Federal Register Vol. 83, No.193,

Federal Register Volume 83, Issue 193 (October 4, 2018)

Page Range49987-50254
FR Document

83_FR_193
Current View
Page and SubjectPDF
83 FR 50253 - Child Health Day, 2018PDF
83 FR 50251 - Gold Star Mother's and Family's Day, 2018PDF
83 FR 50249 - National Substance Abuse Prevention Month, 2018PDF
83 FR 50247 - National Energy Awareness Month, 2018PDF
83 FR 50245 - National Disability Employment Awareness Month, 2018PDF
83 FR 50243 - National Cybersecurity Awareness Month, 2018PDF
83 FR 50241 - National Breast Cancer Awareness Month, 2018PDF
83 FR 50239 - Presidential Determination on Major Drug Transit or Major Illicit Drug Producing Countries for Fiscal Year 2019PDF
83 FR 50237 - Delegation of Authority Under Section 1290(b) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019PDF
83 FR 50093 - Sunshine Act MeetingsPDF
83 FR 50052 - Performance-Based Payments and Progress Payments (DFARS Case 2017-D019)PDF
83 FR 50087 - Sunshine Act MeetingsPDF
83 FR 50088 - Sunshine Act MeetingsPDF
83 FR 50141 - Notice of Determinations: Culturally Significant Objects Imported for Exhibition-Determinations: “Blue Prints: The Pioneering Photographs of Anna Atkins” ExhibitionPDF
83 FR 50123 - Notice of 194th Meeting of the Advisory Council on Employee Welfare and Pension Benefit PlansPDF
83 FR 50075 - In the Matter of: Edgar Garza-Sanchez, Inmate Number: 12512-479, Mid-Valley House, 2520 South Expressway 281, Edinburg, TX 78542; Order Denying Export PrivilegesPDF
83 FR 50072 - In the Matter of: Edward Alexander Duenas, Inmate Number: 27317-479, FCI Beaumont Low, P.O. Box 26020, Beaumont, TX 77720; Order Denying Export PrivilegesPDF
83 FR 50070 - In the Matter of: Francisco Xavier Martinez, Inmate Number: 21369-470, FCI Bastrop, P.O. Box 1010, Bastrop, TX 78602; Order Denying Export PrivilegesPDF
83 FR 50119 - Notice of Temporary Closure of Public Land in Clark County, NVPDF
83 FR 50073 - In the Matter of: Ruben Arnoldo Madrid, Inmate Number: 20727-479, FCI Beaumont Low, P.O. Box 26020, Beaumont, TX 77720; Order Denying Export PrivilegesPDF
83 FR 50076 - In the Matter of Rolando Armando Madrid, Inmate Number: 20726-479, FCI Bastrop, P.O. Box 1010, Bastrop, TX 78602; Order Denying Export PrivilegesPDF
83 FR 50117 - Public Land Order No. 7874; Partial Revocation of Public Land Orders No. 5179, 5180, 5181, 5184, and 5188, AlaskaPDF
83 FR 50074 - In the Matter of: Juan Diego Madrid, Inmate Number: 24877-479, FCI Bastrop, P.O. Box 1010, Bastrop, TX 78602; Order Denying Export PrivilegesPDF
83 FR 50071 - In the Matter of Erik Villasana, Inmate Number: 22762-479, FCI Bastrop, P.O. Box 1010, Bastrop, TX 78602; Order Denying Export PrivilegesPDF
83 FR 50046 - OCC Guidelines Establishing Standards for Recovery Planning by Certain Large Insured National Banks, Insured Federal Savings Associations, and Insured Federal Branches; Technical Amendments; CorrectionPDF
83 FR 50122 - Stainless Steel Flanges From IndiaPDF
83 FR 50056 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Revisions to Sea Turtle Release Gear; Amendment 49PDF
83 FR 50121 - Certain Sleep-Disordered Breathing Treatment Mask Systems and Components Thereof; Institution of InvestigationPDF
83 FR 50087 - Notice of Intent To Grant Exclusive Patent License; Point Semantics CorporationPDF
83 FR 49994 - Fisheries of the Exclusive Economic Zone Off Alaska; Yellowfin Sole Management in the Groundfish Fisheries of the Bering Sea and Aleutian IslandsPDF
83 FR 50120 - Certain Strength-Training Systems and Components Thereof Institution of InvestigationPDF
83 FR 50123 - Advisory Committee for International Science and Engineering; Notice of MeetingPDF
83 FR 50055 - Hours of ServicePDF
83 FR 49987 - Establishing a Performance Standard for Authorizing the Importation and Interstate Movement of Fruits and VegetablesPDF
83 FR 50145 - Creating Options for Veterans Expedited Recovery (COVER) Commission; Notice of MeetingPDF
83 FR 50142 - California Meal and Rest Break Rules; Petition for Determination of PreemptionPDF
83 FR 50143 - Reports, Forms, and Record Keeping Requirements Agency Information Collection Activity Under OMB ReviewPDF
83 FR 50007 - Drawbridge Operation Regulation; Trent River, New Bern, NCPDF
83 FR 50094 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
83 FR 50077 - Initiation of Antidumping and Countervailing Duty Administrative ReviewsPDF
83 FR 50059 - Fisheries of the Northeastern United States; Framework Adjustment 12 to the Atlantic Mackerel, Squid, and Butterfish Fishery Management PlanPDF
83 FR 50069 - Foreign-Trade Zone 64-Jacksonville, Florida; Application for Reorganization (Expansion of Service Area) Under Alternative Site FrameworkPDF
83 FR 50140 - Presidential Declaration Amendment of a Major Disaster for the State of South CarolinaPDF
83 FR 50061 - Fisheries of the United States; Regulations for Striped Bass Fishing in the Block Island Transit ZonePDF
83 FR 50067 - Notice of Intent To Request Revision and Extension of a Currently Approved Information CollectionPDF
83 FR 50067 - Notice of the Advisory Committee on Agriculture Statistics MeetingPDF
83 FR 50102 - Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug ApplicationsPDF
83 FR 50088 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Paul Douglas Teacher Scholarship Performance Report FormPDF
83 FR 50036 - Fisheries of the Exclusive Economic Zone Off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management AreaPDF
83 FR 50092 - Information Collections Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
83 FR 50088 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
83 FR 50109 - Process To Request a Review of the Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment PeriodPDF
83 FR 50107 - Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2019 Proposed Guidance DevelopmentPDF
83 FR 50089 - Information Collections Being Reviewed by the Federal Communications CommissionPDF
83 FR 50110 - United States Food and Drug Administration and Health Canada Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast; Request for CommentsPDF
83 FR 49987 - Indemnification PaymentsPDF
83 FR 50144 - Notice of OFAC Sanctions ActionsPDF
83 FR 50100 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
83 FR 50122 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability ActPDF
83 FR 50068 - Notice of Public Meetings of the Oklahoma Advisory CommitteePDF
83 FR 50099 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
83 FR 50131 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Order Approving a Proposed Rule Change Relating to Anticipatory HedgingPDF
83 FR 50127 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rules 7039, 7047, 7049, 7055, and 7061 To Update the Definition of the Term FINRA/Nasdaq Trade Reporting FacilityPDF
83 FR 50123 - Westinghouse Electric Company, LLC; Hematite SitePDF
83 FR 50132 - Self-Regulatory Organizations; Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 2.160 Related to the Qualification and Registration Requirements for Associated Persons of a Member and To Delete Rule 2.150 Which is ObsoletePDF
83 FR 50141 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of HawaiiPDF
83 FR 50069 - Notice of Public Meeting of the Pennsylvania Advisory CommitteePDF
83 FR 50141 - Presidential Declaration Amendment of a Major Disaster for the State of HawaiiPDF
83 FR 50063 - International Sanitary and Phytosanitary Standard-Setting ActivitiesPDF
83 FR 50116 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
83 FR 50115 - National Institute of Dental & Craniofacial Research: Notice of Closed MeetingPDF
83 FR 50113 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 50115 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 50112 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
83 FR 50098 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
83 FR 50096 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
83 FR 50113 - National Institute of Biomedical Imaging and Bioengineering; Notice of Closed MeetingPDF
83 FR 50112 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed MeetingsPDF
83 FR 50112 - National Center for Advancing Translational Sciences; Notice of Closed MeetingPDF
83 FR 50022 - Air Plan Approval; TN; Revisions to Ambient Air Quality StandardsPDF
83 FR 50012 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Update to Materials Incorporated by ReferencePDF
83 FR 50010 - Approval and Promulgation of Air Quality Implementation Plans; District of Columbia; Update to Materials Incorporated by ReferencePDF
83 FR 50007 - Air Plan Approval; California; San Diego County Air Pollution Control District; Stationary Source Permits and ExemptionsPDF
83 FR 50026 - Protection of Stratospheric Ozone: Determination 34 for Significant New Alternatives Policy ProgramPDF
83 FR 50050 - Proposed Amendment of Class E Airspace; Bethel, MEPDF
83 FR 50047 - Airworthiness Directives; Airbus SAS AirplanesPDF
83 FR 50018 - Air Plan Approval; Texas; Control of Air Pollution from Motor Vehicles with Mobile Source Incentive ProgramsPDF
83 FR 50052 - Air Plan Approval; Texas; Control of Air Pollution From Motor Vehicles With Mobile Source Incentive ProgramsPDF
83 FR 50038 - Increasing Flexibility for Verification of For-Profit Center Eligibility in the Child and Adult Care Food ProgramPDF
83 FR 50053 - Maintenance of and Access to Records Pertaining to IndividualsPDF
83 FR 50024 - Air Plan Approval; State of Iowa; Attainment Redesignation for 2008 Lead NAAQS and Associated Maintenance PlanPDF
83 FR 50003 - Regulatory Reform Revisions to the International Traffic in Arms RegulationsPDF
83 FR 50014 - Air Plan Approval; MS; Section 128 Board Requirements for Infrastructure SIPsPDF
83 FR 50035 - Television Broadcasting Services; Block Island and Newport, Rhode IslandPDF
83 FR 50148 - Disclosure Update and SimplificationPDF

Issue

83 193 Thursday, October 4, 2018 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50094-50096 2018-21618 Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

See

Food and Nutrition Service

See

National Agricultural Statistics Service

Animal Animal and Plant Health Inspection Service RULES Establishing a Performance Standard for Authorizing the Importation and Interstate Movement of Fruits and Vegetables; Correction, 49987 2018-21627 NOTICES International Sanitary and Phytosanitary Standard-Setting Activities, 50063-50067 2018-21577 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50096-50099 2018-21570 2018-21571 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50099-50102 2018-21587 2018-21590 Civil Rights Civil Rights Commission NOTICES Meetings: Oklahoma Advisory Committee, 50068-50069 2018-21588 Pennsylvania Advisory Committee, 50069 2018-21579 Coast Guard Coast Guard RULES Drawbridge Operations: Trent River, New Bern, NC, 50007 2018-21620 Commerce Commerce Department See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Comptroller Comptroller of the Currency PROPOSED RULES OCC Guidelines Establishing Standards for Recovery Planning by Certain Large Insured National Banks, Insured Federal Savings Associations, and Insured Federal Branches; Technical Amendments; Correction, 50046-50047 2018-21638 Consumer Product Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 50087 2018-21710 Defense Acquisition Defense Acquisition Regulations System PROPOSED RULES Performance-Based Payments and Progress Payments, 50052 2018-21714 Defense Department Defense Department See

Defense Acquisition Regulations System

See

Navy Department

Defense Nuclear Defense Nuclear Facilities Safety Board NOTICES Meetings; Sunshine Act, 50088 2018-21703 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Paul Douglas Teacher Scholarship Performance Report Form, 50088 2018-21607 Employee Benefits Employee Benefits Security Administration NOTICES Meetings: Advisory Council on Employee Welfare and Pension Benefit Plans, 50123 2018-21663 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; San Diego County Air Pollution Control District; Stationary Source Permits and Exemptions, 50007-50010 2018-21470 Delaware; Update to Materials Incorporated by Reference, 50012-50014 2018-21472 District of Columbia; Update to Materials Incorporated by Reference, 50010-50012 2018-21471 Iowa; Attainment Redesignation for 2008 Lead National Ambient Air Quality Standards and Associated Maintenance Plan, 50024-50026 2018-21433 Mississippi; Section 128 Board Requirements for Infrastructure State Implementation Plan, 50014-50018 2018-21193 Tennessee; Revisions to Ambient Air Quality Standards, 50022-50024 2018-21473 Texas; Control of Air Pollution from Motor Vehicles with Mobile Source Incentive Programs, 50018-50022 2018-21453 Protection of Stratospheric Ozone: Determination 34 for Significant New Alternatives Policy Program, 50026-50035 2018-21463 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Texas; Control of Air Pollution from Motor Vehicles with Mobile Source Incentive Programs, 50052 2018-21452 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: Airbus SAS Airplanes, 50047-50050 2018-21455 Amendment of Class E Airspace: Bethel, ME, 50050-50052 2018-21456 Federal Communications Federal Communications Commission RULES Television Broadcasting Services: Block Island and Newport, Rhode Island, 50035-50036 2018-21071 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50088-50093 2018-21595 2018-21598 2018-21599 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 50093-50094 2018-21763 Federal Housing Finance Agency Federal Housing Finance Agency RULES Indemnification Payments, 49987-49994 2018-21592 Federal Motor Federal Motor Carrier Safety Administration PROPOSED RULES Hours of Service, 50055-50056 2018-21628 NOTICES Petitions for Determination of Preemption: California Meal and Rest Break Rules, 50142-50143 2018-21624 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Investigational New Drug Applications, 50102-50107 2018-21610 Guidance: Process to Request a Review of the Food and Drug Administration's Decision not to Issue Certain Export Certificates for Devices, 50109-50110 2018-21597 Meetings: United States Food and Drug Administration and Health Canada Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, 50110-50112 2018-21594 Website Location of Center for Devices and Radiological Health Fiscal Year 2019 Proposed Guidance Development, 50107-50109 2018-21596 Food and Nutrition Food and Nutrition Service PROPOSED RULES Increasing Flexibility for Verification of For-Profit Center Eligibility in the Child and Adult Care Food Program, 50038-50046 2018-21445 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 50144-50145 2018-21591 Foreign Trade Foreign-Trade Zones Board NOTICES Reorganizations under Alternative Site Frameworks: Foreign-Trade Zone 64, Jacksonville, FL, 50069-50070 2018-21615 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

Homeland Homeland Security Department See

Coast Guard

Industry Industry and Security Bureau NOTICES Export Privileges; Denials: Edgar Garza-Sanchez, 50075-50076 2018-21654 Edward Alexander Duenas, 50072-50073 2018-21652 Erik Villasana, 50071-50072 2018-21639 Francisco Xavier Martinez, 50070-50071 2018-21651 Juan Diego Madrid, 50074-50075 2018-21640 Rolando Armando Madrid, 50076-50077 2018-21642 Ruben Arnoldo Madrid, 50073-50074 2018-21649 Interior Interior Department See

Land Management Bureau

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Initiation of Administrative Reviews, 50077-50087 2018-21617 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Sleep-Disordered Breathing Treatment Mask Systems and Components Thereof, 50121-50122 2018-21634 Certain Strength-Training Systems and Components Thereof, 50120-50121 2018-21631 Stainless Steel Flanges from India, 50122 2018-21636 Justice Department Justice Department NOTICES Proposed Consent Decrees: CERCLA, 50122-50123 2018-21589 Labor Department Labor Department See

Employee Benefits Security Administration

Land Land Management Bureau NOTICES Public Land Orders: Partial Revocation, Alaska, 50117-50119 2018-21641 Temporary Closure of Public Land: Clark County, NV, 50119-50120 2018-21650 National Agricultural National Agricultural Statistics Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50067-50068 2018-21612 Meetings: Advisory Committee on Agriculture Statistics, 50067 2018-21611 National Highway National Highway Traffic Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50143-50144 2018-21623 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 50113-50116 2018-21573 2018-21574 National Center for Advancing Translational Sciences, 50112 2018-21567 National Institute of Allergy and Infectious Diseases, 50112 2018-21572 National Institute of Biomedical Imaging and Bioengineering, 50113 2018-21569 National Institute of Dental and Craniofacial Research, 50115 2018-21575 National Institute of Diabetes and Digestive and Kidney Diseases, 50112-50113 2018-21568 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area, 50036-50037 2018-21600 Yellowfin Sole Management in the Groundfish Fisheries of the Bering Sea and Aleutian Islands, 49994-50003 2018-21632 PROPOSED RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Reef Fish Fishery of the Gulf of Mexico; Revisions to Sea Turtle Release Gear; Amendment 49, 50056-50059 2018-21635 Fisheries of the Northeastern United States: Framework Adjustment 12 to the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan, 50059-50061 2018-21616 Fisheries of the United States: Regulations for Striped Bass Fishing in the Block Island Transit Zone, 50061-50062 2018-21613 National Science National Science Foundation NOTICES Meetings: Advisory Committee for International Science and Engineering, 50123 2018-21630 Navy Navy Department NOTICES Exclusive Patent Licenses; Approvals: Point Semantics Corp., 50087-50088 2018-21633 Nuclear Regulatory Nuclear Regulatory Commission NOTICES License Terminations: Westinghouse Electric Co., LLC; Hematite Site, 50123-50124 2018-21583 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Child Health Day (Proc. 9797), 50253-50254 2018-21820 Gold Star Mother's and Family's Day (Proc. 9796), 50251-50252 2018-21819 National Breast Cancer Awareness Month (Proc. 9791), 50241-50242 2018-21811 National Cybersecurity Awareness Month (Proc. 9792), 50243-50244 2018-21812 National Disability Employment Awareness Month (Proc. 9793), 50245-50246 2018-21813 National Energy Awareness Month (Proc. 9794), 50247-50248 2018-21816 National Substance Abuse Prevention Month (Proc. 9795), 50249-50250 2018-21817 ADMINISTRATIVE ORDERS Defense and National Security: John S. McCain National Defense Authorization Act for FY 2019; Delegation of Authority (Memorandum of September 10, 2018), 50235-50237 2018-21805 Drug Abuse and Trafficking: Major Drug Transit or Major Illicit Drug Producing Countries (Presidential Determination No. 2018-12 of September 11, 2018), 50239-50240 2018-21806 Securities Securities and Exchange Commission RULES Disclosure Update and Simplification, 50148-50234 2018-18142 NOTICES Self-Regulatory Organizations; Proposed Rule Changes: ICE Clear Credit, LLC, 50124-50127 2018-21585 Investors Exchange, LLC, 50132-50140 2018-21582 Nasdaq PHLX, LLC, 50131-50132 2018-21586 The Nasdaq Stock Market, LLC, 50127-50130 2018-21584 Small Business Small Business Administration NOTICES Major Disaster Declarations: Hawaii, 50141 2018-21578 Hawaii, Public Assistance Only, 50141 2018-21581 South Carolina, 50140-50141 2018-21614 State Department State Department RULES Regulatory Reform Revisions to the International Traffic in Arms Regulations, 50003-50007 2018-21422 NOTICES Culturally Significant Objects Imported for Exhibition: Blue Prints: The Pioneering Photographs of Anna Atkins, 50141 2018-21691 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50116-50117 2018-21576 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

National Highway Traffic Safety Administration

PROPOSED RULES Maintenance of and Access to Records Pertaining to Individuals, 50053-50055 2018-21440
Treasury Treasury Department See

Comptroller of the Currency

See

Foreign Assets Control Office

Veteran Affairs Veterans Affairs Department NOTICES Meetings: Creating Options for Veterans Expedited Recovery Commission, 50145-50146 2018-21626 Separate Parts In This Issue Part II Securities and Exchange Commission, 50148-50234 2018-18142 Part III Presidential Documents, 50235-50237, 50239-50254 2018-21805 2018-21806 2018-21820 2018-21819 2018-21811 2018-21812 2018-21813 2018-21816 2018-21817 Reader Aids

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

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83 193 Thursday, October 4, 2018 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Parts 318 and 319 [Docket No. APHIS-2010-0082] RIN 0579-AD71 Establishing a Performance Standard for Authorizing the Importation and Interstate Movement of Fruits and Vegetables AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule; correction.

SUMMARY:

We are correcting a portion of the summary of the economic analysis presented in the SUPPLEMENTARY INFORMATION portion of our September 14, 2018, final rule amending our regulations governing the importation and interstate movement of fruits and vegetables. The summary reported an incorrect cost savings figure in its discussion of Executive Order 13771. This document corrects that error.

DATES:

This correction is effective October 15, 2018.

FOR FURTHER INFORMATION CONTACT:

Mr. Benjamin J. Kaczmarski, Assistant Director, Regulatory Coordination and Compliance, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1231; (301) 851-2127.

SUPPLEMENTARY INFORMATION:

On September 14, 2018, we published in the Federal Register a final rule (83 FR 46627-46639, Docket No. APHIS-2010-0082) amending our regulations governing the importation of fruits and vegetables by broadening our existing performance standard to provide for approval of all new fruits and vegetables for importation into the United States using a notice-based process. We also removed the region- or commodity-specific phytosanitary requirements currently found in those regulations. Likewise, we made an equivalent revision of the performance standard in our regulations governing the interstate movement of fruits and vegetables from Hawaii and the U.S. territories (Guam, Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands) and removed the commodity-specific phytosanitary requirements from those regulations. That action will allow for the approval of requests to authorize the importation or interstate movement of new fruits and vegetables in a manner that enables a more flexible and responsive regulatory approach to evolving pest situations in both the United States and exporting countries. It will not, however, alter the science-based process in which the risk associated with importation or interstate movement of a given fruit or vegetable is evaluated or the manner in which risks associated with the importation or interstate movement of a fruit or vegetable are mitigated.

As part of the SUPPLEMENTARY INFORMATION portion of the final rule, we provided a summary of the Regulatory Impact Analysis/Final Regulatory Flexibility Analysis (RIA/FRFA) prepared for the rule. In its discussion of Executive Order 13771, the summary provided a cost savings figure from an earlier iteration of the RIA/FRFA. The RIA/FRFA posted with the final rule contains the correct figure. In this document, we are correcting the text of the summary provided in the final rule.

Correction

In FR Doc. 2018-19984, published September 14, 2018 (83 FR 46627-46639), make the following correction:

1. On page 46637, in column 1, the second full paragraph is corrected to read as follows:

Interpreting these gains as cost savings accrued by using the quicker notice-based process rather than having to wait for rule promulgation, and in accordance with guidance on complying with Executive Order 13771, the primary annualized cost savings estimate for this rule is $7,895,000. This value is the midpoint estimate of cost savings annualized in perpetuity using a 7 percent discount rate.

Done in Washington, DC, this 28th day of September 2018. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-21627 Filed 10-3-18; 8:45 am] BILLING CODE 3410-34-P
FEDERAL HOUSING FINANCE AGENCY 12 CFR Part 1231 RIN 2590-AA68 Indemnification Payments AGENCY:

Federal Housing Finance Agency.

ACTION:

Final rule.

SUMMARY:

The Federal Housing Finance Agency (FHFA or Agency) is adopting this final rule establishing standards for identifying whether an indemnification payment by the Federal National Mortgage Association (Fannie Mae), the Federal Home Loan Mortgage Corporation (Freddie Mac), any of the Federal Home Loan Banks (collectively with Fannie Mae and Freddie Mac, the regulated entities), or the Federal Home Loan Bank System's Office of Finance (the OF) to an affiliated party in connection with an administrative proceeding or civil action instituted by FHFA is prohibited or permissible. This final rule applies to all regulated entities, each Federal Home Loan Bank, the Federal National Mortgage Association, the Federal Home Loan Mortgage Corporation and the OF. It does not, however, apply to any regulated entity operating in conservatorship or receivership, or to a limited-life regulated entity.

DATES:

This rule is effective on November 5, 2018.

FOR FURTHER INFORMATION CONTACT:

Mark D. Laponsky, Deputy General Counsel, M[email protected], (202) 649-3054; or Peggy K. Balsawer, Associate General Counsel, [email protected], (202) 649-3060 (these are not toll-free numbers), Office of General Counsel; Federal Housing Finance Agency, Constitution Center, 400 Seventh Street SW, Washington, DC 20219. The telephone number for the Telecommunications Device for the Hearing Impaired is (800) 877-8339.

SUPPLEMENTARY INFORMATION:

I. Background

FHFA published an Interim Final Rule on Golden Parachute and Indemnification Payments in the Federal Register on September 16, 2008 (73 FR 53356). Subsequently, it published corrections rescinding that portion of the regulation that addressed indemnification payments on September 19, 2008 (73 FR 54309) and on September 23, 2008 (73 FR 54673). On November 14, 2008, a proposed amendment to the Interim Final Rule was published in the Federal Register (73 FR 67424). FHFA specifically requested comments on whether it would be in the best interests of the regulated entities to permit indemnification of first and second tier civil money penalties where the administrative proceeding or civil action related to conduct occurring while the regulated entity was in conservatorship. The public notice and comment period closed on December 29, 2008. On January 29, 2009 (74 FR 5101), FHFA published a final rule on Golden Parachute Payments. On June 29, 2009 (74 FR 30975), FHFA published a proposed amendment to that 2009 Golden Parachute final rule. At the same time, FHFA re-proposed the November 14, 2008 proposed amendment on indemnification payments (2009 re-proposal). The 2009 re-proposal noted that comments received in response to the November 14, 2008 publication on indemnification payments would be considered along with comments received in response to the 2009 re-proposal. The golden parachute provisions of the rule were re-proposed in 2013 (78 FR 28452, May 14, 2013), adopted in final form in 2014 (79 FR 4394, Jan. 28, 2014), and codified as 12 CFR 1231.1, 1231.2, 1231.3, 1231.5, and 1231.6. Amendments to the golden parachute provisions of the rule were proposed on August 28, 2018 (83 FR 43801).

On September 20, 2016, FHFA again re-proposed a rule on indemnification payments to affiliated parties (2016 re-proposal, or proposed rule), redrafting the proposed rule to make it simpler and easier to understand. After an extension, the comment period expired on December 21, 2016.1 The substance of the 2016 proposed rule did not change from the 2009 re-proposal, other than to replace a provision concerning indemnification payments by regulated entities in conservatorship with one that clearly states that the regulation does not apply to such entities.2 FHFA further clarified that it does not consider indemnification payments to be subject to FHFA rules and procedures related to compensation, including 12 CFR part 1230.

1See 81 FR 74739 (Oct. 27, 2016).

2 While the 2016 re-proposal proposed to except from the rule entities operating in conservatorship or receivership and limited liability regulated entities (LLREs), it did not expressly address its application to an institution that is rehabilitated in conservatorship and emerges other than through receivership and liquidation. Consistency with the rationale underpinning the exception demands that the exception should apply with respect to an administrative proceeding or civil action initiated by FHFA after rehabilitation if the subject conduct occurred during a conservatorship or receivership.

The final rule generally adopts the 2016 re-proposal's approach to the indemnification provisions of the Federal Deposit Insurance Corporation's (FDIC) counterpart regulation. See 12 CFR part 359. Like the FDIC's regulation, and consistent with the Director's statutory discretion to “prohibit or limit any . . . indemnification payment,” 3 the final rule creates a presumption that indemnification payments for costs, expenses, fees, and penalties by a regulated entity or the OF to affiliated parties are impermissible in connection with an FHFA-initiated administrative proceeding or civil action. As required by section 4518(e)(2) of the Federal Housing Enterprises Financial Safety and Soundness Act of 1992, as amended (the Safety and Soundness Act, or the Act),4 the rule sets forth criteria and standards constituting the “factors” that the Director has determined are to be used to “prohibit or limit” indemnification payments through this regulation. In application, each institution (whether a regulated entity or the OF) is required to ensure that no indemnification payments under this rule are made unless the criteria and standards are met.

3 12 U.S.C. 4518(e)(1).

4See 12 U.S.C. 4501 et seq.

II. Technical Corrections

In the process of drafting this final rule, FHFA staff observed that the definitional section of the existing Golden Parachute and Indemnification regulation required a technical correction to align it with the Safety and Soundness Act. See proposed § 1231.2; 12 U.S.C. 4518(e). The section of the Act explicitly authorizing the Director to prohibit or limit golden parachute and indemnification payments, applies to payments made to “affiliated parties” and does not mention “entity-affiliated parties.” The Act does not define “affiliated parties.” FHFA had adopted the term “entity-affiliated party” and defined it for use in the rule. To align with the Safety and Soundness Act, the correct reference should be to “affiliated party.” In this final rule, FHFA is replacing the term “entity-affiliated party” with the term “affiliated party,” without any change to the substantive definition. The existing definition of “entity-affiliated party” will be the definition of “affiliated party” for the purposes of this final rule to effect this technical correction.5

5 Throughout this final rule “entity-affiliated party” has been replaced with “affiliated party” (unless the context requires retaining the former term) to reflect the technical change made to the regulation. The change in term has substantive effect in the proposed golden parachute amendments, see 83 FR 43801, 43808-09 (Aug. 28, 2018).

FHFA is also making some minor, non-substantive changes to the rule text based on staff's determination that the words “conditions for” should precede the phrase “prohibited and permissible indemnification payments” in proposed § 1231.1 to conform the semantic construction of the final rule's purpose to its other operational provisions; and staff's determination that changing the phrase “the cost” to “any cost” in clause (2) of the definition of “liability or legal expense” in § 1231.2, and adding the word “a” in clauses (3) and (4) of § 1231.4(c) would be more consistent and grammatically correct.6

6 The Agency also made minor grammatical changes to proposed § 1231.4(b)(2)(i) to reduce the text's awkwardness in light of other substantive changes made to the exoneration standard discussed later in this preamble.

III. Comments on the 2016 Re-Proposal

In response to the 2016 re-proposal, FHFA received a public comment from one citizen and a joint comment letter from the 11 Federal Home Loan Banks and the OF. FHFA gave careful consideration to all issues raised by the commenters.

A. Public Comment From a Citizen

A very brief comment from a member of the public was limited to agreeing with the proposed rule's exclusion of coverage for regulated entities in conservatorship. The commenter opined that because the Enterprises are in conservatorship, indemnification payments should be permitted, but that claw backs should be used to avoid excessive indemnification. Though the intended scope of the comment was not clear, the commenter referred to “servicing agreements the GSEs have with issuing banks” and to the “conservatorship agreements.” The comment reflects an apparent understanding of the import of excluding entities operating in conservatorship from the rule's coverage and an endorsement of the proposal.

B. Regulated Entity Public Comments

The eleven Federal Home Loan Banks and the OF (collectively, Banks) jointly submitted the second public comment. See Joint Comment of the Federal Home Loan Banks and Office of Finance on Proposed Rule on Indemnification Payments, dated December 21, 2016 (Joint Comment). The Banks addressed several matters related to the 2016 re-proposal, including: (1) The scope of the rulemaking; (2) certain standards and processes relating to the advancement of defense expenses; (3) insurance coverage issues; (4) partial indemnification issues; (5) the treatment of pre-existing indemnification agreements; and (6) potential impacts of the rulemaking. As discussed below, FHFA has decided to adopt some, but not all, of the suggestions it received.

1. Scope of “Prohibited Indemnification Payment”

The Banks raised four issues relating to the scope of the prohibition on indemnification payments. First, though they applauded FHFA's decision to except regulated entities in conservatorship from the rule's restrictions, they argued this would also lead to what they considered a perverse situation where those entities could be permitted to make indemnification payments for first and second tier civil monetary penalties which healthier institutions would be barred from making under the rule. The Banks recommended that institutions not in conservatorship should have the same breadth of authority to indemnify as entities in conservatorship. This argument for uniform treatment is one that had been raised by commenters—including some Banks—on a prior proposal. FHFA answered the objection and explained its disagreement in the 2016 proposed rule. The Banks' comment letter offers no reason for FHFA to revisit or change its earlier decision declining in general to permit regulated entities not in conservatorship to make indemnification payments for first and second tier civil money penalties. See 81 FR at 64358.

Second, the Banks contended that the proposed rule conflicts with the Safety and Soundness Act. Joint Comment p.2. The Banks argued that since the Safety and Soundness Act expressly prohibits indemnification with respect to third tier civil money penalties (12 U.S.C. 4636(g)), the Director may not also prohibit payments relative to first and second tier civil money penalties. FHFA disagrees with the Banks' assertion that a rule prohibiting or limiting indemnification payments with respect to first and second tier civil money penalties conflicts with, or exceeds, authority granted by the Safety and Soundness Act. The Safety and Soundness Act both expressly prohibits indemnification for third tier Civil Money Penalties and expressly grants authority to the Director to “prohibit or limit, by regulation or order, any . . . indemnification payment” (12 U.S.C. 4518(e)(1)) (emphasis added). The absence of a specific limitation on the Director's authority relative to first and second tier penalties places them squarely within the Director's broad authority to “prohibit or limit” indemnification payments under 12 U.S.C. 4518(e)(1).

Third, the Banks also argued that indemnification should be permissible for the costs and expenses associated with the first and second tier penalties, whether or not the regulated entities are in conservatorship. This comment can be read in two ways. If the Banks are suggesting that indemnification of defense fees and costs should be allowed even when a first or second tier civil money penalty is imposed, FHFA rejects the prospect as undermining the intent and effectiveness of the fundamental presumption of impermissibility, and therefore, the regulation itself. If, however, the Banks mean that indemnification of defense fees and costs should be allowed if the defense against civil money penalties is successful, FHFA believes no revision is necessary because this final rule is clear that such indemnification of defense expenses, and in appropriate cases partial indemnification, is permitted.

Fourth, the Banks argue that the prohibitions in the proposed rule are stricter than typical state governance statutes as may have been selected by an institution under FHFA's corporate governance regulation, 12 CFR part 1239. They believe that the Banks should be allowed to follow state law standards for indemnification and advancement of expenses to avoid confusion and conflicts in implementing standards from disparate sources. FHFA agrees that the proposed rule is more restrictive than many state laws, but nonetheless is satisfied that the proposed rule strikes the correct balance by applying federal law to its regulated entities in actions brought by the Agency, as specifically authorized by the Safety and Soundness Act, 12 U.S.C. 4518(e)(1). Since each regulated entity may identify a singular state or model law for corporate governance purposes under 12 CFR 1239, that choice of law would apply to indemnification payments to the extent not inconsistent with federal law and safety and soundness. 12 CFR 1239.3(a).7 But the corporate governance rule does not constitute a limitation of FHFA's responsibility and authority to establish stricter standards for the regulated entities when the Agency deems them appropriate. The purpose of the federal statute is to provide the Director authority to prohibit or limit indemnification payments in proceedings brought by the Agency, regardless of what other law would permit. FHFA has carefully considered the Banks' comments and observations, but considers it appropriate to apply federal standards for the federal cases it brings. Finally, FHFA does not accept the Banks' generalized and unsupported assertions of “practical conflicts” and confusion in applying this rule to FHFA-initiated actions. FDIC-insured banks and savings associations successfully operate under the parallel FDIC regulation and have done so for the past 20 years.

7See 12 CFR 1239.3(a) (“The corporate governance practices and procedures of each regulated entity, and practices and procedures relating to indemnification (including advancement of expenses), shall comply with and be subject to the applicable authorizing statutes and other Federal law, rules, and regulations, and shall be consistent with the safe and sound operations of the regulated entities.”).

2. Standards and Processes Relating to the Advancement of Defense Expenses

The Banks expressed concern that the proposed rule would require both a prior investigation and board findings by the regulated entity or the OF before an affiliated party could be advanced defense fees and expenses. They argued that a prior investigation is excessive, time consuming and unnecessary, that sufficient facts to make the required findings are likely to be unavailable at the early stage when advancement of expenses is sought, and that a board decision to deny the request under such circumstances could trigger litigation against a Bank by the affiliated party. Therefore, the commenters argued that a prior investigation and board findings should not be a precondition for indemnification. The Banks observed that an investigation and board findings would not be required under the proposed rule to permit a third party insurer to advance expenses directly under insurance policies or fidelity bonds purchased by the Banks, and so should not apply even in the absence of those circumstances. Finally, the Banks contend that, in the interests of Bank safety and soundness and to counter potential confusion and conflicts with different legal standards, the advancement of expenses and costs be permitted pursuant to the provisions already contained in a Bank's bylaws, existing indemnification agreements, and state law for governance chosen under 12 CFR 1239.

FHFA is not persuaded by the Banks' position. The FDIC considered such issues in developing its indemnification rule. The FDIC's first proposed rule would have required a board investigation and a more fulsome determination that the affiliated party had a “substantial likelihood of prevailing on the merits.” 60 FR 16069, 16075 (March 29, 1995). In response to objections to this standard, the FDIC scaled back its proposal to something more on par with the requirements of FHFA's 2016 re-proposal, which requires a prior board investigation and good faith findings that the affiliated party acted in good faith, believing the conduct was in the best interest of the regulated entity or the OF, and that the safety and soundness of the regulated entity or the OF will not be materially and adversely affected (and, also requiring a repayment of advances by the affiliated party if the defense is unsuccessful). See proposed § 1231.4(c)(1); 81 FR at 64360.

Like the FDIC, FHFA considers the foregoing standard to be reasonable. It encourages consistency in interpretation of indemnification standards under similar statutes administered by different agencies, and FHFA's regulation will apply only in FHFA-initiated matters. As the FDIC observed in its final rule, such matters are first subject to significant investigation by the agency in the context of an extensive regulatory scheme. See 61 FR 5926, 5929 (Feb. 15, 1996). At the time of an indemnification or advancement request, substantial factual allegations have been made to focus issues, and nothing inhibits the board from conducting its “due investigation” under the circumstances.

Finally, the Banks' repeated broad assertion that “practical conflicts” and confusion would result from applying these standards instead of disparate and less stringent state standards is unpersuasive for many of the same reasons discussed above regarding the scope of the indemnification prohibition. FHFA again agrees with the FDIC that applying an entity's state law choice for governance issues is inappropriate. See 60 FR at 16075 (FDIC rejecting suggestion to use state law); see also 61 FR at 5929 (FDIC rejecting proposal to adopt Model Business Corporation Act standards). FHFA considers a single federal standard, under a federal statute, implemented by FHFA as a federal agency, applying only to matters initiated by FHFA, and involving institutions chartered by Congress, to be superior to a regulation deferring to disparate state law standards for indemnification payments. This final rule may be more stringent than state law, but FHFA considers it appropriate given the federal interests involved.

