS has determined that an exception to OMB Circular No. A-25R is not required to be in effect to effectuate the FFE user fee adjustment for participating issuers. HHS has implemented an adjustment to FFE user fee collections for each benefit year beginning with the 2014 benefit year, and the adjustment has accounted for less than 2 percent of total FFE user fee collections for each benefit year. Therefore, HHS continues to believe that the adjustment to FFE user fee collections will not materially undermine FFE operations. HHS believes that the reduced user fee collections resulting from the adjustment will not necessitate an exception to OMB Circular No. A-25R. Subject to HHS's standing financial management procedures, HHS will continue to monitor user fee collections and expenditures to ensure compliance under OMB Circular No. A-25R going forward. Additionally, HHS notes that it has not raised the FFE user fee finalized in the annual notice of benefit and payment parameters to offset the FFE user fee adjustments for any applicable benefit year. HHS estimates that payments for contraceptive services will continue to represent only a small portion of total FFE user fees in future benefit years, and it does not anticipate that it will need to increase the FFE user fee rate to offset the FFE user fee adjustment available to participating issuers.

    III. Collection of Information Requirements

    This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.).

    IV. Regulatory Impact Analysis

    HHS has examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (Pub. L. 96-354, enacted September 19, 1980) (RFA), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, enacted March 22, 1995), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs. Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis must be prepared for major rules with economically significant effects ($100 million or more in any one year).

    This final rule is not “economically significant” within the meaning of section 3(f)(1) of Executive Order 12866 because it is unlikely to have an annual effect of $100 million in any single year. In addition, for the reasons noted in this final rule, HHS does not believe that this final rule is a major rule under the Congressional Review Act.

    The RFA requires agencies to analyze options for regulatory relief of small businesses. This rule would not have a significant impact on small businesses.

    In addition, section 1102(b) of the Act requires HHS to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This rule would not have a significant impact on small rural hospitals because the amendments contained in this final rule do not pertain to hospitals.

    Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by state, local, or tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. In 2018, that threshold is approximately $150 million. HHS anticipates this rule would not impact state governments or the private sector.

    Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. HHS does not anticipate this rule would impose direct requirement costs on state or local governments, preempt state law, or otherwise have federalism implications.

    List of Subjects in 45 CFR Part 156

    Administrative appeals, Administrative practice and procedure, Advertising, Advisory Committees, American Indian/Alaska Natives, Brokers, Conflict of interest, Consumer protection, Cost-sharing reductions, Grant programs-health, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, Individuals with disabilities, Loan programs-health, Organization and functions (Government agencies), Medicaid, Payment and collections reports, Public assistance programs, Reporting and recordkeeping requirements, State and local governments, Sunshine Act, Taxes, Technical assistance, Women, and Youth.

    For the reasons set forth in the preamble, the Department of Health and Human Services amends 45 CFR part 156 as set forth below:

    PART 156—HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES 1. The authority citation for part 156 is revised to read as follows: Authority:

    42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, 26 U.S.C. 36B, and 31 U.S.C. 9701.

    2. Section 156.50 is amended by revising paragraphs (d)(3) and (4) to read as follows:
    § 156.50 Financial support.

    (d) * * * * *

    (3) If the requirements set forth in paragraph (d)(2) of this section are met, the participating issuer will be provided a reduction in its obligation to pay the Federally-facilitated Exchange user fee specified in paragraph (c) of this section equal in value to the sum of the following:

    (i) The total dollar amount of the payments for contraceptive services submitted by the applicable third-party administrators, as described in paragraph (d)(2)(iii)(D) of this section; and

    (ii) An allowance for administrative costs and margin. The allowance will be no less than 10 percent of the total dollar amount of the payments for contraceptive services specified in paragraph (d)(3)(i) of this section. HHS will specify the allowance for a particular calendar year in the annual HHS notice of benefit and payment parameters.

    (4) If the amount of the adjustment under paragraph (d)(3) of this section is greater than the amount of the participating issuer's obligation to pay the Federally-facilitated Exchange user fee in a particular month, the participating issuer will be provided a credit in succeeding months in the amount of the excess.

    Dated: November 16, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. Dated: November 20, 2018. Alex M. Azar II, Secretary, Department of Health and Human Services.
    [FR Doc. 2018-26332 Filed 11-30-18; 4:15 pm] BILLING CODE 4120-01-P
    DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Parts 212, 225, and 252 [Docket DARS-2018-0028] RIN 0750-AJ71 Defense Federal Acquisition Regulation Supplement: Sunset of Provision Relating to the Procurement of Certain Goods (DFARS Case 2018-D007) AGENCY:

    Defense Acquisition Regulations System, Department of Defense (DoD).

    ACTION:

    Final rule.

    SUMMARY:

    DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2018 that repeals the Fiscal Year 2015 restrictions on the source of photovoltaic devices in contracts awarded by DoD that result in DoD ownership of photovoltaic devices by means other than DoD purchase of the photovoltaic devices as end products.

    DATES:

    Effective December 5, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Amy G. Williams, telephone 571-372-6106.

    SUPPLEMENTARY INFORMATION:

    I. Background

    DoD published a proposed rule in the Federal Register at 83 FR 42822 on August 24, 2018, to implement section 813(b) of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2018 (Pub. L. 115-91). Section 813(b) repeals section 858 of the NDAA for FY 2015 (Pub. L. 113-291), but does not repeal section 846 of the NDAA for FY 2011 (Pub. L. 111-383), with regard to sources of photovoltaic devises purchased by contractors that become property of DoD. There were no public comments submitted in response to the proposed rule. There are no changes from the proposed rule in the final rule.

    II. Applicability to Contracts at or Below the Simplified Acquisition Threshold and for Commercial Items, Including Commercially Available Off-the-Shelf Items

    This rule does not affect the applicability of DFARS clause 252.225-7017, Photovoltaic Devices, and DFARS provision 252.225-7018, Photovoltaic Devices—Certification. A determination was signed by the Director, Defense Procurement and Acquisition Policy, on October 13, 2011, to not apply the requirements of section 846 of the NDAA for FY 2011 to contracts at or below the simplified acquisition threshold, but to apply the rule to contracts for the acquisition of commercial items, including commercially available off-the-shelf items.

    III. Executive Orders 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

    IV. Executive Order 13771

    This rule is not an E.O. 13771 regulatory action, because this final rule is not significant under E.O. 12866.

    V. Regulatory Flexibility Act

    A final regulatory flexibility analysis (FRFA) has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The FRFA is summarized as follows:

    This rule implements section 813(b) of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2018 (Pub. L. 115-91), which repealed of section 858 of the National Defense Authorization Act (NDAA) for FY 2015 (Pub. L. 113-291), while retaining the requirements of section 846 of the NDAA for FY 2011 (Pub. L. 111-383), with regard to sources of photovoltaic devices purchased by contractors that become the property of DoD.

    The objective of this rule is to revert to the regulations on photovoltaic devices that were in effect prior to superimposing the additional regulations required by section 858 on November 20, 2015 (80 FR 72599). By restoring the tie to the Buy American statute, this rule reinstates the Buy American exceptions for acquisitions of photovoltaic devices below the micro-purchase threshold, nonavailability, unreasonable cost, and public interest, including the DoD class determinations that exempt U.S.-made and qualifying country photovoltaic devices from the requirements of the Buy American statute, as well as the Governmentwide determination that removes the component test for commercially available off-the-shelf items.

    No significant issues were raised by the public comments in response to the initial regulatory flexibility analysis. No public comments were received.

    This rule generally applies at the prime contract level to other than small entities. When purchasing renewable power generated via onsite photovoltaic devices, DoD can either purchase the photovoltaic devices and thereby own, operate, and maintain the devices for their full economic life (already covered in DFARS part 225 under standard Buy American statute/Trade Agreements regulations) or, for example, may do some variation of the following:

    a. Enter into an energy savings performance contract, which is a contracting method in which the contractor provides capital to facilitate energy conservation measures and maintains them in exchange for a portion of the energy savings generated. Under this arrangement, the Government would take title to the devices during contract performance or at the conclusion of the contract. For example, DoD uses either the master indefinite delivery-indefinite quantity contract of the Department of Energy or the Army Corps of Engineers and awards task orders off one of those contracts. Generally, the same approved contractors are on each contract. Of the approved contractors, all but one are large businesses. There are subcontracting goals that each contractor has to meet, but the ultimate task order award is most often made to a large business.

    b. Enter into a power purchase agreement, also referred to as a utility service contract, for the purchase of the power output of photovoltaic devices that are installed on DoD land or buildings, but owned, operated, and maintained by the contractor. At the conclusion of the contract, DoD would either require the contractor to dismantle and remove the photovoltaic equipment or abandon the equipment in place. Prime contractors for this type of contract would generally be large businesses, based on the capital costs involved in these projects. However, many developers tend to subcontract out the majority of the work to smaller companies.

    There are approximately 80 manufacturers of photovoltaic devices. We do not currently have data available on whether any of the manufacturers of photovoltaic devices are small entities, because the Federal Procurement Data System does not collect such data on subcontractors.

    There are no new reporting burdens under this rule. In fact, there is a de minimis reduction in burden, because no certification will be required if the value of the photovoltaic devices does not exceed the micro-purchase threshold, and identification of country of origin will no longer be required if the photovoltaic devices are domestic or U.S.-made. Furthermore, since the prime contractors subject to this rule are other than small businesses, the existing reporting requirements do not impact small entities.

    DoD did not identify any significant alternatives that meet the requirements of the statute and would have less impact on small entities. The overall effect of this rule is deregulatory and it does not have significant impact on small entities.

    VI. Paperwork Reduction Act

    The rule contains information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C chapter 35); however, these changes to the DFARS do not impose additional information collection requirements to the paperwork burden previously approved under OMB Control Number 0704-0229, entitled “Defense Federal Acquisition Regulation Supplement (DFARS) Part 225, Foreign Acquisition, and related clauses at DFARS 252.225.”

    List of Subjects in 48 CFR Parts 212, 225, and 252

    Government procurement.

    Jennifer Lee Hawes, Regulatory Control Officer, Defense Acquisition Regulations System.

    Therefore, 48 CFR parts 212, 225, and 252 are amended as follows:

    1. The authority citation for 48 CFR parts 212, 225, and 252 continues to read as follows: Authority:

    41 U.S.C. 1303 and 48 chapter 1.

    PART 212—ACQUISITION OF COMMERCIAL ITEMS 2. Amend section 212.301 by revising paragraphs (f)(ix)(J) and (K) to read as follows:
    212.301 Solicitation provisions and contract clauses for the acquisition of commercial items.

    (f) * * *

    (ix) * * *

    (J) Use the clause at 252.225-7017, Photovoltaic Devices, as prescribed in 225.7017-4(a), to comply with section 846 of Public Law 111-383.

    (K) Use the provision at 252.225-7018, Photovoltaic Devices—Certificate, as prescribed in 225.7017-4(b), to comply with section 846 of Public Law 111-383.

    PART 225—FOREIGN ACQUISITION 3. Amend section 225.7017-1 by revising the definitions of “covered contract” and “domestic photovoltaic device” to read as follows:
    225.7017-1 Definitions.

    Covered contract means an energy savings performance contract, a utility services contract, or a private housing contract awarded by DoD, to be performed in the United States, if such contract results in DoD ownership of photovoltaic devices, by means other than DoD purchase as end products. DoD is deemed to own a photovoltaic device if the device is—

    (1) Installed in the United States on DoD property or in a facility owned by DoD; and

    (2) Reserved for the exclusive use of DoD in the United States for the full economic life of the device.

    Domestic photovoltaic device means a photovoltaic device that is manufactured in the United States.

    4. Revise section 225.7017-2 to read as follows:
    225.7017-2 Restriction.

    In accordance with section 846 of the National Defense Authorization Act for Fiscal Year 2011 (Pub. L. 111-383), photovoltaic devices provided under any covered contract shall comply with 41 U.S.C. chapter 83, Buy American, subject to the exceptions to that statute provided in the Trade Agreements Act of 1979 (19 U.S.C. 2501 et seq.).

    5. Revise section 225.7017-3 to read as follows:
    225.7017-3 Exceptions.

    DoD requires the contractor to utilize domestic photovoltaic devices in covered contracts that exceed the simplified acquisition threshold, with the following exceptions:

    (a) Qualifying country. Qualifying country photovoltaic devices may be utilized in any covered contract, because 225.103(a)(i)(A) provides an exception to the Buy American statute for products of qualifying countries, as defined in 225.003.

    (b) Buy American—unreasonable cost. For a covered contract that utilizes photovoltaic devices valued at less than $180,000, the exception for unreasonable cost may apply (see FAR 25.103(c). If the cost of a foreign photovoltaic device plus 50 percent is less than the cost of a domestic photovoltaic device, then the foreign photovoltaic device may be utilized.

    (c) Trade agreements—(1) Free Trade Agreements. For a covered contract that utilizes photovoltaic devices valued at $25,000 or more, photovoltaic devices may be utilized from a country covered under the acquisition by a Free Trade Agreement, depending upon dollar threshold (see FAR subpart 25.4).

    (2) World Trade Organization—Government Procurement Agreement. For covered contracts that utilize photovoltaic devices that are valued at $180,000 or more, only U.S.-made photovoltaic devices, designated country photovoltaic devices, or qualifying country photovoltaic devices may be utilized.

    225.7017-4. [Removed]
    6. Remove section 225.7017-4.
    225.7017-5 [Redesignated as 225.7017-4]
    7. Redesignate section 225.7017-5 as 225.7017-4 and in the newly redesignated section 225.7017-4, revise paragraph (a)(1) to read as follows:
    225.7017-4 Solicitation provision and contract clause.

    (a)(1) Use the clause at 252.225-7017, Photovoltaic Devices, in solicitations, including solicitations using FAR part 12 procedures for the acquisition of commercial items, for a contract expected to exceed the simplified acquisition threshold that may be a covered contract, i.e., an energy savings performance contract, a utility service contract, or a private housing contract awarded by DoD, if such contract will result in DoD ownership of photovoltaic devices, by means other than DoD purchase as end products.

    PART 252—SOLICITATION PROVISIONS AND CONTRACT CLAUSES 8. Amend section 252.225-7017 by— a. In the introductory text, removing “225.7017-5(a)” and adding “225.7017-4(a)” in its place; b. Removing the clause date “(JAN 2018)” and adding “(DEC 2018)” in its place; c. In paragraph (a)— i. Removing subparagraph designations “(i)” and “(ii)” and adding “(1)” and (2)” in their places wherever they appear; ii. Removing subparagraph designations “(iii)” and “(iv)” and adding “(3)” and “(4)” in their places wherever they appear; iii. Revising the definition of “domestic photovoltaic device”; d. In paragraph (b), removing “858 of the National Defense Authorization Act for Fiscal Year 2015 (Pub. L. 113-291)” and adding “846 of the National Defense Authorization Act for Fiscal Year 2011 (Pub. L. 111-383)” in its place; and e. In paragraph (c)— i. Revising paragraph (c)(1); ii. In paragraph (c)(2), removing “photovoltaic device as specified, or,” and adding “photovoltaic device, or,” in its place; and iii. Revising paragraphs (c)(3), (4), and (5).

    The revisions read as follows:

    252.225-7017 Photovoltaic Devices.

    (a) * * *

    Domestic photovoltaic device means a photovoltaic device that is manufactured in the United States.

    (c) * * *

    (1) More than the micro-purchase threshold but less than $25,000, then the Contractor shall utilize only domestic photovoltaic devices unless, in its offer, it specified utilization of qualifying country or other foreign photovoltaic devices in paragraph (d)(2) of the Photovoltaic Devices—Certificate provision of the solicitation.

    (3) $80,317 or more but less than $100,000, then the Contractor shall utilize under this contract only domestic photovoltaic devices, unless, in its offer, it specified utilization of Free Trade Agreement country photovoltaic devices (other than Bahrainian, Korean, Moroccan, Panamanian, or Peruvian photovoltaic devices), qualifying country photovoltaic devices, or other foreign photovoltaic devices in paragraph (d)(4) of the Photovoltaic Devices—Certificate provision of the solicitation. If the Contractor certified in its offer that it will utilize a Free Trade Agreement country photovoltaic device (other than a Bahrainian, Korean, Moroccan, Panamanian, or Peruvian photovoltaic device) or a qualifying country photovoltaic device, then the Contractor shall utilize a Free Trade Agreement country photovoltaic device (other than a Bahrainian, Korean, Moroccan, Panamanian, or Peruvian photovoltaic device) or a qualifying country photovoltaic device; or, at the Contractor's option, a domestic photovoltaic device;

    (4) $100,000 or more but less than $180,000, then the Contractor shall utilize under this contract only domestic photovoltaic devices, unless, in its offer it specified utilization of Free Trade Agreement country photovoltaic devices (other than Bahrainian, Moroccan, Panamanian, or Peruvian photovoltaic devices), qualifying country photovoltaic devices, or other foreign photovoltaic devices in paragraph (d)(5) of the Photovoltaic Devices—Certificate provision of the solicitation. If the Contractor certified in its offer that it will utilize a Free Trade Agreement country photovoltaic device (other than a Bahrainian, Moroccan, Panamanian, or Peruvian photovoltaic device) or a qualifying country photovoltaic device, then the Contractor shall utilize a Free Trade Agreement country photovoltaic device (other than a Bahrainian, Moroccan, Panamanian, or Peruvian photovoltaic device) or a qualifying country photovoltaic device; or, at the Contractor's option, a domestic photovoltaic device; or

    (5) $180,000 or more, then the Contractor shall utilize under this contract only U.S.-made, designated country, or qualifying country photovoltaic devices.

    9. Amend section 252.225-7018 by— a. In the introductory text, removing “225.7017-5(b)” and adding “225.7017-4(b)” in its place; b. Removing clause date “(JAN 2018)” and adding “(DEC 2018)” in its place; c. Revising paragraphs (b)(1) and (2); and d. Revising paragraphs (d)(1), (d)(2) introductory text, and (d)(3) through (6).

    The revisions read as follows:

    252.225-7018 Photovoltaic Devices—Certificate.

    (b) * * *

    (1) If more than the micro-purchase threshold but less than $180,000, then the Government will not accept an offer specifying the use of other foreign photovoltaic devices in paragraph (d)(2)(ii), (d)(3)(ii), (d)(4)(ii), or (d)(5)(ii) of this provision, unless the offeror documents to the satisfaction of the Contracting Officer that the price of the foreign photovoltaic device plus 50 percent is less than the price of a comparable domestic photovoltaic device.

    (2) If $180,000 or more, then the Government will consider only offers that utilize photovoltaic devices that are U.S.-made, qualifying country, or designated country photovoltaic devices.

    (d) * * *

    __ (1) No photovoltaic devices will be utilized in performance of the contract, or such photovoltaic devices have an estimated value that does not exceed the micro-purchase threshold.

    (2) If more than the micro-purchase threshold but less than $25,000—

    (3) If $25,000 or more but less than $80,317—

    __ (i) The offeror certifies that each photovoltaic device to be utilized in performance of the contract is a domestic photovoltaic device;

    __ (ii) The offeror certifies that each photovoltaic device to be utilized in performance of the contract is a Canadian photovoltaic device or a qualifying country photovoltaic device [Offeror to specify country of origin___]; or

    __ (iii) The foreign (other than Canadian or qualifying country) photovoltaic devices to be utilized in performance of the contract are the product of ___. [Offeror to specify country of origin, if known, and provide documentation that the cost of a domestic photovoltaic device would be unreasonable in comparison to the cost of the proposed foreign photovoltaic device, i.e. that the price of the foreign photovoltaic device plus 50 percent is less than the price of a comparable domestic photovoltaic device.]

    (4) If $80,317 or more but less than $100,000—

    __ (i) The offeror certifies that each photovoltaic device to be utilized in performance of the contract is a domestic photovoltaic device;

    __ (ii) The offeror certifies that each photovoltaic device to be utilized in performance of the contract is a Free Trade Agreement country photovoltaic device (other than a Bahrainian, Korean, Moroccan, Panamanian, or Peruvian photovoltaic device) or a qualifying country photovoltaic device [Offeror to specify country of origin___]; or

    __ (iii) The offered foreign photovoltaic devices (other than those from countries listed in paragraph (d)(4)(ii) of this provision) are the product of ___. [Offeror to specify country of origin, if known, and provide documentation that the cost of a domestic photovoltaic device would be unreasonable in comparison to the cost of the proposed foreign photovoltaic device, i.e. that the price of the foreign photovoltaic device plus 50 percent is less than the price of a comparable domestic photovoltaic device.]

    (5) If $100,000 or more but less than $180,000—

    __ (i) The offeror certifies that each photovoltaic device to be utilized in performance of the contract is a domestic photovoltaic device;

    __ (ii) The offeror certifies that each photovoltaic device to be utilized in performance of the contract is a Free Trade Agreement country photovoltaic device (other than a Bahrainian, Moroccan, Panamanian, or Peruvian photovoltaic device) or a qualifying country photovoltaic device [Offeror to specify country of origin___]; or

    __ (iii) The offered foreign photovoltaic devices (other than those from countries listed in paragraph (d)(5)(ii) of this provision) are the product of ___. [Offeror to specify country of origin, if known, and provide documentation that the cost of a domestic photovoltaic device would be unreasonable in comparison to the cost of the proposed foreign photovoltaic device, i.e. that the price of the foreign photovoltaic device plus 50 percent is less than the price of a comparable domestic photovoltaic device.]

    (6) If $180,000 or more, the Offeror certifies that each photovoltaic device to be used in performance of the contract is—

    __ (i) A U.S.-made photovoltaic device; or

    __ (ii) A designated country photovoltaic device or a qualifying country photovoltaic device. [Offeror to specify country of origin___.]

    [FR Doc. 2018-26305 Filed 12-3-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Part 217 [Docket DARS-2018-0054] RIN 0750-AK27 Defense Federal Acquisition Regulation Supplement: Documentation for Interagency Contracts (DFARS Case 2018-D073) AGENCY:

    Defense Acquisition Regulations System, Department of Defense (DoD).

    ACTION:

    Final rule.

    SUMMARY:

    DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2019 that removes the requirement to make a best procurement approach determination to use an interagency acquisition.

    DATES:

    Effective December 4, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Carrie Moore, telephone 571-372-6093.

    SUPPLEMENTARY INFORMATION:

    I. Background

    DoD is amending the DFARS to implement section 875 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019 (Pub. L. 115-232). Section 875 amends section 865 of the NDAA for FY 2009 (Pub. L. 110-417) by removing the requirement for agencies, prior to requesting another agency to conduct an acquisition on its behalf, to make a determination that the use of an interagency acquisition represents the best procurement approach. The requirement for a best procurement approach determination is implemented at Federal Acquisition Regulations (FAR) 17.502-1(a). Removal of the requirement from the FAR, in accordance with section 875, is being accomplished under FAR case 2018-015. This rule removes supplemental text from DFARS 217.502-1 that advises contracting officers, when providing acquisition assistance to deployed DoD units or personnel from another DoD Component, to obtain the determination from the requiring DoD unit or personnel.

    II. Applicability to Contracts at or Below the Simplified Acquisition Threshold and for Commercial Items, Including Commercially Available Off-the-Shelf Items

    This rule only impacts the internal operating procedures of the agency. As such, the rule does not impose any new requirements on contracts at or below the simplified acquisition threshold or for commercial items, including commercially available off-the-shelf items.

    III. Executive Orders 12866 and 13563

    Executive Order (E.O.) 12866, Regulatory Planning and Review; and E.O. 13563, Improving Regulation and Regulatory Review, direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Office of Management and Budget, Office of Information and Regulatory Affairs (OIRA), has determined that this is not a significant regulatory action as defined under section 3(f) of E.O. 12866 and, therefore, was not subject to review under section 6(b). This rule is not a major rule as defined at 5 U.S.C. 804(2).

    IV. Executive Order 13771

    This final rule is not an E.O. 13771 regulatory action, because this rule is not significant under E.O. 12866.

    V. Publication of This Final Rule for Public Comment Is Not Required by Statute

    The statute that applies to the publication of the Federal Acquisition Regulation (FAR) is Office of Federal Procurement Policy statute (codified at title 41 of the United States Code). Specifically, 41 U.S.C. 1707(a)(1) requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure, or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment, because it only impacts determination and documentation processes that are internal to the agency.

    VI. Regulatory Flexibility Act

    Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under 41 U.S.C. 1707(a)(1) (see section V. of this preamble), the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

    VII. Paperwork Reduction Act

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

    List of Subjects in 48 CFR Part 217

    Government procurement.

    Jennifer Lee Hawes, Regulatory Control Officer, Defense Acquisition Regulations System.

    Therefore, 48 CFR part 217 is amended as follows:

    PART 217—SPECIAL CONTRACTING METHODS 1. The authority citation for 48 CFR part 217 continues to read as follows: Authority:

    41 U.S.C. 1303 and 48 CFR chapter 1.

    2. Revise section 217.502-1 to read as follows:
    217.502-1 General.

    (a) Written agreement on responsibility for management and administration—

    (1) Assisted acquisitions. Follow the procedures at PGI 217.502-1(a)(1), when a contracting activity from a DoD Component provides acquisition assistance to deployed DoD units or personnel from another DoD Component.

    [FR Doc. 2018-26309 Filed 12-3-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Parts 217 and 252 [Docket DARS-2018-D036] RIN 0750-AJ87 Defense Federal Acquisition Regulation Supplement: Modification of DFARS Clause “Surge Option” (DFARS Case 2018-D025) AGENCY:

    Defense Acquisition Regulations System, Department of Defense (DoD).

    ACTION:

    Final rule.

    SUMMARY:

    DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to revise a clause to reflect current terminology and industry practices, pursuant to action taken by the DoD Regulatory Reform Task Force.

    DATES:

    Effective December 4, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Carrie Moore, telephone 571-372-6093.

    SUPPLEMENTARY INFORMATION:

    I. Background

    DoD published a proposed rule in the Federal Register at 83 FR 30659 on June 29, 2018, to modify DFARS clause 252.217-7001, Surge Option, to replace the term “Production Surge Plan (DI-MGMT-80969)” with “Capabilities Analysis Plan (CAP)” and add text to permit the option increase of supplies or services called for under the clause to be expressed as a specific number. The associated clause prescription at DFARS 217.208-70(b) is amended to reflect that the option increase of supplies or services may also be expressed as a specific number. This rule supports a recommendation from the DoD Regulatory Reform Task Force under Executive Order (E.O.) 13777, Enforcing the Regulatory Reform Agenda.

    One respondent submitted a public comment in response to the proposed rule. The comment is outside the scope of this case and no changes are made in the final rule.

    II. Applicability to Contracts at or Below the Simplified Acquisition Threshold and for Commercial Items, Including Commercially Available Off-the-Shelf Items

    This rule does not propose to create any new provisions or clauses. The proposed changes to DFARS clause 252.217-7001, Surge Option, are minimal and reflect only updates required to mirror current industry terminology and practice for support that may be required for industrial planning for selected essential military items in the event of an emergency. The rule continues to apply to contracts below the simplified acquisition threshold, however, the rule does not apply to commercial items, including commercially available off-the-shelf items.

    III. Executive Orders 12866 and 13563

    E.O. 12866, Regulatory Planning and Review; and E.O. 13563, Improving Regulation and Regulatory Review, direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Office of Management and Budget, Office of Information and Regulatory Affairs (OIRA), has determined that this is not a significant regulatory action as defined under section 3(f) of E.O. 12866 and, therefore, was not subject to review under section 6(b). This rule is not a major rule as defined at 5 U.S.C. 804(2).

    IV. Executive Order 13771

    This final rule is not subject to E.O. 13771, because this rule is not significant under E.O. 12866.

    V. Regulatory Flexibility Act

    A final regulatory flexibility analysis (FRFA) has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The FRFA is summarized as follows:

    The Department of Defense is amending the Defense Federal Acquisition Regulation Supplement (DFARS) to revise a clause to reflect current terminology and industry practices. The objective of this rule is to improve the flexibility offered to contractors submitting pricing for surge options by giving them the option to quote prices by percentage or quantity increases, and to update the terminology used from “Production Surge Plan” to “Capability Analysis Plan” (CAP), since this is the most current and accurate term for this type of plan. The modification of this DFARS text supports a recommendation from the DoD Regulatory Reform Task Force under E.O. 13777, Enforcing the Regulatory Reform Agenda.

    No public comments were received in response to the initial regulatory flexibility analysis.

    This rule is not expected to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the scope of the rule limits the application of the reporting requirement to a small number of service contracts. Based on fiscal year 2017 data from the Federal Procurement Data System, the Government issued approximately 78 contract actions that used mobilization or essential research and development as the reason for other than full and open competition. Of the 78 contract actions, approximately 33 awards were made to 24 unique small entities.

    This rule does not include any new reporting, recordkeeping, or other compliance requirements for small businesses.

    There are no known significant alternative approaches to the rule that would meet the proposed objectives.

    VI. Paperwork Reduction Act

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

    List of Subjects in 48 CFR Parts 217 and 252

    Government procurement.

    Jennifer Lee Hawes, Regulatory Control Officer, Defense Acquisition Regulations System.

    Therefore, 48 CFR parts 217 and 252 are amended as follows: 1. The authority citation for parts 217 and 252 continues to read as follows:

    Authority:

    41 U.S.C. 1303 and 48 CFR chapter 1.

    PART 217—SPECIAL CONTRACTING METHODS
    217.208-70 [Amended]
    2. In section 217.208-70, amend paragraph (b)(1), by removing “percentage” and adding “percentage or quantity” in its place. PART 252—SOLICITATION PROVISIONS AND CONTRACT CLAUSES 3. Amend section 252.217-7001 by— a. Removing the clause date of “(AUG 1992)” and adding “(DEC 2018)” in its place; b. Revising paragraph (a)(1); c. In paragraph (b)(1), removing “Production Surge Plan (DI-MGMT 80969)” and adding “Capabilities Analysis Plan (CAP)” in its place; and d. In paragraph (b)(2), removing “Production Surge Plan” and adding “CAP” in its place.

    The revision reads as follows:

    252.217-7001. Surge option.

    (a) * * *

    (1) Increase the quantity of supplies or services called for under this contract by no more than __percent or __[insert quantity and description of services or supplies to be increased]; and/or

    [FR Doc. 2018-26307 Filed 12-3-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Parts 383 and 384 [Docket No. FMCSA-2001-11117] RIN 2126-AA70 Limitations on the Issuance of Commercial Driver's Licenses With a Hazardous Materials Endorsement AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Interim rules; re-opening of the comment period.

    SUMMARY:

    In May 2003 and April 2005, FMCSA published interim final rules (IFR) regarding the limitations on the issuance of commercial driver's licenses with a hazardous materials endorsement. The comment period for the May 2003 IFR closed on July 7, 2003; there was no comment period for the April 2005 IFR. The Agency received over 50 comments on the 2003 IFR. FMCSA now plans to adopt the provisions of the IFRs that have not previously been made final. To ensure that interested parties have an opportunity to provide comments, the Agency has re-opened the comment period for 15 days.

    DATES:

    The comment periods for the interim final rules published May 5, 2003, at 68 FR 23844, and April 29, 2005, at 70 FR 22268, are reopened. Comments must be received on or before December 19, 2018.

    ADDRESSES:

    You may submit comments identified by Docket Number FMCSA-2001-11117 using any of the following methods:

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

    Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building, Ground Floor, Room W12-140, Washington, DC 20590-0001.

    Hand Delivery or Courier: West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays.

    Fax: (202) 493-2251.

    To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Selden Fritschner, CDL Division, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590-0001; by email at [email protected], or by telephone at 202-366-0677. If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION:

    I. Public Participation and Request for Comments A. Submitting Comments

    If you submit a comment, please include the docket number for this IFR (FMCSA-2001-11117), indicate the specific section of the document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.

    To submit your comment online, go to http://www.regulations.gov, put the docket number, FMCSA-2001-11117, in the keyword box, and click “Search.” When the new screen appears, click on the “Comment Now!” button and type your comment into the text box on the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit.

    If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope.

    FMCSA will consider all comments and material received during the comment period and may change this IFR based on your comments. FMCSA may issue a final rule at any time after the close of the comment period.

    B. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov. Insert the docket number, FMCSA-2001-11117, 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. ET, Monday through Friday, except Federal holidays.

    C. Privacy Act

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

    II. Background

    On May 5, 2003, FMCSA published an IFR titled “Limitations on the Issuance of Commercial Driver's Licenses with a Hazardous Materials Endorsement” (68 FR 23844). It revised its regulations to require State licensing agencies to issue or renew a hazardous materials endorsement for a CDL only if the Transportation Security Administration (TSA) has determined that the applicant does not pose a security risk warranting denial of such endorsement. To determine applicability, a CDL renewal, transfer, or upgrade was also considered a new issuance and fell within the scope of these requirements if it involved a hazardous materials endorsement. The IFR implemented FMCSA's part of the requirements of section 1012 of the USA PATRIOT Act, which limited the issuance of hazardous materials licenses. Because FMCSA shares with TSA the responsibility for implementing section 1012, TSA concurrently published an IFR containing regulations governing the security risk determination process in 49 CFR parts 1570 and 1572 (May 5, 2003, 68 FR 23852). No public meeting was requested and none was held. The IFR became effective upon publication on May 5, 2003.

    On April 29, 2005, FMCSA published an IFR titled “Limitations on the Issuance of Commercial Driver's Licenses with a Hazardous Materials Endorsement” (70 FR 22268). That rule was issued as an IFR because it related to the 2003 IFR. In the preamble, FMCSA wrote that the 2005 IFR would be subsumed into the 2003 IFR when that rulemaking was finalized. FMCSA's 2003 IFR provided a specific date on which States became subject to the new requirement. The 2005 IFR amended the FMCSRs to cross-reference the TSA's compliance date as the date when FMCSA's companion requirements also became applicable (70 FR 22268). Consistent with the TSA regulations, FMCSA also reduced the amount of advance notice that States must provide to drivers that a security threat assessment will be performed when they renew a hazardous materials endorsement.

    FMCSA solicited comments to the 2003 IFR. The Agency received over 50 comments. No comment period was included with the 2005 IFR.

    On October 5, 2018, Congress enacted the FAA Reauthorization Act of 2018 (Pub. L. 115-254). Under Sec. 1977, a CMV driver who wants to obtain a hazardous materials endorsement on a commercial driver's license is an “applicable individual who is subject to credentialing or background investigation”. Section 1978 exempted individuals who hold a valid transportation security card (TSC, or TWIC as implemented by TSA) issued under section 70105 of Title 46. FMCSA intends to incorporate this exemption when finalizing the IFRs, subject to TSA requirements on the issuance of the HME.

    Comments Requested

    Considering the passage of time since the publication of the IFRs, and because some items may not have been touched on during the initial notice and comment, FMCSA is re-opening the comment period. At the end of the comment period, FMCSA will consider all issues under its authority and may change the IFR based on the comments. FMCSA may issue a final rule at any time after the close of the comment period.

    Issued on: November 23, 2018. Raymond P. Martinez, Administrator.
    [FR Doc. 2018-26250 Filed 12-3-18; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 390 [Docket No. FMCSA-2012-0103] RIN 2126-AC22 Lease and Interchange of Vehicles; Motor Carriers of Passengers; Extension of Compliance Date AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Final rule; extension of compliance date.

    SUMMARY:

    FMCSA extends the compliance date of the May 27, 2015, final rule titled “Lease and Interchange of Vehicles; Motor Carriers of Passengers,” from January 1, 2019, to January 1, 2021. The final rule received 37 petitions for reconsideration. To address the concerns in the petitions, FMCSA initiated a new notice of proposed rulemaking (NPRM) that also included a proposal to extend the compliance date of the 2015 final rule from January 1, 2019, to January 1, 2021. This extension of the compliance date is necessary to provide time to consider all the issues raised in comments to the NPRM and to publish a final rule, while giving motor carriers sufficient time to comply with the revised requirements.

    DATES:

    Effective date: December 4, 2018 until January 1, 2021.

    Compliance date: As of December 4, 2018, the compliance date for the requirements in subpart F of 49 CFR part 390 (§§ 390.300T, 390.301, 390.303, and 390.305) is extended until January 1, 2021.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Loretta Bitner, (202) 366-2400, [email protected], Office of Enforcement and Compliance. FMCSA office hours are from 9 a.m. to 5 p.m., Monday through Friday, except Federal holidays.

    SUPPLEMENTARY INFORMATION:

    I. Background A. History

    On May 27, 2015, FMCSA published a final rule titled “Lease and Interchange of Vehicles; Motor Carriers of Passengers” (80 FR 30164). The American Bus Association (ABA) and United Motorcoach Association (UMA) filed a joint request for an extension of the June 26, 2015, deadline to submit petitions for reconsideration of the final rule (80 FR 37553). On July 1, 2015, the Agency extended the deadline for such petitions until August 25, 2015 (80 FR 37553).

    The Agency received 37 petitions for reconsideration, all of which were filed in the public docket referenced above. After the initial review of the petitions, FMCSA held a meeting on October 28, 2015, with a cross section of the petitioners. Attending were representatives from small and large bus companies, charter and regular-route operations, and diverse geographic areas of the nation. Additionally, two insurance company representatives were invited due to litigation and financial liability concerns. The purpose of the meeting was to have an open discussion and to gather additional details about petitioners' specific operations and concerns.

    Based on these discussions, and after further analysis, FMCSA concluded that some aspects of the petitions for reconsideration have merit. The Agency therefore extended the compliance date to January 1, 2018, to allay stakeholder concerns that there would not be sufficient time to adjust passenger carrier operations before compliance with the regulations was required (81 FR 13998, March 16, 2016). After further review of the petitions, the Agency announced on August 31, 2016, that it intended to consider changes to four aspects of the 2015 final rule, but it also denied requests to reconsider other issues raised by petitioners (81 FR 59951). The August 31 document announced that a public roundtable would be held to discuss the four issues. The roundtable was held on October 31, 2016.

    On June 16, 2017, FMCSA published a final rule (2017 final rule) and a proposal in the Federal Register (82 FR 27766, and 27768). The 2017 final rule extended the compliance date of the 2015 final rule from January 1, 2018, to January 1, 2019. The proposal provided information about FMCSA's planned revisions to the 2015 final rule and requested public comment on those revisions.

    B. Related Activity

    To address the concerns in the petitions, FMCSA published an NPRM on September 20, 2018 (83 FR 47764). This NPRM (RIN 2126-AC07) proposed to extend the compliance date of the 2015 final rule from January 1, 2019, to January 1, 2021. It also included proposed revisions to the 2015 final rule and requested public comment by November 19, 2018.

    In October 2018, several passenger carriers petitioned FMCSA to extend the compliance date immediately in accordance with the Agency's prior commitments and provide sufficient time to finalize the NPRM, to avoid an uncertain operating environment, confusion, and disruption in industry operations. ABA wrote that the outcome of an uncertain business environment is entirely avoidable. The Agency should take the same action it has taken on two prior occasions, and simply publish a final rule to extend the compliance date of the current rule. ABA argued that extending the compliance date would not affect safety, as the current rule has never been in force; nor would an extension interfere with the rulemaking process to finalize revisions to the current rule. Further, the Agency has committed to extending the compliance date on several occasions for the stated purpose of allowing sufficient time to complete revisions to the current rule.

    C. Comments Received

    FMCSA received 15 comments supporting the extension of the compliance date of the 2015 final rule to January 1, 2021. The extension is necessary to provide time to consider all the issues and to publish a final rule, while giving motor carriers sufficient time to comply with the revised requirements. FMCSA therefore extends the 2019 compliance date until January 1, 2021.

    D. Extending the Compliance Date

    The Agency is extending the compliance date by 2 years, to January 1, 2021. The temporary section added to subpart F of 49 CFR part 390 when a previous extension of the compliance date was issued, is being updated to include the new compliance date. The temporary section continues to be in effect only from December 4, 2018 through January 1, 2021.

    II. Regulatory Analyses A. Executive Order (E.O.) 12866 (Regulatory Planning and Review), E.O. 13563 (Improving Regulation and Regulatory Review), and DOT Regulatory Policies and Procedures

    FMCSA performed an analysis of the impacts of this final rule and determined it is not a significant regulatory action under section 3(f) of E.O. 12866 (58 FR 51735, October 4, 1993), Regulatory Planning and Review, as supplemented by E.O. 13563 (76 FR 3821, January 21, 2011), Improving Regulation and Regulatory Review. Accordingly, the Office of Management and Budget (OMB) has not reviewed it under that Order. It is also not significant within the meaning of DOT regulatory policies and procedures (DOT Order 2100.5 dated May 22, 1980; 44 FR 11034 (February 26, 1979)). This final rule provides regulatory relief from January 1, 2019, through December 31, 2020, from all compliance costs associated with the 2015 final rule. The Agency's estimates of the cost of the 2015 final rule are thoroughly explained in that rule's Regulatory Evaluation (available in docket FMCSA-2012-0103) and were updated to reflect more recently available data for the NPRM. The analysis of today's final rule utilizes the same data and methodology as the NPRM.

    To estimate the costs that will result from the final rule, the Agency calculated the total compliance costs from 2019 through 2028, albeit with no costs incurred in years 2019 and 2020. These costs are compared to a baseline in which the compliance costs of the 2015 final rule are incurred beginning in 2019, as shown in Table 1.

    Table 1—Total Cost of the Final Rule [In thousands of 2016$] Year 3% discount rate No-action baseline costs Final rule costs Final rule costs relative to
  • no-action
  • baseline costs
  • 7% discount rate No-action baseline costs Final rule costs Final rule costs relative to
  • no-action
  • baseline costs
  • 2019 $33,773 $0 ($33,773) $32,510 $0 ($32,510) 2020 6,083 0 (6,083) 5,636 0 (5,636) 2021 5,956 32,376 26,421 5,312 28,879 23,567 2022 5,831 5,831 0 5,007 5,007 0 2023 5,709 5,709 0 4,719 4,719 0 2024 5,590 5,590 0 4,448 4,448 0 2025 5,473 5,473 0 4,192 4,192 0 2026 5,359 5,359 0 3,951 3,951 0 2027 5,247 5,247 0 3,724 3,724 0 2028 5,137 5,137 0 3,510 3,510 0 10-Year Total 84,158 70,723 (13,435) 73,009 58,429 (14,580) Annualized 9,866 8,291 (1,575) 10,395 8,319 (2,076)

    The Agency estimates that the final rule will result in a cost savings of $13.4 million discounted at 3 percent and $14.6 million discounted at 7 percent over the 10-year analysis period. Expressed on an annualized basis, this equates to a cost savings of $1.6 million at a 3 percent discount rate and $2.1 million at a 7 percent discount rate. All values are in 2016 dollars.

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

    This rule is an E.O. 13771 deregulatory action.1 The present value of the cost savings of this rule, measured on an infinite horizon at a 7 percent discount rate, is approximately $11.9 million. Expressed on an annualized basis, the cost savings are $0.8 million. These values are expressed in 2016 dollars.

    1 Executive Office of the President. Executive Order 13771 of January 30, 2017. “Reducing Regulation and Controlling Regulatory Costs.” 82 FR 9339-9341. February 3, 2017.

    C. Regulatory Flexibility Act

    Section 603 of the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 857, March 29, 1996) and the Small Business Jobs Act of 2010 (Pub. L. 111-240, September 27, 2010), requires FMCSA to perform a detailed analysis of the potential impact of the final rule on small entities. Accordingly, DOT policy requires that agencies shall strive to lessen any adverse effects on these businesses and other entities. The Final Regulatory Flexibility Analysis conducted as part of the May 27, 2015, rule continues to be applicable to this final rule.

    D. Assistance for Small Entities

    In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, FMCSA wants to assist small entities in understanding this rule so that they can better evaluate its effects on themselves. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult the FMCSA point of contact, Loretta Bitner, listed in the FOR FURTHER INFORMATION CONTACT section of this rule.

    Small businesses may send comments on the actions of Federal employees who enforce or otherwise determine compliance with Federal regulations to the SBA's 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 FMCSA, call 1-888-REG-FAIR (1-888-734-3247). DOT has a policy ensuring the rights of small entities to regulatory enforcement fairness and an explicit policy against retaliation for exercising these rights.

    E. Federalism (E.O. 13132)

    A rule has federalism implications if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on the States. FMCSA analyzed this rule under E.O. 13132 and has determined that it has no federalism implications.

    F. Unfunded Mandates Reform Act of 1995

    This final rule does not impose an unfunded Federal mandate, as defined by the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532 et seq.), that would result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $161 million (which is the value of $100 million in 2017 after adjusting for inflation) or more in any 1 year.

    G. E.O. 12988 (Civil Justice Reform)

    This final rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

    H. E.O. 13045 (Protection of Children)

    FMCSA analyzed this action under E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks. The Agency has determined that this rule does not create an environmental risk to health or safety that would disproportionately affect children.

    I. E.O. 12630 (Taking of Private Property)

    FMCSA reviewed this final rule in accordance with E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, and has determined it would not effect a taking of private property or otherwise have taking implications.

    J. Privacy Impact Assessment

    Section 522 of title I of division H of the Consolidated Appropriations Act, 2005, enacted December 8, 2004 (Pub. L. 108-447, 118 Stat. 2809, 3268, 5 U.S.C. 552a note), requires the Agency to conduct a privacy impact assessment (PIA) of a regulation that will affect the privacy of individuals. This final rule does not require the collection of any personally identifiable information.

    The Privacy Act (5 U.S.C. 552a) applies only to Federal agencies and any non-Federal agency which receives records contained in a system of records from a Federal agency for use in a matching program. FMCSA has determined this final rule does not result in a new or revised Privacy Act System of Records for FMCSA.

    K. E.O. 12372 (Intergovernmental Review)

    The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this program.

    L. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.), Federal agencies must obtain approval from the OMB for each collection of information they conduct, sponsor, or require through regulations. On August 5, 2015, OMB approved the May 27, 2015, final rule's two information collections titled “Commercial Motor Vehicle Marking Requirements,” OMB No. 2126-0054, and “Lease and Interchange of Motor Vehicles,” OMB No. 2126-0056. OMB renewed these collections of information in October 2018, and they will both expire on October 31, 2021.

    M. Environment (NEPA)

    FMCSA analyzed this final rule in accordance with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.). The Agency has determined under its environmental procedures Order 5610.1, published March 1, 2004, in the Federal Register (69 FR 9680), that this action is categorically excluded from further environmental documentation under Appendix 2, Paragraphs 6.y(2) and 6.y(7) of the Order (69 FR 9702). These categorical exclusions relate to:

    • 6.y(2) Regulations implementing motor carrier identification and registration reports; and

    • 6.y(7) Regulations implementing prohibitions on motor carriers, agents, officers, representatives, and employees from making fraudulent or intentionally false statements on any application, certificate, report, or record required by FMCSA.

    Thus, this final action does not require an environmental assessment or an environmental impact statement.

    N. E.O. 13211 (Energy Supply, Distribution, or Use)

    FMCSA has analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Agency has determined that it is not a “significant energy action” under that Executive Order because it is not economically significant and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

    O. E.O. 13175 (Indian Tribal Governments)

    This rule does not have tribal implications under E.O. 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.

    P. National Technology Transfer and Advancement Act (Technical Standards)

    The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) are standards that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, FMCSA did not consider the use of voluntary consensus standards.

    List of Subjects in 49 CFR Part 390

    Highway safety, Intermodal transportation, Motor carriers, Motor vehicle safety, Reporting and recordkeeping requirements.

    The Final Rule

    For the reasons stated in the preamble, FMCSA amends 49 CFR part 390 in title 49, Code of Federal Regulations, chapter III, subchapter B, as follows:

    PART 390—FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL 1. The authority citation for part 390 continues to read as follows: Authority:

    49 U.S.C. 504, 508, 31132, 31133, 31134, 31136, 31137, 31144, 31149, 31151, 31502; sec. 114, Pub. L. 103-311, 108 Stat. 1673, 1677; secs. 212 and 217, Pub. L. 106-159, 113 Stat. 1748, 1766, 1767; sec. 229, Pub. L. 106-159 (as added and transferred by sec. 4115 and amended by secs. 4130-4132, Pub. L. 109-59, 119 Stat. 1144, 1726, 1743; sec. 4136, Pub. L. 109-59, 119 Stat. 1144, 1745; secs. 32101(d) and 32934, Pub. L. 112-141, 126 Stat. 405, 778, 830; sec. 2, Pub. L. 113-125, 128 Stat. 1388; secs. 5403, 5518, and 5524, Pub. L. 114-94, 129 Stat. 1312, 1548, 1558, 1560; sec. 2, Pub. L. 115-105, 131 Stat. 2263; and 49 CFR 1.81, 1.81a, 1.87.