3. Insurance Coverage Issues

The Banks correctly observed that the rule would allow regulated entities to pay insurance premiums for policies that provide reimbursement of costs and expenses, but would not allow them to use the proceeds of the policies to pay or reimburse for civil money penalties or an adverse judgment. They also correctly interpreted the proposed rule as prohibiting payment of insurance premiums on any policy that would cover civil money penalties or judgments. Such a ban means that costs and expenses could not be insured against through a policy that by its terms could cover civil money penalties, even if the Banks agreed to take steps to ensure policy proceeds were not actually used to pay those penalties. The Banks contend that if they are prohibited from purchasing policies that include the broader coverage, they may be forced to forgo insurance policies that would cover even those fines and penalties that are not FHFA-related.

FHFA is not persuaded to change the regulation to permit the regulated entities and the OF to pay premiums for insurance policies with the broad coverage requested by the Banks. The various alternatives they offer do not address the purpose of this provision—to avoid back-door payment of civil money penalties and judgments in favor of FHFA through the use of insurance policies. FHFA is concerned that insurance coverage provided by a regulated entity or the OF for the benefit of its affiliated parties would be enforceable directly by the affiliated party, thereby evading the proposed rule's indemnification restrictions. FHFA believes that its goal is best accomplished by prohibiting any insurance coverage of civil money penalties assessed by FHFA or judgments in FHFA's favor.

However, FHFA is not unsympathetic to the larger concerns implicit in the Banks' comment, namely, that the regulated entities and the OF not be unduly limited from accessing a broad insurance market particularly if they might be required to forego certain insurance policies in order to remain compliant with the regulation. FHFA has determined to counter this concern by expanding the market of available insurance products beyond “professional liability insurance” to also entitle the regulated entities and the OF to pay premiums on “any commercial insurance policy” so long as the other requirements of the final rule are satisfied. In addition to increasing the types of policies that may be employed, this change has the added benefit of aligning the final rule with both the language of the statute and the FDIC's treatment of the issue. See 12 U.S.C. 4518(e)(6); see also 12 CFR 359.1(l)(2)(i) (the FDIC described the product that may be purchased as “any commercial insurance policy or fidelity bond.”).

Another insurance issue raised by the Banks (though somewhat obliquely) is whether the prohibition on paying premiums for policies that cover civil money penalties and judgments is intended to prohibit coverage of any civil money penalties, or only those imposed by FHFA. FHFA agrees that the language of the proposed rule is ambiguous and could chill the regulated entities from purchasing insurance coverage covering penalties imposed by other state or federal regulators, which is not in keeping with FHFA's intent. The final rule therefore expressly clarifies in § 1231.4(b)(1) that the prohibition on indemnification payments only applies to a civil money penalty when it is “imposed by FHFA.”

4. Partial Indemnification and Expenses

The Banks' comments on the partial indemnification provisions of the proposed rule covered three distinct objections: first, that the rule's standard for “exoneration” is too narrowly crafted; second, that the obligation to repay is capable of being prematurely triggered; and third, that the rule does not sufficiently account for the precise allocation of defense expenses when an affiliated party faces more than one charge.

The Banks objected to the exoneration standard in the proposed rule—expressed in the rule as “not exonerated”—as being too narrowly tailored and unlikely to permit, in keeping with the proposed rule's presumed intent, an affiliated party to retain expenses advanced to it in connection with charges for which it ultimately is not found to be at fault. They expressed concern that an affiliated party often will not receive an affirmative ruling of exoneration with respect to charges against it, and in such circumstances, there would be few if any judicial or administrative processes available at a reasonable cost to obtain such an affirmative ruling. The Banks also included a hypothetical example to demonstrate their concerns, describing a situation where an affiliated party is initially investigated on three different claims and advanced the expenses to defend against them. The Banks argued that if only two of the claims were pursued and the affiliated party ultimately was found liable on only one claim, the proposed rule's exoneration standard would produce an inequitable result by requiring repayment of all of the expenses advanced despite the affiliated party having been found culpable on only one of the three original claims. The Banks therefore suggested it is more appropriate to replace the “exoneration” standard with a more conventional legal standard, namely, one examining “whether the party is found to be liable based on a judgment not subject to judicial review.” Joint Comment p.4.

FHFA agrees with the Banks' conclusions and acknowledges that the exoneration standard under the proposed rule could have led to the undesirable outcomes set out in their hypothetical example. In fact, the standard itself is too amorphous to be useful; it resists consistent interpretation from case-to-case and year-to-year, and thus may very often lead to an application of the regulation that is inconsistent with the Agency's intent. The Agency therefore finds that the term “not exonerated” under the proposed rule warrants reconsideration and revision. FHFA has determined to revise § 1231.4(b)(2)(i) to make the final rule clearer, more in keeping with familiar standards already in the regulation and more definitive in its application. The final rule turns the question of exoneration (or rather, non-exoneration) into one of “culpab[ility] for violating a law or regulation that is the basis for the charges to which the expenses specifically relate” thereby clarifying the standard to be that for which culpability is assessed and unambiguously linking it to the charges at hand. The concept of culpability is also a more familiar benchmark in that it ties in to the standard used for indemnification after settlements (has not “admit[ted]”). See § 1231.4(b)(2)(ii). Perhaps even more importantly, the final rule adopts a concept of finality, requiring an order to be final and non-reviewable before a lack of culpability qualifies an affiliated party for partial indemnification. See § 1231.4(b)(2)(i).

In making these changes, FHFA acknowledges that it is diverging from the FDIC's parallel provision requiring “a formal and final adjudication or finding in connection with a settlement that the [affiliated party] has not violated certain banking laws or regulations or has not engaged in certain unsafe or unsound banking practices” to describe the standard that qualifies for partial reimbursement. 12 CFR 359.1(l)(2)(ii). FHFA's final rule diverges from the FDIC's regulation by: (1) Temporarily relieving the financial burden of defense on an affiliated party pending a proceeding's finality; and (2) creating a scope of permissible indemnification beyond that available under the FDIC's regulation. With these changes, indemnification becomes permissible if the party to be indemnified is not held responsible for a violation of law or regulation. In contrast, the FDIC regulation is constructed to prohibit indemnification unless the party is found (presumably via an express determination) not to have violated a law or regulation at issue. In the potentially very large zone in which there is no determination or admission that the affiliated party has engaged in wrongdoing, but similarly no exoneration, FHFA's final rule permits the affiliated party to keep the indemnification payments for expenses of defense, while the FDIC's regulation requires that he or she repay them. FHFA's changes as reflected in the final rule provide clearer regulatory standards and greater certainty to FHFA, the regulated entities, and affiliated parties, and do not require explanatory hypotheticals. FHFA believes that the balance of interests in this instance is in favor of greater certainty and clarity.

The Banks' second objection to the partial indemnification provisions in the proposed rule concerns the possibility that an affiliated party's obligation to repay advanced expenses would be triggered prematurely upon the issuance of an unfavorable order, even when that order is not final. The commenters argued that such a trigger does not allow for appeal or review, nor any possible changes before the order becomes final, essentially cutting off funding before the legal process is complete. The Banks instead suggested that proposed § 1231.4(b)(2)(i) be changed from “results in an order” to “results in a final order not subject to judicial review.” They also argued for a corresponding change to § 1231.4(b)(2)(iii), relating to the issuance of a prohibition order to prevent an affiliated party having to repay advances pending resolution of any request for a judicial stay with respect to such order.

FHFA agrees with the Banks that the obligation to repay advances should not be triggered upon the issuance of an order until the order is final and no longer subject to review. Such a change is consistent with the Agency's intent regarding application of the final rule generally, as well as with the rule changes discussed above and made in the context of the “exoneration” standard. In the discussion accompanying the 2016 re-proposal, FHFA responded to several Bank commenters' requests to clarify what was meant by “final prohibition order” and in doing so relied on a reference to section 1377(c)(5) of the Act.8 FHFA's clarification at that time did not adopt the measure of finality sought by the Banks. To account for the Banks' concerns and also to reflect the Agency's intent with regard to when advanced expenses ought to be repaid, FHFA is revising proposed § 1231.4(b)(2)(i) to require that repayment be based on a “final and non-reviewable order.” For the sake of consistency, FHFA is also revising proposed § 1231.4(b)(2)(iii) to reference a “final and non-reviewable prohibition order.”

8 FHFA expressly defined “final prohibition order” as “an order under section 1377 of the [Safety and Soundness] Act (12 U.S.C. 4636a) prohibiting . . . [an affiliated party] from continuing or commencing to hold any office in, or participate in any manner in the conduct of the affairs of, a regulated entity, which order has become and remains effective as described in section 1377(c)(5) of the Safety and Soundness Act (12 U.S.C. 4636a(c)(5)).” 81 FR at 64358.

The Banks' third objection to the partial indemnification provisions concerns the appropriate apportionment of expenses when multiple charges are at issue against an affiliated party. The commenters correctly noted that the proposed rule would have permitted partial indemnification of defense costs and expenses only when they “specifically relate to” a charge or charges on which an affiliated party is exonerated, if the proceeding results in an order; or on which the affiliated party enters a settlement without admitting culpability. See proposed § 1231.4(b), 81 FR at 64360. The Banks contend that this narrow construction is insufficient to account for a precise allocation of defense expenses among multiple charges where each charge may result in a different outcome for the affiliated party. To the extent that this comment suggests partial indemnification should permit an affiliated party to recover the proportion of all costs and expenses represented by the charge(s) on which he or she is successful, FHFA already considered and rejected the suggestion in the 2016 proposed rule 9 and finds no reason to reconsider the comment here.

9 As FHFA noted in the preamble to the Proposed Rule: “In many cases the appropriate amount of partial indemnification will be difficult to ascertain with certainty. The value of each charge might not equal each other charge. Services provided often will relate to multiple charges or all charges and cannot conveniently be segregated.” 81 FR at 64359.

However, in reviving this allocation issue the Banks are asserting a slightly different proposition than the earlier comment, one not necessarily resulting in the same proportional allocation of expenses permitted for partial indemnification. In their latest comment, the Banks recommended that FHFA allow the board of directors of the regulated entity or the OF to determine the weight of each charge and accordingly allow indemnification of expenses for the proportion of the charges otherwise satisfying the rule's standards. According to the Banks, the board is in the best position to conduct such an apportionment. The Banks contend that without a board-driven allocation of costs and expenses, the proposed rule would be a disincentive to settlement of charges, since the affiliated party would not have certainty in advance as to that portion of expenses for which he or she could expect reimbursement or be required to repay.

FHFA does not believe the Banks' comment is sufficiently distinct to warrant a change to the final rule. It remains a proportional allocation, just one determined by the board's collective perception of value instead of one based on a simple arithmetic formula. In reality, the Banks' proposal provides less certainty than a formula-driven proposal and no more certainty than the proposed rule, unless the board's apportionment is known in advance of a settlement or final order. This lack of certainty was among the reasons FHFA rejected the analogous comment to the proposed rule.10 Moreover, it is far from clear that, as the Banks assert, the board would be in a better position to assign weight to different charges than would the parties involved in negotiating a settlement or a judge receiving evidence. Permitting the board to tip the scales in this manner would improperly substitute the board's judgment for the Agency of the parties involved or usurp the authority of the judge presiding over the matter. FHFA therefore continues to believe, as it noted when it issued the 2016 re-proposal, “that the appropriate amount of any partial indemnification is best determined on a case-by-case basis rather than by applying a predetermined formula.” 81 FR at 64359.

10 In this view, FHFA again aligns with the FDIC's views as reflected in its corresponding regulation. Even the Banks note that the FDIC also recognized the lack of certainty in determining partial indemnification amounts. Joint Comment p.3 n.2. The FDIC, like FHFA, decided not to constrain partial indemnification determinations with an artificial and predetermined formula.

5. Treatment of Pre-Existing Indemnification Arrangements

The Banks also objected to the proposed rule's treatment of pre-existing indemnification agreements. They generally restated earlier objections to the text and the effect of the indemnification agreement grandfathering provision in § 1231.4(b)(3), see 81 FR at 64360, which would have permitted payment of amounts due under individualized indemnification agreements with a named affiliated party. The commenters argued that the proposed rule did not define an indemnification “agreement” sufficiently to inform affected parties about what would, or would not, be grandfathered. The Banks further protested that individualized indemnification agreements are rare since most state laws would consider a regulated entity's bylaws provisions on indemnification to be enforceable contractual obligations to officers, directors, employees and agents, as exercises of the Banks' express authority under section 7 of the Federal Home Loan Bank Act, 12 U.S.C. 1427(k). Consequently, the Banks urged FHFA to consider bylaws provisions on indemnification to be “agreements” entitled to grandfathering under the rule. In the alternative, they asked that FHFA delay the effective date of this final rule for 60 days during which regulated entities could execute individualized indemnification agreements that then will be subject to grandfathering. Finally, the Banks requested that FHFA confirm that those whose agreements are grandfathered will not also be subject to any new limitation that did not exist before the effective date of the final rule.11

11 In effect, such a confirmation would override the proposed grandfathering date and replace it with the effective date of the final rule, unless extended.

As the Banks themselves admitted in their comment letter, FHFA has already addressed many of their stated objections in the preamble discussion accompanying the 2016 re-proposal. See Joint Comment p.5. At that time, FHFA rejected those comments, and the Banks have not presented any new arguments warranting reconsideration of this Agency's position. FHFA identified indemnification agreements as “specific indemnification agreements entered into by a regulated entity with a named [affiliated party] on or before the day this proposed amendment is published” and clarified that “only agreements of that type . . . justify grandfathering.” 81 FR at 64359. This definition of what constitutes an “indemnification agreement” subject to grandfathering is clear enough that the Banks should need no further explanation. The commenter's observation that the Bank Act offers the Banks express authority to determine indemnification terms and conditions, does not in any way limit the Director's unambiguous authority to introduce additional prohibitions on indemnification pursuant to section 4518(e) of the Act. Finally, the commenters' request for a delay in the Final Rule's effective date, to permit execution of new agreements that would be subject to grandfathering but no new rule restrictions, is but a minor variation on comments previously submitted and dismissed. FHFA dismissed those comments in the 2016 proposed rule and in so doing rejected any circumstances leading to a scenario like the one proposed by the Banks that would permit a Bank to immunize “[its] entire corps of managers and directors from the effect of this regulation in perpetuity.” 81 FR at 64359. FHFA rejects the Banks' requests to change the final rule in any manner with respect to the treatment of pre-existing indemnification agreements. The final rule retains September 20, 2016 (the 2016 re-proposal's publication date) as the grandfathering date for pre-existing individualized indemnification agreements. See § 1231.4(b)(3).

6. Deterrent Effects on Service as a Bank Director

The Banks' final objection to the proposed rule concerns its potential detrimental impact. The commenters contended that because the proposal departs from current corporate governance and indemnification practices, recruiting for, and the continuing service of, directors, officers, and employees could be adversely affected.

FHFA is not persuaded by this objection. Although FHFA recognizes the risk of deterrence, the Banks offer no evidence to demonstrate that the risk is as great as they suggest, and FHFA remains unconvinced that the asserted deterrent effect is likely to materialize. As noted above, FDIC-insured banks and savings associations have been operating under the equivalent FDIC rule for the past 20 years and have been able consistently to recruit well-qualified directors and officers. FHFA believes it has struck the correct balance between traditional state law-based indemnification and a regime that is appropriate for these institutions, specially subject to and created under federal law, and therefore has not made an accommodation for this comment.

IV. Consideration of Differences Between the Banks and the Enterprises

Section 1313(f) of the Safety and Soundness Act, as amended, requires the Director, when promulgating regulations relating to the Banks, to consider the differences between Fannie Mae and Freddie Mac (collectively, the Enterprises) and the Banks with respect to: The Banks' cooperative ownership structure; mission of providing liquidity to members; affordable housing and community development mission; capital structure; joint and several liability; and any other differences the Director considers appropriate. See 12 U.S.C. 4513(f). The Director considered the differences between the Banks and the Enterprises as they relate to the above criteria and determined that the Banks should not be treated differently from the Enterprises for purposes of this final rule. Any regulated entity in conservatorship (or receivership or a limited-life regulated entity), whether a Bank or an Enterprise, would be outside the scope of the rule.

V. Paperwork Reduction Act

This final rule does not contain any information collection requirement that requires the approval of the Office of Management and Budget (OMB) under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Therefore, FHFA has not submitted any information to OMB for review with respect to information collection.

VI. Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires that a regulation that has a significant economic impact on a substantial number of small entities, small businesses, or small organizations must include an initial regulatory flexibility analysis describing the regulation's impact on small entities. Such an analysis need not be undertaken if the agency has certified that the regulation will not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 605(b). FHFA has considered the impact of this final rulemaking under the Regulatory Flexibility Act. The General Counsel of FHFA certifies that this final rule is not likely to have a significant economic impact on a substantial number of small entities because it would apply primarily to the regulated entities and the OF, which are not small entities for purposes of the Regulatory Flexibility Act.

VII. Congressional Review Act

In accordance with the Congressional Review Act, FHFA has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB). See 5 U.S.C. 804(2).

List of Subjects in 12 CFR Part 1231

Golden parachutes, Government-sponsored enterprises, Indemnification payments.

Accordingly, for the reasons stated in the preamble, and under the authority of 12 U.S.C. 4511, 4513, 4517, 4518, 4518a, and 4526, FHFA amends part 1231 of subchapter B of chapter XII of title 12 of the CFR as follows:

PART 1231—GOLDEN PARACHUTE AND INDEMNIFICATION PAYMENTS 1. The authority citation for part 1231 is revised to read as follows: Authority:

12 U.S.C. 4511; 4513; 4517; 4518; 4518a; and 4526.

2. In part 1231, wherever they occur: a. Revise all references to “entity-affiliated party” to read “affiliated party”; b. Revise all references to “entity-affiliated parties” to read “affiliated parties”; and c. Revise all references to “entity-affiliated party's” to read “affiliated party's”. 3. Revise § 1231.1 to read as follows:
§ 1231.1 Purpose.

The purpose of this part is to implement section 1318(e) of the Safety and Soundness Act (12 U.S.C. 4518(e)) by setting forth the standards that the Director will take into consideration in determining whether to limit or prohibit golden parachute payments and by setting forth conditions for prohibited and permissible indemnification payments that regulated entities and the Office of Finance may make to affiliated parties.

4. In § 1231.2 add definitions for “Indemnification payment” and “Liability or legal expense” in alphabetical order to read as follows:
§ 1231.2 Definitions.

Indemnification payment means any payment (or any agreement to make any payment) by any regulated entity or the OF for the benefit of any current or former affiliated party, to pay or reimburse such person for any liability or legal expense.

Liability or legal expense means—

(1) Any legal or other professional expense incurred in connection with any claim, proceeding, or action;

(2) The amount of, and any cost incurred in connection with, any settlement of any claim, proceeding, or action; and

(3) The amount of, and any cost incurred in connection with, any judgment or penalty imposed with respect to any claim, proceeding, or action.

5. Add § 1231.4 to read as follows:
§ 1231.4 Indemnification payments.

(a) Prohibited indemnification payments. Except as permitted in paragraph (b) of this section, a regulated entity or the OF may not make indemnification payments with respect to an administrative proceeding or civil action that has been initiated by FHFA.

(b) Permissible indemnification payments. A regulated entity or the OF may pay:

(1) Premiums for any commercial insurance policy or fidelity bonds for directors and officers, to the extent that the insurance or fidelity bond covers expenses and restitution, but not a judgment in favor of FHFA or a civil money penalty imposed by FHFA.

(2) Expenses of defending an action, subject to the affiliated party's agreement to repay those expenses if the affiliated party either:

(i) When the proceeding results in a final and non-reviewable order, is found culpable for violating a law or regulation that is the basis for the charges to which the expenses specifically relate; or

(ii) Enters into a settlement of those charges in which the affiliated party admits culpability with respect to them; or

(iii) Is subject to a final and non-reviewable prohibition order under 12 U.S.C. 4636a.

(3) Amounts due under an indemnification agreement entered into with a named affiliated party on or prior to September 20, 2016.

(c) Process; factors. With respect to payments under paragraph (b)(2) of this section:

(1) The board of directors of the regulated entity or the OF must conduct a due investigation and make a written determination in good faith that:

(i) The affiliated party acted in good faith and in a manner that he or she reasonably believed to be in the best interests of the regulated entity or the OF; and

(ii) Such payments will not materially adversely affect the safety and soundness of the regulated entity or the OF.

(2) The affiliated party may not participate in the board's deliberations or decision.

(3) If a majority of the board are respondents in the action, the remaining board members may approve payment after obtaining a written opinion of outside counsel that the conditions of this regulation have been met.

(4) If all of the board members are respondents, they may approve payment after obtaining a written opinion of outside counsel that the conditions of this regulation have been met.

(d) Scope. This section does not apply to a regulated entity operating in conservatorship or receivership or to a limited-life regulated entity.

Dated: September 28, 2018. Melvin L. Watt, Director, Federal Housing Finance Agency.
[FR Doc. 2018-21592 Filed 10-3-18; 8:45 am] BILLING CODE 8070-01-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 15 CFR Part 902 50 CFR Part 679 [Docket No. 170630613-8749-02] RIN 0648-BH02 Fisheries of the Exclusive Economic Zone Off Alaska; Yellowfin Sole Management in the Groundfish Fisheries of the Bering Sea and Aleutian Islands AGENCY:

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

ACTION:

Final rule.

SUMMARY:

NMFS issues regulations to implement Amendment 116 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP). Amendment 116 and this final rule limit access to the Bering Sea and Aleutian Islands (BSAI) Trawl Limited Access Sector (TLAS) yellowfin sole directed fishery by vessels that deliver their catch of yellowfin sole to motherships for processing. This final rule establishes eligibility criteria based on historical participation in the BSAI TLAS yellowfin sole directed fishery; issues an endorsement to those groundfish License Limitation Program (LLP) licenses that meet the eligibility criteria; and authorizes delivery of BSAI TLAS yellowfin sole to motherships by only those vessels designated on a groundfish LLP license that is endorsed for the BSAI TLAS yellowfin sole directed fishery. This action is necessary to prevent increased catcher vessel (CV) participation from reducing the benefits the fishery provides to historic and recent participants, mitigate the risk that a “race for fish” could develop, and help to maintain the consistently low rates of halibut bycatch in the BSAI TLAS yellowfin sole directed fishery. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, Amendment 116, the BSAI FMP, and other applicable laws.

DATES:

This rule is effective November 5, 2018.

ADDRESSES:

Electronic copies of Amendment 116 and the Environmental Assessment/Regulatory Impact Review (collectively the “Analysis”) prepared for this action may be obtained from www.regulations.gov. A Small Entity Compliance Guide for this final rule is available on the NMFS Alaska Region website at https://alaskafisheries.noaa.gov/.

Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this rule may be submitted by mail to NMFS Alaska Region, P.O. Box 21668, Juneau, AK 99802-1668, Attn: Ellen Sebastian, Records Officer; in person at NMFS Alaska Region, 709 West 9th Street, Room 420A, Juneau, AK; by email to [email protected]; or by fax to (202)-395-5806.

FOR FURTHER INFORMATION CONTACT:

Bridget Mansfield, 907-586-7228.

SUPPLEMENTARY INFORMATION:

Authority for Action

NMFS manages the groundfish fisheries in the exclusive economic zone of the BSAI under the BSAI FMP. The North Pacific Fishery Management Council (Council) prepared the BSAI FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801 et seq. Regulations governing U.S. fisheries and implementing the BSAI FMP appear at 50 CFR parts 600 and 679.

This final rule implements Amendment 116. The Council submitted Amendment 116 for review by the Secretary of Commerce, and the notice of availability of this amendment was published in the Federal Register on May 18, 2018 (83 FR 23250), with comments invited through July 17, 2018. NMFS published the proposed rule for this action on June 6, 2018 (83 FR 26237), with comments invited through July 6, 2018. A correction notice to the proposed rule was published on June 20, 2018 (83 FR 28604). The Secretary of Commerce approved Amendment 116 on August 10, 2018. NMFS received five comment letters containing nine individual comments from five unique individuals during the comment periods for Amendment 116 and the proposed rule. The five commenters consisted of three individuals and two companies representing CVs. A summary of these comments and the responses by NMFS are provided under the heading “Comments and Responses” below.

A detailed review of the provisions of Amendment 116, the proposed regulations to implement Amendment 116, and the rationale for this action is provided in the preamble to the proposed rule and is briefly summarized in this final rule.

Background

The BSAI yellowfin sole directed fishery is managed under a total allowable catch (TAC) limit with portions of the TAC allocated to the Community Development Quota (CDQ) Program, the Amendment 80 sector, and the BSAI TLAS. The BSAI TLAS comprises all BSAI trawl fishery participants not in the CDQ Program or Amendment 80 sector. The Council's intent in establishing the BSAI TLAS was to provide harvesting opportunities for American Fisheries Act (AFA) catcher/processors (CPs), AFA CVs, and non-AFA CVs. The current BSAI TLAS yellowfin sole directed fishery is almost entirely an offshore fishery composed of two primary harvesting groups: (1) AFA CPs, and (2) AFA and non-AFA CVs delivering yellowfin sole to AFA and Amendment 80 CPs or stationary floating processors operating as motherships. A “mothership” is defined as a vessel that receives and processes groundfish from other vessels (see definition at 50 CFR 679.2) and for purposes of this rule includes stationary floating processors.

Since 2015, the BSAI TLAS yellowfin sole directed fishery has seen dramatic increases in CV and mothership participation as compared to the first seven years of the fishery (2008 through 2014). Also since 2015, the BSAI TLAS yellowfin sole TAC has been more fully harvested and the fishing season has grown shorter as the TAC has been reached earlier. The Analysis prepared for this action notes that the potential exists for up to seven additional Amendment 80 CPs to participate as motherships in the fishery, providing processing capacity for up to 21 additional CVs, which would put greater fishing pressure on the fishery. The Council determined and NMFS agrees that limiting access to the BSAI TLAS yellowfin sole directed fishery by CVs delivering to motherships is needed given the expectation of additional capacity entering the fishery. The Council adopted its preferred alternative for Amendment 116 at its June 2017 meeting.

This final rule balances protections for the benefits from the fishery for long-time, historic, and recent participants, given the increasing number of participants in the fishery and shorter fishing seasons. This final rule promotes stability in the fishery by reducing the risk of a race for fish, lengthening the fishing season, and creating a safer, more predictable fishery. That stability will also minimize the potential for increased halibut prohibited species catch (PSC) rates, which could lead to closure of the fishery before the TAC is fully harvested.

This final rule establishes the requirement that a vessel used to harvest yellowfin sole in the BSAI TLAS yellowfin sole directed fishery and deliver that catch to a mothership must be designated on a groundfish LLP license with a BSAI TLAS yellowfin sole directed fishery endorsement. This final rule also establishes the eligibility criteria and issuance process for this new endorsement. Vessels not designated on groundfish LLP licenses that receive the endorsement are prohibited from participating in the BSAI TLAS yellowfin sole directed fishery and delivering their catch to a mothership for processing. This final rule does not preclude any vessel from delivering BSAI TLAS yellowfin sole to a shoreside processor. This final rule also does not preclude a vessel without a BSAI TLAS yellowfin sole directed fishery endorsement from delivering incidental catch of yellowfin sole that is caught while participating in other directed fisheries to a mothership for processing. Finally, this final action does not preclude a vessel from participating as a CP and processing its own catch in the BSAI TLAS yellowfin sole directed fishery.

Under this action, NMFS will issue a BSAI TLAS yellowfin sole directed fishery endorsement to a groundfish LLP license with a Bering Sea trawl endorsement if (1) the groundfish LLP license is credited with at least one legal trip target landing in the BSAI TLAS yellowfin sole directed fishery; and (2) the credited legal trip target landing was to a mothership in any one year of the qualifying period (2008 through 2015). Under this final rule, the term “trip target” is defined as a groundfish species that is retained in an amount greater than the retained amount of any other groundfish species for that trip. Where a vessel that made at least one trip target landing in the BSAI TLAS directed fishery from 2008 through 2015 was designated on more than one groundfish LLP license during the qualifying period, all groundfish LLP licenses on which the vessel was designated and was used to make a trip target landing in a BSAI TLAS fishery during the qualifying period are eligible to be credited with the qualifying landings made by the vessel. However, none of these groundfish LLP licenses will be credited with a qualifying landing and receive an endorsement from NMFS until the vessel owner notifies NMFS in writing to identify which single groundfish LLP license is to be credited with the qualifying landing(s). NMFS anticipates that a total of eight groundfish LLP licenses will receive a BSAI TLAS yellowfin sole directed fishery endorsement under this final rule, resulting in up to eight vessels that may participate in the BSAI TLAS yellowfin sole directed fishery and deliver their catch to a mothership.

Overview of Measures Implemented by This Rule

This final rule limits access to the BSAI TLAS yellowfin sole directed fishery by CVs delivering to motherships to those CVs designated on a groundfish LLP license with a BSAI TLAS yellowfin sole directed fishery endorsement.

In order to implement Amendment 116, this final rule—

• Authorizes delivery of BSAI TLAS yellowfin sole to motherships by only those vessels designated on a groundfish LLP license endorsed for the BSAI TLAS yellowfin sole directed fishery.

• Includes the provisions that are necessary for a groundfish LLP license to qualify for and receive a BSAI TLAS yellowfin sole directed fishery endorsement.

• Prohibits the delivery of yellowfin sole harvested with trawl gear in the BSAI TLAS directed fishery to a mothership without a copy of a valid LLP license with a BSAI TLAS yellowfin sole directed fishery endorsement.

• Lists those groundfish LLP licenses that NMFS has determined are eligible, will be credited with qualifying landings, and will receive a BSAI TLAS yellowfin sole directed fishery endorsement under this final rule.

• Lists those pairs of groundfish LLP licenses that NMFS has determined are eligible, but will not be credited with qualifying landings and will not receive a BSAI TLAS yellowfin sole directed fishery endorsement until the vessel owner notifies NMFS which single groundfish LLP license on which the vessel was designated during the qualifying period NMFS should credit with the qualifying landings.

• Establishes the process for notifying groundfish LLP license holders of eligibility for a BSAI TLAS yellowfin sole directed fishery endorsement.

• Establishes the process for the issuance of revised groundfish LLP licenses with a BSAI TLAS yellowfin sole directed fishery endorsement.

• Establishes an administrative adjudicative process to challenge NMFS's determinations on eligibility for a BSAI TLAS yellowfin sole directed fishery endorsement.

Additional detail about the rationale for and effect of the regulatory changes in this rule is provided in the preamble to the proposed rule and in the Analysis for this action.

Summary of Regulatory Changes

The following provides a brief summary of the regulatory changes made by this final rule.

Revisions to Prohibitions at § 679.7

This final rule adds § 679.7(i)(11) to prohibit the delivery of yellowfin sole harvested with trawl gear in the BSAI TLAS directed fishery to a mothership without a copy of a valid LLP license with a BSAI TLAS yellowfin sole directed fishery endorsement except as provided in § 679.4(k)(2).

Revisions to Permits at § 679.4

This final rule adds § 679.4(k)(14) to include the provisions that are necessary to qualify for, and receive, a BSAI TLAS yellowfin sole directed fishery endorsement. Section 679.4(k)(14) establishes a notification process for holders of groundfish LLP licenses eligible and ineligible for a BSAI TLAS yellowfin sole directed fishery endorsement. This section also establishes an administrative adjudicative process to challenge NMFS's determinations on eligibility for a BSAI TLAS yellowfin sole directed fishery endorsement.

Revisions to Tables to Part 679

This final rule adds Table 52 to part 679 to list those groundfish LLP licenses that NMFS has determined are eligible, will be credited with qualifying landings, and will receive a BSAI TLAS yellowfin sole directed fishery endorsement under this final rule.

This final rule also adds Table 53 to part 679 to list those pairs of groundfish LLP licenses that NMFS has determined are eligible, but are not credited with qualifying landings. One groundfish LLP license from each pair in Table 53 will be credited with qualifying landings and will receive a BSAI TLAS yellowfin sole directed fishery endorsement once the vessel owner notifies NMFS in writing which one of the pair is selected to be credited with the qualifying landings and receive the BSAI TLAS yellowfin sole directed fishery endorsement.

Comments and Responses

NMFS received five comment letters containing nine individual comments from five unique individuals during the comment periods for Amendment 116 and the proposed rule. The five commenters consisted of three individuals and two companies. Four comments did not support this action, three comments supported this action, and two comments addressed topics that were outside the scope of this action.

In responding to these comments, reference to Amendment 116, unless otherwise noted, means Amendment 116 and this final rule implementing Amendment 116.

Comment 1: This rule would eliminate most of the AFA and non-AFA CVs from harvesting yellowfin sole in the trawl limited access fishery and allow AFA CPs to continue to harvest as much as they can. That means the elimination of a very good fishing opportunity for most of the small CVs, in favor of further consolidation among the AFA CPs, which violates AFA Section 211. This proposed action is a de-facto exclusive allocation to a small, closed class of participants who have already shown their intention to privately organize and manage the fishery with harvest allocation agreements in 2016 and before. In addition, this proposed action conflicts with NMFS's policy allowing Amendment 80 vessels to participate as motherships in the BSAI TLAS fishery by limiting the opportunities for Amendment 80 vessels to partner with CVs.

Response: NMFS disagrees that this final rule violates AFA section 211, creates a de-facto allocation, or conflicts with NMFS policy regarding the ability of Amendment 80 vessels to act as motherships. AFA section 211(a) specifies that: “The North Pacific Council shall recommend for approval by the Secretary such conservation and management measures as it determines necessary to protect fisheries under its jurisdiction and the participants in those fisheries, including processors, from adverse impacts caused by this Act or fishery cooperatives in the directed pollock fishery.” This provision is intended to protect non-AFA vessels from potential negative impacts associated with the directed pollock fishery created by the AFA.

This action is consistent with the provisions of section 211 of the AFA for several reasons. This action does not modify (i.e., increase) the amount of BSAI TLAS yellowfin sole that may be harvested by AFA CPs or CVs. Further, this action does not change (i.e., decrease) the allocation of BSAI yellowfin sole to the Amendment 80 sector or the BSAI TLAS yellowfin sole directed fishery. In developing this action, the Council considered and recommended management measures for the BSAI TLAS yellowfin sole fishery that it determined were necessary to protect both AFA and non-AFA vessels from the negative impacts of a potential race for fish in the BSAI TLAS yellowfin sole directed fishery. The final rule does not provide benefits to AFA vessels related to their rights in the directed pollock fishery, nor does it provide benefits to AFA vessels at the expense of non-AFA vessels. Under this action, AFA CPs and CVs are still subject to the sideboard provisions that limit harvests of AFA CPs and CVs established by the final rule implementing Amendment 80 (72 FR 52668, September 14, 2007) and in regulations at § 679.64(a) and (b), which were created to minimize potential adverse impacts caused by the AFA pursuant to AFA section 211. In the final rule implementing Amendment 80, NMFS noted that the Council considered and recommended “management measures applicable to the AFA sector that it determined necessary to protect other fisheries during the development of the [Amendment 80] Program” (see 72 FR 5267).

This final rule is not expected to significantly alter the amount of yellowfin sole that is harvested by AFA CPs. Since 2015, the proportion of harvest by AFA CPs has decreased, not increased, relative to the proportion of harvest by CVs. Section 2.7.1.1 of the Analysis states that, from 2008 through 2014, AFA CPs harvested approximately 85 percent of the total catch in the BSAI TLAS yellowfin sole directed fishery. In 2015, 2016, and 2017 (the last year of complete data), AFA CPs have harvested 55 percent, 51 percent, and 42 percent of the total catch in the BSAI TLAS yellowfin sole directed fishery, respectively (see Section 2.7.1.1). This final rule limits the number of CVs that may deliver catch in the BSAI TLAS yellowfin sole directed fishery to motherships to approximately the number of CVs that have participated in recent years. This final rule is not expected to result in an increase in catch by AFA CPs.

This final rule does not create a closed class of participants in the fishery. This final rule does not limit the number or specific AFA or non-AFA CPs that can participate in the BSAI TLAS yellowfin sole directed fishery, although AFA CPs are constrained by sideboard limits established under Amendment 80. This final rule does not establish a closed class of AFA or non-AFA CVs, because it does not preclude CVs from delivering catch in the BSAI TLAS yellowfin sole directed fishery to shoreside processors; this action limits only the number of CVs that deliver to motherships. Although the Analysis notes that currently CVs are not delivering harvests in the BSAI TLAS yellowfin sole directed fishery to shoreside processors, should such markets develop, this final rule would not limit the ability of existing or new CVs from harvesting and delivering BSAI TLAS yellowfin sole to shoreside processors.

This final rule does not establish or require any private agreements among fishery participants in order to participate in the BSAI TLAS yellowfin sole directed fishery. This final rule was developed in response to the Council's and NMFS's concerns over the developing “race for fish,” which has already shortened the fishing season and raised management, conservation, and safety issues detailed in the preamble to the proposed rule (83 FR 26237, June 6, 2018). Because these concerns stem directly from the recent, dramatic increase in participation in this fishery by CVs delivering to motherships, the Council and NMFS determined that the appropriate response is to limit additional participation to provide stability to the fishery and predictability for participants and managers. This limitation allows for continued participation by the majority of CVs that have historically fished BSAI TLAS yellowfin sole and delivered to motherships. Only two CVs that have shown interest in participating in the fishery, notably after the Council signaled its intent to limit participation by CVs in the BSAI TLAS yellowfin sole fishery, are precluded from future participation under this rule.