    2. Effective December 4, 2018 until January 1, 2021, revise § 390.300T to read as follows:
    § 390.300T Compliance date.

    Motor carriers of passengers operating CMVs under a lease or interchange agreement are subject to §§ 390.301, 390.303, and 390.305 of this subpart on January 1, 2021.

    Issued under the authority delegated in 49 CFR 1.87 on: November 23, 2018.

    Raymond P. Martinez, Administrator.
    [FR Doc. 2018-26249 Filed 12-3-18; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 180720681-8999-02] RIN 0648-BI38 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery off the Southern Atlantic Region; Regulatory Amendment 28 AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    NMFS issues regulations to implement Regulatory Amendment 28 to the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP) (Regulatory Amendment 28), as prepared and submitted by the South Atlantic Fishery Management Council (Council). This final rule revises the commercial and recreational annual catch limits (ACLs) for golden tilefish in the South Atlantic. The purpose of this final rule is to end overfishing of golden tilefish while minimizing, to the extent practicable, adverse socio-economic effects and achieve optimum yield (OY) on a continuing basis.

    DATES:

    This final rule is effective on January 4, 2019.

    ADDRESSES:

    Electronic copies of Regulatory Amendment 28 may be obtained from the Southeast Regional Office website at http://sero.nmfs.noaa.gov. Regulatory Amendment 28 includes an environmental assessment (EA), a Regulatory Flexibility Act (RFA) analysis, a regulatory impact review (RIR), and a Fishery Impact Statement.

    FOR FURTHER INFORMATION CONTACT:

    Karla Gore, telephone: 727-824-5305; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The snapper-grouper fishery of the South Atlantic is managed under the FMP, and includes golden tilefish along with other snapper-grouper species. The FMP was prepared by the Council and is implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

    NMFS issued a temporary rule to implement interim measures to reduce the total annual catch limit (ACL), commercial and recreational sector ACLs, and quotas for the hook-and-line and longline components of the commercial sector on January 2, 2018 (83 FR 65). On June 19, 2018, NMFS extended the interim measures for an additional 186 days, through January 3, 2019 (83 FR 28387). On September 27, 2018, NMFS published a proposed rule for Regulatory Amendment 28 and requested public comment (83 FR 48788). Regulatory Amendment 28 and the proposed rule outline the rationale for the actions contained in this final rule. A summary of the actions implemented by Regulatory Amendment 28 and this final rule is provided below.

    Background

    The Magnuson-Stevens Act requires that NMFS and regional fishery management councils prevent overfishing and achieve, on a continuing basis, the OY from federally managed fish stocks. These mandates are intended to ensure that fishery resources are managed for the greatest overall benefit to the nation, particularly with respect to providing food production and recreational opportunities, and protecting marine ecosystems.

    Golden tilefish are harvested by both commercial and recreational fishermen throughout the South Atlantic, although the majority of landings are attributed to the bottom longline component of the commercial sector. Using data through 2010, the golden tilefish stock was assessed in 2011 through the Southeast Data, Assessment, and Review (SEDAR) stock assessment process (SEDAR 25). SEDAR 25 results indicated that the golden tilefish stock was not subject to overfishing and was not overfished. Based upon the results of SEDAR 25, the final rule for Amendment 18B to the FMP specified ACL based upon the acceptable biological catch (ABC) recommendation from the Council's Scientific and Statistical Committee (SSC). The total ACL was distributed among the sectors and commercial gear components (i.e., bottom longline and hook and line) based on allocations specified in Amendment 18B (78 FR 23858; April 23, 2013). For golden tilefish, 97 percent of the combined (commercial and recreational sectors together) ACL is allocated to the commercial sector, with 25 percent of the commercial ACL available for harvest by the hook-and-line component and 75 percent of the commercial ACL available for the longline component. The recreational sector is allocated 3 percent of the combined ACL.

    In April 2016, an update to the SEDAR 25 stock assessment was completed for golden tilefish using data through 2014 (SEDAR 25 Update 2016). In May 2016, the Council's SSC reviewed the updated assessment, determined the assessment was based on the best scientific information available, and provided an ABC recommendation. In a letter dated January 4, 2017, NMFS notified the Council of the updated golden tilefish stock status (SEDAR 25 Update 2016) determination that the stock is undergoing overfishing but is not overfished. As mandated by the Magnuson-Stevens Act, NMFS and the Council must prepare and implement a plan amendment and regulations to end overfishing of golden tilefish. Therefore, the Council began development of an amendment to end overfishing of golden tilefish. Because the ABC recommendation from the Council's SSC was not available until late October 2017, there was insufficient time for the Council and NMFS to develop and implement management measures to end overfishing of golden tilefish by the start of the 2018 fishing year on January 1, 2018. Consequently, in a letter to NMFS dated June 27, 2017, the Council requested that NMFS implement interim measures to immediately reduce overfishing of golden tilefish while long-term measures could be developed through Regulatory Amendment 28. A temporary rule, published in the Federal Register on January 2, 2018 (83 FR 65), reduced the combined ACL based on a projected yield at 75 percent of the yield produced by the fishing mortality rate at maximum sustainable yield (F = 75%FMSY), which was 362,000 lb (164,654 kg), whole weight. Converting this value to gutted weight using a conversion factor of 1.12 provided a value of 323,000 lb (146,510 kg), gutted weight. On June 19, 2018 (83 FR 28387), the temporary rule was extended for an additional 186 days, through January 3, 2019.

    Management Measures Contained in This Final Rule

    This final rule revises the combined ACL for golden tilefish to be 342,000 lb (155,129 kg), gutted weight. In May 2016, the Council's SSC reviewed the SEDAR 25 assessment update and provided fishing level recommendations based on a P* (probability of overfishing) value of 30 percent derived from the Council's ABC control rule. However, at their March 2018 meeting, the Council determined that they were willing to accept a risk of overfishing at the level implemented through the temporary interim rule (F = 75%FMSY) when the population is at equilibrium. Thus, the Council requested the SSC recommend an ABC based on F = 75%FMSY, which represented a level closer to a P* value of 40 percent. At their May 2018 meeting, the SSC reviewed the Council's request to revise the ABC recommendation and agreed to change the ABC to the value at F = 75%FMSY. Therefore, the SSC's most recent ABC recommendation was 362,000 lb (164,654 kg), whole weight.

    This combined ACL specified in Regulatory Amendment 28 is equal to the Council's SSC ABC recommendation of 362,000 lb (164,654 kg), whole weight, when converted to gutted weight. The SEDAR 25 Update (2016) for golden tilefish used a whole weight to gutted weight conversion factor of 1.059, but the interim rule used a conversion value of 1.12. At their June 2018 meeting, the Council indicated that a conversion factor of 1.059 rather than a 1.12 was more appropriate to convert the ABC recommendation from whole weight to gutted weight. Both SEDAR 25 Update 2016 and the 1.059 conversion factor constitute the best scientific information available for golden tilefish. The SSC's ABC recommendation forms the basis for the actions in Regulatory Amendment 28 and this final rule, which is expected to end overfishing of golden tilefish in the South Atlantic.

    This final rule also specifies the commercial and recreational sector ACLs and component commercial quotas using the existing sector allocations of 97 percent commercial and 3 percent recreational, as well as allocating 25 percent of the commercial ACL to the hook-and-line component and 75 percent of the commercial ACL to the longline component. Therefore, through this final rule, the commercial ACL (equivalent to the commercial quota) is 331,740 lb (150,475 kg), gutted weight. The commercial ACL for the hook-and-line component is 82,935 lb (37,619 kg), gutted weight, and the commercial ACL for the longline component is 248,805 lb (112,856 kg), gutted weight. The recreational ACL is 2,316 fish.

    The reduction in the ACLs in this final rule is expected to end overfishing of golden tilefish and minimize future adverse socio-economic effects. Adhering to sustainable harvest through an ACL based on information from the most recent stock assessment (Southeast Data Assessment and Review (SEDAR) 25 2016 Update) is expected to be more beneficial to fishers and fishing communities in the long term because catch limits are based on the current conditions. The reduction in the ACLs in this final rule is expected to provide biological benefits (such as protections against recruitment failure) to the golden tilefish stock by reducing the levels of fishing mortality. The revised ACL values in Regulatory Amendment 28 and implemented through this final rule are based on the best scientific information available.

    The measures in Regulatory Amendment 28, as described in this final rule, replace the current interim measures outlined in the temporary rule. Failure to implement Regulatory Amendment 28 by the expiration of the temporary rule (January 4, 2019) may risk overfishing of golden tilefish because ACLs will revert to higher levels in place prior to implementation of the temporary rule, and those levels exceed the SSC's most recent ABC recommendation. In addition, implementing Regulatory Amendment 28 by the expiration date of the temporary rule will avoid confusion among fishers and law enforcement with changing catch levels.

    Comments and Responses

    During the public comment period, NMFS received a total of 10 comments on Regulatory Amendment 28 and the proposed rule from individuals and fishing organizations. Of these, three comments supported the need for protection of golden tilefish, with which NMFS agrees. Two comments generally expressed support for golden tilefish harvest by the recreational sector and complained of increasing costs, but those comments were not directed to the ACL changes contained in the proposed rule; thus, they are considered to be outside the scope of Regulatory Amendment 28. Two additional comments were entirely unrelated to golden tilefish harvest and were, therefore, also outside the scope of Regulatory Amendment 28. Comments that were beyond the scope of Regulatory Amendment 28 and the proposed rule, are not addressed further in this final rule. Comments that specifically relate to the actions contained in the Regulatory Amendment 28 and the proposed rule, as well as NMFS' respective responses, are summarized below.

    Comment 1: Regulatory Amendment 28 does not adequately consider the socio-economic impacts that will disproportionately impact the small fishing communities that are affected by the South Atlantic fishing industry.

    Response: As described in the EA and the for Regulatory Amendment 28 and the proposed rule, the ACL reductions are necessary to end overfishing of golden tilefish in the South Atlantic. The Council and NMFS have adequately considered the socio-economic impacts through the socio-economic impact analysis developed in Regulatory Amendment 28 for implementing this final rule. NMFS conducted a RIR, an Initial Regulatory Flexibility Analysis (IRFA), and a Final Regulatory Flexibility Analysis (FRFA) that analyze the expected impacts of the actions in the regulatory amendment on the commercial and recreational sectors engaged in fishing for South Atlantic golden tilefish.

    NMFS expects the reductions to the ACLs and quotas will result in adverse, short-term economic effects. These effects will apply directly on the participants of the golden tilefish commercial and recreational sectors and indirectly on the supporting industries, such as dealers, tackle and bait shops, and fishing communities. However, Regulatory Amendment 28 and this final rule will likely minimize future adverse socio-economic effects by ending overfishing of South Atlantic golden tilefish and preventing the stock from being overfished.

    NMFS has determined that all entities directly affected by the management measures outlined in Regulatory Amendment 28 and this final rule are small entities as this term is defined in the Classification section of this rule, so that disproportionate impacts on small versus large entities are not expected to occur. However, effects on affected entities will not be uniform. In general, the larger the sector (e.g., commercial sector) or commercial component's (e.g., longline fishermen) percentage of the allocation, the greater the short-term adverse economic impacts will be. In addition, the more dependent a location or fishing community is on fishing for golden tilefish, the greater the adverse impacts will be on an area's fishing participants and supporting industries.

    Comment 2: Why is the commercial ACL, listed in weight, significantly greater than the recreational ACL, which is given in numbers of fish?

    Response: The commercial ACL is greater than the recreational ACL because 97 percent of the total ACL is allocated to the commercial sector and 3 percent to the recreational sector. The sector allocations were specified in 2010 (75 FR 82280; December 30, 2010). Regulatory Amendment 28 and this final rule revise the ACL for golden tilefish based on the ABC recommendation from the Council's SSC, but do not change the allocation of the ACL among the commercial and recreational sectors. This allocation was previously determined by the Council and NMFS to be fair and equitable, based on landings data, and considered the least disruptive to economic and social environments. The commercial ACL is further allocated into commercial quotas with 75 percent to the commercial longline sector and 25 percent to the commercial hook-and-line sector, as established in 2013 through Amendment 18B to the FMP (78 FR 23858; April 23, 2013). These quota allocations were also based on commercial landings data, as more of the commercial harvest is from the commercial longline component than the hook-and-line component.

    The commercial allocation is listed in pounds (lb) of gutted weight (gw) and the recreational allocation is in numbers of fish. To convert the recreational ACL into numbers of fish, the recreational landings data collected through the Marine Recreational Information Program and Southeast Region Headboat Survey were used to calculate the average weight of South Atlantic golden tilefish. From 2012-2016, the average weights of recreational golden tilefish have ranged annually from 4.21 lb, gw to 5.11 lb, gw. Using these 5 years of data (2012-2016) provides an average weight of 4.43 lb, gw. Therefore, a conversion factor of 4.43 lb, gw per fish is used for converting the South Atlantic golden tilefish recreational ACL into numbers of fish.

    Comment 3: There needs to be better data collected on golden tilefish instead of continuing to use limited existing data applied in inconsistent methods because it is irresponsible with the goal of achieving MSY.

    Response: NMFS determined that the data used in Regulatory Amendment 28 represents the best scientific information available and that the data used in SEDAR 25 2016 Update is applied neither inconsistently nor irresponsibly. NMFS notes that Regulatory Amendment 28 and the final rule respond to the latest stock assessment for golden tilefish in the South Atlantic (SEDAR 25 Update 2016). The SEDAR 25 Update 2016 concluded that the stock is undergoing overfishing, but is not overfished.

    The SEDAR 25 participants outlined the research needs for the golden tilefish stock assessment and these are contained in the SEDAR 25 Assessment Report. The next golden tilefish stock assessment, which will include a review of all existing data, is scheduled to begin in 2019.

    The golden tilefish stock of the South Atlantic was assessed through the SEDAR process, which is a peer-reviewed cooperative effort to assess the status of stocks in the jurisdictions of the South Atlantic, Caribbean, and Gulf of Mexico Fishery Management Councils; as well as NMFS' Southeast Fisheries Science Center and Southeast Regional Office, and the NMFS Highly Migratory Species Division; and the Atlantic and Gulf States Marine Fisheries Commissions. SEDAR also relies on state agencies and universities throughout the region for research, data collection, and stock assessment expertise. Fishery-dependent and independent data were utilized in the stock assessment. All of the data sources used are further described in the SEDAR 25 Update 2016, which is available on the SEDAR website at http://sedarweb.org. The SEDAR website also provides supporting documentation that describes data collection programs and research findings.

    The Council received the results of the assessment update from their SSC in June 2016, and Council members expressed concern over the large differences in biological benchmarks and fishing level recommendations between SEDAR 25 Update 2016 and SEDAR 25. Subsequently, the Council requested an updated stock assessment for golden tilefish.

    To address the Council's concerns, in May 2017, the SEDAR Steering Committee agreed to revise the SEDAR 25 Update 2016, because a new golden tilefish stock assessment could not be completed in 2017. The SSC reviewed the 2017 revision to the SEDAR 25 Update 2016 at their October 2017 meeting and determined that it was unsuitable for management. Therefore, the best scientific information available for golden tilefish remains the SEDAR 25 Update 2016.

    Classification

    The Regional Administrator for the NMFS Southeast Region has determined that this final rule is consistent with Regulatory Amendment 28, the Magnuson-Stevens Act, and other applicable laws.

    This final rule has been determined to be not significant for purposes of Executive Order 12866. This final rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.

    In compliance with section 604 of the RFA, NMFS prepared a Final Regulatory Flexibility Analysis (FRFA) for this final rule. The FRFA incorporates the IRFA, a summary of the significant economic issues raised by public comments, NMFS' responses to those comments, and a summary of the analyses completed to support the action. The FRFA follows.

    A description of this final rule, and its rationale, objectives, and legal basis are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble. The Magnuson-Stevens Act provides the statutory basis for this final rule. No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this final rule. Accordingly, this final rule does not implicate the Paperwork Reduction Act.

    No comments specific to the IRFA were received from the public or from the Chief Counsel for the Advocacy of the Small Business Administration; however, there are comments that have socio-economic implications, and they are addressed in the Comments and Responses section, specifically in Comment 1.

    No changes to the proposed rule were made in response to public comments. NMFS agrees that the Council's recommendation for the action will best achieve their objectives for this final rule while minimizing, to the extent practicable, the adverse effects on fishermen, support industries, and associated communities.

    NMFS expects this final rule will directly affect all commercial vessels that harvest South Atlantic golden tilefish under the FMP. The change in the recreational ACL in this final rule will not directly affect or regulate for-hire businesses. Any impact to the profitability or competitiveness of for-hire fishing businesses will be the result of changes in for-hire angler demand and will therefore be indirect in nature. Under the RFA, recreational anglers who will be directly affected by this final rule, are not considered small entities, so they are outside the scope of this analysis and only the effects on commercial vessels were analyzed. For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide.

    From 2012 through 2016, an average of 23 longline vessels per year landed golden tilefish from the South Atlantic. The Federal golden tilefish longline endorsement to the snapper-grouper permit started in 2013 upon implementation of the final rule for Amendment 18B to the snapper-grouper FMP (78 FR 23858; April 23, 2013). Endorsed vessels, combined, averaged 255 trips per year in the South Atlantic on which golden tilefish were landed, and 182 other trips that took place either in the South Atlantic (but no golden tilefish were caught) or in other areas (Gulf of Mexico or Mid-Atlantic) that caught any species including golden tilefish. The average annual total dockside revenue (2016 dollars) for these vessels combined was approximately $1.56 million from golden tilefish, approximately $0.10 million from other species co-harvested with golden tilefish (on the same trips), and approximately $0.43 million from other trips by these vessels on trips in the South Atlantic on which no golden tilefish were harvested or on trips which occurred in other areas. Total average annual revenue from all species harvested by longline vessels landing golden tilefish in the South Atlantic was approximately $2.10 million, or approximately $92,000 per vessel. Longline vessels generated approximately 74 percent of their total revenues from golden tilefish. For the same period, an average of 82 vessels per year landed golden tilefish using other gear types (mostly hook-and-line) in the South Atlantic. These vessels, combined, averaged 483 trips per year in the South Atlantic on which golden tilefish were landed and 2,862 trips taken in the South Atlantic on which golden tilefish were not harvested or trips that took place in other areas and caught any species including golden tilefish. The average annual total dockside revenue (2016 dollars) for these 82 vessels was approximately $0.36 million from golden tilefish, approximately $0.66 million from other species co-harvested with golden tilefish (on the same trips in the South Atlantic), and approximately $4.13 million from the other trips taken by these vessels. The total average annual revenue from all species harvested by these 82 vessels was approximately $5.16 million, or approximately $62,000 per vessel. Approximately 7 percent of these vessels' total revenues came from golden tilefish.

    Based on the foregoing revenue information, all commercial vessels using longlines or hook-and-line gear affected by this final rule may be considered to be small entities. Because all entities expected to be directly affected by this final rule are assumed to be small entities, NMFS has determined that this final rule will affect a substantial number of small entities. However, since all affected entities are small entities, the issue of disproportionate effects on small versus large entities does not arise in the present case.

    This final rule will reduce the combined stock ACL, and consequently the ACLs for the commercial and recreational sectors as well as the longline and hook-and-line component ACLs of the commercial sector. The longline and hook-and-line components of the commercial sector will be expected to lose approximately $592,000 ($25,739 per vessel) and $217,000 ($2,646 per vessel) respectively, in annual ex-vessel revenues. This will very likely translate to profit reductions for both the longline and hook-and-line components, particularly for longline vessels, as they are more dependent on golden tilefish. As noted above, golden tilefish account for about 74 percent of longline vessel revenues and 7 percent of hook-and-line vessel revenues. The ACLs may be changed in the future if this final rule is successful in addressing the overfishing condition for the South Atlantic golden tilefish. Economic benefits would ensue if the ACLs are subsequently increased based on an improved stock status.

    The following discussion analyzes the alternatives that were considered by the Council, including those that were not selected as preferred by the Council. Unlike the preferred alternative, six of the other alternatives would provide for varying ACLs over 6 years, at least. For this reason, a 6-year period is considered for comparing alternatives. To carry out a 6-year comparison, the ACL under the preferred alternative is kept constant for 6 years. It is noted that a stock assessment for golden tilefish would be completed in 2019, so the Council may opt to revise the ACL in 2020 or later. Over a 6-year period with constant ACL, the preferred alternative will be expected to reduce revenues by approximately $3.02 million for the longline component and $1.11 million for the hook-and-line component of the commercial sector, using a 7 percent discount rate.

    Ten alternatives, including the preferred alternative as described above, were considered for reducing the South Atlantic golden tilefish ACLs. The first alternative, the no action alternative, would maintain the current economic benefits to all participants in the South Atlantic golden tilefish component of the snapper-grouper fishery. This alternative, however, would not address the need to end overfishing of the stock, thereby increasing the likelihood that more stringent measures would need to be implemented in the near future.

    With one exception, all the other alternatives would result in larger revenue losses to the longline and hook-and-line vessels than the preferred alternative. Alternatives that would result in larger revenue losses than the preferred alternative would provide for lower ACLs over a 6-year period. Total losses over 6 years from these alternatives would range from $3.17 million to $4.29 million for longline vessels and from $1.16 million to $1.83 million for hook-and-line vessels. The alternative with lower attendant revenue losses than the preferred alternative would be expected to reduce total ex-vessel revenues by approximately $2.65 million for longline vessels and $0.97 million for hook-and-line vessels over 6 years. Relative to the preferred alternative, this alternative would result in larger ex-vessel revenue losses initially but lower revenue losses in subsequent years, because the ACLs in subsequent years would be greater than those of the preferred alternative. Both alternatives would be expected to result in early harvest closures as a result of reaching the ACL during the fishing year, and in the first fishing year, harvest closure under the preferred alternative would occur later than that of the other alternative. The reverse may be expected for the subsequent years. The Council considered the preferred alternative as affording the best means to end overfishing of golden tilefish in the South Atlantic, because it is based on the best scientific information available.

    List of Subjects in 50 CFR Part 622

    Annual catch limit, Fisheries, Fishing, Golden tilefish, Snapper-grouper, South Atlantic.

    Dated: November 29, 2018. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 622 is amended as follows:

    PART 622—FISHERIES OF THE CARIBBEAN, GULF OF MEXICO, AND SOUTH ATLANTIC 1. The authority citation for part 622 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    2. In § 622.190, revise paragraphs (a)(2)(i) through (iii) to read as follows:
    § 622.190 Quotas.

    (a) * * *

    (2) * * *

    (i) Commercial sector (hook-and-line and longline components combined)—331,740 lb (150,475 kg).

    (ii) Hook-and-line component—82,935 lb (37,619 kg).

    (iii) Longline component—248,805 lb (112,856 kg).

    3. In § 622.193, revise paragraphs (a)(1)(i) through (iii), and (a)(2), to read as follows:
    § 622.193 Annual catch limits (ACLs), annual catch targets (ACTs), and accountability measures (AMs).

    (a) * * *

    (1) * * *

    (i) Hook-and-line component. If commercial hook-and-line landings for golden tilefish, as estimated by the SRD, reach or are projected to reach the commercial ACL (commercial quota) specified in § 622.190(a)(2)(ii), the AA will file a notification with the Office of the Federal Register to close the hook-and-line component of the commercial sector for the remainder of the fishing year. Applicable restrictions after a commercial quota closure are specified in § 622.190(c).

    (ii) Longline component. If commercial longline landings for golden tilefish, as estimated by the SRD, reach or are projected to reach the longline commercial ACL (commercial quota) specified in § 622.190(a)(2)(iii), the AA will file a notification with the Office of the Federal Register to close the longline component of the commercial sector for the remainder of the fishing year. After the commercial ACL for the longline component is reached or projected to be reached, golden tilefish may not be fished for or possessed by a vessel with a golden tilefish longline endorsement. Applicable restrictions after a commercial quota closure are specified in § 622.190(c).

    (iii) If all commercial landings of golden tilefish, as estimated by the SRD, exceed the commercial ACL (including both the hook-and-line and longline component quotas) specified in § 622.190(a)(2)(i), and the combined commercial and recreational ACL of 342,000 lb (155,129 kg) is exceeded during the same fishing year, and golden tilefish are overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.

    (2) Recreational sector. (i) If recreational landings of golden tilefish, as estimated by the SRD, reach or are projected to reach the recreational ACL of 2,316 fish, the AA will file a notification with the Office of the Federal Register to close the recreational sector for the remainder of the fishing year regardless if the stock is overfished, unless NMFS determines that no closure is necessary based on the best scientific information available. On and after the effective date of such a notification, the bag and possession limits for golden tilefish in or from the South Atlantic EEZ are zero.

    (ii) If recreational landings of golden tilefish, as estimated by the SRD, exceed the recreational ACL specified of 2,316 fish, then during the following fishing year, recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 342,000 lb (155,129 kg) is exceeded during the same fishing year. The AA will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for golden tilefish in or from the South Atlantic EEZ are zero.

    [FR Doc. 2018-26317 Filed 12-3-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket No. 180117042-8884-02] RIN 0648-XG651 Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries AGENCY:

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

    ACTION:

    Temporary rule; inseason quota transfer.

    SUMMARY:

    NMFS is transferring 129.2 metric tons (mt) of Atlantic bluefin tuna (BFT) quota from the Reserve category to the General category, and 9.9 mt from the Harpoon category to the General category for the remainder of the 2018 fishing year, to account for accrued overharvests of previous time period subquotas. This action is intended to provide opportunities for General category fishermen to participate in the December General category fishery, which is scheduled to reopen on December 1, 2018, and is based on consideration of the regulatory determination criteria regarding inseason adjustments. This action would affect Atlantic tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat category permitted vessels with a commercial sale endorsement when fishing commercially for BFT.

    DATES:

    The quota transfer is effective November 29, 2018 through December 31, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Uriah Forest-Bulley, 978-675-2154, or Brad McHale, 978-281-9260.

    SUPPLEMENTARY INFORMATION:

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

    NMFS published a final rule (i.e., the “quota rule” (83 FR 51391, October 11, 2018)) that increased the baseline U.S. BFT quota from 1,058.79 mt to 1,247.86 mt consistent with a 2017 ICCAT recommendation and accordingly increased the category quotas for 2018. Within the General category quota, each time period (January, June through August, September, October through November, and December) is further allocated a subquota or portion of the annual General category quota. Although it is called the “January” subquota, the regulations allow the General category fishery under this quota to continue until the subquota is reached or March 31, whichever comes first. The baseline subquotas for each time period are as follows: 29.5 mt for January; 277.9 mt for June through August; 147.3 mt for September; 72.2 mt for October through November; and 28.9 mt for December. Any unused General category quota rolls forward from one time period to the next and is available for use in subsequent time periods within the fishing year, which coincides with the calendar year.

    For the January 2018 subquota period, NMFS transferred 14.3 mt of BFT quota from the December 2018 subquota period, and transferred 10 mt from the Reserve category, resulting in an adjusted subquota of 53.8 mt for the January 2018 period and a subquota of 14.6 mt for the December 2018 period (82 FR 60680, December 22, 2017, and 83 FR 9232, March 5, 2018, respectively). For 2018, NMFS also transferred a total of 75 mt from the Reserve and 40 mt from the Harpoon category to the General category through two inseason actions in September and October, resulting in an adjusted 2018 General category quota of 680.8 mt and adjusted 2018 Harpoon category of 36 mt (83 FR 47843, September 21, 2018, and 83 FR 50857, October 10, 2018, respectively). NMFS closed the October through November General category fishery after multiple reopenings when the subquota (127.2 mt) was met, effective November 16, 2018 (83 FR 57340, November 15, 2018). The 2018 General category fishery reopens December 1, 2018, and will remain open until December 31, 2018, or until the General category quota is reached, whichever comes first. Prior to this action, the adjusted Reserve category quota was 142.9 mt, and was most recently adjusted in the October 11, 2018 quota rule, which augmented the 2018 BFT Reserve category quota with available underharvest of the 2017 adjusted U.S. BFT quota. The Harpoon category fishery automatically closed for the year on November 15, 2018.

    Quota Transfer

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

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

    NMFS considered the catches of the General category quota to date (including during the summer/fall and winter fisheries in the last several years), and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(8)(ii) and (ix)). Preliminary landings data as of November 26, 2018, indicate that the Harpoon category landed 26.1 mt of the 36 mt adjusted Harpoon quota before closing. They also indicate that the General category has landed 770 mt this year, which exceeds the overall General category adjusted quota of 680.8 mt. For all commercial categories, however, approximately 23 percent (267.9 mt) of the total of the BFT category quotas remains available as of November 26, 2018 (i.e., 881 mt of 1148.9 mt has been harvested), and NMFS anticipates that some amount of quota may remain unused by the end of the year even with the transfer. Absent a transfer, the December General category fishery would remain closed, even though quota remains available within the overall quota for the year and NMFS anticipates that commercial-sized BFT will be readily available on the fishing grounds when the fishery is otherwise scheduled to re-open December 1, 2018. Transferring 129.2 mt of BFT quota from the Reserve category, and 9.9 mt from the Harpoon category would allow the General category fishery to resume as scheduled and would result in a total of 50.0 mt being available to the General category in December after accounting for quota exceedances. It would also leave 13.7 mt in the Reserve category to account for any BFT mortalities associated with research and/or any overharvests that may occur in December. In analyzing the criteria for transfer, NMFS also considered the fact that BFT quota management throughout the year had been informed, in part, by anticipated upward adjustments to the overall quota. Such adjustments, while not certain, were anticipated as a result of the 2017 ICCAT recommendation increasing the overall BFT quota and upward adjustments for last year's underharvests, although any such adjustments would only take effect after appropriate rulemaking procedures and actions (i.e., the 2018 quota rule).

    Regarding the projected ability of the vessels fishing under the particular category quota (here, the General category) to harvest the additional amount of BFT quota transferred before the end of the fishing year (§ 635.27(a)(8)(iii)), NMFS considered General category landings over the last several years and landings to date this year. Landings are highly variable and depend on access to commercial-sized BFT and fishing conditions, among other factors. A portion of the transferred quota covers overharvests in the category to date, and NMFS anticipates that General category participants will be able to harvest the remaining 50 mt of transferred BFT quota by the end of the fishing year.

    NMFS also considered the estimated amounts by which quotas for other gear categories of the fishery might be exceeded (§ 635.27(a)(8)(iv)) and the ability to account for all 2018 landings and dead discards. In the last several years, total U.S. BFT landings have been below the total available U.S. quota such that the United States has carried forward the maximum amount of underharvest allowed by ICCAT from one year to the next. NMFS will need to account for 2018 landings and dead discards within the adjusted U.S. quota, consistent with ICCAT recommendations, and NMFS anticipates having sufficient quota to do that, even with this 139.1 mt transfer to the General category.

    This transfer would be consistent with the current U.S. quota, which was established and analyzed in the 2018 BFT quota final rule, and with objectives of the 2006 Consolidated HMS FMP and amendments. (§ 635.27(a)(8)(v) and (vi)). Another principal consideration is the objective of providing opportunities to harvest the full annual U.S. BFT quota without exceeding it based on the goals of the 2006 Consolidated HMS FMP and amendments, including to achieve optimum yield on a continuing basis and to optimize the ability of all permit categories to harvest their full BFT quota allocations (related to § 635.27(a)(8)(x)).

    Based on the considerations above, NMFS is transferring 129.2 mt from the Reserve category to the General category. Therefore, NMFS adjusts the General category December subquota quota to 50.0 mt for the 2018 General category fishing season and adjusts the Reserve category quota to 13.7 mt. The 2018 General category fishery reopens December 1, 2018, and will remain open until December 31, 2018, or until the adjusted General category quota is reached, whichever comes first.

    Monitoring and Reporting

    NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustment, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General and HMS Charter/Headboat category vessel owners are required to report the catch of all BFT retained or discarded dead within 24 hours of the landing(s) or end of each trip, by accessing hmspermits.noaa.gov or by using the HMS Catch Reporting app, or calling (888) 872-8862 (Monday through Friday from 8 a.m. until 4:30 p.m.).

    Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional action (e.g., quota adjustment or closure) is necessary to ensure available subquotas are not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the Federal Register. In addition, fishermen may call the Atlantic Tunas Information Line at (978) 281-9260, or access hmspermits.noaa.gov, for updates on quota monitoring and inseason adjustments.

    NMFS reminds General category participants that when the fishery reopens December 1, 2018, the BFT General category daily retention limit will be one large medium or giant BFT (measuring 73” or greater) per vessel per day/trip.

    Classification

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

    The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Affording prior notice and opportunity for public comment to implement the quota transfer for the remainder of 2018 is impracticable and contrary to the public interest as such a delay would result in continued closure of the General category fishery (because the available quota has been exceeded) and the need to re-open the fishery later in the December time period, rather than the fishery automatically re-opening on December 1. The delay would preclude the fishery from harvesting BFT that are available on the fishing grounds and that might otherwise become unavailable during a delay. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For these reasons, there also is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.

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

    Authority:

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

    Dated: November 29, 2018. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-26325 Filed 11-29-18; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 170816769-8162-02] RIN 0648-XG470 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher Vessels Less Than 50 Feet Length Overall Using Hook-and-Line Gear in the Central Regulatory Area of the Gulf of Alaska AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is prohibiting directed fishing for Pacific cod by catcher vessels less than 50 feet length overall (LOA) using hook-and-line gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2018 Pacific cod total allowable catch apportioned to catcher vessels less than 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), December 1, 2018, through 2400 hours, A.l.t., December 31, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Obren Davis, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

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

    The 2018 Pacific cod total allowable catch (TAC) apportioned to catcher vessels less than 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA is 880 metric tons (mt), as established by the final 2018 and 2019 harvest specifications for groundfish of the GOA (83 FR 8768, March 1, 2018).

    In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the 2018 Pacific cod TAC apportioned to catcher vessels less than 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 870 mt and is setting aside the remaining 10 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels less than 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA. While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the directed fishing closure of Pacific cod by catcher vessels less than 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of November 28, 2018.

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

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

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: November 29, 2018. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-26302 Filed 11-29-18; 4:15 pm] BILLING CODE 3510-22-P
    83 233 Tuesday, December 4, 2018 Proposed Rules SMALL BUSINESS ADMINISTRATION 13 CFR Parts 121, 124, 125, 126, 127, and 129 RIN 3245-AG86 National Defense Authorization Acts of 2016 and 2017, Recovery Improvements for Small Entities After Disaster Act of 2015, and Other Small Business Government Contracting AGENCY:

    U.S. Small Business Administration.

    ACTION:

    Proposed rule.

    SUMMARY:

    The U.S. Small Business Administration (SBA or Agency) is proposing to amend its regulations to implement several provisions of the National Defense Authorization Acts (NDAA) of 2016 and 2017 and the Recovery Improvements for Small Entities After Disaster Act of 2015 (RISE Act), as well as implementing other clarifying amendments. The proposed rule would clarify that contracting officers have the authority to request information in connection with a contractor's compliance with applicable limitations on subcontracting clauses; provide exclusions for purposes of compliance with the limitations on subcontracting for certain contracts performed outside of the United States, environmental remediation contracts, and information technology service acquisitions that require substantial cloud computing; require a prime contractor with a commercial subcontracting plan to include indirect costs in its subcontracting goals; establish that failure to provide timely subcontracting reports may constitute a material breach of the contract; clarify the requirements for size and status recertification; and limit the scope of Procurement Center Representative reviews of Department of Defense acquisitions performed outside of the United States and its territories. The proposed rule would also authorize agencies to receive double credit for small business goaling achievements as announced in SBA's scorecard for local area small business set asides in connection with a disaster. Finally, SBA is proposing to remove the kit assembler exception to the non-manufacturer rule.

    DATES:

    Comments must be received on or before February 4, 2019.

    ADDRESSES:

    You may submit comments, identified by RIN 3245-AG86, by any of the following methods:

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

    For mail, paper, disk, or CD-ROM submissions: Brenda Fernandez, U.S. Small Business Administration, Office of Policy, Planning and Liaison, 409 Third Street SW, 8th Floor, Washington, DC 20416.

    Hand Delivery/Courier: Brenda Fernandez, U.S. Small Business Administration, Office of Policy, Planning and Liaison, 409 Third Street SW, 8th Floor, Washington, DC 20416.

    SBA will post all comments on www.regulations.gov. If you wish to submit confidential business information (CBI) as defined in the User Notice at www.regulations.gov, please submit the information to Brenda Fernandez, U.S. Small Business Administration, Office of Policy, Planning and Liaison, 409 Third Street SW, 8th Floor, Washington, DC 20416, or send an email to [email protected] Highlight the information that you consider to be CBI and explain why you believe SBA should hold this information as confidential. SBA will review the information and make the final determination on whether it will publish the information.

    FOR FURTHER INFORMATION CONTACT:

    Brenda Fernandez, Office of Policy, Planning and Liaison, 409 Third Street SW, Washington, DC 20416; (202) 205-7337; [email protected]

    SUPPLEMENTARY INFORMATION:

    I. National Defense Authorization Act for Fiscal Year 2016, Public Law 114-92, 129 Stat. 726, November 25, 2015 (NDAA of 2016) Posting Notice of Substantial Bundling

    Section 863 of the NDAA of 2016 amended section 15(e)(3) of the Small Business Act (15 U.S.C. 644(e)(3)) to provide that if the head of a contracting agency determines that an acquisition plan involves a substantial bundling of contract requirements, the head of the contracting agency shall publish a notice of such determination on a public website within 7 days of making such determination. Section 863 also amended section 44(c)(2) of the Small Business Act (15 U.S.C. 657q(c)(2)) to provide that upon determining that a consolidation of contract requirements is necessary and justified, the Senior Procurement Executive (SPE) or Chief Acquisition Officer (CAO) shall publish a notice on a public website that such determination has been made. An agency may not issue the solicitation any earlier than 7 days after publication of the notice. The SPE or CAO must also publish the justification along with the solicitation. The requirement may be delegated. SBA proposes to amend § 125.2(d) by adding new paragraphs (d)(1)(v) and (d)(7) to implement these changes.

    II. National Defense Authorization Act for Fiscal Year 2017, Public Law 114-328, 130 Stat. 2000, December 23, 2016 (NDAA of 2017) Procurement Center Representative Reviews

    Section 1811 of the NDAA of 2017 amended section 15(l) of the Small Business Act (15 U.S.C. 644(l)) to provide that Procurement Center Representatives (PCRs) may review any acquisition, even those where the acquisition is set aside, partially set aside or reserved for small business. SBA's current rules provide that PCRs will review all acquisitions that are not set aside or reserved for small business. These rules were intended to focus limited resources on acquisitions that were not already going to small business, but were not intended to prohibit a PCR from reviewing any acquisition as part of the PCR's role as an advocate for small business. SBA proposes to amend § 125.2(b)(1)(i) to provide that PCRs may review any acquisition regardless of whether it is set aside, partially set aside, or reserved for small business or other socioeconomic categories. SBA believes that this change will enable PCRs to advocate for total set asides, or partial set asides, when appropriate and necessary.

    Section 1811 of the NDAA of 2017 also amended section 15(l) of the Small Business Act to limit the scope of PCR review of solicitations for contracts or orders by or for the Department of Defense if the acquisition is conducted pursuant to the Arms Control Export Act (22 U.S.C. 2762), is a humanitarian operation as defined in 10 U.S.C. 401(e), is for a contingency operation as defined in 10 U.S.C. 101(a)(13), is to be awarded pursuant to an agreement with the government of a foreign country in which Armed Forces of the United States are deployed, or where both the place of award and place of performance are outside of the United States and its territories. SBA is proposing to amend § 125.2(b)(1)(i) to implement these amendments. PCRs may still review acquisitions awarded in the United States and its territories but performed outside of the United States and its territories, or awarded outside of the United States and its territories for performance in the United States or its territories, if the acquisition is not a foreign military sales, or in connection with a contingency operation, humanitarian operation or status of forces agreement. SBA considers performance to be outside of the United States and its territories if the acquisition is awarded and performed or delivered outside of the United States and its territories. If the acquisition is awarded in the United States and its territories or some performance or delivery occurs in the United States and its territories, SBA considers that to be performed in the United States and its territories.

    Material Breach of Subcontracting Plan

    Section 1821 of the NDAA of 2017 amended section 8(d)(9) of the Small Business Act (15 U.S.C. 637(d)(9)) to provide that it shall be a material breach of a contract or subcontract when the contractor or subcontractor with a subcontracting plan fails to comply in good faith with the requirement to provide assurances that the offeror shall submit such periodic reports or cooperate in any studies or surveys as may be required by the Federal agency or the Administration in order to determine the extent of compliance by the offeror with the subcontracting plan. Such a breach may be considered in any past performance evaluation of the contractor. SBA is proposing to revise § 125.3(d) to implement this provision.

    Section 1821 also provides that SBA must provide examples of activities that would be considered a failure to make a good faith effort to comply with a small business subcontracting plan. Good faith effort considers a totality of the contractor's actions to provide the maximum practicable opportunity to small businesses to participate as subcontractors (including those in the socio-economic small business areas), consistent with the information and assurances provided in the subcontracting plan. A failure to exert good faith effort is first predicated upon evidence that an other-than-small-business (OTSB) federal prime contractor, required to have a subcontracting plan with negotiated Small Business Concern (SBC) goals approved by a federal contracting officer, has failed to attain these goals and this failure may be attributable to a lack of good faith effort by the OTSB prime contractor. The term SBC for purposes of this rule includes all categories of small business socio-economic concerns including small business, small disadvantaged businesses, veteran owned small businesses, service disabled veteran owned small businesses, women owned small businesses, small businesses in historically underutilized business zones, Historically Black Colleges and Universities (HBCU/Minority Institutions (MI)) (NASA only) and any successor small business designations. A failure to exert good faith efforts must take into account all actions, or lack thereof, the contractor made to promote subcontracting opportunity to small businesses to the extent agreed upon in the approved subcontracting plan. SBA is reorganizing this section to reflect these new examples in proposed § 125.3(d)(3)(ii). SBA is proposing to renumber current § 125.3(d)(3)(i) through (iii) as § 125.3(d)(3)(i)(A) through (C) to better organize this section for clarity and ease of understanding . This rule does not add a new requirement for supporting documentation for the subcontracting plan.

    III. Recovery Improvements for Small Entities After Disaster Act of 2015, Public Law 114-88, 129 Stat. 686, November 25, 2015 (RISE Act)

    Section 2108 of the RISE Act authorizes SBA to establish contracting preferences for small business concerns located in disaster areas, and provide agencies with double credit for awards to small business concerns located in disaster areas. In order to implement the changes made by section 2108 of the RISE Act, SBA is proposing to add a new part 129 to title 13 of the Code of Federal Regulations. SBA will implement section 2105 in a separate rulemaking.

    Section 2108 of the RISE Act amends section 15 of the Small Business Act (15 U.S.C. 644) by adding a subsection (f), which authorizes procuring agencies to provide contracting preferences for small business concerns located in areas for which the President has declared a major disaster, during the period of the declaration. Section 2108 provides that this contracting preference shall be available for small business concerns located in disaster areas if the small business will perform the work required under the contract in the disaster area. Under § 6.208 of Federal Acquisition Regulation (FAR), title 48 of the Code of Federal Regulations, contracting officers may set aside solicitations to allow only offerors residing or doing business in the area affected by a major disaster. Under existing FAR 26.202-1, such local area set asides may be further set aside for small business concerns. SBA is proposing to use the existing FAR definitions to provide that an agency will receive credit for an “emergency response contract” awarded to a “local firm” that qualifies as a small business concern under the applicable size standard for a “Major disaster or emergency area.” FAR 26.201.

    Section 2108 also provides that if an agency awards a contract to a small business located in a disaster area through a contracting preference, the value of the contract shall be doubled for purposes of determining compliance with the small business contracting goals described in section 15(g)(1)(A) of the Small Business Act. Proposed § 129.300 states that agencies shall receive double credit for awarding a contract through the use of a local small business or socioeconomic set aside authorized by proposed § 129.200, i.e., a set-aside restricted to SBCs, 8(a) Business Development (BD) Program Participants, Women-Owned, Service-Disabled Veteran-Owned or HUBZone SBCs located in a disaster area. It is SBA's intent that agencies will enter accurate data into the Federal Procurement Data System (FPDS). SBA will provide the extra credit through the agency scorecard process. Local area set aside and small business contract designations already exist in FPDS, and implementation has already occurred in FY 2017.

    IV. Other Small Business Government Contracting Amendments Clarification That the Non-Manufacturer 500 Employee Size Standard Does Not Apply to Information Technology Value Added Resellers

    On September 10, 2014, SBA proposed to eliminate the information technology value added reseller (ITVAR) exception to NAICS 541519, which had a size standard of 150 employees. 79 FR 53646. In the proposed rule, SBA specifically noted that elimination of the exception would result in these acquisitions, which are primarily for supplies, being subject to the non-manufacturer rule (NMR), which has a size standard of 500 employees. As a result of public comment, SBA altered the language in the ITVAR exception (13 CFR 121.201, footnote 18) to make it clear that the manufacturing performance or limitations on subcontracting requirements and the NMR apply to acquisitions under the ITVAR exception, but retained the 150 employee size standard. 81 FR 4436 (January 26, 2016). By definition, contractors under the ITVAR exception are non-manufacturers, and it would make no sense for SBA to retain a 150 employee size standard if concerns could also qualify under the NMR 500 employee size standard. In a size appeal before the SBA Office of Hearings and Appeals, a firm tried to argue that the size standard under the ITVAR exception was the 500 employee non-manufacturer size standard. Size Appeal of York Telecom Corporation, SBA No. SIZ-5742 (May 18, 2016). The appeal was denied, and this rule proposes to clarify in § 121.406(b)(1)(i) that the NMR size standard of 500 employees does not apply to acquisitions that have been assigned the ITVAR NAICS code 541519 exception, footnote 18. The size standard for any acquisition under 541519, footnote 18 is 150 employees for all offerors.

    Setting Aside an Order Under a Multiple Award Set Aside Contract

    In the final rule implementing 15 U.S.C. 644(r), SBA contemplated the set aside of orders for certain types of SBCs, such as HUBZone SBCs, 8(a) BD Program Participants, SDVO SBCs, or WOSBs. 78 FR 61114, 61124 (October 2, 2013). SBA noted that at the time, the small business programs had major differences with respect to application of the limitations on subcontracting (LOS) and NMR, and therefore it would be difficult for SBCs and agencies to determine the rules that applied to a particular order. SBA was also concerned about the possibility that SBCs could be deprived of an opportunity to compete for orders under a set aside contract if an agency repeatedly set aside orders for other socioeconomic categories. Since that time, SBA has attempted to harmonize the application of the LOS and NMR for each of the various types of small business contracts. The concerns identified in the SBA final rule have since been addressed to enable fair and proper implementation of order set asides. Specifically, the SBA final rule standardized the LOS and NMR across the socioeconomic programs. 81 FR 34243. In addition, some agencies have pursued the strategy of allowing order set asides against set aside multiple award contracts, including notification and incorporation of the clause at FAR 52.219-13, and agencies have reported that they have not encountered any industry concerns. SBA is requesting comment on whether SBA should allow agencies to set aside orders for a socioeconomic small business program (8(a), HUBZone, SDVO, WOSB) under a multiple award contract that was originally conducted as a total small business set-aside. Because SBA believes that a change is appropriate at this time, SBA is proposing to remove the term “Full and Open” from § 125.2(e)(6) to specifically afford discretion to an agency to set-aside one or more particular orders for HUBZone SBCs, 8(a) BD SBCs, SDVO SBCs or WOSBs, as appropriate, where the underlying multiple award contract was initially set-aside for small business. Set asides under multiple award set-aside contracts may be implemented by agencies in different ways, including: (1) Establishing set asides to socioeconomic programs at the order solicitation level under multiple award small business set-aside contracts, and (2) establishing socioeconomic set-aside pools at the master contract solicitation level for a multiple award small business set-aside contract. SBA is requesting comments on any burden or adverse impact associated with each of these two approaches. In addition, SBA is specifically interested in whether these two approaches impact the ability for all types of small businesses (e.g. 8(a), HUBZone, WOSB, SDVOSB) to compete and receive orders.