This final rule is consistent with the establishment of the BSAI TLAS under Amendment 80, defined in regulations at § 679.2 as all other BSAI trawl fishery participants not in the Amendment 80 or CDQ sectors, and specifically includes AFA CPs, AFA CVs, and non-AFA CVs. The final rule implementing Amendment 80 makes clear that the BSAI TLAS fisheries were created specifically to preserve the opportunity for such vessels to fish in the non-pollock trawl fisheries in the BSAI. This action does not favor AFA or non-AFA CVs. NMFS has determined that of the ten groundfish LLP licenses with CV designations eligible for a BSAI TLAS yellowfin sole directed fishery endorsement, three are endorsed as AFA groundfish LLP licenses, while the remaining seven have no AFA or Amendment 80 endorsement.

This final rule implementing Amendment 116 is also consistent with the determination under Amendment 80 that Amendment 80 vessels could be used as motherships to receive harvest from CVs fishing in the BSAI TLAS fisheries. The final rule implementing Amendment 80 noted that it allowed the continued participation of one Amendment 80 vessel that had historically been used as a mothership and acknowledged potential future growth in the use of Amendment 80 vessels as motherships in the BSAI TLAS. Under this rule Amendment 80 vessels can still act as motherships and receive deliveries of BSAI TLAS yellowfin sole from CVs with a BSAI TLAS yellowfin sole directed fishery endorsement. However, NMFS and the Council believe that further growth of CVs delivering to motherships must be limited at this time to maintain a balance between the ability of participants to fully harvest the TAC and the management, conservation, and safety concerns that result from accelerated harvest caused by continued increase in participation.

Comment 2: As originally intended by NMFS, the partnerships between CVs and Amendment 80 mothership operations are lucrative for CVs, their crews, and the State of Alaska. Partnerships between Amendment 80 vessels and CVs allow CVs the opportunity to harvest yellowfin sole and earn revenue during times they would not otherwise be fishing. This puts Alaskan vessels and crew to work during times that they would otherwise be sitting idle and collecting unemployment. The BSAI TLAS yellowfin sole fishery provides CVs significant, predictable income that CV owners can invest into Alaska and for new halibut reduction technology. Restricting the CV fleet to eight vessels under this proposed rule will divert this revenue to the largest fishing companies, the AFA CP owners, who already receive massive revenue from their protected pollock monopoly.

Response: Capping the number of CVs delivering TLAS yellowfin sole to motherships will not significantly reduce CV participation in the fishery from historic levels. Under this rule, it is anticipated that eight groundfish LLPs will qualify for a BSAI TLAS yellowfin sole directed fishery endorsement. CV participation in the fishery has never exceeded nine vessels in any one year. As noted in the response to Comment 1, the AFA CP sector is still subject to BSAI TLAS yellowfin sole sideboard limits as required at § 679.64(a) and (b). Also noted in the response to Comment 1, the harvest has shifted from CPs harvesting the majority of the BSAI TLAS yellowfin sole to CVs harvesting a slight majority of the BSAI TLAS yellowfin sole TAC in recent years. The Analysis (Section 2.7.1.1) states that from 2008 through 2014 AFA CPs harvested approximately 85 percent of the total catch in the BSAI TLAS yellowfin sole directed fishery. In 2015, 2016, and 2017 (the last year of complete data), AFA CPs have harvested 55 percent, 51 percent, and 42 percent of the total catch in the BSAI TLAS yellowfin sole directed fishery, respectively (see Section 2.7.1.1). This final rule limits the number of CVs that may deliver catch in the BSAI TLAS yellowfin sole directed fishery to motherships to approximately the number of CVs that have participated in recent years, and is not expected to result in an increase in catch by AFA CPs. Therefore, this rule is not expected to divert revenue from the CV sector to the CP sector.

Comment 3: The proposed rule described the Council's concern regarding “the likelihood of decreasing benefits from the yellowfin sole TLAS fishery for long-time, historic, and recent participants given the increasing number of participants in the fishery and shorter fishing seasons.” The proposed action should not proceed based on “dependency” because (a) there is no legal “dependency” by the AFA CPs on the BSAI TLAS yellowfin sole directed fishery, and (b) mere “dependency” of a favored set of companies is not a legally sufficient reason under the Magnuson-Stevens Act to exclude their competitors from a fishery.

Response: This action does not protect any particular group of vessels based on dependency on this fishery. As explained in the response to Comment 1, this action is consistent with the final rule implementing Amendment 80, which established criteria for participation in the BSAI TLAS fisheries. In developing this final rule to implement Amendment 116, the Council and NMFS based eligibility qualifications on historic participation, which is described in the rule as at least one legal trip target landing of BSAI TLAS yellowfin sole directed catch to a mothership in any one year during the qualifying period (2008 through 2015). The Council and NMFS did not consider dependency on this fishery by participants and did not equate the fishery's benefits to long-time, historic, and recent participants with dependency on the fishery by those participants. To the extent that historic participation was taken into account in the development of this rule, it was the historic participation of CVs, rather than the historic participation of CPs. Further, in considering historic participation, the Council chose the more inclusive alternative that required participation in the fishery in any one year during the qualifying period, rather than any two years. For the eight CVs designated on a groundfish LLP license eligible to participate in the BSAI TLAS yellowfin sole directed fishery endorsement under this final rule, participation in the fishery ranged from one to seven years. Of those eight vessels, five participated in the fishery for only one of the eight qualifying years.

Comment 4: These regulations should not proceed in the guise of a halibut bycatch (PSC) management program. The Analysis states that under the status quo management, halibut PSC usage in the fishery will likely continue at similar levels. There are no data to support the creation of a closed class of participants on the basis of halibut bycatch concerns in the status quo fishery. Halibut bycatch has been reduced with CVs competing for lower halibut PSC in the TLAS. The entrance of new CVs into the fishery has created a new tool promoting bycatch reduction through competition between harvesters for the lowest halibut bycatch rates. The proposed regulations may actually reverse the bycatch reduction gains achieved by the competition between CPs and CVs.

Response: NMFS acknowledges that the halibut PSC in the BSAI TLAS yellowfin sole directed fishery varies from year-to-year for a variety of reasons. With the exception of 2013, halibut PSC rates are generally low and within the PSC limits set through the annual specifications process. However, the preamble to the proposed rule states that this action is necessary to mitigate the risk that a “race for fish” could develop, which could increase halibut PSC rates. The Analysis (Section 2.7.1.2) notes that overall, under status quo, halibut PSC usage in the BSAI TLAS yellowfin sole directed fishery will likely continue at similar levels if participation is stable. However, the Council noted the increase in the number of participating CVs that deliver to motherships in recent years and anticipated that such participation would continue to increase without action to curtail the increase. The recent increased participation, combined with recent lower BSAI TLAS yellowfin sole allocations, has resulted in a fully utilized fishery with increasingly shorter fishing seasons. Shorter fishing seasons can enhance the incentives for vessels to harvest quickly in order to gain a greater share of the TAC before it is fully harvested and the fishery is closed. These circumstances create a substantial disincentive for harvesters to take actions to reduce bycatch use and waste, particularly if those actions could reduce groundfish catch rates. This increases the potential for higher halibut PSC rates. Accordingly, the Analysis (Section 2.7.1.2 and 3.2.2.1) notes that by limiting the level of participation by CVs, this action has the potential to mitigate future increases in halibut PSC in this fishery by relieving the harvest pressure and providing more flexibility in fishing operations, which allows vessels to better avoid halibut PSC. In this way, this action may help maintain current low levels or even decrease halibut PSC in the fishery.

Further, NMFS believes that limiting the number of CVs delivering to motherships provides more stability and predictability in the fishery over the long term. This can facilitate better communication among participants and provide a better opportunity to implement a voluntary best practices agreement. Section 2.7.1.2 of the Analysis describes this best practices agreement as “target rates of halibut mortality, reporting real-time halibut mortality and location of the mortality, and established procedures for sharing halibut mortality information via Sea-State [a private third-party data manager]. In some years, the agreement has also included informal apportionment of remaining halibut mortality among participating vessels that fish late in the year.” This action does not preclude competition between CPs and CVs to reduce halibut PSC rates from continuing to help maintain the consistently low rates of halibut bycatch in the BSAI TLAS yellowfin sole directed fishery.

Comment 5: The proposed rule states that this action does not create a Limited Access Privilege (LAP) program. We believe the proposed action is a LAP program. The AFA-CP companies have previously operated in the TLAS subject to a voluntary cooperative agreement that these companies have refused to produce to NMFS or other participants. We believe that this cooperative agreement included allocation of harvest among its members. Thus, this action likely will have the effect of allocating species to the participants who may revert to their previously agreed and undisclosed allocation agreement.

Response: As noted in the proposed rule, Section 3 of the Magnuson-Stevens Act (16 U.S.C. 1802) defines a LAP as a Federal permit issued as part of a limited access system under section 303A to harvest a quantity of fish expressed by a unit or units representing a portion of the TAC of the fishery that may be received or held for exclusive use by a person and includes an individual fishing quota but does not include community development quotas. This final rule limits the number of groundfish LLP licenses, and therefore the number of CVs, that could be used to harvest BSAI TLAS yellowfin sole and deliver that harvest to a mothership, but it does not assign a portion of the BSAI TLAS yellowfin sole TAC for exclusive use by a person. An individual owner of a groundfish LLP license that receives an endorsement would not be allocated a specific amount of BSAI TLAS yellowfin sole for the owner's exclusive use. All vessels eligible to participate in the offshore BSAI TLAS yellowfin sole directed fishery, including CPs as well as CVs designated on groundfish LLP licenses with the BSAI TLAS yellowfin sole directed fishery endorsement, will continue to compete with each other in harvesting the BSAI TLAS yellowfin sole TAC rather than act together as one entity. Additionally, although CVs have not historically delivered their catch of yellowfin sole to shore-based processing plants, this proposed action does not preclude CVs from conducting directed fishing for BSAI TLAS yellowfin sole and delivering that harvest to shore-based processing plants. This proposed action does not limit the amount of BSAI TLAS yellowfin sole that can be harvested by a CV designated on a groundfish LLP license with a BSAI TLAS yellowfin sole directed fishery endorsement; rather, it limits the number of CVs that are eligible to participate in the directed fishery and deliver their harvest to a mothership. This action does not limit CPs participating in the BSAI TLAS yellowfin sole fishery or assign a portion of the TAC for exclusive use by individual CPs or any specific group of CPs. Voluntary cooperative agreements are not equivalent to a LAP program created by NMFS. Moreover, NMFS maintains the ability to reallocate BSAI TLAS yellowfin sole TAC to the Amendment 80 sector, if NMFS determines that it will go unharvested.

Comment 6: We support this action, because it tightens eligibility of CVs and will decelerate the race for fish to avoid the “Tragedy of the Commons,” whereby the common resource is depleted as the number of vessels harvesting fish increases, and over time the survival of the fish species itself is threatened. The recent influx of CV effort has resulted in shortened seasons and affects participants historically dependent on the fishery. The additional CV effort also reduces incentives and opportunities for participants to adopt measures to reduce halibut bycatch and associated mortality.

Response: NMFS acknowledges the comment in support of Amendment 116.

Comment 7: We support this action, because it will (1) allow for a reasonable level of CV participation in the offshore sector without limiting potential markets for sales of catch by qualifying vessels, (2) maintain competition for catches and landings of those catches, (3) reduce the race for fish, (4) protect historically dependent participants, and (5) allow for reasonable measures to reduce halibut bycatch mortality. The commenter also noted that the onshore sector is not constrained by this rule and that there is no restriction on the number of CVs that could deliver shoreside, which would allow for new entrants.

Response: NMFS acknowledges the comment in support of Amendment 116.

Comment 8: The correction to the proposed rule (83 FR 28604; June 20, 2018) is appropriate, as is NMFS's interpretation of the Council's motion overall. Further, NMFS's interpretation of the Council's motion to treat stationary floating processors as motherships is consistent with the analysis of alternatives and the purpose and need statement of the Council, which explicitly mentioned a concern with CV deliveries to floating processors.

Response: NMFS acknowledges the comment in support of the correction to the proposed rule. The definition of a “mothership” in 679.2 includes vessels that are operating as “stationary floating processors” as that term is defined in 679.2. In addition, Section 2.7.1.1 of the Analysis notes that two stationary floating processors participated in the fishery as motherships in 2008. Although those stationary floating processors did not participate in the fishery after 2008, data from landings to those vessels were included in the analysis of impacts of the alternatives.

Comment 9: NMFS received two comments addressing issues outside the scope of this action. One commenter did not support this action because of the effects of fishing on natural resources, including marine mammals, and suggested that NMFS cut the yellowfin sole quota by 50 percent. One commenter did not support this action and suggested that NMFS further limit industrial-level commercial fishing in favor of small, traditional fishing boats to reduce the impact of overfishing on natural resources and revitalize local fishing economy and tourism.

Response: These comments address management issues that are beyond the scope of Amendment 116 and this regulatory action. This final rule does not change the process of allocating quota or establishing TACs or sideboard limits under the AFA or Amendment 80 Programs, nor will this final rule change specific management measures that govern the harvest of BSAI TLAS yellowfin sole, such as fishing location, timing, effort, or authorized gear types. This final rule limits access to the BSAI TLAS yellowfin sole fishery by CVs that deliver to motherships by requiring that those CVs be designated on a groundfish LLP license with a BSAI TLAS yellowfin sole CV endorsement and establishes eligibility criteria for such an endorsement.

OMB Revisions to PRA References in 15 CFR 902.1(b)

Section 3507(c)(B)(i) of the Paperwork Reduction Act (PRA) requires that agencies inventory and display a current control number assigned by the Director of the Office of Management and Budget (OMB), for each agency's information collection. Section 902.1(b) identifies the location of NOAA regulations for which OMB approval numbers have been issued. Because this final rule adds a new collection-of-information for recordkeeping and reporting requirements, 15 CFR 902.1(b) is revised to reference correctly the section resulting from this final rule.

Changes From the Proposed Rule

This final rule contains no substantive changes from the proposed rule, as corrected by the correction notice published on June 20, 2018 (83 FR 28604). The final rule includes minor changes to the proposed rule text to correct citations and remove redundant language. These changes include: (1) Removed “as defined at 679.2” throughout the final rule; (2) Corrected incorrect references to other sections of the rule; and (3) Removed the word “proposed” when referring to new Tables 52 and 53.

Classification

The Administrator, Alaska Region, NMFS, has determined that Amendment 116 to the BSAI FMP and this final rule are necessary for the conservation and management of the groundfish fishery and are consistent with the Magnuson-Stevens Act and other applicable laws.

This final rule has been determined to be not significant for the purposes of Executive Order 12866.

Small Entity Compliance Guide

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a final regulatory flexibility analysis, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a letter to groundfish LLP license holders that also serves as small entity compliance guide (the guide) was prepared. Copies of the guide, i.e., groundfish LLP license holder letter, will be sent to all holders of groundfish LLP license for the Bering Sea trawl fisheries. The guide and this final rule will be available upon request from the Alaska Regional Office (see ADDRESSES). This action does not require any additional compliance from small entities that is not described in the preambles. Copies of the proposed rule, the correction notice, and this final rule are available from the NMFS website at http://alaskafisheries.noaa.gov.

Final Regulatory Flexibility Analysis (FRFA)

This FRFA incorporates the initial regulatory flexibility analysis (IRFA), a summary of the significant issues raised by the public comments in response to the IRFA, NMFS's responses to those comments, and a summary of the analyses completed to support this action.

Section 604 of the Regulatory Flexibility Act (RFA) requires that, when an agency promulgates a final rule under section 553 of Title 5 of the U.S. Code, after being required by that section or any other law to publish a general notice of proposed rulemaking, the agency shall prepare a FRFA. Section 604 describes the required contents of a FRFA: (1) A statement of the need for and objectives of the rule; (2) a statement of the significant issues raised by the public comments in response to the IRFA, a statement of the assessment of the agency of such issues, and a statement of any changes made to the proposed rule as a result of such comments; (3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA) in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments; (4) a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available; (5) a description of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities that will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and (6) a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in this final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.

A description of this final rule and the need for and objectives of this rule are contained in the preamble to this final rule and the preambles to the proposed rule (83 FR 26237, June 6, 2018) and the correction notice (83 FR 28604, June 20, 2018), and are not repeated here.

Public and Chief Counsel for Advocacy Comments on the IRFA

NMFS published the proposed rule on June 6, 2018 (83 FR 26237), and a correction notice to the proposed rule on June 20, 2018 (83 FR 28604). An IRFA was prepared and summarized in the Classification section of the preamble to the proposed rule. The comment period for the proposed rule closed on July 6, 2018. The comment period for the notice of availability for Amendment 116 closed on July 17, 2018. NMFS received five letters of public comment on the proposed rule and Amendment 116. The Chief Counsel for Advocacy of the SBA did not file any comments on the proposed rule.

NMFS received no comments specifically on the IRFA. However, one of the comments supported this action, because it provides operational relief to the owners and operators of trawl CVs.

Number and Description of Small Entities Regulated by This Final Action

This final rule directly regulates (1) holders of groundfish LLP licenses that authorize a vessel designated on the LLP license to harvest groundfish using trawl gear in the Bering Sea, and (2) vessel owners that must choose one of two LLP licenses on which the vessel was designated during the qualifying period. Based on the best available and most recent complete data from 2008 through 2017, 163 groundfish LLP license holders and five vessel owners will be directly regulated by this action.

For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide.

The RFA requires consideration of affiliations between entities for the purpose of assessing whether an entity is classified as small. The AFA pollock and Amendment 80 cooperatives are types of affiliation between entities. All of the AFA and Amendment 80 cooperatives have gross annual revenues that are substantially greater than $11 million. Therefore, NMFS considers members in these cooperatives “affiliated” large (non-small) entities for RFA purposes.

Of the 163 groundfish LLP license holders directly regulated by this action, 128 were members of an AFA cooperative and 26 were members of an Amendment 80 cooperative in 2017. Therefore, NMFS considers those 154 groundfish LLP license holders to be “affiliated” large (non-small) entities for RFA purposes. All of the groundfish LLP licenses with designated vessels that participated in the BSAI TLAS yellowfin sole directed fishery and delivered catch to a mothership from 2008 through 2017 were affiliated with either an AFA or an Amendment 80 cooperative in 2017. NMFS therefore considers these LLP license holders to be “affiliated” large (non-small) entities for RFA purposes.

The remaining nine groundfish LLP license holders are not affiliated with AFA or Amendment 80 cooperatives and are assumed to be small entities directly regulated by this action for purposes of the RFA. All five vessel owners who are considered regulated entities under this final rule were affiliated with either an AFA pollock or an Amendment 80 cooperative in 2017. Therefore, NMFS considers them “affiliated” large (non-small) entities for RFA purposes. This FRFA assumes that each vessel owner and each groundfish LLP license holder is a unique entity; therefore, the total number of directly regulated entities may be an overestimate because some vessel owners and groundfish LLP license holders are likely affiliated through common ownership. These potential affiliations are not known with the best available data and cannot be predicted.

Recordkeeping, Reporting, and Other Compliance Requirements

This final rule does not add additional reporting or recordkeeping requirements for the vessels that choose to submit an appeal. An appeal process exists for LLP license endorsement issuance. No small entity is subject to reporting requirements that are in addition to or different from the requirements that apply to all directly regulated entities. No unique professional skills are needed for the LLP license or vessel owners or operators to comply with the reporting and recordkeeping requirements associated with this final rule. This final rule does not implement or increase any fees that NMFS collects from directly regulated entities. The Analysis identifies no operational costs of the endorsement (see ADDRESSES).

Description of Significant Alternatives Considered to the Final Action That Minimize Adverse Impacts on Small Entities

None of the nine regulated small entities identified by NMFS have previously delivered TLAS YFS to a mothership. This rule will not affect existing delivery patterns of those vessels, and possible future impacts to these vessels could not be quantified. However, none of the alternatives considered by the Council that would have avoided regulating these small entities would have accomplished the stated objectives of the rule. Each of those alternatives would have allowed increased catcher vessel participation under certain conditions and thereby failed to mitigate the risk of a race for fish. The Council and NMFS selected the alternative in this rule because it best achieves their stated policy objectives.

Collection-of-Information Requirements

This final rule contains collection-of-information requirements subject to the PRA, which have been approved by OMB under Control Number 0648-0766. The public reporting burden for the collection-of-information requirements in this final rule is estimated to average 2 hours per response for a one-time Election to Assign Qualifying Landings to an LLP license and 4 hours per response to submit an appeal, which includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments on these or any other aspects of the collection of information to NMFS Alaska Region at the ADDRESSES above, and by email to [email protected] or fax to (202) 395-5806.

Notwithstanding any other provision of law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at http://www.cio.noaa.gov/services_programs/prasubs.html.

List of Subjects 15 CFR Part 902

Reporting and recordkeeping requirements.

50 CFR Part 679

Alaska, Fisheries, Reporting and recordkeeping requirements.

Dated: October 1, 2018. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

For the reasons set out in the preamble, NMFS amends 15 CFR part 902 and 50 CFR part 679 as follows:

Title 15—Commerce and Foreign Trade PART 902—NOAA INFORMATION COLLECTION REQUIREMENTS UNDER THE PAPERWORK REDUCTION ACT: OMB CONTROL NUMBERS 1. The authority citation for part 902 continues to read as follows: Authority:

44 U.S.C. 3501 et seq.

2. In §  902.1, in the table in paragraph (b), under the entry “50 CFR”, revise the entry for “679.4” to read as follows:
§  902.1 OMB control numbers assigned pursuant to the Paperwork Reduction Act.

(b) * * *

CFR part or section where the information collection requirement is located Current OMB control number (all numbers begin with 0648-) *    *    *    *    * 50 CFR: *    *    *    *    * 679.4 -0206, -0272, -0334, -0393, -0513, -0545, -0565, -0665, and -0766 *    *    *    *    *
Title 50—Wildlife and Fisheries PART 679—FISHERIES OF THE EXCLUSIVE ECONOMIC ZONE OFF ALASKA 3. The authority citation for part 679 continues to read as follows: Authority:

16 U.S.C. 773 et seq.; 1801 et seq.; 3631 et seq.; Pub. L. 108-447; Pub. L. 111-281.

4. In § 679.4, add paragraph (k)(14) to read as follows:
§ 679.4 Permits.

(k) * * *

(14) Yellowfin sole trawl limited access sector (TLAS) directed fishery endorsement in the BSAI—(i) General. In addition to other requirements of this part, and unless specifically exempted in paragraph (k)(2) of this section, a vessel must be designated on a groundfish LLP license that has a BSAI TLAS yellowfin sole directed fishery endorsement in order to conduct directed fishing for yellowfin sole with trawl gear in the BSAI Trawl Limited Access Sector fishery and deliver the catch to a mothership. A vessel designated on a groundfish LLP license with trawl and catcher/processor vessel designations and a BSAI TLAS yellowfin sole directed fishery endorsement may operate as a catcher vessel and deliver its catch of yellowfin sole harvested in the directed BSAI TLAS fishery to a mothership, or operate as a catcher/processor and catch and process its own catch in this fishery.

(ii) Eligibility requirements for a BSAI TLAS yellowfin sole directed fishery endorsement. (A) A groundfish LLP license is eligible to receive a BSAI TLAS yellowfin sole directed fishery endorsement if the groundfish LLP license:

(1) Had a vessel designated on it, in any year from 2008 through 2015, that made at least one legal trip target landing of yellowfin sole in the BSAI TLAS directed fishery to a mothership in any one year from 2008 through 2015, inclusive, where a trip target is the groundfish species for which the retained amount of that groundfish species is greater than the retained amount of any other groundfish species for that trip;

(2) Has a Bering Sea area endorsement and a trawl gear designation; and

(3) Is credited by NMFS with a legal trip target landing specified in paragraph (k)(14)(ii)(A)(1) of this section.

(B) If a vessel specified in paragraph (k)(14)(ii)(A)(1) of this section was designated on more than one groundfish LLP license from 2008 through 2015 and made at least one legal trip target landing in a BSAI TLAS directed fishery from 2008 through 2015, the vessel owner must specify to NMFS only one of those groundfish LLP licenses to receive credit with the legal trip target landing(s) specified in paragraph (k)(14)(ii)(A)(1) of this section.

(iii) Explanations for BSAI TLAS yellowfin sole directed fishery endorsement. (A) NMFS will determine whether a groundfish LLP license is eligible to receive a BSAI TLAS yellowfin sole directed fishery endorsement under paragraph (k)(14)(ii) of this section based only on information contained in the official record described in paragraph (k)(14)(v) of this section.

(B) NMFS will credit a groundfish LLP license with a legal trip target landing specified in paragraph (k)(14)(ii)(A)(1) of this section if that groundfish LLP license was the only groundfish LLP license on which the vessel was designated from 2008 through 2015. If a vessel that made at least one legal trip target landing specified in paragraph (k)(14)(ii)(A)(1) of this section was designated on more than one groundfish LLP license from 2008 through 2015 and made at least one legal trip target landing in a BSAI TLAS directed fishery from 2008 through 2015, the vessel owner must notify NMFS which one of those groundfish LLP licenses NMFS is to credit with the legal trip target landing(s) specified in paragraph (k)(14)(ii)(A)(1) of this section.

(C) Trip target landings will be determined based on round weight equivalents.

(iv) Exemptions to BSAI TLAS yellowfin sole endorsements. Any vessel exempted from the License Limitation Program at paragraph (k)(2) of this section is exempted from the requirement to have a BSAI TLAS yellowfin sole endorsement to deliver catch of BSAI TLAS yellowfin sole to a mothership for processing.

(v) BSAI TLAS yellowfin sole participation official record. (A) The official record will contain all information used by the Regional Administrator that is necessary to administer the requirements described in paragraph (k)(14) of this section.

(B) The official record is presumed to be correct. A groundfish LLP license holder has the burden to prove otherwise.

(C) Only legal landings as defined in § 679.2 and documented on State of Alaska fish tickets or NMFS weekly production reports will be used to determine legal trip target landings under paragraph (k)(14)(ii)(A)(1) of this section.

(vi) Process for issuing BSAI TLAS yellowfin sole endorsements. (A) NMFS will issue to the holder of each groundfish LLP license endorsed to use trawl gear in the Bering Sea and designated in Column A of Table 52 to this part a notice of eligibility to receive a BSAI TLAS yellowfin sole directed fishery endorsement and a revised groundfish LLP license with a BSAI TLAS yellowfin sole directed fishery endorsement.

(B) NMFS will issue to the holder of each groundfish LLP license endorsed to use trawl gear in the Bering Sea and designated in Column A of Table 53 to this part a notice of eligibility to be credited with a legal trip target landing specified in (k)(14)(ii)(A)(1) of this section.

(1) NMFS will also issue to the owner of the vessel designated on the groundfish LLP licenses in Column A of Table 53 a notice of eligibility for the two listed groundfish LLP licenses to be credited with a legal trip target landing specified in (k)(14)(ii)(A)(1) of this section. The notice to the vessel owner will provide instructions for the vessel owner to select the one groundfish LLP license that NMFS is to credit with the legal trip target landing specified in (k)(14)(ii)(A)(1) of this section.

(2) The holder of a groundfish LLP license in Column A of Table 53 will receive a revised groundfish LLP license with a BSAI TLAS yellowfin sole directed fishery endorsement if:

(i) The owner of the vessel designated on the groundfish LLP license requests in writing that NMFS credit that groundfish LLP license with the legal trip target landing specified in paragraph (k)(14)(ii)(A)(1) of this section;

(ii) The vessel owner, or the authorized agent, signs the request;

(iii) The written request is submitted to NMFS using one of the following methods: Mail at Regional Administrator, c/o Restricted Access Management Program, NMFS, P.O. Box 21668, Juneau, AK 99802-1668; fax at 907-586-7352; or hand delivery or carrier at NMFS, Room 713, 709 West 9th Street, Juneau, AK 99801;

and

(iv) NMFS receives the written request and credits the groundfish LLP license with the legal trip target landing specified in paragraph (k)(14)(ii)(A)(1) of this section.

(3) The holder of a groundfish LLP license in Column A of Table 53 that is not selected by the vessel owner will receive a notice, using the address on record at the time the notification is sent, informing the holder that the groundfish LLP license was not selected by the vessel owner, will not be credited with a legal trip target landing, and will not receive a BSAI TLAS yellowfin sole endorsement. The notice will inform the holder of the groundfish LLP license of the timing and process through which the holder can provide additional information or evidence to amend or challenge the information in the official record of this section as specified in paragraphs (k)(14)(vi)(D) and (E) of this section.

(C) NMFS will issue to the holder of a groundfish LLP license with a Bering Sea trawl designation and that is not listed in either Table 52 or 53 a notice informing that holder that the groundfish LLP license is not eligible to be credited with a legal trip target landing or receive a BSAI TLAS yellowfin sole directed fishery endorsement based on the official record, using the address on record at the time the notification is sent. The notice will inform the holder of the groundfish LLP license of the timing and process through which the holder can provide additional information or evidence to amend or challenge the information in the official record of this section, as specified in paragraphs (k)(14)(vi)(D) and (E) of this section.

(D) The Regional Administrator will specify by letter a 30-day evidentiary period during which an applicant may provide additional information or evidence to amend or challenge the information in the official record. A person will be limited to one 30-day evidentiary period. Additional information or evidence received after the 30-day evidentiary period specified in the letter has expired will not be considered for purposes of the initial administrative determination (IAD).

(E) The Regional Administrator will prepare and send an IAD to the applicant following the expiration of the 30-day evidentiary period, if the Regional Administrator determines that the information or evidence provided by the person fails to support the person's claims and is insufficient to rebut the presumption that the official record is correct, or if the additional information, evidence, or revised application is not provided within the time period specified in the letter that notifies the applicant of his or her 30-day evidentiary period. The IAD will indicate the deficiencies with the information or evidence submitted. The IAD will also indicate which claims cannot be approved based on the available information or evidence. A person who receives an IAD may appeal pursuant to 15 CFR part 906. NMFS will issue a non-transferable interim license that is effective until final agency action on the IAD to an applicant who avails himself or herself of the opportunity to appeal an IAD and who has a credible claim to eligibility for a BSAI TLAS yellowfin sole endorsement.

5. In § 679.7, add paragraph (i)(11) to read as follows;
§ 679.7 Prohibitions.

(i) * * *

(11) Prohibitions specific to the BSAI Trawl Limited Access Sector yellowfin sole directed fishery. Deliver yellowfin sole harvested with trawl gear in the BSAI Trawl Limited Access Sector yellowfin sole directed fishery to a mothership without a legible copy of a valid groundfish LLP license with a BSAI Trawl Limited Access Sector yellowfin sole directed fishery endorsement, except as provided in § 679.4(k)(2).

6. Add Table 52 to part 679 to read as follows: Table 52 to Part 679—Groundfish LLP Licenses Eligible for a BSAI Trawl Limited Access Sector Yellowfin Sole Directed Fishery Endorsement [X indicates that Column A applies] Column A Column B The Holder of Groundfish License Number . . . Is eligible under 50 CFR 679.4(k)(14)(ii) to be assigned an Endorsement for the BSAI Trawl Limited Access Sector Yellowfin Sole Fishery. LLG 3944 X. LLG 2913 X. LLG 1667 X. LLG 3714 X. LLG 1820 X. LLG 3741 X. 7. Add Table 53 to part 679 to read as follows: Table 53 to Part 679—Groundfish LLP Licenses That Require Qualified Landings Assignment To Be Eligible for a BSAI Trawl Limited Access Sector Yellowfin Sole Directed Fishery Endorsement [X indicates that Column A applies] Column A Column B A single vessel was designated on the following pairs of groundfish LLP licenses during the qualifying period identified in 50 CFR 679.4(k)(14)(ii)(A)(1) . . . The owner of the vessel designated on the pair of LLP licenses in Column A must notify NMFS which LLP license from each pair in Column A is to be credited with qualifying landing(s) under 50 CFR 679.4(k)(14)(vi)(B)(2). LLG 3838 and LLG 2702 X. LLG 3902 and LLG 3826 X.
[FR Doc. 2018-21632 Filed 10-3-18; 8:45 am] BILLING CODE 3510-22-P
DEPARTMENT OF STATE 22 CFR Parts 121 and 123 [Public Notice 10349] RIN 1400-AE52 Regulatory Reform Revisions to the International Traffic in Arms Regulations AGENCY:

Department of State.

ACTION:

Interim final rule; request for comments.

SUMMARY:

In response to public comments, the Department of State removes certain notification requirements from the International Traffic in Arms Regulations and revises several entries on the United States Munitions List to remove items that do not warrant continued inclusion. Specifically, this rule adds notes to USML Category IV and V, revises control text in USML Categories VIII, XI and XV, and revises a section of the regulations.

DATES:

Effective date: This rule is effective on October 4, 2018.

Comments due date: Interested parties may submit comments by November 19, 2018.

ADDRESSES:

Interested parties may submit comments by one of the following methods:

Email: [email protected] with the subject line, “Regulatory Reform Revisions”

Internet: At www.regulations.gov, search for this notice using Docket DOS-2018-0020.

FOR FURTHER INFORMATION CONTACT:

Mr. Robert Monjay, Office of Defense Trade Controls Policy, Department of State, telephone (202) 663-2817; email [email protected] ATTN: Regulatory Reform Revisions.

SUPPLEMENTARY INFORMATION: Responses to Regulatory Reform Comments and Other Feedback

On January 30, 2017, the President issued Executive Order 13771, Reducing Regulation and Controlling Regulatory Costs. On February 24, 2017, the President issued Executive Order 13777, Enforcing the Regulatory Reform Agenda.

On July 14, 2017, the Department published a Request for Comments in the Federal Register (82 FR 32493) to get feedback from the public on how it could achieve meaningful burden reduction while continuing to achieve the Department's statutory obligations. The Department sought comments on the Department regulations, guidance documents, and collections of information that members of the public believe should be removed or modified to alleviate unnecessary burdens. The Department also requested economic data to support any proposed changes.

In response to the July 14, 2017 request for comments, the Department received several comments related to the International Traffic in Arms Regulations (ITAR). The Department has concluded its review of two of the comments and has accepted one of the changes suggested. The Department received several additional comments, which we are beginning to review. Any response to these additional comments, none of which are relevant to this rulemaking, will be done via a separate rule. These comments and the Department's responses are set forth below. The Department has also received feedback from the public, the regulated industry, and other government and private sector experts, through a variety of formal and informal channels, that several entries on the United States Munitions List (USML) are controlling items that are, or soon will be, in normal commercial use. The Department has determined that it can revise certain entries in a manner consistent with the objectives set forth in Executive Order 13777 to remove the controls on these items, while maintaining control on those items that warrant continued control on the USML.

One commenter requested that the Department eliminate the requirement to return licenses for tech data, in § 123.22(b)(3)(i) and (c)(2) (all citations are to 22 CFR). Exporters are required to return licenses for the export of technical data to the Department after the initial export of all of the approved technical data. Exporters are also required to return all licenses that are exported against, but not electronically decremented. The Department has reviewed the comments and the use of the returned licenses and has determined that it can garner the necessary information via other means. The Department accepts these changes and will remove the relevant language in § 123.22(b)(3)(i) and (c)(2).

Two commenters requested that the Department eliminate the Initial Export Notification in § 123.22(b)(3)(ii). The Department does not accept these changes. Section 123.22(b)(3)(ii) requires that prior to the initial export of any technical data or defense services under an Agreement, the Agreement holder inform DDTC that exports are beginning. These notifications are for exports of defense articles and defense services that are generally not reported to the U.S. government through the Automated Export System and as such, these notifications are often the only way that the Department knows that the export has occurred.

Two commenters requested that the Department eliminate the notification of termination in § 124.6. The Department does not accept these changes. Section 124.6 requires that an Agreement holder inform DDTC of the impending termination of the agreement not less than 30 days prior to the expiration date of such agreement. The Department uses this notification as part of its compliance assessment practices. However, the Department is undertaking a modernization of its IT systems for export licensing and will review whether an IT solution can be put in place to allow the elimination of this notification requirement.

Two commenters requested that the Department eliminate the annual status letter on agreements in § 124.4(a). The Department does not accept these changes. Section 124.4(a) requires that if the agreement is not concluded within one year of the date of approval, the applicant notify DDTC in writing and provide the status of the agreement, unless and until the agreement is concluded, or a decision is made not to conclude the agreement. The Department uses this notification as part of its compliance assessment practices.

Two commenters requested that the Department eliminate the requirement in § 123.1(c)(4) that purchase documents be submitted with licenses in furtherance of agreements. The Department does not accept these changes. Submitting purchase documentation with a license application is an important tool to ensure only bona fide transactions are approved and to minimize the risk of diversion of approved exports.

One commenter requested that the Department eliminate the requirement that defense articles be U.S. origin to use the temporary import exemption in § 123.4(a)(1). The Department does not accept this change. Non-U.S.-origin defense articles sent to the United States for repair and maintenance do not require approval from the U.S. government for future reexports and retransfers, the way that U.S.-origin defense articles do. Therefore, the Department does not allow non-U.S. origin defense articles to be sent to the United States for servicing without individually approving the end-use and end-user.

One commenter requested that the Department create an exemption for temporary exports of defense articles for repair/replacement by foreign Original Equipment Manufacturer (“OEM”). The Department believes that it may be possible to implement such an exemption in a way that maintains U.S. foreign policy and national security interests. The Department is working on this effort and any change to the ITAR to this effect will be published separately.

One commenter requested that the Department streamline the Canadian Exemption in § 126.5 by integrating the excluded technologies list (ETL), currently in Supplement No. 1 to part 126, into § 126.5. The Department does not accept this change. The ETL applies to the Canadian Exemption, as well as the Defense Trade Cooperation Treaties with Australia and the United Kingdom; therefore, the utility of the ETL would be reduced if it were moved out of Supplement No. 1 to part 126 and the Department were required to recreate it in the sections for the treaties as well.

One commenter requested that the Department implement certain definitions that were proposed in the Department's June 6, 2015 Federal Register proposed rule (80 FR 31525). The Department continues to work on the definitions that were not included in the June 3, 2016 interim final rule (81 FR 35611) or the September 8, 2016 final rule (81 FR 62004). Any change to the ITAR to this effect will be published separately.

One commenter requested that the Department establish a definition of manufacturing. The Department believes that the implementation of a definition for manufacturing is a matter that should be subject to public review and comment. Any change to the ITAR to this effect will be published separately.

One commenter asserted that the definition of U.S. person in the ITAR does not include U.S. citizens. This is incorrect. Section 120.15 defines U.S. persons to include protected individuals as defined by 8 U.S.C. 1324b(a)(3). This provision includes all U.S. citizens within the scope of protected individuals.

One commenter asserted that there is an inconsistency between the definition of defense service in § 120.9 and the definition of export in § 120.17 and requested that the Department revise them. The Department does not accept this change. The definition of defense service defines when a defense service occurs. The definition of export, in part, describes when the performance of a defense service constitutes an export and requires approval from the Department prior to performance.

One commenter noted that there is an inconsistency between the text in USML Category IV(i) and XV(f) related to mission integration and launch failure analysis, as the text in Category IV(i) includes the limiter “to a foreign person,” which the text in Category XV(f) does not. The commenter suggested resolving this inconsistency. The Department accepts this change, and revises USML Category XV(f) to achieve consistency between the provisions. However, the Department notes that this does not change the scope of the controls. The definition of export, as detailed above, provides that an export of a defense service occurs when it is performed for, or on behalf of, a foreign person.

One commenter requested that the Department remove the record-keeping requirement in § 125.6(a) and (b), asserting that they are duplicative of the record keeping requirement in § 123.22(b)(3)(ii). The Department does not accept this change. The requirement in § 123.22(b)(3)(ii) is only to maintain records that exist. The requirement in § 125.6 is to create documents that provide the necessary assurance against diversion and information about the transaction to allow these exports to occur under exemptions, without individual licenses for each export.

One commenter requested that the Department implement an IT system that includes a single input and single output, to reduce compliance burdens. The Department is undertaking to modernize its IT systems for export licensing and will review whether an IT solution can be put in place to allow a single output document that sufficiently protects U.S. foreign policy and national security interests.

The Department received feedback from industry that industry is not certain as to the jurisdiction of certain satellites and spacecraft thrusters. Some manufacturers reclassified satellites and spacecraft thrusters, formerly controlled under USML Category XV, as rocket engines under USML Category IV(d), following the revisions to USML Category XV in 2014 and 2017. Some manufacturers reclassified these same, or similar, thrusters as subject to the Export Administration Regulations (EAR) under ECCN 9A515. Thrusters for satellites and spacecraft may meet certain USML Category IV(d) controls, such as based on total impulse, but such thrusters are not rocket or missile power plants per se. Therefore, the Department is adding Note 2 to USML Category IV(d) to clarify that it does not control such thrusters. For controls on satellite and spacecraft thrusters, exporters should review USML Category XV(e)(12) and ECCN 9A515.

The Department received feedback from industry that, as currently structured, USML Category V maintains control over the items described in the EAR on the Commerce Control List (CCL) in Export Control Classification Number (ECCN) 1C608, if they include a material described in USML Category V. The Department added a new Note 3 to USML Category V to clarify that for materials described in USML Category V, except for the materials described in paragraph (c)(6), (h), or (i), approval from the Department is not required for any export, reexport, or retransfer when the defense articles are incorporated into an item subject to the EAR and classified under ECCN 1C608.

The Department received feedback from industry that commercial drone technologies have progressed to the state where the industry is developing flight control systems for cooperative operations, and there is concern that the control text in USML Category VIII(h)(12), for unmanned aerial vehicle (UAV) flight control systems and vehicle management systems with swarming capability, will capture these commercial drone flight control systems and vehicle management systems. The Department believes that swarming is a military capability that continues to warrant control on the USML. However, the current text describes swarming capabilities as UAVs interacting with each other to avoid collisions and stay together, or, if weaponized, coordinate targeting. The Department believes that this control could be more precise.

Swarming is not simply the ability to avoid collisions, maintain formation, and work cooperatively. Swarming requires the ability to adapt in real-time to changes in operational/threat environment or to deliver munitions on a target. Therefore, the Department updated USML Category VIII(h)(12).

The Department received feedback from industry that commercial drones will make use of airborne radars that are currently described by the control text in USML Category XI(a)(3)(i) and XI(a)(3)(xii). The Department recognizes the importance of commercial drones to the U.S. economy and the importance that those drones have effective detect-and-avoid radar to minimize collisions. Therefore, the Department has added a note to USML Category XI(a)(3)(i), to allow commodity jurisdiction reviews for radars, such as those meeting the criteria of the forthcoming Federal Aviation Administration (FAA) Minimum Operational Performance Standards (MOPS) to support sense and avoid operations of UAVs, and revised the Note to USML Category XI(a)(3)(xii) to increase the power threshold of articles that are not controlled by the paragraph.

The Department received feedback from industry that the control text in USML Category XI(c)(4) will capture electronic components required for 5G wireless technology. The Department does not intend the USML to include civil communications systems. Therefore, the Department revised USML Category XI(c)(4) to implement power thresholds that will exclude those components necessary for 5G wireless technology, but maintain control on those items that do provide the United States a critical military or intelligence advantage.

Comment Submissions

Interested parties may submit comments within 45 days of the date of publication. Comments received after that date may be considered if feasible, but consideration cannot be assured. Those submitting comments should not include any personally identifying information they do not desire to be made public or information for which a claim of confidentiality is asserted because those comments and/or transmittal emails will be made available for public inspection and copying after the close of the comment period via the Directorate of Defense Trade Controls website at www.pmddtc.state.gov. Parties who wish to comment anonymously may do so by submitting their comments via www.regulations.gov, leaving the fields that would identify the commenter blank and including no identifying information in the comment itself.

Regulatory Findings Administrative Procedure Act

This rulemaking is exempt from section 553 (Rulemaking) and section 554 (Adjudications) of the Administrative Procedure Act (APA) pursuant to 5 U.S.C. 553(a)(1) as a military or foreign affairs function of the United States Government. Although the Department is of the opinion that this rule is exempt from the rulemaking provisions of the APA, the Department is publishing this rule as a final rule with 45-day provision for public comment, without prejudice to its determination that controlling the import and export of defense services is a military or foreign affairs function. The Department will review and respond to all relevant comments and make any necessary amendments.

Regulatory Flexibility Act

Since the Department is of the opinion that this rule is exempt from the provisions of 5 U.S.C. 553, there is no requirement for an analysis under the Regulatory Flexibility Act.

Unfunded Mandates Reform Act of 1995

This rulemaking does not involve a mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

The Department does not believe this rulemaking is a major rule under the criteria of 5 U.S.C. 804.

Executive Orders 12372 and 13132

This rulemaking does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this rulemaking.

Executive Orders 12866 and 13563

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, distributed impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule is being treated as a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget (OMB). The Department believes that benefits of the rulemaking, narrowing and clarifying the scope of existing USML controls and removing certain notification requirements, outweigh any costs to implement these changes.

Executive Order 12988

The Department of State has reviewed this rulemaking in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

Executive Order 13175

The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.

Paperwork Reduction Act

This rulemaking does not impose or revise any information collections subject to 44 U.S.C. Chapter 35.

Executive Order 13771

This final rule is being reviewed as an E.O. 13771 deregulatory action. This rule will remove regulatory uncertainty regarding the controls on the commercial aspects of these technologies that could prevent U.S. companies from investing in next generation technologies.

List of Subjects 22 CFR Part 121

Arms and munitions, Classified information, Exports.

22 CFR Part 123

Arms and munitions, Exports, Reporting and recordkeeping.

For reasons stated in the preamble, the State Department amends 22 CFR parts 121 and 123 as follows:

PART 121—THE UNITED STATES MUNITIONS LIST 1. The authority citation for part 121 continues to read as follows: Authority:

Secs. 2, 38, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2651a; Pub. L. 105-261, 112 Stat. 1920; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.

2. Section 121.1 is amended as follows: a. In Category IV, redesignate Note to Paragraph (d) as Note 1 to Paragraph (d) and add Note 2 to paragraph (d); b. In Category V, add Note 3 to USML Category V; c. In Category VIII, revise paragraph (h)(12); d. In Category XI, add Note to Paragraph (a)(3)(i), revise Note to Paragraph (a)(3)(xii), and revise paragraph (c)(4); and e. In Category XV, revise the second and third sentences of paragraph (f).

The additions and revisions read as follows:

§ 121.1 The United States Munitions List. Category IV—Launch Vehicles, Guided Missiles, Ballistic Missiles, Rockets, Torpedoes, Bombs, and Mines

(d) * * *

Note 2 to Paragraph (d):

This paragraph does not control thrusters for spacecraft.

Category V—Explosives and Energetic Materials, Propellants, Incendiary Agents, and Their Constituents Note 3 to USML Category V:

Items controlled in this Category, except for materials described in paragraph (c)(6), (h), or (i), are licensed by the Department of Commerce when incorporated into an item subject to the EAR and classified under ECCN 1C608.

Category VIII—Aircraft and Related Articles

(h) * * *

(12) Unmanned aerial vehicle (UAV) flight control systems and vehicle management systems with swarming capability (i.e. UAVs that operate autonomously (without human input) to interact with each other to avoid collisions, fly in formations, and are capable of adapting in real-time to changes in operational/threat environment, or, if weaponized, coordinate targeting) (MT if for an aircraft, excluding manned aircraft, or missile that has a “range” equal to or greater than 300 km);

Category XI—Military Electronics

(a) * * *

* (3) * * *

(i) * * *

Note to Paragraph (a)(3)(i):

This paragraph does not control radars that: (1) Are incapable of free space detection of 1 square meter Radar Cross Section (RCS) target beyond 8 nautical miles (nmi); (2) contain a radar update rate of not more than 1Hz; and (3) employ a design determined to be subject to the EAR via a commodity jurisdiction determination (see § 120.4 of this subchapter).

(xii) * * *

Note to Paragraph (a)(3)(xii):

This paragraph does not control radars not otherwise controlled in this subchapter, operating with a peak transmit power less than or equal to 550 watts, and employing a design determined to be subject to the EAR via a commodity jurisdiction determination (see § 120.4 of this subchapter).

(c) * * *

(4) Transmit/receive modules, transmit/receive monolithic microwave integrated circuits (MMICs), transmit modules, and transmit MMICs having all of the following:

(i) A peak saturated power output (in watts), Psat, greater than 505.62 divided by the maximum operating frequency (in GHz) squared [Psat > 505.62 W * GHz2/fGHz2] for any channel;

(ii) A fractional bandwidth of 5% or greater for any channel;

(iii) Any planar side with length d (in cm) equal to or less than 15 divided by the lowest operating frequency in GHz [d ≤ 15cm * GHz/fGHz]; and

(iv) At least one electronically variable phase shifter per channel.

Note 1 to Paragraph (c)(4):

A MMIC: (a) Is formed by means of diffusion processes, implantation processes, or deposition processes in or on a single semiconducting piece of material; (b) can be considered as indivisibly associated; (c) performs the function(s) of a circuit; and (d) operates at microwave frequencies (i.e., 300 MHz to 300 GHz).

Note 2 to Paragraph (c)(4):

A transmit/receive module is a multifunction electronic assembly that provides bi-directional amplitude and phase control for transmission and reception of signals.

Note 3 to Paragraph (c)(4):

A transmit module is an electronic assembly that provides amplitude and phase control for transmission of signals.

Note 4 to Paragraph (c)(4):

A transmit/receive MMIC is a multifunction MMIC that provides bi-directional amplitude and phase control for transmission and reception of signals.

Note 5 to Paragraph (c)(4):

A transmit MMIC is a MMIC that provides amplitude and phase control for transmission of signals.

Note 6 to Paragraph (c)(4):

USML Category XI(c)(4) applies to transmit/receive modules and to transmit modules, with or without a heat sink. The value of length d in USML Category XI(c)(4)(iii) does not include any portion of the transmit/receive module or transmit module that functions as a heat sink.

Note 7 to Paragraph (c)(4):

Transmit/receive modules, transmit modules, transmit/receive MMICs, and transmit MMICs may or may not have N integrated radiating antenna elements, where N is the number of transmit or transmit/receive channels.

Note 8 to Paragraph (c)(4):

Fractional bandwidth is the bandwidth over which output power remains constant within 3 dB (without the adjustment of other operating parameters), divided by the center frequency, and multiplied by 100. Fractional bandwidth is expressed as a percentage.

Category XV—Spacecraft and Related Articles

(f) * * * Defense services include the furnishing of assistance (including training) to a foreign person in the integration of a satellite or spacecraft to a launch vehicle, including both planning and onsite support, regardless of the jurisdiction, ownership, or origin of the satellite or spacecraft, or whether technical data is used. It also includes the furnishing of assistance (including training) to a foreign person in the launch failure analysis of a satellite or spacecraft, regardless of the jurisdiction, ownership, or origin of the satellite of spacecraft, or whether technical data is used. * * *

PART 123—LICENSES FOR THE EXPORT AND TEMPORARY IMPORT OF DEFENSE ARTICLES 3. The authority citation for part 123 continues to read as follows: Authority:

Secs. 2, 38, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2753; 22 U.S.C. 2651a; 22 U.S.C. 2776; Pub. L. 105-261, 112 Stat. 1920; Sec. 1205(a), Pub. L. 107-228; Sec. 520, Pub. L. 112-55; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.

4. Section 123.22 is amended by revising paragraphs (b)(3)(i) and (c)(2) to read as follows:
§ 123.22 Filing, retention, and return of export licenses and filing of export information.

(b) * * *

(3) * * *

(i) Technical data license. Prior to the permanent export of technical data licensed using a Form DSP-5, the applicant shall electronically provide export information using the system for direct electronic reporting to DDTC of export information and self-validate the original of the license. Exports of copies of the licensed technical data should be made in accordance with existing exemptions in this subchapter. Should an exemption not apply, the applicant may request a new license.

(c) * * *

(2) Licenses issued by DDTC but not decremented by U.S. Customs and Border Protection through its electronic system(s) (e.g., oral or visual technical data releases) must be maintained by the applicant in accordance with § 122.5 of this subchapter.

Andrea Thompson, Under Secretary for Arms Control and International Security, U.S. Department of State.
[FR Doc. 2018-21422 Filed 10-3-18; 8:45 am] BILLING CODE 4710-25-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0925] Drawbridge Operation Regulation; Trent River, New Bern, NC AGENCY:

Coast Guard, DHS.

ACTION:

Notice of deviation from drawbridge regulation.

SUMMARY:

The Coast Guard has issued a temporary deviation from the operating schedule that governs the U.S. 70 (Alfred C. Cunningham) Bridge across the Trent River, mile 0.0, at New Bern, NC. The deviation is necessary to accommodate the free movement of pedestrians and vehicles during the 2018 Mumfest celebration. This deviation allows the bridge to remain in the closed-to-navigation position.

DATES:

This deviation is effective from 9:30 a.m. on October 13, 2018, to 6:30 p.m. on October 14, 2018.

ADDRESSES:

The docket for this deviation, [USCG-2018-0925], is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this temporary deviation, call or email Mr. Mickey Sanders, Bridge Administration Branch Fifth District, Coast Guard; telephone (757) 398-6587, email [email protected]

SUPPLEMENTARY INFORMATION:

The Event Director, Swiss Bear Inc., with approval from the North Carolina Department of Transportation, who owns and operates the U.S. 70 (Alfred C. Cunningham) Bridge, has requested a temporary deviation from the current operating regulations to accommodate the free movement of pedestrians and vehicles during the 2018 Mumfest. The bridge is a double bascule bridge and has a vertical clearance in the closed position of 14 feet above mean high water.

The current operating schedule is set out in 33 CFR 117.843(a). Under this temporary deviation, the bridge will be maintained in the closed-to-navigation position and open every two hours, on the hour, from 9:30 a.m. to 7:30 p.m. on Saturday, October 13, 2018, and from 9:30 a.m. to 6:30 p.m. on Sunday, October 14, 2018. From 7:30 p.m. on Saturday, October 13, 2018, to 9:30 a.m. on Sunday, October 14, 2018, the drawbridge will open on signal.

The Alfred C. Cunningham Bridge is used by a variety of vessels including recreational vessels, tug and barge traffic, fishing vessels, and small commercial vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic on the waterway in publishing this temporary deviation.

Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

Dated: September 27, 2018. Hal R. Pitts, Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2018-21620 Filed 10-3-18; 8:45 am] BILLING CODE 9110-04-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2018-0233; FRL-9982-44-Region 9] Air Plan Approval; California; San Diego County Air Pollution Control District; Stationary Source Permits and Exemptions AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is taking final action to approve and conditionally approve revisions to the San Diego County Air Pollution Control District (SDAPCD or “District”) portion of the California State Implementation Plan (SIP). These revisions concern the District's New Source Review (NSR) permitting program for new and modified sources of air pollution under section 110(a)(2)(C) and part D of title I of the Clean Air Act (CAA or the Act). This action updates the SDAPCD's applicable SIP with current SDAPCD permitting rules.

DATES:

These rules will be effective on November 5, 2018.

ADDRESSES:

The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2018-0233. 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:

Ya-Ting Tsai, EPA Region IX, (415) 972-3328, [email protected]

SUPPLEMENTARY INFORMATION:

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

Table of Contents I. Proposed Action II. Public Comments and EPA Responses III. EPA Action IV. Incorporation by Reference V. Statutory and Executive Order Reviews I. Proposed Action

On June 25, 2018 (83 FR 29483) the EPA proposed to approve and conditionally approve the following rules into the California SIP.

Rule number Rule title Adopted date Submitted date 11 Exemptions from Rule 10 Permit Requirements 05/11/2016 08/22/2016 20 Standards for Granting Permits 06/10/1986 11/21/1986 20.1 New Source Review—General Provisions 04/27/2016 06/17/2016 20.2* New Source Review—Non-Major Stationary Sources 04/27/2016 06/17/2016 20.3* New Source Review—Major Stationary Sources and PSD Stationary Sources 04/27/2016 06/17/2016 20.4* New Source Review—Portable Emission Units 04/27/2016 06/17/2016 20.6 Standards for Permit to Operate Air Quality Analysis 04/27/2016 06/17/2016 24 Temporary Permit to Operate 06/29/2016 08/22/2016 * The following subsections of the Rules 20.2-20.4 were not submitted to the EPA for inclusion in the San Diego SIP: Rule 20.2 Subsections (d)(2)(i)(B), (d)(2)(v), (d)(2)(vi)(B) and (d)(3); Rule 20.3 Subsections (d)(1)(vi), (d)(2)(i)(B), (d)(2)(v), (d)(2)(vi)(B) and (d)(3); and Rule 20.4 Subsections (b)(2), (b)(3), (d)(1)(iii), (d)(2)(i)(B), (d)(2)(iv), (d)(2)(v)(B), (d)(3) and (d)(5).

We determined that these rules generally comply with most applicable CAA requirements, but that they do not satisfy the requirements at 40 CFR 51.165(a)(6) and (7) and section 173(a)(4) of the Act. First, the submitted rules do not contain recordkeeping and reporting requirements for sources using an actual-to-potential-actual test to determine applicability of major source requirements. Second, the rules do not incorporate the requirement at section 173(a)(4) of the Act, which states that nonattainment NSR permit programs shall provide that permits to construct and operate may not be issued if the EPA Administrator has determined that the applicable implementation plan for the nonattainment area is not being adequately implemented. These deficiencies are the basis for the EPA's final conditional approval of the District's June 17, 2016 submittal. The District and the California Air Resources Board (CARB) have committed to adopt and submit revisions to address the identified deficiencies by July 31, 2019, consistent with the requirements at CAA section 110(k)(4) for conditional approval. Based on our evaluation of the submitted rules, the EPA proposed to fully approve the SDAPCD's August 22, 2016 and November 21, 1986 submittals (consisting of Rules 11, 20, and 24), and to conditionally approve the District's June 17, 2016 submittal (consisting of Rules 20.1, 20.2, 20.3, 20.4, and 20.6).

II. Public Comments and EPA Responses

The EPA's proposed action provided a 30-day public comment period. During this period, we received one comment. This comment raised issues outside the scope of this rulemaking, including renewable energy spending in other countries. This comment is not germane to our evaluation of these SDAPCD NSR Rules.

III. EPA Action

No comments were submitted that change our assessment of the rules as described in our proposed action. Therefore, as authorized in section 110(k)(3) and (k)(4) of the Act, the EPA is approving and conditionally approving these rules into the California SIP as proposed. While we cannot grant full approval of the June 17, 2016 submittal at this time, the SDAPCD and CARB have satisfactorily committed to address deficiencies listed in our proposed action by providing the EPA with a SIP submittal by July 31, 2019, which will include specific rule revisions that would adequately address the deficiencies. If the State submits the rule revisions that it has committed to submit by this deadline and the EPA approves the submission, then these deficiencies will be cured. However, if the State fails to submit these revisions within the required timeframe, the conditional approval will become a disapproval, and the EPA will issue a finding of disapproval. The EPA is not required to propose the finding of disapproval. A finding of disapproval would start an 18-month clock to apply sanctions under CAA section 179(b) and a two-year clock for a Federal implementation plan under CAA section 110(c)(1).

In this action, the EPA is also correcting an error in the existing regulatory text. On June 21, 2017 (82 FR 28240) we approved regulatory materials from CARB's submittal dated August 22, 2016 into 40 CFR 52.220 at paragraph (c)(488). We inadvertently provided an incorrect date of April 21, 2016, for the CARB submittal in the June 21, 2017 regulatory text. As this action addresses additional materials that were submitted on August 22, 2016, we are taking action today to correct this error under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act, which authorizes agencies, upon finding “good cause,” to dispense with public participation where public notice and comment procedures are impracticable, unnecessary, or contrary to the public interest. Public notice and comment for this correction is unnecessary because this action merely corrects an inadvertent error in the regulatory text added by the June 21, 2017 rulemaking, and is consistent with that action as described in the preamble. The EPA can identify no particular reason why the public would be interested in having the opportunity to comment on the correction prior to this action being finalized, since this action does not change the EPA's analysis or overall action as stated in the June 21, 2017 rulemaking. This correction will become effective on the same date as the other changes to the regulatory text, as set out above.

IV. Incorporation by Reference

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the San Diego Air Pollution Control District rules described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through www.regulations.gov and at the EPA Region IX 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, the 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);

• 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 Clean Air Act; and

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the 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 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 December 3, 2018. 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

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

Dated: August 6, 2018. Deborah Jordan, Acting Regional Administrator, Region IX.

Part 52, 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 F—California 2. Section 52.220 is amended by adding paragraphs (c)(6)(i)(E), (c)(51)(vii)(E), (c)(64)(i)(B), (c)(171)(i)(E), and (c)(241)(i)(A)(8), revising paragraph (c)(488) introductory text, and adding paragraphs (c)(488)(i)(A)(3) and (4) and (c)(508) to read as follows:
§ 52.220 Identification of plan—in part.

(c) * * *

(6) * * *

(i) * * *

(E) Previously approved on September 22, 1972 and now deleted with replacement in paragraph (c)(171)(i)(E)(1) of this section, Rule 20.

(51) * * *

(vii) * * *

(E) Previously approved on July 6, 1982 in paragraph (c)(51)(vii)(C) of this section, and now deleted with replacement in paragraph (c)(488)(i)(A)(3) of this section, Rule 11.

(64) * * *

(i) * * *

(B) Previously approved on April 14, 1981 in paragraph (c)(64)(i)(A) of this section, and now deleted with replacement in paragraph (c)(508)(i)(A) of this section, Rules 20.1, 20.2, 20.3, 20.4, and 20.6.

(171) * * *

(i) * * *

(E) San Diego County Air Pollution Control District.

(1) Rule 20, “Standards for Granting Permits,” revision adopted on June 10, 1986.

(241) * * *

(i) * * *

(A) * * *

(8) Previously approved on October 24, 2007 in paragraph (c)(241)(i)(A)(6) of this section, and now deleted with replacement in paragraph (c)(488)(i)(A)(4) of this section, Rule 24, “Temporary Permit to Operate,” adopted on March 20, 1996.

(488) New and amended regulations were submitted on August 22, 2016 by the Governor's designee.

(i) * * *

(A) * * *

(3) Rule 11, “Exemptions from Rule 10 Permit Requirements,” revision adopted on May 11, 2016.

(4) Rule 24, “Temporary Permit to Operate,” revision adopted on June 29, 2016.

(508) New or amended regulations for the following APCD was submitted on June 17, 2016 by the Governor's designee.

(i) Incorporation by reference. (A) San Diego County Air Pollution Control District.

(1) Rule 20.1, “New Source Review—General Provisions,” revision adopted on April 27, 2016.

(2) Rule 20.2, “New Source Review—Non-Major Stationary Sources” (except subsections (d)(2)(i)(B), (d)(2)(v), (d)(2)(vi)(B) and (d)(3)), revision adopted on April 27, 2016.

(3) Rule 20.3, “New Source Review—Major Stationary Sources and PSD Stationary Sources” (except subsections (d)(1)(vi), (d)(2)(i)(B), (d)(2)(v), (d)(2)(vi)(B) and (d)(3)), revision adopted on April 27, 2016.

(4) Rule 20.4, “New Sources Review—Portable Emission Units” (except subsections (b)(2), (b)(3), (d)(1)(iii), (d)(2)(i)(B), (d)(2)(iv), (d)(2)(v)(B), (d)(3) and (d)(5)), revision adopted on April 27, 2016.

(5) Rule 20.6, “Standards for Permit to Operate Air Quality Analysis,” revision adopted on April 27, 2016.

3. Section 52.248 is amended by adding paragraph (e) to read as follows:
§ 52.248 Identification of plan—conditional approval.

(e) The EPA is conditionally approving California State Implementation Plan (SIP) revisions submitted on June 17, 2016, updating New Source Review permitting rules for the San Diego Air Pollution Control District (SDAPCD). The conditional approval is based on a commitment from the State to submit a SIP revision that will correct identified deficiencies in the following rules for the SDAPCD:

(1) Rule 20.1, “New Source Review—General Provisions”;

(2) Rule 20.2, “New Source Review—Non-Major Stationary Sources” (except subsections (d)(2)(i)(B), (d)(2)(v), (d)(2)(vi)(B) and (d)(3));

(3) Rule 20.3, “New Source Review—Major Stationary Sources and PSD Stationary Sources” (except subsections (d)(1)(vi), (d)(2)(i)(B), (d)(2)(v), (d)(2)(vi)(B) and (d)(3));

(4) Rule 20.4, “New Sources Review—Portable Emission Units” (except subsections (b)(2), (b)(3), (d)(1)(iii), (d)(2)(i)(B), (d)(2)(iv), (d)(2)(v)(B), (d)(3) and (d)(5)); and

(5) Rule 20.6, “Standards for Permit to Operate Air Quality Analysis.” If the State fails to meet its commitment by July 31, 2019, the conditional approval is treated as a disapproval.

[FR Doc. 2018-21470 Filed 10-3-18; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [DC105-2053; FRL-9983-57-Region 3] Approval and Promulgation of Air Quality Implementation Plans; District of Columbia; Update to Materials Incorporated by Reference AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule; administrative change.

SUMMARY:

The Environmental Protection Agency (EPA) is updating the materials that are incorporated by reference (IBR) into the District of Columbia State implementation plan (SIP). The regulations affected by this update have been previously submitted by the District of Columbia Department of Energy and Environment (DoEE) and approved by EPA. This update affects the SIP materials that are available for public inspection at the National Archives and Records Administration (NARA) and the EPA Regional Office.

DATES:

This action is effective October 4, 2018.

ADDRESSES:

SIP materials which are incorporated by reference into 40 CFR part 52 are available for inspection at the following locations: Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103; and the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. EPA requests that you email the contact listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT:

Erin Trouba, (215) 814-2023 or by email at [email protected]

SUPPLEMENTARY INFORMATION: I. Background

Each State has a SIP containing the control measures and strategies used to attain and maintain the national ambient air quality standards (NAAQS). The SIP is extensive, containing such elements as air pollution control regulations, emission inventories, monitoring networks, attainment demonstrations, and enforcement mechanisms.

Each State must formally adopt the control measures and strategies in the SIP after the public has had an opportunity to comment on them and then submit the proposed SIP revisions to EPA. Once these control measures and strategies are approved by EPA, and after notice and comment, they are incorporated into the federally-approved SIP and are identified in part 52 “Approval and Promulgation of Implementation Plans,” title 40 of the Code of Federal Regulations (40 CFR part 52). The full text of the State regulation approved by EPA is not reproduced in its entirety in 40 CFR part 52, but is “incorporated by reference.” This means that EPA has approved a given State regulation with a specific effective date. The public is referred to the location of the full text version should they want to know which measures are contained in a given SIP. The information provided allows EPA and the public to monitor the extent to which a State implements a SIP to attain and maintain the NAAQS and to take enforcement action if necessary.

The SIP is a living document which a State revises as necessary to address its unique air pollution problems. Therefore, EPA, from time to time, must take action on SIP revisions containing new and/or revised regulations as being part of the SIP. On May 22, 1997 (62 FR 27968), EPA revised the procedures for incorporating by reference federally-approved SIPs, as a result of consultations between EPA and the Office of the Federal Register (OFR). The description of the revised SIP document, IBR procedures and “Identification of plan” format are discussed in further detail in the May 22, 1997 Federal Register document. On December 7, 1998 (63 FR 67407), EPA published a document in the Federal Register beginning the new IBR procedure for the District of Columbia. On August 6, 2004 (69 FR 47773), September 6, 2005 (70 FR 52919), March 19, 2009 (74 FR 11647), February 22, 2011 (76 FR 9652), and March 21, 2017 (82 FR 14458), EPA published updates to the IBR material for the District of Columbia. Since the publication of the last IBR update, EPA has approved into the SIP the following regulatory changes to the following District of Columbia regulations:

A. Added Regulations

None.

B. Revised Regulations

1. Chapter 1 Section 199 (Definitions and Abbreviations).

2. Chapter 5 Section 502.1 through 502.15 (Sampling, Tests, and Measurements).

3. Chapter 8 Section 801 (Sulfur Content of Fuel Oils).

4. Chapter 8 Section 899 (Definitions and Abbreviations).

C. Removed Regulations

None.

II. EPA Action

In this action, EPA is announcing the update to the IBR material as of May 14, 2018 and revising the text within 40 CFR 52.470(b).

III. Good Cause Exemption

EPA has determined that this rule falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3) which allows an agency to make a rule effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). This rule simply codifies provisions which are already in effect as a matter of law in Federal and approved State programs. Under section 553 of the APA, an agency may find good cause where procedures are “impractical, unnecessary, or contrary to the public interest.” Public comment is “unnecessary” and “contrary to the public interest” since the codification only reflects existing law. Immediate notice in the CFR benefits the public by removing outdated citations and incorrect table entries.

IV. 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 previously EPA approved regulations promulgated by the District of Columbia and federally effective prior to May 14, 2018. 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).

V. Statutory and Executive Order Reviews A. General Requirements

Under the Clean Air Act (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 rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

EPA has also determined that the provisions of section 307(b)(1) of the CAA pertaining to petitions for judicial review are not applicable to this action. Prior EPA rulemaking actions for each individual component of the District of Columbia SIP compilations had previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, EPA sees no need in this action to reopen the 60-day period for filing such petitions for judicial review for this “Identification of plan” update action for the District of Columbia.

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: August 27, 2018. Cecil Rodrigues, Acting Regional Administrator, Region III.

40 CFR part 52 is amended as follows:

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

42 U.S.C. 7401 et seq.

Subpart J—District of Columbia 2. Section 52.470 is amended by revising paragraph (b) to read as follows:
§ 52.470 Identification of plan.

(b) Incorporation by reference. (1) Material listed in paragraphs (c) and (d) of this section with an EPA approval date prior to May 14, 2018, was approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Material is incorporated as it exists on the date of approval, and notice of any change in the material will be published in the Federal Register. Entries in paragraphs (c) and (d) of this section with the EPA approval dates after May 14, 2018 for the District of Columbia, will be incorporated by reference in the next update to the SIP compilation.

(2) EPA Region III certifies that the materials provided by EPA at the addresses in paragraph (b)(3) of this section are an exact duplicate of the officially promulgated State rules/regulations which have been approved as part of the State implementation plan as of the dates referenced in paragraph (b)(1) of this section. No additional revisions were made to paragraph (d) of this section between July 1, 2016 and May 14, 2018.

(3) Copies of the materials incorporated by reference into the State implementation plan may be inspected at the Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. To obtain the material, please call the Regional Office at (215) 814-3376. You may also inspect the material with an EPA approval date prior to July 1, 2016 for the District of Columbia at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

[FR Doc. 2018-21471 Filed 10-3-18; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [DE105-1105; FRL-9983-49-Region 3] Approval and Promulgation of Air Quality Implementation Plans; Delaware; Update to Materials Incorporated by Reference AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule; administrative change.

SUMMARY:

The Environmental Protection Agency (EPA) is updating the materials that are incorporated by reference (IBR) into the Delaware State implementation plan (SIP). The regulations affected by this update have been previously submitted by the Delaware Department of Natural Resources and Environmental Control (DNREC) and approved by EPA. This update affects the SIP materials that are available for public inspection at the National Archives and Records Administration (NARA) and the EPA Regional Office.

DATES:

This action is effective October 4, 2018.

ADDRESSES:

SIP materials which are incorporated by reference into 40 CFR part 52 are available for inspection at the following locations: Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103; and the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. EPA requests that you email the contact listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT:

Erin Trouba, (215) 814-2023 or by email at [email protected]

SUPPLEMENTARY INFORMATION:

I. Background

Each State has a SIP containing the control measures and strategies used to attain and maintain the national ambient air quality standards (NAAQS). The SIP is extensive, containing such elements as air pollution control regulations, emission inventories, monitoring networks, attainment demonstrations, and enforcement mechanisms.

Each State must formally adopt the control measures and strategies in the SIP after the public has had an opportunity to comment on them and then submit the proposed SIP revisions to EPA. Once these control measures and strategies are approved by EPA, and after notice and comment, they are incorporated into the federally-approved SIP and are identified in part 52 “Approval and Promulgation of Implementation Plans,” title 40 of the Code of Federal Regulations (40 CFR part 52). The full text of the State regulation approved by EPA is not reproduced in its entirety in 40 CFR part 52, but is “incorporated by reference.” This means that EPA has approved a given State regulation with a specific effective date. The public is referred to the location of the full text version should they want to know which measures are contained in a given SIP. The information provided allows EPA and the public to monitor the extent to which a State implements a SIP to attain and maintain the NAAQS and to take enforcement action if necessary.

The SIP is a living document which a State revises as necessary to address its unique air pollution problems. Therefore, EPA, from time to time, must take action on SIP revisions containing new and/or revised regulations as being part of the SIP. On May 22, 1997 (62 FR 27968), EPA revised the procedures for incorporating by reference federally-approved SIPs, as a result of consultations between EPA and the Office of the Federal Register (OFR). The description of the revised SIP document, IBR procedures and “Identification of plan” format are discussed in further detail in the May 22, 1997 Federal Register document. On December 7, 1998 (63 FR 67407), EPA published a document in the Federal Register beginning the new IBR procedure for Delaware. On June 21, 2004 (69 FR 34285), April 3, 2007 (72 FR 15839), April 17, 2009 (74 FR 17771), May 2, 2011 (76 FR 24372), September 24, 2013 (78 FR 58465), and May 30, 2017 (82 FR 24529) EPA published updates to the IBR material for Delaware.

Since the publication of the last IBR update, EPA has not made any regulatory changes to paragraph (c) of the Delaware SIP. However, in paragraph (c), EPA is correcting the title in section 1112 to read, Control of Nitrogen Oxides Emissions. In paragraph (d) of the Delaware SIP, source specific requirements, EPA incorporated a Secretary's Order for Delaware City Refining and removed Secretary's orders for SPI Polyols, Inc. and General Chemical Corporation.

A. Added Regulations

In paragraph (d) of the Delaware SIP, source specific requirements, EPA incorporated a Secretary's Order for Delaware City Refining.

B. Revised Regulations

None.

C. Removed Regulations

In paragraph (d) of the Delaware SIP, source specific requirements, EPA removed Secretary's orders for SPI Polyols, Inc. and General Chemical Corporation.

II. EPA Action

In this action, EPA is announcing the update to the IBR material as of May 25, 2018 and revising the text within 40 CFR 52.420(b), (c), and (d).

III. Good Cause Exemption

EPA has determined that this rule falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3) which allows an agency to make a rule effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). This rule simply codifies provisions which are already in effect as a matter of law in Federal and approved State programs. Under section 553 of the APA, an agency may find good cause where procedures are “impractical, unnecessary, or contrary to the public interest.” Public comment is “unnecessary” and “contrary to the public interest” since the codification only reflects existing law. Immediate notice in the CFR benefits the public by removing outdated citations and incorrect table entries.

IV. 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 previously EPA approved regulations promulgated by the State of Delaware and federally effective prior to May 25, 2018. 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).

V. Statutory and Executive Order Reviews A. General Requirements

Under the Clean Air Act (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 rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

EPA has also determined that the provisions of section 307(b)(1) of the CAA pertaining to petitions for judicial review are not applicable to this action. Prior EPA rulemaking actions for each individual component of the Delaware SIP compilations had previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, EPA sees no need in this action to reopen the 60-day period for filing such petitions for judicial review for this “Identification of plan” update action for Delaware.

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: August 21, 2018. Cecil Rodrigues, Acting Regional Administrator, Region III.

40 CFR part 52 is amended as follows:

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

42 U.S.C. 7401 et seq.

Subpart I: Delaware 2. Section 52.420 is amended by: a. Revising paragraph (b). b. In paragraph (c), revising the table heading for section 1112.

The revisions read as follows:

§ 52.420 Identification of plan.

(b) Incorporation by reference. (1) Material listed in paragraphs (c) and (d) of this section with an EPA approval date prior to May 25, 2018, was approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Entries in paragraphs (c) and (d) of this section with the EPA approval dates after May 25, 2018 for the State of Delaware have been approved by EPA for inclusion in the State implementation plan and for incorporation by reference into the plan as it is contained in this section, and will be considered by the Director of the Federal Register for approval in the next update to the SIP compilation.