    Recertification of Size and Status

    SBA's rules require recertification of size and status for all long-term (over 5 years) contracts. This includes indefinite delivery contracts under which orders will be placed at a future date and contracts that had not been set-aside for small business, but were awarded to a small business. Thus, SBA is proposing to amend §§ 125.18(e), 126.601(h), and 127.503(h) to clarify that a concern must recertify its status on full and open contracts. In addition, SBA is adding a new paragraph to §§ 124.521 and 124.1015 to reflect the status recertification requirements for 8(a) participants and SDB concerns, which are already present in the SDVO, HUBZone, and WOSB regulations. This change provides greater consistency among the status recertification requirements for small business program contracts. One result of these proposed changes, is that a prime contractor relying on similarly situated entities (an SDVOSB prime with an SDVOSB subcontractor, for example) to meet the applicable performance requirements may not count the subcontractor towards its performance requirements if the subcontractor recertifies as an entity other than that which it had previously certified.

    Indirect Costs in Commercial Subcontracting Plans

    Other than small business concerns that have a commercial subcontracting plan report on performance through a summary subcontracting report (SSR), and SBA's rules currently require that a contractor using a commercial subcontracting plan must include all indirect costs in its SSR. However, SBA's rules do not require contractors to include indirect costs in their commercial subcontracting plan goals, which leads to inconsistencies when comparing the SSR to the commercial subcontracting plan. SBA is proposing to revise § 125.3(c)(1)(iv) to require that prime contractors with commercial subcontracting plans must include indirect costs in the commercial subcontracting plan goals. This will allow agencies to negotiate more realistic commercial subcontracting plans and monitor performance through the SSR.

    Subcontracting Compliance Reviews

    SBA is also proposing to change the nomenclature that applies to subcontracting compliance reviews. Instead of rating firms as “Outstanding,” “Highly Successful,” or “Acceptable,” SBA will utilize the terminology “Exceptional,” “Very Good,” and “Satisfactory.” SBA proposes to revise § 125.3(f)(3) to implement these changes to align title 13 of the CFR and the FAR to rectify ambiguity in terminology which causes confusion by Government personnel and industry partners when attempting to ascertain the value and differences of the SBA's rating under § 125.3(f)(3) in an SBA Compliance Review and the ratings in FAR 42.1503 under a Subcontracting Evaluation when FAR 52.219-9 is used and made part of the firm's past performance record.

    Independent Contractors—Employees/Subcontractors

    SBA's size regulations provide that SBA considers “all individuals employed on a full-time, part-time, or other basis” to be employees of the firm whose size is at issue. 13 CFR 121.106(a). “This includes employees obtained from a temporary employee agency, professional employee organization or leasing concern.” Id. Further, “SBA will consider the totality of the circumstances, including criteria used by the IRS for Federal income tax purposes, in determining whether individuals are employees of a concern.” Id. In determining what it means to be employed on an “other” basis, SBA issued Size Policy Statement No. 1. 51 FR 6099-01 (February 20, 1986). The Size Policy Statement sets forth 11 criteria SBA will consider in determining whether an individual should be treated as an employee. If an individual meets one or more of the criteria they may be treated as an employee. Pursuant to this guidance, an individual contractor paid through a 1099 may be properly treated as an employee for purposes of SBA's regulations (including SBA's regulations governing performance of work or LOS requirements). The reason for such treatment was to prevent a firm that exceeded an applicable employee-based size standard from “firing” a specific number of employees in order to get below the size standard, but to then hire them back or “subcontract” to them as independent contractors. SBA did not want to encourage firms to attempt to evade SBA's size regulations.

    Historically, SBA has said that if an individual qualifies as an “employee” under part 121 of SBA's regulations for purposes of determining size, then SBA should consider that individual to be an employee of the firm for the performance of work (or now LOS) requirements of 13 CFR 125.6 (or 124.510). It would not be equitable to say that a given individual counts against a firm in determining size (because he/she is considered an “employee” of the firm) and then to say that that same individual also counts against the firm for the LOS requirements (because he/she is not considered an “employee” of the firm). Thus, for a contract that is assigned a NAICS code having an employee-based size standard, an independent contractor could be deemed an “employee” of the concern for which he/she is doing work. If such an individual is considered an employee for size purposes, he/she would also be considered an employee for LOS purposes.

    It appears that SBA's regulation at 13 CFR 125.6(e)(3) has caused some confusion as to how to properly treat independent contractors for purposes of the LOS provisions. That provision provides that “Work performed by an independent contractor shall be considered a subcontract, and may count toward meeting the applicable LOS where the independent contractor qualifies as a similarly situated entity.” (Emphasis added). This provision was meant to apply to service or construction contracts. For service contracts, work performed by an independent contractor would always be considered a subcontract, so that a service contractor could not claim that a non-similarly situated entity independent contractor should be considered an employee of the service contractor. For example, for a WOSB service contract, SBA did not want a WOSB prime contractor to pass performance of the contract to one or more independent contractors that would not themselves qualify as WOSBs. The provision identifies that an independent contractor could qualify as a “similarly situated entity” and meet the LOS that way, but would not permit a service contractor to effectively avoid meeting the LOS by claiming that independent contractors were in fact employees of the firm.

    This proposed rule revises § 125.6(e)(3) to clarify SBA's intent regarding both contracts assigned a NAICS code with an employee-based size standard and those assigned a NAICS code with a receipts-based size standard. Where a contract is assigned a NAICS code with an employee-based size standard, an independent contractor may be deemed an employee of the firm under the terms of the Size Policy Statement. Where a contract is assigned a NAICS code with a receipts-based size standard, an independent contractor could not be considered an employee of the firm for which he or she is performing work, but, rather, would always be deemed a subcontractor. In either case, as a subcontractor, an independent contractor may be considered a “similarly situated entity” and work performed by the independent contractor would then count toward meeting the applicable limitation on subcontracting.

    Limitation on Subcontracting Compliance

    Congress has expressed its strong support for small business government contracting, and has provided agencies with numerous tools to set aside acquisitions for exclusive competition among, or in some cases award contracts on a sole source basis to, SBCs, 8(a) BD Program Participants, HUBZone SBCs, WOSBs, Economically Disadvantaged Women-Owned (EDWOSB) SBCs, and SDVO SBCs. 15 U.S.C. 631(a), 637(a), (m), 644(a), (j), 657a, 657f. As a condition of these preferences, small businesses are limited in their ability to subcontract to other than small business concerns, so that small businesses actually perform a certain percentage of the work. These LOS appear in solicitations and contract clauses for small business set aside and sole source awards. Like with all contract administration, it is the responsibility of the contracting officer to monitor compliance with terms and conditions of a contract. (FAR 1.602-2), including the LOS clause. SBA is proposing language to clarify that contracting officers have the discretion to request information from contractors to demonstrate compliance with LOS clauses. The Government Accountability Office (GAO) has noted in reports that contracting officers have not been monitoring compliance with the limitations on subcontracting. “Contract Management; Increased Use of Alaska Native Corporations' Special 8(a) Provisions Calls for Tailored Oversight,” GAO-06-39, April 2006; “8(a) Subcontracting Limitations, Continued Noncompliance with Monitoring Requirements Signals Need for Regulatory Change,” GAO-14-706, September 2014; and “Federal Contracting Monitoring and Oversight of Tribal 8(a) Firms Need Attention,” GAO-12-84, January 2012. The type of information that small business prime contractors may be requested to provide to demonstrate compliance with the LOS could be copies of subcontracts for a particular procurement or an email that lists the amount that the prime contractor has paid to its subcontractors for a particular procurement and whether those subcontractors are similarly situated entities. In addition, SBA proposed to require information demonstrating compliance with the applicable LOS from all prime contractors performing set-aside and sole-source contracts awarded through SBA's small business programs when the prime contractor intends to rely on similarly situated subcontractors to comply with the LOS. 79 FR 77955 (December 29, 2014). SBA did not adopt such a requirement in the final rule, but indicated that it intended to seek comment on this issue. 81 FR 34243 (May 31, 2016).

    SBA is proposing to add new § 125.6(e)(4) to clarify that contracting officers may request information regarding LOS compliance, and to clarify that it is not required for every contract. SBA is requesting comment on whether all small business prime contractors performing set-aside or sole source contracts should be required to demonstrate compliance with LOS to the contracting officer, and if so, how often should this be required, such as annually or quarterly. What salient data would best provide assurance of compliance? Should demonstrating compliance depend on the length of the contract or the type of contract? Whether it is for commercial products and services? Whether the contract is fixed price? Whether the contract is above the SAT or the TINA threshold? What other considerations should there be when applying the requirement for a contractor to document LOS compliance? We are requesting that industry provide comment on what information can be efficiently requested and provided.

    Exclusions From the Limitations on Subcontracting

    SBA's LOS regulations provide that for a set aside service contract, the prime contractor must agree that it will not pay more than 50% of the amount paid from the government to firms that are not similarly situated. 13 CFR 125.6(a)(1). Unlike supply and construction contracts, where materials are excluded, no costs are specifically excluded under a service contract, other than for mixed contracts where the non-service portion, such as incidental supplies, are excluded. SBA has received several requests from industry for exclusions related to specific types of contracts, and one related to all industries. Some have advocated that certain direct costs, such as airline tickets and hotel costs, be excluded from the calculation of the amount paid under the contract. In addition, in certain types of contracts or industries, there are factors that may complicate compliance with the LOS, potentially hindering agencies from setting aside acquisitions for small business concerns.

    For example, for certain contracts performed outside of the United States, contractors must use non-U.S. local organizations or independent contractors to perform consulting services regarding a particular foreign country. These individuals are not located in the United States, do not reside in the United States, and are not likely to be employees of a United States SBC. SBA is proposing to further clarify how to determine whether an individual is an employee or independent contractor.

    In the environmental remediation industry (NAICS 562910), a large part of the cost of the contract is tied to the transportation and disposal of hazardous, toxic and radiological waste. According to some SBCs in this industry that have contacted SBA, given the fact that these services are highly regulated and capital intensive, these particular transportation services can generally be performed only by other than small business concerns. For example, all of the disposal facilities in the United States are large businesses, and most railroads and shipping companies that transport hazardous waste are other than small concerns. This rule proposes to exclude transportation and disposal services from the LOS compliance determination where small business concerns cannot provide the disposal or transportation services. Similarly, where the government acquires media services from small business concerns, the placement of the content in the media may require large payments to the other than small business concerns, even though that is not the principal purpose of the acquisition. SBA is proposing to exclude these media purchases from the LOS determination.

    In a prior rulemaking, SBA determined that remote hosting on servers or networks, or cloud computing, should be considered a service and therefore the NMR would not apply. 13 CFR 121.1203(d)(3). Due to the costs and scale involved, cloud computing is generally provided by other than small business concerns. SBA is proposing to exclude cloud computing from the LOS calculation, where the small business concern will perform other services that are the primary purpose of the acquisition. Alternatively, SBA is requesting comment on whether it should treat cloud computing as a supply, and therefore the NMR would apply, which would allow SBA to issue individual or class waivers of the NMR for cloud computing. SBA is also requesting comment on the definition of cloud computing, such as the definition in National Institute of Standards and Technology Special Publication 800-145, so that we can ensure the definition is not used to allow other than small businesses to provide an excessive portion of services on small business set aside contracts.

    SBA is requesting comment on whether these types of costs should be excluded from the calculation for purposes of compliance with the LOS. For example, some have suggested that travel costs should be excluded. However, SBA is also concerned about abuse of such exceptions. For example, SBA does not want agencies to receive credit for a small business contract award where the principal purpose of the acquisition is to obtain services from an other than small business concern. If that is the norm for a particular type of contract, perhaps that type of contract should not be set aside for small business concerns. The intent of the LOS is to prevent other than small business concerns from benefitting more than small business concerns on small business set aside contracts. SBA is requesting comment from industry on these issues.

    Subcontracting to a Small Business Under a Socioeconomic Program Set Aside

    In the context of socioeconomic set aside or sole source service contracts, the ostensible subcontractor rule applies when a small business is unduly reliant on an other than small subcontractor, or when the other than small subcontractor will perform primary and vital parts of the contract. In such cases, assuming that an exception to joint venture affiliation does not apply, SBA will treat the small business prime contractor and its subcontractor as joint venturers, and therefore affiliates. If the subcontractor is other than small, the prime contractor is ineligible for award due to this affiliation. SBA has become aware of service contract set asides for the SDVO, HUBZone, 8(a) or WOSB programs, where the prime contractor subcontracts most or all of the actual performance to a small business that is small for the applicable NAICS code but not eligible to compete for award of the prime contract, and thus not a similarly situated entity as that term is defined at § 125.1.

    Under SBA's recently amended joint venture rules (81 FR 34243, May 31, 2016; 13 CFR 121.103(h)(3)(i)), a joint venture can qualify as small as long as each member of the joint venture is small. In the scenario described above, the joint venture regulation prevents SBA from performing an analysis under the ostensible subcontractor rule because both the prime contractor and subcontractor are small for the size standard that applies to the contract and thus subject to the exception from affiliation for joint venture partners that are each small for the size standard. There is no existing regulatory mechanism for an unsuccessful offeror, SBA, or contracting officer to protest a socioeconomic set aside or sole source award to a prime contractor that is unduly reliant on a small, but not similarly situated entity subcontractor. The underlying premise that ostensible subcontractors and their prime contractors should be treated as joint ventures is still SBA's policy. Firms that are performing contracts in a manner more consistent with a joint venture than a prime/sub relationship should follow the requirements of SBA's regulations regarding socioeconomic joint ventures.

    The performance of a set-aside or sole source service contract by a small business concern that is not eligible to compete for the prime contract is contrary to the intent and purpose of the statutory authorities for socioeconomic category set-aside and sole source procurements. Thus, SBA is proposing language at §§ 124.507(b)(2), 125.18(f), 125.29(c), 126.601(i), 126.801(a), 127.504(c), and 127.602, which will allow SBA to make a determination concerning a small business program participant's overreliance on a non-similarly situated subcontractor as part of an eligibility or status protest determination. SBA will evaluate these contractor relationships under the established ostensible subcontractor test. If SBA finds that the subcontractor is an ostensible subcontractor, SBA will treat the arrangement between the contractors as a joint venture that does not comply with the formal requirements necessary to receive and perform the socioeconomic program set aside or sole source award as a joint venture.

    This rulemaking will not apply to non-service contracts, such as construction contracts or contracts involving non-manufacturers. Due to the nature of the industry, SBA's rules allow small businesses to subcontract large amounts of performance on construction contracts. The Small Business Act, and SBA's regulations generally provide that for set aside supply contracts, a non-manufacturer must supply the product of a small business, unless SBA has issued a waiver. This means that for an SDVO, HUBZone, 8(a), or WOSB set aside or sole source supply contract, the prime contractor that is a non-manufacturer must qualify as an SDVO, HUBZone, 8(a) or WOSB, but the product can be made by a small business that does not qualify as SDVO, HUBZone, 8(a), or WOSB. When the non-manufacturer rule applies to a small business program contract, it is considered an exception to the limitations on subcontracting. Where a waiver of the non-manufacturer rule has been issued that applies to a small business program set-aside or sole source contract, the prime contractor may supply a product manufactured by any size business, also without regard to whether the subcontractor qualifies for the applicable small business program set-aside or sole source contract.

    Kit Assemblers

    SBA is proposing to remove specific rules related to kit assemblers and the NMR, which are currently contained at 13 CFR 121.406(c). The existing kit assembler rule requires that 50 percent of the total value of the items in the kit must be manufactured by small business concerns, but excludes items manufactured by other than small business concerns if the contracting officer specifies the item for the kit. This rule has led to confusion concerning how to calculate total value, and whether a waiver of the non-manufacturer rule can or must be requested in order to supply items manufactured by other than small concerns. SBA recently amended its rules to address the NMR and multiple item acquisitions. If the majority of items in a kit are made by small business concerns, then the acquisition can be set aside for small business without the need to request a waiver. If the majority of items in a kit are not made by small business concerns, then an individual or class waiver of one or more of the items is necessary for the acquisition to be set aside for small business concerns for acquisitions above the simplified acquisition threshold or for all other socioeconomic set-asides, regardless of value. SBA is proposing to delete the kit assembler exception, and instead apply the multiple item rule in § 121.406(e) to kit assembler acquisitions. Like all other acquisitions, the NMR will not apply to small business set-asides with a value at or below the simplified acquisition threshold.

    Clarification on Size Determinations

    SBA is also proposing to amend its regulations to remove language that has caused confusion on when size is determined. The general rule is that size is determined at the time of initial offer including price, with the understanding that there are some exceptions such as architecture and engineering procurements, and certain unpriced indefinite delivery indefinite quantity (IDIQ) contracts. However, § 121.404(a) also contains the parenthetical, “(or other formal response to the solicitation).” Some parties have misread this to mean formal responses that are after the initial offer, such as final proposal revisions. The clear intent of SBA's general rule is to give both firms and the government certainty as to when size will be determined, the initial response, including price, because in the current government contracting environment a vast amount of time may pass between initial offer and award. Offer covers bids and proposals, and SBA recognizes that in simplified acquisitions the initial response may be acceptance of the government's offer. Thus, SBA is proposing to amend § 121.404(a) to make it clear that size is generally determined at the time of initial offer or response including price. SBA is also proposing to add a paragraph at § 121.404(a)(1)(iv), to articulate an exception to the general rule for when size is determined. When an agency uses an IDIQ multiple award contract that does not require offers for the contract to include price, size will be determined on the date of initial offer for the IDIQ contract, which may not include price. This proposed change reflects the statutory change found at section 825 of the National Defense Authorization Act for Fiscal Year 2017, 114 Public Law 328, (December 23, 2016), and section 876 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019, 115 Public Law 232, (August 13, 2018). SBA is also proposing to remove the last sentence of paragraph § 121.404(g)(5), because it conflicts with recent rules that provide that a firm may rely on similarly situated entities to meet the applicable LOS. The last sentence of (g)(5) is unnecessary, as § 121.103(h) is controlling with respect to the affiliation.

    SBA proposes to amend § 121.103(h)(4) to clarify that when two or more small businesses either form a joint venture or are treated as joint venturers due to their relationship as prime and subcontractor, the joint venture exception to affiliation found at § 121.103(h)(3)(i) applies if both firms are considered small for the size standard associated with the procurement. SBA proposes to remove the phrase “and therefore affiliates” from the ostensible subcontractor rule at § 121.103(h)(4) to clarify this point. To allow affiliation between firms that are considered joint venturers because of their ostensible subcontracting relationship, even when each firm is individually small for the size standard associated with the procurement, would negate the purpose of § 121.103(h)(3)(i), which explicitly provides an exception to affiliation for such joint ventures.

    The purpose of the ostensible subcontractor rule is to treat the relationship between a prime contractor and its subcontractor as a joint venture where the subcontractor performs primary and vital work for the procurement. SBA's current joint venture rules do not aggregate the partners to a joint venture in determining the size of the joint venture, but rather permit a joint venture to qualify as small as long as each partner to the joint venture is individually small. Thus, a rule that equates a prime-sub relationship to that of a joint venture because the subcontractor is performing primary and vital work and then affiliates the two parties (i.e., requiring them to aggregate their revenues or employees) is inconsistent with the joint venture size rules themselves. The phrase “and therefore affiliates” that SBA proposes to delete was a holdover from previous regulations that aggregated the receipts or employees of joint venture partners when determining whether a joint venture qualified as a small business. When SBA changed its size regulations to broaden the exclusion from affiliation for small business to allow two or more small businesses to joint venture for any procurement without being affiliated (i.e., the joint venture would be considered small provided each of the joint venture partners individually qualified as small and SBA would not aggregate the receipts or employees of joint venture partners), SBA amended § 121.103(h)(3), but did not make a correspondingly similar change in § 121.103(h)(4). See 81 FR 34243, 34258 (May 31, 2016). This proposed rule intends to make it clear that if a prime-sub relationship is deemed to be a joint venture because of the ostensible subcontractor rule, then all of the rules pertaining to joint ventures would apply. As already noted, a prime-sub relationship where both parties individually qualified as small would be considered an award to small business. Similarly, if the ostensible subcontractor were a large business that was the SBA-approved mentor of the prime contractor, then the award could qualify as an award to small business if the prime contractor/protégé firm qualifies as small and the relationship (treated as a joint venture) meets the normal requirements for a joint venture. See §§ 124.513(c) and (d); 125.18(b)(2) and (3); 126.616(c) and (d); and 127.506(c) and (d). Although SBA recognizes that it is unlikely that a prime-subcontractor relationship would meet the necessary joint venture requirements of those paragraphs, it is possible, and a prime-sub/joint venture that did in fact meet those requirements could qualify as small.

    In addition, the proposed rule further clarifies in § 121.103(h)(4) to provide that the ostensible subcontractor rule does not apply to similarly situated entities, as that term is defined at § 125.1. SBA notes, however, that when both partners to a joint venture are small for the assigned NAICS code but the subcontractor partner is not a similarly situated entity, the prime alone is responsible for compliance with the applicable LOS and cannot rely on its subcontractors to satisfy the LOS requirement.

    Clarification Where One Acceptable Offer Is Received on a Set Aside

    SBA is proposing to add new § 125.2(e)(5) to clarify that a contracting officer may make an award under a small business or socioeconomic set-aside where only one acceptable offer is received. The decision to conduct a set aside is based on the contracting officer's expectation based on market research that he or she will obtain two or more fair market price offers from capable small business concerns. Pursuant to the FAR, the contracting officer must perform market research before issuing a solicitation to determine whether there are small businesses (including 8(a), HUBZone, SDVO SBCs, WOSBs) that can perform the requirement. 48 CFR 10.001(a)(2); 19.202-2. A contracting officer's “rule of two” determination is prospective. Whether there appear to be at least two small businesses that can perform a procurement at a fair price is an analysis that is done during acquisition strategy planning and prior to the issuance of a solicitation. As long as the market research leads a contracting officer to conclude that the agency will receive offers from at least two small business concerns that are technically acceptable and award will be made at a fair market price, the “rule of two” is satisfied, no matter how many offers are actually received or how many offers remain after evaluations are conducted, a competitive range is established, or offerors are eliminated in some other fashion.

    The FAR currently addresses small business set-asides below $150,000, and provides, “If the contracting officer receives only one acceptable offer from a responsible small business concern in response to a set-aside, the contracting officer should make an award to that firm.” FAR 19.502-2(a). There is no reason this policy should not apply to all set-asides above or below $150,000. The contracting officer must determine that an offeror is responsible and price is fair and reasonable before awarding any contract. FAR 9.103(a); 9.104-1; 14.408-2; and 15.304(c)(1). It would be inefficient and detrimental to the Government and offerors to arbitrarily prevent an award where a competition was conducted but only one offer was received. Such a policy would unreasonably prolong the procurement process, requiring a procuring agency to cancel one solicitation and reprocure using another where only one small business offer is received, and could cause contracting officers to limit the use of set-asides.

    Compliance With Executive Orders 12866, 13563, 12988, 13132, 13771, the Unfunded Mandates Reform Act of 1995, the Paperwork Reduction Act (44 U.S.C. Ch. 35), and the Regulatory Flexibility Act (5 U.S.C. 601-612) Executive Order 12866

    The Office of Management and Budget (OMB) has determined that this proposed rule is a “significant” regulatory action for purposes of Executive Order 12866. The benefits to small business from this proposed rule far outweigh any associated costs. The proposed rule makes several other changes needed to clarify ambiguities in or remedy perceived problems with the current regulations. These proposed changes should make SBA's regulations easier for SBCs to use and understand. The proposed change to § 121.404 clarifies when size for a government contract is determined, which will reduce confusion for small business concerns. The proposed change to § 121.406 clarifies that the size standard for information technology value added resellers is 150 employees, again to eliminate confusion among small business concerns. The proposed changes to § 125.2(a) will benefit small business by clarifying that a contracting officer can award a contract to a small business under a set-aside if only one offer is received. The proposed changes to § 125.2(b) implement section 1811 of the NDAA of 2017, and govern what acquisitions PCRs can review and would not impact small business concerns. The proposed changes to § 125.2(d) implement section 863 of the NDAA of 2016 and direct contracting officers on how to notify the public about consolidation and substantial bundling, and will not impact small business concerns. The proposed changes to § 125.2(e) authorize agencies to set aside orders for socioeconomic programs where the contract was set aside for small business, and will benefit firms that qualify for those set asides. The proposed changes to § 125.3 implement section 1821 of the NDAA of 2017 by providing examples of a failure to make a good faith effort to comply with small business subcontracting plans, and will benefit small businesses by providing such examples so that contracting officers can hold other than small prime contractors accountable for failing to make a good faith effort to comply with their small business subcontracting plan. The proposed changes to § 125.3 also implement section 1821 by providing that the contracting officer should evaluate whether an other than small business complied with the requirement to report on small business subcontracting plan performance. The proposed changes to § 125.6(a) will benefit small business concerns by allowing small businesses to exclude certain costs from the calculation of the limitations on subcontracting. Without these changes, some agencies will not be able to set contracts aside for small business, because certain costs attributable to other than small concerns are too high. The proposed changes to § 125.6 also help small businesses by clarifying the difference between an employee and an independent contractor. The proposed changes to § 125.6 will impose some requirements on small business concerns to demonstrate compliance with the LOS, but only to the extent the information is not already in the possession of the government. Contractors may have this information readily available since it pertains to contract performance and subcontracting of that performance. These information requests are not mandatory, as the contracting officer simply has the discretion to request such information. Contracting officers already have the authority to request information on performance, and this proposed change simply clarifies that the authority exists. Finally, the benefits to small business concerns of this proposed rule substantially outweigh any minor costs imposed by the exercise of existing contracting authority. The proposed addition of part 129 implements section 2108 of the RISE Act and benefits small businesses by providing agencies with an incentive to set aside contracts for small business concerns located in a disaster area. Accordingly, the next section contains SBA's Regulatory Impact Analysis. However, this is not a major rule under the Congressional Review Act, 5 U.S.C. 801, et seq.

    Regulatory Impact Analysis 1. Is there a need for the regulatory action?

    The proposed rule implements section 863 of the National Defense Authorization Act of 2016, Public Law 114-92, 129 Stat. 726 (15 U.S.C. 644(e)(3)); section 2108 of the Recovery Improvements for Small Entities After Disaster Act of 2015 (RISE Act), Public Law 114-88, 129 Stat. 686 (15 U.S.C. 644(f)); and sections 1811 and 1821 of the National Defense Authorization Act of 2017, Public Law 114-328, 130 Stat. 2000 (15 U.S.C. 637(d), 644(l)). In addition, it makes several other changes needed to clarify ambiguities in or remedy perceived problems with the current regulations. These proposed changes should make SBA's regulations easier to use and understand. With respect to contractors demonstrating compliance with the limitations on subcontracting, for decades the general rule has been that on a set aside contract, a small business or socioeconomic small business must generally perform some of the work (services, construction, or manufacturing). This helps ensure that the benefits of a small business set-aside contract flow to the recipients whom Congress intends to help by creating the set aside authority. If performance of a set-aside contract is passed through to other-than-small business concerns, there may not be a need for set-asides in the first place, and the government may be paying more for a good or service without any value added. These limitations on subcontracting appear as a clause in a set aside contract and help to ensure that the intended beneficiaries of set aside contracts are receiving those benefits. The contracting officer is responsible for monitoring compliance with clauses in a contract. FAR 1.602. Nothing in SBA's regulations or the FAR prohibits a contracting officer from requesting documents demonstrating compliance with the limitations on subcontracting clause. It is SBA's view that such authority exists, but that the authority is not clear or express. Without clarifying the authority or process, some contracting officers simply are not monitoring compliance. The result is that there may be increased fraud, waste, and abuse, in the performance of contracts that are set aside for small business concerns, because subcontractors that are not eligible to receive the prime contract may be performing more work than section 46 of the Small Business Act (15 U.S.C. 657s), SBA regulations at 13 CFR 125.6, and FAR clause 52.219-14 permit. This type of fraud frustrates the policy goals associated with awarding contracts set aside for small business concerns.

    In this proposed rule, SBA proposes to clarify, by expressly stating, that the contracting officer may request information to demonstrate a contractor's compliance with the limitations on subcontracting clause. SBA proposes to clarify that it is within the contracting officers' discretion to request such a showing of compliance, because in some cases it will not be necessary, such as when a small business performs the contract itself without the use of subcontractors or when information regarding compliance is already available to the Government. Through this proposed rule, SBA intends to deter and reduce potential fraud, waste, and abuse, due to noncompliance with the limitations on subcontracting. Additionally, clarifying a contracting officer's authority to request that a small business concern demonstrate compliance with the limitations on subcontracting is consistent with recommendations made by the U.S. Government Accountability Office (GAO) in several reports: “Contract Management; Increased Use of Alaska Native Corporations' Special 8(a) Provisions Calls for Tailored Oversight,” GAO-06-39, April 2006; “8(a) Subcontracting Limitations, Continued Noncompliance with Monitoring Requirements Signals Need for Regulatory Change,” GAO-14-706, September 2014; and “Federal Contracting Monitoring and Oversight of Tribal 8(a) Firms Need Attention,” GAO-12-84, January 2012.

    2. What are the potential benefits and costs of this regulatory action?

    The majority of the proposed changes in this rule will have de minimis costs and qualitative benefits that are difficult to quantity: Protecting the integrity of the small business procurement system. The rule proposes to provide exceptions to the LOS in certain service contracts where small businesses must use the services of other than small subcontractors in substantial amounts in order to fully perform a set aside service contract. This will help small business by making acquisitions available for small business set-asides that would not otherwise be available. Many of the other clarifications in this rule will benefit small businesses, by reducing confusion in the marketplace, but this benefit is difficult to quantify. The proposed rule allowing agencies to receive double credit toward its small business procurement goals for awards to local small business concerns in the event of a disaster is intended to benefit local small businesses and provide employment and revenue to concerns located in an area devastated by a disaster. While the authority for contracting preferences for businesses located in a disaster area already exists in FAR subpart 26.2, small businesses located in these areas may receive a greater benefit under this proposed rule due to the incentive for the procuring agency to receive double credit toward its small business procurement goals by utilizing this authority.

    SBA is proposing to clarify that the contracting officer may require the prime contractor to demonstrate compliance with the LOS. We believe that contracting officers already possesses the authority to request information from a contractor concerning compliance with a clause in the contract pursuant to FAR 1.602-2. In addition, on some contracts, compliance can already be reviewed or monitored by reviewing invoices. The proposed rule would clarify that contracting officers have the authority to request information in connection with a contractor's compliance with applicable limitations on subcontracting clauses. Approximately 56,000 firms received approximately 180,000 sole source or set aside awards in FY 2016. SBA is proposing that a contracting officer may request information regarding compliance with prime contractors' limitations on subcontracting. In some cases this information may not be necessary based on the nature of the contract and the invoices submitted. SBA estimates that less than ten percent of small business concerns and contracts would be subject to a request for this information (5,600 small business concerns and 18,000 contracts), and compliance should take on average less than an hour. Small businesses that do not issue subcontracts will not have anything to report. Small businesses may be able to easily report on any subcontracts, as information on subcontracting and paying subcontractors is routinely compiled as part of the normal accounting procedures for any business concern. Accounting or contract management personnel should be able to determine whether the firm issued any subcontracts in connection with the prime contract. SBA estimates that this rule will be finalized in FY 2019. SBA estimates an overall annual cost of approximately $600,120 for small businesses to provide information on compliance with the limitations on subcontracting, as requested by the contracting officer.

    This proposed rule will require an other than small prime contractor with a commercial subcontracting plan to include indirect costs in its subcontracting goals. Based on data from the Electronic Subcontracting Reporting System (eSRS), in FY 2017 approximately 700 firms had commercial subcontracting plans. SBA estimates that approximately 95% of those 700 firms include indirect costs in their subcontracting goals. Thus, this proposal would impact approximately 35 firms. The burden would be de minimis, as the accounting or contract manager would know the firm's indirect costs. The benefit of requiring that indirect costs be included in subcontracting goals where a commercial subcontracting plan is utilized, is that it will increase the small business subcontracting goal and thus increase the amount of funds the prime contractor will subcontract to small business concerns. Increasing the value and number of awards to small business concerns provides financial benefits to those firms, who may hire more staff and invest in more resources to support the increased demand. Furthermore, increasing the number and value of awards to small business concerns has macroeconomic and qualitative benefits to the national economy because small businesses are the foundation of the country's economic success.

    This proposed rule will establish that failure to provide timely subcontracting reports may constitute a material breach of the contract. These reports are already required by law at 13 CFR 125.3(a). This rule will make failure to provide the report a material breach of the contract, which could subject other than small business concerns to liquidated damages. SBA is not aware of any case where a firm has been subject to liquidated damages for failure to comply with a subcontracting plan. Thus any costs would be de minimis. The benefit of this proposed rule is that it will assist SBA and contracting officers with oversight of prime contractor compliance with subcontracting plans and may result in increased compliance with subcontracting plans.

    This proposed rule requires recertification of status on full and open contracts. SBA intended for recertification to occur whenever an agency receives credit for an award towards it goals, and this proposed rule is just a clarification that socioeconomic recertification is required on all contracts, including full and open contracts. We estimate that approximately 150 firms a year recertify on full and open contracts. This will only impact firms that are acquired, merged, or where there is a novation or the firm grows to be other than small on a long term contract. Agencies have goals for the award of prime contractor dollars to small and socioeconomic concerns. The purpose of recertification is to ensure that an agency does not receive small business credit for an award to an other-than-small concern.

    This proposed rule will limit the scope of Procurement Center Representative reviews of Department of Defense acquisitions performed outside of the United States and its territories. This applies to the government and will not impose costs or burdens on the public.

    This proposed rule will remove the kit assembler exception to the non-manufacturer rule. This clarification requires agencies to request a waiver of the non-manufacturer rule for kits, in accordance with existing regulations. This will reduce confusion, by having only one non-manufacturer rule procedure for purposes of multi-item procurements.

    3. What are the alternatives to this rule?

    Many of the proposed regulations are required to implement statutory provisions, thus there are no apparent alternatives for these regulations. With respect to the proposal clarifying that contracting officers may request information on compliance with the limitations on subcontracting, SBA considered whether prime contractors should be required to provide this information on compliance with the LOS on all set aside or sole source contracts. However, that may unnecessarily burden small businesses, if compliance is already readily apparent to the contracting officer based on the type of contract, invoicing, or observation. We estimate the alternative considered, having all small businesses provide information on compliance, would have an annual cost of $1,867,040. SBA decided to clarify instead that the contracting officer has the discretion to request such information to the extent such information is not already available. This will enable the contracting officer to request this information as he or she sees fit, in order to ensure that the benefits of the small business programs are flowing to the intended recipients. However, SBA is requesting comment on whether all small businesses should provide information on compliance with the LOS for set aside or sole source contracts.

    Executive Order 13563

    This executive order directs agencies to, among other things: (a) Afford the public a meaningful opportunity to comment through the internet on proposed regulations, with a comment period that should generally consist of not less than 60 days; (b) provide for an “open exchange” of information among government officials, experts, stakeholders, and the public; and (c) seek the views of those who are likely to be affected by the rulemaking, even before issuing a notice of proposed rulemaking. As far as practicable or relevant, SBA considered these requirements in developing this rule, as discussed below.

    1. Did the agency use the best available techniques to quantify anticipated present and future costs when responding to E.O. 12866 (e.g. , identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes)?

    To the extent possible, the agency utilized the most recent data available in the Federal Procurement Data System—Next Generation, System for Award Management and Electronic Subcontracting Reporting System.

    2. Public participation: Did the agency: (a) Afford the public a meaningful opportunity to comment through the internet on any proposed regulation, with a comment period that should generally consist of not less than 60 days; (b) provide for an “open exchange” of information among government officials, experts, stakeholders, and the public; (c) provide timely online access to the rulemaking docket on Regulations.gov; and (d) seek the views of those who are likely to be affected by rulemaking, even before issuing a notice of proposed rulemaking?

    The proposed rule will have a 60 day comment period and will be posted on www.regulations.gov to allow the public to comment meaningfully on its provisions. In addition, the proposed rule was discussed with the Small Business Procurement Advisory Council, which consists of the Directors of the Office of Small and Disadvantaged Business Utilization. SBA also submitted the rule to multiple agencies with representatives on the FAR Small Business Subcommittee prior to submitting the rule to the Office of Management and Budget for interagency review.

    3. Flexibility: Did the agency identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public?

    Yes, the proposed rule implements statutory provisions and will provide clarification to rules that were requested by agencies and stakeholders. In addition, SBA is proposing to make clear that contracting officers may request information from their contractors in order to determine whether the contractor is complying with the LOS. This information may already be provided as part of invoicing under certain contracts, and in any event, the information should be readily provided by the contractor, as it simply pertains to what extent the prime contractor is subcontracting work under the contract. Clarifying that the contracting officer has the authority to request this information, instead of requiring all small businesses to submit reports, significantly reduces cost and burden.

    Executive Order 12988

    This action meets applicable standards set forth set forth in section 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. This action does not have any retroactive or preemptive effect.

    Unfunded Mandates Reform Act

    This rule will not result in an unfunded mandate that will result in expenditures by State governments of $100 million or more (adjusted annually for inflation since 1995).

    Executive Order 13132

    SBA has determined that this proposed rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

    Executive Order 13771

    This proposed rule is expected to be an Executive Order 13771 regulatory action. Details on the estimated costs of this proposed rule can be found in the rule's economic analysis.

    Paperwork Reduction Act, 44 U.S.C. Ch. 35

    Small businesses, such as 8(a) BD Program Participants, HUBZone SBCs, WOSBs, Economically Disadvantaged Women-Owned (EDWOSBCs, and SDVO SBCs, are eligible to receive set-aside or sole source contracts. 15 U.S.C. 631(a), 637(a), (m), 644(a), (j), 657a, 657f. As a condition of these preferences, and to help ensure that small businesses actually perform a certain percentage of the work on a contract, the recipients of set-aside or sole source contracts are limited in their ability to subcontract to other-than-small business concerns by the limitations on subcontracting (LOS) clauses in the particular contract. See, 48 CFR 52.219-3, 52.219-4, 52.219-7, 52.219-14, 52.219-18, 52.219-27, 52.219-29, 52.219-30. Contracting officers are responsible for ensuring contractor compliance with the terms of a contract (FAR 1.602-2). The SBA proposed rule will provide express authority for contracting officers to request information on contractor's compliance with the LOS. Therefore, SBA will seek PRA review and approval from the Office of Management and Budget (OMB) to cover contracting officers' requests for information from small businesses regarding their LOS compliance.

    A summary description of the reporting requirement, description of respondents, and estimate of the annual burden is described below. Included in the estimate is the time for reviewing requirements, gathering and maintaining the data needed, and submitting the report to the contracting officer.

    Title: Compliance with the Limitations on Subcontracting.

    OMB Control Number: (To be determined; new collection).

    Summary Description of Compliance Information: In order to show that it is in compliance with the limitations on subcontracting terms that are included in its set-aside or sole source contract, a small business concern may be required to submit certain information to the contracting officer. The specific information relevant to a particular contract will be identified by the contracting officer but could include, where applicable, identification of subcontractor, dollar amount of subcontract, and costs to be excluded from the LOS calculation (e.g., for contracts for supplies, materials).

    Description of and Estimated Number of Respondents: Small business concerns that are awarded set-aside or sole source contracts. Based on FPDS data, SBA estimates that approximately 56,000 concerns receive approximately 180,000 small business sole source or set-aside awards in a fiscal year and that no more than ten percent (5,600) of concerns will be asked to provide information on compliance with the limitations on subcontracting for no more than ten percent (18,000) of the awards that have been received.

    Estimated Annual Responses: 18,000.

    Estimated Response Time per Respondent: 1 hour.

    Total Estimated Annual Hour Burden: 18,000.

    Estimated costs based on officer's salary: $33.34/hour (based on median pay for accountants and auditors, Bureau of Labor Statistics).

    Total estimated hour annual cost burden: 18,000 hours × $33.34/hour = $600,120.

    SBA will submit this new information collection (reporting requirement) to the Office of Management and Budget (OMB) for review, and invites the public to comment on: (1) Whether the reporting requirement is necessary for the proper performance of SBA programs, including whether the information will have a practical utility; (2) the accuracy of SBA's estimate of the burden for the reporting requirement; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden imposed as a result of the reporting requirement on the respondents, including the use of automated collection techniques, when appropriate, and other forms of information technology.

    Comments must be received by the deadline stated in the DATES section of this rule. Refer to the ADDRESS section for instructions on how and where to submit comments.

    Regulatory Flexibility Act, 5 U.S.C. 601-612

    Under the Regulatory Flexibility Act (RFA), this proposed rule may have a significant impact on a substantial number of small businesses. Immediately below, SBA sets forth an initial regulatory flexibility analysis (IRFA) addressing the impact of the proposed rule in accordance with section 603, Title 5, of the United States Code. The IRFA examines the objectives and legal basis for this proposed rule; the kind and number of small entities that may be affected; the projected recordkeeping, reporting, and other requirements; whether there are any Federal rules that may duplicate, overlap, or conflict with this proposed rule; and whether there are any significant alternatives to this proposed rule.

    1. What are the need for and objective of the rule?

    The proposed rule implements section 863 of the National Defense Authorization Act of 2016, Public Law 114-92, 129 Stat. 726 (15 U.S.C. 644(e)(3)); section 2108 of the Recovery Improvements for Small Entities After Disaster Act of 2015 (RISE Act), Public Law 114-88, 129 Stat. 686 (15 U.S.C. 644(f)); and sections 1811 and 1821 of the National Defense Authorization Act of 2017, Public Law 114-328, 130 Stat. 2000 (15 U.S.C. 637(d), 644(l)). In addition, the proposed rule makes several other changes needed to clarify ambiguities in or remedy perceived problems with the current regulations. These proposed changes should make SBA's regulations easier to use and understand. The proposed rule will make it easier for agencies to award set aside contracts to SBCs. Failure to promulgate this rule could result in a loss of set aside opportunities for SBCs.

    The proposed change to § 121.404 clarifies when size for a government contract is determined, which will reduce confusion for small business concerns. The proposed change to § 121.406 clarifies that the size standard for information technology value added resellers is 150 employees, again to eliminate confusion among small business concerns. The proposed changes to § 125.2(a) will benefit small business by clarifying that a contracting officer can award a contract to a small business under a set aside if only one offer is received. The proposed changes to § 125.2(b) implement section 1811 of the NDAA 2017, and govern what acquisitions PCRs can review and would not impact small business concerns. The proposed changes to § 125.2(d) implement section 863 of the NDAA of 2016 and direct contracting officers on how to notify the public about consolidation and substantial bundling, and will not impact small business concerns. The proposed changes to § 125.2(e) authorize agencies to set aside orders for socioeconomic programs where the contract was set aside for small business, and will benefit firms that qualify for those set asides. The proposed changes to § 125.3 implement section 1821 of the NDAA of 2017 by providing examples of a failure to make a good faith effort to comply with small business subcontracting plans, and will benefit small businesses by providing such examples so that contracting officers can hold other than small prime contractors accountable for failing to make a good faith effort to comply with their small business subcontracting plan. The proposed changes to § 125.3 also implement section 1821 by providing that the contracting officer should evaluate whether an other than small business complied with the requirement to report on small business subcontracting plan performance. The proposed changes to § 125.6(a) will benefit small business concerns by allowing small businesses to exclude certain costs from the calculation of the limitations on subcontracting. Without these changes, some agencies will not be able to set contracts aside for small business, because certain costs attributable to other than small concerns are too high. The proposed changes to § 125.6 also help small businesses by clarifying the difference between an employee and an independent contractor. The proposed changes to § 125.6 will impose some information production requirements on small business concerns, but only to the extent the information is not already in the possession of the government. Further, this information is readily available since it pertains to contract performance and subcontracting of that performance. These reports are not mandatory, as the contracting officer simply has the discretion to request such reports. Contracting officers already have the authority to request information demonstrating performance, and this proposed change simply clarifies that the authority exists. Finally, the benefits to small business concerns of this proposed rule substantially outweigh any minor costs imposed by the reporting authority. The proposed addition of part 129 implements section 2108 of the RISE Act and benefits small businesses by providing agencies with an incentive to set aside contracts for small business concerns located in a disaster area.

    With respect to the limitation on subcontracting to an ineligible small business under a socioeconomic set aside (proposed 13 CFR 124.507(b)(2)(vi), 125.29(c), 126.601(i), and 127.504(c)), the rule will impact very few firms. The vast majority of small business prime contractors self-perform the required percentage of work, or will subcontract to a similarly situated entity, as is allowed under FAR 52.219-3 (Notice of HUBZone Set-Aside or Sole Source Award), 52-219-27 (Notice of Service-Disabled Veteran-Owned Small Business Set-Aside), and as will be allowed when SBA's rules on similarly situated entities (13 CFR 125.6) are implemented in the FAR. The benefits that will flow to the intended beneficiaries of a socio-economic set-aside far outweigh any impact on firms that have no intention of performing the contract or are not eligible to bid on that contract.

    2. What are SBA's description and estimate of the number of small entities to which the rule will apply?

    If the proposed rule is adopted in its present form, the rule would be applicable to all small business concerns participating in the Federal procurement market that seek to perform government prime contracts or to perform subcontracts awarded by other than small concerns. SBA estimates that there are approximately 320,000 firms identified as small business concerns in the Dynamic Small Business Search database.

    3. What are the projected reporting, recordkeeping, and other compliance requirements of the rule and an estimate of the classes of small entities which will be subject to the requirements?

    The proposed rule does not impose new recordkeeping requirements. Contractors already keep records on contract performance and subcontracting. Information may be required, but only to the extent the information is not available through invoices or existing progress reports. The proposed rule would clarify that contracting officers may request access to information in connection with a contractor's compliance with applicable limitations on subcontracting clauses. Approximately 56,000 firms received sole source or set aside awards in FY 2016. SBA is clarifying that a contracting officer may request information to assure compliance with the LOS clause, and in some cases this information may not be necessary based on the nature of the contract and the invoices submitted. We estimate that less than ten percent of contracts would be subject to a request to provide this information (18,000), and compliance should take less than an hour for each of those contracts. Accounting or contract management personnel should be able to determine whether the firm issued any subcontracts in connection with the prime contract. We estimate the SBA rule will be finalized in FY 2019. We estimate an overall annual cost of approximately $600,120.

    4. What are the relevant Federal rules which may duplicate, overlap or conflict with the rule?

    We are not aware of any rules that duplicate, overlap or conflict with this rule. The FAR will have to be amended to implement portions of this rule. That will be done through a separate rulemaking.

    5. What alternatives will allow the Agency to accomplish its regulatory objectives while minimizing the impact on small entities?

    Many of the proposed changes are required to implement statute, and impose requirements on contracting personnel, agencies or other than small concerns, and do not impact small business concerns. Further, many of the proposed changes will benefit small business concerns by clarifying areas where there is confusion and by making it easier for agencies to set aside contracts and orders for small business and small socioeconomic concerns. As an alternative, SBA considered whether prime contractors should be required to provide information on compliance with the LOS on all set aside or sole source contracts. However, that may unnecessarily burden small businesses, if compliance is already readily apparent to the contracting officer based on the type of contract, invoicing, or observation.

    List of Subjects 13 CFR Part 121

    Government procurement; Government property; Grant programs—business, Individuals with disabilities; Loan programs—business; Small businesses.

    13 CFR Part 124

    Administrative practice and procedure, Government procurement, Government property, Small businesses.

    13 CFR Part 125

    Government contracts, Government procurement, Reporting and recordkeeping requirements, Small businesses, Technical assistance.

    13 CFR Part 126

    Administrative practice and procedure, Government procurement, Reporting and recordkeeping requirements, Small businesses.

    13 CFR Part 127

    Government contracts, Reporting and recordkeeping requirements, Small businesses.

    13 CFR Part 129

    Administrative practice and procedure, Government contracts, Government procurement, Small businesses.

    Accordingly, for the reasons stated in the preamble, SBA proposes to amend 13 CFR parts 121, 124, 125, 126, and 127 and to add 13 CFR part 129 as follows:

    PART 121—SMALL BUSINESS SIZE REGULATIONS 1. The authority citation for part 121 continues to read as follows: Authority:

    15 U.S.C. 632, 634(b)(6), 662, and 694a(9).

    2. Amend § 121.103 by revising the first sentence of paragraph (h)(4) to read as follows:
    § 121.103 How does SBA determine affiliation?

    (h) * * *

    (4) A contractor and its ostensible subcontractor are treated as joint venturers for size determination purposes. * * *

    3. Amend § 121.404 by revising paragraph (a) introductory text, adding paragraph (a)(1)(iv), and revising paragraph (g)(5) to read as follows:
    § 121.404 When is the size status of a business concern determined?

    (a) SBA determines the size status of a concern, including its affiliates, as of the date the concern submits a written self-certification that it is small to the procuring activity as part of its initial offer or response which includes price.

    (1) * * *

    (iv) For an indefinite delivery, indefinite quantity (IDIQ), Multiple Award Contract, where concerns are not required to submit price as part of the offer for the IDIQ contract, size will be determined as of the date of initial offer, which may not include price.

    (g) * * *

    (5) If during contract performance a subcontractor that is not a similarly situated entity performs primary and vital requirements of a contract, the contractor and its ostensible subcontractor will be treated as joint venturers. See § 121.103(h)(4).

    4. Amend § 121.406 by: a. Revising paragraph (b)(1)(i); b. Removing paragraph (c); and c. Redesignating paragraphs (d) through (f) as paragraphs (c) through (e) respectively.

    The revision to read as follows:

    § 121.406 How does a small business concern qualify to provide manufactured products or other supply items under a small business set-aside, service-disabled veteran-owned small business, HUBZone, WOSB or EDWOSB, or 8(a) contract?

    (b) * * *

    (1) * * *

    (i) Does not exceed 500 employees (or 150 employees for the Information Technology Value Added Reseller exception to NAICS Code 541519, which is found at § 121.201, footnote 18);

    PART 124—8(a) BUSINESS DEVELOPMENT/SMALL DISADVANTAGED BUSINESS STATUS DETERMINATIONS 5. The authority citation for part 124 continues to read as follows: Authority:

    15 U.S.C. 634(b)(6), 636(j), 637(a), 637(d), 644 and Pub. L. 99-661, Pub. L. 100-656, sec. 1207, Pub. L. 101-37, Pub. L. 101-574, section 8021, Pub. L. 108-87, and 42 U.S.C. 9815.

    6. Amend § 124.503 by revising paragraphs (c)(1)(iii) and (iv) and adding paragraph (c)(1)(v) to read as follows:
    § 124.503 How does SBA accept a procurement for award through the 8(a) BD program?

    (c) * * *

    (1) * * *

    (iii) The Participant is small for the size standard corresponding to the NAICS code assigned to the requirement by the procuring activity contracting officer;

    (iv) The Participant has submitted required financial statements to SBA; and

    (v) The Participant is performing the primary and vital requirements of the service contract, or of an order, and is not unusually reliant on a subcontractor that is not similarly situated, as that term is defined at § 125.1.

    7. In § 124.507, add paragraph (b)(2)(vi) to read as follows:
    § 124.507 What procedures apply to competitive 8(a) procurements?

    (b) * * *

    (2) * * *

    (vi) Performing the primary and vital requirements of the service contract, or of an order, or is unusually reliant on a subcontractor that is not a similarly situated entity, as that term is defined at § 125.1.

    8. In § 124.521, add paragraph (e) to read as follows:
    § 124.521 What are the requirements for representing 8(a) status, and what are the penalties for misrepresentation?

    (e) Recertification. (1) Generally, a concern that represents itself and qualifies as an 8(a) Participant at the time of initial offer (or other formal response to a solicitation), which includes price, including a Multiple Award Contract, is considered an 8(a) Participant throughout the life of that contract. For an indefinite delivery, indefinite quantity (IDIQ), Multiple Award Contract, where concerns are not required to submit price as part of the offer for the contract, a concern that represents itself and qualifies as an 8(a) Participant at the time of initial offer, which may not include price, is considered an 8(a) Participant throughout the life of that contract. This means that if an 8(a) Participant is qualified at the time of initial offer for a Multiple Award Contract, then it will be considered an 8(a) Participant for each order issued against the contract, unless a contracting officer requests a new 8(a) certification in connection with a specific order. Where a concern later fails to qualify as an 8(a) Participant, the procuring agency may exercise options and still count the award as an award to an SDB. However, the following exceptions apply:

    (i) Where an 8(a) contract is novated to another business concern, or where the concern performing the 8(a) contract is acquired by, acquires, or merges with another concern and contract novation is not required, the concern must comply with the process outlined at §§ 124.105(i) and 124.515.

    (ii) Where an 8(a) Participant receives a non-8(a) contract that is novated to another business concern, the concern that will continue performance on the contract must certify its status as an 8(a) Participant to the procuring agency, or inform the procuring agency that it does not qualify as an 8(a) Participant, within 30 days of the novation approval. If the concern is not an 8(a) Participant, the agency can no longer count the options or orders issued pursuant to the contract, from that point forward, towards its SDB goals.

    (iii) Where an 8(a) Participant receives a non-8(a) contract, and that Participant acquires, is acquired by, or merges with another concern and contract novation is not required, the concern must, within 30 days of the transaction becoming final, recertify its 8(a) status to the procuring agency, or inform the procuring agency that it no longer qualifies as an 8(a) Participant. If the contractor is not an 8(a) Participant, the agency can no longer count the options or orders issued pursuant to the contract, from that point forward, towards its SDB goals. The agency and the contractor must immediately revise all applicable Federal contract databases to reflect the new status.

    (2) For the purposes of contracts (including Multiple Award Contracts) with durations of more than five years (including options), a contracting officer must request that a business concern recertify its 8(a) status no more than 120 days prior to the end of the fifth year of the contract, and no more than 120 days prior to exercising any option. Where a concern fails to recertify its 8(a) status during the 120 days prior to the end of the fifth year of the contract, the option shall not be exercised.

    (3) Recertification does not change the terms and conditions of the contract. The limitations on subcontracting, nonmanufacturer and subcontracting plan requirements in effect at the time of contract award remain in effect throughout the life of the contract.

    (4) Where the contracting officer explicitly requires concerns to recertify their status in response to a solicitation for an order, SBA will determine eligibility as of the date the concern submits its self-representation as part of its response to the solicitation for the order.

    (5) A concern's status may be determined at the time of a response to a solicitation for an basic ordering agreement (BOA), basic agreement (BA), or blanket purchase agreement (BPA) and each order issued pursuant to the BPA, BOA, or BA.

    9. In § 124.1015, add paragraph (f) to read as follows:
    § 124.1015 What are the requirements for representing SDB status, and what are the penalties for misrepresentation?

    (f) Recertification. (1) Generally, a concern that represents itself and qualifies as an SDB at the time of initial offer (or other formal response to a solicitation), which includes price, including a Multiple Award Contract, is considered an SDB throughout the life of that contract. For an indefinite delivery indefinite quantity (IDIQ), Multiple Award Contract, where concerns are not required to submit price as part of their offer for the contract, a concern that represents itself and qualifies as an SDB at the time of initial offer, which may not include price, is considered an SDB throughout the life of that contract. This means that if an SDB is qualified at the time of initial offer for a Multiple Award Contract, then it will be considered an SDB for each order issued against the contract, unless a contracting officer requests a new SDB certification in connection with a specific order. Where a concern later fails to qualify as an SDB, the procuring agency may exercise options and still count the award as an award to an SDB. However, the following exceptions apply:

    (i) Where a contract is novated to another business concern, the concern that will continue performance on the contract must certify its status as an SDB to the procuring agency, or inform the procuring agency that it does not qualify as an SDB, within 30 days of the novation approval. If the concern is not an SDB, the agency can no longer count the options or orders issued pursuant to the contract, from that point forward, towards its SDB goals.

    (ii) Where a concern that is performing a contract acquires, is acquired by, or merges with another concern and contract novation is not required, the concern must, within 30 days of the transaction becoming final, recertify its SDB status to the procuring agency, or inform the procuring agency that it no longer qualifies as an SDB. If the contractor is not an SDB, the agency can no longer count the options or orders issued pursuant to the contract, from that point forward, towards its SDB goals. The agency and the contractor must immediately revise all applicable Federal contract databases to reflect the new status.

    (2) For the purposes of contracts (including Multiple Award Contracts) with durations of more than five years (including options), a contracting officer must request that a business concern recertify its SDB status no more than 120 days prior to the end of the fifth year of the contract, and no more than 120 days prior to exercising any option.

    (3) A business concern that did not certify itself as an SDB, either initially or prior to an option being exercised, may recertify itself as an SDB for a subsequent option period if it meets the eligibility requirements at that time.

    (4) Recertification does not change the terms and conditions of the contract. The limitations on subcontracting, nonmanufacturer and subcontracting plan requirements in effect at the time of contract award remain in effect throughout the life of the contract.

    (5) Where the contracting officer explicitly requires concerns to recertify their status in response to a solicitation for an order, SBA will determine eligibility as of the date the concern submits its self-representation as part of its response to the solicitation for the order.

    (6) A concern's status may be determined at the time of a response to a solicitation for an Agreement and each order issued pursuant to the Agreement.

    PART 125—GOVERNMENT CONTRACTING PROGRAMS 9. The authority citation for part 125 is revised to read as follows: Authority:

    15 U.S.C. 632(p), (q); 634(b)(6); 637; 644; 657f; 657r.

    10. Amend § 125.2 by: a. Revising paragraph (a); b. In paragraph (b)(1)(i)(A): i. Revising the second sentence; and ii. Adding a sentence at the end of the paragraph; c. Adding paragraph (d)(1)(v); d. Redesignating paragraph (d)(7) as paragraph (d)(8); e. Adding new paragraph (d)(7); and f. Revising paragraph (e)(6).

    The revisions and additions to read as follows:

    § 125.2 What are SBA's and the procuring agency's responsibilities when providing contracting assistance to small businesses?

    (a)(1) The objective of the SBA's contracting programs is to assist small business concerns, including 8(a) BD Participants, HUBZone small business concerns, Service Disabled Veteran-Owned Small Business Concerns, Women-Owned Small Businesses and Economically Disadvantaged Women-Owned Small Businesses, in obtaining a fair share of Federal Government prime contracts, subcontracts, orders, and property sales. Therefore, these regulations apply to all types of Federal Government contracts, including Multiple Award Contracts, and contracts for architectural and engineering services, research, development, test and evaluation. Small business concerns must receive any award (including orders, and orders placed against Multiple Award Contracts) or contract, part of any such award or contract, any contract for the sale of Government property, or any contract resulting from a reverse auction, regardless of the place of performance, which SBA and the procuring or disposal agency determine to be in the interest of:

    (i) Maintaining or mobilizing the Nation's full productive capacity;

    (ii) War or national defense programs;

    (iii) Assuring that a fair proportion of the total purchases and contracts for property, services and construction for the Government in each industry category are placed with small business concerns; or

    (iv) Assuring that a fair proportion of the total sales of Government property is made to small business concerns.

    (2) If the contracting officer receives only one acceptable offer from a responsible small business concern in response to any small or socioeconomic set-aside, the contracting officer should make an award to that firm.

    (b) * * *

    (1) * * *

    (i) * * * (A) * * * At the SBA's discretion, PCRs may review any acquisition to determine whether a set aside or sole source award to a small business under one of SBA's programs is appropriate and to identify alternative strategies to maximize the participation of small businesses in the procurement. * * * Unless the contracting agency requests a review, PCRs will not review an acquisition by or on behalf of the Department of Defense if the acquisition is conducted for a foreign government pursuant to section 22 of the Arms Control Export Act (22 U.S.C. 2762), is a humanitarian operation as defined in 10 U.S.C. 401(e), is for a contingency operation as defined in 10 U.S.C. 101(a)(13), is to be awarded pursuant to an agreement with the government of a foreign country in which Armed Forces of the United States are deployed, or where both the place of award and place of performance are entirely outside of the United States and its territories.

    (d) * * *

    (1) * * *

    (v) Not later than 7 days after making a determination that an acquisition strategy involving a consolidation of contract requirements is necessary and justified under subparagraph (d)(1)(i) of this section, the Senior Procurement Executive (SPE) or Chief Acquisition Officer (CAO), or designee, shall publish a notice on the agency's website that such determination has been made. Any solicitation for a procurement related to the acquisition strategy shall not be issued earlier than 7 days after such notice is published. Along with the publication of the solicitation, the SPE or CAO (or designee) must publish in the Government-wide Point of Entry (GPE) the justification for the determination, which shall include the information in paragraphs (d)(1)(i)(A) through (E) of this section.

    (7) Notification to Public of Rationale for Substantial Bundling. If the head of a contracting agency determines that an acquisition plan for a procurement involves a substantial bundling of contract requirements, the head of a contracting agency shall publish a notice on the agency's website that such determination has been made not later than 7 days after making such determination. Any solicitation for a procurement related to the acquisition plan may not be published earlier than 7 days after such notice is published. Along with the publication of the solicitation, the head of a contracting agency shall publish in the GPE a justification for the determination, which shall include the following information:

    (i) The specific benefits anticipated to be derived from the bundling of contract requirements and a determination that such benefits justify the bundling.

    (ii) An identification of any alternative contracting approaches that would involve a lesser degree of bundling of contract requirements.

    (iii) An assessment of—the specific impediments to participation by small business concerns as prime contractors that result from the bundling of contract requirements; and

    (iv) The specific actions designed to maximize participation of small business concerns as subcontractors (including suppliers) at various tiers under the contract or contracts that are awarded to meet the requirements.

    (e) * * *

    (6) * * *

    (i) Notwithstanding the fair opportunity requirements set forth in 10 U.S.C. 2304c and 41 U.S.C. 253j, the contracting officer has the authority to set aside orders against Multiple Award Contracts, including contracts that were set aside for small business. This includes order set asides for 8(a) Participants, HUBZone SBCs, SDVO SBCs and WOSBs.

    11. Amend § 125.3 by: a. Revising the last sentence of paragraph (c)(1)(iv); b. Revising paragraph (d)(3); c. Adding paragraph (d)(11); and d. Revising the first sentence of paragraph (f)(3).

    The revisions and addition to read as follows:

    § 125.3 What types of subcontracting assistance are available to small businesses?

    (c) * * *

    (1) * * *

    (iv) * * * A contractor authorized to use a commercial subcontracting plan must include all indirect costs in its subcontracting goals and in its SSR;

    (d) * * *

    (3) Evaluating whether the prime contractor made a good faith effort to comply with its small business subcontracting plan.

    (i) Evidence that a large business prime contractor has made a good faith effort to comply with its subcontracting plan or other subcontracting responsibilities includes supporting documentation that:

    (A) The contractor performed one or more of the actions described in paragraph (b) of this section, as appropriate for the procurement;

    (B) Although the contractor may have failed to achieve its goal in one socioeconomic category, it over-achieved its goal by an equal or greater amount in one or more of the other categories; or

    (C) The contractor fulfilled all of the requirements of its subcontracting plan.

    (ii) Examples of activities reflective of a failure to make a good faith effort to comply with a subcontracting plan include, but are not limited, to:

    (A) Failure to submit the acceptable individual or summary subcontracting reports in eSRS by the report due dates or as provided by other agency regulations within prescribed time frames;

    (B) Failure to pay small business concern subcontractors in accordance with the terms of the contract with the prime;

    (C) Failure to designate and maintain a company official to administer the subcontracting program and monitor and enforce compliance with the plan;

    (D) Failure to maintain records or otherwise demonstrate procedures adopted to comply with the plan including subcontracting flow-down requirements;

    (E) Adoption of company policies or documented procedures that have as their objectives the frustration of the objectives of the plan;

    (F) Failure to correct substantiated findings from federal subcontracting compliance reviews or participate in subcontracting plan management training offered by the government;

    (G) Failure to conduct market research identifying potential small business concern subcontractors through all reasonable means including outreach, industry days, or the use of federal database marketing systems such as SBA's Dynamic Small Business Search (DSBS) or SUBNet Systems or any successor federal systems;

    (H) Failure to comply with regulations requiring approval by the contracting officer to change small business concern subcontractors that were used in preparing offers; or

    (I) Falsifying records of subcontracting awards to SBCs.

    (11) Evaluating whether the contractor or subcontractor complied in good faith with the requirement to provide periodic reports and cooperate in any studies or surveys as may be required by the Federal agency or the Administration in order to determine the extent of compliance by the contractor or subcontractor with the subcontracting plan. Failure to make a good faith effort shall be a material breach of such contract or subcontract and may be considered in any past performance evaluation of the contractor.

    (f) * * *

    (3) Upon completion of the review and evaluation of a contractor's performance and efforts to achieve the requirements in its subcontracting plans, the contractor's performance will be assigned one of the following ratings: Exceptional, Very Good, Satisfactory, Marginal or Unsatisfactory. * * *

    12. Amend § 125.6 by: a. Adding two sentences at the end of paragraph (a)(1); b. Adding a sentence at the end of paragraph (c); c. Revising paragraph (e)(3); and d. Adding paragraph (e)(4).

    The revision and additions to read as follows:

    § 125.6 What are the prime contractor's limitations on subcontracting?

    (a) * * *

    (1) * * * Other direct costs may be excluded to the extent they are not the principal purpose of the acquisition and small business concerns do not provide the service, such as airline travel, work performed by a transportation or disposal entity under a contract assigned the environmental remediation NAICS code (562910), cloud computing services, or mass media purchases. In addition, work performed by an independent contractor under a contract that was awarded pursuant to the Foreign Assistance Act of 1961 may also be excluded.

    (c) * * * A prime contractor may no longer count a similarly situated entity towards compliance with the limitations on subcontracting where the subcontractor ceases to qualify as small or under the relevant socioeconomic status.

    (e) * * *

    (3)(i) For contracts assigned a NAICS code with an employee-based size standard, where an independent contractor is not otherwise treated as an employee of the concern for which he/she is performing work for size purposes under § 121.106(a) of this chapter, work performed by the independent contractor shall be considered a subcontract. Such work will count toward meeting the applicable limitation on subcontracting where the independent contractor qualifies as a similarly situated entity.

    (ii) For contracts assigned a NAICS code with a revenue-based size standard, work performed by an independent contractor shall be considered a subcontract, and will count toward meeting the applicable limitation on subcontracting where the independent contractor qualifies as a similarly situated entity. A firm's treatment and reporting of an individual for tax purposes governs whether that individual should be treated as an employee or independent contractor for limitations on subcontracting purposes.

    (4) The contracting officer may require the contractor to demonstrate its compliance with the limitations on subcontracting, if the information regarding such compliance is not already available to the contracting officer (e.g., invoices).

    13. Amend § 125.18 by: a. In paragraph (e)(1)(i), removing the phrase “an SDVO contract” and adding in its place the phrase “a contract”; b. In paragraph (e)(1)(ii), removing the phrase “an SDVO SBC contract” and adding in its place the phrase “a contract”; and c. Adding paragraph (f).

    The addition to read as follows:

    § 125.18 What requirements must an SDVO SBC meet to submit an offer on a contract?

    (f) Ostensible subcontractor. Where a subcontractor that is not similarly situated performs primary and vital requirements of a set aside or sole source service contract or order, or where a prime contractor is unduly reliant on a small business that is not similarly situated to perform the set aside service or sole source contract or order, the prime contractor is not eligible for award of an SDVO contract. When the subcontractor is small for the size standard assigned to the procurement, this issue may be grounds for an SDVO status protest, as described in subpart D of this part. When the subcontractor is other than small, or alleged to be other than small for the size standard assigned to the procurement, this issue may be grounds for a size protest subject to the ostensible subcontractor rule, as described at § 121.103(h)(4) of this chapter.

    14. In § 125.29, add paragraph (c) to read as follows:
    § 125.29 What are the grounds for filing an SDVO SBC protest?

    (c) Ostensible subcontractor. In cases where the prime contractor appears unduly reliant on a small, non-similarly situated entity subcontractor or where the small non-similarly situated entity is performing the primary and vital requirements of the contract, the Director, Office of Government Contracting will consider a protest only if the protester presents credible evidence of the alleged undue reliance or credible evidence that the primary and vital requirements will be performed by the subcontractor.

    PART 126—HUBZONE PROGRAM 15. The authority citation for part 126 is revised to read as follows: Authority:

    15 U.S.C. 632(a), 632(j), 632(p), 644 and 657a; Pub. L. 111-240, 24 Stat. 2504.

    16. Amend § 126.601 by: a. In paragraph (h)(1)(i), removing the phrase “HUBZone contract (or a HUBZone contract awarded through full and open competition based on the HUBZone price evaluation preference” and adding in its place the word “contract”; b. In paragraph (h)(1)(ii), removing the phrase “HUBZone contract” and adding in its place the word “contract”; and c. Adding paragraph (i).

    The addition to read as follows:

    § 126.601 What additional requirements must a qualified HUBZone SBC meet to bid on a contract?

    (i) Ostensible subcontractor. Where a subcontractor that is not similarly situated performs primary and vital requirements of a set aside service contract, or where a prime contractor is unduly reliant on a small business that is not similarly situated to perform the set aside service contract, the prime contractor is not eligible for award of a HUBZone contract. When the subcontractor is small for the size standard assigned to the procurement, this issue may be grounds for a HUBZone status protest, as described in subpart H of this part. When the subcontractor is alleged to be other than small for the size standard assigned to the procurement, this issue may be grounds for a size protest under the ostensible subcontractor rule, as described at § 121.103(h)(4) of this chapter.

    17. Amend § 126.801 by adding in paragraph (a) a sentence after the third sentence to read as follows:
    § 126.801 How does one file a HUBZone status protest?

    (a) * * * SBA will also consider a protest challenging whether a HUBZone prime contractor is unduly reliant on a small, non-similarly situated entity subcontractor or if such subcontractor performs the primary and vital requirements of the contract. * * *

    PART 127—WOMEN-OWNED SMALL BUSINESS FEDERAL CONTRACT PROGRAM 18. The authority citation for part 127 continues to read as follows: Authority:

    15 U.S.C. 632, 634(b)(6), 637(m), 644 and 657r.

    § 127.503 [Amended]
    19. In § 127.503, amend paragraphs (h)(1)(i) and (ii) by removing the phrase “WOSB/EDWOSB contract” wherever it appears and adding in its place the word “contract”. 20. In § 127.504, add paragraph (c) to read as follows:
    § 127.504 What additional requirements must a concern satisfy to submit an offer on an EDWOSB or WOSB requirement?

    (c) Where a subcontractor that is not similarly situated performs primary and vital requirements of a set aside service contract, or where a prime contractor is unduly reliant on a small business that is not similarly situated to perform the set aside service contract, the prime contractor is not eligible for award of a WOSB or EDWOSB contract. When the subcontractor is small for the size standard assigned to the procurement, this issue may be grounds for a WOSB or EDWOSB status protest, as described in subpart F of this part. When the subcontractor is other than small, or alleged to be other than small, for the size standard assigned to the procurement, this issue may be a ground for a size protest, as described at § 121.103(h)(4) of this chapter.

    21. Amend § 127.602 by revising the second sentence and adding a new third sentence to read as follows:
    § 127.602 What are the grounds for filing an EDWOSB or WOSB status protest?

    * * * SBA will also consider a protest challenging the status of a concern as an EDWOSB or WOSB if the contracting officer has protested because the WOSB or EDWOSB apparent successful offeror has failed to provide all of the required documents, as set forth in § 127.300. In addition, when sufficient credible evidence is presented, SBA will consider a protest challenging whether the prime contractor is unusually reliant on a small, non-similarly situated entity subcontractor, as defined in § 125.1 of this chapter, or a protest alleging that such subcontractor is performing the primary and vital requirements of a set aside or sole source WOSB or EDWOSB contract.

    22. Add part 129 to read as follows: PART 129—CONTRACTS FOR SMALL BUSINESSES LOCATED IN DISASTER AREAS Sec. 129.100 What definitions are important in this part? 129.200 What contracting preferences are available for small business concerns located in disaster areas? 129.300 What small business goaling credit do agencies receive for awarding a contract to a small business concern under this part? 129.400 What are the applicable performance requirements? 129.500 What are the penalties of misrepresentation of size or status? Authority:

    15 U.S.C. 636(j)(13)(F)(ii), 644(f).

    § 129.100 What definitions are important in this part?

    For the purposes of this part:

    Concern located in a disaster area is a firm that during the last twelve months—

    (1)(i) Had its main operating office in the area; and

    (ii) That office generated at least half of the firm's gross revenues and employed at least half of the offeror's permanent employees.

    (2) If the firm does not meet the criteria in paragraph (1) of this definition, factors to be considered in determining whether a firm resides or primarily does business in the disaster area include—

    (i) Physical location(s) of the firm's permanent office(s) and date any office in the disaster area(s) was established;

    (ii) Current state licenses;

    (iii) Record of past work in the disaster area(s) (e.g., how much and for how long);

    (iv) Contractual history the firm has had with subcontractors and/or suppliers in the disaster area;

    (v) Percentage of the firm's gross revenues attributable to work performed in the disaster area;

    (vi) Number of permanent employees the firm employs in the disaster area;

    (vii) Membership in local and state organizations in the disaster area; and

    (viii) Other evidence that establishes the firm resides or primarily does business in the disaster area. For example, sole proprietorships may submit utility bills and bank statements.

    Disaster area means the area for which the President has declared a major disaster under section 401 of the Robert T. Stafford Disaster Relief and Assistance Act (42 U.S.C. 5170), during the period of the declaration.

    Emergency response contract means a contract with private entities that supports assistance activities in a disaster area, such as debris cleanup, distribution of supplies, or reconstruction.

    § 129.200 What contracting preferences are available for small business concerns located in disaster areas?

    Contracting officers may set aside solicitations for emergency response contracts to allow only small businesses located in the disaster area to compete.

    § 129.300 What small business goaling credit do agencies receive for awarding an emergency response contract to a small business concern under this part?

    If an agency awards an emergency response contract to a local small business concern through the use of a local area set aside that is also set aside under a small business or socioeconomic set-aside (8(a), HUBZone, SDVO, WOSB, EDWOSB), the value of the contract shall be doubled for purposes of determining compliance with the goals for procurement contracts under section 15(g)(1)(A) of the Small Business Act (15 U.S.C. 644(g)(1)(A)). The procuring agency shall enter the actual contract value, not the doubled contract value in the required contract reporting systems, and appropriately code the contract action to receive the credit. SBA will provide the double credit as part of the Scorecard process.

    § 129.400 What are the applicable performance requirements?

    The performance requirements of § 125.6 of this chapter apply to small and socioeconomic set asides under this part. A similarly situated entity as that term is used in § 125.6 of this chapter must qualify as a concern located in a disaster area.

    § 129.500 What are the penalties of misrepresentation of size or status?

    The penalties relevant to the particular size or socioeconomic status representation under title 13 §§ 121.108, 125.32, 126.900, and 127.700 of this chapter are applicable to set asides under this part.

    Dated: November 8, 2018. Linda E. McMahon, Administrator.
    [FR Doc. 2018-25705 Filed 12-3-18; 8:45 am] BILLING CODE 8025-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2018-0676; FRL-9986-65-Region 6] Air Plan Approval; Texas; Emission Statements AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is proposing to approve a portion of a State Implementation Plan (SIP) revision submitted by the State of Texas for the 2008 8-hour ozone national ambient air quality standards (NAAQS). The portion of the SIP revision being approved pertains to CAA 2008 ozone NAAQS requirement for emission statements in the Dallas/Fort Worth ozone nonattainment area (DFW area).

    DATES:

    Written comments should be received on or before January 3, 2019.

    ADDRESSES:

    Submit your comments, identified by EPA-R06-OAR-2018-0676, at https://www.regulations.gov or via email to [email protected] For additional information on how to submit comments see the detailed instructions in the ADDRESSES section of the direct final rule located in the rules section of this Federal Register.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Karolina Ruan Lei, 214-665-7346, [email protected]

    SUPPLEMENTARY INFORMATION:

    In the final rules section of this Federal Register, the EPA is approving the State's SIP submittal as a direct rule without prior proposal because the Agency views this as noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no relevant adverse comments are received in response to this action no further activity is contemplated. If the EPA receives relevant adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. The EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

    For additional information, see the direct final rule which is located in the rules section of this Federal Register.

    Dated: November 26, 2018. Anne Idsal, Regional Administrator, Region 6.
    [FR Doc. 2018-26297 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R01-OAR-2018-0771; FRL-9987-00-Region 1] Air Plan Approval; Massachusetts; Air Emissions Inventory, Emissions Statements, Source Registration, and Emergency Episode Planning Provisions AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve State Implementation Plan (SIP) revisions submitted by the Commonwealth of Massachusetts. The revisions establish a 2011 base year emissions inventory, an emissions statement certification, revisions to an existing stationary source registration program, and requirements to be undertaken during air pollution emergencies. This action is being taken under the Clean Air Act.

    DATES:

    Written comments must be received on or before January 3, 2019.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R01-OAR-2018-0771 at https://www.regulations.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the For Further Information Contact section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. Publicly available docket materials are available at https://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA Region 1 Regional Office, Office of Ecosystem Protection, Air Quality Planning Unit, 5 Post Office Square—Suite 100, Boston, MA. EPA requests that if at all possible, you contact the contact listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Bob McConnell, Environmental Engineer, Air Quality Planning Unit, Air Programs Branch (Mail Code OEP05-02), U.S. Environmental Protection Agency, Region 1, 5 Post Office Square, Suite 100, Boston, Massachusetts, 02109-3912; (617) 918-1046; [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. The term “the Commonwealth” refers to the State of Massachusetts.

    Table of Contents I. Background II. Description and Evaluation of Commonwealth's Submittals A. Emissions Statement Certification B. 2011 Base Year Emissions Inventory C. Stationary Source Registration Requirements D. Emergency Episode Planning Provisions III. Proposed Action IV. Incorporation by Reference V. Statutory and Executive Order Reviews I. Background

    On March 12, 2008, the EPA revised both the primary and secondary NAAQS for ozone to a level of 0.075 parts per million (ppm) (annual fourth-highest daily maximum 8-hour average concentration, averaged over three years) to provide increased protection of public health and the environment (73 FR 16436, March 27, 2008). The 2008 ozone NAAQS retains the same general form and averaging time as the 0.08 ppm NAAQS set in 1997, but is set at a more protective level. Under the EPA's regulations at 40 CFR part 50, the 2008 8-hour ozone NAAQS is attained when the 3-year average of the annual fourth highest daily maximum 8-hour average ambient air quality ozone concentrations is less than or equal to 0.075 ppm. See 40 CFR 50.15.

    Effective July 20, 2012, the EPA designated as nonattainment any area that was violating the 2008 8-hour ozone NAAQS based on the three most recent years (2008-2010) of air monitoring data (77 FR 30088, May 21, 2012). Within that rulemaking, Dukes County in Massachusetts was designated as a marginal ozone nonattainment area. Pursuant to section 182(a) of the Clean Air Act (CAA), marginal ozone nonattainment areas are required to submit a number of SIP revisions, including, pursuant to section 182(a)(1), an emissions inventory containing actual emission estimates from all sources, and, pursuant to section 182(a)(3)(B), an emissions statement program to collect actual emissions data from certain industrial sources within the state. Massachusetts accomplishes the latter by means of requirements within title 310 of the Code of Massachusetts Regulations (CMR), specifically, within 310 CMR 7.12, Source Registration.

    Each time EPA revises a NAAQS, states are required by section 110(a)(2) to submit a certification that their SIP contains the necessary requirements to carry out all the state's obligations under the CAA. These SIPs are referred to as infrastructure SIPs, and EPA conditionally approved several aspects of Massachusetts' infrastructure SIPs for the 1997 ozone, 2008 ozone, and 2010 SO2 NAAQS. See 81 FR 93627 (December 21, 2016). On February 9, 2018, Massachusetts submitted 310 CMR 8.00, The Prevention and/or Abatement of Air Pollution Episode and Air Pollution Incident Emergencies, to satisfy one of the conditions within EPA's December 21, 2016, final rule.

    II. Description and Evaluation of Commonwealth's Submittals A. Emissions Statement Certification

    EPA's implementation rule for the 2008 ozone NAAQS, herein referred to as the 2008 ozone rule, was published in the Federal Register on March 6, 2015. See 80 FR 12264. The 2008 ozone rule notes than many areas that were nonattainment for the 2008 ozone NAAQS had previously adopted an emissions statement reporting program due to being nonattainment for a prior ozone NAAQS. For these areas, the 2008 ozone rule indicates that the state should review its existing rule to see whether it still meets the requirements of section 182(a)(3)(B) of the CAA, and if the state determines that it does, the state may submit a SIP revision certification to that effect to meet this obligation for purposes of the 2008 ozone NAAQS.

    On February 9, 2018, Massachusetts submitted an emissions statement certification as a SIP revision request. The submittal notes that Massachusetts had previously adopted an emissions statement program pursuant to obligations it had under the one-hour ozone standard, and that EPA approved that program into the Massachusetts SIP on March 24, 1996. See 61 FR 11556. Massachusetts reviewed its current set of air pollution reporting requirements and confirmed that pursuant to its authority under 310 CMR 7.12, Source Registration, all stationary sources of volatile organic compounds (VOCs) and/or nitrogen oxides (NOX) that emit 25 tons or more per year of those pollutants are required to report their emissions to the Commonwealth, along with a certification as to the accuracy of the reported emissions. EPA has approved 310 CMR 7.12 into the Massachusetts SIP, most recently on April 24, 2014. See 79 FR 22774. Emissions from smaller stationary sources that emit less than 25 tons per year of VOC and/or NOX are inventoried as area sources within emissions inventories prepared by the Commonwealth, such as the 2011 emissions inventory that is described in section II.B of this proposal. Given the above, we propose to approve Massachusetts' emissions statement certification for purposes of the 2008 ozone NAAQS.

    B. 2011 Base Year Emissions Inventory

    CAA section 172(c)(3) requires that each SIP include a “comprehensive, accurate, current inventory of actual emissions from all sources of the relevant pollutant or pollutants in [the] area. . . .” In requiring an accounting of actual emissions from all sources of the relevant pollutants in the area, this section provides for the “base year” inventory to include all emissions that contribute to the formation of a particular NAAQS pollutant. Additionally, for the 2008 ozone NAAQS, EPA's March 6, 2015, ozone rule recommended 2011 be used as the base year.

    On February 9, 2018, the Commonwealth submitted to EPA an emissions inventory of ozone precursors for 2011 as a SIP revision request. The inventory was submitted to meet the CAA section 182(a)(3)(A) obligation to develop a base year inventory. Massachusetts conducted a public comment process on the inventory which concluded on February 2, 2018. The inventories include emission estimates in tons per summer day and represent emissions estimates from stationary and mobile source categories during a typical summer day when ozone formation is highest. The ozone emissions inventory catalogs NOX and VOC emissions because these pollutants are precursors to ozone formation. The Commonwealth's 2011 emissions inventory contains emission estimates for each county in the Commonwealth.1

    1 Although the Massachusetts 2011 emissions inventory contains emissions estimates for all counties in the Commonwealth, pursuant to Section 182(a)(3)(A), only an inventory for the Commonwealth's marginal nonattainment area, Dukes county, was required.

    The Massachusetts 2011 emission inventory documents the procedures used to estimate emissions from individual stationary sources, referred to as point sources. The inventory describes how individual industrial sources with emissions as low as 1 ton per year submit, by means of the Massachusetts Department of Environmental Protections (MA-DEPs) “eDEP” online application, information on fuel use, materials use, air pollution control equipment, and air emissions. The Commonwealth transmitted its 2011 point source air emissions data to EPA's National Emissions Inventory (NEI) database in accordance with the requirements found within 40 CFR part 51, subpart A.

    Area source emission estimates are made for small, stationary sources of air pollution that do not emit much individually but do have significant emissions collectively. Examples include gasoline stations, automobile refinishing shops, and architectural and industrial maintenance coatings. The Commonwealth's area source emissions inventory identifies the source categories for which the Commonwealth relied upon EPA's estimates, provides information on any adjustments made to EPA estimates, and notes which categories' emission estimates were prepared by the Commonwealth. The inventory also explains how double counting was avoided between emissions from facilities inventoried as individual point sources and area source emission estimates.

    Massachusetts relied upon emission estimates obtained from EPA's Motor Vehicle Emissions Simulator (MOVES) model to calculate emissions for on-road and most non-road mobile source sectors. The Commonwealth provided the model with local activity inputs including vehicle miles traveled (VMT) provided by the Massachusetts Department of Transportation, and data on vehicle type from the Massachusetts Registry of Motor Vehicles. Massachusetts also provided inputs to the model for meteorological parameters and fuel characteristics.

    We propose to find that the air emission estimates for these sources were adequately accounted for in the Commonwealth's 2011 emissions inventory. The methodology used to calculate emissions for each source category followed relevant EPA guidance, most notably the July 2017 guidance entitled “Emissions Inventory Guidance for Implementation of Ozone and Particulate Matter National Ambient Air Quality Standards and Regional Haze Regulations.” Additionally, the Commonwealth used appropriate, documented emission factors, or relied on emission estimates prepared for EPA's National Emissions Inventory. Furthermore, the inventory submittal is sufficiently documented as to the techniques used to prepare the emission estimates.

    Table 1 shows the emissions by source category, in tons per summer day (tpsd), from the 2011 base year emission inventory for Dukes County.

    Table 1—Emissions Inventory Summary for Dukes County [Tons/summer day] Dukes County Source VOC NOX Point 0.09 0.67 Area 1.20 0.06 Nonroad 4.01 6.47 Onroad 0.10 0.21 Biogenic 3.31 0.19 Totals 8.71 7.00

    Additional details regarding the Massachusetts emissions inventory are included in the Commonwealth's 2011 Periodic Emissions Inventory document, which is available in the docket for this proposed rulemaking. The inventories are based on the most current and accurate information available to the Commonwealth at the time the inventories were being developed. Additionally, the inventories comprehensively address all source categories in the Commonwealth's nonattainment area and were developed consistent with the relevant EPA inventory guidance. For these reasons, we are proposing to approve the 2011 base year emissions inventory for Dukes county into the Massachusetts SIP as meeting the requirements of CAA section 172(c)(3).

    C. Stationary Source Registration Requirements

    On May 10, 2018, Massachusetts submitted updates to 310 CMR 7.12, Source Registration, which provides the applicability levels and reporting requirements for industrial sources to use to report air emissions data to the Commonwealth. The revisions include an exemption for small combustion sources whose only emissions come from burning oil or gas, a revision to the annual reporting due date for some filers, and a lowered reporting threshold for lead.

    The Commonwealth's previous reporting thresholds had been quite low, requiring approximately 2,300 individual facilities to report their air emissions to the Commonwealth, and was considerably lower than required by the federal reporting guidelines found within 40 CFR part 51, subpart A, Air Emissions Reporting Requirements. Subpart A essentially only requires sources considered major for Title V permitting purposes to report their emissions to the state. The Commonwealth's reporting requirements will continue to be more stringent than what is minimally required by 40 CFR part 51, subpart A, after accounting for the exemption. Additionally, emissions from the small, exempted sources will be covered within the area source portion of the emission inventories that the Commonwealth periodically prepares.

    Subpart A's air emissions reporting requirements directs states to report their data to EPA by December 31 of the year following that in which the emissions occurred. To accomplish this, states set reporting deadlines generally in the springtime for sources to report their emissions to the state. Massachusetts has moved up some of its reporting deadlines for sources reporting to the Commonwealth in order to provide the Commonwealth with more time to review the submitted information and prepare electronic files for submittal to EPA.

    In February of 2015, EPA made a number of changes to the air emissions reporting requirements of 40 CFR part 51, subpart A, including a lowering of the threshold for sources emitting lead from 5 tons per year to 0.5 tons per year. The Commonwealth is, therefore, modifying its lead reporting threshold to match the new federal reporting threshold of 0.5 tons per year.

    In addition to the above, Massachusetts made several other minor updates and clarifications to 310 CMR 7.12. These changes, as well as additional details regarding the changes described above, are available within the Commonwealth's SIP submittal which is available in the docket for this action. We are proposing approval of these revisions for the reasons stated above.

    D. Emergency Episode Planning Provisions

    On February 9, 2018, Massachusetts submitted 310 CMR 8.00, The Prevention and/or Abatement of Air Pollution Episode and Air Pollution Incident Emergencies, to EPA as a SIP revision request. The Commonwealth submitted this regulation in response to EPA's December 21, 2016, final rule, which conditionally approved one aspect of the Commonwealth's Infrastructure SIP submissions for CAA section 110(a)(2)(G) for the 1997 ozone, 2008 ozone, and 2010 SO2 NAAQS. See 81 FR 93629. Specifically, EPA conditionally approved the submissions for the contingency plan requirements of section 110(a)(2)(G). Additional details regarding EPA's rationale for requiring that the Commonwealth revise its SIP to address this issue are explained within our July 20, 2016, Notice of Proposed Rulemaking. See 81 FR 47133.

    We propose that 310 CMR 8.00 satisfies the contingency plan requirements of CAA section 110(a)(2)(G) and implementing regulations at 40 CFR part 51, subpart H. More specifically, 310 CMR 8.00 is modeled on EPA's example regulations for emergency contingency plans at 40 CFR part 51, appendix L, and specifies episode criteria and control actions for air pollution alerts, warnings, and emergencies to prevent ambient pollution concentrations from reaching significant harm levels, thereby satisfying 40 CFR 51.151 and 51.152(a)(1) and (3). See 310 CMR 8.03 and 8.07. Section 8.03 also specifically provides for acquisition of forecasts of atmospheric stagnation conditions from the National Weather Service (NWS), thereby satisfying 40 CFR 51.152(b)(1). See 310 CMR 8.03(1)(a). Moreover, the Commonwealth, as a matter of practice, posts on the internet daily forecasted ozone and fine particle levels through the EPA AirNow and EPA EnviroFlash systems. Information regarding these two systems is available on EPA's website at https://www.airnow.gov. Notices are sent out to EnviroFlash participants when levels are forecast to exceed the current 8-hour ozone and fine particle standards. In addition, when levels are expected to exceed these standards in Massachusetts, the media are alerted via a press release, and the NWS is alerted to issue an Air Quality Advisory through the normal NWS weather alert system. See also 310 CMR 8.05(4). These actions are similar to the notification and communication requirements of 40 CFR 51.152(a)(2), (b)(1), and (b)(3). Finally, Massachusetts' emergency contingency plan satisfies 40 CFR 51.152(b)(2) insofar as 310 CMR 8.22 authorizes state and local police, fire department officials, and public health officials to enforce compliance with applicable emergency control action requirements.

    For these reasons, EPA proposes that 310 CMR 8.00 satisfies the requirements of CAA § 110(a)(2)(G) and 40 CFR part 51, subpart H. Consequently, we propose to approve 310 CMR 8.00 into the Massachusetts SIP and to convert to full approvals the previous conditional approvals for the contingency plan requirements of CAA § 110(a)(2)(G) for the 1997 ozone, 2008 ozone, and 2010 SO2 NAAQS infrastructure SIPs.

    III. Proposed Action

    EPA is proposing to approve SIP revisions submitted by the Commonwealth of Massachusetts representing a 2011 base year emissions inventory, an emissions statement certification, revisions to 310 CMR 7.12, Source Registration, and 310 CMR 8.00, The Prevention and/or Abatement of Air Pollution Episode and Air Pollution Incident Emergencies. EPA also proposes to convert to full approvals the previous conditional approvals for the contingency plan requirements of CAA § 110(a)(2)(G) for the 1997 ozone, 2008 ozone, and 2010 SO2 NAAQS infrastructure SIPs. EPA is soliciting public comments on the issues discussed in this document or on other relevant matters. These comments will be considered before taking final action. Interested parties may participate in the Federal rulemaking procedure by submitting written comments to this proposed rulemaking by following the instructions listed in the ADDRESSES section of this Federal Register.

    IV. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference 310 CMR 7.12, Source Registration, discussed in section 2.C. of this preamble, and 310 CMR 8.00, The Prevention and/or Abatement of Air Pollution Episodes and Air Pollution Incident Emergencies, discussed in section 2. D. of this preamble. The EPA has made, and will continue to make, these documents generally available through https://www.regulations.gov and at the EPA Region 1 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

    V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:

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

    • This action is not expected to be an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866;

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

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

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

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

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

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

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

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

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: November 28, 2018. Alexandra Dunn, Regional Administrator, EPA Region 1.
    [FR Doc. 2018-26283 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 147 [EPA-HQ-OW-2018-0669; FRL-9987-17-OW] State of North Dakota Underground Injection Control Program; Class I, III, IV, and V Primacy Revisions AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) proposes to approve an application from the State of North Dakota under the Safe Drinking Water Act (SDWA) to revise the State's existing Underground Injection Control (UIC) program for Class I, III, IV, and V injection wells located within the State, except those in Indian country. North Dakota is revising its UIC Class I, III, IV, and V program regulations to transfer primary enforcement authority from the North Dakota Department of Health to the North Dakota Department of Environmental Quality.

    DATES:

    Comments must be received on or before January 8, 2019. A public hearing is scheduled to be held on January 8, 2019 from 2 p.m. to 5 p.m. and 6 p.m. to 8 p.m., central daylight time. The hearing will be held only if requests are received within 30 days of publication. If no requests are received by January 3, 2019, the hearing will be cancelled. Confirmation or cancellation of the public hearing will be announced on January 3, 2019, on the EPA Region VIII's website at: https://www.epa.gov/uic/underground-injection-control-epa-region-8-co-mt-nd-sd-ut-and-wy.

    ADDRESSES:

    Hearing location: North Dakota Department of Health's fourth floor Conference Room, 918 East Divide Avenue, Bismarck, North Dakota. Requests for a public hearing may be mailed or emailed to: Omar Sierra-Lopez, U.S. Environmental Protection Agency, Region VIII, Mail Code: 8WP-SUI, 1595 Wynkoop Street, Denver, Colorado 80202-1129, or [email protected]

    Docket Review and Comments Requested: The application and supplemental docket materials are available electronically on https://www.regulations.gov, identified by Docket ID No. EPA-HQ-OW-2018-0669. Submit your comments to the Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. The EPA may publish any comments received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system).

    For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Kyle Carey, Drinking Water Protection Division, Office of Ground Water and Drinking Water (4606M), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2322; fax number: (202) 564-3754; email address: [email protected], or Omar Sierra-Lopez, Underground Injection Control Unit, Safe Drinking Water Program, Office of Water Protection (8WP-SUI), U.S. Environmental Protection Agency, Region VIII, 1595 Wynkoop Street, Denver, Colorado 80202-1129; telephone number: (303) 312-7045; fax number: (303) 312-7517; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Introduction

    The EPA approved North Dakota's UIC program as meeting the requirements for primary enforcement responsibility (primacy) for Class I, III, IV, and V injection wells, under section 1422 of the Safe Drinking Water Act, on September 21, 1984. The State is revising its UIC Class I, III, IV, and V program statutes and regulations to transfer this authority from the North Dakota Department of Health to the North Dakota Department of Environmental Quality.

    II. Legal Authorities

    These regulations are being promulgated under authority of sections 1422 and 1450 of the SDWA, 42 U.S.C. 300h-1 and 300j-9.