(2) EPA Region III certifies that the materials provided by EPA at the addresses in paragraph (b)(3) of this section are an exact duplicate of the officially promulgated State rules/regulations which have been approved as part of the State implementation plan as of the dates referenced in paragraph (b)(1) of this section.

(3) Copies of the materials incorporated by reference into the State implementation plan may be inspected at the Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. To obtain the material, please call the Regional Office at (215) 814-3376. You may also inspect the material with an EPA approval date prior to May 25, 2018 for the State of Delaware at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) * * *

EPA-Approved Regulations and Statutes in the Delaware SIP State citation
  • (7 DNREC 1100)
  • Title/subject State effective date EPA approval date Additional
  • explanation/
  • citation
  • *         *         *         *         *         *         * 1112 Control of Nitrogen Oxides Emissions *         *         *         *         *         *         *
    [FR Doc. 2018-21472 Filed 10-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2017-0546; FRL-9984-53-Region 4] Air Plan Approval; MS; Section 128 Board Requirements for Infrastructure SIPs AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action to approve a State Implementation Plan (SIP) submission, submitted by the State of Mississippi, through the Mississippi Department of Environmental Quality (MDEQ), on June 26, 2018. This SIP submission addresses specific Clean Air Act (CAA or Act) requirements applicable to Mississippi state boards or bodies that approve CAA permits or enforcement orders. This submission also specifically addresses related requirements for implementation of the following national ambient air quality standards (NAAQS): 2008 8-hour Ozone, 2008 Lead, 2010 Nitrogen Dioxide (NO2), 2010 Sulfur Dioxide (SO2), and 1997, 2006 and 2012 fine particulate matter (PM2.5). Whenever EPA promulgates a new or revised NAAQS, the CAA requires the state to make a new SIP submission establishing that the existing SIP meets the various applicable requirements, or revising the SIP to meet those requirements. This type of SIP submission is commonly referred to as an “infrastructure” SIP. In this final action, EPA is approving the June 26, 2018, submission with respect to the CAA requirements applicable to state boards; and the related state board infrastructure SIP requirements for the 2008 8-hour Ozone, 2008 Lead, 2010 NO2, 2010 SO2 and 1997, 2006 and 2012 PM2.5, NAAQS. This action removes EPA's obligation to promulgate a Federal Implementation Plan (FIP) to address these CAA state board requirements for Mississippi.

    DATES:

    This rule will be effective November 5, 2018.

    ADDRESSES:

    EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2017-0546. 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:

    Nacosta C. Ward, 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. The telephone number is (404) 562-9140. Ms. Ward can be reached via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    States must submit infrastructure SIP submissions meeting the applicable requirements of sections 110(a)(1) and (2) of the CAA within three years after EPA's promulgation of a new or revised NAAQS. Sections 110(a)(1) and (2) require states to address basic SIP requirements, including emissions inventories, monitoring, and modeling to assure attainment and maintenance of the new or revised NAAQS. More specifically, section 110(a)(1) provides the procedural and timing requirements for infrastructure SIP submissions. Section 110(a)(2) lists specific requirements that states must meet for “infrastructure” SIP purposes, as applicable, related to the newly established or revised NAAQS. In particular, section 110(a)(2)(E)(ii) requires states to include provisions in their SIP to address the state board requirements of section 128. Section 128 of the CAA requires that states include provisions in their SIP that require that any state board or body which approves permits or enforcement orders shall have a majority of members who represent the public interest and do not receive a significant portion of their income from parties subject to such permits or enforcement orders (section 128(a)(1)); and require that the members of any such board or body, or the head of an executive agency with similar power to approve permits or enforcement orders under the CAA, shall adequately disclose potential conflicts of interest (section 128(a)(2)).

    In a notice of proposed rulemaking (NPRM) published on March 30, 2018 (83 FR 13712), EPA proposed to approve Mississippi's June 23, 2017, and February 2, 2018, parallel processing submissions related to the state board requirements as meeting the significant portion of income requirements of section 128(a)(1), and also as meeting the infrastructure requirements of section 110(a)(2)(E)(ii) for the 1997, 2006, and 2012 PM2.5, 2008 8-hour Ozone, 2008 Lead, 2010 NO2, and 2010 SO2 NAAQS. In the NPRM, EPA also proposed approval of the new supplemental provisions regarding representation of the public interest of section 128(a)(1) for the MDEQ Permit Board and Mississippi Commission on Environmental Quality, and disclosure of potential conflicts of interest of section 128(a)(2) for the Mississippi Commission on Environmental Quality. The details of Mississippi's submissions and the rationale for EPA's actions related to how Mississippi addressed the requirements of section 128 and the related infrastructure section 110(a)(2)(E)(ii) requirements for the aforementioned NAAQS are explained in the NPRM.

    EPA is finalizing its proposed approval of Mississippi's June 26, 2018 1 submission to incorporate into its SIP certain regulatory provisions to address the significant portion of income requirement of section 128(a)(1). As a result of the addition of these new SIP provisions to meet the requirements of section 128(a)(1), EPA is also finalizing approval of this submission as satisfying the section 110(a)(2)(E)(ii) infrastructure requirement for the 1997, 2006, and 2012 PM2.5, 2008 8-hour Ozone, 2008 Lead, 2010 NO2, and 2010 SO2 NAAQS. This final action fully addresses the SIP deficiencies related to section 110(a)(2)(E)(ii) and section 128 from EPA's prior disapprovals of infrastructure SIP submissions for the 2008 8-hour Ozone NAAQS on March 2, 2015 (80 FR 11133), 2008 lead NAAQS on March 30, 2015 (80 FR 16566), 2010 NO2 NAAQS on August 16, 2016 (81 FR 63705), 2010 SO2 NAAQS on September 30, 2016 (81 FR 67171), and 2012 PM2.5 NAAQS on December 12, 2016 (81 FR 89391). Thus, this final action also satisfies EPA's FIP obligation with regard to that infrastructure SIP requirement for these NAAQS based on the prior disapprovals.

    1 The three components of Mississippi's June 26, 2018 submission became state effective on July 1, 2016, May 11, 2018, and June 25, 2018.

    II. Response to Comments

    EPA received comments from a total of nine commenters, but only one commenter submitted comments relevant to this action.

    Comment 1: With regard to the parallel proceedings process used in the proposed rulemaking, the Commenter states that: “[b]ecause EPA is required to allow the public to submit meaningful comments, we cannot comment on any changes the State may make after we submit these comments. Therefore, if the State makes any changes after EPA's public comment period is up, EPA could not approve the submittal with those changes without a new public comment period.”

    Response to Comment 1: EPA notes that the final SIP revision adopted and submitted to EPA by Mississippi is identical to the draft regulations EPA described in the proposal. As a result, the potential scenario described by the Commenter does not exist in the instant action, as the Commenter and others had the opportunity to comment on the exact regulatory language that was adopted by Mississippi in its final submission and is approved in this final rulemaking action. Nevertheless, EPA takes this opportunity to confirm its longstanding interpretation of parallel processing requirements as allowing EPA to finalize a proposal without further public comment where there are no significant changes in the state's final submission, i.e., when the state's final submission is substantively similar to the draft state regulations on which the NPRM was based. To the extent the Commenter suggests otherwise, EPA disagrees. EPA's established procedures for parallel processing are codified at 40 CFR part 51, appendix V, 2.3 and serve to expedite review of SIP submissions. Under parallel processing, a state will submit a draft SIP revision to EPA prior to final adoption of that revision by the state. If EPA believes the draft SIP submission is approvable, it publishes a notice of proposed rulemaking prior to finalization at the state level and the public is able to comment on EPA's proposed approval of the state's draft SIP submission. After finalization at the state level and receipt of the final submission from the state, EPA reviews this final submittal and can finalize its prior proposed approval of the submission if it is substantively similar to the draft. If there are significant changes in the state's final submission such that it is not substantively similar to the prior draft, then EPA will issue a subsequent proposal to solicit comment on those changes or other issues that were not included in the initial proposed action. By this process, commenters are provided an opportunity to comment on all pertinent issues related to the SIP submission, as mandated under Federal law establishing procedural requirements for agency rulemakings. EPA notes that this approach was reflected in the proposed rulemaking for this action wherein we stated that if the State's SIP submission as finally adopted and submitted to EPA is changed in aspects other than those identified in the proposed rulemaking, then “EPA will evaluate those changes, and if necessary and appropriate, issue another notice of proposed rulemaking.” See 83 FR 13713.

    Comment 2: The Commenter notes that the submission does not include evidence of adoption of the SIP revision and states that EPA cannot approve the SIP submittal without this evidence.

    EPA Response to Comment 2: Because SIP submissions that a state submits for parallel processing are by definition not yet final at the state level, 40 CFR part 51, appendix V, 2.3 provides exceptions from the SIP completeness criteria specified in 40 CFR part 51, appendix V, 2.0. Appendix V, 2.3.1(b) does not require a state to provide evidence of adoption of the plan in final form at the state level in a SIP submission submitted for parallel processing. The state, however, is required to submit a SIP submission meeting these completeness requirements before EPA can make a final determination of approvability. See 40 CFR part 51, appendix V, 2.3.2. For this action, Mississippi's final submission includes the required evidence of adoption of the SIP revisions in Attachment 3 of the Technical Support Document.

    Comment 3: The Commenter states that EPA should include the dates of the version of the State's code and regulations it is incorporating by reference so that future readers can determine exactly what language is incorporated by reference. More specifically the Commenter states that: “EPA should specify that it is incorporating by reference the July 1, 2016 version of paragraph 6 of Section 49-2-5 and the effective date, which we cannot determine by the documents in the current docket, of the Mississippi Administrative Code.”

    EPA Response to Comment 3: EPA agrees that incorporations by reference should specify the appropriate state law effective date as a means of identifying the precise version of the statutory or regulatory requirements at issue in a SIP submission. In this instance, July 1, 2016, is the state law effective date for Mississippi Code section 49-2-5(6). This final action specifies the provisions that are being incorporated into the Code of Federal Regulation (CFR) at 40 CFR 52.1270 and identifies them by their state law effective dates. EPA notes that SIP submissions that states submit for parallel processing are not required to identify the state effective date (see 40 CFR part 51, appendix V, 2.3.1(b)). In fact the state law effective date of draft SIP submissions that a state submits for parallel processing would typically not be known at the time of submission, because submissions for parallel processing will often (if not always) predate adoption at the state level. But again, EPA cannot make a final determination of plan approvability until the state adopts the final version of the state law at issue in the SIP submission and submits evidence of adoption with the state law effective date in its final submission.

    Comment 4: The Commenter also notes a typographical error in EPA's proposed action in the second column of 83 FR13715. Specifically, the Commenter notes that the proposal states: “and a process for replacing members as needed to ensure that a majority does derive a significant portion of income from regulated entities,” but should state: “and a process for replacing members as needed to ensure that a majority does not derive a significant portion of income from regulated entities. (Emphasis added)”

    EPA Response to Comment 4: EPA acknowledges that the omission of the word “not” from the preamble to EPA's proposed action was a scrivener's error and that the Commenter is correct that the word “not” should be inserted into this statement, consistent with EPA's discussion of the SIP revision in the proposal and the actual provisions EPA is incorporating in this action.

    III. 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 Mississippi Code section 49-2-5, state effective date July 1, 2016, which includes certain section 128 requirements for the MDEQ Commission on Environmental Quality. EPA is also finalizing the incorporation by reference of “Air Emissions Regulations for the Prevention, Abatement, and Control of Air Contaminants” Title 11, Part 2, Chapter 1, Rule 1.1, state effective date June 25, 2018; and “Regulations Regarding Administrative Procedures Pursuant to the Mississippi Administrative Procedures Act”, Title 11, Part 1 Chapter 5, Rule 5.1, state effective date May 11, 2018, which both include certain section 128 requirements for the MDEQ Permit Board. 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 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 in the next update to the SIP compilation.2

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

    IV. Final Action

    As described above, EPA is taking action to approve SIP revisions needed to assure that Mississippi's SIP meets the significant portion of income requirements of 128(a)(1) of the CAA. Approval of Mississippi's June 26, 2018 submission also meets the section 110(a)(2)(E)(ii) requirements for the 2008 8-hour Ozone, 2008 Lead, 2010 NO2, 2010 SO2, and 1997, 2006 and 2012 PM2.5, NAAQS for section 110(a)(2)(E)(ii). With this approval, the deficiencies that EPA identified in the previous partial disapprovals of Mississippi's infrastructure SIP submissions related to the significant portion of income requirements respecting state boards for the 2008 8-hour Ozone, 2008 Lead, 2010 NO2, 2010 SO2, and 1997, 2006 and 2012 PM2.5, NAAQS are resolved. This action therefore removes EPA's obligation to promulgate a FIP to address these CAA state board requirements for Mississippi. Finally, EPA is also approving the new supplemental provisions regarding representation of the public interest of section 128(a)(1) for the MDEQ Permit Board and Mississippi Commission on Environmental Quality, and disclosure of potential conflicts of interest of section 128(a)(2) for the Mississippi Commission on Environmental Quality.

    V. 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 December 3, 2018. 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, Intergovernmental relations, Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: September 10, 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 Z—Mississippi 2. Section 52.1270 is amended by: a. In paragraph (c) table: i. Adding under the heading “Mississippi Code” the entry “Section 49-2-5” in numerical order; ii. Adding at the end of the table the undesignated heading “11 MAC—Part 2—Chapter 1 Air Emission Regulations for the Prevention, Abatement, and Control of Air Contaminants” and the entry “Rule 1.1”; and iii. Adding at the end of the table the undesignated heading “11 MAC—Part 1—Chapter 5 Mississippi Environmental Quality Permit Board: Regulations Regarding Administrative Procedures Pursuant to the Mississippi Administrative Procedures Act,” and the entry “Rule 5.1”; and b. In paragraph (e) table by adding entries “110(a)(1) and (2) Infrastructure Requirements for the 1997 Annual PM2.5 NAAQS”, “110(a)(1) and (2) Infrastructure Requirements for the 2006 24-hour PM2.5 NAAQS”, “110(a)(1) and (2) Infrastructure Requirements for the 2012 24-hour PM2.5 NAAQS”, “110(a)(1) and (2) Infrastructure Requirements for the 2008 Lead NAAQS”, “110(a)(1) and (2) Infrastructure Requirements for the 2008 8-hour Ozone NAAQS”, “110(a)(1) and (2) Infrastructure Requirements for the 2010 NO2 NAAQS”, and “110(a)(1) and (2) Infrastructure Requirements for the 2010 SO2 NAAQS” at the end of the table.

    The additions read as follows:

    § 52.1270 Identification of plan.

    (c) * * *

    EPA-Approved Mississippi Regulations State citation Title/subject State effective date EPA approval date Explanation *         *         *         *         *         *         * Mississippi Code *         *         *         *         *         *         * Section 49-2-5 Commission on Environmental Quality 7/1/2016 10/4/2018, [Insert Federal Register citation]. *         *         *         *         *         *         * 11 MAC—Part 2—Chapter 1 Air Emission Regulations for the Prevention, Abatement, and Control of Air Contaminants Rule 1.1 General 6/25/2018 10/4/2018, [Insert Federal Register citation]. 11 MAC—Part 1—Chapter 5 Mississippi Environmental Quality Permit Board: Regulations Regarding Administrative Procedures Pursuant to the Mississippi Administrative Procedures Act Rule 5.1 Description of Mississippi Environmental Quality Permit Board 5/11/2018 10/4/2018, [Insert Federal Register citation]

    (e) * * *

    EPA Approved Mississippi Non-Regulatory Provisions Name of
  • non-regulatory
  • SIP provision
  • Applicable geographic or nonattainment area State submittal date/effective date EPA approval date Explanation
    *         *         *         *         *         *         * 110(a)(1) and (2) Infrastructure Requirements for the 1997 Annual PM2.5 NAAQS Mississippi 6/25/2018 10/4/2018, [Insert Federal Register citation] Addressing the state board requirements of sections 128 and 110(a)(2)(E)(ii) only. 110(a)(1) and (2) Infrastructure Requirements for the 2006 24-hour PM2.5 NAAQS Mississippi 6/25/2018 10/4/2018, [Insert Federal Register citation] Addressing the state board requirements of sections 128 and 110(a)(2)(E)(ii) only. 110(a)(1) and (2) Infrastructure Requirements for the 2012 24-hour PM2.5 NAAQS Mississippi 6/25/2018 10/4/2018, [Insert Federal Register citation] Addressing the state board requirements of sections 128 and 110(a)(2)(E)(ii) only. 110(a)(1) and (2) Infrastructure Requirements for the 2008 Lead NAAQS Mississippi 6/25/2018 10/4/2018, [Insert Federal Register citation] Addressing the state board requirements of sections 128 and 110(a)(2)(E)(ii) only. 110(a)(1) and (2) Infrastructure Requirements for the 2008 8-hour Ozone NAAQS Mississippi 6/25/2018 10/4/2018, [Insert Federal Register citation] Addressing the state board requirements of sections 128 and 110(a)(2)(E)(ii) only. 110(a)(1) and (2) Infrastructure Requirements for the 2010 NO2 NAAQS Mississippi 6/25/2018 10/4/2018, [Insert Federal Register citation] Addressing the state board requirements of sections 128 and 110(a)(2)(E)(ii) only. 110(a)(1) and (2) Infrastructure Requirements for the 2010 SO2 NAAQS Mississippi 6/25/2018 10/4/2018, [Insert Federal Register citation] Addressing the state board requirements of sections 128 and 110(a)(2)(E)(ii) only.
    3. Section 52.1272 is revised to read as follows:
    § 52.1272 Approval status.

    With the exceptions set forth in this subpart, the Administrator approves Mississippi's plan for the attainment and maintenance of the national standards under section 110 of the Clean Air Act. Furthermore, the Administrator finds that the plan satisfies all requirements of part D, title 1, of the Clean Air Act as amended in 1977.

    [FR Doc. 2018-21193 Filed 10-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R6-OAR-2018-0386; FRL-9983-93-Region 6] Air Plan Approval; Texas; Control of Air Pollution from Motor Vehicles with Mobile Source Incentive Programs 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 revisions to the Texas State Implementation Plan (SIP) submitted by the State of Texas that pertain to regulations to control air pollution from motor vehicles with mobile source incentive programs.

    DATES:

    This rule is effective on January 2, 2019 without further notice, unless the EPA receives relevant adverse comment by November 5, 2018. 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-R6-OAR-2018-0386, at http://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 Mr. Randy Pitre, (214) 665-7299, [email protected] For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    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:

    Mr. Randy Pitre, (214) 665-7299, [email protected] To inspect the hard copy materials, please schedule an appointment with Mr. Randy Pitre or Mr. Bill Deese at (214) 665-7253.

    SUPPLEMENTARY INFORMATION:

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

    I. Background A. CAA and SIPs

    Section 110 of the CAA requires states to develop and submit to the EPA a SIP to ensure that state air quality meets National Ambient Air Quality Standards. 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.

    B. Texas' Submittal

    Texas submitted a revision to its SIP to update and improve the mobile source incentive program regulations for diesel vehicles, clean fleets and drayage trucks.1 Specifically, on May 25, 2018, the State of Texas through the Texas Commission on Environmental Quality (TCEQ) submitted revisions to its Mobile Source Incentive Programs that are found in Title 30 of the Texas Administrative Code (30 TAC), Chapter 114 (Control of Air Pollution from Motor Vehicles), Subchapter K (Mobile Source Incentive Programs). The May 25, 2018, submittal revised regulations for the (1) Diesel Emissions Reduction Incentive Program for On-Road and Non-Road Vehicles (Division 3), (2) Texas Clean Fleet Program (Division 5), and (3) Drayage Truck Incentive Program (Division 8, renamed as “Seaport and Rail Yard Areas Emissions Reduction Program”).

    1 The revisions to the Texas SIP submitted to EPA as part of this action were in response to the adoption of Senate Bill 1731 enacted by the 85th Texas Legislature, 2017, Regular Session, which amended the statutory provisions pertaining to programs that are part of the Texas Emissions Reduction Plan (TERP). The mobile incentive programs implemented by the SIP revision are part of the TERP. For more information on TERP, please see: www.tceq.texas.gov/airquality/terp.

    C. What Criteria must be met for the EPA to Approve this SIP revision?

    In general, economic and mobile source incentive programs are programs that provide economic incentives for reducing air pollution emissions from on-road heavy-duty motor vehicles and non-road equipment emission sources. Because the SIP submittal revision pertains to economic incentive programs to reduce air pollution emissions from mobile sources, we evaluated them using (1) CAA section 182(g) (Economic Incentive Program) (2) our policy guidance on economic incentive programs found in 40 CFR part 51, subpart U (Economic Incentive Programs) and (3) our guidance document “Improving Air Quality with Economic Incentive Programs” (EPA-452/R-01-001, January 2001, www.epa.gov/sites/production/files/2015-07/documents/eipfin.pdf). An economic incentive program achieves an air quality objective by providing market-based incentives or information to emission sources. Three fundamental principles apply to all approvable economic incentive programs: Integrity, equity, and environmental benefit.

    Pursuant to 40 CFR part 51.493 (State Program Requirements), Economic Incentive Programs (EIPs) shall be (1) State and federally enforceable, (2) nondiscriminatory, and (3) consistent with the timely attainment of national ambient air quality standards, all applicable reasonable further progress and visibility requirements, applicable prevention of significant deterioration increments, and all other requirements of the CAA. Programs in nonattainment areas for which credit is taken in attainment and RFP demonstrations shall be designed to ensure that the effects of the program are quantifiable and permanent over the entire duration of the program, and that the credit taken is limited to that which is surplus. Statutory programs shall be designed to result in quantifiable, significant reductions in actual emissions.2 As discussed below, we find the State's SIP revision submittal is consistent with above-referenced elements and our review and evaluation of the revisions are discussed in detail in our Technical Support Document (TSD).

    2 As explained in more detail in the technical support document (and below), we have previously approved the Texas mobile source economic incentive program regulations, as we found that the regulations met the CAA and 40 CFR 51 Subpart U (Economic Incentive Programs) requirements. We have provided references to those prior approvals upon which these revisions are based.

    II. The EPA's Evaluation

    We have prepared a TSD for this rulemaking which details our evaluation of the SIP revisions. Our TSD may be accessed online at http://www.regulations.gov, Docket No. EPA-R06-OAR-2018-0386. As detailed more below, and in our TSD, we believe the SIP revisions to the Texas mobile source incentive programs meet the federal EIP requirements and are approvable. The Texas Mobile Source Economic Incentive Programs are consistent with the CAA as they will reduce air pollution and emissions of nitrogen oxides (NOX), which is a precursor to ozone and particulate matter. The emission reductions from replacing vehicles or replacing, repowering or retrofitting engines can be quantified, and provide an environmental benefit by reducing air pollution emissions by encouraging the use of newer diesel technologies in the Texas nonattainment areas. If Texas includes emission reductions from these programs in future attainment or reasonable further progress SIPs, EPA will evaluate the amount of reductions it achieves at that time. We are approving the Texas SIP submittal as part of the Texas SIP.

    As stated earlier, we have previously approved the Texas mobile source incentive program regulations as meeting CAA and 40 CFR 51.493 regulatory requirements (See 82 FR 26756, June 9, 2017; 79 FR 5287, January 31, 2014; 75 FR 18061, April 9, 2010; 70 FR 18308, April 11, 2005). The May 25, 2018 SIP revision continues to meet these federal requirements.

    A summary of our evaluation is discussed below:

    A. Diesel Emission Reduction Incentive Program for On-Road and Non-Road Vehicles

    The Diesel Emission Reduction Incentive Program for On-Road and Non-Road Vehicles provides funding for businesses to reduce emissions from diesel engines. The program includes a component that applies to small businesses. The revisions to this program revise 30 TAC Sections 114.620, 114.622 and 114.623. The revisions amended the 30 TAC 114.622(h) Incentive Program Requirements from the Executive Director “shall” to “may” waive certain program eligibility criteria “on a finding of good cause.” 3 The revisions amended the definition of a “Small Business” to a business that (1) owns or operates not more than five vehicles (previously 2), (2) owns or operates an on-road diesel vehicle (previously one with a pre-1994 engine model) or a non-road diesel (previously one with uncontrolled emissions) and (3) has owned the on-road or non-road diesel subject to the funding for more than two years (previously one year). This revision would expand the small business component of the program and make it more efficient by focusing on older diesel engines. An itemized list of the revisions, with our evaluation of each, is provided in the TSD.

    3 The original 30 TAC 114.622(h) provision was approved in a previous regulatory action (79 FR 67068) on November 12, 2014. We find the change from “shall” to “may” continues to be approvable. In determining good cause and deciding whether to grant a waiver, the executive director shall ensure that the emissions reductions that will be attributed to the project will still be valid and, where applicable, meet the conditions for assignment for credit to the state implementation plan. See our TSD for a detailed history and rationale for approval of this provision.

    B. Texas Clean Fleet Program

    The Texas Clean Fleet Program provides funding to businesses with a fleet of 75 or more vehicles to replace diesel vehicles with a lower emitting hybrid or alternative fuel vehicle. The revisions to this program revise 30 TAC Sections 114.650-114.653. The number of vehicles qualifying for replacement was revised to 10 or more (previously 20 or more). This revision would allow for more replacements to be eligible for the program. The revisions include a change in definition from “clean transportation triangle” to “clean transportation zone” that would include additional counties that were not a part of the previous “clean transportation triangle.” The revisions include a change to 30 TAC 114.653(e) from the executive director “shall” to “may” waive certain specified eligibility criteria upon “a finding of good cause.” 4 An itemized list of the revisions, with our evaluation of each, is provided in the TSD.

    4 EPA previously approved the original 30 TAC 114.653(e) provision at 79 FR 5287 on January 31, 2014. This provision change from “shall” to “may” continues to be approvable. Similar to 114.622(h), we interpret that the executive director shall ensure that the projected emissions reductions will be valid and, where applicable, meet the conditions for assignment for credit to the state implementation plan. See our TSD for a detailed history and rationale for approval of this provision.

    C. Seaport and Rail Yard Areas Emissions Reduction Program

    The Seaport and Rail Yard Areas Emissions Reduction Program (formerly the Drayage Truck Incentive Program) provides funding to encourage owners to reduce emissions from drayage trucks at seaports and rail yards. Drayage refers to the transport of goods over a short distance. The revisions to this program revise 30 TAC Sections 114.680-114.682. In addition to changing the name of the program, the revisions changed the requirements for replacing or repowering drayage trucks. As revised, the replacement engine must: (1) Be powered by an electric motor or contain an engine certified to current federal emissions standards and (2) emit at least 25% less NOX. In addition, unless otherwise determined by the commission, the NOX emissions rate of engines replaced or purchased under this program will be based on the emissions standard or family emissions limit to which the engine is certified or, for replacement of an uncontrolled engine, a baseline emissions rate established by the commission.5 The previous requirements were that: (1) The replacement drayage truck have an engine of model year 2010 or later and (2) the drayage truck being replaced must have an engine of model year 2006 or earlier. This revision would set a minimum in the amount of NOX reduced (at least 25% less). An itemized list of the revisions, with our evaluation of each, is provided in the TSD.

    5 Similar to 30 TAC 114.622(h) and 30 TAC 114. 653(e), we interpret this provision so that the executive director shall ensure that the projected emissions reductions will be valid and, where applicable, meet the conditions for assignment for credit to the state implementation plan. See our TSD for a detailed history and rationale for approval of this provision.

    D. CAA 110(l) Demonstration

    Section 110 (l) of the CAA requires that each revision to an implementation plan submitted by a State under the CAA shall be adopted by such State after reasonable notice and public hearing. The Administrator shall not approve a revision of a SIP if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in Section 7501 of the CAA) or any other applicable requirements of the CAA. As the regulation revisions discussed above pertain to voluntary incentive programs for reducing emissions, they will not interfere with any applicable requirement concerning attainment and reasonable further progress or any other applicable requirement of the CAA. EPA approval of the revisions is consistent with CAA 110(l).

    III. Final Action

    We are approving revisions to the Texas SIP that pertain to regulations to control air pollution from motor vehicles with mobile source incentive programs. Specifically, we are approving revisions to 30 TAC Sections 114.620, 114.622, 114.623, 114.650-114.653, and 114.680-114.682.

    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 January 2, 2019 without further notice unless we receive relevant adverse comment by November 5, 2018. 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. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the revisions to the Texas regulations as described in the Final Action section above. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 6 Office (please contact Randy Pitre, (214) 665-7299, [email protected] 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.

    V. 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 December 3, 2018. 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, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: September 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, in paragraph (c), the table titled “EPA Approved Regulations in the Texas SIP” is amended by revising the entries for sections 114.620, 114.622, 114.623, 114.650-114.653 and 114.680-114.682; and for Division 8 of Subchapter K in Chapter 114 to read as follows.
    § 52.2270 Identification of plan.

    (c) * * *

    EPA Approved Regulations in the Texas SIP State citation Title/subject State approval/
  • Submittal date
  • EPA approval date Explanation
    *         *         *         *         *         *         * Section 114.620 Definitions 4/4/2018 10/4/2018; [Insert Federal Register citation] *         *         *         *         *         *         * Section 114.622 Incentive Program Requirements 4/4/2018 10/4/2018; [Insert Federal Register citation] Section 114.623 Small Business Incentives 4/4/2018 10/4/2018; [Insert Federal Register citation] *         *         *         *         *         *         * Section 114.650 Definitions 4/4/2018 10/4/2018; [Insert Federal Register citation] Section 114.651 Applicability 4/4/2018 10/4/2018; [Insert Federal Register citation] Section 114.652 Qualifying Vehicles 4/4/2018 10/4/2018; [Insert Federal Register citation] Section 114.653 Grant Eligibility 4/4/2018 10/4/2018; [Insert Federal Register citation] *         *         *         *         *         *         * Division 8: Seaport and Rail Yard Areas Emissions Reduction Program Section 114.680 Definitions 4/4/2018 10/4/2018; [Insert Federal Register citation] Section 114.681 Applicability 4/4/2018 10/4/2018; [Insert Federal Register citation] Section 114.682 Eligible Vehicle Models 4/4/2018 10/4/2018; [Insert Federal Register citation] *         *         *         *         *         *         *
    [FR Doc. 2018-21453 Filed 10-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2017-0395; FRL-9984-89-Region 4] Air Plan Approval; TN; Revisions to Ambient Air Quality Standards AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action to approve a portion of a revision to the Chattanooga/Hamilton County portion of the Tennessee State Implementation Plan (SIP) submitted by the State of Tennessee through the Tennessee Department of Environment and Conservation (TDEC) on behalf of Chattanooga/Hamilton County Air Pollution Control Bureau (Chattanooga/Hamilton County) on June 25, 2008. The changes to the SIP that EPA is taking final action to approve include changes to Chattanooga/Hamilton County's air quality standards for carbon monoxide, lead, nitrogen dioxide, particulate matter, ozone, and sulfur dioxide to reflect the current National Ambient Air Quality Standards (NAAQS). The portions of the SIP revision that EPA is approving are consistent with the requirements of the Clean Air Act (CAA or Act).

    DATES:

    This rule will be effective November 5, 2018.

    ADDRESSES:

    EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2017-0395. 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 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, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. Ms. Bell can be reached by phone at (404) 562-9088 or via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Sections 108 and 109 of the CAA govern the establishment, review, and revision, as appropriate, of the NAAQS to protect public health and welfare. The CAA requires periodic review of the air quality criteria—the science upon which the standards are based—and the standards themselves. EPA's regulatory provisions that govern the NAAQS are found at 40 CFR part 50—National Primary and Secondary Ambient Air Quality Standards.

    In a proposed rulemaking published on May 21, 2018 (83 FR 23407), EPA proposed to approve into the Tennessee SIP a portion of a revision to Chattanooga/Hamilton County's air quality rules in Chapter 4 of Part II, Section 4-41, submitted by TDEC on behalf of the Chattanooga/Hamilton County Air Pollution Control Bureau on June 25, 2008. Specifically, EPA proposed to approve a new version of Chapter 4 of Part II, Section 4-41, Rule 21 of the Chattanooga City Code “Ambient Air Quality Standards,” 1 which was updated to be consistent with the Federal NAAQS in effect at the time of the SIP submittal in 2008. The details of Tennessee's submission and the rationale for EPA's action are explained in the proposed rulemaking. Comments on the proposed rulemaking were due on or before June 20, 2018. EPA did not receive any adverse comments on the proposed action. EPA is now taking final action to approve the above-referenced revision.

    1 EPA will consider the other changes included in Tennessee's June 25, 2008, SIP revision in a future rulemaking.

    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 Chattanooga/Hamilton Regulation Chapter 4 of Part II, Section 4-41, Rule 21, “Ambient Air Quality Standards,” State effective on June 11, 2008. 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 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.2

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

    III. Final Action

    EPA is taking final action to approve a change to the Chattanooga/Hamilton County portion of the Tennessee SIP for Chapter 4 of Part II, Section 4-41, Rule 21. EPA has evaluated the relevant portion of Tennessee's June 25, 2008, 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 December 3, 2018. 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, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: September 19, 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 RR—Tennessee 2. In § 52.2220(c), Table 4 is amended under the heading “Article II. Section 4-41 Rules, Regulations, Criteria, Standards” by revising the entry for “Section 4-41 Rule 21” to read as follows:
    § 52.2220 Identification of plan.

    (c) * * *

    Table 4—EPA Approved Chattanooga Regulations State section Title/subject Adoption date EPA approval date Explanation *         *         *         *         *         *         * Article II. Section 4-41 Rules, Regulations, Criteria, Standards *         *         *         *         *         *         * Section 4-41 Rule 21 Ambient Air Quality Standards 6/11/2008 10/4/2018, [Insert citation of publication] *         *         *         *         *         *         *
    [FR Doc. 2018-21473 Filed 10-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 81 [EPA-R07-OAR-2018-0532; FRL-9984-64-Region 7] Air Plan Approval; State of Iowa; Attainment Redesignation for 2008 Lead NAAQS and Associated Maintenance Plan AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action to approve the State of Iowa's request to redesignate portions of Pottawattamie County, Council Bluffs, Iowa to attainment for the 2008 lead (Pb) National Ambient Air Quality Standards (NAAQS). EPA's approval of the redesignation request is based on the determination that the Council Bluffs area has met the criteria for redesignation to attainment set forth in the Clean Air Act (CAA), including the determination that the area has attained the standard. Additionally, EPA is granting final approval of the State's plan for maintaining the 2008 Pb NAAQS in the Council Bluffs area for ten years beyond redesignation.

    DATES:

    This final rule is effective on November 5, 2018.

    ADDRESSES:

    EPA has established a docket for this action under Docket ID No. EPA-R07-OAR-2018-0532. 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 through https://www.regulations.gov or please contact the person identified in the FOR FURTHER INFORMATION CONTACT section for additional information.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Stephanie Doolan, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, KS 66219 at (913) 551-7719 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document “we,” “us,” and “our” refer to EPA. This section provides additional information by addressing the following:

    I. What is being addressed in this document? II. Have the requirements for approval of a SIP submission been met? III. EPA's Response To Comments IV. What action is EPA taking? V. Statutory and Executive Order Reviews I. What action is being addressed in this document?

    EPA is granting final approval of Iowa's request to redesignate the Council Bluffs area to attainment for the 2008 Pb NAAQS. On September 18, 2017, the State submitted a request for redesignation that demonstrates NAAQS attainment and an associated maintenance plan to ensure that the area continues to attain the standard. The basis for EPA's final approval is that the area met the requirements of the Clean Air Act (CAA) for approval as discussed below.

    II. Have the requirements for approval of a SIP submission been met?

    On October 15, 2008, EPA promulgated a revision to the Pb NAAQS, lowering the standard from 1.5 micrograms per cubic meter (µg/m3) to 0.15 µg/m3 (73 FR 66963). The State conducted ambient air monitoring for Pb in the Council Bluffs area near Pb emitting facilities. The 2010 through 2012 design value for Pb at the monitor was 0.26 µg/m3, violating the 2008 Pb NAAQS.

    Effective December 31, 2011, EPA designated a portion of Pottawattamie County, Council Bluffs, Iowa, as nonattainment for the 2008 Pb NAAQS (76 FR 72097). EPA approved the State's SIP revision for the plan to bring the area into attainment of the Pb NAAQS in a Federal Register action dated February 26, 2016 (81 FR 9770). The area attained the 2008 Pb NAAQS by the statutory deadline of December 31, 2016. The 2014 through 2016 design value for the area is 0.10 µg/m3.

    EPA's proposed approval document dated August 16, 2018, (83 FR 40728) presents a detailed analysis of the CAA requirements for redesignating a nonattainment area to attainment. Specifically, section 107(d)(3)(E) of the CAA allows for redesignation provided the following criteria are met: (1) The Administrator determines that the area has attained the applicable NAAQS; (2) the Administrator has fully approved the applicable implementation plan for the area under section 110(k); (3) the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable SIP and applicable Federal air pollutant control regulations and other permanent and enforceable reductions; (4) the Administrator has fully approved a maintenance plan for the area as meeting the requirements of section 175A; and (5) the State containing such area has met all requirements applicable to the area under section 110 and part D of title I of the CAA. EPA believes the area has met these criteria and that the State's maintenance plan will ensure that the area continues to attain the standard.

    III. EPA's Response to Comments

    The public was provided an opportunity to comment on the proposed document from August 16, 2018, through September 17, 2018. During this period, EPA received one comment which is available in the docket but outside of the scope of the proposed rule. Therefore, EPA will not provide a specific response to the comment.

    IV. What action is EPA taking?

    EPA is granting final approval of Iowa's request to redesignate the Council Bluffs area to attainment for the 2008 Pb NAAQS. Based on the detailed analysis presented in its proposed approval document dated August 16, 2018, (83 FR 40728), EPA believes that the State's September 18, 2017, request for redesignation demonstrates NAAQS attainment and the associated maintenance plan will ensure that the area continues to attain the standard. Thus, EPA is approving the redesignation request for the area and associated maintenance plan.