    A. Revision of State UIC Programs

    As required by section 1421 of the SDWA, the EPA promulgated minimum requirements in the Code of Federal Regulations (CFR) at 40 CFR part 145, for effective State UIC programs, to prevent underground injection activities that endanger underground sources of drinking water (USDWs). Under section 1422 of the SDWA, once the EPA approves a State UIC program, the State has primary enforcement responsibility for underground water sources. A State may revise its UIC program as provided under 40 CFR 145.32(a) and by following the procedures described under 40 CFR 145.32(b), which require the State to submit a modified program description, an Attorney General's statement, a Memorandum of Agreement, or other such documentation as the EPA determines to be necessary under the circumstances (40 CFR 145.32(b)(1)). States with approved programs are required to notify the EPA whenever they propose to transfer all or part of the approved State agency to any other State agency and to identify any new division of responsibilities amongst the agencies involved. Organizational charts required in the State's original primacy approval package must be revised and resubmitted. The new agency is not authorized to administer the program until approval by the Administrator (40 CFR 145.32(c)).

    All revisions to the UIC program would be federally enforceable as of the effective date of the EPA's approval of the respective revision and 40 CFR part 147 codification. The State plans to rely on the date when the EPA signs the final notice for purposes of notifying the State legislature that the EPA has approved these revisions, which will provide for the transfer authority from the North Dakota Department of Health to the North Dakota Department of Environmental Quality (NDDEQ) to be effective under State law. Thus, prior to the effective date of this approval, the State intends to take the necessary additional steps as specified in S.L. 2017, ch. 199, Section 1, to ensure that the NDDEQ rules would become federally enforceable on the effective date of the EPA's approval and codification of the approved program in 40 CFR part 147.

    Consistent with the EPA Guidance 16, the EPA considers State-initiated program revisions to transfer all or part of any program from the approved authority to another State agency as substantial program revisions. Under the EPA regulations, this means there is an opportunity for public comment and to request a public hearing (40 CFR 145.32(b)(2)).

    B. Indian Country

    The EPA's approval of North Dakota's application to transfer its SDWA UIC Class I, III, IV, and V primary enforcement authority from the North Dakota Department of Health to the North Dakota Department of Environmental Quality does not extend to Indian lands. Pursuant to the EPA's UIC regulations at 40 CFR 144.3, Indian lands “means `Indian country' as defined in 18 U.S.C. 1151.” As defined in 18 U.S.C. 1151, Indian country generally includes lands within the exterior boundaries of the following Indian reservations located within North Dakota: The Fort Berthold Indian Reservation, The Spirit Lake Reservation, The Standing Rock Sioux Reservation, and The Turtle Mountain Reservation; any land held in trust by the United States for an Indian tribe; and any other areas that are Indian country within the meaning of 18 U.S.C. 1151. The EPA, or eligible Indian tribes, as appropriate, will retain responsibilities under the SDWA UIC program for Class I, III, IV, and V injection wells in Indian country.

    III. North Dakota's Application A. Notice of Completion

    On September 18, 2018, the EPA received a complete program revision package from the State of North Dakota, requesting approval of its revised UIC regulations for Class I, III, IV, and V injection wells, to transfer primary enforcement authority from the North Dakota Department of Health to the North Dakota Department of Environmental Quality. The EPA has determined the application contains all the required elements; the application and supplemental materials are available electronically at https://www.regulations.gov; and a copy of the application can be accessed for inspection and copying at: The EPA Region VIII, 1595 Wynkoop Street, Denver, Colorado 80202-1129, by contacting Omar Sierra-Lopez at: Telephone number: (303) 312-7045; fax number: (303) 312-7517; email address: [email protected] Public comments are requested, and a public hearing will be held if requests are received within 30 days of publication (see ADDRESSES for further information on how to request a public hearing).

    The UIC program revision package from the State of North Dakota includes revised versions of: (1) The description of the State's UIC program (40 CFR 145.23); (2) copies of all applicable State statutes, regulations, and forms (40 CFR 145.22(a)(5)); (3) the Attorney General's statement that the State has adequate legal authority to carry out the program described and to meet the requirements of 40 CFR part 145; and (4) the Memorandum of Agreement between the State of North Dakota and the EPA's Region VIII Administrator (40 CFR 145.25).

    B. Public Participation Activities Conducted by the State of North Dakota

    On April 12, 2018, the North Dakota Department of Environmental Quality provided public notice of its intent to amend and adopt North Dakota's 1422 Underground Injection Control Rules. The public notice was published in 52 North Dakota newspapers. Written comments on the proposed rule changes were accepted between April 12, 2018 and May 31, 2018; no comments were received. A public hearing regarding the UIC rules was held on March 21, 2018; the hearing was unattended.

    C. Public Participation Activities Conducted by the EPA

    On December 4, 2018, a public notice announcing this proposed approval, request for public comment, and notice of a public hearing to be held on January 8, 2019, was published in the Bismarck Tribune and posted to the EPA Region VIII's website at: https://www.epa.gov/uic/underground-injection-control-epa-region-8-co-mt-nd-sd-ut-and-wy. Confirmation or cancellation of the public hearing will be announced on January 3, 2019 and on the EPA Region VIII's website at: https://www.epa.gov/uic/underground-injection-control-epa-region-8-co-mt-nd-sd-ut-and-wy. For information regarding the public hearing, including a request to hold a hearing, please contact Omar-Sierra Lopez, U.S. Environmental Protection Agency, Region VIII, Mail Code: 8WP-SUI, 1595 Wynkoop Street, Denver, Colorado 80202-1129, or [email protected]

    IV. The EPA's Proposed Action A. What is the EPA proposing?

    In this action, the EPA is proposing to approve the State of North Dakota's application to transfer its Class I, III, IV, and V primary enforcement authority from the North Dakota Department of Health to the North Dakota Department of Environmental Quality and to make conforming changes to its regulations to reflect such transfer. Regulations under 40 CFR part 147 set forth the applicable UIC programs for each of the States. This rule would update 40 CFR part 147 subpart JJ to reflect the transfer of authority.

    Support of this proposed approval is part of the public record in the EPA's Docket No. EPA-HQ-OW-2018-0669. When finalized, this action will amend 40 CFR part 147 Subpart JJ to incorporate by reference the revised EPA-approved State statutes and regulations. The EPA will continue to administer its UIC program for Class I, III, IV, and V injection wells in Indian country.

    The EPA will continue to oversee the State of North Dakota's administration of UIC Class I, III, IV, V and VI programs as authorized under the SDWA. Part of the EPA's oversight responsibility will require State quarterly reports of non-compliance and annual UIC performance reports pursuant to 40 CFR 144.8. The Memorandum of Agreement between the EPA and the State of North Dakota, signed by the Regional Administrator on September 18, 2018, provides the EPA with the opportunity to review and comment on all draft permits.

    B. What codification decisions is the EPA proposing in this rule?

    In this rule, the EPA is proposing to finalize the federal regulatory text that incorporates by reference the federally authorized North Dakota UIC program for Class I, III, IV, and V injection wells, except those in Indian country. In accordance with the requirements of 1 CFR 51.5, we are proposing to finalize the incorporation by reference of the North Dakota rules described in the amendments to 40 CFR part 147 set forth below. The EPA has made, and will continue to make, these documents generally available through www.regulations.gov and at the U.S. Environmental Protection Agency, Region VIII, Library 2nd Floor, 1595 Wynkoop Street, Denver, Colorado 80202-1129.

    The EPA will revise the binder at 40 CFR 147.1751 that contains the EPA-approved North Dakota Statutes and Regulations for Well Classes I, III, IV, V, and VI. This binder will be incorporated by reference into 40 CFR 147.1751. The EPA will also revise the table listing the EPA-approved North Dakota Statutes and Regulations for Well Classes I, III, IV, V, and VI in 40 CFR 147.1751. Section 147.1751 also references the Memorandum of Agreement, the statement of legal authority (the Attorney General's Statement), and the Program Description, which are approved as part of the UIC program authorized under the SDWA.

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

    This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

    B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs

    This action is not expected to be an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.

    C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2040-0042. Reporting or record-keeping requirements will be based on the State of North Dakota UIC Regulations, and the State of North Dakota is not subject to the PRA.

    D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This rule does not impose any requirements on small entities as this rule approves the State of North Dakota's UIC program revisions. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.

    E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector. The EPA's approval of the State of North Dakota's program revisions will not constitute a federal mandate because there is no requirement that a State establish UIC regulatory programs and because the program is a State, rather than a federal program.

    F. Executive Order 13132: Federalism

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

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

    This action does not have tribal implications as specified in Executive Order 13175. This action contains no federal mandates for tribal governments and does not impose any enforceable duties on tribal governments. Thus, Executive Order 13175 does not apply to this action.

    H. Executive Order 13045: Protection of Children From Environmental Health & Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it approves the State of North Dakota's UIC program revisions.

    I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use

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

    J. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

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

    The EPA has determined that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This action will simply provide that the State of North Dakota is transferring its primary enforcement authority for its Class I, III, IV, and V wells, pursuant to which the State of North Dakota will be implementing and enforcing a State UIC regulatory program that is as stringent as the existing federal program.

    List of Subjects in 40 CFR Part 147

    Environmental protection, Indian lands, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Water supply.

    Dated: November 20, 2018. Andrew R. Wheeler, Acting Administrator.

    For the reasons set out in the preamble, the Environmental Protection Agency is proposing to amend 40 CFR part 147 as follows:

    PART 147—STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION CONTROL PROGRAMS 1. The authority citation for part 147 is revised to read as follows: Authority:

    42 U.S.C. 300f et seq.; and 42 U.S.C. 6901 et seq.

    2. Amend § 147.1751 by: a. Revising the introductory text and paragraph (a); b. Revising paragraph (b)(2) and removing paragraphs (b)(3) and (b)(4); c. Revising paragraphs (c), (d), (e), (f), (g), (h); and e. Adding paragraph (i).

    The revisions and addition read as follows:

    § 147.1751 State-administered program—Class I, III, IV, V and VI wells.

    The UIC Program for Class I, III, IV, and V wells in the State of North Dakota, except those located on Indian lands, as defined under 40 CFR 144.3, is the program administered by the North Dakota Department of Environmental Quality, approved by the EPA pursuant to section 1422 of the SDWA. Notification of this approval was published in the Federal Register on [date of publication of the final rule in the Federal Register]; the effective date of this program is (date to be determined at time of final decision but will be no less than 30 days after publication in the Federal Register). The UIC Program for Class VI wells in the State of North Dakota, except those located on Indian lands, is the program administered by the North Dakota Industrial Commission (NDIC), approved by the EPA pursuant to section 1422 of the SDWA. Notification of this approval was published in the Federal Register on April 24, 2018; the effective date of the NDIC UIC Class VI program is April 24, 2018. The State-administered UIC programs for Classes I, III, IV, V, and VI consist of the following elements, as submitted to the EPA in the State's program applications.

    (a) The requirements set forth in the State statutes and regulations cited in the binder entitled “EPA-Approved North Dakota SDWA § 1422 Underground Injection Control Program Statutes and Regulations for Well Classes I, III, IV, V and VI”, dated December 2018, and Table 1 to paragraph (a) of this section are incorporated by reference and made a part of the applicable UIC program under the SDWA for the State of North Dakota. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the North Dakota regulations that are incorporated by reference in this paragraph (a) may be inspected at the U.S. Environmental Protection Agency, Region VIII, Library 2nd Floor, 1595 Wynkoop Street, Denver, Colorado 80202-1129; Water Docket, EPA Docket Center (EPA/DC), EPA WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20460; and the National Archives and Records Administration (NARA). If you wish to obtain materials from the EPA Regional Office, please call (303) 312-1226; for materials from a docket in the EPA Headquarters Library, please call the Water Docket at (202) 566-2426. For information on the availability of this material at NARA, call (202) 741-6030, or go to www.archives.gov/federal-register/cfr/ibr-locations.html.

    Table 1 to Paragraph (a) EPA-Approved North Dakota SDWA § 1422 Underground Injection Control Program Statutes and Regulations for Well Classes I, III, IV, V and VI State citation Title/subject State effective date EPA approval date North Dakota Century Code Sections 38-12-01—38-12-03 Regulation, Development and Production of Subsurface Minerals 1980 September 21, 1984, 49 FR 37066. North Dakota Century Code Sections 61-28-02 and 61-28-06 Control, Prevention and Abatement of Pollution of Surface Waters 1989 March 6, 1991, 56 FR 9418. North Dakota Century Code Sections 61-28.1-01—61-28.1-12 Safe Drinking Water Act 2018 [insert FR citation of final rule]. North Dakota Administrative Code Sections 33.1-25-01-01—33.1-25-01-18 Underground Injection Control Program 2018 [insert FR citation of final rule]. North Dakota Administrative Code Sections 43-02-02-01-43-02-02-50 Subsurface Mineral Exploration and Development 1986 March 6, 1991, 56 FR 9418. North Dakota Administrative Code Sections 43-02-02.1-01—43-02-02.2-19 Underground Injection Control Program 1984 September 21, 1984, 49 FR 37066. North Dakota Century Code Sections 38-22-01—38-22-23 Carbon Dioxide Underground Storage 2009 April 24, 2018, 83 FR 17761. North Dakota Administrative Code Sections 38-08-16—38-08-17 Control of Oil and Gas Resources 2013 April 24, 2018, 83 FR 17761. North Dakota Administrative Code Sections 43-05-01-01—43-05-01-20 Geologic Storage of Carbon Dioxide 2013 April 24, 2018, 83 FR 17761.

    (b) * * *

    (2) North Dakota Administrative Code Article 33-22 (Practice and Procedure) (1983).

    (c) The Memorandum of Agreement for the Class I, III, IV, and V Underground Injection Control Program between EPA Region VIII and the North Dakota Department of Environmental Quality, signed by the EPA Regional Administrator on September 18, 2018.

    (d) The statement of legal authority, “Class I, III, IV, and V Underground Injection Control Program, Attorney General's Statement,” signed by the Assistant Attorney General of North Dakota on July 30, 2018, and “Supplement to the Attorney General Statements Relating to Programs Being Transferred to the North Dakota Department of Environmental Quality” signed by the Assistant Attorney General of North Dakota on October 23, 2018.

    (e) The Class I, III, IV, and V Underground Injection Control Program Description and any other materials submitted as part of the program revision or as supplements thereto.

    (f) The Memorandum of Agreement for the Class VI Underground Injection Control Program between EPA Region VIII and the North Dakota Industrial Commission, signed by the EPA Regional Administrator on October 28, 2013.

    (g) The Memorandum of Understanding for Class VI between the North Dakota Industrial Commission, Department of Mineral Resources, Oil and Gas Division and the North Dakota Department of Health, Water Quality Division Related to the Underground Injection Control Program, signed on June 19, 2013.

    (h) The statement of legal authority, “Class VI Underground Injection Control Program, Attorney General's Statement,” signed by the Attorney General of North Dakota on January 22, 2013.

    (i) The Class VI Underground Injection Control Program Description and any other materials submitted as part of the program revision or as supplements thereto.

    [FR Doc. 2018-25893 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 48 CFR Parts 19 and 52 [FAR Case 2016-011; Docket No. 2016-0011, Sequence No. 1] RIN 9000-AN35 Federal Acquisition Regulation: Revision of Limitations on Subcontracting AGENCY:

    Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

    ACTION:

    Proposed rule.

    SUMMARY:

    DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement the final rule published by the Small Business Administration implementing section 1651 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2013, which revised and standardized the limitations on subcontracting, including the nonmanufacturer rule, that apply to small business concerns under FAR part 19 procurements.

    DATES:

    Interested parties should submit comments to the Regulatory Secretariat Division at one of the addresses shown below on or before February 4, 2019 to be considered in the formulation of a final rule.

    ADDRESSES:

    Submit comments in response to FAR Case 2016-011 by any of the following methods:

    Regulations.gov: http://www.regulations.gov.

    Submit comments via the Federal eRulemaking portal by entering “FAR Case 2016-011” under the heading “Enter Keyword or ID” and selecting “Search.” Select the link “Comment Now” that corresponds with “FAR Case 2016-011.” Follow the instructions provided on the screen. Please include your name, company name (if any), and “FAR Case 2016-011” on your attached document.

    Mail: General Services Administration, Regulatory-Secretariat Division (MVCB), ATTN: Lois Mandell, 1800 F Street NW, 2nd floor, Washington, DC 20405.

    Instructions: Please submit comments only and cite “FAR case 2016-011” in all correspondence related to this case. All comments received will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    For clarification of content, contact Ms. Mahruba Uddowla, Procurement Analyst, at 703-605-2868. For information pertaining to status or publication schedules, contact the Regulatory Secretariat Division at 202-501-4755. Please cite “FAR Case 2016-011.”

    SUPPLEMENTARY INFORMATION:

    I. Background

    DoD, GSA, and NASA are proposing to revise the FAR to implement regulatory changes made by the SBA in its final rule published in the Federal Register at 81 FR 34243 on May 31, 2016. SBA's final rule implements the statutory requirements of section 1651 of the NDAA for FY 2013 (15 U.S.C. 657s). Section 1651 revised and standardized the limitations on subcontracting, including the nonmanufacturer rule, that apply to small business concerns under FAR part 19 procurements. SBA's final rule became effective on June 30, 2016.

    Prior to passage of section 1651 of the NDAA for FY 2013, the limitations on subcontracting and the nonmanufacturer rule were inconsistent across the small business programs. For example, for awards under some small business programs, the prime contractor was required to perform a certain percentage of work itself, whereas under other programs, the prime contractor could include subcontracts to “similarly situated entities” in the percentage of work it performed. The method for calculating compliance with the limitations on subcontracting also varied across small business programs.

    Section 1651 of the NDAA for FY 2013 changed the focus of the limitations on subcontracting rules. Instead of requiring a percentage of work to be performed by a prime contractor, the limitations on subcontracting rules now limit subcontracting to a percentage of the overall award amount to be spent by the prime on subcontractors. As a result, the prime contractor no longer has to track the percentage of costs incurred that it spends performing work itself; it only has to track the percentage of the overall award amount (i.e., contract price) that it spends on subcontractors. For small businesses, this change will reduce a substantial burden associated with tracking and demonstrating compliance with the limitations on subcontracting.

    In addition, the percentage of the award amount that the prime contractor spends on subcontractors who are similarly situated entities is not considered subcontracted for purposes of compliance with the limitations on subcontracting. The statute and SBA's implementing regulations define “similarly situated entity” as a subcontractor that has the same small business program status as that which qualified the prime contractor for the award and that is considered small for the North American Industry Classification System (NAICS) code the prime contractor assigned to the subcontract the subcontractor will perform. Work performed by similarly situated entities is counted as if it were performed by the prime contractor in determining compliance with the limitations on subcontracting.

    These important changes give small businesses greater flexibility on how they choose to comply with the limitations on subcontracting. Under the current FAR clauses, there is only one way for a small business to comply with the limitations: It must spend the required amount on work performed in-house. As proposed in this rule, there will be more than one way to comply with the limitations, and the small business will be able to choose how to comply. For example, a small business that is in compliance with the existing FAR clause will be able to comply with the new limitations on subcontracting. Alternatively, a small business can decide to subcontract more than it did before, and it will be able to comply with the new limitations where it would not have complied before, as long as the amount spent on subcontracts does not exceed 50 percent of the price of the prime contract, for other than construction contracts; different percentages apply for construction contracts. Finally, a small business can decide to subcontract work to a similarly situated entity, in any amount of its choosing, that it previously subcontracted or performed in-house, and it will be in compliance with the new limitations on subcontracting because work performed by a similarly situated entity is counted as if it were performed by the prime contractor. In short, the new rules will make it easier for prime contractors to do business with Federal agencies by giving them more, and less burdensome, options for pursuing and winning larger contracts than before.

    SBA's final rule specified that similarly situated entities must also comply with the limitations on subcontracting. Requiring prime contractors and their similarly situated entity subcontractors to comply with the limitations on subcontracting will ensure that the benefits from small business and socioeconomic set-aside and sole-source contracts flow to the intended parties. SBA's final rule also provided updated guidance on the nonmanufacturer rule, including the process for obtaining waivers to the nonmanufacturer rule and the proper application of these waivers to procurements.

    The SBA rule also clarified that the limitations on subcontracting and the nonmanufacturer rule do not apply to small business set-aside contracts valued at or below $150,000, but do apply to set-aside and sole-source awards under the other small business programs regardless of dollar value. This proposed rule reflects the same clarification. Thus, this rule provides that the limitations on subcontracting and the nonmanufacturer rule clauses are prescribed for small business set-asides that are expected to exceed $150,000, and for requirements set aside for or awarded on a sole-source basis to 8(a) participants, Historically Underutilized Business Zone (HUBZone) small business, service-disabled veteran-owned small business (SDVOSB), economically disadvantaged women-owned small business (EDWOSB), or Women-Owned Small Business(WOSB) concerns eligible under the WOSB program.

    II. Discussion and Analysis

    This proposed rule would amend FAR parts 19 and 52. This rule implements the revised and standardized limitations on subcontracting through a single FAR clause applicable to every small business program, instead of continuing to implement through multiple FAR clauses that were specific to particular small business programs. Similarly, this proposed rule creates a new FAR clause implementing the revised and standardized the nonmanufacturer rule across all the small business programs.

    These changes are summarized in the following paragraphs:

    A. Nonmanufacturer rule implementation. Paragraph (f) in section 19.102 is deleted, and 19.502-2 and 19.1303(e) are revised to remove the outdated nonmanufacturer rule guidance. New section 19.103, Nonmanufacturer rule, provides full and updated guidance on the application of the nonmanufacturer rule, including the requirements associated with the nonmanufacturer rule and the circumstances and procedures related to waivers. This section clarifies that the nonmanufacturer rule does not apply to small business set-aside acquisitions at or below $150,000, but does apply to 8(a), HUBZone, SDVOSB, EDWOSB, and WOSB set-aside and sole-source acquisitions regardless of dollar value. Previous references to 19.102(f) at 19.303 and 19.1403 have been updated to refer to the new 19.103 section.

    New clause 52.219-XX, Nonmanufacturer Rule, implements the requirements in solicitations and contracts. The prescription for this clause is added at 19.508(g). References to this prescription were added at 19.811-3(f), 19.1309(d), 19.1407(c), and 19.1507(d). The outdated nonmanufacturer rule has been removed from the clauses at 52.219-3, 52.219-6 and its Alternate I, 52.219-7 and its Alternate I, 52.219-18 and its Alternate II, 52.219-27, 52.219-29, and 52.219-30. The prescriptions have been removed from subparts 19.5 and 19.8 for the following clauses: Alternate I of 52.219-6, Alternate I of 52.219-7, and Alternate II of 52.219-18. However, paragraph (f) of the clause at 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns, is not revised because the application of the nonmanufacturer rule to acquisitions in which the HUBZone price evaluation preference is used is still under review.

    The following provisions and clause are updated to clarify when the size standard for nonmanufacturers applies: 52.204-8, 52.212-1, 52.219-1, and 52.219-28. Additionally, the definition of “nonmanufacturer rule” is deleted from 19.001.

    B. Limitations on subcontracting implementation. The clause at 52.219-14, Limitations on Subcontracting, is revised to implement the updated limitations on subcontracting requirements in solicitations and contracts. The prescription for this clause at 19.508(e) is revised to apply to all small business programs. References to this prescription were added at 19.1309(c), 19.1407(b), and 19.1507(c), and revised at 19.811-3(e). Additionally, the clause at 52.219-4 is revised to reflect the updated limitations on subcontracting.

    The outdated limitations on subcontracting guidance is removed from the following clauses: 52.219-3, 52.219-27, 52.219-29, and 52.219-30. The following clauses have been deleted: Alternate I of 52.219-3 and Alternate I of 52.219-4. In addition, the prescriptions for these clauses at 19.1309 have been deleted. The outdated limitations on subcontracting text at 19.1308 is deleted.

    Lastly, the definition of “similarly situated entity” is added to 19.001 to support the implementation of the updated limitations on subcontracting.

    C. Conforming changes. The clause at 52.212-5 is revised to include 52.219-XX, Nonmanufacturer Rule, and to update the dates of clauses revised in this rule.

    III. Applicability to Contracts at or Below the Simplified Acquisition Threshold and for Commercial Items, Including Commercially Available Off-the-Shelf Items

    The Federal Acquisition Regulatory (FAR) Council has made the following preliminary determinations with respect to the proposed rule's application of section 1651 of the NDAA for FY 2013 to contracts at or below the simplified acquisition threshold (SAT) and for the acquisition of commercial items, including commercially available off-the-shelf (COTS) items. Discussion of these preliminary determinations is set forth below. The FAR Council will consider public feedback before making a final determination on the scope of the final rule.

    A. Applicability to Contracts at or Below the SAT.

    Pursuant to 41 U.S.C. 1905, a provision of law is not applicable to acquisitions at or below the SAT unless the law (i) contains criminal or civil penalties; (ii) specifically refers to 41 U.S.C. 1905 and states that the law applies to acquisitions at or below the SAT; or (iii) the FAR Council makes a written determination that it is not in the best interest of the Federal Government to exempt contracts or subcontracts at or below the SAT. If none of these conditions are met, the FAR is required to include the statutory requirement(s) on a list of provisions of law that are inapplicable to acquisitions at or below the SAT.

    The purpose of this rule is to implement section 1651 of the NDAA for FY 2013. Section 1651 provides revised limitations on subcontracting that apply across all small business programs. It also requires that the limitations on subcontracting be determined based on the percentage of the overall award amount that a prime contractor spends on its subcontractors. In addition, section 1651 provides that the percentage of the award amount that the prime contractor spends on subcontractors who are similarly situated entities is not considered subcontracted for purposes of the limitations on subcontracting in section 1651.

    These statutory requirements are reflected in SBA's final rule published in the Federal Register at 81 FR 34243, on May 31, 2016, which did not exempt acquisitions at or below the SAT that are set aside for, or awarded on a sole-source basis to, 8(a) program participants, HUBZone, service-disabled veteran-owned, women-owned, or economically disadvantaged women-owned small business concerns. SBA's final rule did exempt acquisitions at or below the SAT that are set aside for small businesses.

    The law is silent on the applicability of these requirements to acquisitions at or below the SAT and does not independently provide for criminal or civil penalties; nor does it include terms making express reference to 41 U.S.C. 1905 and its application to acquisitions at or below the SAT. Therefore, it does not apply to acquisitions at or below the SAT unless the FAR Council makes a written determination as provided at 41 U.S.C. 1905.

    Application of the law to acquisitions at or below the SAT will maximize the positive impact set-aside and sole-source contracts provide for small businesses in the socioeconomic programs (e.g., HUBZone, 8(a), service-disabled veteran-owned, and women-owned small business programs) by ensuring these benefits extend to the many contracts valued below the SAT. According to fiscal year 2015 data from the Federal Procurement Data System (FPDS), more than 70 percent of the number of acquisitions that were set aside or sole-sourced under the socioeconomic programs were in amounts at or below the SAT. Failure to apply section 1651 to the maximum extent possible would exclude a significant number of acquisitions, which would not advance the interests of small businesses and increase their opportunities in the Federal marketplace. Further, the primary FAR clauses implementing the limitations on subcontracting and the nonmanufacturer rule are currently prescribed for use in solicitations and contracts at or below the SAT that are set aside for, or awarded on a sole-source basis to, 8(a) program participants, HUBZone, service-disabled veteran-owned, women-owned, or economically disadvantaged women-owned small business concerns. This rule merely revises these clauses to implement the requirements of section 1651. Exclusion of these acquisitions would create confusion among contractors and the Federal contracting workforce. Under the FAR clauses amended by this rule, contractors are already required to comply with the limitations on subcontracting and the nonmanufacturer rule. The new requirements will result in substantial savings for contractors.

    For these reasons, it is in the best interest of the Federal Government to apply the requirements of the rule to acquisitions at or below the SAT.

    B. Applicability to Contracts for the Acquisition of Commercial Items

    Pursuant to 41 U.S.C. 1906, acquisitions of commercial items (other than acquisitions of COTS items, which are addressed in 41 U.S.C. 1907) are exempt from a provision of law unless the law (i) contains criminal or civil penalties; (ii) specifically refers to 41 U.S.C. 1906 and states that the law applies to acquisitions of commercial items; or (iii) the FAR Council makes a written determination and finding that it would not be in the best interest of the Federal Government to exempt contracts for the procurement of commercial items from the provision of law. If none of these conditions are met, the FAR is required to include the statutory requirement(s) on a list of provisions of law that are inapplicable to acquisitions of commercial items.

    The purpose of this rule is to implement section 1651 of the NDAA for FY 2013. Section 1651 provides revised limitations on subcontracting that apply across all small business programs. It also requires that the limitations on subcontracting be determined based on the percentage of the overall award amount that a prime contractor spends on its subcontractors. In addition, section 1651 provides that the percentage of the award amount that the prime contractor spends on subcontractors who are similarly situated entities is not considered subcontracted for purposes of the limitations on subcontracting in section 1651.

    These statutory requirements are reflected in SBA's final rule published in the Federal Register at 81 FR 34243, on May 31, 2016, which did not exempt acquisitions of commercial items.

    The law is silent on the applicability of these requirements to acquisitions of commercial items and does not independently provide for criminal or civil penalties; nor does it include terms making express reference to 41 U.S.C. 1906 and its application to acquisitions of commercial items. Therefore, it does not apply to acquisitions of commercial items unless the FAR Council makes a written determination as provided at 41 U.S.C. 1906.

    The law furthers the Administration's goal of simplifying the acquisition process and facilitating easier access to the Federal marketplace, in this case for small business contractors who make up an important component of the Government's industrial base. It advances the interests of small business prime contractors by making it easier to comply with the limitations on subcontracting, which makes it possible for those contractors to compete for larger contracts than they could in the past. The law also advances the interests of small business subcontractors by encouraging small business prime contractors to award more subcontracts to similarly situated small businesses. Exclusion of a large segment of Federal contracting, such as acquisitions for commercial items, will limit the full implementation of these objectives. Further, the primary FAR clauses implementing the limitations on subcontracting and the nonmanufacturer rule are currently prescribed for use in solicitations and contracts for commercial items. Exclusion of acquisitions for commercial items from these requirements would create confusion among contractors and the Federal contracting workforce. The burden on contractors would not increase significantly if the requirements of section 1651 were applied to acquisitions for commercial items. Under the FAR clauses amended by this rule, contractors are already required to comply with the limitations on subcontracting and the nonmanufacturer rule. The new requirements will result in substantial savings for contractors.

    For these reasons, it is in the best interest of the Federal Government to apply the requirements of the rule to the acquisition of commercial items.

    C. Applicability to Contracts for the Acquisition of COTS Items

    Pursuant to 41 U.S.C. 1907, acquisitions of COTS items will be exempt from a provision of law unless the law (i) contains criminal or civil penalties; (ii) specifically refers to 41 U.S.C. 1907 and states that the law applies to acquisitions of COTS items; (iii) concerns authorities or responsibilities under the Small Business Act (15 U.S.C. 644) or bid protest procedures developed under the authority of 31 U.S.C. 3551 et seq., 10 U.S.C. 2305(e) and (f), or 41 U.S.C. 3706 and 3707; or (iv) the Administrator for Federal Procurement Policy makes a written determination and finding that would not be in the best interest of the Federal Government to exempt contracts for the procurement of COTS items from the provision of law. If none of these conditions are met, the FAR is required to include the statutory requirement(s) on a list of provisions of law that are inapplicable to acquisitions of COTS items.

    The purpose of this rule is to implement section 1651 of the NDAA for FY 2013. Section 1651 provides revised limitations on subcontracting that apply across all small business programs. It also requires that the limitations on subcontracting be determined based on the percentage of the overall award amount that a prime contractor spends on its subcontractors. In addition, section 1651 provides that the percentage of the award amount that the prime contractor spends on subcontractors who are similarly situated entities is not considered subcontracted for purposes of the limitations in section 1651.

    These statutory requirements are reflected in SBA's final rule published in the Federal Register at 81 FR 34243, on May 31, 2016, which did not exempt acquisitions of COTS items.

    The law is silent on the applicability of these requirements to acquisitions of COTS items and does not independently provide for criminal or civil penalties; nor does it include terms making express reference to 41 U.S.C. 1907 and its application to acquisitions of COTS items. Therefore, it does not apply to acquisitions of COTS items unless the Administrator for Federal Procurement Policy makes a written determination as provided at 41 U.S.C. 1907.

    The law furthers the Administration's goal of simplifying the acquisition process and facilitating easier access to the Federal marketplace, in this case for small business contractors who make up an important component of the Government's industrial base. It advances the interests of small business prime contractors by making it easier to comply with the limitations on subcontracting, which makes it possible for those contractors to compete for larger contracts than they could in the past. The law also advances the interests of small business subcontractors by encouraging small business prime contractors to award more subcontracts to similarly situated small businesses. Exclusion of a large segment of Federal contracting, such as acquisitions for COTS items, will limit the full implementation of these objectives. Further, the primary FAR clauses implementing the limitations on subcontracting and the nonmanufacturer rule are currently prescribed for use in solicitations and contracts for COTS items. Exclusion of acquisitions for COTS items from these requirements would create confusion among contractors and the Federal contracting workforce. The burden on contractors would not increase significantly if the requirements of section 1651 were applied to acquisitions for COTS items. Under the FAR clauses amended by this rule, contractors are already required to comply with the limitations on subcontracting and the nonmanufacturer rule. The new requirements will result in substantial savings for contractors.

    For these reasons, it is in the best interest of the Federal Government to apply the requirements of the rule to the acquisition of COTS items.

    IV. Expected Cost Savings

    The purpose of this rule is to implement statutory authorities and SBA regulations that are designed to make it easier and less burdensome for small business prime contractors to comply with requirements related to how much work they may subcontract under Federal contracts and task and delivery orders (i.e., the “limitations on subcontracting”). The proposed changes to these requirements would both ease compliance costs and provide more authorized ways to subcontract. Section 1651 of the NDAA for FY 2013 revised and standardized the limitations on subcontracting, including the nonmanufacturer rule. The nonmanufacturer rule is the requirement that the prime contractor provide an end product manufactured by a small business in the United States or its outlying areas. The limitations on subcontracting and the nonmanufacturer rule are meant to ensure that the benefits of contracts and orders awarded to small businesses flow to the intended beneficiaries.

    Prior to section 1651, the limitations on subcontracting and the nonmanufacturer rule were inconsistent across the small business programs. For example, under the 8(a) and WOSB Programs, the prime contractor was required to perform a certain percentage of work itself, whereas under the HUBZone and SDVOSB Programs, the prime contractor could include subcontracts to other HUBZone small business or SDVOSB concerns in the percentage of work it performed. Similarly, with regard to the nonmanufacturer rule, a prime contractor for a contract or order set aside or awarded on a sole-source basis under the HUBZone Program was required to provide products manufactured by another HUBZone small business, but for awards under the other small business programs, the prime contractor was required to provide products manufactured by any small business.

    In addition, the basis of the limitations on subcontracting has changed. Prior to section 1651, the limitations on subcontracting were calculated as a percentage of work to be performed by a prime contractor; the calculation was based on the contractor's costs to perform the contract (e.g., salaries and other allowable costs under FAR part 31). As a result of section 1651, the limitations on subcontracting will be calculated as a percentage of the overall contract or order amount (i.e., the contract price, including costs and profit or fee) to be spent by the prime contractor on subcontractors. For small businesses, this change will reduce the burden associated with tracking and documenting compliance with the limitations on subcontracting.

    Section 1651 also applied the concept of “similarly situated entities” to all small business programs. A similarly situated entity is a small business subcontractor that has the same small business program status as that which qualified the prime contractor for the prime contract. The percentage of the contract or order amount that the prime contractor spends on subcontractors who are similarly situated entities is not considered subcontracted for purposes of compliance with the limitations on subcontracting. Prior to section 1651, small businesses that wanted to work together to comply with the limitations on subcontracting were required to form a joint venture or a new legal entity (except in small business programs where the concept of similarly situated entities was already applied). The concept of similarly situated entities eliminates the need for paperwork, coordination, and other costs associated with forming such a joint venture or new legal entity simply to comply with the limitations on subcontracting.

    These important changes allow small businesses greater flexibility on how they choose to comply with the limitations on subcontracting. The impact is illustrated in the following example of a non-construction contract:

    Limitations on subcontracting Previous New Contract Value $1,000 $1,000 Small Business' Cost of Contract Performance incurred for personnel $800 Not tracked. LOS Requirement Must spend $400—i.e., 50 percent of the cost of contract performance incurred for its own personnel May pay up to $500 (50 percent of the contract price) to a non-similarly situated entity, e.g., large business, AND/OR subcontract to a similarly situated entity without limitation.

    Under the current limitations on subcontracting, the small business only has one way to comply. In the example above, it must spend at least $400 on its own employees and, therefore, must be able to track its contract costs to ensure compliance with the requirement. Under the new limitations on subcontracting, there are multiple and less costly ways to comply, and the small business can choose the most efficient option, as demonstrated below:

    • The small business can continue to spend $400 on its own employees and subcontract $400 to any business, as it did to comply with the previous limitations on subcontracting. Because the prime contractor is not subcontracting more than $500 to businesses that are not similarly situated entities, it will meet the new limitations on subcontracting.

    • The small business can subcontract to any combination of similarly situated and non-similarly situated entities and remain in compliance with the new limitations on subcontracting as long as the amount spent on non-similarly situated entities does not exceed $500. For example, the small business can subcontract $500 to any business and spend $300 on its own employees, or subcontract $500 to any business, $100 to a similarly situated entity, and spend only $200 on its own employees.

    SBA's final rule specified that similarly situated entities must also comply with the limitations on subcontracting. As part of implementing section 1651, the Small Business Administration (SBA) made a few more revisions to their regulations that are reflected in this FAR rule:

    • The nonmanufacturer rule does not apply to small business set-asides at or below $150,000. Note that currently, the FAR applies the nonmanufacturer rule to small business set-asides above $25,000.

    • Waivers of the nonmanufacturer rule will now be allowed for procurements under the HUBZone Program. Such waivers allow a HUBZone small business to provide the product of any size business.

    • In the event SBA grants a nonmanufacturer rule waiver after the issuance of a solicitation, but before award, contracting officers are required to amend that solicitation to notify potential offerors of the waiver and to give them more time to submit proposals.

    The above changes drive both costs and savings; however, the rule is expected to result in net savings to small entities, as well as to the Government. Since the rule will only revise regulations under the various small business programs, there will be no costs or savings to large businesses.

    The following is a summary of the estimated public cost savings calculated in perpetuity in 2016 dollars at a 7-percent discount rate:

    Present Value at 7 percent −$271,391,140 Annualized 7 percent −$18,997,380

    The full cost analysis narrative can be accessed at http://www.regulations.gov.

    V. Executive Orders 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is a significant regulatory action and, therefore, was subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

    VI. Executive Order 13771

    This rule is considered to be an E.O. 13771 deregulatory action. Details on the estimated cost savings can be found in section IV. of this preamble.

    VII. Regulatory Flexibility Act

    The change may have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The Initial Regulatory Flexibility Analysis (IRFA) has been performed and is summarized as follows:

    DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement regulatory changes made by the Small Business Administration (SBA) in its final rule published in the Federal Register at 81 FR 34243 on May 31, 2016. SBA's final rule implements the statutory requirements of section 1651 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2013. Section 1651 revised and standardized the limitations on subcontracting, including the nonmanufacturer rule, that apply to small business concerns under FAR part 19 procurements.

    The objectives of this proposed rule are to apply the limitations on subcontracting consistently to the small business concerns identified in FAR 19.000(a)(3) and to change the method of calculation to the percentage of the award amount to be spent on subcontractors. The legal basis for the rule is section 1651 of the NDAA for FY 2013, codified at section 46 of the Small Business Act (15 U.S.C. 657s).

    This rule may have a positive economic impact on small businesses, because it will make application of the limitations on subcontracting and the nonmanufacturer rule uniform across all small business programs and make it easier to calculate compliance with the limitations on subcontracting. Through the ability to meet the limitations by means of subcontracts with similarly situated entities, this rule will make it possible for small businesses to compete for larger contracts than they could in the past. The rule will encourage small business prime contractors to award subcontracts to other, similarly situated, small businesses. Analysis of the System for Award Management (SAM) indicates there are over 321,938 small business registrants. Firms looking to be prime contractors of Government contracts are required to register in SAM. However, firms do not need to register in SAM to participate in subcontracting. Thus, the number of small business firms impacted by this rule may be greater than the number of firms registered in SAM.

    This proposed rule does not include any new reporting or recordkeeping requirements for small entities. This rule does not include any new compliance requirements. The FAR already required compliance with the limitations on subcontracting and the nonmanufacturer rule for small business prime contractors receiving awards pursuant to set-aside and sole-source acquisitions under part 19. This rule simply revises the limitations on subcontracting and the nonmanufacturer rule to match that required by section 1651 of the NDAA for FY 2013. According to the Federal Procurement Data System (FPDS), in fiscal year 2015 there were 45,963 small business prime contractors performing on acquisitions to which the limitations on subcontracting or the nonmanufacturer rule would apply.

    The proposed rule does not duplicate, overlap, or conflict with any other Federal rules.

    There are no known significant alternative approaches to the proposed rule that would meet the requirements of the applicable statute.

    The Regulatory Secretariat Division has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat Division. DoD, GSA, and NASA invite comments from small business concerns and other interested parties on the expected impact of this rule on small entities.

    DoD, GSA, and NASA will also consider comments from small entities concerning the existing regulations in subparts affected by this rule consistent with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FAR Case 2016-011) in correspondence.

    VIII. Paperwork Reduction Act

    The Paperwork Reduction Act (44 U.S.C. chapter 35) does apply; however, these changes to the FAR do not impose additional information collection requirements to the paperwork burden previously approved under OMB Control Number 3245-0374, titled: Certification for the Women-Owned Small Business Federal Contract Program.

    List of Subjects in 48 CFR Parts 19 and 52

    Government procurement.

    Dated: November 19, 2018. William F. Clark, Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.

    Therefore, DoD, GSA, and NASA are proposing to amend 48 CFR parts 19 and 52 as set forth below:

    1. The authority citation for 48 CFR parts 19 and 52 continues to read as follows: Authority:

    40 U.S.C. 121(c); 10 U.S.C. chapter 137; and 51 U.S.C. 20113.

    PART 19—SMALL BUSINESS PROGRAMS 2. Amend section 19.001 by removing the definition “Nonmanufacturer rule” and adding, in alphabetical order, the definition “Similarly situated entity” to read as follows:
    19.001 Definitions.

    “Similarly situated entity” means a first-tier subcontractor, including an independent contractor, that has the same small business program status as that which qualified the prime contractor for the award; and is considered small for the NAICS code the prime contractor assigned to the subcontract the subcontractor will perform. An example of a similarly situated entity is a first-tier subcontractor that is a HUBZone small business concern for a HUBZone set-aside or sole-source award under the HUBZone Program.

    19.102 [Amended]
    3. Amend section 19.102 by removing paragraph (f). 4. Add section 19.103 to read as follows.
    19.103 Nonmanufacturer rule.

    (a) Application. (1) The nonmanufacturer rule applies to small business set-asides above $150,000; it does not apply to small business set-asides at or below $150,000. The nonmanufacturer rule applies to all set-aside and sole-source awards under the 8(a), HUBZone, Service-Disabled Veteran-Owned Small Business, Women-Owned Small Business programs regardless of dollar value.

    (2) The nonmanufacturer rule applies to nonmanufacturers in accordance with paragraph (b) and to kit assemblers who are nonmanufacturers in accordance with paragraph (c).

    (b) Nonmanufacturers. Any concern, including suppliers, that submits an offer for a set-aside or a sole-source award in accordance with part 19, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce (i.e., a “nonmanufacturer”), is required to—

    (1) Provide an end item that a small business has manufactured, processed, or produced in the United States or its outlying areas (see paragraph (d) of this section for determining the manufacturer of an end item);

    (2) Not exceed 500 employees;

    (3) Be primarily engaged in the retail or wholesale trade and normally sell the type of item being supplied; and

    (4) Take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice; for example, providing storage, transportation, or delivery.

    (c) Kit assemblers. When the end item being acquired is a kit of supplies—

    (1) The offeror may not exceed 500 employees; and

    (2) At least 50 percent of the total cost of the components of the kit shall be manufactured, processed, or produced in the United States or its outlying areas by business concerns that are small under the size standards for the NAICS codes of the components of the kit.

    (d) Identification of manufacturers. For the purposes of applying the nonmanufacturer rule, the manufacturer, processor, or producer is the concern that manufactures, processes, or produces an end item with its own facilities (i.e., transforms raw materials, miscellaneous parts, or components into the end item being acquired). See 13 CFR 121.406(b)(2).

    (e) Waiver of nonmanufacturer rule. (1) SBA may grant an individual or a class waiver to the nonmanufacturer rule to allow a nonmanufacturer to provide the end item of an other than small business without regard to the place of manufacture, processing, or production.

    (i) Class waiver. An agency may request that SBA waive the requirement at paragraph (b)(1) or (c)(2) of this section for a specific product or class of products. SBA may issue a waiver when SBA has determined that there are no small business manufacturers, processors, or producers in the United States or its outlying areas for a specific product or class of products.

    (ii) Individual waiver. The contracting officer may request a waiver of the requirements at paragraph (b)(1) or (c)(2) of this section for an individual acquisition once the contracting officer determines through market research that no known small business manufacturers, processors, or producers in the United States or its outlying areas can reasonably be expected to offer an end item meeting the requirements of the solicitation. An individual waiver applies only to a specific acquisition.

    (2) Waiver requests. Requests for waivers shall include the content specified at 13 CFR 121.1204 and shall be sent via email to [email protected] or by mail to the—Director, Office of Government Contracting, Small Business Administration, 409 Third Street SW, Washington, DC 20416.

    (3) List of class waivers. The current listing of class waivers is available at http://www.sba.gov/content/class-waivers, or contact the SBA Office of Government Contracting.

    (4) Notification of waiver. The contracting officer shall provide potential offerors with written notification of any class or individual waiver in the solicitation. If providing the notification after solicitation issuance, the contracting officer shall provide potential offerors a reasonable amount of additional time to respond to the solicitation.

    (f) Multiple-item acquisitions. (1) If at least 50 percent of the estimated acquisition cost is composed of items that are manufactured, processed, or produced by small business concerns, then a waiver of the nonmanufacturer rule is not required. There is no requirement that each item acquired in a multiple-item acquisition be manufactured, processed, or produced by a small business in the United States or its outlying areas.

    (2) If more than 50 percent of the estimated acquisition cost is composed of items manufactured, processed, or produced by other than small business concerns, then a waiver is required. SBA may grant an individual waiver for one or more items in an acquisition in order to ensure that at least 50 percent of the cost of the items to be supplied by the nonmanufacturer comes from small business manufacturers, processors, and producers in the United States or its outlying areas or are subject to a waiver.

    (3) If a small business offeror is both a manufacturer of item(s) and a nonmanufacturer of other item(s) for an acquisition, the contracting officer shall apply the manufacturer size standard.

    19.303 [Amended]
    5. Amend section 19.303 by removing from paragraph (a)(2) “of 19.102(f)” and adding “of 19.103” in its place.
    19.502-2 [Amended]
    6. Amend section 19.502-2 by removing paragraph (c). 7. Amend section 19.508 by— a. Revising paragraphs (c), (d) and (e); and b. Adding paragraph (g).

    The revisions and addition read as follows:

    19.508 Solicitation provisions and contract clauses.

    (c) The contracting officer shall insert the clause at 52.219-6, Notice of Total Small Business Set-Aside, in solicitations and contracts involving total small business set-asides or reserves. This includes multiple-award contracts when orders may be set aside for any of the small business concerns identified in 19.000(a)(3), as described in 8.405-5 and 16.505(b)(2)(i)(F). Use the clause at 52.219-6 with its Alternate I when including FPI in the competition in accordance with 19.504.

    (d) The contracting officer shall insert the clause at 52.219-7, Notice of Partial Small Business Set-Aside, in solicitations and contracts involving partial small business set-asides. This includes part or parts of multiple-award contracts, including those described in 38.101. Use the clause at 52.219-7 with its Alternate I when including FPI in the competition in accordance with 19.504.

    (e) The contracting officer shall insert the clause at 52.219-14, Limitations on Subcontracting, in solicitations and contracts for supplies, services, and construction, if any portion of the requirement is to be set aside or reserved for small business and the contract amount is expected to exceed $150,000, and in any solicitations and contracts that are set aside or awarded on a sole-source basis in accordance with subparts 19.8, 19.13, 19.14, or 19.15, regardless of dollar value. This includes multiple-award contracts when orders may be set aside for small business concerns, as described in 8.405-5 and 16.505(b)(2)(i)(F).

    (g)(1) The contracting officer shall insert the clause at 52.219-XX, Nonmanufacturer Rule, in solicitations and contracts when the item being acquired has been assigned a manufacturing or supply NAICS code and—

    (i) Any portion of the requirement is set aside for small business and is expected to exceed $150,000; or

    (ii) The requirement is set aside or awarded on a sole-source basis in accordance with subparts 19.8, 19.13, 19.14, or 19.15, regardless of dollar value.

    (2) The contracting officer shall not insert the clause at 52.219-XX when SBA has waived the nonmanufacturer rule (see 19.103(e)).

    8. Amend section 19.811-3 by a. Revising paragraphs (d) and (e); and b. Adding a new paragraph (f).

    The revision and addition read as follows:

    19.811-3 Contract clauses.

    (d) The contracting officer shall insert the clause at 52.219-18, Notification of Competition Limited to Eligible 8(a) Participants, in competitive solicitations and contracts when the acquisition is accomplished using the procedures of 19.805. Use the clause at 52.219-18 with its Alternate I when competition is to be limited to 8(a) concerns within one or more specific SBA districts pursuant to 19.804-2.

    (e) The contracting officer shall insert the clause at 52.219-14, Limitations on Subcontracting, in accordance with the prescription at 19.508(e).

    (f) The contracting officer shall insert the clause at 52.219-XX, Nonmanufacturer Rule, in accordance with the prescription at 19.508(g).

    9. Amend section 19.1303 by revising paragraph (e) to read as follows:
    19.1303 Status as a HUBZone small business concern.

    (e) A HUBZone small business concern may submit an offer for supplies as a nonmanufacturer if it meets the requirements of the nonmanufacturer rule set forth at 13 CFR 121.406.

    19.1308 [Removed and Reserved]
    10. Remove and reserve section 19.1308. 11. Revise section 19.1309 to read as follows:
    19.1309 Contract clauses.

    (a) The contracting officer shall insert the clause at 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award, in solicitations and contracts for acquisitions that are set aside, or reserved for, or awarded on a sole-source basis to, HUBZone small business concerns under 19.1305 or 19.1306. This includes multiple-award contracts when orders may be set aside for HUBZone small business concerns as described in 8.405-5 and 16.505(b)(2)(i)(F).

    (b) The contracting officer shall insert the clause at 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns, in solicitations and contracts for acquisitions conducted using full and open competition.

    (c) The contracting officer shall insert the clause at 52.219-14, Limitations on Subcontracting, in accordance with the prescription at 19.508(e).

    (d) The contracting officer shall insert the clause at 52.219-XX, Nonmanufacturer Rule, in accordance with the prescription at 19.508(g).

    19.1403 [Amended]
    11. Amend section 19.1403 by removing from paragraph (d) “19.102(f)” and adding “19.103” in its place. 12. Revise section 19.1407 to read as follows:
    19.1407 Contract clauses.

    (a) The contracting officer shall insert the clause at 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside, in solicitations and contracts for acquisitions that are set aside or reserved for, or awarded on a sole-source basis to, service-disabled veteran-owned small business concerns under 19.1405 and 19.1406. This includes multiple-award contracts when orders may be set aside for service-disabled veteran-owned small business concerns as described in 8.405-5 and 16.505(b)(2)(i)(F).

    (b) The contracting officer shall insert the clause at 52.219-14, Limitations on Subcontracting, in accordance with the prescription at 19.508(e).

    (c) The contracting officer shall insert the clause at 52.219-XX, Nonmanufacturer Rule, in accordance with the prescription at 19.508(g).

    13. Amend section 19.1507 by— a. Removing from paragraph (a) “clause 52.219-29” and adding “clause at 52.219-29” in its place; b. Removing from paragraph (b) “clause 52.219-30” and adding “clause at 52.219-30” in its place; and c. Adding paragraphs (c) and (d) to read as follows:
    19.1507 Contract clauses.

    (c) The contracting officer shall insert the clause at 52.219-14, Limitations on Subcontracting, in accordance with the prescription at 19.508(e).

    (d) The contracting officer shall insert the clause at 52.219-XX, Nonmanufacturer Rule, in accordance with the prescription at 19.508(g).

    PART 52—SOLICITATION PROVISIONS AND CONTRACT CLAUSES 14. Amend section 52.204-8 by revising the date of the provision and paragraph (a)(3) to read as follows:
    52.204-8 Annual Representations and Certifications. Annual Representations and Certifications (Date)

    (a)(3) If the acquisition is set aside for small business and has a value above $150,000, or is an 8(a), HUBZone, Service-Disabled Veteran-Owned, Economically Disadvantaged Women-Owned, or Women-Owned Small Business set-aside or sole-source award regardless of dollar value, the small business size standard for a concern that submits an offer for a set-aside or sole-source award in accordance with part 19, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees.

    15. Amend section 52.212-1 by revising the date of the provision and paragraph (a) to read as follows:
    52.212-1 Instructions to Offerors—Commercial Items. Instructions to Offerors—Commercial Items (Date)

    (a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code and small business size standard for this acquisition appear in Block 10 of the solicitation cover sheet (SF 1449). However, if the acquisition is set aside for small business and has a value above $150,000, or is an 8(a), HUBZone, Service-Disabled Veteran-Owned, Economically Disadvantaged Women-Owned, or Women-Owned Small Business set-aside or sole-source award regardless of dollar value, the small business size standard for a concern that submits an offer for a set-aside or sole-source award in accordance with part 19, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees.

    16. Amend section 52.212-5 by— a. Revising the date of the clause and paragraphs (b)(11), (b)(12), (b)(14), (b)(15), (b)(19), (b)(21), (b)(22), (b)(23), and (b)(24); b. Redesignating paragraphs (b)(25) through (b)(60) as paragraphs (b)(26) through (b)(61), respectively; and c. Adding a new paragraph (b)(25).

    The revisions and additions read as follows:

    52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items. Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Date)

    (b) * * *

    __ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (DATE) (15 U.S.C. 657a).

    __ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (DATE) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

    __ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (DATE) (15 U.S.C. 644).

    __ (ii) Alternate I (DATE).

    __ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (DATE) (15 U.S.C. 644).

    __ (ii) Alternate I (DATE) of 52.219-7.

    __ (19) 52.219-14, Limitations on Subcontracting (DATE) (15 U.S.C. 657s).

    __ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (DATE) (15 U.S.C. 657f).

    __ (22) 52.219-28, Post Award Small Business Program Rerepresentation (DATE) (15 U.S.C. 632(a)(2)).

    __ (23) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (DATE) (15 U.S.C. 637(m)).

    __ (24) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (DATE) (15 U.S.C. 637(m)).

    __ (25) 52.219-XX, Nonmanufacturer Rule (DATE) (15 U.S.C. 657s).

    17. Amend section 52.219-1 by— a. Revising the date of the provision; b. Removing from paragraph (b)(1) “—” and adding a space in its place; and c. Revising paragraph (b)(3) to read as follows:
    52.219-1 Small Business Program Representations. Small Business Program Representations (Date)

    (b) * * *

    (3) If the acquisition is set aside for small business and has a value above $150,000, or is an 8(a), HUBZone, Service-Disabled Veteran-Owned, Economically Disadvantaged Women-Owned, or Women-Owned Small Business set-aside or sole-source award regardless of dollar value, the small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees.

    18. Amend section 52.219-3 by— a. Revising the date of the clause; b. Revising paragraph (a); c. Removing from paragraph (b)(3) “set-aside” and adding “set aside” in its place; d. Removing paragraphs (d), (e), and (f); e. Redesignating paragraph (g) as paragraph (d); and f. Removing Alternate I.

    The revision reads as follows:

    52.219-3 Notice of HUBZone Set-Aside or Sole-Source Award.

    As prescribed in 19.1309(a), insert the following clause:

    Notice of HUBZone Set-Aside or Sole-Source Award (Date)

    (a) Definition. “HUBZone small business concern,” as used in this clause, means a small business concern, certified by the Small Business Administration (SBA), that appears on the List of Qualified HUBZone Small Business Concerns maintained by the SBA (13 CFR 126.103).

    19. Amend section 52.219-4 by— a. Revising the date of the clause and paragraphs (a), (d) and (e) to read as follows; and b. Removing Alternate I.
    52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns. Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Date)

    (a) Definition. “Similarly situated entity,” as used in this clause, means a first-tier subcontractor, including an independent contractor, that has the same small business program status as that which qualified the prime contractor for the award; and is considered small for the NAICS code the prime contractor assigned to the subcontract the subcontractor will perform. An example of a similarly situated entity is a first-tier subcontractor that is a HUBZone small business concern for a HUBZone set-aside or sole-source award under the HUBZone Program.

    (d) Agreement. By submission of an offer and execution of a contract, a HUBZone small business concern agrees that, in the case of a contract for—

    (1) Services (except construction), it will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the 50 percent subcontract amount that cannot be exceeded;

    (2) Supplies (other than procurement from a nonmanufacturer of such supplies), it will not pay more than 50 percent of the amount paid by the Government for contract performance, excluding the cost of materials (see 13 CFR 125.1), to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count toward the 50 percent subcontract amount that cannot be exceeded;

    (3) General construction, it will not pay more than 85 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the 85 percent subcontract amount that cannot be exceeded; or

    (4) Construction by special trade contractors, it will not pay more than 75 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the 75 percent subcontract amount that cannot be exceeded.

    (e) A HUBZone joint venture agrees that the aggregate of the HUBZone small business concerns to the joint venture, not each concern separately, will perform the applicable requirements specified in paragraph (d) of this clause.

    20. Amend section 52.219-6 by— a. Revising the date of the clause; b. Removing paragraph (d); c. Removing Alternate I; d. Redesignating Alternate II as Alternate I; and e. Revising the date of newly redesignated Alternate I.

    The revisions read as follows:

    52.219-6 Notice of Total Small Business Set-Aside. Notice of Total Small Business Set-Aside (Date)

    Alternate I (DATE). As prescribed in 19.508(c), substitute the following paragraph (c) for paragraph (c) of the basic clause:

    21. Amend section 52.219-7 by— a. Revising the date of the clause; b. Removing paragraph (c); c. Removing Alternate I; d. Redesignating Alternate II as Alternate I; and e. Revising the newly redesignated Alternate I.

    The revision reads as follows:

    52.219-7 Notice of Partial Small Business Set-Aside. Notice of Partial Small Business Set-Aside (Date)

    Alternate I (Date). As prescribed in 19.508(d), add the following paragraph (c) to the basic clause:

    (c) Notwithstanding paragraph (b) of this clause, offers from Federal Prison Industries, Inc., will be solicited and considered for both the set-aside and non-set-aside portion of this requirement.

    22. Amend section 52.219-14 by— a. Removing from the introductory text of the clause “or 19.811-3(e)”; b. Revising the date of the clause; c. Redesignating paragraph (c) as paragraph (e) and paragraph (b) as paragraph (c); d. Revising newly designated paragraphs (c) and (e); and e. Adding paragraphs (b), (d), and (f).

    The revisions and additions read as follows:

    52.219-14 Limitations on Subcontracting. Limitations on Subcontracting (Date)

    (b) Definition. “Similarly situated entity,” as used in this clause, means a first-tier subcontractor, including an independent contractor, that has the same small business program status as that which qualified the prime contractor for the award; and is considered small for the NAICS code the prime contractor assigned to the subcontract the subcontractor will perform. An example of a similarly situated entity is a first-tier subcontractor that is a HUBZone small business concern for a HUBZone set-aside or sole-source award under the HUBZone Program.

    (c) Applicability. This clause applies only to—

    (1) Contracts that have been set aside or reserved any of the small business concerns identified in 19.000(a)(3);

    (2) Part or parts of a multiple-award contract that have been set aside for any of the small business concerns identified in 19.000(a)(3);

    (3) Contracts that have been awarded on a sole-source basis in accordance with subparts 19.8, 19.13, 19.14, and 19.15; and

    (4) Orders set aside for any of the small business concerns identified in 19.000(a)(3) under multiple-award contracts as described in 8.405-5 and 16.505(b)(2)(i)(F).

    (d) Independent contractors. An independent contractor shall be considered a subcontractor.

    (e) By submission of an offer and execution of a contract, the Offeror/Contractor agrees that, in the case of a contract for—

    (1) Services (except construction), it will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the 50 percent subcontract amount that cannot be exceeded;

    (2) Supplies (other than procurement from a nonmanufacturer of such supplies), it will not pay more than 50 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the 50 percent subcontract amount that cannot be exceeded;

    (3) General construction, it will not pay more than 85 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the 85 percent subcontract amount that cannot be exceeded; or

    (4) Construction by special trade contractors, it will not pay more than 75 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the 75 percent subcontract amount that cannot be exceeded.

    (f) A joint venture agrees that, in the performance of the contract, the applicable percentage specified in paragraph (e) of this clause will be performed by the aggregate of the joint venture participants.

    23. Amend section 52.219-18 by— a. Revising the date of the clause; b. Removing paragraph (d)(1), redesignating paragraph (d)(2) as paragraph (d) and c. Removing Alternate II.

    The revision reads as follows:

    52.219-18 Notification of Competition Limited to Eligible 8(a) Participants. Notification of Competition Limited to Eligible 8(a) Participants (Date)
    24. Amend section 52.219-27 by— a. Revising the date of the clause; b. Removing paragraph (d); c. Redesignating paragraph (e) as paragraph (d); d. Revising the newly redesignated paragraph (d); and e. Removing paragraph (f).

    The revisions read as follows:

    52.219-27 Notice of Service-Disabled Veteran-Owned Small Business Set-Aside. Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Date)

    (d) A joint venture may be considered a service-disabled veteran owned small business concern if—

    (1) At least one member of the joint venture is a service-disabled veteran-owned small business concern, and makes the following representations:

    (i) That it is a service-disabled veteran-owned small business concern, and

    (ii) That it is a small business concern under the North American Industry Classification Systems (NAICS) code assigned to the procurement;

    (2) Each other concern is small under the size standard corresponding to the NAICS code assigned to the procurement;

    (3) The joint venture meets the requirements of paragraph 7 of the explanation of Affiliates in 19.101 of the Federal Acquisition Regulation; and

    (4) The joint venture meets the requirements of 13 CFR 125.15(b).

    25. Amend section 52.219-28 by revising the date of the clause and paragraph (d) to read as follows:
    52.219-28 Post-Award Small Business Program Rerepresentation. Post-Award Small Business Program Rerepresentation (Date)

    (d) If the acquisition was set aside for small business and has a value above $150,000, or is an 8(a), HUBZone, Service-Disabled Veteran-Owned, Economically Disadvantaged Women-Owned, or Women-Owned Small Business set-aside or sole-source award regardless of dollar value, the small business size standard for a Contractor providing a product which it does not manufacture, process, or produce itself, for a contract other than a construction or service contract, is 500 employees.

    26. Amend section 52.219-29 by— a. Revising the date of the clause; b. Removing from the definition “Economically disadvantaged women-owned small business (EDWOSB)” “means- A small” and adding “means a small” in its place; c. Removing from paragraph (c)(3) “contracting officer” and adding “Contracting Officer” in its place; d. Removing paragraph (d); e. Redesignating paragraph (e) as paragraph (d); f. Removing newly redesignated paragraph (d)(4); g. Redesignating paragraph (d)(5) as (d)(4) and revising newly redesignated paragraph (d)(4); and h. Removing paragraph (f).

    The revisions read as follows:

    52.219-29 Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns. Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Date)

    (d) * * *

    (4) The Contracting Officer executes the contract in the name of the EDWOSB or joint venture.

    27. Amend section 52.219-30 by— a. Revising the date of the clause and the introductory text of paragraph (a); b. Removing from the second sentence of paragraph (c)(1) “WOSB program” and adding “WOSB Program” in its place; c. Removing paragraph (d); d. Redesignating paragraph (e) as paragraph (d); e. Removing newly redesignated paragraph (d)(4); f. Redesignating paragraph (d)(5) as (d)(4) and revising newly redesignated paragraph (d)(4); g. Removing paragraph (f).

    The revision reads as follows:

    52.219-30 Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program. Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Date)

    (a) Definitions. As used in this clause—

    (d) * * *

    (4) The Contracting Officer executes the contract in the name of the WOSB concern eligible under the WOSB Program or joint venture.

    28. Add section 52.219-XX to read as follows:
    52.219-XX Nonmanufacturer Rule.

    As prescribed in 19.508(g), insert the following clause:

    Nonmanufacturer Rule (Date)

    (a) Definitions. As used in this clause—

    “Manufacturer” means the concern that transforms raw materials, miscellaneous parts, or components into the end item. Concerns that only minimally alter the item being procured do not qualify as manufacturers of the end item. Concerns that add substances, parts, or components to an existing end item to modify its performance will not be considered the end item manufacturer, where those identical modifications can be performed by and are available from the manufacturer of the existing end item.

    “Nonmanufacturer” means a concern, including a supplier, that provides an end item it did not manufacture, process, or produce.

    (b) Applicability.

    (1) This clause does not apply to contracts awarded pursuant to the unrestricted portion of a partial set-aside or to a contractor that is the manufacturer of the product or end item.

    (2) This clause applies to—

    (i) Contracts that have been awarded pursuant to a set-aside, in total or in part, for any of the small business concerns identified in 19.000(a)(3);

    (ii) Contracts that have been awarded on a sole-source basis in accordance with subparts 19.8, 19.13, 19.14, and 19.15; and

    (iii) Orders set aside for any of the small business concerns identified in 19.000(a)(3) under multiple-award contracts as described in 8.405-5 and 16.505(b)(2)(i)(F).

    (c) Requirements.

    (1) The Contractor shall—

    (i) Provide an end item that a small business has manufactured, processed, or produced in the United States or its outlying areas; for kit assemblers who are nonmanufacturers, see paragraph (c)(2) of this clause instead;

    (ii) Be primarily engaged in the retail or wholesale trade and normally sell the type of item being supplied; and

    (iii) Take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice; for example, providing storage, transportation, or delivery.

    (2) When the end item being acquired is a kit of supplies, at least 50 percent of the total cost of the components of the kit shall be manufactured, processed, or produced in the United States or its outlying areas by small business concerns. Where the Government has specified an item for the kit that is not produced by small business concerns in the United States or its outlying areas, such item is excluded from the calculation of total cost.

    (End of clause)
    [FR Doc. 2018-25506 Filed 12-3-18; 8:45 am] BILLING CODE 6820-EP-P
    DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Parts 208, 212, 213, 215, 216, 217, 234, and 237 [Docket DARS-2018-0055] RIN 0750-AJ74 Defense Federal Acquisition Regulation Supplement: Restrictions on Use of Lowest Priced Technically Acceptable Source Selection Process (DFARS Case 2018-D010) AGENCY:

    Defense Acquisition Regulations System, Department of Defense (DoD).

    ACTION:

    Proposed rule.

    SUMMARY:

    DoD proposes to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement sections of the National Defense Authorization Acts for Fiscal Years 2017 and 2018 that establish limitations and prohibitions on the use of the lowest price technically source selection process.

    DATES:

    Comments on the proposed rule should be submitted in writing to the address shown below on or before February 4, 2019, to be considered in the formation of a final rule.

    ADDRESSES:

    Submit comments identified by DFARS Case 2018-D010, using any of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Search for “DFARS Case 2018-D010.” under the heading “Enter keyword or ID” and selecting “Search.” Select “Comment Now and” follow the instructions provided to submit a comment. Please include “DFARS Case 2018-D010” on your attached documents.

    Email: [email protected] Include DFARS Case 2018-D010 in the subject line of the message.

    Fax: 571-372-6093.

    Mail: Defense Acquisition Regulations System, Attn: Ms. Carrie Moore, OUSD (A&S)DPC/DARS, Room 3B941, 3060 Defense Pentagon, Washington, DC 20301-3060.

    Comments received generally will be posted without change to http://www.regulations.gov, including any personal information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Ms. Carrie Moore, telephone 703-372-6093.

    SUPPLEMENTARY INFORMATION:

    I. Background

    DoD is proposing to amend the DFARS to implement the limitations and prohibitions on use of the lowest prices technical acceptable (LPTA) source selection process provided in sections 813, 814, and 892 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017 (Pub. L. 114-328) and sections 822, 832, 882, and 1002 of the NDAA for FY 2018 (Pub. L. 115-91). The following is a summary of the statutory restrictions:

    • Section 813 of the NDAA for FY 2017, as amended by section 822 of the NDAA for FY 2018, establishes that the LPTA source selection process shall only be used when—

    ○ Minimum requirements can be described clearly and comprehensively and expressed in terms of performance objectives, measures, and standards that will be used to determine the acceptability of offers;

    ○ No, or minimal, value will be realized from a proposal that exceeds the minimum technical or performance requirements;

    ○ The proposed technical approaches will require no, or minimal, subjective judgment by the source selection authority as to the desirability of one offeror's proposal versus a competing proposal;

    ○ The source selection authority has a high degree of confidence that reviewing the technical proposals of all offerors would not result in the identification of characteristics that could provide value or benefit;

    ○ No, or minimal, additional innovation or future technological advantage will be realized by using a different source selection process;

    ○ Goods to be procured are predominantly expendable in nature, are nontechnical, or have a short life expectancy or short shelf life;

    ○ The contract file contains a determination that the lowest price reflects full life-cycle costs of the product(s) or service(s) being acquired; and

    ○ The contracting officer documents the contract file describing the circumstances justifying the use of the lowest price technically acceptable source selection process.

    Section 813, as amended, further provides that use of the LPTA process should be avoided, to the maximum extent practicable, when acquiring information technology, cybersecurity services, systems engineering and technical assistance services, advanced electronic testing, other knowledge-based professional services, personal protective equipment, or certain services in support of contingency or other operations outside the United States.

    • Section 814 of the NDAA for FY 2017 prohibits the use of reverse auctions or the LPTA source selection process when purchasing personal protective equipment, if the level of quality or failure of the item could result in combat casualties. Section 882 of the NDAA for FY 2018 amends section 814 to further prohibit the use of reverse auctions or the LPTA source selection process for aviation critical safety items as defined in 10 U.S.C. 2319(g).

    • Section 832 of the NDAA for FY 2018 prohibits the use of the LPTA source selection process for engineering and manufacturing development (EMD) of a major defense acquisition program (MDAP) for which budgetary authority is requested beginning in FY 2019.

    • Section 892 of the NDAA for FY 2017, as amended by section 1002 of the NDAA for FY 2018, amended 10 U.S.C. 254b to prohibit the use of the LPTA source selection process when acquiring auditing services and requires selection of service providers based on the best value to the Department, as determined by the resource sponsor for an auditing contract.

    II. Discussion and Analysis

    Use of the LPTA source selection process is implemented in Federal Acquisition Regulation (FAR) section 15.101-2. To supplement the FAR, DoD is proposing to add a new DFARS section 215.101-2-70 that addresses the various limitations and prohibitions on the use of the LPTA source selection process. This new section is broken into two paragraphs: Paragraph (a) addresses the limitations provided in section 813 of the NDAA for FY 2017, as amended by section 822 of the NDAA for FY 2018; paragraph (b) addresses the prohibitions provided in sections 814, 832, and 892 of the NDAA for FY 2017, as amended by sections 882 and 1002 of the NDAA for FY 2018.

    Currently, reverse auctions are not addressed in the FAR or DFARS. To implement the specific restriction on the use of reverse auctions to procure personal protective equipment and aviation critical safety items, DoD is proposing to add a new subpart 217.7X under DFARS part 217, Special Contracting Methods, to address the prohibition associated with reverse auctions under a section titled “Prohibitions.”

    The new statutory limitations and prohibitions on the use of the LPTA source selection process and reverse auctions apply to not only acquisitions conducted using FAR part 15 procedures for negotiation, but also—

    • Orders placed against Federal Supply Schedules using FAR subpart 8.4 procedures;

    • Acquisitions for commercial items using FAR part 12 procedures;

    • Acquisitions conducted using FAR part 13 simplified acquisition procedures; and

    • Orders placed under multiple award indefinite delivery contracts using FAR 16.505 procedures for fair opportunity.

    In order to notify contracting officers of the new limitations and prohibitions when using these other procedures, DoD is proposing to add cross-references to the new limitations and prohibitions outlined at DFARS 215.101-2-70 in DFARS sections 208.405, 212.203, 213.106-1, and 216.505. The new cross-references make clear that the limitations and prohibitions on the use of LPTA at DFARS 215.101-2-70 apply to the type of procurement being conducted. In addition, separate cross-references are added in these sections to highlight the restriction on the use of reverse auctions for the procurement of personal protective equipment and aviation critical safety items at 217.7XXX.

    The new list of prohibitions at DFARS 215.101-2-70(b) includes the prohibitions on use of the LPTA source selection process for EMD of certain MDAPs and for audit services. Special requirements associated with the major system acquisitions are addressed in FAR part 234 and special requirements for the acquisition of audit services are addressed at DFARS 237.270. As such, DoD is proposing to add cross-references at DFARS 234.005-2 and 237.270 to the prohibitions associated with these types of procurement at DFARS 215.101-2-70(b).

    III. Applicability to Contracts at or Below the Simplified Acquisition Threshold and for Commercial Items, Including Commercially Available Off-the-Shelf Items

    This rule does not propose to create any new provisions or clauses or impact any existing provisions or clauses.

    IV. Executive Orders 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

    V. Executive Order 13771

    This proposed rule is not expected to be subject to E.O. 13771, because this rule is not a significant regulatory action under E.O. 12866.

    VI. Regulatory Flexibility Act

    DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The rule primarily affects internal Government requirements determination and acquisition strategy decisions, and contract file documentation requirements. However, an initial regulatory flexibility analysis has been performed and is summarized as follows:

    The rule proposes to revise the Defense Federal Acquisition Regulation Supplement (DFARS) to establish a preference for the use of the tradeoff source selection process for certain safety items and auditing services; prohibit the use of reverse auctions or the lowest priced technically acceptable (LPTA) source selection process for specific supplies and services; and specify criteria for use of the LPTA source selection process. The legal basis for the rule is the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017 (Pub. L. 114-328) and the NDAA for FY 2018 (Pub. L. 115-91).

    DoD does not have access to information on the total number of solicitations issued on an annual basis that did or did not specify the use of the lowest price technically acceptable source selection process. However, the Federal Procurement Data System (FPDS) provides the following information for fiscal year 2016:

    DoD competitive contracts using FAR part 15 procedures. DoD awarded 18,361 new contracts and orders using negotiated competitive procedures, of which 47% were awarded to 5,221 unique small businesses. It is important to note that FPDS does not collect data for solicitations using the LPTA source selection process; therefore, this data applies to solicitations using both tradeoff and LPTA source selection procedures, which will be subject to future considerations and restrictions provided by section 813 of the NDAA for FY 2017 and section 822 of the NDAA for FY 2018.

    Personal protective equipment. Based on information from FPDS for FY 2016, DoD issued 9,130 new competitive contract actions (including task, delivery, and call orders) potentially for combat-related personal protective equipment (PPE) items that could be impacted by restrictions in section 814 of the NDAA for FY 2017. Of those new contract actions, 89% were awarded to 668 unique small businesses.

    Aviation critical safety items. As discussed during the rulemaking process for DFARS 252.209-7010 published in the Federal Register at 76 FR 14641 on March 17, 2011, the identification of aviation critical safety items occurs entirely outside the procurement process and is not captured in FPDS. Therefore, it is not possible to assess the impact on small businesses.

    Audit-related services. DoD issued 46 new competitive contract actions (including task, delivery, and call orders) for audit services which may be impacted by section 1002 of the NDAA for FY 2018. Of those new contract actions, 61% were awarded to 17 unique small businesses. The average award (including all options) to small business was valued over the simplified acquisition threshold.

    Major defense acquisition programs (MDAPs). The impact to small businesses resulting from implementation of sections 832 and 882 of the NDAA for FY 2018 cannot be assessed, since FPDS does not collect data for major defense acquisition programs (MDAPs) or for specific acquisition phases (i.e., engineering and manufacturing development (EMD)). Subject matter experts within DoD know of no instances where the LPTA source selection process has been used for procurement of EMD of an MDAP.

    The proposed rule does not impose any Paperwork Reduction Act reporting or recordkeeping requirements on any small entities. The rule may impact some small businesses as offerors may need to change the way their quotations or offers are structured to conform to proposal instructions and corresponding evaluation criteria when responding to solicitations that use the tradeoff source selection process for supplies or services where the LPTA source selection process is now prohibited or must now be avoided. This incremental impact, which represents the incremental difference between a noncomplex LPTA proposal and additional information required for a tradeoff proposal, is expected to be minimal.

    The rule does not duplicate, overlap, or conflict with any other Federal rules.

    There are no known, significant, alternative approaches to the proposed rule that would meet the requirements of the applicable statute.

    DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.

    DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2018-D010), in correspondence.

    VII. Paperwork Reduction Act

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

    List of Subjects in 48 CFR Parts 208, 212, 213, 215, 216, 217, 234, and 237

    Government procurement.

    Jennifer Lee Hawes, Regulatory Control Officer, Defense Acquisition Regulations System.

    Therefore, 48 CFR parts 208, 212, 213, 215, 216, 217, 234, and 237 are proposed to be amended as follows:

    1. The authority citation for 48 CFR parts 208, 212, 213, 215, 216, 217, 234, and 237 continues to read as follows: Authority:

    41 U.S.C. 1303 and 48 CFR chapter 1.

    PART 208—REQUIRED SOURCES OF SUPPLIES OR SERVICES 2. Amend section 208.405 by redesignating the text as paragraph (1) and adding paragraphs (2) and (3) to read as follows:
    208.405 Ordering procedures for Federal Supply Schedules.

    (2) See 215.101-2-70 for the limitations and prohibitions on the use of the lowest price technically acceptable source selection process, which are applicable to orders placed under Federal Supply Schedules.

    (3) See 217.7XXX for the prohibition on the use of reverse auctions for personal protective equipment and aviation critical safety items.

    PART 212—ACQUISITION OF COMMERCIAL ITEMS 3. Add section 212.203 to read as follows:
    212.203 Procedures for solicitation, evaluation, and award.

    (1) See 215.101-2-70 for the limitations and prohibitions on the use of the lowest price technically acceptable source selection process, which are applicable to the acquisition of commercial items.

    (2) See 217.7XXX for the prohibition on the use of reverse auctions for personal protective equipment and aviation critical safety items.

    PART 213—SIMPLIFIED ACQUISITION PROCEDURES 4. Revise section 213.106-1 to read as follows:
    213.106-1 Soliciting competition.

    (a) Considerations. (2)(i) Include an evaluation factor regarding supply chain risk (see subpart 239.73) when acquiring information technology, whether as a service or as a supply, that is a covered system, is a part of a covered system, or is in support of a covered system, as defined in 239.7301.

    (ii) See 215.101-2-70 for limitations and prohibitions on the use of the lowest price technically acceptable source selection process, which are applicable to simplified acquisitions.

    (iii) See 217.7XXX for the prohibition on the use of reverse auctions for personal protective equipment and aviation critical safety items.

    PART 215—CONTRACTING BY NEGOTIATION 5. Add section 215.101-2 heading to read as follows:
    215.101-2 Lowest price technically acceptable source selection process.
    6. Add section 215.101-2-70 to read as follows:
    215.101-2-70 Limitations and prohibitions.

    The following limitations and prohibitions apply when considering the use of the lowest price technically acceptable source selection procedures.

    (a) Limitations. (1) In accordance with section 813 of the National Defense Authorization Act for Fiscal Year 2017 (Pub. L. 114-328) as amended by section 822 of the National Defense Authorization Act for Fiscal Year 2018 (Pub. L. 115-91) (see 10 U.S.C. 2305 note), the lowest price technically acceptable source selection process shall only be used when—

    (i) Minimum requirements can be described clearly and comprehensively and expressed in terms of performance objectives, measures, and standards that will be used to determine the acceptability of offers;

    (ii) No, or minimal, value will be realized from a proposal that exceeds the minimum technical or performance requirements;

    (iii) The proposed technical approaches will require no, or minimal, subjective judgment by the source selection authority as to the desirability of one offeror's proposal versus a competing proposal;

    (iv) The source selection authority has a high degree of confidence that reviewing the technical proposals of all offerors would not result in the identification of characteristics that could provide value or benefit;

    (v) No, or minimal, additional innovation or future technological advantage will be realized by using a different source selection process;

    (vi) Goods to be procured are predominantly expendable in nature, are nontechnical, or have a short life expectancy or short shelf life;

    (vii) The contract file contains a determination that the lowest price reflects full life-cycle costs (as defined at FAR 7.101) of the product(s) or service(s) being acquired; and

    (viii) The contracting officer documents the contract file describing the circumstances justifying the use of the lowest price technically acceptable source selection process.

    (2) In accordance with section 813 of the National Defense Authorization Act for Fiscal Year 2017, as amended by section 822 of the National Defense Authorization Act for Fiscal Year 2018 (see 10 U.S.C. 2305 note), contracting officers shall avoid, to the maximum extent practicable, using the lowest price technically acceptable source selection process in the case of a procurement that is predominately for the acquisition of—

    (i) Information technology services, cybersecurity services, systems engineering and technical assistance services, advanced electronic testing, or other knowledge-based professional services;

    (ii) Items designated by the requiring activity as personal protective equipment (except see paragraph (b)(1) of this section); or

    (iii) Services designated by the requiring activity as knowledge-based training or logistics services in contingency operations or other operations outside the United States, including in Afghanistan or Iraq.

    (b) Prohibitions. (1) In accordance with section 814 of the National Defense Authorization Act for Fiscal Year 2017 as amended by section 882 of the National Defense Authorization Act for Fiscal Year 2018 (see 10 U.S.C. 2302 note), contracting officers shall not use the lowest price technically acceptable source selection process to procure items designated by the requiring activity as personal protective equipment or an aviation critical safety item, when the requiring activity advises the contracting officer that the level of quality or failure of the equipment or item could result in combat casualties. See 252.209-7010 for the definition and identification of critical safety items.

    (2) In accordance with section 832 of the National Defense Authorization Act for Fiscal Year 2018 (see 10 U.S.C. 2442 note), contracting officers shall not use the lowest price technically acceptable source selection process to acquire engineering and manufacturing development for a major defense acquisition program for which budgetary authority is requested beginning in fiscal year 2019.

    (3) Contracting officers shall make award decisions based on best value factors and criteria, as determined by the resource sponsor (in accordance with agency procedures), for an auditing contract. The use of the lowest price technically acceptable source selection process is prohibited (10 U.S.C. 254b).

    PART 216—TYPES OF CONTRACTS 7. Amend section 216.505 by— a. Adding new paragraph (a) heading; b. Redesignating paragraph (1) as paragraph (a)(S-70); c. Redesignating paragraph (2) as paragraph (a)(6); d. Adding new paragraph (b) heading; and e. Adding new paragraph (b)(1).

    The additions read as follows:

    216.505 Ordering.

    (a) General.

    (b) Orders under multiple-award contracts—(1) Fair opportunity.

    (A) See 215.101-2-70 for the limitations and prohibitions on the use of the lowest price technically acceptable source selection process, which are applicable to orders placed against multiple award indefinite delivery contracts.

    (B) See 217.7XXX for the prohibition on the use of reverse auctions for personal protective equipment and aviation critical safety items.

    PART 217—SPECIAL CONTRACTING METHODS 8. Add new subpart 217.7X, to read as follows: 217.7X—REVERSE AUCTIONS Sec. 7XXX Prohibition. 217.7X—REVERSE AUCTIONS
    217.7XXX Prohibition.

    In accordance with section 814 of the National Defense Authorization Act for Fiscal Year 2017 (Pub. L. 114-328) as amended by section 882 of the National Defense Authorization Act for Fiscal Year 2018 (Pub. L. 115-91) (see 10 U.S.C. 2302 note), contracting officers shall not use reverse auctions when procuring items designated by the requiring activity as personal protective equipment or an aviation critical safety item, when the requiring activity advises the contracting officer that the level of quality or failure of the equipment or item could result in combat casualties. See 252.209-7010 for the definition and identification of critical safety items.

    PART 234—MAJOR SYSTEM ACQUISITION 9. Add section 234.005-2 to read as follows:
    234.005-2 Mission-oriented solicitation.

    See 215.101-2-70(b)(2) for the prohibition on the use of the lowest price technically acceptable source selection process for engineering and manufacturing development of a major defense acquisition program for which budgetary authority is requested beginning in fiscal year 2019.

    PART 237—SERVICE CONTRACTING 10. Amend section 237.270 by— a. Redesignating paragraph (a)(2) as paragraph (a)(3); and b. Adding new paragraph (a)(2) to read as follows:
    237.270 Acquisition of audit services.

    (a) * * *

    (2) See 215.101-2-70(b)(3) for the prohibition on the use of the lowest price technically acceptable source selection process when acquiring audit services.

    [FR Doc. 2018-26306 Filed 12-3-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Part 219 [Docket DARS-2018-0056] RIN 0750-AK18 Defense Federal Acquisition Regulation Supplement: Small Business Set-Asides for Architect-Engineer and Construction Design Contracts (DFARS Case 2018-D057) AGENCY:

    Defense Acquisition Regulations System, Department of Defense (DoD).

    ACTION:

    Proposed rule.

    SUMMARY:

    DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2019 regarding set-asides for architect-engineer and construction design contracts.

    DATES:

    Comments on the proposed rule should be submitted in writing to the address shown below on or before February 4, 2019, to be considered in the formation of a final rule.

    ADDRESSES:

    Submit comments identified by DFARS Case 2018-D057, using any of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Search for “DFARS Case 2018-D057.” Select “Comment Now” and follow the instructions provided to submit a Comment. Please include “DFARS Case 2018-D057” on any attached documents.

    Email: [email protected] Include DFARS Case 2018-D057 in the subject line of the message.

    Fax: 571-372-6094.

    Mail: Defense Acquisition Regulations System, Attn: Ms. Jennifer D. Johnson, OUSD(A&S)DPC/DARS, Room 3B941, 3060 Defense Pentagon, Washington, DC 20301-3060.

    Comments received generally will be posted without change to http://www.regulations.gov, including any personal information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Ms. Jennifer D. Johnson, telephone 571-372-6100.

    SUPPLEMENTARY INFORMATION:

    I. Background

    DoD is proposing to revise the DFARS to implement section 2804 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019 (Pub. L. 115-232), which amends the thresholds at 10 U.S.C. 2855 for small business set-asides of acquisitions for architect-engineer services, including construction design, in connection with military construction projects or military family housing projects. Section 2804 requires these acquisitions to be set aside for small business if valued at less than $1,000,000. Section 2804 also removes the prohibition on setting aside these acquisitions; as a result, these acquisitions may now be set aside for small business, if valued at $1,000,000 or more.

    II. Discussion and Analysis

    This rule proposes to delete paragraph (2) at DFARS 219.502-1. This paragraph prohibits small business set-asides of acquisitions for architect-engineer services for military construction or family housing projects valued at $400,000 or more. The remaining paragraphs would be combined into a single unnumbered paragraph. In addition, this rule proposes to revise the dollar value at DFARS 219.502-2, paragraph (a)(iii), from $400,000 to $1,000,000. This paragraph requires acquisitions for architect-engineer services for military construction or family housing projects to be set aside for small business below a certain dollar value.

    III. Applicability to Contracts at or Below the Simplified Acquisition Threshold and for Commercial Items, Including Commercially Available Off-the-Shelf Items

    This rule does not propose to create any new provisions or clauses or impact any existing provisions or clauses.

    IV. Executive Orders 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

    V. Executive Order 13771

    This proposed rule is not expected to be an E.O. 13771 regulatory action, because this rule is not significant under E.O. 12866.

    VI. Regulatory Flexibility Act

    DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the rule impacts a small number of small entities. However, an initial regulatory flexibility analysis has been performed and is summarized as follows:

    DoD is proposing to revise the DFARS to implement section 2804 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019 (Pub. L. 115-232), which amends the thresholds at 10 U.S.C. 2855 for small business set-asides of acquisitions for architect-engineer services, including construction design, in connection with military construction projects or military family housing projects.

    The objective of this rule is to implement statutory changes to 10 U.S.C. 2855 by removing the restriction on small business set-asides for these acquisitions and increasing the threshold for small business set-aside to $1,000,000. The legal basis for the rule is section 2804 of the NDAA for FY 2019.

    The rule applies to contract awards for architect-engineer services, including construction design. Data from the Federal Procurement Data System shows that, during FY 2017, DoD awarded 232 contracts for architect-engineer services to 187 unique small entities. In FY 2017, DoD awarded 41 contracts for architect-engineer services valued at more than the prior threshold of $400,000 and less than the new threshold of $1,000,000. This rule proposes to require future contracts in this range to be awarded pursuant to FAR part 19 set-aside procedures. DoD also awarded 290 contracts for architect-engineer services valued at more than $1,000,000. This rule proposes to make it possible for future contracts at those dollar values to be awarded pursuant to part 19 set-aside procedures. There are more than 33,000 small entities listed in the Small Business Administration's Dynamic Small Business Search that provide architect-engineer services. Of these entities, approximately 300 could benefit from this rule.

    This rule does not impose any new reporting, recordkeeping, or other compliance requirements for small entities.

    This rule does not duplicate, overlap, or conflict with any other Federal rules.

    There are no known alternatives that would meet the requirements of the applicable statute.

    DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities. DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C 610 (DFARS Case 2018-D057), in correspondence.

    VII. Paperwork Reduction Act

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

    List of Subjects in 48 CFR Part 219

    Government procurement.

    Jennifer Lee Hawes, Regulatory Control Officer, Defense Acquisition Regulations System.

    Therefore, 48 CFR part 219 is proposed to be amended as follows:

    PART 219—SMALL BUSINESS PROGRAMS 1. The authority citation for 48 CFR part 219 continues to read as follows: Authority:

    41 U.S.C. 1303 and 48 CFR chapter 1.

    2. Revise section 219.502-1 to read as follows:
    219.502-1 Requirements for setting aside acquisitions.

    Do not set aside acquisitions for supplies which were developed and financed, in whole or in part, by Canadian sources under the U.S.-Canadian Defense Development Sharing Program.

    219.502-2 [Amended]
    3. Amend section 219.502-2, in paragraph (a)(iii), by removing “of under $400,000” and adding “under $1,000,000” in its place.
    [FR Doc. 2018-26308 Filed 12-3-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 180724688-8688-01] RIN 0648-BI39 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Revisions to Red Snapper and Hogfish Management Measures AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS proposes to implement management measures described in two framework actions to the Fishery Management Plan (FMP) for the Reef Fish Resources of the Gulf of Mexico (Gulf), as prepared by the Gulf of Mexico Fishery Management Council (Council). The framework actions are titled “Modify the Annual Catch Limit (ACL) for the Gulf Red Snapper and Hogfish Stocks” (ACL Framework Action) and “Modify the Red Snapper Recreational Annual Catch Targets (ACT)” (ACT Framework Action). This proposed rule would modify Gulf red snapper commercial and recreational ACLs (quotas) and ACTs, as well as the Gulf hogfish (West Florida stock) stock ACL, as a result of recent stock assessments for each species. Additionally, this proposed rule would reduce the Federal charter vessel/headboat (for-hire) component's red snapper ACT buffer to a level that would allow a greater harvest in 2019 while continuing to constrain landings to the component and total recreational ACLs. The purposes of this proposed rule are to respond to updated stock assessment information, maximize socio-economic opportunities for red snapper in the Federal for-hire component, and to continue to achieve optimum yield (OY) for each stock.

    DATES:

    Written comments must be received by January 3, 2019.

    ADDRESSES:

    You may submit comments on the proposed rule identified by “NOAA-NMFS-2018-0130” by either of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2018-0130, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit all written comments to Peter Hood, NMFS Southeast Regional Office, 263 13th Avenue South, St. Petersburg, FL 33701.

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

    Electronic copies of the two framework actions, which each includes an environmental assessment, a regulatory impact review, and a Regulatory Flexibility Act (RFA) analysis may be obtained from the Southeast Regional Office website at https://www.fisheries.noaa.gov/action/framework-action-modification-recreational-red-snapper-annual-catch-target-buffers-0.

    FOR FURTHER INFORMATION CONTACT:

    Peter Hood, NMFS Southeast Regional Office, telephone: 727-824-5305, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    NMFS and the Council manage the Gulf reef fish fishery under the FMP. The FMP, which includes red snapper and hogfish, was prepared by the Council and is implemented by NMFS through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) (16 U.S.C. 1801 et seq.).

    The Magnuson-Stevens Act requires NMFS and regional fishery management councils to prevent overfishing and achieve, on a continuing basis, the OY from federally managed fish stocks. These mandates are intended to ensure fishery resources are managed for the greatest overall benefit to the nation, particularly with respect to providing food production and recreational opportunities, and protecting marine ecosystems.

    All weights described in this proposed rule are in round (whole) weight.

    Background Red Snapper

    The current red snapper stock ACL is equal to the acceptable biological catch (ABC) of 13.74 million lb (6.23 million kg); 51 percent is allocated to the commercial sector and 49 percent to the recreational sector. The recreational sector's ACL is further divided into the private angling component (57.7 percent) and Federal for-hire component (42.3 percent). In addition, recreational ACTs are in place for the recreational sector and its respective components. These component ACLs and ACTs were implemented in 2015 and are currently set to expire in 2022 (81 FR 86971, December 2, 2016).

    The regulations require NMFS to project the component fishing seasons based on the respective ACTs, which are set 20 percent below the ACLs. The ACTs were implemented to reduce the likelihood of exceeding the private angling or Federal for-hire component ACLs, as well as the total recreational ACL. The commercial sector does not have an ACT because it is managed under an individual fishing quota program that effectively constrains landings to the commercial ACL.

    As set through a framework action in 2017, the current red snapper sector ACLs are 7.007 million lb (3.178 million kg) for the commercial sector and 6.733 million lb (3.054 million kg) for the recreational sector (82 FR 26376, June 7, 2017). The current recreational component ACLs are 2.848 million lb (1.292 million kg) for the for-hire component and 3.885 million lb (1.762 million kg) for the private angling component.

    The current red snapper recreational ACT is 5.386 million lb (2.443 million kg). The Federal for-hire component ACT is 2.278 million lb (1.033 million kg) and the private angling component ACT is 3.108 million lb (1.410 million kg). As noted above, the component ACLs and ACTs are effective through 2022, after which sector separation ends and the recreational sector will be managed through a recreational ACL and an ACT, but no component ACLs or ACTs.

    The Southeast Data, Assessment, and Review (SEDAR) 52 stock assessment for Gulf red snapper was completed in 2018 and was reviewed by the Council's Scientific and Statistical Committee (SSC) in May 2018. The assessment indicated the Gulf red snapper stock is not overfished or undergoing overfishing, and is still rebuilding consistent with the plan to rebuild the stock by 2032. The SSC determined that the stock assessment represented the best scientific information available, acknowledged the red snapper ABC could be increased, and recommended two different ABC options to the Council: A declining yield stream and a constant catch scenario. The Council decided to use the constant catch recommendation and set the ABC at 15.1 million lb (6.85 million kg).

    Because the Federal for-hire component has not exceeded its applicable ACL or ACT, the ACT Framework Action was developed to reduce the buffer between the Federal for-hire component ACT and ACL. The Council did not consider decreasing the private angling component ACT buffer because this component exceeded its ACL in 2 of the past 3 years. Application of the Council's ACL/ACT Control Rule resulted in a suggested buffer of 9 percent for the Federal for-hire component. The ACL/ACT Control Rule is used to determine a buffer based on factors such as recent harvest overages, the percent standard error in Federal for-hire landing estimates, stock status, and whether in-season accountability measures are used. The Council decided to change the Federal for-hire component ACT for the 2019 fishing year to reflect this reduced buffer. The reduction in the Federal for-hire component's ACL/ACT buffer would be effective only for 2019 to coincide with the second year of temporary changes to the management of the private angling component. All five Gulf states received exempted fishing permits (EFPs) from NMFS for the 2018 and 2019 fishing years to allow them to test limited state management of the private angling component. Each state was allocated a percentage of the private angling ACL and each state determined whether to manage a reduced portion of its ACL to account for management uncertainty. Therefore, the Council determined that the reduction in the Federal for-hire component ACT buffer should be limited to 2019. If state management of the private angling component is extended through an amendment to the FMP, the Council could consider retaining the 9 percent buffer for the Federal for-hire component.