    EPA has determined that these actions are effective immediately upon publication under the authority of 5 U.S.C. 553(d). The purpose of the 30-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Section 553(d)(1) allows an effective date less than 30 days after publication if a substantive rule “relieves a restriction.” These actions qualify for the exception under section 553(d)(1) because they relieve the State of various requirements for the Area. Furthermore, section 553(d)(3) allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” EPA finds good cause to make these actions effective immediately pursuant to section 553(d)(3) because they do not create any new regulatory requirements such that affected parties would need time to prepare before the actions take effect.

    V. 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, 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 the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; 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 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 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.

    40 CFR Part 81

    Environmental protection, Air pollution control.

    Dated: September 26, 2018. James B. Gulliford, Regional Administrator, Region 7.

    For the reasons stated in the preamble, EPA amends 40 CFR parts 52 and 81 as set forth below:

    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 Q-Iowa 2. In § 52.820, the table in paragraph (e) is amended by adding the entry “(50) Lead Redesignation SIP and Maintenance Plan” in numerical order to read as follows:
    § 52.820 Identification of plan.

    (e) * * *

    EPA-Approved Iowa Nonregulatory Provisions Name of
  • nonregulatory
  • SIP provision
  • Applicable
  • geographic or
  • nonattainment
  • area
  • State submittal date EPA Approval date Explanation
    *         *         *         *         *         *         * (50) Lead Redesignation SIP and Maintenance Plan Portions of Pottawattamie County 9/18/2017 10/4/2018, [Insert Federal Register citation] [EPA-R07-OAR-2018-0532; FRL-9984-64-Region 7].
    PART 81—DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES 3. The authority citation for part 81 continues to read as follows: Authority:

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

    4. In § 81.316, the table entitled “Iowa-2008 Lead NAAQS” is amended by revising the entry “Pottawattamie County, IA:” to read as follows:
    § 81.316 Iowa. Iowa-2008 Lead NAAQS Designated area Designation for the 2008 NAAQS a Date 1 Type Pottawattamie County, IA: Pottawattamie County (part) 10/4/2018 Attainment. Area bounded by Avenue G on the north, N 16th/S 16th street on the east, 23rd Avenue on the south, and N 35th/S 35th street on the west *         *         *         *         *         *         * a Includes Indian Country located in each county or area, except as otherwise specified. 1 December 31, 2011 unless otherwise noted.
    [FR Doc. 2018-21433 Filed 10-3-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 82 [EPA-HQ-OAR-2003-0118; FRL-9984-77-OAR] RIN 2060-AG12 Protection of Stratospheric Ozone: Determination 34 for Significant New Alternatives Policy Program AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Determination of acceptability.

    SUMMARY:

    This determination of acceptability expands the list of acceptable substitutes pursuant to the U.S. Environmental Protection Agency's (EPA) Significant New Alternatives Policy (SNAP) program. This action lists as acceptable additional substitutes for use in the refrigeration and air conditioning, foam blowing, fire suppression, cleaning solvents, and aerosols sectors.

    DATES:

    This determination is applicable on October 4, 2018.

    ADDRESSES:

    EPA established a docket for this action under Docket ID No. EPA-HQ-OAR-2003-0118 (continuation of Air Docket A-91-42). All electronic documents in the docket are listed in the index at www.regulations.gov. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Publicly available docket materials are available either electronically at www.regulations.gov or in hard copy at the EPA Air Docket (Nos. A-91-42 and EPA-HQ-OAR-2003-0118), EPA Docket Center (EPA/DC), William J. Clinton West, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20460. 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 Air Docket is (202) 566-1742.

    FOR FURTHER INFORMATION CONTACT:

    Gerald Wozniak by telephone at (202) 343-9624, by email at [email protected], or by mail at U.S. Environmental Protection Agency, Mail Code 6205T, 1200 Pennsylvania Avenue NW, Washington, DC 20460. Overnight or courier deliveries should be sent to the office location at 1201 Constitution Avenue NW, Washington, DC 20004.

    For more information on the Agency's process for administering the SNAP program or criteria for the evaluation of substitutes, refer to the initial SNAP rulemaking published in the Federal Register on March 18, 1994 (59 FR 13044). Notices and rulemakings under the SNAP program, as well as other EPA publications on protection of stratospheric ozone, are available at EPA's Ozone Layer Protection website at www.epa.gov/ozone-layer-protection including the SNAP portion at www.epa.gov/snap/.

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Listing of New Acceptable Substitutes A. Refrigeration and Air Conditioning B. Foam Blowing C. Fire Suppression and Explosion Protection D. Cleaning Solvents E. Aerosols Appendix A: Summary of Decisions for New Acceptable Substitutes I. Listing of New Acceptable Substitutes 1

    1 On April 27, 2018 (83 FR 18431) EPA provided information on the Agency's plan to address the decision of the Court of Appeals for the District of Columbia Circuit in the case of Mexichem Fluor, Inc. v. EPA. That decision vacated the 2015 Rule (80 FR 42870) “to the extent it requires manufacturers to replace HFCs with a substitute substance” and remanded the rule to EPA for further proceedings. EPA plans to issue a proposed rule to address the court's vacatur and remand in early 2019.

    This action is limited to listing as acceptable additional substitutes for use in the refrigeration and air conditioning, foam blowing, fire suppression, cleaning solvents, and aerosols sectors. This action presents EPA's most recent decision to list as acceptable several substitutes throughout different SNAP end-uses. New substitutes are:

    • R-448A in ice skating rinks (retrofit equipment only);

    • R-449A in ice skating rinks (retrofit equipment only);

    • R-449B in ice skating rinks (retrofit equipment only);

    • R-450A in ice skating rinks (new and retrofit equipment);

    • R-513A in ice skating rinks (new and retrofit equipment);

    • Acetone/isopentane blend in rigid polyurethane and polyisocyanurate laminated boardstock;

    • Powdered Aerosol E in total flooding fire suppression (normally occupied areas); and

    • HFO-1336mzz(Z) in electronics cleaning, metals cleaning, and precision cleaning and aerosol solvents.

    EPA's review of certain substitutes listed in this document is pending for other end-uses. Listing in the end-uses and applications in this document does not prejudge EPA's listing decision for these substitutes for other end-uses. For many of the substitutes being added through this document to the acceptable lists for specific end-uses, there are other listed substitutes for the end-use whose overall risk is comparable except that they have a lower risk in one SNAP criterion, for example toxicity or global warming potential (GWP). However, for the end-uses addressed in this action, those alternatives have not yet proven feasible in those specific end-uses.

    For additional information on SNAP, visit the SNAP portion of EPA's Ozone Layer Protection website at: www.epa.gov/snap. Copies of the full lists of acceptable substitutes for ozone depleting substances (ODS) in all industrial sectors are available at www.epa.gov/snap/substitutes-sector. For more information on the Agency's process for administering the SNAP program or criteria for evaluation of substitutes, refer to the initial SNAP rulemaking published March 18, 1994 (59 FR 13044), codified at 40 CFR part 82, subpart G. SNAP decisions and the appropriate Federal Register citations are found at: www.epa.gov/snap/snap-regulations. Substitutes listed as unacceptable; acceptable, subject to narrowed use limits; or acceptable, subject to use conditions are also listed in the appendices to 40 CFR part 82, subpart G.

    The sections below discuss each substitute listing in detail. Appendix A contains tables summarizing this action's listing decisions. The statements in the “Further Information” column in the tables provide additional information but these are not legally binding under section 612 of the Clean Air Act (CAA). In addition, the “Further Information” column may not include a comprehensive list of other legal obligations you may need to meet when using the substitute. Although you are not required to follow recommendations in the “Further Information” column of the table to use a substitute consistent with section 612 of the CAA, some of these statements may refer to obligations that are enforceable or binding under federal or state programs other than the SNAP program. In many instances, the information simply refers to standard operating practices in existing industry standards and/or building codes. When using these substitutes, EPA strongly encourages you to apply the information in this column. Many of these recommendations, if adopted, would not require significant changes to existing operating practices.

    You can find submissions to EPA for the substitutes listed in this document, as well as other materials supporting the decisions in this action, in Docket EPA-HQ-OAR-2003-0118 at www.regulations.gov.

    A. Refrigeration and Air Conditioning 1. R-448A

    EPA's decision: EPA finds R-448A acceptable as a substitute for use in:

    • Ice Skating Rinks (Retrofit Equipment Only)

    R-448A, marketed under the trade name Solstice® N-40, is a weighted blend of 26 percent hydrofluorocarbon (HFC)-32, which is also known as difluoromethane (Chemical Abstracts Service Registry Number [CAS Reg. No.] 75-10-5); 26 percent HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); 21 percent HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); 20 percent hydrofluoroolefin (HFO)-1234yf, which is also known as 2,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No 754-12-1); and seven percent HFO-1234ze(E), which is also known as trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 29118-24-9).

    You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at www.regulations.gov under the name, “Supporting Documentation for Notice 30 Listing of R-448A (N-40) in Certain Refrigeration and Air Conditioning End-Uses Submission Received May 29, 2014.” EPA performed assessments to examine the health and environmental risks of this substitute. These assessments are available in Docket EPA-HQ-OAR-2003-0118 under the following name:

    • “Risk Screen on Substitutes in Ice Skating Rinks Substitute: R-448A (Solstice® N-40)”

    EPA previously listed R-448A as an acceptable refrigerant in a number of other refrigeration and air conditioning end-uses (e.g., July 16, 2015, 80 FR 42053; October 11, 2016, 81 FR 70029; July 21, 2017, 82 FR 33809).

    Environmental information: R-448A has an ozone depletion potential (ODP) of zero. Its components, HFC-32, HFC-125, HFC-134a, HFO-1234yf, and HFO-1234ze(E) have GWPs of 675; 3,500; 1,430; one to four; 2 3 and one to six; 4 respectively. If these values are weighted by mass percentage, then R-448A has a GWP of about 1,390. The components of R-448A are excluded from the definition of volatile organic compounds (VOC) under CAA regulations (see 40 CFR 51.100(s)) addressing the development of state implementation plans (SIPs) to attain and maintain the National Ambient Air Quality Standards (NAAQS). Knowingly venting or releasing this refrigerant blend is limited by the venting prohibition under section 608(c)(2) of the CAA, codified at 40 CFR 82.154(a)(1).

    2 Hodnebrog Ø., Etminan, M., Fuglestvedt, J.S., Marston, G., Myhre, G., Nielsen, C.J., Shine, K.P., Wallington, T.J.: Global Warming Potentials and Radiative Efficiencies of Halocarbons and Related Compounds: A Comprehensive Review, Reviews of Geophysics, 51, 300-378, doi:10.1002/rog.20013, 2013.

    3 Nielsen, O.J., Javadi, M.S., Sulbaek Andersen, M.P., Hurley, M.D., Wallington, T.J., Singh, R. Atmospheric chemistry of CF3CF=CH2: Kinetics and mechanisms of gas-phase reactions with Cl atoms, OH radicals, and O3. Chemical Physics Letters 439, 18-22, 2007.

    4 Hodnebrog et al., 2013 and Atmospheric chemistry of trans-CF3CH=CHF: products and mechanisms of hydroxyl radical and chlorine atom initiated oxidation”, M.S. Javadi, R. Søndergaard, O.J. Nielsen, M.D., Hurley, and T.J. Wellington, Atmospheric Chemistry and Physics Discussions 8, 1069-1088, 2008.

    Flammability information: R-448A, as formulated and even considering the worst-case fractionation for flammability, is not flammable.

    Toxicity and exposure data: Potential health effects of exposure to this substitute include drowsiness or dizziness. The substitute may also irritate the skin or eyes or cause frostbite. At sufficiently high concentrations, the substitute may cause irregular heartbeat. The substitute could cause asphyxiation if air is displaced by vapors in a confined space. These potential health effects are common to many refrigerants.

    The American Industrial Hygiene Association (AIHA) has established workplace environmental exposure limits (WEELs) of 1,000 ppm as an eight-hour time-weighted (TWA) for HFC-32, HFC-125, and HFC-134a; 500 ppm for HFO-1234yf; and 800 ppm for HFO-1234ze(E), the components of R-448A. The manufacturer of R-448A recommends an acceptable exposure limit (AEL) of 890 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet the AIHA WEELs and manufacturer's AEL and address potential health risks by following requirements and recommendations in the manufacturer's safety data sheet (SDS), in the American Society for Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) Standard 15, and other safety precautions common to the refrigeration and air conditioning industry.

    Comparison to other substitutes in this end-use: R-448A has an ODP of zero, comparable to or lower than other listed substitutes in this end-use, with ODPs ranging from zero to 0.098.

    R-448A's GWP of 1,390 is lower than or comparable to that of acceptable substitutes for ice skating rinks (retrofit), such as HFC-134a, R-407C, and R-507A, with GWPs ranging from 1,430 to 3,990. R-448A's GWP is higher than the GWPs of other acceptable substitutes for ice skating rinks (retrofit), including R-401A and R-401B with GWPs ranging from 1,182 to 1,288.

    Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-use. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15 and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.

    EPA finds R-448A acceptable in the end-use listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.

    2. R-449A

    EPA's decision: EPA finds R-449A acceptable as a substitute for use in:

    • Ice Skating Rinks (Retrofit Equipment Only)

    R-449A, marketed under the trade name Opteon® XP 40, is a weighted blend of 24.3 percent HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); 24.7 percent HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); 25.7 percent HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); and 25.3 percent HFO-1234yf, which is also known as 2,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 754-12-1).

    You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at www.regulations.gov under the name, “Supporting Documentation for Notice 30 Listing of R-449A (XP40) in Certain Refrigeration and Air Conditioning End-Uses. SNAP Submission Received August 6, 2014.” EPA performed assessments to examine the health and environmental risks of this substitute. These assessments are available in Docket EPA-HQ-OAR-2003-0118 under the following name:

    • “Risk Screen on Substitutes in Ice Skating Rinks Substitute: R-449A (Opteon® XP40)”

    EPA previously listed R-449A as an acceptable refrigerant in a number of other refrigeration and air conditioning end-uses (e.g., July 16, 2015, 80 FR 42053; October 11, 2016, 81 FR 70029; July 21, 2017, 82 FR 33809).

    Environmental information: R-449A has an ODP of zero. Its components, HFC-32, HFC-125, HFC-134a, and HFO-1234yf, have GWPs of 675; 3,500; 1,430; and one to four,5 respectively. If these values are weighted by mass percentage, then R-449A has a GWP of about 1,400. The components of R-449A are excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS. Knowingly venting or releasing this refrigerant blend is limited by the venting prohibition under section 608(c)(2) of the CAA, codified at 40 CFR 82.154(a)(1).

    5 Hodnebrog et al., 2013 and Nielsen et al., 2007. Op. cit.

    Flammability information: R-449A, as formulated and even considering the worst-case fractionation for flammability, is not flammable.

    Toxicity and exposure data: Potential health effects of exposure to this substitute include drowsiness or dizziness. The substitute may also irritate the skin or eyes or cause frostbite. At sufficiently high concentrations, the substitute may cause irregular heartbeat. The substitute could cause asphyxiation if air is displaced by vapors in a confined space. These potential health effects are common to many refrigerants.

    The AIHA has established WEELs of 1,000 ppm as an 8-hr TWA for HFC-32, HFC-125, and HFC-134a and 500 ppm for HFO-1234yf, the components of R-449A. The manufacturer of R-449A recommends an AEL of 830 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet each of the AIHA WEELs and the manufacturer's AEL and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.

    Comparison to other substitutes in this end-use: R-449A has an ODP of zero, comparable to or lower than the other listed substitutes in this end-use, with ODPs ranging from zero to 0.098.

    R-449A's GWP of 1,400 is lower than or comparable to that of acceptable substitutes for ice skating rinks (retrofit), such as HFC-134a, R-407C, and R-507A with GWPs ranging from 1,430 to 3,990. R-449A's GWP is higher than the GWPs of other acceptable substitutes for ice skating rinks (retrofit), including R-401A and R-401B with GWPs ranging from 1,182 to 1,288.

    Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-uses. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15 and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.

    EPA finds R-449A acceptable in the end-use listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.

    3. R-449B

    EPA's decision: EPA finds R-449B acceptable as a substitute for use in:

    • Ice Skating Rinks (Retrofit Equipment Only)

    R-449B, marketed under the trade name Forane® 449B, is a weighted blend of 25.2 percent HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); 24.3 percent HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); 27.3 percent HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); and 23.2 percent HFO-1234yf, which is also known as 2,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 754-12-1).

    You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at www.regulations.gov under the name, “Supporting Documentation for Notice 32 Listing of R-449B in Refrigeration and Air Conditioning. SNAP Submission Received October 2, 2015.” EPA performed assessments to examine the health and environmental risks of this substitute. These assessments are available in Docket EPA-HQ-OAR-2003-0118 under the following name:

    • “Risk Screen on Substitutes in Ice Skating Rinks Substitute: R-449B (Forane® 449B)”

    EPA previously listed R-449B as an acceptable refrigerant in a number of other refrigeration and air conditioning end-uses (e.g., October 11, 2016, 81 FR 70029; July 21, 2017, 82 FR 33809).

    Environmental information: R-449B has an ODP of zero. Its components, HFC-32, HFC-125, HFC-134a, and HFO-1234yf, have GWPs of 675; 3,500; 1,430; and one to four,6 respectively. If these values are weighted by mass percentage, then R-449B has a GWP of about 1,410. The components of R-449B are excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS. Knowingly venting or releasing this refrigerant blend is limited by the venting prohibition under section 608(c)(2) of the CAA, codified at 40 CFR 82.154(a)(1).

    6 Hodnebrog et al., 2013 and Nielsen et al., 2007. Op. cit.

    Flammability information: R-449B, as formulated and even considering the worst-case fractionation for flammability, is not flammable.

    Toxicity and exposure data: Potential health effects of exposure to this substitute include drowsiness or dizziness. The substitute may also irritate the skin or eyes or cause frostbite. At sufficiently high concentrations, the substitute may cause irregular heartbeat. The substitute could cause asphyxiation if air is displaced by vapors in a confined space. These potential health effects are common to many refrigerants.

    The AIHA has established WEELs of 1,000 ppm as an 8-hr TWA for HFC-32, HFC-125, and HFC-134a and 500 ppm for HFO-1234yf, the components of R-449B. The manufacturer of R-449B recommends an AEL of 865 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet each of the AIHA WEELs and the manufacturer's AEL and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.

    Comparison to other substitutes in this end-use: R-449B has an ODP of zero, comparable to or lower than the other listed substitutes in this end-use, with ODPs ranging from zero to 0.098.

    R-449B's GWP of 1,410 is lower than or comparable to that of acceptable substitutes for ice skating rinks (retrofit), such as HFC-134a, R-407C, and R-507A with GWPs ranging from 1,430 to 3,990. R-449B's GWP is higher than the GWPs of other acceptable substitutes for ice skating rinks (retrofit), including R-401A and R-401B with GWPs ranging from 1,182 to 1,288.

    Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-use. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15 and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.

    EPA finds R-449B acceptable in the end-use listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.

    4. R-450A

    EPA's decision: EPA finds R-450A acceptable as a substitute for use in:

    • Ice Skating Rinks (New and Retrofit Equipment)

    R-450A, marketed under the trade name Solstice® N-13, is a weighted blend of 42 percent HFC-134a, which is also known as 1,1,1,2 tetrafluoroethane (CAS Reg. No. 811-97-2), and 58 percent HFO-1234ze(E), which is also known as trans-1,3,3,3-tetrafluoropro-l-ene (CAS Reg. No. 29118-24-9).

    You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at www.regulations.gov under the name, “Supporting Materials for Notice 30 Listing of R-450A in Vending Machines.” EPA performed an assessment to examine the health and environmental risks of this substitute. This assessment is available in Docket EPA-HQ-OAR-2003-0118 under the following name:

    • “Risk Screen on Substitutes for Use in Ice Skating Rinks Substitute: R-450A”

    EPA previously listed R-450A as acceptable for use as a refrigerant in several refrigeration and air conditioning end-uses (October 21, 2014, 79 FR 62863; July 16, 2015, 80 FR 42053).

    Environmental information: R-450A has an ODP of zero. Its components, HFC-134a and HFO-1234ze(E), have GWPs of 1,430 and one to six,7 respectively. If these values are weighted by mass percentage, then R-450A has a GWP of about 600. The components of R-450A are both excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS. Knowingly venting or releasing this refrigerant blend is limited by the venting prohibition under section 608(c)(2) of the CAA, codified at 40 CFR 82.154(a)(1).

    7 Hodnebrog et al., 2013 and Nielsen et al., 2007. Op. cit.

    Flammability information: R-450A, as formulated and even considering the worst-case fractionation for flammability, is not flammable.

    Toxicity and exposure data: Potential health effects of exposure to this substitute include drowsiness or dizziness. The substitute may also irritate the skin or eyes or cause frostbite. At sufficiently high concentrations, the substitute may cause irregular heartbeat. The substitute could cause asphyxiation if air is displaced by vapors in a confined space. These potential health effects are common to many refrigerants.

    The AIHA has established WEELs of 1,000 ppm and 800 ppm as an 8-hour TWA for HFC-134a and HFO-1234ze(E), respectively, the components of R-450A. The manufacturer of R-450A recommends an AEL of 880 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet each of the manufacturer's AEL and AIHA WEELs and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.

    Comparison to other substitutes in this end-use: R-450A has an ODP of zero, comparable to other listed substitutes in this end-use, with ODPs ranging from zero to 0.098.

    R-450A's GWP of 600 is lower than that of other acceptable substitutes (for new and retrofit use for ice skating rinks) such as HFC-134a, R-407C, and R-507A with GWPs ranging from 1,430 to 3,990. R-450A's GWP is higher than the GWPs of other acceptable substitutes for new ice skating rinks, including ammonia absorption, ammonia vapor compression and carbon dioxide with GWPs ranging from zero to 1.

    Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-use. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15, and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.

    EPA finds R-450A acceptable in the end-use listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.

    5. R-513A

    EPA's decision: EPA finds R-513A acceptable as a substitute for use in:

    • Ice Skating Rinks (New and Retrofit Equipment)

    R-513A, marketed under the trade name Opteon® XP 10, is a weighted blend of 44 percent HFC-134a, which is also known as 1,1,1,2 tetrafluoroethane (CAS Reg. No. 811-97-2), and 56 percent HFO-1234yf, which is also known as 2,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 754-12-1).

    You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at www.regulations.gov under the name, “Supporting Documentation for Notice 30 Listing of R-513A (XP10) in Certain Refrigeration and Air Conditioning End-Uses. SNAP Submission Received July 24, 2014.” EPA performed an assessment to examine the health and environmental risks of this substitute. This assessment is available in Docket EPA-HQ-OAR-2003-0118 under the following name:

    • “Risk Screen on Substitutes for Use in Ice Skating Rinks Substitute: R-513A”

    EPA previously listed R-513A as acceptable for use as a refrigerant in several refrigeration and air conditioning end-uses (July 16, 2015, 80 FR 42053; May 23, 2016, 81 FR 32241; July 21, 2017, 82 FR 33809).

    Environmental information: R-513A has an ODP of zero. Its components, HFC-134a and HFO-1234yf, have GWPs of 1,430 and one to four,8 respectively. If these values are weighted by mass percentage, then R-513A has a GWP of about 630. The components of R-513A are both excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS. Knowingly venting or releasing this refrigerant blend is limited by the venting prohibition under section 608(c)(2) of the CAA, codified at 40 CFR 82.154(a)(1).

    8 Hodnebrog et al., 2013 and Nielsen et al., 2007. Op. cit.

    Flammability information: R-513A, as formulated and even considering the worst-case fractionation for flammability, is not flammable.

    Toxicity and exposure data: Potential health effects of exposure to this substitute include drowsiness or dizziness. The substitute may also irritate the skin or eyes or cause frostbite. At sufficiently high concentrations, the substitute may cause irregular heartbeat. The substitute could cause asphyxiation if air is displaced by vapors in a confined space. These potential health effects are common to many refrigerants.

    The AIHA has established WEELs of 1,000 ppm and 500 ppm as an 8-hour TWA for HFC-134a and HFO-1234yf, respectively, the components of R-513A. The manufacturer of R-513A recommends an AEL of 653 ppm on an 8-hour TWA for the blend. EPA anticipates that users will be able to meet each of the manufacturer's AEL and AIHA WEELs and address potential health risks by following requirements and recommendations in the manufacturer's SDS, in ASHRAE 15, and other safety precautions common to the refrigeration and air conditioning industry.

    Comparison to other substitutes in this end-use: R-513A has an ODP of zero, comparable to other listed substitutes in this end-use, with ODPs ranging from zero to 0.098.

    R-513A's GWP of 630 is lower than that of other acceptable substitutes for new and retrofit use for ice skating rinks, such as HFC-134a, R-407C, and R-507A with GWPs ranging from 1,430 to 3,990. R-513A's GWP is higher than the GWPs of other acceptable substitutes for new ice skating rinks, including ammonia absorption, ammonia vapor compression and carbon dioxide with GWPs ranging from zero to 1.

    Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-use. Toxicity risks can be minimized by use consistent with the AIHA WEELs, ASHRAE 15, and other industry standards, recommendations in the manufacturer's SDS, and other safety precautions common in the refrigeration and air conditioning industry.

    EPA finds R-513A acceptable in the end-use listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.

    B. Foam Blowing 1. Acetone/Isopentane Blend

    EPA's decision: EPA finds Acetone/Isopentane blend acceptable as a substitute for use in:

    • Rigid Polyurethane and Polyisocyanurate Laminated Boardstock

    Acetone/Isopentane, is a weighted blend of 10-30 percent acetone (CAS Reg. No. 67-64-1) and 70-90 percent isopentane (CAS Reg. No. 78-78-4).

    You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at www.regulations.gov under the name, “Supporting Documentation for Notice 34 Listing of Acetone/Isopentane blend in rigid polyurethane and polyisocyanurate laminated boardstock. SNAP Submission Received August 8, 2017.” EPA performed an assessment to examine the health and environmental risks of this substitute. This assessment is available in Docket EPA-HQ-OAR-2003-0118 under the following name:

    • “Risk Screen on Substitutes for Use in Rigid Polyurethane and Polyisocyanurate Laminated Boardstock Substitute: Acetone/Isopentane Blend”

    EPA previously listed acetone as acceptable for use as a foam-blowing agent in flexible polyurethane and in integral skin polyurethane (March 18, 1994, 59 FR 13044; February 24, 1998, 63 FR 9151). EPA previously listed C3-C6 light saturated hydrocarbons, which include isopentane, as acceptable for use as a foam-blowing agent in a number of foam-blowing end-uses. (August 26, 1994, 59 FR 44240; April 11, 2000, 65 FR 19327).

    Environmental information: Acetone/isopentane blend has an ODP of zero. Its components, acetone and isopentane, have GWPs of 0.5 and <10, respectively.9 Acetone is excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS, while isopentane is defined as VOC under those regulations.

    9 GWP for acetone comes from IPCC, 2007. GWP for isopentane is estimated based on GWP of butane from IPCC, 2007 and the relative atmospheric lifetimes of butane and isopentane from: Safeguarding the Ozone Layer and the Global Climate System. IPCC/TEAP, 2005—Bert Metz, Lambert Kuijpers, Susan Solomon, Stephen O. Anderson, Ogunlade Davidson, Jose Pons, David de Jager, Tahl Kestin, Martin Manning, and Leo Meyer (Eds.). Cambridge University Press, UK. pp 478. Available from Cambridge University Press, The Edinburgh Building Shaftesbury Road, Cambridge CB2 2RU ENGLAND Available online at https://www.ipcc.ch/report/sroc.

    Flammability information: Acetone/isopentane blend is flammable.

    Toxicity and exposure data: Potential health effects of exposure to this substitute include drowsiness or dizziness. Higher concentrations may cause central nervous system depression and loss of consciousness. The substitute may also irritate the skin or eyes. The substitute could cause asphyxiation if air is displaced by vapors in a confined space. These potential health effects are common to many foam-blowing agents.

    For acetone, the Occupational Safety and Health Administration (OSHA) has established a permissible exposure limit (PEL) of 1000 ppm and the American Conference of Governmental Industrial Hygienists (ACGIH) has established a threshold limit value (TLV) of 750 ppm, both on an 8-hr TWA. For isopentane, ACGIH has established a TLV of 600 ppm on an 8-hr TWA. EPA anticipates that users will be able to meet the ACGIH's TLVs for both components and address potential health risks by following requirements and recommendations in the manufacturer's SDS and other safety precautions common to the foam-blowing industry.

    Comparison to other substitutes in this end-use: Acetone/isopentane blend has an ODP of zero, comparable to other listed substitutes in this end-use, with ODPs ranging from zero to 0.012.

    For rigid polyurethane and polyisocyanurate laminated boardstock, acetone/isopentane blend's GWP of <10 is comparable to the GWPs of other acceptable substitutes for rigid polyurethane and polyisocyanurate laminated boardstock, including EcomateTM, CO2, HFO-1336mzz(Z) and C3-C6 light saturated hydrocarbons with GWPs ranging from less than 1 to approximately 12.

    Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-use. Toxicity risks can be minimized by use consistent with the ACGIH TLVs, recommendations in the manufacturer's SDS, and other safety precautions common in the foam-blowing industry.

    EPA finds acetone/isopentane blend acceptable in the end-use listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.

    C. Fire Suppression and Explosion Protection 1. Powdered Aerosol E (FireProTM)

    EPA's decision: EPA finds Powdered Aerosol E acceptable as a substitute for:

    • Total Flooding Uses

    Powdered Aerosol E is generated in an automated manufacturing process during which the chemicals, in powder form, are mixed and then supplied to end users as a solid contained within a fire extinguisher. In the presence of heat, the solid converts to an aerosol consisting mainly of potassium salts. EPA previously listed Powdered Aerosol E as acceptable subject to use conditions in areas that are not normally occupied (71 FR 56359; September 27, 2006). Based on a review of additional information from the submitter to support the safe use of Powdered Aerosol E in normally occupied spaces, EPA now determines that Powdered Aerosol E is also acceptable for use in total flooding systems for normally occupied spaces, and EPA is adding Powdered Aerosol E to the list of acceptable substitutes for total flooding uses, which would include both unoccupied and occupied spaces. In a subsequent rulemaking EPA will remove the previous listing as acceptable subject to use conditions. In the “Further Information” column of the tables summarizing today's listing decisions and found at the end of this document, we also state that use of this agent should continue to be in accordance with the safety guidelines in the latest edition of the National Fire Protection Association (NFPA) 2010 Standard for Aerosol Extinguishing Systems.

    You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at www.regulations.gov under the name, “Supporting Documentation for Notice 34 Listing of Powdered Aerosol E (FirePro) in Fire Suppression. SNAP Submission Received November 17, 2016.” EPA performed an assessment to examine the health and environmental risks of this substitute. This assessment is available in Docket EPA-HQ-OAR-2003-0118 under the following name:

    • “Risk Screen on Substitutes for Total Flooding Systems in Occupied Spaces Substitute: Powdered Aerosol E (FirePro)”

    Environmental information: The active ingredients of Powdered Aerosol E are solids both before and after use; thus, their ODP and GWP are both zero. The gaseous post-activation products for Powdered Aerosol E also have zero ODP and GWPs of 120 or less. The solid active ingredients and particulate post-activation products do not participate in atmospheric photochemical reactions and are not VOCs. The gaseous post-activation products are either not organic or excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS.

    Flammability information: Powdered Aerosol E's post-activation products are nonflammable.

    Toxicity and exposure data: Exposure to Powdered Aerosol E after activation may cause temporary, mild irritation of the mucous membrane. If eye or skin contact occurs, end users should flush eyes with water or wash skin with soap and water. If inhaled, end users should be removed and exposed to fresh air. Exposure to the post-discharge products is expected to be below the relevant workplace exposure limits for those compounds. Because it is housed in a hermetically sealed container, exposure should not occur unless the system is activated.

    The post-activation components of the proposed substitute are common compounds that are not expected to exceed immediately dangerous to life or health (IDLH) levels from the National Institute for Occupational Safety and Health (NIOSH) that apply to occupational and end use exposure.

    Information on additional safety recommendations: The discharge of the aerosol results in a reduction of visibility in the protected space due to the uniform distribution of the particulate generated. Use according to the NFPA 2010 Standard will reduce any safety risks due to reduced visibility. In addition, EPA recommends that cross-zone detection systems and abort switches located near an exit from the protected space be employed; improved detection systems within the protected space and manual abort switches outside of the space could help avoid inadvertent discharge.

    In the “Further Information” column of the tables summarizing today's listing decisions, EPA recommends the following for establishments manufacturing Powdered Aerosol E and filling containers to be used in total flooding applications:

    —Workers should use appropriate safety and protective equipment (e.g., protective gloves, tightly sealed goggles, protective work clothing, and particulate-removing respirators using NIOSH type N95 or better filters) consistent with OSHA guidelines. —A local exhaust system should be installed and operated to provide adequate ventilation to reduce airborne exposure to Powdered Aerosol E constituents. —An eye wash fountain and quick drench facility should be close to the production area. —Training for safe handling procedures should be provided to all employees that would be likely to handle the containers of the agent or extinguishing units filled with the agent. —Workers responsible for cleanup should allow particulates to settle before reentering area and wear appropriate personal protective equipment. —All spills should be cleaned up immediately in accordance with good industrial hygiene practices.

    EPA expects that procedures identified in the SDS for Powdered Aerosol E and good manufacturing practices will be adhered to, and that the appropriate safety and personal protective equipment (PPE) consistent with OSHA guidelines will be used during installation, servicing, post-discharge clean-up and disposal of total flooding systems using Powdered Aerosol E. The manufacturer should provide guidance upon installation of the system regarding the appropriate time after which workers may re-enter the area for disposal to allow the maximum settling of all particulates.

    Comparison to other substitutes in this end-use: Powdered Aerosol E has an ODP of zero, comparable to other listed substitutes in this end-use, with ODPs ranging from zero to 0.048.

    For total flooding agents, Powdered Aerosol E's GWP of 0 (and 1 to 120 for certain post-activation products) is lower than that of other acceptable substitutes, such as HFC-227ea, other HFCs, and some HCFC fire suppressants, with GWPs which range from about 1,550 to 14,800. Other acceptable substitutes in this end-use have comparable GWPs ranging from zero to one, such as water, inert gases, and a number of other powdered aerosol fire suppressants.

    Toxicity risks can be minimized by use consistent with the NFPA 2010 standard, recommendations in the SDS, and other safety precautions common in the fire suppression industry. The potential toxicity risks due to inhalation exposure are common to many total flooding agents, including those already listed as acceptable under SNAP for this same end-use. Powdered Aerosol E's post-activation products are nonflammable, as are all other available total flooding agents.

    EPA finds Powdered Aerosol E acceptable in the end-use listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.

    D. Cleaning Solvents 1. HFO-1336mzz(Z)

    EPA's decision: EPA finds HFO-1336mzz(Z)) acceptable as a substitute for use in:

    • Electronics cleaning • Metals cleaning • Precision cleaning

    HFO-1336mzz(Z) is also known as (Z)-1,1,1,4,4,4-hexafluoro-2-butene and cis-1,1,1,4,4,4-hexafluoro-2-butene (CAS Reg. No. 692-49-9).

    You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at www.regulations.gov under the name, “Supporting Documentation for Notice 34 Listing of HFO-1336mzz(Z) in Cleaning Solvents and Aerosol Solvents. SNAP Submission Received June 19, 2017.” EPA performed an assessment to examine the health and environmental risks of this substitute. This assessment is available in Docket EPA-HQ-OAR-2003-0118 under the following name:

    • “Risk Screen on Substitutes for Use in Cleaning Solvents Substitute: HFO-1336mzz(Z)”

    EPA previously listed HFO-1336mzz(Z) as acceptable for use in several refrigeration and air conditioning and foam-blowing end-uses (October 21, 2014, 79 FR 62863; July 16, 2015, 80 FR 42053; May 23, 2016, 81 FR 32241).

    Environmental information: HFO-1336mzz(Z) has an ODP of zero. It has a 100-year GWP of about nine.10 HFO-1336mzz(Z) is a VOC, and it is not exempted from the definition of VOC under CAA regulation (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS. EPA has issued a proposed rule that, if finalized as proposed, would exclude HFO-1336mzz(Z) from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS (May 1, 2018; 83 FR 19026).

    10 Baasandorj, M., Ravishankara, A.R., Burkholder, J.B., Atmospheric Chemistry of (Z)-CF3CHÕCHCF3: OH Radical Reaction Rate Coefficient and Global Warming Potential, Journal of Physical Chemistry A, 2011, 115, 10,539-10,549, 2011.

    Flammability information: HFO-1336mzz(Z) is not flammable.

    Toxicity and exposure data: Potential health effects of exposure to this substitute include skin or eye irritation or frostbite. At sufficiently high concentrations, the substitute may cause irregular heartbeat. The substitute could cause asphyxiation if air is displaced by vapors in a confined space. EPA issued a Significant New Use Rule under the Toxic Substances Control Act on June 5, 2015, to require persons to submit a Significant New Use Notice to EPA at least 90 days before they manufacture or process HFO-1336mzz(Z) for uses other than those described in the Premanufacture Notice (80 FR 32003).

    EPA anticipates that HFO-1336mzz(Z) will be used consistent with the recommendations specified in the SDS. The WEEL committee of the Occupational Alliance for Risk Science (OARS) recommends a WEEL for the workplace of 500 ppm on an 8-hour TWA. EPA anticipates that users will be able to meet the WEEL and address potential health risks by following requirements and recommendations in the SDS and other safety precautions common to the cleaning solvents industry.

    Comparison to other substitutes in this end-use: HFO-1336mzz(Z) has an ODP of zero, comparable to other listed substitutes in this end-use, with ODPs ranging from zero to 0.033.