    Hogfish

    The West Florida stock of hogfish is contained completely within the jurisdiction of the Council and includes hogfish in the Gulf exclusive economic zone (EEZ) except south of 25°09′ N lat. off the west coast of Florida. As implemented through Amendment 43 to the FMP, the West Florida stock ACL is 159,300 lb (72,257 kg) for the 2019 and subsequent fishing years (82 FR 34574, July 25, 2017). There is no ACT designated for West Florida hogfish.

    The SEDAR 37 Update assessment for the West Florida hogfish stock was completed in 2018. The assessment indicated the West Florida stock is not overfished or undergoing overfishing. The Council's SSC reviewed the assessment in May 2018, determined that the stock assessment represented the best scientific information available, and provided overfishing limit (OFL) and ABC recommendations based on an increasing yield stream. As a result of uncertainties in the update assessment, the SSC did not provide OFL and ABC recommendations beyond 2021. West Florida hogfish has a stock ACL that is equal to the ABC.

    Management Measures Contained in This Proposed Rule

    For red snapper, this proposed rule would revise the commercial and recreational sector ACLs and ACTs. For the 2019 fishing year, the for-hire component ACT would be set 9 percent below the component ACL. For hogfish, this proposed rule would revise the stock ACL for the West Florida stock.

    Red Snapper ACLs, ACTs, and For-Hire Component ACT Buffer

    Through this proposed rule, and as a result of the SEDAR 52 stock assessment and the recommendations of the Council's SSC, the ACL Framework Action would increase the total red snapper ACL from 13.74 million lb (6.23 million kg) to 15.1 million lb (6.85 million kg). Using the current sector allocation ratios the resulting ACLs would be 7.701 million lb (3.493 million kg) for the commercial sector, 7.399 million lb (3.356 million kg) for the recreational sector, 3.130 million lb (1.420 million kg) for the Federal for-hire component, and 4.269 million lb (1.936 million kg) for the private angling component.

    As described in the ACT Framework Action, this proposed rule would temporarily reduce the Federal for-hire component ACL/ACT buffer from 20 percent to 9 percent in 2019, which in turn would increase the Federal for-hire component ACT. This would consequently increase the recreational ACT as it is the sum of the Federal for-hire and private angling component's ACTs.

    As a result of the increased red snapper ACLs and ACTs through the ACL Framework Action and the increased recreational and Federal for-hire component ACTs through the ACT Framework Action, for the 2019 fishing year, the recreational ACT would be 6.263 million lb (2.841 million kg) and the Federal for-hire component ACT would be 2.848 million lb (1.292 million kg). For 2020 and subsequent fishing years, the recreational ACT would be 5.919 million lb (2.830 million kg) and the Federal for-hire component ACT would be 2.504 million lb (1.136 million kg) for the 2020 through 2022 fishing years. The private angling component ACT would be 3.415 million lb (1.549 million kg) for the 2019 through 2022 fishing years. Therefore, the component ACTs in this proposed rule reflect a 9 percent buffer applied to the Federal for-hire component and a 20 percent buffer applied to the private angling component for 2019, and a 20 percent buffer applied to both for 2020 through 2022.

    Hogfish Stock ACL

    The ACL Framework Action would set the hogfish stock ACLs equal to the Council's SSC recommended ABCs of 129,500 lb (58,740 kg) for 2019, 141,300 lb (64,093 kg) for 2020, and 150,400 lb (68,220 kg) for 2021. Additionally, the ACL (and ABC) proposed for 2021 would be in effect for the 2021 and subsequent fishing years. Although the proposed ACLs for 2019 through 2021 and beyond are less than the current stock ACL, landings in recent years have not exceeded the current ACL (e.g., less than 50 percent of the stock ACL in 2017). Landings are also expected to be constrained to the stock ACL by an increase in the minimum size limit from 12 to 14 inches (30.5 to 35.6 cm), fork length, implemented in 2017. This measure is expected to reduce the directed harvest of hogfish.

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the framework actions, the FMP, the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.

    This proposed rule has been determined to be not significant for purposes of Executive Order 12866. This proposed rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination follows.

    A description of the proposed rule, why it is being considered, and the objectives of, and legal basis for this proposed rule are contained in the preamble of this rule at the beginning of the SUPPLEMENTARY INFORMATION section and in the SUMMARY section. The Magnuson-Stevens Act provides the statutory basis for this rule. No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this proposed rule. Accordingly, the requirements of the Paperwork Reduction Act do not apply to this proposed rule.

    This proposed rule would directly apply to recreational fishers (anglers) and indirectly to for-hire fishing businesses (NAICS code 487210) that harvest red snapper and/or West Florida hogfish in Federal waters of the Gulf. Anglers are not considered small entities as that term is defined in 5 U.S.C. 601(6), whether fishing from for-hire fishing, private or leased vessels. Therefore, estimates of the number of anglers directly affected by the rule and the impacts on them are not provided here. For-hire fishing businesses that harvest red snapper and/or hogfish in Federal waters would be indirectly affected if the rule were to cause changes in angler demand for their services. The RFA does not consider such indirect impacts on small entities.

    This proposed rule would directly affect commercial fishing businesses (NAICS code 11411) that harvest red snapper and/or hogfish in the Gulf. First, it would increase the commercial ACL for red snapper, and second, it would decrease the commercial ACL for hogfish.

    For RFA purposes, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily involved in commercial fishing (NAICS 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and its combined annual receipts are not in excess of $11 million for all of its affiliated operations worldwide.

    The best economic data available related to the commercial harvest of red snapper is available through 2016. From 2012 through 2016, an annual average of 409 vessels landed at least 1 lb (0.45 kg) of red snapper in the Gulf. On average, these vessels combined generated total revenues of approximately $60.37 million, of which $24.96 million were from red snapper and $35.41 million from other species. The average annual revenue per vessel was approximately $148,000. Red snapper accounted for about 41 percent of these vessels' total revenues. Net revenues from fishing operations of these vessels were approximately 36 percent of total revenues.

    The best economic data available related to the commercial harvest of hogfish is available through 2017. From 2012 through 2017, an annual average of 61 vessels landed at least 1 lb (0.45 kg) of West Florida hogfish. The average annual total revenue was approximately $0.12 million from hogfish, approximately $0.51 million from other species co-harvested with hogfish (on the same trips), and approximately $1.66 million from trips in the Gulf on which no hogfish were harvested or occurred in the South Atlantic. The average total annual revenue from all species harvested by vessels that harvest hogfish in the Gulf was approximately $2.29 million, or approximately $37,000 per vessel. Hogfish accounted for about 5 percent of these vessels' total revenues.

    Based on annual revenue information, all of the commercial fishing businesses with the 409 vessels that annually harvest red snapper and those with the 61 vessels that land West Florida hogfish from the Gulf are small entities.

    Because all entities expected to be directly affected by this proposed rule are small entities, NMFS has determined that this proposed rule would affect a substantial number of small entities; however, the issue of disproportionate effects on small versus large entities does not arise in the present case.

    Since 2007, the commercial sector's harvest of red snapper has operated under an individual fishing quota (RS-IFQ) program. The RS-IFQ program uses shares and allocations to distribute and account for the commercial fishing quota. The proposed rule would increase the quota, which would increase dockside revenue from red snapper. Total dockside revenue for all vessels combined would increase by $4.462 million in 2019, $4.170 million in 2020, and $3.897 in 2021. For the 409 vessels, total revenue per vessel would increase by $10,909 in 2019, $10,195 in 2020, and $9,528 in 2021. The total value of all IFQ shares and all allocation for 2019 through 2021 would also increase.

    The reduction of the West Florida hogfish ACL would reduce dockside revenue by $27,387 (2017 dollars) in 2019, by $16,543 in 2020, and $8,179 annually thereafter. The average annual revenue loss per vessel for the 61 vessels that land hogfish would be $449 in 2019, $271 in 2020 and $134 annually thereafter. Those revenue losses represent 1.12 percent, 0.72 percent and 0.36 percent of average annual revenue of the 61 vessels that land West Florida hogfish. The 61 vessels represent approximately 7 percent of the average 877 vessels permitted to harvest Gulf reef fish annually.

    The information provided above supports a determination that this proposed rule would not have a significant economic impact on a substantial number of small entities. Because this proposed rule, if implemented, is not expected to have a significant economic impact on any small entities, an initial regulatory flexibility analysis is not required and none has been prepared.

    List of Subjects in 50 CFR Part 622

    Commercial, Fisheries, Fishing, Hogfish, Gulf, Recreational, Red snapper.

    Dated: November 28, 2018. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 622 is proposed to be amended as follows:

    PART 622—FISHERIES OF THE CARIBBEAN, GULF, AND SOUTH ATLANTIC 1. The authority citation for part 622 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    2. In § 622.39, revise paragraphs (a)(1)(i) and (a)(2)(i) to read as follows:
    § 622.39 Quotas.

    (a) * * *

    (1) * * *

    (i) Commercial quota for red snapper—7.701 million lb (3.493 million kg), round weight.

    (2) * * *

    (i) Recreational quota for red snapper—(A) Total recreational. The total recreational quota, is 7.399 million lb (3.356 million kg), round weight.

    (B) Federal charter vessel/headboat component quota. The Federal charter vessel/headboat component quota applies to vessels that have been issued a valid Federal charter vessel/headboat permit for Gulf reef fish any time during the fishing year. This component quota is effective through the 2022 fishing year. For the 2023 and subsequent fishing years, the applicable total recreational quota, specified in paragraph (a)(2)(i)(A) of this section, will apply to the recreational sector. The Federal charter vessel/headboat component quota is 3.130 million lb (1.420 million kg), round weight.

    (C) Private angling component quota. The private angling component quota applies to vessels that fish under the bag limit and have not been issued a Federal charter vessel/headboat permit for Gulf reef fish any time during the fishing year. This component quota is effective through the 2022 fishing year. For the 2023 and subsequent fishing years, the applicable total recreational quota, specified in paragraph (a)(2)(i)(A) of this section, will apply to the recreational sector. The private angling component quota is 4.269 million lb (1.936 million kg), round weight.

    3. In § 622.41, revise paragraphs (p) and (q)(2)(iii) to read as follows:
    § 622.41 Annual catch limits (ACLs), annual catch targets (ACTs), and accountability measures (AMs).

    (p) Hogfish in the Gulf EEZ except south of 25°09′ N lat. off the west coast of Florida. If the sum of the commercial and recreational landings, as estimated by the SRD, exceeds the stock ACL, then during the following fishing year, if the sum of commercial and recreational landings reaches or is projected to reach the stock ACL, the AA will file a notification with the Office of the Federal Register to close the commercial and recreational sectors for the remainder of that fishing year. The stock ACL for hogfish, in round weight, in the Gulf EEZ except south of 25°09′ N lat. off the west coast of Florida, is 129,500 lb (58,740 kg), for the 2019 fishing year, 141,300 lb (64,093 kg), for the 2020 fishing year, and 150,400 lb (68,220 kg) for the 2021 fishing year and subsequent fishing years. See § 622.193(u)(2) for the ACLs, ACT, and AMs for hogfish in the Gulf EEZ south of 25°09′ N lat. off the west coast of Florida.

    (q) * * *

    (2) * * *

    (iii) Recreational ACT for red snapper—(A) Total recreational ACT. For the 2019 fishing year, the total recreational ACT is 6.263 million lb (2.841 million kg), round weight. For the 2020 and subsequent fishing years, the total recreational ACT is 5.919 million lb (2.830 million kg), round weight.

    (B) Federal charter vessel/headboat component ACT. The Federal charter vessel/headboat component ACT applies to vessels that have been issued a valid Federal charter vessel/headboat permit for Gulf reef fish any time during the fishing year. This component ACT is effective through the 2022 fishing year. For the 2019 fishing year, the component ACT is 2.848 million lb (1.292 million kg), round weight. For the 2020, 2021, and 2022 fishing years, the component ACT is 2.504 million lb (1.136 million lb), round weight. For the 2023 and subsequent fishing years, the applicable total recreational ACT, specified in paragraph (q)(2)(iii)(A) of this section, will apply to the recreational sector.

    (C) Private angling component ACT. The private angling component ACT applies to vessels that fish under the bag limit and have not been issued a Federal charter vessel/headboat permit for Gulf reef fish any time during the fishing year. This component ACT is effective through the 2022 fishing year. The component ACT is 3.415 million lb (1.549 million kg), round weight. For the 2023 and subsequent fishing years, the applicable total recreational ACT, specified in paragraph (q)(2)(iii)(A) of this section, will apply to the recreational sector.

    [FR Doc. 2018-26196 Filed 12-3-18; 8:45 am] BILLING CODE 3510-22-P
    83 233 Tuesday, December 4, 2018 Notices DEPARTMENT OF COMMERCE Census Bureau Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

    Agency: Census Bureau.

    Title: Construction Progress Reporting Surveys.

    OMB Control Number: 0607-0153.

    Form Number(s): C-700, C-700(R), C-700(SL), C-700(F).

    Type of Request: Extension of a currently approved collection.

    Number of Respondents: 25,000.

    Average Hours per Response: 11.67 minutes.

    Burden Hours: 58,333.

    Needs and Uses: The U.S. Census Bureau is requesting an extension of a currently approved collection for forms: C-700, for Private Construction Projects; C-700(R), for Multifamily Residential Projects; C-700(SL), for State and Local Governments Projects; and C-700(F), for Federal Government Projects.

    These forms are used to conduct the Construction Progress Reporting Surveys (CPRS) which collect information on the dollar value of construction put in place on non-residential building projects under construction by private companies or individuals, private multifamily residential buildings, and building projects under construction by federal and state and local governments.

    The Census Bureau uses the information collected on these forms to publish estimates of the monthly dollar value of construction put in place. These data are a Principal Federal Economic Indicator that is used extensively by the federal government in making policy decisions and is used by the Bureau of Economic Analysis (BEA) to estimate Gross Domestic Product (GDP), with construction spending (nonresidential fixed investment on structures and residential fixed investment) accounting for 6.9 percent of GDP in 2017. The private sector uses the statistics for market analysis and other research.

    There are currently no planned content changes to the CPRS questionnaires. However, beginning with the September 2018 statistical period, we mailed redesigned forms, which were previously printed on a single legal page, and are now in booklet form. Additionally, the contact information is now requested on the front page of the booklet rather than on the back page, and the numbering scheme reflects this rearrangement of questions.

    Affected Public: Businesses; Not-for-profit institutions; State, local or Tribal governments; Federal Government.

    Frequency: Monthly.

    Respondent's Obligation: Voluntary.

    Legal Authority: Title 13 U.S.C., Sections 131 and 182.

    This information collection request may be viewed at www.reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202)395-5806.

    Sheleen Dumas, Departmental Lead PRA Officer, Office of the Chief Information Officer, Commerce Department.
    [FR Doc. 2018-26300 Filed 12-3-18; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-094] Refillable Stainless Steel Kegs From the People's Republic of China: Postponement of Preliminary Determination in the Countervailing Duty Investigation AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    DATES:

    Applicable December 4, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Nicholas Czajkowski or Robert Brown, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-1395 or (202) 482-3702, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On October 10, 2018, the Department of Commerce (Commerce) initiated the countervailing duty (CVD) investigation of imports of refillable stainless steel kegs (kegs) from the People's Republic of China.1 The preliminary determination is currently due no later than December 14, 2018.

    1See Refillable Stainless Steel Kegs: Initiation of Countervailing Duty Investigation, 83 FR 52192 (October 16, 2018).

    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 of the date on which Commerce initiated the investigation. However, if the petitioner makes a request for an extension of the period within which the determination must be made, 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 the administering authority initiated the investigation.

    On November 27, 2018, the petitioner 2 submitted a request pursuant to section 703(c)(1)(A) of the Act and 19 CFR 351.205(e) to postpone the preliminary determination.3 The petitioner states that additional time is necessary in light of the number of programs under investigation and the expected complexity of the issues.

    2 The petitioner is American Keg Company LLC.

    3See the petitioner's Letter dated November 27, 2018, requesting postponement of the preliminary determination.

    For the reasons stated above, Commerce, in accordance with section 703(c)(l)(B) of the Act, is postponing the deadline for the preliminary determination to no later than 130 days after the day on which Commerce initiated this investigation. Therefore, the new deadline for the preliminary determination is February 19, 2019.4 Pursuant to section 705(a)(1) of the Act and 19 CFR 351.210(b)(1), the deadline for the final determination will continue to be 75 days after the date of the preliminary determination, unless postponed.

    4 The actual deadline is February 17, 2019, which is a Sunday. Further, Monday, February 18, 2018 is a Federal holiday. In accordance with Commerce's practice, where a deadline falls on a weekend or federal holiday, the appropriate deadline is the next business day. 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 in accordance with section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).

    Dated: November 28, 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. 2018-26316 Filed 12-3-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-489-815] Light-Walled Rectangular Pipe and Tube From Turkey: Rescission of Antidumping Duty Administrative Review; 2017-2018 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Commerce) is rescinding the administrative review of the antidumping duty order on light-walled rectangular pipe and tube (LWRPT) from Turkey for the period of review (POR) May 1, 2017, through April 30, 2018.

    DATES:

    Applicable December 4, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jonathan Hill, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3518.

    SUPPLEMENTARY INFORMATION:

    Background

    On May 1, 2018, Commerce published in the Federal Register a notice of opportunity to request an administrative review of the antidumping duty order on LWRPT from Turkey for the POR May 1, 2017, through April 30, 2018.1 On May 31, 2018, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(b), Noksel Celik Boru Sanayi A.S. (Noksel), requested a review of the order with respect to itself.2 On July 12, 2018, in accordance with section 751(a) of the Act and 19 CFR 351.221(c)(1)(i), Commerce initiated an administrative review of the antidumping duty order on LWRPT from Turkey with respect to Noksel.3 On August 7, 2018, Noksel timely withdrew its request for an administrative review of itself.4 No other party requested a review.

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 83 FR 19047 (May 1, 2018).

    2See Noksel's May 31, 2018 Request for Administrative Review.

    3 See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 83 FR 32270 (July 12, 2018).

    4See Noksel's August 7, 2018 Withdrawal of Request for Administrative Review.

    Rescission of Review

    Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the publication date of the notice of initiation of the requested review. Noksel withdrew its request for review within the 90-day deadline. Because Commerce received no other requests for review of Noksel, and no other requests were made for a review of the antidumping duty order on LWRPT from Turkey with respect to other companies, we are rescinding the administrative review covering the POR May 1, 2017, through April 30, 2018, in full, in accordance with 19 CFR 351.213(d)(1).

    Assessment

    Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries of LWRPT from Turkey during the May 1, 2017, through April 30, 2018, at rates equal to the cash deposit rate for estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP 15 days after the date of publication of this notice in the Federal Register.

    Notification to Importers

    This notice serves as the only reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

    Notification Regarding Administrative Protective Order

    This notice also serves as the only reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

    This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(d)(4).

    Dated: November 29, 2018. James Maeder, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2018-26318 Filed 12-3-18; 8:45 am] BILLING CODE 3510-DS-P
    CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2011-0074] Notice of Availability: Table Saw Blade-Contact Injuries Special Study Report, 2017 AGENCY:

    U.S. Consumer Product Safety Commission.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Consumer Product Safety Commission (CPSC) is announcing the availability of a report titled, “Table Saw Blade-Contact Injuries Special Study Report, 2017.” The CPSC requests comments on the report.

    DATES:

    Submit comments by February 4, 2019.

    ADDRESSES:

    You may submit comments, identified by Docket No. CPSC-2011-0074, by any of the following methods:

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

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

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

    Docket: For access to the docket to read background documents or comments received, go to: http://www.regulations.gov, and insert the docket number CPSC-2011-0074, into the “Search” box, and follow the prompts.

    FOR FURTHER INFORMATION CONTACT:

    Caroleene Paul, Directorate for Engineering Sciences, U.S. Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone: 301-987-2225; email: [email protected].

    SUPPLEMENTARY INFORMATION:

    On May 12, 2017, the CPSC published in the Federal Register a notice of proposed rulemaking (NPR) on a safety standard for table saw blade-contact injuries. 82 FR 22190. In January 2017, staff began collecting additional information on incident data identified in the National Electronic Injury Surveillance System (NEISS) for table saws to: (1) Obtain information regarding the type of table saws involved in the cases to generate national estimates by saw type and estimated risk of injury associated with each table saw type; (2) gain information regarding the type and usage pattern of the blade guard; and (3) collect additional injury and incident data.

    On April 27, 2017, the Commission held a decisional hearing on the NPR. The Commission directed “staff to analyze and seek public comment on the Table Saw Study started in January 2017, based on the most appropriate time period that will generate information to determine a national estimate from NEISS incidents. Results will be published in the Federal Register for notice and comment as part of the docket for this rulemaking.”

    CPSC staff has completed the report titled, Table Saw Blade-Contact Injuries Special Study Report, 2017. The report is available on the CPSC's website at: https://www.cpsc.gov/Newsroom/FOIA/ReportList?field_nfr_type_value=commission, and in http://www.regulations.gov, under Supporting and Related Materials, docket number CPSC-2011-0074, and from the CPSC's Division of the Secretariat, at the location listed in the ADDRESSES section of this notice.

    The CPSC invites comments on the report. Comments should be submitted by February 4, 2019. Information on how to submit comments can be found in the ADDRESSES section of this notice.

    Abioye Mosheim, Acting Secretary, Consumer Product Safety Commission.
    [FR Doc. 2018-26260 Filed 12-3-18; 8:45 am] BILLING CODE 6355-01-P
    DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers Intent To Prepare a Draft Supplemental Environmental Impact Statement (DSEIS) for the Haile Gold Mine in Lancaster County, South Carolina AGENCY:

    U.S. Army Corps of Engineers, DoD.

    ACTION:

    Notice of intent.

    SUMMARY:

    The U.S. Army Corps of Engineers, Charleston District intends to prepare a Draft Supplemental Environmental Impact Statement (DSEIS) to assess the likely social, economic and environmental effects of the proposed expansion of an existing gold mine with the potential to impact Waters of the United States near Kershaw in Lancaster County, South Carolina. The DSEIS will assess potential effects of a range of alternatives.

    DATES:

    Public Scoping Meeting: A public scoping meeting has not been scheduled; however, a local public notice will be issued by the Charleston District, and a meeting announcement will be published in local newspapers once the date and location for the scoping meeting has been determined.

    ADDRESSES:

    Mr. Shawn Boone, Project Manager, Charleston District, Regulatory Division, 69-A Hagood Avenue, Charleston, SC 29403.

    FOR FURTHER INFORMATION CONTACT:

    For further information and/or questions about the proposed mine expansion project and DSEIS, please contact Mr. Shawn Boone, Project Manager, by telephone: 843-329-8158, or toll-free 1-866-329-8187, or by mail: [email protected] For inquiries from the media, please contact the Corps, Charleston District Corporate Communications Officer (CCO), Ms. Glenn Jeffries by telephone: (843) 329-8123.

    SUPPLEMENTARY INFORMATION:

    The Corps is evaluating a proposal from OceanaGold for the expanded development of the Haile Gold Mine in accordance with Corps regulations and the policies and procedures that are established in the National Environmental Policy Act (NEPA). Based on the available information, the Corps has determined that the expansion of the mine has the potential to significantly affect the quality of the human environment and therefore warrant the preparation of a Supplemental EIS. Additional information about the proposed project and the NEPA process is available on the project website at: www. hailegoldmineseis.com.

    1. Description of Proposed Project. The Haile Gold Mine expansion plan (the proposed Project) includes the ore mining and processing operations that would recover gold and silver by excavating pits and underground deposits, storing excavated soils and overburden, processing the ore, managing surface water and ground water during operations, reclaiming the site at the end of operations, and monitoring site conditions post-mining. The site of the Project is currently an operating mine which was the subject of an Environmental Impact Statement published in 2014.

    2. Alternatives. A range of alternatives to the proposed action will be identified, and those found to be reasonable alternatives will be fully evaluated in the DSEIS, including: The no-action alternative, the applicant's proposed alternative, alternative site configurations, alternatives that may result in avoidance and minimization of impacts, and mitigation measures not in the proposed action. However, this list is not exclusive and additional alternatives may be considered for inclusion.

    3. Scoping and Public Involvement Process. A scoping meeting will be conducted to gather information on the scope of the project and alternatives to be addressed in the DSEIS. Individuals and organizations that are interested in the proposed mine expansion or whose interests may be affected by the proposed work are encouraged to attend the scoping meeting to submit oral and/or written comments to the Charleston District. Additional public and agency involvement will be sought through the implementation of a public involvement plan and through an agency coordination team.

    4. Significant Issues. Issues associated with the proposed project to be given detailed analysis in the DSEIS are likely to include, but are not necessarily limited to, the potential impacts of the proposed development on surface and groundwater quality, aquatic habitat and biota, wetlands and stream habitats, federal and state listed species of concern, indirect and cumulative impacts, threatened and endangered species, environmental justice, mitigation, emergency response and contingency plans, noise, conservation, economics, cultural resources, aesthetics, general environmental concerns, historic properties, fish and wildlife values, flood hazards, land use, recreation, water supply and conservation, water quality, energy needs, safety, the transportation network, and in general, the needs and welfare of the people.

    5. Additional Review and Consultation. Additional review and consultation, which will be incorporated into the preparation of this DSEIS, will include, but will not necessarily be limited to, Section 401 of Clean Water Act; the National Environmental Policy Act; the Endangered Species Act; and the National Historic Preservation Act.

    6. Availability of the Draft Supplemental Environmental Impact Statement. The DSEIS is anticipated to be available in early 2020. A Public Hearing will be conducted following the release of the DSEIS.

    Jeffrey S. Palazzini, Lieutenant Colonel, U.S. Army Corps of Engineers, Charleston District.
    [FR Doc. 2018-26341 Filed 12-3-18; 8:45 am] BILLING CODE 3720-58-P
    DEPARTMENT OF EDUCATION 2018-2019 Award Year Deadline Dates for Reports and Other Records Associated With the Free Application for Federal Student Aid (FAFSA), the Federal Supplemental Educational Opportunity Grant Program (FSEOG), the Federal Work-Study (FWS) Programs, the Federal Pell Grant (Pell Grant) Program, the William D. Ford Federal Direct Loan (Direct Loan) Program, the Teacher Education Assistance for College and Higher Education (TEACH) Grant Program, and the Iraq and Afghanistan Service Grant Program AGENCY:

    Federal Student Aid, Department of Education.

    ACTION:

    Notice.

    Catalog of Federal Domestic Assistance (CFDA) Numbers: 84.007 FSEOG Program; 84.033 FWS Program; 84.063 Pell Grant Program; 84.268 Direct Loan Program; 84.379 TEACH Grant Program; 84.408 Iraq and Afghanistan Service Grant Program.

    SUMMARY:

    The Secretary announces deadline dates for the receipt of documents and other information from applicants and institutions participating in certain Federal student aid programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA), for the 2018-2019 award year. These programs, administered by the U.S. Department of Education (Department), provide financial assistance to students attending eligible postsecondary educational institutions to help them pay their educational costs.

    The Federal student aid programs (title IV, HEA programs) covered by this deadline date notice are the Pell Grant, Direct Loan, TEACH Grant, Iraq and Afghanistan Service Grant, and campus-based (FSEOG and FWS) programs.

    DATES:

    Deadline and Submission Dates: See Tables A and B at the end of this notice.

    FOR FURTHER INFORMATION CONTACT:

    Bruce Hughes, U.S. Department of Education, Federal Student Aid, 830 First Street NE, Union Center Plaza, 11th Floor, Washington, DC 20202-5345. Telephone: (202) 377-3882. Email: [email protected]

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

    SUPPLEMENTARY INFORMATION:

    Table A—2018-2019 Award Year Deadline Dates by Which a Student Must Submit the FAFSA, by Which the Institution Must Receive the Student's Institutional Student Information Record (ISIR) or Student Aid Report (SAR), and by Which the Institution Must Submit Verification Outcomes for Certain Students.

    Table A provides information and deadline dates for receipt of the FAFSA, corrections to and signatures for the FAFSA, ISIRs, and SARs, and verification documents.

    The deadline date for the receipt of a FAFSA by the Department's Central Processing System is June 30, 2019, regardless of the method that the applicant uses to submit the FAFSA. The deadline date for the receipt of a signature page for the FAFSA (if required), corrections, notices of change of address or institution, or requests for a duplicate SAR is September 14, 2019.

    For all title IV, HEA programs, an ISIR or SAR for the student must be received by the institution no later than the student's last date of enrollment for the 2018-2019 award year or September 21, 2019, whichever is earlier. Note that a FAFSA must be submitted and an ISIR or SAR received for the dependent student for whom a parent is applying for a Direct PLUS Loan.

    Except for students selected for Verification Tracking Groups V4 and V5, verification documents must be received by the institution no later than 120 days after the student's last date of enrollment for the 2018-2019 award year or September 21, 2019, whichever is earlier. For students selected for Verification Tracking Groups V4 and V5, institutions must submit identity and high school completion status verification results no later than 60 days following the institution's first request to the student to submit the documentation.

    For all title IV, HEA programs except for (1) Direct PLUS Loans that will be made to parent borrowers, and (2) Direct Unsubsidized Loans that will be made to dependent students who have been determined by the institution, pursuant to section 479A(a) of the HEA, to be eligible for such a loan without providing parental information on the FAFSA, the ISIR or SAR must have an official expected family contribution (EFC) and the ISIR or SAR must be received by the institution no later than the earlier of the student's last date of enrollment for the 2018-2019 award year or September 21, 2019. For the two exceptions mentioned above, the ISIR or SAR must be received by the institution by the same dates noted in the paragraph but the ISIR or SAR is not required to have an official EFC.

    For a student who is requesting aid through the Pell Grant, FSEOG, or FWS programs or for a student requesting Direct Subsidized Loans, who does not meet the conditions for a late disbursement under 34 CFR 668.164(j), a valid ISIR or valid SAR must be received by the institution by the student's last date of enrollment for the 2018-2019 award year or September 21, 2019, whichever is earlier.

    In accordance with 34 CFR 668.164(j)(4)(i), an institution may not make a late disbursement of title IV, HEA program funds later than 180 days after the date of the institution's determination that the student was no longer enrolled. Table A provides that, to make a late disbursement of title IV, HEA program funds, an institution must receive a valid ISIR or valid SAR no later than 180 days after its determination that the student was no longer enrolled, but not later than September 21, 2019.

    Table B—2018-2019 Award Year Pell Grant, Iraq and Afghanistan Service Grant, Direct Loan, and TEACH Grant Programs Deadline Dates for Disbursement by Institutions.

    For the Pell Grant, Iraq and Afghanistan Service Grant, Direct Loan, and TEACH Grant programs, Table B provides the earliest disbursement date, the earliest dates for institutions to submit disbursement records to the Department's Common Origination and Disbursement (COD) System, and deadline dates by which institutions must submit disbursement and origination records.

    An institution must submit Pell Grant, Iraq and Afghanistan Service Grant, Direct Loan, and TEACH Grant disbursement records to COD, no later than 15 days after making the disbursement or becoming aware of the need to adjust a previously reported disbursement. In accordance with 34 CFR 668.164(a), title IV, HEA program funds are disbursed on the date that the institution: (a) Credits those funds to a student's account in the institution's general ledger or any subledger of the general ledger; or (b) pays those funds to a student directly. Title IV, HEA program funds are disbursed even if an institution uses its own funds in advance of receiving program funds from the Department.

    An institution's failure to submit disbursement records within the required timeframe may result in the Department rejecting all or part of the reported disbursement. Such failure may also result in an audit or program review finding or the initiation of an adverse action, such as a fine or other penalty for such failure, in accordance with subpart G of the General Provisions regulations in 34 CFR part 668.

    Deadline Dates for Enrollment Reporting by Institutions.

    In accordance with 34 CFR 674.19(f), 682.610(c), 685.309(b), and 690.83(b)(2), upon receipt of an enrollment report from the Secretary, institutions must update all information included in the report and return the report to the Secretary in a manner and format prescribed by the Secretary and within the timeframe prescribed by the Secretary. Consistent with the National Student Loan Data System (NSLDS) Enrollment Reporting Guide, the Secretary has determined that institutions must report at least every two months. Institutions may find the NSLDS Enrollment Reporting Guide on the Information for Financial Aid Professionals website at https://ifap.ed.gov.

    Other Sources for Detailed Information

    We publish a detailed discussion of the Federal student aid application process in the Application and Verification Guide volume of the 2018-2019 Federal Student Aid Handbook and in the 2018-2019 ISIR Guide.

    Information on the institutional reporting requirements for the Pell Grant, Iraq and Afghanistan Service Grant, Direct Loan, and TEACH Grant programs is included in the 2018-2019 Common Origination and Disbursement (COD) Technical Reference. Also, see the NSLDS Enrollment Reporting Guide.

    You may access these publications by selecting the “iLibrary” link at the Information for Financial Aid Professionals website at: https://ifap.ed.gov.

    Additionally, the 2018-2019 award year reporting deadline dates for the Federal Perkins Loan, FWS, and FSEOG programs were published in the Federal Register on January 3, 2018 (83 FR 356).

    Applicable Regulations: The following regulations apply:

    (1) Student Assistance General Provisions, 34 CFR part 668.

    (2) Federal Pell Grant Program, 34 CFR part 690.

    (3) William D. Ford Direct Loan Program, 34 CFR part 685.

    (4) Teacher Education Assistance for College and Higher Education Grant Program, 34 CFR part 686.

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

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. 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.

    Program Authority: 20 U.S.C. 1070a, 1070a-1, 1070b-1070b-4, 1070g, 1070h, 1087a-1087j, and 1087aa-1087ii; 42 U.S.C. 2751-2756b.

    Dated: November 29, 2018. James F. Manning, Acting Chief Operating Officer, Federal Student Aid. Table A—2018-2019 Award Year Deadline Dates by Which a Student Must Submit the FAFSA, by Which the Institution Must Receive the Student's Institutional Student Information Record (ISIR) or Student Aid Report (SAR), and by Which the Institution Must Submit Verification Outcomes for Certain Students Who submits? What is submitted? Where is it submitted? What is the deadline date for receipt? Student FAFSA—“FAFSA on the Web” (original or renewal) Electronically to the Department's Central Processing System (CPS) 1 June 30, 2019. Signature page (if required) To the address printed on the signature page September 14, 2019. Student through an Institution An electronic FAFSA (original or renewal) Electronically to the Department's CPS using “Electronic Data Exchange” (EDE) or “FAA Access to CPS Online” 1 June 30, 2019. Student A paper original FAFSA To the address printed on the FAFSA or envelope provided with the FAFSA June 30, 2019. Student Electronic corrections to the FAFSA using “Corrections on the Web” Electronically to the Department's CPS 1 September 14, 2019. Signature page (if required) To the address printed on the signature page September 14, 2019. Student through an Institution Electronic corrections to the FAFSA Electronically to the Department's CPS using EDE or “FAA Access to CPS Online” 1 September 14, 2019. Student Paper corrections to the FAFSA using a SAR, including change of mailing and email addresses and change of institutions To the address printed on the SAR September 14, 2019. Student Change of mailing and email addresses, change of institutions, or requests for a duplicate SAR To the Federal Student Aid Information Center by calling 1-800-433-3243 September 14, 2019. Student A SAR with an official EFC calculated by the Department's CPS, except for Parent PLUS Loans and Direct Unsubsidized Loans made to a dependent student under HEA section 479A(a), for which the ISIR does not need to have an official EFC To the institution The earlier of:
  • — The student's last date of enrollment for the 2018-2019 award year; or
  • — 2 September 21, 2019.
  • Student through CPS An ISIR with an official EFC calculated by the Department's CPS, except for Parent PLUS Loans and Direct Unsubsidized Loans made to a dependent student under HEA section 479A(a), for which the ISIR does not need to have an official EFC To the institution from the Department's CPS Student Valid SAR (Pell Grant, FSEOG, FWS, and Direct Subsidized Loans) To the institution Except for a student meeting the conditions for a late disbursement under 34 CFR 668.164(j), the earlier of: Student through CPS Valid ISIR (Pell Grant, FSEOG, FWS, and Direct Subsidized Loans) To the institution from the Department's CPS — The student's last date of enrollment for the 2018-2019 award year; or
  • — 2 September 21, 2019.
  • Student Valid SAR (Pell Grant, FSEOG, FWS, and Direct Subsidized Loans) To the institution For a student receiving a late disbursement under 34 CFR 668.164(j)(4)(i), the earlier of: Student through CPS Valid ISIR (Pell Grant, FSEOG, FWS, and Direct Subsidized Loans) To the institution from the Department's CPS — 180 days after the date of the institution's determination that the student withdrew or otherwise became ineligible; or — 2 September 21, 2019. Student Verification documents To the institution 3 The earlier of: — 120 days after the student's last date of enrollment for the 2018-2019 award year; or — 2 September 21, 2019 Institution Identity and high school completion verification results for a student selected for verification by the Department and placed in Verification Tracking Group V4 or V5 Electronically to the Department's CPS using “FAA Access to CPS Online” 4 60 days following the institution's first request to the student to submit the required V4 or V5 identity and high school completion documentation. 1 The deadline for electronic transactions is 11:59 p.m. (Central Time) on the deadline date. Transmissions must be completed and accepted before 12:00 midnight to meet the deadline. If transmissions are started before 12:00 midnight but are not completed until after 12:00 midnight, those transmissions do not meet the deadline. In addition, any transmission submitted on or just prior to the deadline date that is rejected may not be reprocessed because the deadline will have passed by the time the user gets the information notifying him or her of the rejection. 2 The date the ISIR/SAR transaction was processed by CPS is considered to be the date the institution received the ISIR or SAR regardless of whether the institution has downloaded the ISIR from its Student Aid Internet Gateway (SAIG) mailbox or when the student submits the SAR to the institution. 3 Although the Secretary has set this deadline date for the submission of verification documents, if corrections are required, deadline dates for submission of paper or electronic corrections and, for Pell Grant applicants and applicants selected for verification, deadline dates for the submission of a valid SAR or valid ISIR to the institution must still be met. An institution may establish an earlier deadline for the submission of verification documents for purposes of the campus-based programs and the Direct Loan Program, but it cannot be later than this deadline date. 4 Note that changes to previously submitted Identity Verification Results must be updated within 30 days of the institution becoming aware that a change has occurred.
    Table B—Pell Grant, Iraq and Afghanistan Service Grant, Direct Loan, and TEACH Grant Programs Deadline Dates for Disbursement Information by Institutions for the 2018-2019 Award Year or Processing Year 1 Which program? What is submitted? Under what
  • circumstances is it
  • submitted?
  • Where is it submitted? What are the deadlines for disbursement and for submission of records and information?
    Pell Grant, Direct Loan, TEACH Grant, and Iraq and Afghanistan Service Grant programs An origination or disbursement record The institution has made or intends to make a disbursement To the Common Origination and Disbursement (COD) System using the Student Aid Internet Gateway (SAIG); or to the COD System using the COD website at: https://cod.ed.gov The earliest disbursement date is January 31, 2018.
  • The earliest submission date for anticipated disbursement information is March 25, 2018.
  • The earliest submission date for actual disbursement information is March 25, 2018, but no earlier than:
  • (a) 7 calendar days prior to the disbursement date under the advance payment method or the Heightened Cash Monitoring Payment Method 1 (HCM1); or
  • (b) The disbursement date under the reimbursement or the Heightened Cash Monitoring Payment Method 2 (HCM2).
  • Pell Grant, Iraq and Afghanistan Service Grant, and TEACH Grant programs An origination or disbursement record The institution has made a disbursement and will submit records on or before the deadline submission date To COD using SAIG; or to COD using the COD website at: https://cod.ed.gov The deadline submission date 2 is the earlier of:
  • (a) 15 calendar days after the institution makes a disbursement or becomes aware of the need to make an adjustment to previously reported disbursement data, except that records for disbursements made between January 31, 2018 and March 25, 2018 must be submitted no later than April 9, 2018; or
  • (b) September 30, 2019.
  • Direct Loan Program An origination or disbursement record The institution has made a disbursement and will submit records on or before the deadline submission date To COD using SAIG; or to COD using the COD website at: https://cod.ed.gov The deadline submission date 2 is the earlier of:
  • (a) 15 calendar days after the institution makes a disbursement or becomes aware of the need to make an adjustment to previously reported disbursement data, except that records of disbursements made between October 1, 2017 and March 25, 2018, may be submitted no later than April 9, 2018; or
  • (b) July 31, 2020.
  • Pell Grant and Iraq and Afghanistan Service Grant programs A downward adjustment to an origination or disbursement record It is after the deadline submission date To COD using SAIG; or to COD using the COD website at: https://cod.ed.gov No later than September 30, 2024. Pell Grant and Iraq and Afghanistan Service Grant programs An origination or disbursement record It is after the deadline submission date and the institution has received approval of its request for an extension to the deadline submission date
  • Requests for extensions to the established submission deadlines may be made for reasons including, but not limited to:
  • (a) A program review or initial audit finding under 34 CFR 690.83;
  • (b) A late disbursement under 34 CFR 668.164(j); or
  • (c) Disbursements previously blocked as a result of another institution failing to post a downward adjustment
  • Via the COD website at: https://cod.ed.gov The earlier of:
  • (a) When the institution is fully reconciled and is ready to submit all additional data for the program and the award year; or
  • (b) September 30, 2024.
  • TEACH Grant and Direct Loan programs When the institution is fully reconciled and is ready to submit all additional data for the program and the award year. Pell Grant and Iraq and Afghanistan Service Grant programs An origination or disbursement record It is after the deadline submission date and the institution has received approval of its request for an extension to the deadline submission date based on a natural disaster, other unusual circumstances, or an administrative error made by the Department Via the COD website at: https://cod.ed.gov The earlier of:
  • (a) A date designated by the Secretary after consultation with the institution; or
  • (b) February 1, 2020.
  • Pell Grant and Iraq and Afghanistan Service Grant programs An origination or disbursement record It is after the deadline submission date and the institution has received approval of its request for administrative relief to extend the deadline submission date based on a student's reentry to the institution within 180 days after initially withdrawing 3 Via the COD website at: https://cod.ed.gov The earlier of:
  • (a) 15 days after the student reenrolls; or
  • (b) May 1, 2020.
  • 1 A COD Processing Year is a period of time in which institutions are permitted to submit Direct Loan records to the COD System that are related to a given award year. For a Direct Loan, the period of time includes loans that have a loan period covering any day in the 2018-2019 award year. 2 Transmissions must be completed and accepted before the designated processing time on the deadline submission date. The designated processing time is published annually via an electronic announcement posted to the Information for Financial Aid Professionals website (https://ifap.ed.gov). If transmissions are started at the designated time, but are not completed until after the designated time, those transmissions will not meet the deadline. In addition, any transmission submitted on or just prior to the deadline date that is rejected may not be reprocessed because the deadline will have passed by the time the user gets the information notifying him or her of the rejection. 3 Applies only to students enrolled in clock-hour and nonterm credit-hour educational programs. Note: The COD System must accept origination data for a student from an institution before it accepts disbursement information from the institution for that student. Institutions may submit origination and disbursement data for a student in the same transmission. However, if the origination data is rejected, the disbursement data is rejected.
    [FR Doc. 2018-26313 Filed 12-3-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket ID ED-2018-FSA-0080] Privacy Act of 1974; Matching Program AGENCY:

    Department of Education.

    ACTION:

    Notice of a new matching program.

    SUMMARY:

    This provides notice of the re-establishment of the matching program between the U.S. Department of Education (Department or ED) (recipient agency) and the U.S. Department of Veterans Affairs (VA) (source agency). The purpose of the matching program is to assist the Department with verification of a veteran's status during the processing of applications for financial assistance under title IV of the Higher Education Act of 1965, as amended (HEA).

    DATES:

    Submit your comments on the proposed matching program on or before January 3, 2019.

    The matching program will go into effect at the later of the following two dates: (1) January 2, 2019, or (2) 30 days after the publication of this notice, December 4, 2018, unless comments have been received from interested members of the public requiring modification and replication of the notice. The matching program will continue for 18 months after the effective date and may be extended for an additional 12 months, if the respective Data Integrity Boards (DIBs) of the Department and VA determine that the conditions specified in 5 U.S.C. 552a(o)(2)(D) have been met.

    ADDRESSES:

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

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

    Postal Mail, Commercial Delivery, or Hand Delivery: If you mail or deliver your comments about these proposed regulations, address them to Marya Dennis, Management and Program Analyst, U.S. Department of Education, Federal Student Aid, Union Center Plaza, 830 First Street NE, Washington, DC 20002-5345.

    Privacy Note:

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

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

    FOR FURTHER INFORMATION CONTACT:

    Ms. Marya Dennis, Management and Program Analyst, U.S. Department of Education, Federal Student Aid, Union Center Plaza, 830 First Street NE, Washington, DC 20002-5345. Telephone: (202) 377-3385.

    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:

    We provide this notice in accordance with the Privacy Act of 1974, as amended (5 U.S.C. 552a); Office of Management and Budget (OMB) Final Guidance Interpreting the Provisions of Public Law 100-503, the Computer Matching and Privacy Protection Act of 1988, 54 FR 25818 (June 19, 1989); and OMB Circular No. A-108, 81 FR 94424 (December 23, 2016).

    The prior Computer Matching Agreement (CMA) was published in the Federal Register on June 1, 2016 (81 FR 35003). Under the provisions of the Computer Matching and Privacy Protection Act of 1988, Public Law 100-503, the CMA was renewed for an additional 12 months through January 1, 2019, because: (1) The program was conducted without change; and (2) each Data Integrity Board Chairperson certified in writing that the program was conducted in compliance with the CMA. ED and VA are now re-establishing the matching program through this notice.

    Participating Agencies

    ED and VA.

    Authority for Conducting the Matching Program

    ED is authorized to participate in the matching program under sections 480(c)(1) and 480(d)(1)(D) of the HEA (20 U.S.C. 1087vv(c)(1) and (d)(1)(D)). VA is authorized to participate in the matching program under 38 U.S.C. 523.

    Purpose(s)

    The purpose of this matching program is to assist the Secretary of Education with verification of a veteran's status during the processing and review of applications for financial assistance under title IV of the Higher Education Act of 1965, as amended (HEA).

    The Secretary of Education is authorized by the HEA to administer the title IV programs and to enforce the terms and conditions of the HEA.

    Section 480(c)(1) of the HEA defines the term “veteran” to mean “any individual who (A) has engaged in the active duty in the United States Army, Navy, Air Force, Marines, or Coast Guard; and (B) was released under a condition other than dishonorable.” (20 U.S.C. 1087vv(c)(1)). Under section 480(d)(1)(D) of the HEA, an applicant who is a veteran (as defined in section 480(c)(1)) is considered an independent student for purposes of title IV, HEA program assistance eligibility, and, therefore, does not have to provide parental income and asset information to apply for title IV, HEA program assistance. (20 U.S.C. 1087vv(d)(1)(D)).

    Categories of Individuals

    Individuals who have completed the Free Application for Federal Student Aid (FAFSA) and have indicated that they are a veteran.

    Categories of Records

    ED will provide to the VA the Social Security number, first and last name, and date of birth of each applicant for financial assistance under title IV of the HEA who indicates veteran status in his or her application for financial assistance under title IV of the HEA.

    System(s) of Records

    ED system of records: Federal Student Aid Application File (18-11-01) (76 FR 46774, August 3, 2011).

    VA system of records: Veterans and Beneficiaries Identification and Records Location Subsystem—VA (38VA21) last published in full at 47 FR 367 (January 5, 1982) and most recently amended at 66 FR 30049 (June 4, 2001).

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

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. 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: November 29, 2018. James F. Manning, Acting Chief Operating Officer, Federal Student Aid.
    [FR Doc. 2018-26312 Filed 12-3-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Extension of the Public Comment Period for the U.S. Department of Energy Interpretation of High-Level Radioactive Waste AGENCY:

    Office of Environmental Management, U.S. Department of Energy.