    For cleaning solvents, HFO-1336mzz(Z)'s GWP of about nine is lower than that of other acceptable substitutes, such as HFE-7200, HFE-7100, HFC-365mfc and HFC-4310mee with GWPs ranging from 59 to 1,640. HFO-1336mzz(Z)'s GWP is higher than or comparable to the GWPs of other acceptable substitutes for cleaning solvents, including acetone, methoxytridecafluoroheptene isomers (MPHE), and trans-1-chloro-3,3,3-trifluoroprop-1-ene with GWPs ranging from less than 1 to 7.

    Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-use. Toxicity risks can be minimized by use consistent with the OARS WEEL, recommendations in the manufacturer's SDS, and other safety precautions common in the cleaning solvents industry; moreover, those risks are common to many cleaning solvents, including many of those already listed as acceptable under SNAP for this end-use.

    EPA finds HFO-1336mzz(Z) acceptable in the end-uses listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-uses.

    E. Aerosols 1. HFO-1336mzz(Z)

    EPA's decision: EPA finds HFO-1336mzz(Z) acceptable as a substitute for use in:

    • Aerosol Solvents

    HFO-1336mzz(Z) is also known as (Z)-1,1,1,4,4,4-hexafluoro-2-butene and cis-1,1,1,4,4,4-hexafluoro-2-butene (CAS Reg. No. 692-49-9).

    You may find the redacted submission in Docket EPA-HQ-OAR-2003-0118 at www.regulations.gov under the name, “Supporting Documentation for Notice 34 Listing of HFO-1336mzz(Z) in Cleaning Solvents and Aerosol Solvents. SNAP Submission Received June 19, 2017.” EPA performed an assessment to examine the health and environmental risks of this substitute. This assessment is available in Docket EPA-HQ-OAR-2003-0118 under the following name:

    • “Risk Screen on Substitutes for Use in Aerosol Solvents Substitute: HFO-1336mzz(Z)”

    EPA previously listed HFO-1336mzz(Z) as acceptable for use in several refrigeration and air conditioning and foam-blowing end-uses (October 21, 2014, 79 FR 62863; July 16, 2015, 80 FR 42053; May 23, 2016, 81 FR 32241).

    Environmental information: The environmental information for this substitute is set forth in the “Environmental information” section in listing I.D.1.

    Flammability information: HFO-1336mzz(Z) is not flammable.

    Toxicity and exposure data: The toxicity information for this substitute is set forth in the “Toxicity and exposure data” section in listing I.D.1, above.

    EPA anticipates that HFO-1336mzz(Z) will be used consistent with the recommendations specified in the SDS. The WEEL committee of the Occupational Alliance for Risk Science (OARS) recommends a WEEL for the workplace of 500 ppm on an 8-hour TWA. EPA anticipates that users will be able to meet the WEEL and address potential health risks by following requirements and recommendations in the SDS and other safety precautions common to the aerosols industry.

    Comparison to other substitutes in this end-use: HFO-1336mzz(Z) has an ODP of zero, comparable to other listed substitutes in this end-use, with ODPs ranging from zero to 0.033.

    For aerosol solvents, HFO-1336mzz(Z)'s GWP of about nine is lower than that of other acceptable substitutes, such as HFE-7200, HFE-7000, HFC-365mfc and HFC-4310mee with GWPs ranging from 59 to 1,640. HFO-1336mzz(Z)'s GWP is higher than or comparable to the GWPs of other acceptable substitutes for aerosol solvents, including acetone, MPHE, and trans-1-chloro-3,3,3-trifluoroprop-1-ene with GWPs ranging from less than 1 to 7.

    Flammability and toxicity risks are comparable to or lower than flammability and toxicity risks of other available substitutes in the same end-use. Toxicity risks can be minimized by use consistent with the OARS WEEL, recommendations in the manufacturer's SDS, and other safety precautions common in the aerosols industry; moreover, those risks are common to many aerosol solvents, including many of those already listed as acceptable under SNAP for this end-use.

    EPA finds HFO-1336mzz(Z) acceptable in the end-use listed above because it does not pose greater overall environmental and human health risk than other available substitutes in the same end-use.

    List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure, Air pollution control, Reporting and recordkeeping requirements.

    Dated: September 19, 2018. Sarah Dunham, Director, Office of Atmospheric Programs. Appendix A: Summary of Decisions for New Acceptable Substitutes

    End-use Substitute Decision Further Information 1 Refrigeration and Air Conditioning Ice skating rinks (retrofit equipment only) R-448A Acceptable R-448A has a 100-yr global warming potential (GWP) of approximately 1,390. This substitute is a blend of HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); HFO-1234yf, which is also known as 2,3,3,3-tetrafluoro-prop-l-ene (CAS Reg. No. 754-12-1); and HFO-1234ze(E), which is also known as trans-1,3,3,3-tetrafluoroprop-l-ene (CAS Reg. No. 29118-24-9). The blend is nonflammable. The American Industrial Hygiene Association (AIHA) has established Workplace Environmental Exposure Limits (WEELs) of 1,000 ppm on an eight-hour time-weighted average (8-hr TWA) basis for HFC-32, HFC-125, and HFC-134a; 500 ppm for HFO-1234yf; and 800 ppm for HFO-1234ze(E). The manufacturer recommends an acceptable exposure limit (AEL) for the workplace for R-448A of 890 ppm (8-hr TWA). Ice skating rinks (retrofit equipment only) R-449A Acceptable R-449A has a 100-year GWP of approximately 1,400. This substitute is a blend of HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); and HFO-1234yf, which is also known as 2,3,3,3-tetrafluoroprop-l-ene (CAS Reg. No. 754-12-1). The blend is nonflammable. The AIHA has established WEELs of 1,000 ppm (8-hr TWA) for HFC-32, HFC-125, and HFC-134a; and 500 ppm for HFO-1234yf. The manufacturer recommends an AEL for the workplace for R-449A of 830 ppm (8-hr TWA). Ice skating rinks (retrofit equipment only) R-449B Acceptable R-449B has a 100-year GWP of approximately 1,410. This substitute is a blend of HFC-32, which is also known as difluoromethane (CAS Reg. No. 75-10-5); HFC-125, which is also known as 1,1,1,2,2-pentafluoroethane (CAS Reg. No. 354-33-6); HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); and HFO-1234yf, which is also known as 2,3,3,3-tetrafluoroprop-l-ene (CAS Reg. No. 754-12-1). The blend is nonflammable. The AIHA has established WEELs of 1,000 ppm (8-hr TWA) for HFC-32, HFC-125, and HFC-134a; and 500 ppm for HFO-1234yf. The manufacturer recommends an AEL for the workplace for R-449B of 865 ppm (8-hr TWA). Ice skating rinks (new and retrofit equipment) R-450A Acceptable R-450A has a 100-year GWP of approximately 600. This substitute is a blend of HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); and HFO-1234ze(E), which is also known as trans-1,3,3,3, -tetrafluoropro-1-ene (CAS Reg. No. 29118-24-9). This blend is nonflammable. The AIHA has established WEELs of 1,000 ppm and 800 ppm (8-hr TWA) for HFC-134a and HFO-1234yf, respectively. The manufacturer recommends an AEL for the workplace for R-450A of 880 ppm (8-hr TWA). Ice skating rinks (new and retrofit equipment) R-513A Acceptable R-513A has a 100-year GWP of approximately 630. This substitute is a blend of HFC-134a, which is also known as 1,1,1,2-tetrafluoroethane (CAS Reg. No. 811-97-2); and HFO-1234yf, which is also known as 2,3,3,3-tetrafluoroprop-l-ene (CAS Reg. No. 754-12-1). This blend is nonflammable. The AIHA has established WEELs of 1,000 ppm and 500 ppm (8-hr TWA) for HFC-134a and HFO-1234yf, respectively. The manufacturer recommends an AEL for the workplace for R-513A of 653 ppm (8-hr TWA). Foam Blowing Rigid polyurethane and polyisocyanurate laminated boardstock Acetone/isopentane blend Acceptable Acetone/isopentane blend has no ozone depletion potential (ODP) and a 100-year GWP of approximately <10. Acetone is excluded from the definition of volatile organic compounds (VOC) under CAA regulations (see 40 CFR 51.100(s)) addressing the development of state implementation plans (SIPs) to attain and maintain the National Ambient Air Quality Standards (NAAQS), while isopentane is defined as VOC. This foam-blowing agent is flammable. For acetone, the Occupational Safety and Health Administration (OSHA) has established a permissible exposure limit of 1000 ppm and the American Conference of Governmental Industrial Hygienists (ACGIH) has established a threshold limit value (TLV) of 750 ppm, both on an 8-hr TWA. For isopentane, ACGIH has established a TLV of 600 ppm on an 8-hr TWA. Fire Suppression Total flooding Powdered Aerosol E Acceptable Use of this agent should be in accordance with the safety guidelines in the latest edition of the National Fire Protection Association 2010 standard for Aerosol Extinguishing Systems. For establishments manufacturing the agent or filling, installing, or servicing containers or systems to be used in total flooding applications, EPA recommends the following: —The appropriate safety and personal protective equipment (PPE) (e.g., protective gloves, tightly sealed goggles, protective work clothing, and particulate-removing respirators with National Institute for Occupational Safety and Health type N95 or better filters) consistent with Occupational Safety and Health Administration (OSHA) guidelines should be used during manufacture, installation, servicing, and disposal of total flooding systems using the agent; —adequate ventilation should be in place to reduce airborne exposure to constituents of agent; —an eye wash fountain and quick drench facility should be close to the production area; —training for safe handling procedures should be provided to all employees that would be likely to handle containers of the agent or extinguishing units filled with the agent; —workers responsible for clean-up should allow for maximum settling of all particulates before reentering area and wear appropriate personal protective equipment; and —all spills should be cleaned up immediately in accordance with good industrial hygiene practices. As required by the manufacturer, units installed in normally occupied spaces will be equipped with features such as a system-isolate switch and cross-zone detection system to reduce risk of accidental activation of an agent generator while persons are present in the protected space. Also required by the manufacturer is warning of pending discharge and delay in release to ensure egress prior to activation of the agent to reduce the risk of exposure. See additional comments 1, 2, 3, 4, 5. 1. The EPA recommends that users consult Section VIII of the OSHA Technical Manual for information on selecting the appropriate types of personal protective equipment for all listed fire suppression agents. The EPA has no intention of duplicating or displacing OSHA coverage related to the use of personal protective equipment (e.g., respiratory protection), fire protection, hazard communication, worker training or any other occupational safety and health standard with respect to halon substitutes. 2. Use of all listed fire suppression agents should conform to relevant OSHA requirements, including 29 CFR part 1910, subpart L, sections 1910.160 and 1910.162. 3. Per OSHA requirements, protective gear (SCBA) should be available in the event personnel should reenter the area. 4. Discharge testing should be strictly limited to that which is essential to meet safety or performance requirements. 5. The agent should be recovered from the fire protection system in conjunction with testing or servicing, and recycled for later use or destroyed. End-use Substitute Decision Further Information 1 Cleaning Solvents Electronics cleaning, metals cleaning, precision cleaning HFO-1336mzz(Z) Acceptable HFO-1336mzz(Z) has no ozone depletion potential (ODP) and a 100-year GWP of approximately nine. EPA has proposed to exclude it from the definition of volatile organic compounds under CAA regulations (see 40 CFR 51.100(s)) addressing the development of state implementation plans (SIPs) to attain and maintain the National Ambient Air Quality Standards (NAAQS). This compound is nonflammable. The Occupational Alliance for Risk Science (OARS) has established a Workplace Environmental Exposure Limit (WEEL) of 500 ppm (8-hr TWA) for HFO-1336mzz(Z). This substitute is subject to a Toxic Substance Control Act (TSCA) section 5(a)(2) Significant New Use Rule (SNUR) (40 CFR 721.10830). Aerosols Aerosol solvents HFO-1336mzz(Z) Acceptable HFO-1336mzz(Z) has no ozone depletion potential (ODP) and a 100-year GWP of approximately nine. EPA has proposed to exclude it from the definition of volatile organic compounds under CAA regulations (see 40 CFR 51.100(s)) addressing the development of state implementation plans (SIPs) to attain and maintain the National Ambient Air Quality Standards (NAAQS). This compound is nonflammable. The OARS has established a Workplace Environmental Exposure Limit (WEEL) of 500 ppm (8-hr TWA) for HFO-1336mzz(Z). This substitute is subject to a Toxic Substance Control Act (TSCA) section 5(a)(2) Significant New Use Rule (SNUR) (40 CFR 721.10830). 1 Observe recommendations in the manufacturer's SDS and guidance for all listed substitutes. [FR Doc. 2018-21463 Filed 10-3-18; 8:45 am] BILLING CODE 6560-50-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [MB Docket No. 18-153; RM-11801; DA 18-962] Television Broadcasting Services; Block Island and Newport, Rhode Island AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule.

    SUMMARY:

    At the request of ION Television License, LLC (ION), the Commission amends the DTV Table of Allotments to reallot channel 17 from Block Island, Rhode Island, to Newport, Rhode Island. The Commission also grants ION's request to change WPXQ's community of license to Newport, Rhode Island, amending the DTV Table of Allotments to reflect this change while modifying WPXQ's license to reflect that its community of license is Newport, Rhode Island. The new allotment will be mutually exclusive with WPXQ's existing allotment and the reallotment will result in a preferential arrangement of allotments pursuant to the Commission's second allotment priority by providing Newport its first local television service. The reallotment will cause no public harm because Block Island will continue to be served by five full power commercial and one full power non-commercial television stations and receive over-the-air service from WPXQ.

    DATES:

    Effective October 4, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Darren Fernandez, Media Bureau, at [email protected]; or Joyce Bernstein, Media Bureau, at [email protected]

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Report and Order in MB Docket No. 18-153; RM-11801; DA 18-962, adopted September 18, 2018, and released September 18, 2018. The full text of this document is available for public inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street SW, Washington, DC 20554, or online at http://apps.fcc.gov/ecfs/. To request materials in accessible formats (braille, large print, computer diskettes, or audio recordings), please send an email to [email protected] or call the Consumer & Government Affairs Bureau at (202) 418-0530 (VOICE), (202) 418-0432 (TTY).

    This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to this proceeding.

    The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A).

    List of Subjects in 47 CFR Part 73

    Television.

    Federal Communications Commission. Barbara Kreisman, Chief, Video Division, Media Bureau. Final Rule

    For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:

    1. The authority citation for part 73 continues to read as follows: Authority:

    47 U.S.C. 154, 303, 334, 336, and 339.

    § 73.622 [Amended]
    2. Amend § 73.622(i) in the Post-Transition Table of DTV Allotments under Rhode Island by removing Block Island, channel 17, and adding, in alphabetical order, Newport, channel 17.
    [FR Doc. 2018-21071 Filed 10-3-18; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 170817779-8186-02] RIN 0648-XG508 Fisheries of the Exclusive Economic Zone Off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area AGENCY:

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

    ACTION:

    Temporary rule; reallocation.

    SUMMARY:

    NMFS is exchanging allocations of Amendment 80 cooperative quota (CQ) for Amendment 80 acceptable biological catch (ABC) reserves and Community Development Quota (CDQ) reserves in the Bering Sea and Aleutian Islands management area. This action is necessary to allow the 2018 total allowable catch of flathead sole, rock sole, and yellowfin sole in the Bering Sea and Aleutian Islands management area to be harvested.

    DATES:

    Effective October 4, 2018 through December 31, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

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

    The 2018 flathead sole, rock sole, and yellowfin sole Amendment 80 allocations of the total allowable catch (TAC) specified in the BSAI are 8,949 metric tons (mt), 36,060 mt, and 115,171 mt as established by the final 2018 and 2019 harvest specifications for groundfish in the BSAI (83 FR 8365, February 27, 2018). The 2018 flathead sole, rock sole, and yellowfin sole Amendment 80 ABC reserves are 46,680 mt, 85,728 mt, and 110,286 mt as established by the final 2018 and 2019 harvest specifications for groundfish in the BSAI (83 FR 8365, February 27, 2018). The 2018 flathead sole, rock sole, and yellowfin sole CDQ reserves specified in the BSAI are 1,552 mt, 5,040 mt, and 16,478 mt as established by the final 2018 and 2019 harvest specifications for groundfish in the BSAI (83 FR 8365, February 27, 2018). The 2018 flathead sole, rock sole, and yellowfin sole CDQ ABC reserves are 5,593 mt, 10,272 mt, and 13,215 mt as established by the final 2018 and 2019 harvest specifications for groundfish in the BSAI (83 FR 8365, February 27, 2018).

    The Alaska Seafood Cooperative has requested that NMFS exchange 3,650 mt of rock sole Amendment 80 allocations of the TAC for 2,650 mt of flathead sole and 1,000 mt of yellowfin sole Amendment 80 ABC reserves under § 679.91(i). Therefore, in accordance with § 679.91(i), NMFS exchanges 3,650 mt of rock sole Amendment 80 allocations of the TAC for 2,650 mt of flathead sole and 1,000 mt of yellowfin sole Amendment 80 ABC reserves in the BSAI. This action also decreases and increases the TACs and Amendment 80 ABC reserves by the corresponding amounts.

    The Aleutian Pribilof Island Community Development Association has requested that NMFS exchange 250 mt of rock sole CDQ reserves for 250 mt of yellowfin sole CDQ ABC reserves under § 679.31(d). Therefore, in accordance with § 679.31(d), NMFS exchanges 250 mt of rock sole CDQ reserves for 250 mt of yellowfin sole CDQ ABC reserves in the BSAI. This action also decreases and increases the TACs and CDQ ABC reserves by the corresponding amounts.

    The Coastal Villages Regional Fund has requested that NMFS exchange 45 mt of flathead sole CDQ reserves and 250 mt of rock sole CDQ reserves for 295 mt of yellowfin sole CDQ ABC reserves under § 679.31(d). Therefore, in accordance with § 679.31(d), NMFS exchanges 45 mt of flathead sole CDQ reserves and 250 mt of rock sole CDQ reserves for 295 mt of yellowfin sole CDQ ABC reserves in the BSAI. This action also decreases and increases the TACs and CDQ ABC reserves by the corresponding amounts.

    Tables 11 and 13 of the final 2018 and 2019 harvest specifications for groundfish in the BSAI (83 FR 8365, February 27, 2018), are revised as follows:

    Table 11—Final 2018 Community Development Quota (CDQ) Reserves, Incidental Catch Amounts (ICAS), and Amendment 80 Allocations of the Aleutian Islands Pacific Ocean Perch, and BSAI Flathead Sole, Rock Sole, and Yellowfin Sole TACs [Amounts are in metric tons] Sector Pacific ocean perch Eastern
  • Aleutian
  • district
  • Central
  • Aleutian
  • district
  • Western
  • Aleutian
  • district
  • Flathead sole BSAI Rock sole BSAI Yellowfin sole BSAI
    TAC 9,000 7,500 9,000 17,105 42,950 155,545 CDQ 963 803 963 1,507 4,540 17,023 ICA 100 120 10 4,000 6,000 4,000 BSAI trawl limited access 794 658 161 0 0 18,351 Amendment 80 7,143 5,920 7,866 11,599 32,410 116,171 Note: Sector apportionments may not total precisely due to rounding.
    Table 13—Final 2018 and 2019 ABC Surplus, ABC Reserves, Community Development Quota (CDQ) ABC Reserves, and Amendment 80 ABC Reserves in the BSAI for Flathead Sole, Rock Sole, and Yellowfin Sole [Amounts are in metric tons] Sector 2018
  • Flathead sole
  • 2018
  • Rock sole
  • 2018
  • Yellowfin sole
  • 2019 1
  • Flathead sole
  • 2019 1
  • Rock sole
  • 2019 1
  • Yellowfin sole
  • ABC 66,773 143,100 277,500 65,227 132,000 267,500 TAC 17,105 42,950 155,545 16,500 49,100 156,000 ABC surplus 49,668 100,150 121,955 48,727 82,900 111,500 ABC reserve 49,668 100,150 121,955 48,727 82,900 111,500 CDQ ABC reserve 5,638 10,772 12,670 5,214 8,870 11,931 Amendment 80 ABC reserve 44,030 89,378 109,286 43,513 74,030 99,570 1 The 2019 allocations for Amendment 80 species between Amendment 80 cooperatives and the Amendment 80 limited access sector will not be known until eligible participants apply for participation in the program by November 1, 2018.
    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 flatfish exchange by the Alaska Seafood Cooperative, the Aleutian Pribilof Island Community Development Association, and the Coastal Villages Regional Fund in the BSAI. Since these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 21, 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: September 28, 2018. Margo B. Schulze-Haugen, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-21600 Filed 10-3-18; 8:45 am] BILLING CODE 3510-22-P
    83 193 Thursday, October 4, 2018 Proposed Rules DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Part 226 [FNS-2018-0009] RIN 0584-AE59 Increasing Flexibility for Verification of For-Profit Center Eligibility in the Child and Adult Care Food Program AGENCY:

    Food and Nutrition Service (FNS), USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    USDA proposes a deregulatory action to simplify the requirement for for-profit child care centers, for-profit adult care centers, and sponsoring organizations of for-profit centers in the Child and Adult Care Food Program to verify that they are eligible to submit claims for reimbursement each month. This rule would exempt for-profit centers from monthly verification if they annually demonstrate that at least 50 percent of children served are eligible for free and reduced-price meals or benefits under title XX of the Social Security Act, or at least 50 percent of adult participants are eligible for benefits under title XIX or title XX of the Social Security Act. Monthly verification represents a small but duplicative paperwork burden. Allowing a less frequent verification cycle would reduce the administrative burden for those centers that consistently serve a high percentage of eligible children or adult participants from low-income households.

    DATES:

    Written comments must be received on or before December 3, 2018 to be assured of consideration.

    ADDRESSES:

    USDA invites interested persons to submit written comments on this proposed rule, including the information collection. Comments may be submitted in writing by one of the following methods:

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

    Mail: Send comments to Community Meals Branch, Policy and Program Development Division, USDA Food and Nutrition Service, 3101 Park Center Drive, Alexandria, Virginia 22302.

    • All written comments submitted in response to this proposed rule will be included in the record and will be made available to the public. Please be advised that the substance of the comments and the identity of the individuals or entities submitting the comments will be subject to public disclosure. USDA will make the written comments publicly available via http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Andrea Farmer, Chief, Community Meals Branch, Policy and Program Development Division, USDA Food and Nutrition Service, 703-305-2590.

    SUPPLEMENTARY INFORMATION:

    I. Overview

    USDA is committed to working with States to highlight flexibilities and local choices that would both ensure that the Child and Adult Care Food Program (CACFP) operates with integrity and alleviate unnecessary regulatory burdens, such as the monthly verification required of private for-profit centers that serve a high percentage of eligible children or adult participants from low-income households. To be eligible to claim reimbursement for meals and snacks served in CACFP, for-profit centers must document that they meet specified criteria, which demonstrates that at least 25 percent of children or adult participants in care are from low-income households. This proposed rule would simplify the requirement for some for-profit child and adult care centers and sponsoring organizations of for-profit centers to verify that the 25 percent standard is met. It would allow a less frequent verification cycle, from monthly to annual verification, in those centers where low-income children or adult participants make up a large proportion of the enrollment. This rule proposes to make the following amendments to CACFP regulations:

    1. At 7 CFR 226.10(c), exempt for-profit child or adult care centers from re-verifying their eligibility on monthly claim forms if they annually meet the criteria for for-profit centers to demonstrate that at least 50 percent of children or adult participants in care are from low-income households.

    2. At 7 CFR 226.6(f), make verification of eligibility of participating for-profit institutions an annual State agency responsibility.

    3. At 7 CFR 226.9(b) and 226.11(c), allow State agencies to use free and reduced-price counts to support the annual eligibility determination for for-profit centers that are assigned claiming percentages or blended rates of reimbursement, when the 50 percent standard is met.

    II. Background

    CACFP, authorized under section 17 of the Richard B. Russell National School Lunch Act, 42 U.S.C. 1766, supports the efforts of public, private non-profit, and private for-profit child care centers, outside school-hours-care centers, and adult day care centers to provide nutritious foods that contribute to the wellness, healthy growth, and development of young children and the health and wellness of older and chronically impaired adults. Independent public and private non-profit centers and sponsoring organizations of centers submit claims to the State agency for reimbursement each month, based on the number of meals served to eligible children or adult participants and their eligibility for free and reduced-priced meals. However, the claiming process is not as simple for independent for-profit centers and sponsoring organizations of for-profit centers. The Omnibus Reconciliation Act of 1981, Public Law 97-35, established a legislative standard of participation for for-profit centers that would reduce spending and target benefits to low-income children. Consequently, for-profit centers must meet additional criteria and verify each month that they are eligible to submit claims for reimbursement.

    Based on informal input from CACFP stakeholders, USDA understands that for-profit centers that have to report information to verify monthly eligibility on their claim forms find it to be an unnecessary administrative burden, particularly for centers where low-income children or adult participants make up a greater proportion of the enrollment. USDA has been working with State agencies and local partners to examine administrative requirements and explore recommendations for reducing unnecessary paperwork and easing the burden of those requirements.

    In 2011, USDA formed the Paperwork Reduction Work Group to explore ways to streamline CACFP. The Work Group consisted of a representative panel of CACFP professionals from State and local agencies and national associations, as well as experts in early childhood education and care, nutrition, and technology to help USDA understand how to make operational requirements more efficient, without compromising the measures we have taken to protect program integrity. Recommendations from the Work Group were included in a report, Reducing Paperwork in the Child and Adult Care Food Program, which was submitted to Congress in August 2015.

    The Work Group found it confusing and burdensome that CACFP regulations under 7 CFR 226.2 and 226.6 require for-profit centers to verify their eligibility in their applications and then, under 7 CFR 226.10, require for-profit centers to re-verify their eligibility to participate and submit claims for reimbursement each month. The Work Group reasoned that centers do not experience large variability in the percentage of enrollment or licensed capacity and that submitting monthly documentation results in a disproportional amount of work for any center that serves a high number of low-income children or adult participants. To address this paperwork burden, the Work Group considered several recommendations regarding eligibility verification and payments, including proposals to:

    • Establish annual eligibility determinations for for-profit centers serving high numbers of low-income children;

    • Eliminate requirements to submit monthly backup documentation of attendance, income eligibility forms, or title XX participation;

    • Establish a single, blended-rate method of payment, determined annually for centers;

    • Compute the blended rates of payment for centers based on an individual center's enrollment; and

    • Allow centers the option of amending the rate more frequently than annually.

    The report's recommendations urged USDA to work with State agencies to streamline the annual eligibility determinations for participating for-profit centers meeting a 50 percent standard, and eliminate requirements to submit monthly backup documentation of children or adult participants' attendance or eligibility for meal benefits to verify that the 25 percent standard is met. The report also proposed recommendations on the assignment of rates of reimbursement, reflecting the Work Group's broader concerns about the paperwork burden placed on any center, not just for-profit centers, and on sponsoring organizations of centers when payment rates must be re-evaluated monthly. Instead of basing payments on the actual number or a claiming percentage of meals served free, at a reduced-price, or at the paid rate, the report asked State agencies to consider updating computer systems to move toward an annual blended payment rate, based on an individual center's enrollment, and allowing centers the option of amending the rate more frequently than annually.

    Through this deregulatory action, USDA proposes to address the verification issue in the report by streamlining reporting requirements of for-profit centers and sponsoring organizations of for-profit centers that meet a 50 percent standard. In those centers where low-income children or adult participants make up a large proportion of the enrollment, the number of times eligibility must be verified would be reduced from monthly to annually.

    This rule would exempt for-profit child or adult care centers from re-verifying their eligibility to submit claims each month, if they annually meet the criteria for for-profit centers to demonstrate that at least 50 percent of children or adult participants in care are from low-income households. The 50 percent standard is consistent with the Paperwork Reduction Work Group's recommendation and adopts a benchmark that has been applied by Congress to define low-income areas and determine eligibility in CACFP for streamlined reimbursements for non-profit centers. Corresponding changes would make verification of eligibility of participating for-profit institutions an annual State agency responsibility and provide options that would allow the State agency to use separate free and reduced-price counts that support the for-profit eligibility determination to assign each for-profit center an annual claiming percentage or blended rate.

    The amendments proposed in this rule would not change fundamental CACFP requirements. USDA's intent is to find reasonable ways to ease CACFP operational burdens, through State flexibilities and options for child and adult care institutions that would make it easier to demonstrate and verify compliance with for-profit center requirements. For example, this rule would not change the 25 percent standard for application approval or the criteria to verify that each for-profit center is eligible to submit claims for reimbursement. Every for-profit center must continue to meet the 25 percent standard in order to be eligible to claim reimbursement each calendar month. No claims for reimbursement may be paid for meals served at a for-profit center in a calendar month when less than 25 percent of eligible children or adult participants meet this standard.

    This rule would also not change the States' responsibilities for the assignment and calculation of rates of reimbursement. To calculate payments for public, private non-profit, and for-profit centers, State agencies receive monthly information from CACFP institutions about the eligibility of children and adult participants. Public and private non-profit institutions will continue to report this information to the State agency each month. For-profit institutions that do not meet the criteria demonstrating that at least 50 percent of children or adult participants in care are from low-income households would also continue to report eligibility information each month.

    More than 65,300 child care centers and 2,700 adult care centers participated in CACFP in 2017, according to USDA administrative data released in April 2018. The numbers represent independent centers and centers that participate under a sponsoring organization, which the data collectively refer to as outlets—the individual child or adult care centers where meals are actually served. Of these outlets, USDA estimates that 18,841, or about 28 percent, were for-profit centers. In North Carolina, Georgia, and Florida, for-profit centers made up over half of the total number of centers.

    The changes proposed in this rule would only apply to CACFP institutions—the independent centers and sponsoring organizations that are responsible for CACFP for-profit reporting requirements—not the individual centers that participate under a sponsoring organization. USDA administrative data showed that, in 2017, 9,770 independent for-profit centers and sponsoring organizations of for-profit centers participated in CACFP. Out of this universe of 9,770 for-profit institutions, USDA estimates that this rule would change reporting requirements for 7,920, or about 80 percent.

    USDA recognizes that State agencies take different approaches in assigning and computing rates of reimbursement, depending on the structure and capabilities of their automated financial systems and the other technology investments they choose. Some of the options that USDA has considered addressing in this rule, such as allowing eligible for-profit centers to receive the assigned payment rate or submit information to the State agency to recalculate the rate at other intervals, have raised program integrity issues. Some have also raised concerns about preserving equity among public, private non-profit, and for-profit centers.

    USDA seeks comments to help determine further changes, particularly from States where for-profit centers make up a significant proportion of CACFP centers. We encourage your comments to help us better understand what the differences in claims processing systems are and how they may impact for-profit institutions differently from public and non-profit centers and sponsoring organizations. It would be especially helpful to know how State administrators and local partners view the Paperwork Reduction Work Group's recommendations for assigning and amending payment rates to centers in CACFP.

    Eligibility Determination and Verification

    A for-profit center in CACFP is defined under 7 CFR 226.2 as a child care center, outside-school-hours care center, or adult day care center providing nonresidential day care services that does not qualify for tax-exempt status under the Internal Revenue Code of 1986. Claims for reimbursement from, or on behalf of, a for-profit child care center or an outside-school-hours-care center may be submitted only for calendar months during which at least 25 percent of the children in care are eligible for free and reduced-price meals or receive benefits, for which the center receives compensation, under title XX of the Social Security Act. For-profit centers serving adults may submit claims for reimbursement only for calendar months during which at least 25 percent of the adults enrolled in care receive benefits, for which the center receives compensation, under title XIX or title XX of the Social Security Act, or a combination of both.

    CACFP payment procedures under 7 CFR 226.10(c) require all for-profit child and adult care institutions to submit information to the State agency to verify their eligibility, for each month in which a for-profit child care center, for-profit outside-school-hours care center, or for-profit adult day care center claims reimbursement. Child care institutions must provide the number and percentage of children in care that documents that at least 25 percent of their enrollment or licensed capacity, whichever is less, is eligible for free and reduced-price meals or receive benefits, for which the center receives compensation, under title XX of the Social Security Act. Adult day care institutions must provide the percentage of enrolled adult participants that documents that at least 25 percent receive benefits, for which the center receives compensation, under title XIX or title XX of the Social Security Act.

    USDA proposes several amendments to 7 CFR 226.10(c), including technical changes that would conform 7 CFR 226.10(c) with the codification requirements of the Office of the Federal Register and present the information in paragraph (c) in a clear, concise, yet thorough manner. Programmatically, this rule would exempt new institutions from re-verifying their monthly eligibility if their initial application demonstrates that at least 50 percent of children or adult participants in care are from low-income households.

    With an annual eligibility determination, independent for-profit centers and sponsoring organizations of for-profit centers would not be required to re-verify their eligibility on monthly claim forms if the 50 percent standard is met.

    However, to be eligible to submit a monthly claim for reimbursement, each institution must also ensure that, if enrollment changes, the center will still meet the criteria for for-profit centers to demonstrate that at least 25 percent of children or adult participants in care are from low-income households. No claims for reimbursement may be paid for meals served at a for-profit center in a calendar month when less than 25 percent of eligible children or adult participants meet this standard. Under this rule, it would be the responsibility of the institution to notify the State agency each month in which reimbursement would not be claimed.

    This rule would encourage State agencies to utilize flexibilities that would also ease the administrative burden of State requirements. Based on informal input, USDA understands that in some States, additional paperwork may be requested to verify that a for-profit center meets the 25 percent standard. For example, a State agency may require the sponsoring organization to collect documentation of attendance, income eligibility, or title XIX or title XX participation, from its for-profit centers, with each month's claiming data. Under this rule, no additional submission of information to support the eligibility determination would be necessary if the center's annual for-profit eligibility percentage were 50 percent or greater. The sponsoring organization would check the center's eligibility documentation to verify children or adult participants' attendance or eligibility for meal benefits during a review. The center would not need to submit additional information to the sponsoring organization.

    This rule would also exempt renewing institutions if they annually demonstrate that at least 50 percent of the children or adult participants in care are from low-income households. USDA proposes corresponding changes to make verification of eligibility of participating for-profit institutions an annual State agency responsibility.

    USDA has not required renewing for-profit institutions to provide documentation of eligibility because, as a condition of their eligibility, for-profit centers are required to document that the 25 percent standard is met each month. Although the State agency receives this information monthly as part of the claiming process, 7 CFR 226.6(f)(3)(iv) of the regulations allows, but does not require, the State agency to request periodic resubmission of documentation to determine the continued eligibility of renewing centers. This rule would make annual reporting of eligibility information a requirement for all for-profit institutions, and move this provision from 7 CFR 226.6(f)(3)(iv) to the list of responsibilities under 7 CFR 226.6(f)(1).

    Accordingly, this rule proposes to make technical changes to 7 CFR 226.10(c). New paragraphs at 7 CFR 226.10(c)(3) and (c)(4) would exempt for-profit child or adult care centers from re-verifying their eligibility to submit claims each month, if they annually meet the criteria for for-profit centers to demonstrate that at least 50 percent of children or adult participants in care are from low-income households. A new paragraph at 7 CFR 226.10(c)(5) would require the institution to notify the State agency each month in which reimbursement would not be claimed if a for-profit center that had verified an annual eligibility percentage of 50 percent or greater did not meet the 25 percent standard. This rule would also add a new paragraph at 7 CFR 226.6(f)(1) to make verification of eligibility of all participating for-profit institutions an annual State agency responsibility.

    Assignment and Computation of Rates of Reimbursement

    State agencies have three options—actual counts, claiming percentages, and blended per-meal rates—for assigning rates of reimbursement, at 7 CFR 226.9(b), and computing reimbursement, at 7 CFR 226.11(c)(5), for child care centers, outside-school-hours-care centers, and adult day care centers.

    State agencies may assign rates of reimbursement, not less frequently than annually, on the basis of family-size and income information reported by each institution. The assigned rates of reimbursement may be changed more frequently than annually if warranted by changes in family size and income information. Annual assignment of rates is a State option, not a requirement.

    USDA is not proposing any changes in the assignment or computation of rates of reimbursement when the annual for-profit eligibility percentage is less than 50 percent. The State agency would continue to have the option of assigning rates of reimbursement annually or more frequently than annually for for-profit centers that do not meet the 50 percent standard. However, in States which elect claiming percentages or blended rates, this rule proposes that the State agency assign an annual rate of reimbursement when the 50 percent standard is met. The State agency would use the separate free and reduced-price counts that support each center's annual for-profit eligibility percentage to compute an annual claiming percentage or an annual blended rate. This rule would also provide flexibility, as needed for proper administration of CACFP, to allow the State agency to require a for-profit center to submit information to recalculate the claiming percentage or blended rate more frequently than annually.

    These proposed changes are consistent with USDA's long-standing view that State agencies should utilize the flexibilities available in the regulations to simplify CACFP operations. In policy guidance, CACFP 15-2013, Existing Flexibilities in the Child and Adult Care Food Program, issued on July 26, 2013, USDA encourages State agencies to annually assign rates of reimbursement for centers.

    When reviews disclose serious noncompliance, requiring centers to re-evaluate the claiming percentage or blended rate each month would be an appropriate component of a corrective action plan.

    However, for most centers which operate CACFP in good standing, allowing an annually determined claiming percentage or an annually determined blended rate would streamline the eligibility process. It would reduce the number of times the centers have to determine eligibility and provide more transparency for them to understand how they are reimbursed.

    Accordingly, this rule proposes to add new paragraphs at 7 CFR 226.9(b)(2) and 226.11(c)(4) for computing rates of reimbursement for for-profit centers in States where claiming percentages or blended rates are assigned, if the center's annual eligibility percentage is 50 percent or greater. The proposed changes would allow State agencies to use the free and reduced-price counts that support the for-profit eligibility determination to assign each eligible for-profit center an annual claiming percentage or annual blended rate, with exceptions when needed for proper program administration.

    Public Submission

    Public input and assessment, with an opportunity to examine CACFP operations and consider improvements related to this rule, are essential elements of the rulemaking process. We invite the public to submit comments to help USDA gain a better understanding of both the possible benefits and any negative impacts associated with the changes proposed in this rule.