    ACTION:

    Extension of public comment period.

    SUMMARY:

    The U.S. Department of Energy (DOE) is extending the public comment period for the request for public comments on its proposed interpretation of the statutory term high-level radioactive waste (HLW). DOE published a notice in the Federal Register on October 10, 2018, establishing a 60-day public comment period ending on December 10, 2018. DOE is extending the public comment period for 30 days, ending on January 9, 2019.

    DATES:

    The comment period for the Notice published on October 10, 2018 (83 FR 50909) is extended. DOE will consider all comments submitted or postmarked by January 9, 2019.

    ADDRESSES:

    Please direct comments to:

    (a) Email: Send comments to [email protected] Please submit comments in MicrosoftTM Word, or PDF file format, and avoid the use of encryption.

    (b) Mail: Send to the following address: Theresa Kliczewski, U.S. Department of Energy, Office of Environmental Management, Office of Waste and Materials Management (EM-4.2), 1000 Independence Avenue SW, Washington, DC 20585.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Theresa Kliczewski at [email protected] or at U.S. Department of Energy, Office of Environmental Management, Office of Waste and Materials Management (EM-4.2), 1000 Independence Avenue SW, Washington, DC 20585. Telephone: (202) 586-3301.

    SUPPLEMENTARY INFORMATION:

    On October 10, 2018, DOE published a notice in the Federal Register [83 FR 50909] soliciting public comment on its interpretation of the statutory term high-level radioactive waste (HLW) as set forth in the Atomic Energy Act of 1954 and the Nuclear Waste Policy Act of 1982. This statutory term indicates that not all wastes from reprocessing of spent nuclear fuel are HLW, and DOE interprets the statutory term such that some reprocessing wastes may be classified as not HLW (non-HLW) and may be disposed of in accordance with their radiological characteristics. DOE established a 60-day public comment period ending on December 10, 2018. DOE has received public comments in response to the Notice, including requests from several entities requesting extensions of the public comment period. Commenters noted the significance of this matter, the overlap in comment periods with another DOE radioactive waste proceeding at DOE's Hanford site, etc. DOE has reviewed the requests for an extension of the public comment period and considered the benefit to DOE and stakeholders in providing additional time to the public to review the Notice and provide comments to DOE on its HLW interpretation. Accordingly, DOE has determined that an extension of the comment period is appropriate, and is hereby extending the comment period an additional 30 days, with the public comment period ending on January 9, 2019.

    Issued at Washington, DC, on November 28, 2018. Anne Marie White, Assistant Secretary, Office of Environmental Management.
    [FR Doc. 2018-26319 Filed 12-3-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP19-311-000.

    Applicants: NEXUS Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rate—CNX Gas to DTE Energy to be effective 12/1/2018.

    Filed Date: 11/27/18.

    Accession Number: 20181127-5023.

    Comments Due: 5 p.m. ET 12/10/18.

    Docket Numbers: RP19-312-000.

    Applicants: Guardian Pipeline, L.L.C.

    Description: § 4(d) Rate Filing: Non-Conforming and Negotiated Rate Agreement Wisconsin Gas & Wisconsin Electric to be effective 12/1/2018.

    Filed Date: 11/27/18.

    Accession Number: 20181127-5060.

    Comments Due: 5 p.m. ET 12/10/18.

    Docket Numbers: RP19-313-000.

    Applicants: Guardian Pipeline, L.L.C.

    Description: § 4(d) Rate Filing: Non-Conforming and Negotiated Rate Agreement Wisconsin Gas & Wisconsin Electric to be effective 12/1/2018.

    Filed Date: 11/27/18.

    Accession Number: 20181127-5077.

    Comments Due: 5 p.m. ET 12/10/18.

    Docket Numbers: RP19-314-000.

    Applicants: Gas Transmission Northwest LLC.

    Description: § 4(d) Rate Filing: Annual Fuel Filing 2018 to be effective 1/1/2019.

    Filed Date: 11/27/18.

    Accession Number: 20181127-5094.

    Comments Due: 5 p.m. ET 12/10/18.

    Docket Numbers: RP19-315-000.

    Applicants: Florida Gas Transmission Company, LLC.

    Description: § 4(d) Rate Filing: New Service Agreement (PowerSouth) Filing on 11-27-18 to be effective 12/1/2018.

    Filed Date: 11/27/18.

    Accession Number: 20181127-5101.

    Comments Due: 5 p.m. ET 12/10/18.

    Docket Numbers: RP19-316-000.

    Applicants: Florida Gas Transmission Company, LLC.

    Description: § 4(d) Rate Filing: Update Non-Conforming List (PowerSouth) Filing on 11-27-18 to be effective 12/1/2018.

    Filed Date: 11/27/18.

    Accession Number: 20181127-5102.

    Comments Due: 5 p.m. ET 12/10/18.

    Docket Numbers: RP19-317-000.

    Applicants: Northern Natural Gas Company.

    Description: § 4(d) Rate Filing: 20181127 Negotiated Rate to be effective 11/28/2018.

    Filed Date: 11/27/18.

    Accession Number: 20181127-5137.

    Comments Due: 5 p.m. ET 12/10/18.

    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: November 28, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-26331 Filed 12-3-18; 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 exempt wholesale generator filings:

    Docket Numbers: EG19-26-000.

    Applicants: Solomon Forks Wind Project, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of Solomon Forks Wind Project, LLC.

    Filed Date: 11/28/18.

    Accession Number: 20181128-5033.

    Comments Due: 5 p.m. ET 12/19/18.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-3079-014.

    Applicants: Tyr Energy, LLC.

    Description: Amendment to December 12, 2017 Updated Market Power Analysis for the Southeast Region of Tyr Energy, LLC.

    Filed Date: 11/27/18.

    Accession Number: 20181127-5159.

    Comments Due: 5 p.m. ET 12/18/18.

    Docket Numbers: ER19-66-001.

    Applicants: Conemaugh Power Pass-Through Holders LLC.

    Description: Tariff Amendment: Modify Market-Based Rate Application to be effective 11/29/2018.

    Filed Date: 11/28/18.

    Accession Number: 20181128-5128.

    Comments Due: 5 p.m. ET 12/19/18.

    Docket Numbers: ER19-70-001.

    Applicants: Keystone Power Pass-Through Holders LLC.

    Description: Tariff Amendment: Modify Market-Based Rate Tariff Application to be effective 11/29/2018.

    Filed Date: 11/28/18.

    Accession Number: 20181128-5134.

    Comments Due: 5 p.m. ET 12/19/18.

    Docket Numbers: ER19-406-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Original ISA, SA No. 5236; Queue No. AA2-070 to be effective 10/26/2018.

    Filed Date: 11/27/18.

    Accession Number: 20181127-5113.

    Comments Due: 5 p.m. ET 12/18/18.

    Docket Numbers: ER19-407-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-11-27_SA 3155 Termination of ATC-ACEC PCA (Springwater) to be effective 11/28/2018.

    Filed Date: 11/27/18.

    Accession Number: 20181127-5158.

    Comments Due: 5 p.m. ET 12/18/18.

    Docket Numbers: ER19-408-000.

    Applicants: Wisconsin Power and Light Company.

    Description: § 205(d) Rate Filing: WPL—Pioneer Power Wholesale Service Agreement to be effective 1/28/2019.

    Filed Date: 11/28/18.

    Accession Number: 20181128-5000.

    Comments Due: 5 p.m. ET 12/19/18.

    Docket Numbers: ER19-409-000

    Applicants: NSTAR Electric Company.

    Description: Initial rate filing: NSTAR-HQUS Transfer Agreement (MMWEC Use Rights) to be effective 12/20/2018.

    Filed Date: 11/28/18.

    Accession Number: 20181128-5016.

    Comments Due: 5 p.m. ET 12/19/18.

    Docket Numbers: ER19-410-000.

    Applicants: Midcontinent Independent System Operator, Inc., ALLETE, Inc.

    Description: § 205(d) Rate Filing: 2018-11-28_SA 3215 MP-GRE ICA (Bear Creek) to be effective 11/29/2018.

    Filed Date: 11/28/18.

    Accession Number: 20181128-5020.

    Comments Due: 5 p.m. ET 12/19/18.

    Docket Numbers: ER19-411-000.

    Applicants: Midcontinent Independent System Operator, Inc., ALLETE, Inc.

    Description: § 205(d) Rate Filing: 2018-11-28_SA 3216 MP-GRE IA (Long Lake) to be effective 11/29/2018.

    Filed Date: 11/28/18.

    Accession Number: 20181128-5024.

    Comments Due: 5 p.m. ET 12/19/18.

    Docket Numbers: ER19-412-000.

    Applicants: P.H. Glatfelter Company.

    Description: Notice of Cancellation of Market-Based Rate Tariff of P.H. Glatfelter Company.

    Filed Date: 11/28/18.

    Accession Number: 20181128-5103.

    Comments Due: 5 p.m. ET 12/19/18.

    Docket Numbers: ER19-413-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: LGIA Willy 9 Project SA No. 216 to be effective 11/29/2018.

    Filed Date: 11/28/18.

    Accession Number: 20181128-5113.

    Comments Due: 5 p.m. ET 12/19/18.

    Docket Numbers: ER19-414-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: LGIA Willow Springs 4 Project SA No. 215 to be effective 11/29/2018.

    Filed Date: 11/28/18.

    Accession Number: 20181128-5115.

    Comments Due: 5 p.m. ET 12/19/18.

    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: November 28, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-26330 Filed 12-3-18; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2017-0750; FRL-9985-62] Registration Review Proposed Interim Decisions for Several Pesticides; Notice of Availability AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the availability of EPA's proposed interim registration review decisions and opens a 60-day public comment period on the proposed interim decisions for the following pesticides: 2,4-xylenol, Abamectin, Ametryn, Bacteriophage active against Xanthomonas campestris pv. vesicatoria, Bacteriophage active against Pseudomonas syringae pv. tomato, Barium metaborate, Bicarbonates, Biobor, Butralin, Chondrostereum Purpureum, Corn glutens, Cyhalofop-butyl, Diphenylamine, Indole-3-acetic acid, L-glutamic acid and gamma aminobutyric acid, Lysophosphatidylethanolamine, Meta-cresol, Methiocarb, Methyl anthranilate, Oil of black pepper, Oryzalin, Phosphoric acid and its salts, Potato leaf roll virus resistance gene, Predator urines, Prodiamine, Pyrithiobac-sodium, Sodium cyanide, Sodium fluoroacetate, Straight chain lepidopteran pheromones, Verticillium isolate WCS850, Yeast extract hydrolysate, and Zinc borate.

    DATES:

    Comments must be received on or before February 4, 2019.

    ADDRESSES:

    Submit your comments, identified by the docket identification (ID) number for the specific pesticide of interest provided in the Table in Unit IV, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

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

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

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

    FOR FURTHER INFORMATION CONTACT:

    For pesticide specific information, contact: The Chemical Review Manager for the pesticide of interest identified in the Table in Unit IV.

    For general information on the registration review program, contact: Dana Friedman, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (703) 347-8827; email address: [email protected].

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

    This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager for the pesticide of interest identified in the Table in Unit IV.

    B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    II. Background

    Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed proposed interim decisions for all pesticides listed in the Table in Unit IV. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.

    III. Authority

    EPA is conducting its registration review of the chemicals listed in the Table in Unit IV pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.

    IV. What action is the Agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability of EPA's proposed interim registration review decisions for the pesticides shown in the following table, and opens a 60-day public comment period on the proposed interim decisions. For barium metaborate, cyhalofop-butyl, prodiamine, sodium cyanide, and sodium fluoroacetate this notice also opens a comment period on the ecological and human health risk assessments. For diphenylamine, this notice also opens a comment period on the human health risk assessment.

    Registration review case name and No. Docket ID number Chemical review manager and
  • contact information
  • 2,4-Xylenol, Case 4098 EPA-HQ-OPP-2010-0240 Jonathan Williams, [email protected], (703) 347-0670. Abamectin, Case 7430 EPA-HQ-OPP-2013-0360 Julie Javier, [email protected], (703) 347-0790. Ametryn, Case 2010 EPA-HQ-OPP-2013-0249 Christian Bongard, [email protected], (703) 347-0337. Bacteriophage active against Xanthomonas campestris pv. vesicatoria, Case 6509 and, Bacteriophage active against Pseudomonas syringae pv. Tomato, Case 6510 EPA-HQ-OPP-2015-0702 Susanne Cerrelli [email protected], (703) 308-8077. Barium Metaborate, Case 0632 EPA-HQ-OPP-2008-0047 Daniel Halpert, [email protected], (703) 347-0133. Bicarbonates, Case 4048 EPA-HQ-OPP-2012-0407 Maggie Rudick, [email protected], (703) 347-0257. Biobor, Case 3029 EPA-HQ-OPP-2008-0453 Megan Snyderman, [email protected], (703) 347-0671. Butralin, Case 2075 EPA-HQ-OPP-2011-0720 Lauren Bailey, [email protected], (703) 347-0374. Chondrostereum Purpureum, Case 6091 EPA-HQ-OPP-2015-0051 Daniel Schoeff, [email protected], (703-347-0143. Corn Glutens, Case 6040 EPA-HQ-OPP-2016-0253 Maggie Rudick, [email protected], (703) 347-0257. Cyhalofop-butyl, Case 7255 EPA-HQ-OPP-2014-0115 Rachel Fletcher, [email protected], (703 347-0512. Diphenylamine, Case 2210 EPA-HQ-OPP-2015-0749 Samantha Thomas, [email protected], (703) 347-0514. Indole-3-Acetic acid, Case 6205 EPA-HQ-OPP-2016-0665 Maggie Rudick, [email protected], (703) 347-0257. L-Glutamic Acid (LGA) and Gamma Aminobutyric Acid (GABA), Case 6025 EPA-HQ-OPP-2014-0109 Cody Kendrick [email protected], (703) 347-0468. Lysophosphatidylethanolamine (LPE), Case 6043 EPA-HQ-OPP-2017-0059 Maggie Rudick, [email protected], (703) 347-0257. meta-Cresol, Case 4027 EPA-HQ-OPP-2010-0244 Jonathan Williams, [email protected], (703) 347-0670. Methiocarb, Case 0577 EPA-HQ-OPP-2010-0278 Veronica Dutch, [email protected], (703) 308-8585. Methyl Anthranilate, Case 6056 EPA-HQ-OPP-2011-0678 Susanne Cerrelli [email protected], (703) 308-8077. Oil of Black Pepper, Case 6004 EPA-HQ-OPP-2017-0262 Cody Kendrick [email protected], 703) 347-0468. Oryzalin, Case 0186 EPA-HQ-OPP-2010-0940 Christina Scheltema, [email protected], (703) 308-2201. Phosphoric Acid and Its Salts Case 6072 EPA-HQ-OPP-2012-0672 Cody Kendrick [email protected], (703) 347-0468. Potato Leaf Roll Virus Resistance Gene, Case 6505 EPA-HQ-OPP-2012-0416 Michael Glikes, [email protected], (703) 305-6231. Predator Urines: Coyote Urine and Fox Urine, Case 6202 EPA-HQ-OPP-2016-0086 Alexandra Boukedes, [email protected], (703) 347-0305. Prodiamine, Case 7201 EPA-HQ-OPP-2010-0920 Jordan Page, [email protected], (703 347-0467. Pyrithiobac-sodium, Case 7239 EPA-HQ-OPP-2011-0661 Linsey Walsh, [email protected], (703) 347-8030. Sodium Cyanide, Case 3086 EPA-HQ-OPP-2010-0752 Leigh Rimmer, [email protected], (703) 347-0553. Sodium Fluoroacetate, Case 3073 EPA-HQ-OPP-2010-0753 Leigh Rimmer, [email protected], (703) 347-0553. Straight Chain Lepidopteran Pheromones (SCLP), Case 8200 EPA-HQ-OPP-2012-0127 Maggie Rudick, [email protected], (703) 347-0257. Verticillium isolate WCS850 Case 6508 EPA-HQ-OPP-2016-0306 Maggie Rudick, [email protected], (703) 347-0257. Yeast Extract Hydrolysate, Case 6081 EPA-HQ-OPP-2017-0282 Daniel Schoeff, [email protected], (703) 347-0143. Zinc Borate, Case 5025 EPA-HQ-OPP-2007-0675 Stephen Savage, [email protected], (703) 347-0345.

    The registration review docket for a pesticide includes earlier documents related to the registration review case. For example, the review opened with a Preliminary Work Plan, for public comment. A Final Work Plan was placed in the docket following public comment on the Preliminary Work Plan.

    The documents in the dockets describe EPA's rationales for conducting additional risk assessments for the registration review of the pesticides included in the table in Unit IV, as well as the Agency's subsequent risk findings and consideration of possible risk mitigation measures. These proposed interim registration review decisions are supported by the rationales included in those documents. Following public comment, the Agency will issue interim or final registration review decisions for the pesticides listed in the table in Unit IV.

    The registration review final rule at 40 CFR 155.58(a) provides for a minimum 60-day public comment period on all proposed interim registration review decisions. This comment period is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the proposed interim decision. All comments should be submitted using the methods in ADDRESSES, and must be received by EPA on or before the closing date. These comments will become part of the docket for the pesticides included in the Table in Unit IV. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

    The Agency will carefully consider all comments received by the closing date and may provide a “Response to Comments Memorandum” in the docket. The interim registration review decision will explain the effect that any comments had on the interim decision and provide the Agency's response to significant comments.

    Background on the registration review program is provided at: http://www.epa.gov/pesticide-reevaluation.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: October 25, 2018. Yu-Ting Guilaran, Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.
    [FR Doc. 2018-26344 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2017-0751; FRL-9985-61] Interim Registration Review Decisions and Case Closures for Several Pesticides; Notice of Availability AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the availability of EPA's interim registration review decision for the following chemicals: Acibenzolar-s-methyl, Aspergillus flavus, Asulam, Bacillus licheniformis strain SB3086, Chloroxylenol, Copper compounds, Dried Fermentation Solids and Solubles of Myrothecium verrucaria, EPTC, Ethylene, Fludioxonil, Formic Acid, Methyl Nonyl Ketone, Niclosamide, N6-Benzyladenine, Potassium Silicate, Propamocarb hydrochloride, Putrescent Whole Egg Solids, Sodium carbonate and TFM. It also announces the case closure for Bis (bromoacetoxy)-2-butene (BBAB) (Case 3030, Docket ID Number EPA-HQ-OPP-2014-0799) because the last U.S. registrations for these pesticides have been canceled.

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

    This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the pesticide specific contact person listed under FOR FURTHER INFORMATION CONTACT: For pesticide specific information, contact: The Chemical Review Manager for the pesticide of interest identified in the Table in Unit IV.

    For general information on the registration review program, contact: Dana Friedman, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (703) 347-8827; email address: [email protected].

    II. Background

    Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed interim decisions for all pesticides listed in the Table in Unit IV. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.

    III. Authority

    EPA is conducting its registration review of the chemicals listed in the Table in Unit IV pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.

    IV. What action is the Agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability of EPA's interim registration review decisions for the pesticides shown in the following table. The interim registration review decisions are supported by rationales included in the docket established for each chemical.

    Table 1—Registration Review Interim Decisions Being Issued Registration review case name and number Docket ID number Chemical review manager and contact information Acibenzolar-S-methyl, Case 7031 EPA-HQ-OPP-2013-0755 Leigh Rimmer, [email protected], (703) 347-0553 Aspergillus flavus, Case 6008 EPA-HQ-OPP-2015-0281 Alexandra Boukedes, [email protected], (703) 347-0305 Asulam, Case 0265 EPA-HQ-OPP-2010-0783 Caitlin Newcamp, [email protected], (703) 347-0325 Bacillus licheniformis strain SB3086, Case 6014 EPA-HQ-OPP-2014-0184 Daniel Schoeff, [email protected], (703) 347-0143 Chloroxylenol, Case 3045 EPA-HQ-OPP-2009-0010 Rachel Ricciardi, [email protected], (703) 347-0465 Copper Compounds, Cases 0636, 0649, 4025, 4026 EPA-HQ-OPP-2010-0212 Jordan Page, [email protected], (703) 347-0467, Kimberly Wilson, [email protected], (703) 347-0495 Dried Fermentation Solids and Solubles of Myrothecium verrucaria, Case 6051 EPA-HQ-OPP-2013-0539 Cody Kendrick, [email protected], (703) 347-0468 EPTC, Case 0064 EPA-HQ-OPP-2012-0720 Patricia Biggio, [email protected], (703) 347-0547 Ethylene, Case 3071 EPA-HQ-OPP-2009-0877 Susanne Cerrelli, [email protected], (703) 308-8077 Fludioxonil, Case 7017 EPA-HQ-OPP-2010-1067 Patricia Biggio, [email protected], (703) 347-0547 Formic Acid, Case 6073 EPA-HQ-OPP-2014-0105 Cody Kendrick, [email protected], (703) 347-0468 Methyl Nonyl Ketone, Case 3094 EPA-HQ-OPP-2012-0125 Daniel Schoeff, [email protected], (703) 347-0143 Niclosamide, Case 2455 EPA-HQ-OPP-2013-0137 R. David Jones, [email protected], (703) 305-6725 N6-Benzyladenine, Case 2040 EPA-HQ-OPP-2011-0190 Alexandra Boukedes, [email protected], (703) 347-0305 Potassium Silicate, Case 6204 EPA-HQ-OPP-2017-0329 Donna Kamarei, [email protected], (703) 347-0443 Propamocarb hydrochloride, Case 3124 EPA-HQ-OPP-2011-0662 Christina Scheltema, [email protected], (703) 308-2201 Putrescent Whole Egg Solids, Case 4079 EPA-HQ-OPP-2010-0726 Susanne Cerrelli, [email protected], (703) 308-8077 Sodium carbonate, Case 4066 EPA-HQ-OPP-2012-0809 SanYvette Williams, [email protected], (703) 305-7702 TFM, Case 3082 EPA-HQ-OPP-2013-0137 R. David Jones, [email protected], (703) 305-6725

    The proposed interim registration review decisions for the chemicals in the table above were posted to the docket and the public was invited to submit any comments or new information. EPA addressed the comments or information received during the 60-day comment period for the proposed interim decisions in the discussion for each pesticide listed in the table. Comments from the 60-day comment period that were received may or may not have affected the Agency's interim decision. Pursuant to 40 CFR 155.58(c), the registration review case docket for the chemicals listed in the Table will remain open until all actions required in the interim decision have been completed.

    This document also announces the closure of the registration review case for Bis (bromoacetoxy)-2-butene (BBAB) (Case 3030, Docket ID Number EPA-HQ-OPP-2014-0799), because the last U.S. registrations for these pesticides have been canceled. Background on the registration review program is provided at: http://www.epa.gov/pesticide-reevaluation.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: October 25, 2018. Yu-Ting Guilaran, Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.
    [FR Doc. 2018-26354 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-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 December 31, 2018.

    A. Federal Reserve Bank of Atlanta (Kathryn Haney, Assistant Vice President) 1000 Peachtree Street NE, Atlanta, Georgia 30309. Comments can also be sent electronically to [email protected]:

    1. B.P.C. Corporation, Cookeville, Tennessee; to merge with CFB Bancshares, Inc., and thereby indirectly acquire Citizens First Bank, both of Wartburg, Tennessee.

    Board of Governors of the Federal Reserve System, November 29, 2018. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2018-26328 Filed 12-3-18; 8:45 am] BILLING CODE P
    GENERAL SERVICES ADMINISTRATION [Notice-MA-2018-10; Docket No. 2018-0002; Sequence No. 28] Relocation Allowances: Taxes on Travel, Transportation, and Relocation Expenses AGENCY:

    Office of Government-wide Policy (OGP), General Services Administration (GSA).

    ACTION:

    Notice of Federal Travel Regulation (FTR) Bulletin 19-02, Relocation Allowances—Taxes on Travel, Transportation, and Relocation Expenses.

    SUMMARY:

    The purpose of this notice is to inform Federal agencies that FTR Bulletin 19-02, pertaining to travel, transportation, and relocation allowances impacted by recent changes to Federal tax law, has been published and is now available online at www.gsa.gov/ftrbulletin.

    DATES:

    Applicability: This notice applies to travel, transportation, and relocation expenses paid on or after January 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    For clarification of content, please contact Mr. Rick Miller, Office of Government-wide Policy, Office of Asset and Transportation Management, at 202-501-3822, or by email at [email protected]. Please cite Notice of FTR Bulletin 19-02.

    Dated: November 27, 2018. Jessica Salmoiraghi, Associate Administrator, Office of Government-wide Policy.
    [FR Doc. 2018-26342 Filed 12-3-18; 8:45 am] BILLING CODE 6820-14-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Interventions for Substance Use Disorders in Adolescents: A Systematic Review AGENCY:

    Agency for Healthcare Research and Quality (AHRQ), HHS.

    ACTION:

    Request for supplemental evidence and data submissions.

    SUMMARY:

    The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Interventions for Substance Use Disorders in Adolescents: A Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

    DATES:

    Submission Deadline on or before January 3, 2019.

    ADDRESSES:

    Email submissions: [email protected]

    Print submissions:

    Mailing Address: Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.

    Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857.

    FOR FURTHER INFORMATION CONTACT:

    Jenae Benns, Telephone: 301-427-1496 or Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Interventions for Substance Use Disorders in Adolescents: A Systematic Review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

    The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on Interventions for Substance Use Disorders in Adolescents: A Systematic Review, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https://effectivehealthcare.ahrq.gov/topics/substance-use-disorders-adolescents/protocol.

    This is to notify the public that the EPC Program would find the following information on Interventions for Substance Use Disorders in Adolescents: A Systematic Review helpful:

    A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.

    For completed studies that do not have results on ClinicalTrials.gov, please provide a summary, including the following elements: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.

    A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.

    Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file.

    Your contribution will be very beneficial to the EPC Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.

    The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.

    The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.

    The Key Questions

    KQ 1: What are the effects of behavioral, pharmacologic, and combined interventions compared with placebo or no active treatment for substance use disorders and problematic substance use 1 in adolescents to achieve abstinence, reduce quantity and frequency of use, improve functional outcomes, and reduce substance-related harms?

    1 Substances considered: Alcohol, cannabis, opioids, sedatives/hypnotics/anxiolytics, stimulants, inhalants and hallucinogens. Tobacco is excluded.

    a. How do benefits and adverse outcomes of interventions vary by subpopulations? 2

    2 Subpopulations considered: Psychiatric co-morbidities, age (early, middle and late adolescence), sex and gender, race/ethnicity, socioeconomic status and related characteristics (e.g., homelessness, poverty), pregnant, postpartum, and parenting adolescents, demographic/family characteristics. Factors in bold will be prioritized if necessary.

    b. How do benefits and adverse outcomes of interventions vary by intervention characteristics? 3

    3 Intervention characteristics: Target (e.g. teen, family or group of teens), duration and setting.

    KQ 2: What are the comparative effects of active interventions for substance use disorders and problematic substance use 1 in adolescents to achieve abstinence, reduce quantity and frequency of use, improve functional outcomes, and reduce harms?

    a. How do comparative benefits and adverse outcomes of interventions vary by subpopulations? 2

    b. How do comparative benefits and adverse outcomes of interventions vary by intervention characteristics? 3

    PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings)

    Population (all KQs) Age: Adolescents (12-20 years inclusive) Exclude if >20 percent of study sample (or identifiable subgroup) is <12 or >20 years, combined • SUD or problematic use of: ○ Alcohol Exclude primary studies of treatment of alcohol use disorder/problematic alcohol use in the college setting (we will include existing systematic reviews) ○ Cannabis ○ Opioids Nonmedical prescription drug use (codeine, hydrocodone, oxycodone) Illicit (e.g., heroin, illicit synthetics) ○ Sedatives, hypnotics, or anxiolytics (e.g., benzodiazepines, carbamates, barbiturates, methaqualone) ○ Stimulants Nonmedical prescription drug use (e.g., methylphenidate) Illicit (e.g., cocaine, methamphetamine) ○ Inhalants ○ Hallucinogens (e.g., phencyclidine, ketamine, MDMA, LSD) ○ Unspecified or polysubstance use Exclude if predominately tobacco/nicotine use Exclude tobacco/nicotine use disorder or problematic tobacco/nicotine use Exclude limited (or experimental) substance use that has not been deemed to be at least “problematic” • Subpopulations of interest (not necessary for eligibility) ○ Psychiatric comorbidities Attention deficit hyperactivity disorder (ADHD), depression, other internalizing and externalizing disorders. Age Early adolescence (12-14 years) Middle adolescence (15-17 years) Late adolescence (18-20 years) Sex and gender Male vs. female Gender identity (cis vs. transgender) Sexual orientation Racial/ethnic minority ○ Socioeconomic status and related characteristics (e.g., homelessness, poverty) ○ Pregnant, postpartum, and parenting adolescents ○ Demographic/family characteristics Demographics Family and community dynamics (i.e. substance using family member) Involvement with child protection services. Interventions • Behavioral health treatments (major intervention models are indicated by arrowhead bullets, in bold) Family Therapies ○ Family behavioral therapy (FBT) ○ Family systems therapy (FST) Brief strategic family therapy (BSFT) ○ Functional family therapy (FFT) ○ Ecological family therapy ○ Multidimensional family therapy (MDFT) ○ Ecologically based family therapy (EBFT) ○ Family systems network (FSN) ○ Educational family therapy ○ Multi-systemic therapy (MST) Cognitive Behavioral Therapy (CBT) ○ Adolescent community reinforcement approach (ACRA) ○ Dialectical behavior therapy ○ Cognitive therapy Contingency Management Motivational Interviewing/Motivation Enhancement Therapy Multi-Component Interventions consisting of two or more models ( e.g., MST + CBT; FFT + CBT) Psychoeducation Treatment as Usual (does not meet criteria for any of the above categories) Integrated Interventions for substance use and a co-occurring disorder Other ○ Culturally sensitive interventions Recovery Support ○ 12-step programs ○ Peer-based and/or peer supports ○ Assertive continuing care (ACC)

    Exclude primary (universal) and secondary preventive interventions.

    Exclude interventions used in population that do not aim to reduce substance use (e.g., needle exchange).

    • Pharmacologic Interventions Exclude medications being used to treat overdose (e.g., naloxone) Exclude pharmacologic management of acute withdrawal symptoms ○ Medications to reduce and/or eliminate substance use and to prevent relapse (See Appendix B for details of FDA approvals) Alcohol • Gabapentin • Naltrexone • Acamprosate • Disulfiram • Topiramate • Ondansetron Cannabis • N-acetylcysteine (NAC) Opioids • Methadone • Buprenorphine • Buprenorphine/Naloxone • Naltrexone ○ Medications to treat co-occurring psychiatric disorders in patients in patients with concurrent problematic substance use or SUD. Comparators KQ 1 • No active treatment ○ Wait list ○ Placebo (for medications) • Usual care (if not a clearly defined behavioral intervention) KQ 2 • Active interventions (we will evaluate other comparisons if the evidence allows) ○ Pharmacologic plus behavioral vs. behavioral or pharmacologic alone ○ Between major behavioral intervention models (e.g. family therapy, cognitive behavioral therapy) ○ Multicomponent interventions vs. single behavioral intervention model Outcomes Abstinence ○ Urine drug test results (from substance identified on admission to treatment, abstinence from all substances, duration of abstinence) Quantity, Frequency, or Severity of Use (of primary substance identified on entry to treatment and other substances) ○ Days of use/abstinence over specified time period ○ Quantity of use over specified time period ○ Substance-related problems/symptom count scales Functional Outcomes ○ School performance and educational attainment Attendance Grades/academic performance Graduation rates Entering higher education (including trade schools) ○ Social relationships Family functioning Peer relationships Harmful Consequences Associated With SUD ○ Mental health outcomes Suicidal ideation and behavior ○ Physical health outcomes • Mortality All-cause Drug-related, including fatal overdose Morbidity Injuries (non-fatal) • Infections HIV Hepatitis C Other sexually transmitted infections ○ Legal outcomes • Arrests • Drunk or impaired driving • Contact with juvenile justice system Adverse Effects of Intervention(s) ○ Side effects of pharmacologic interventions ○ Loss of privacy/confidentiality ○ Stigmatization/discrimination ○ Iatrogenic effects of group therapy due to peer deviance ○ Other reported adverse effects ascribed to interventions Study Designs and Information Sources • Published, peer reviewed articles and data from clinicaltrials.gov ○ Randomized controlled trials (including cross-over trials) N ≥ 10 participants per study group ○ Large nonrandomized comparative studies with longitudinal follow-up N ≥ 100 participants per study group Must report multiple regression, other adjustment, matching, propensity scoring, or other method to account for confounding. ○ Single arm pharmacologic studies with at least 200 participants and longitudinal follow-up (to identify side-effects of medications) ○ We will summarize information from existing systematic reviews specific to treatment of alcohol SUD on college campuses SR eligible if inclusion criteria for individual studies consistent with our PICOTS criteria for individual studies. Exclusions ○ Case-control studies ○ Cross-sectional studies ○ Single-arm studies of behavioral interventions ○ Conference abstracts letters, and other non-peer reviewed reports Timing • Any duration of treatment • Duration of follow-up of at least a month (but must be longitudinal with separation in time between intervention and outcomes) Setting • Any setting, including (but not limited to) primary care, school, outpatient, emergency department, in-patient, intensive outpatient, partial hospitalization, intensive inpatient/residential, juvenile justice

    Exclude: laboratory-based assessments.

    Francis D. Chesley, Jr., Acting Deputy Director.
    [FR Doc. 2018-26304 Filed 12-3-18; 8:45 am] BILLING CODE 4160-90-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC-2018-0065; Docket Number NIOSH-317] Final National Occupational Research Agenda for Oil and Gas Extraction AGENCY:

    National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice of availability.

    SUMMARY:

    NIOSH announces the availability of the final National Occupational Research Agenda for Oil and Gas Extraction

    DATES:

    The final document was published on November 27, 2018 on the CDC website.

    ADDRESSES:

    The document may be obtained at the following link: https://www.cdc.gov/nora/councils/oilgas/agenda.html

    FOR FURTHER INFORMATION CONTACT:

    Emily Novicki, M.A., M.P.H, ([email protected]), National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Mailstop E-20, 1600 Clifton Road NE, Atlanta, GA 30329, phone (404) 498-2581 (not a toll free number).

    SUPPLEMENTARY INFORMATION:

    On July 26, 2018, NIOSH published a request for public review in the Federal Register [83 FR 35485] of the draft version of the National Occupational Research Agenda for Oil and Gas Extraction. The single comment received expressed support.

    Dated: November 29, 2018. Frank J. Hearl, Chief of Staff, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.
    [FR Doc. 2018-26315 Filed 12-3-18; 8:45 am] BILLING CODE 4163-19-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-6063-N4] Medicare Program; Extension of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. The extension of this model is applicable to the following states and the District of Columbia: Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia.

    DATES:

    This extension begins on December 2, 2018 and ends on December 1, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Angela Gaston, (410) 786-7409. Questions regarding the Medicare Prior Authorization Model Extension for Repetitive Scheduled Non-Emergent Ambulance Transport should be sent to [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    Medicare may cover ambulance services, including air ambulance (fixed-wing and rotary-wing) services, if the ambulance service is furnished to a beneficiary whose medical condition is such that other means of transportation are contraindicated. The beneficiary's condition must require both the ambulance transportation itself and the level of service provided in order for the billed service to be considered medically necessary.

    Non-emergent transportation by ambulance is appropriate if either the— (1) beneficiary is bed-confined and it is documented that the beneficiary's condition is such that other methods of transportation are contraindicated; or (2) beneficiary's medical condition, regardless of bed confinement, is such that transportation by ambulance is medically required. Thus, bed confinement is not the sole criterion in determining the medical necessity of non-emergent ambulance transportation; rather, it is one factor that is considered in medical necessity determinations.1

    1 42 CFR 410.40(d)(1).

    A repetitive ambulance service is defined as medically necessary ambulance transportation that is furnished in 3 or more round trips during a 10-day period, or at least 1 round trip per week for at least 3 weeks.2 Repetitive ambulance services are often needed by beneficiaries receiving dialysis or cancer treatment.

    2 Program Memorandum Intermediaries/Carriers, Transmittal AB-03-106.

    Medicare may cover repetitive, scheduled non-emergent transportation by ambulance if the—(1) medical necessity requirements described previously are met; and (2) ambulance provider/supplier, before furnishing the service to the beneficiary, obtains a written order from the beneficiary's attending physician certifying that the medical necessity requirements are met (see 42 CFR 410.40(d)(1) and (2)).3

    3 Per 42 CFR 410.40(d)(2), the physician's order must be dated no earlier than 60 days before the date the service is furnished.

    In addition to the medical necessity requirements, the service must meet all other Medicare coverage and payment requirements, including requirements relating to the origin and destination of the transportation, vehicle and staff, and billing and reporting. Additional information about Medicare coverage of ambulance services can be found in 42 CFR 410.40, 410.41, and in the Medicare Benefit Policy Manual (Pub. 100-02), Chapter 10, at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c10.pdf.

    According to a study published by the Government Accountability Office in October 2012, entitled “Costs and Medicare Margins Varied Widely; Transports of Beneficiaries Have Increased,” 4 the number of basic life support (BLS) non-emergent transports for Medicare Fee-For-Service beneficiaries increased by 59 percent from 2004 to 2010. A similar finding published by the Department of Health and Human Services' Office of Inspector General in a 2006 study, entitled “Medicare Payments for Ambulance Transports,” 5 indicated a 20 percent nationwide improper payment rate for non-emergent ambulance transport. Likewise, in June 2013, the Medicare Payment Advisory Commission published a report 6 that included an analysis of non-emergent ambulance transports to dialysis facilities and found that, during the 5-year period between 2007 and 2011, the volume of transports to and from a dialysis facility increased 20 percent, more than twice the rate of all other ambulance transports combined.

    4 Government Accountability Office Cost and Medicare Margins Varied Widely; Transports of Beneficiaries Have Increased (October 2012).

    5 Office of Inspector General Medicare Payment for Ambulance Transport (January 2006).

    6 Medicare Payment Advisory Commission, June 2013, pages 167-193.

    Section 1115A of the Social Security Act (the Act) authorizes the Secretary to test innovative payment and service delivery models to reduce program expenditures, while preserving or enhancing the quality of care furnished to Medicare, Medicaid, and Children's Health Insurance Program beneficiaries. Section 1115A(d)(1) of the Act authorizes the Secretary to waive such requirements of Titles XI and XVIII, as well as sections 1902(a)(1), 1902(a)(13), 1903(m)(2)(A)(iii), and 1934 (other than subsections (b)(1)(A) and (c)(5)) of the Act as may be necessary solely for purposes of carrying out section 1115A of the Act with respect to testing models described in section 1115A(b) of the Act. Consistent with this standard, we will continue to waive the same provisions for the extension of this model as have been waived for the prior 4 years of the model. Additionally, we have determined that the implementation of this model does not require the waiver of any fraud and abuse law, including sections 1128A, 1128B, and 1877 of the Act. Thus providers and suppliers affected by this model must comply with all applicable fraud and abuse laws.

    In the November 14, 2014 Federal Register (79 FR 68271), we published a notice entitled “Medicare Program; Prior Authorization of Repetitive Scheduled Non-emergent Ambulance Transports,” which announced the implementation of a 3-year Medicare Prior Authorization model that established a process for requesting prior authorization for repetitive, scheduled non-emergent ambulance transport rendered by ambulance providers/suppliers garaged in three states (New Jersey, Pennsylvania, and South Carolina). These states were selected as the initial states for the model because of their high utilization and improper payment rates for these services. The model began on December 1, 2014, and was originally scheduled to end in all three states on December 1, 2017.

    In the October 23, 2015 Federal Register (80 FR 64418), we published a notice titled “Medicare Program; Expansion of Prior Authorization of Repetitive Scheduled Non-emergent Ambulance Transports,” which announced the inclusion of six additional states (Delaware, the District of Columbia, Maryland, North Carolina, West Virginia, and Virginia) in the Repetitive Scheduled Non-Emergent Ambulance Transport Prior Authorization model in accordance with section 515(a) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10). These six states began participation on January 1, 2016, and the model was originally scheduled to end in all nine model states on December 1, 2017.

    In the December 12, 2017 Federal Register (82 FR 58400), we published a notice titled “Medicare Program; Extension of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports,” which announced a 1-year extension of the prior authorization model in all states through December 1, 2018.

    II. Provisions of the Notice

    This notice announces that the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport is again being extended in the current model states of Delaware, the District of Columbia, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia for an additional year while we continue to evaluate the model and determine if the model meets the statutory requirements for nationwide expansion under section 1834(l)(16) of the the Act, as added by section 515(b) of MACRA (Pub. L. 114-10). The model is currently scheduled to end in all states on December 1, 2019. Prior authorization will not be available for repetitive scheduled non-emergent ambulance transportation services furnished after that date.

    We will continue to test whether prior authorization helps reduce expenditures, while maintaining or improving quality of care, using the established prior authorization process for repetitive, scheduled non-emergent ambulance transport to reduce utilization of services that do not comply with Medicare policy.

    We will continue to use this prior authorization process to help ensure that all relevant clinical or medical documentation requirements are met before services are furnished to beneficiaries and before claims are submitted for payment. This prior authorization process further helps to ensure that payment complies with Medicare documentation, coverage, payment, and coding rules.

    The use of prior authorization does not create new clinical documentation requirements. Instead, it requires the same information that is already required to support Medicare payment, just earlier in the process. Prior authorization allows providers and suppliers to address coverage issues prior to furnishing services.

    The prior authorization process under this model will continue to apply in the nine states listed previously for the following codes for Medicare payment:

    • A0426 Ambulance service, advanced life support, non-emergency transport, Level 1 (ALS1).

    • A0428 Ambulance service, BLS, non-emergency transport.

    While prior authorization is not needed for the mileage code, A0425, a prior authorization decision for an A0426 or A0428 code will automatically include the associated mileage code.

    We have conducted and will continue to conduct outreach and education to ambulance providers/suppliers, as well as beneficiaries, through such methods as updating the operational guide, frequently asked questions (FAQs) on our website, a physician letter explaining the ambulance providers/suppliers' need for the proper documentation, and educational events and materials issued by the Medicare Administrative Contractors (MACs). We will also continue our recent initiative to help find alternative resources for beneficiaries who do not meet the requirements of the Medicare repetitive scheduled non-emergent ambulance transport benefit. Additional information about the implementation of the prior authorization model is available on the CMS website at http://go.cms.gov/PAAmbulance.

    Under this model, submitting a prior authorization request is voluntary. However, an ambulance provider/supplier or beneficiary is encouraged to submit to the MAC a request for prior authorization along with all relevant documentation to support Medicare coverage of a repetitive, scheduled non-emergent ambulance transport. If prior authorization has not been requested by the fourth round trip in a 30-day period, the subsequent claims will be stopped for prepayment review.

    In order for a prior authorization request to be provisionally affirmed, the request for prior authorization must meet all applicable rules and policies, including any local coverage determination (LCD) requirements for ambulance transport claims. A provisional affirmation is a preliminary finding that a future claim submitted to Medicare for the service likely meets Medicare's coverage, coding, and payment requirements. After receipt of all relevant documentation, the MACs will make every effort to conduct a review and postmark the notification of their decision on a prior authorization request within 10 business days for an initial submission. Notification will be provided to the ambulance provider/supplier and to the beneficiary. If a subsequent prior authorization request is submitted after a non-affirmative decision on an initial prior authorization request, the MACs will make every effort to conduct a review and postmark the notification of their decision on the resubmitted request within 20 business days.

    An ambulance provider/supplier or beneficiary may request an expedited review when the standard timeframe for making a prior authorization decision could jeopardize the life or health of the beneficiary. If the MAC agrees that the standard review timeframe would put the beneficiary at risk, the MAC will make reasonable efforts to communicate a decision within 2 business days of receipt of all applicable Medicare-required documentation. As this model is for non-emergent services only, we expect requests for expedited reviews to be extremely rare.

    A provisional affirmative prior authorization decision may affirm a specified number of trips within a specific amount of time. The prior authorization decision, justified by the beneficiary's condition, may affirm up to 40 round trips (which equates to 80 one-way trips) per prior authorization request in a 60-day period. Alternatively, a provisional affirmative decision may affirm less than 40 round trips in a 60-day period, or may affirm a request that seeks to provide a specified number of transports (40 round trips or less) in less than a 60-day period. A provisional affirmative decision can be for all or part of the requested number of trips. Transports exceeding 40 round trips (or 80 one-way trips) in a 60-day period require an additional prior authorization request.

    The following describes examples of various prior authorization scenarios:

    Scenario 1: When an ambulance provider/supplier or beneficiary submits a prior authorization request to the MAC with appropriate documentation and all relevant Medicare coverage and documentation requirements are met for the ambulance transport, the MAC will send a provisional affirmative prior authorization decision to the ambulance provider/supplier and the beneficiary. When the subsequent claim is submitted to the MAC by the ambulance provider/supplier, it is linked to the prior authorization decision via the claims processing system, and the claim will be paid so long as all Medicare coding, billing, and coverage requirements are met. However, the claim could be denied for technical reasons, such as the claim was a duplicate claim or the claim was for a deceased beneficiary. In addition, a claim denial could occur because certain documentation, such as the trip record, needed in support of the claim cannot be submitted with a prior authorization request because it is not available until after the service is provided.

    Scenario 2: When an ambulance provider/supplier or beneficiary submits a prior authorization request, but all relevant Medicare coverage requirements are not met, the MAC will send a non-affirmative prior authorization decision to the ambulance provider/supplier and to the beneficiary advising them that Medicare will not pay for the service. The provider/supplier or beneficiary may then resubmit the request with additional documentation showing that Medicare requirements have been met. Alternatively, an ambulance provider/supplier could furnish the service and submit a claim with a non-affirmative prior authorization tracking number, at which point the MAC would deny the claim. The ambulance provider/supplier and the beneficiary would then have the Medicare denial for secondary insurance purposes and would have the opportunity to submit an appeal of the claim denial if they believe Medicare coverage was denied inappropriately.

    Scenario 3: When an ambulance provider/supplier or beneficiary submits a prior authorization request with incomplete documentation, a detailed decision letter will be sent to the ambulance provider/supplier and to the beneficiary, with an explanation of what information is missing. The ambulance provider/supplier or beneficiary can rectify the error(s) and resubmit the prior authorization request with appropriate documentation.

    Scenario 4: If an ambulance provider or supplier renders a service to a beneficiary and does not request prior authorization by the fourth round trip in a 30-day period, and the claim is submitted to the MAC for payment, then the claim will be stopped for prepayment review and documentation will be requested.

    ++ If the claim is determined to be for services that were not medically necessary or for which there was insufficient documentation, the claim will be denied, and all current policies and procedures regarding liability for payment will apply. The ambulance provider/supplier or the beneficiary, or both, can appeal the claim denial if they believe the denial was inappropriate.

    ++ If the claim is determined to be payable, it will be paid.

    Only one prior authorization request per beneficiary per designated time period can be provisionally affirmed. If the initial ambulance provider/supplier cannot complete the total number of prior authorized transports (for example, the initial ambulance company closes or no longer services that area), the initial request is cancelled. In this situation, a subsequent prior authorization request may be submitted for the same beneficiary and must include the required documentation in the submission. If multiple ambulance providers/suppliers are providing transports to the beneficiary during the same or overlapping time period, the prior authorization decision will only cover the ambulance provider/supplier indicated in the provisionally affirmed prior authorization request. Any ambulance provider/supplier submitting claims for repetitive, scheduled non-emergent ambulance transports for which no prior authorization request is submitted by the fourth round trip in a 30-day period will be subject to 100 percent prepayment medical review of those claims.

    Under the model, we will work to limit any adverse impact on beneficiaries and to educate beneficiaries about the process. If a prior authorization request is non-affirmed, and the claim is still submitted by the ambulance provider/supplier, the claim will be denied, but beneficiaries will continue to have all applicable administrative appeal rights. We have also recently implemented a process to help find alternative resources for beneficiaries who do