    This proposed rule reflects USDA's commitment to work with all of our partners, including State administrators, sponsoring organization leaders, for-profit center operators, advocates, and other CACFP stakeholders to develop innovative strategies to ensure that CACFP requirements are effective and practical.

    USDA is actively looking for more information, particularly regarding the Paperwork Reduction Work Group's recommendations for assigning reimbursement rates and USDA's efforts to balance operational flexibilities with improvements in program integrity.

    Comments on the economic effects of this rule that include quantitative and qualitative data—such as the public's insights on the occupations responsible for the paperwork and other inputs, which would help USDA prepare benefit cost analyses and narrow down the range of cost savings—are also especially helpful.

    Please select those issues that most concern and affect you, or that you best understand, and include examples of how the proposed rule would impact you, positively or negatively. Consider what could be done to foster incentives for flexibility, consistency, eliminating duplication, ensuring compliance, and protecting program integrity. For example, consider:

    • How easily State agency and sponsoring organization financial systems could support the changes;

    • What impacts, if any, there would be for State agencies or sponsoring organizations in processing claims for reimbursement;

    • How State agency financial systems could impact for-profit institutions differently from other types of institutions;

    • How compliance would be monitored;

    • How likely it would be for a for-profit center to drop below the 25 percent standard, after the center verified an annual eligibility percentage of 50 percent;

    • How the State agency or sponsoring organization would determine that a for-profit center dropped below the 25 percent standard, after the center had verified an annual eligibility percentage of 50 percent, and how the claiming process would be impacted;

    • What flexibilities, if any, there could be for for-profit centers that fall below the 50 percent standard, but above the 25 percent standard;

    • What impacts there would be if for-profit centers could request the State agency to amend the claiming percentages or blended rates more frequently than annually;

    • How participation could be impacted if for-profit centers have the option of submitting information to the State agency to amend the claiming percentages or blended rates more frequently than annually; and

    • How, or if, the changes proposed in this rule would make CACFP more efficient and easier to manage.

    We welcome your ideas for improving CACFP and ways that USDA can serve you better. USDA will carefully consider all relevant comments submitted during the 60-day comment period for this rule. Comments may be submitted as outlined in Addresses.

    Procedural Matters Executive Order 12866, 13563 and 13771

    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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This proposed rule was initially determined to be significant and was reviewed by the Office of Management and Budget (OMB). On July 24, 2018, OMB changed the designation to not significant. Executive Order 13771 directs agencies to reduce regulation and control regulatory costs and provides that for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process. FNS considers this rule to be an Executive Order 13771 deregulatory action.

    Economic Summary

    A regulatory impact analysis must be prepared for major rules with economically significant effects ($100 million or more in any one year). USDA does not anticipate that this proposed rule is likely to have an economic impact of $100 million or more in any one year, and therefore, does not meet the definition of “economically significant” under Executive Order 12866. The changes proposed in this rule would result in a small amount of administrative savings from reducing the monthly reporting requirements to once a year.

    The proposed changes are not expected to increase CACFP costs. The proposed rule decreases the estimated annual staff time required to do the reporting by 5.5 hours per year per center. According to the Paperwork Reduction Act section of this rule, the number of estimated annual responses per center decreases from 12 to 1. At 30 minutes per response, this is a decrease of 5.5 staff hours per center per year. It is highly unlikely that saving 5.5 hours of staff time per year would provide sufficient incentive to induce additional eligible centers to participate if those centers are not already participating in CACFP. USDA does not estimate that there would be any change in center participation, or any changes to any other costs associated with CACFP, resulting from this proposed rule.

    While the changes proposed in this rule impact for-profit institutions, which are responsible for the reporting requirements, it is important to get a sense of how many for-profit outlets—the individual child or adult care centers where the meals are actually served—would meet the 50 percent standard, and how it would impact the decision to participate in CACFP. Administrative data collected by USDA does not contain outlet-level information needed to assess the potential impact of this proposed rule to participation. USDA obtained informal outlet-level information from a number of States to analyze. The data contained the number of for-profit outlets and the percent of eligible participants as well as two separate months of information to evaluate the potential monthly volatility of the eligibility percentages in for-profit outlets. These States represent a variety of sizes and regions and account for roughly 40 percent of the total number of for-profit outlets in Fiscal Year (FY) 2017.

    The majority of for-profit outlets in the State data had annual eligibility percentages of 50 percent or more. The percent of for-profit outlets with an annual eligibility percentage of 50 percent or more ranged from 60 percent of the total number of for-profit outlets to over 90 percent of the total number of for-profit outlets. The data demonstrate that the majority of for-profit outlets continue to participate in CACFP because the number of eligible children and adult participants make it financially viable. While this rule would create administrative efficiencies, it is unlikely that the proposed changes would provide the incentive for more outlets with an annual eligibility percentage of 50 percent to participate in CACFP.

    USDA also reviewed the State data to gain a sense of the distribution of the percentages of eligible participants in for-profit outlets that would meet or exceed the proposed 50 percent standard. The average percentage of eligible participants was between 70 percent and 90 percent for those sites meeting or exceeding the standard across all eight States. The average percent of eligible participants in sites not meeting the standard was above 35 percent. This indicates that, not only do the majority of for-profit outlets meet the 50 percent standard, but on average, outlets serve a much higher percentage of eligible participants.

    The likelihood of outlets falling below the proposed 50 percent threshold would be very low. To better understand how many outlets may potentially fall below the 50 percent standard, USDA reviewed the State data to determine the number of for-profit outlets that have eligibility percentages between 50 percent and 55 percent.

    Overall, about 6 percent of outlets (about 300) had eligibility percentages that fell within this range. The individual States ranged from less than 1 percent to slightly more than 10 percent. Likewise, the number of outlets falling between 45 percent and 50 percent were slightly less, with only about 4 percent (about 200) of the for-profit outlets in the eight States falling in this range.

    The monthly variation in the percentage of for-profit outlets that meet the 50 percent standard is relatively small. Overall, there was an increase of about 1 percent in the number of for-profit outlets meeting the proposed 50 percent threshold from July to September 2017.

    The high percentages of eligible participants, along with the large numbers of for-profit outlets meeting the proposed 50 percent standard, indicate that the impact of the proposed changes in this rule would be largely administrative. The changes aim to increase efficiencies, but are not projected to impact CACFP participation and costs.

    Based on this evidence, USDA estimates that the only savings associated with this proposed rule would be a decrease in annual reporting burden on existing for-profit institutions. There were 9,770 independent for-profit centers and sponsoring organizations of for-profit centers participating in CACFP in FY 2017, according to USDA administrative data. USDA estimates about 80 percent of for-profit institutions would be impacted by this rule and would experience a reduction in burden. This percentage allows for some sponsoring organizations that do not have outlets meeting the proposed 50 percent standard.

    The data provided by the States indicate that the majority of outlets exceed the proposed 50 percent standard, making it very likely that the vast majority of sponsors contain at least one outlet meeting or exceeding the standard.

    As described in the Paperwork Reduction Act section of this rule, the reporting burden for these institutions would be 43,559 hours. Depending on whether one assumes that an administrative assistant or the center director or submits these reports, this decrease would result in an annualized estimated savings of $1.3 million (assuming administrative assistants submit the reports) to $2.2 million (assuming center directors submit the reports), each year from FY 2019 through FY 2023.

    Regulatory Flexibility Act

    The Regulatory Flexibility Act, 5 U.S.C. 601-612, requires Agencies to analyze the impact of rulemaking on small entities and consider alternatives that would minimize any significant impacts on a substantial number of small entities. Pursuant to that review, it has been certified that this rule would not have a significant impact on a substantial number of small entities. This rule would exempt for-profit centers from re-verifying their eligibility to submit claims each month, if they annually meet the criteria for for-profit centers that consistently serve a high number of children or adult participants from low-income households. This rule is a deregulatory action that would not impact a substantial number of small entities. USDA estimates that 28 percent of centers participating in CACFP are for-profit.

    Unfunded Mandates Reform Act

    Title II of the Unfunded Mandate Reform Act of 1995 (UMRA) established requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments, and the private sector.

    Under Section 202 of UMRA, USDA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, or tribal governments in the aggregate, or to the private sector, of $100 million or more in any one year. When such a statement is needed for a rule, section 205 of UMRA generally requires USDA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, more cost-effective or least burdensome alternative that achieves the objectives of the rule. This proposed rule contains no Federal mandates, under the regulatory provisions of title II of UMRA, for State, local, and tribal governments, or the private sector, of $100 million or more in any one year. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

    Executive Order 12372

    CACFP is listed in the Assistance Listings under the Catalog of Federal Domestic Assistance (CFDA) Number 10.558 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. Since the Child Nutrition Programs are State-administered, USDA has formal and informal discussions with State and local officials, including representatives of Indian Tribal Organizations, on an ongoing basis regarding CACFP requirements and operation. This provides USDA with the opportunity to receive regular input from State administrators and local CACFP operators, which contributes to the development of feasible requirements.

    Federalism Summary Impact Statement

    Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulations describing the agency's considerations in terms of the three categories called for under section 6(b)(2)(B) of Executive Order 13132. USDA has determined that this rule does not have federalism implications. This rule does not impose substantial or direct compliance costs on State and local governments. Therefore, under section 6(b) of the Executive Order, a federalism summary is not required.

    Executive Order 12988, Civil Justice Reform

    This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rulemaking, when published as a final rule, is intended to have preemptive effect with respect to any State or local laws, regulations, or policies which conflict with its provisions or which would otherwise impede its full and timely implementation. This rulemaking is not intended to have retroactive effect. Prior to any judicial challenge to the provisions of a final rule, all applicable administrative procedures must be exhausted.

    Civil Rights Impact Analysis

    FNS has reviewed this proposed rule in accordance with USDA Regulation 4300-4, “Civil Rights Impact Analysis,” to identify any major civil rights impacts the rule might have on CACFP participants on the basis of age, race, color, national origin, sex, or disability. After a careful review of the rule's intent and provisions, USDA has determined that this rule would not be expected to limit or reduce the ability of protected classes of individuals to participate as CACFP operators or as recipients of CACFP meal benefits. USDA also would not expect this rule to have any disparate impacts on CACFP operators by protected classes of individuals.

    Executive Order 13175

    Executive Order 13175 requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. A consultation with Indian Tribal Organizations took place on March 14, 2018. USDA proposes this deregulatory action to encourage existing for-profit centers, including for-profit child care, outside-school-hours care, and adult day care centers in Indian country, to continue to participate in CACFP, and maintain access to nutritious meals for eligible children and adult participants. USDA anticipates that this action would have no significant cost and no major increase in regulatory burden on tribal organizations.

    Paperwork Reduction Act

    The Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35 and 5 CFR 1320, requires OMB to approve all collections of information by a Federal agency before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number. This rule contains an information collection requirement that has been approved by OMB under OMB Control Number 0584-0055.

    This is a revision to an existing collection: Child and Adult Food Care Program, OMB Control Number 0584-0055. This change is contingent upon OMB approval under the Paperwork Reduction Act of 1995.

    When the information collection requirement has been approved, FNS will publish a separate action in the Federal Register announcing OMB's approval. Comments on this proposed rule must be received by December 3, 2018.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. All responses to this notification will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

    Title: 7 CFR part 226, Increasing Flexibility for Verification of For-Profit Center Eligibility in the Child and Adult Care Food Program.

    OMB Number: 0584-0055.

    Expiration Date: February 29, 2020.

    Type of Request: Revision.

    Abstract: This is a revision of an existing information collection associated with 7 CFR part 226, OMB Number 0584-0055, based on this rulemaking. USDA proposes to modify regulatory requirements for for-profit institutions in the Child and Adult Care Food Program (CACFP) to provide information verifying their eligibility to submit claims for reimbursement each month.

    Under this proposed rule for-profit centers, institutions that annually demonstrate that at least 50 percent of children or adult participants in care are from low-income households would be exempt from monthly verification.

    By reducing the frequency of verification, this rule would modestly reduce the reporting burden for eligible for-profit centers and sponsoring organizations of for-profit centers.

    There would be no change in reporting burden for for-profit centers that do not meet the 50 percent standard. This rule would also not affect reporting requirements for public and non-profit institutions.

    The CACFP information collection, approved with a nonsubstantive change on August 31, 2018, includes a reporting requirement under 7 CFR 226.10(c) for sponsoring organizations and other institutions to submit documentation to verify the eligibility of for-profit centers. USDA estimates that 9,770 for-profit institutions each provide 12 reports annually, for a total of 117,240 responses. The estimated average number of burden hours per response is 0.50, resulting in an estimated total of 58,620 burden hours.

    The program change proposed in this rule would only impact for-profit institutions that meet the 50 percent standard. USDA estimates a subset of 1,850 for-profit institutions, or about 20 percent of the 9,770 institution respondents that would not meet this standard, would each continue to provide 12 reports annually, for a total of 22,203 responses. Their reporting burden would not change.

    The estimated average number of burden hours per response is 0.50, resulting in an estimated total of 11,101 burden hours.

    However, a larger subset of 7,920 for-profit institutions, or about 80 percent of the 9,770 institution respondents, would meet the 50 percent standard.

    Each respondent would be exempt from monthly verification and would provide only one report annually for a total of 7,920 responses. The number of estimated responses from each eligible institution would decrease from 12 responses to only one per year. The estimated average number of burden hours per response is 0.50, resulting in an estimated total of 3,960 burden hours. The estimated total number of burden hours would be reduced by 43,559 hours, from 58,620 to 15,061.

    This rule would not require any additional reporting of eligibility information from any for-profit institution, nor would it impose any changes in recordkeeping requirements. Although this rule would ease administrative burden for institutions that may have to report information requested by the State agency to support the eligibility determination, the collection of information under the Paperwork Reduction Act only addresses estimates of federally-imposed reporting or recordkeeping requirements. Due to rounding, our estimates may not match to totals. Here is a summary of our analysis:

    Respondents: For-Profit Institutions.

    Estimated Number of Respondents: 7,920.

    Estimated Number of Responses per Respondent: 1.

    Estimated Total Annual Responses: 7,920.

    Estimated Time per Response: 0.50.

    Estimated Total Annual Burden: 3,960.

    Current OMB Inventory (Reporting): 1,870,412.

    Current OMB Inventory (Reporting and Recordkeeping): 2,481,136.

    OMB Inventory with Proposed Rule (Reporting and Recordkeeping): 2,437,577.

    Difference in Burden as a Result of the Proposed Rule: −43,559.

    7 CFR Part 226 Child and Adult Food Care Program Sponsors and Institutions (Currently Approved) Requirement Estimated number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Estimated total hours per
  • response
  • Estimated total burden
    226.10(c): All for-profit institutions submit documentation to verify for-profit center eligibility 9,770.00 12.00 117,240.00 0.50 58,620.00 Total Sponsor/Institution reporting burden 21,052.00 31.88 671,048.00 0.92 616,697.18 Total reporting burden for 0584-0055 2,828,158.00 2.57 7,276,600.84 0.26 1,870,411.75 * Some totals may not add due to rounding.
    7 CFR Part 226 Child and Adult Food Care Program Sponsors and Institutions (With Proposed Changes) Requirement Estimated number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Estimated total hours per
  • response
  • Estimated total burden
    226.10(c): For-profit institutions that would not be exempt from monthly verification submit documentation to verify for-profit eligibility 1,850.24 12.00 22,202.86 0.50 11,101.43 226.10(c): For-profit institutions that would be exempt from monthly verification 7,919.76 1.00 7,919.76 0.50 3,959.88 Total Sponsor/Institution reporting burden 21,052.00 27.74 583,930.62 0.98 573,138.49 * Some totals may not add due to rounding.
    7 CFR Part 226 Increasing Flexibility for Verification of For-Profit Center Eligibility in the Child and Adult Care Food Program Affected public Estimated number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Estimated total hours per
  • response
  • Estimated total burden
    Total Reporting State Agency 56.00 552.16 30,921.00 0.14 4,200.92 Sponsor/Institution 21,052.00 27.74 583,930.62 0.98 573,138.49 Facilities 180,740.00 12.00 2,168,880.00 0.41 883,761.00 Household 2,626,310.00 1.68 4,405,751.84 0.08 365,752.64 Total reporting burden for 0584-0055 2,828,158.00 2.54 7,189,483.46 0.25 1,826,853.06 Total Recordkeeping State Agency 56.00 27.00 1,512.00 1.37 2,072.00 Sponsor/Institution 21,052.00 9.22 194,196.00 0.34 66,432.00 Facilities 180,740.00 3.00 542,220.00 1.00 542,222.00 Total recordkeeping burden for 0584-0055 201,848.00 3.66 737,928.00 0.83 610,724.00 Total of Reporting and Recordkeeping Reporting 2,828,158.00 2.54 7,189,483.46 0.25 1,826,853.06 Recordkeeping 201,848.00 3.66 737,928.00 0.83 610,724.00 Total 3,030,006.00 2.62 7,927,411.46 0.31 2,437,577.06 * Some totals may not add due to rounding.
    E-Government Act Compliance

    USDA is committed to complying with the E-Government Act of 2002, 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.

    List of Subjects in 7 CFR Part 226

    Accounting, Day care, Food assistance programs, Grant programs, Grant programs—health, Infants and children, Reporting and recordkeeping requirements.

    Accordingly, 7 CFR part 226 is proposed to be amended as follows:

    PART 226—CHILD AND ADULT CARE FOOD PROGRAM 1. The authority citation for 7 CFR part 226 continues to read as follows: Authority:

    Secs. 9, 11, 14, 16, and 17, Richard B. Russell National School Lunch Act, as amended, 42 U.S.C. 1758, 1759a, 1762a, 1765 and 1766.

    2. In §  226.6: a. Add a new paragraph (f)(1)(x). b. Remove paragraphs (f)(3)(iv)(D) and (E). c. Redesignate paragraphs (f)(3)(iv)(F) and (G) as paragraphs (f)(3)(iv)(D) and (E).

    The addition reads as follows:

    § 226.6 State agency administrative responsibilities.

    (f) * * *

    (1) * * *

    (x) Comply with the following requirements for determining the eligibility of for-profit centers:

    (A) Require for-profit child care institutions to submit documentation on behalf of their centers of:

    (1) Eligibility of at least 25 percent of children in care (enrolled or licensed capacity, whichever is less) for free or reduced-price meals; or

    (2) Compensation received under title XX of the Social Security Act of nonresidential day care services and certification that at least 25 percent of children in care (enrolled or licensed capacity, whichever is less) were title XX beneficiaries during the most recent calendar month;

    (B) Require for-profit adult care centers to submit documentation that they are currently providing nonresidential day care services for which they receive compensation under title XIX or title XX of the Social Security Act, and certification that not less than 25 percent of enrolled participants in each such center, during the most recent calendar month, were title XIX or title XX beneficiaries;

    3. In § 226.9: a. Redesignate paragraphs (b)(1), (b)(2), and (b)(3), as paragraphs (b)(1)(i), (b)(1)(ii), and (b)(1)(iii), respectively. Redesignate the introductory text in paragraph (b) as paragraph (b)(1) and add the paragraph heading “Reimbursement methods.” b. Add a new paragraph (b)(2).

    The addition reads as follows:

    § 226.9 Assignment of rates of reimbursement for centers.

    (b) * * *

    (2) Options for for-profit centers.

    (i) In States where the State agency has elected the methods described under paragraphs (b)(1)(ii) or (b)(1)(iii) of this section, the State agency uses the free and reduced-price counts that support each center's annual for-profit eligibility percentage, if it is 50 percent or greater, to assign an annual claiming percentage or an annual blended per-meal rate.

    (ii) The State agency may require a for-profit center to submit information to recalculate the claiming percentage or blended rate more frequently than annually, as needed for proper administration of the Program.

    4. In §  226.10: a. In paragraph (a), remove the reference “§ 226.6(f)(3)(iv)(F)” and add in its place the reference “§ 226.6(f)(3)(iv)(D)”. b. Revise paragraph (c).

    The revision reads as follows:

    § 226.10 Program payment procedures.

    (c) Claims for reimbursement.

    (1) Each institution must report information required by the State agency's financial management system. This information must have sufficient detail to justify the claim for reimbursement and enable the State agency to complete the final Report of the Child and Adult Care Food Program (FNS-44) required under § 226.7(d) of this part.

    (2) In submitting a claim for reimbursement, each institution must certify that the claim is correct and that records are available to support it.

    (3) For each month in which reimbursement is claimed, each independent for-profit child care center, independent for-profit outside-school-hours care center, and sponsoring organization of for-profit centers must also certify that at least 25 percent of children in care (enrolled or licensed capacity, whichever is less) are eligible for free or reduced-price meals or receive title XX benefits.

    (i) Claims for reimbursement may be submitted only for months in which the 25 percent standard for participation of eligible children is met.

    (ii) Children who drop in only to participate in afterschool activities and receive at-risk afterschool meals or snacks must not be considered in determining this standard.

    (iii) Reimbursement may not be claimed for any meals served at a for-profit center when less than 25 percent of children in care meet this standard.

    (iv) If the center's annual for-profit eligibility percentage is less than 50 percent, as determined under §§ 226.6(b)(1)(ix) and (f)(1)(x)(A) of this part, the center must report the percentage of children in care who meet this standard.

    (v) If the center's annual for-profit eligibility percentage is 50 percent or greater, as determined under §§ 226.6(b)(1)(ix) and (f)(1)(x)(A) of this part, the center does not need to report the percentage of children in care who meet this standard.

    (vi) No additional submission of information to support the eligibility determination, such as attendance or title XX participation, is necessary if the center's annual for-profit eligibility percentage is 50 percent or greater.

    (4) For each month in which reimbursement is claimed, each independent for-profit adult day care center and sponsoring organization of for-profit adult day care centers must also certify that at least 25 percent of enrolled adult participants received title XIX or title XX benefits.

    (i) Claims for reimbursement may be submitted only for months in which the 25 percent standard for participation of eligible adult participants is met.

    (ii) Reimbursement may not be claimed for any meals served at a for-profit center when less than 25 percent of enrolled adult participants meet this standard.

    (iii) If the center's annual for-profit eligibility percentage is less than 50 percent, as determined under §§ 226.6(b)(1)(ix) and (f)(1)(x)(B) of this part, the center must report the percentage of enrolled adult participants who meet this standard.

    (iv) If the center's annual for-profit eligibility percentage is 50 percent or greater, as determined under §§ 226.6(b)(1)(ix) and (f)(1)(x)(B) of this part, the center does not need to report the percentage of enrolled adult participants who meet this standard.

    (v) No additional submission of information to support the eligibility determination, such as attendance or participation in title XIX or title XX, is necessary if the center's annual for-profit eligibility percentage is 50 percent or greater.

    (5) For each month in which a for-profit center, described under paragraphs (c)(3)(v) or (c)(4)(iv) of this section, does not meet the 25 percent standard, the institution must notify the State agency that reimbursement will not be claimed.

    (6) Prior to submitting its consolidated monthly claim to the State agency, each sponsoring organization must perform edit checks on each facility's meal claim. At a minimum, the sponsoring organization's edit checks must:

    (i) Verify that each facility has been approved to serve the types of meals claimed; and

    (ii) Compare the number of children or adult participants enrolled for care at each facility, multiplied by the number of days on which the facility is approved to serve meals, to the total number of meals claimed by the facility for that month. Discrepancies between the facility's meal claim and its enrollment must be subjected to more thorough review to determine if the claim is accurate.

    5. In § 226.11, revise paragraph (c)(4) to read as follows:
    § 226.11 Program payments for centers.

    (c) * * *

    (4) For-profit centers.

    (i) For-profit child care centers, including for-profit at-risk and outside-school-hours care centers, must be reimbursed only for the calendar months during which at least 25 percent of the children in care (enrolled or licensed capacity, whichever is less) were eligible for free or reduced-price meals or were title XX beneficiaries. However, children who only receive at-risk afterschool meals or snacks must not be considered in determining this eligibility.

    (ii) For-profit adult day care centers must be reimbursed only for the calendar months during which at least 25 percent of enrolled adult participants were beneficiaries of title XIX, title XX, or a combination of titles XIX and XX.

    (iii) In States where the State agency has elected the methods described under paragraphs (c)(5)(ii) and (c)(5)(iii) of this section, the State agency uses the free and reduced-price counts that support each center's annual for-profit eligibility percentage, if it is 50 percent or greater, to assign an annual claiming percentage or an annual blended per-meal rate.

    (iv) The State agency may require a for-profit center to submit information to recalculate the claiming percentage or blended rate more frequently than annually, as needed for proper administration of the Program.

    Dated: June 28, 2018. Brandon Lipps, Acting Deputy Under Secretary, Food, Nutrition, and Consumer Services.
    [FR Doc. 2018-21445 Filed 10-3-18; 8:45 am] BILLING CODE 3410-30-P
    DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency 12 CFR Part 30 [Docket ID OCC-2018-0028] RIN 1557-AE51 OCC Guidelines Establishing Standards for Recovery Planning by Certain Large Insured National Banks, Insured Federal Savings Associations, and Insured Federal Branches; Technical Amendments; Correction AGENCY:

    Office of the Comptroller of the Currency, Treasury.

    ACTION:

    Proposed rulemaking; correction.

    SUMMARY:

    This document corrects the SUPPLEMENTARY INFORMATION section to a proposed rule published in the Federal Register on September 19, 2018, regarding OCC's enforceable guidelines relating to recovery planning standards for insured national banks, insured federal savings associations, and insured federal branches (Guidelines). This document corrects two technical errors.

    DATES:

    October 4, 2018.

    ADDRESSES:

    400 7th Street SW, Suite 3E-218, Washington, DC 20219.

    FOR FURTHER INFORMATION CONTACT:

    Andra Shuster, Senior Counsel (202) 649-5490; or, for persons who are deaf or hard of hearing, TTY, (202) 649-5597.

    SUPPLEMENTARY INFORMATION:

    Correction

    In the Federal Register of September 19, 2018, in FR Doc. 2018-20166, on page 47313, in the third column, remove “September 19, 2016” and add in its place “September 29, 2016”; and on page 47314, in the second column, remove “October 19, 2018” and add in its place “30 days from date of publication of the final guidelines in the Federal Register”.

    Dated: September 28, 2018. Bao Nguyen, Acting Senior Deputy Comptroller and Chief Counsel.
    [FR Doc. 2018-21638 Filed 10-3-18; 8:45 am] BILLING CODE 4810-33-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0806; Product Identifier 2018-NM-056-AD] RIN 2120-AA64 Airworthiness Directives; Airbus SAS Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to supersede Airworthiness Directive (AD) 2015-12-08, which applies to all Airbus SAS Model A318 and A319 series airplanes and all Model A320-211, A320-212, A320-214, A320-231, A320-232, A320-233, A321-111, A321-112, A321-131, A321-211, A321-212, A321-213, A321-231, and A321-232 airplanes. AD 2015-12-08 requires an inspection to determine the batch number or installation date of the oxygen pipe assembly that is installed at the end of the right-hand crew distribution line, and replacement of the pipe if necessary. Since we issued AD 2015-12-08, further investigation determined that affected oxygen pipes may have been installed on more airplanes than initially identified. This proposed AD would revise the applicability to include additional airplane models and additional pipes to be replaced if necessary. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by November 19, 2018.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office—EIAS, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email [email protected]; internet http://www.airbus.com. You may view this referenced service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0806; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations (phone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0806; Product Identifier 2018-NM-056-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    We issued AD 2015-12-08, Amendment 39-18182 (80 FR 34262, June 16, 2015) (“AD 2015-12-08”), for all Airbus SAS Model A318-111, A318-112, A318-121, A318-122, A319-111, A319-112, A319-113, A319-114, A319-115, A319-131, A319-132, A319-133, A320-211, A320-212, A320-214, A320-231, A320-232, A320-233, A321-111, A320-112, A320-131, A320-211, A320-212, A320-213, A320-231, and A320-232 airplanes. AD 2015-12-08 requires an inspection to determine the batch number or installation date of the oxygen pipe assembly that is installed at the end of the right-hand crew distribution line, and replacement of the pipe if necessary. AD 2015-12-08 resulted from a report of corrosion found during the manufacturing process for some oxygen pipe assemblies that are used to supply oxygen to the flight crew. We issued AD 2015-12-08 to address corrosion of the oxygen pipe assemblies, which could lead to blocked or reduced oxygen supply to a flight crew in case of decompression or smoke/fire in the flight deck. In addition, the presence of particles in oxygen lines, under certain conditions, increases the risk of fire in the flight deck.

    Actions Since AD 2015-12-08 Was Issued

    Since we issued AD 2015-12-08, we have determined that additional airplane models may be subject to the identified unsafe condition.

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0060R1, dated July 19, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus SAS Model A318 and A319 series airplanes; all Model A320-211, A320-212, A320-214, A320-215, A320-216, A320-231, A320-232, A320-233, A321-111, A321-112, A321-131, A321-211, A321-212, A321-213, A321-231, and A321-232 airplanes; and certain Model A320-251N, A320-271N, and A321-271N airplanes. The MCAI states:

    Some oxygen pipe assemblies were found corroded during manufacturing at supplier level. The affected pipe assembly was installed at the end of the right hand (RH) crew distribution line, just upstream of the First Officer and RH Observer oxygen mask boxes.

    The investigation showed that the affected pipes had been heat treated just 4 weeks before the summer factory closure and were only cleaned after re-opening of the factory. During this interruption, corrosion developed in these pipes.

    This condition, if not detected and corrected, could lead to blocked or reduced oxygen supply to a flight crew member in case of decompression or smoke/fire in the cockpit. In addition, the presence of particles in oxygen lines, under certain conditions, increases the risk of fire in the cockpit.

    The parts manufacturer identified the batch numbers of the potentially affected pipes that were manufactured in a specific period in 2011. Based on that information, Airbus identified the aeroplanes on which those pipes were installed on the production line and issued SB A320-35-1069, containing instructions to remove the affected pipes from service.

    Consequently, EASA issued AD 2013-0278 [which corresponds to FAA AD 2015-12-08, Amendment 39-18182 (80 FR 34262, June 16, 2015) (“AD 2015-12-08”)] to require the identification and replacement of the affected oxygen pipes. That [EASA] AD also prohibited installation of any affected pipe on other aeroplanes.

    After EASA AD 2013-0278 was issued, further investigation determined that affected oxygen pipes may have been installed on more aeroplanes than initially identified. Consequently, Airbus revised SB A320-35-1069 and EASA issued AD 2017-0150, retaining the requirements of EASA AD 2013-0278, which was superseded, and requiring the same actions on these additional aeroplanes.

    After EASA AD 2017-0150 was issued, it was determined that five A320 and A321 NEO aeroplanes had been delivered with a configuration which potentially allows the installation of an affected oxygen pipe.

    Consequently, EASA issued AD 2018-0060, retaining the requirements of EASA AD 2017-0150, which was superseded, expanding the Applicability to include the five A320 and A321 NEO aeroplanes, and correcting the Table in Appendix 1 by removing MSN [manufacturer serial number] 5091 which belongs to Group 2.

    Since that AD was issued, several operator requests were received to clarify the required actions for Group 3 and Group 4 aeroplanes. It was determined that, as per Airbus configuration control, the EASA AD No.: 2018-0060R1 affected parts have been identified as being potentially installed in production only on Group 1 and Group 2 aeroplanes. However, it is possible that those parts migrated to other aeroplanes during maintenance; for that reason, Group 3 and 4 aeroplanes need to be considered. This AD is revised accordingly.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0806.

    Model A320-216 Airplanes

    The Airbus SAS Model A320-216 was type certificated on December 19, 2016. Before that date, any EASA AD that affected Model A320-216 airplanes was included on the Required Airworthiness Action List (RAAL). Model A320-216 airplanes have subsequently been placed on the U.S. Register, and will now be included in FAA AD actions. For Airbus SAS Model A320-216 airplanes, the requirements that correspond to AD 2015-12-08 were mandated by the MCAI via the RAAL. Although that RAAL requirement is still in effect, for continuity and clarity we have identified Airbus SAS Model A320-216 airplanes in paragraph (c) of this proposed AD; the restated requirements of paragraphs (g), (h), and (i) of this proposed AD would therefore apply to those airplanes.

    Related Service Information Under 1 CFR Part 51

    Airbus SAS has issued Service Bulletin A320-35-1069, Revision 3, dated December 8, 2017. The service information describes an inspection to determine the batch number or installation date of the oxygen pipe assembly that is installed at the end of the right hand crew distribution line, and replacement of the pipe. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    Explanation of Revised Service Information

    AD 2015-10-08 required using Airbus Service Bulletin A320-35-1069, dated April 26, 2013, for an inspection to determine the batch number or installation date of the oxygen pipe assembly that is installed at the end of the right-hand crew distribution line, and replacement of the pipe if necessary. We have determined that Airbus Service Bulletin A320-35-1069, Revision 3, December 8, 2017, adds additional airplane models to the applicability, but adds no new actions.

    FAA's Determination

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

    Proposed Requirements of This NPRM

    This proposed AD would retain all requirements of AD 2015-12-08, and would revise the applicability to include additional airplane models and additional pipes to be replaced if necessary.

    Costs of Compliance

    We estimate that this proposed AD affects 50 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • 2 work-hours × $85 per hour = $170 $0 $170 $8,500

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

    Estimated Costs of On-Condition Actions Labor cost Parts cost Cost per
  • product
  • 5 work-hours × $85 per hour = $425 $0 $425

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

    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska, and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2015-12-08, Amendment 39-18182 (80 FR 34262, June 16, 2015), and adding the following new AD: Airbus SAS: Docket No. FAA-2018-0806; Product Identifier 2018-NM-056-AD. (a) Comments Due Date

    We must receive comments by November 19, 2018.

    (b) Affected ADs

    This AD replaces AD 2015-12-08, Amendment 39-18182 (80 FR 34262, June 16, 2015) (“AD 2015-12-08”).

    (c) Applicability

    This AD applies to the Airbus SAS airplanes identified in paragraphs (c)(1) through (c)(5) of this AD, certificated in any category.

    (1) Model A318-111, -112, -121, and -122 airplanes, all manufacturer serial numbers.

    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes, all manufacturer serial numbers.

    (3) Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes, all manufacturer serial numbers.

    (4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes, all manufacturer serial numbers.

    (5) Model A320-251N, A320-271N, and A321-271N airplanes, manufacturer serial numbers 6101, 6286, 6419, 6642, and 6673.

    (d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

    (e) Reason

    This AD was prompted by a report of corrosion found during the manufacturing process for some oxygen pipe assemblies that are used to supply oxygen to the flight crew. We are issuing this AD to address corrosion of the oxygen pipe assemblies, which could lead to blocked or reduced oxygen supply to a flight crew in case of decompression or smoke/fire in the flight deck. In addition, the presence of particles in oxygen lines, under certain conditions, increases the risk of fire in the flight deck.

    (f) Compliance

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

    (g) Retained Inspection for Batch Numbers and Replacement, With New Service Information

    This paragraph restates the requirements of paragraph (g) of AD 2015-12-08, with new service information. For airplanes identified in paragraph 1.A. of Airbus Service Bulletin A320-35-1069, dated April 26, 2013: Within 7,500 flight hours or 26 months, whichever occurs first after July 21, 2015 (the effective date of AD 2015-12-08), inspect the crew oxygen pipe, having part number (P/N) D3511032000640, to determine the batch number of that pipe, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-35-1069, dated April 26, 2013; or Airbus Service Bulletin A320-35-1069, Revision 03, dated December 8, 2017. A review of airplane maintenance records is acceptable in lieu of this inspection if the batch number of the pipe can be conclusively determined from that review. If the batch number of the oxygen pipe is 19356252, 40008586, 40076689, 40187414, 40292749, 40405164, 40649383, 40724994, 40820410, or 40911832: Within 7,500 flight hours or 26 months, whichever occurs first after July 21, 2015, replace the oxygen pipe with a serviceable part, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-35-1069, dated April 26, 2013; or Airbus Service Bulletin A320-35-1069, Revision 03, dated December 8, 2017. After the effective date of this AD, only Airbus Service Bulletin A320-35-1069, Revision 3, dated December 8, 2017, may be used to do the actions required by this paragraph.

    (h) Retained Inspection for Part Number and Installation Date of Crew Oxygen Pipe, With No Changes

    This paragraph restates the requirements of paragraph (h) of AD 2015-12-08, with no changes. For airplanes identified in paragraphs (c)(1) through (c)(4) of this AD that are not identified in paragraph 1.A. of Airbus Service Bulletin A320-35-1069, dated April 26, 2013: Within 7,500 flight hours or 26 months, whichever occurs first after July 21, 2015 (the effective date of AD 2015-12-08), inspect the crew oxygen pipe to determine whether P/N D3511032000640 was installed after June 2011. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number and installation date of the pipe can be conclusively determined from that review. If the pipe was installed after June 2011, or the date cannot be conclusively determined, before further flight, do the actions required in paragraph (g) of this AD.

    (i) Retained Parts Installation Prohibition, With No Changes

    This paragraph restates the requirements of paragraph (i) of AD 2015-12-08, with no changes. For airplanes identified in paragraphs (c)(1) through (c)(4) of this AD, except for Model A320-216 airplanes: As of July 21, 2015 (the effective date of AD 2015-12-08), do not install, on any airplane, a crew oxygen pipe P/N D3511032000640, that is identified as belonging to batch number 19356252, 40008586, 40076689, 40187414, 40292749, 40405164, 40649383, 40724994, 40820410, or 40911832.

    (j) New Requirement of This AD: Inspection for Batch Numbers and Replacement for Certain Airplanes

    For airplanes identified in paragraph (c)(5) of this AD and for Model A320-216 airplanes: Within 7,500 flight hours or 26 months, whichever occurs first after the effective date of this AD, inspect the crew oxygen pipe, having P/N D3511032000640, to determine the batch number of that pipe, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-35-1069, Revision 03, dated December 8, 2017. A review of airplane maintenance records is acceptable in lieu of this inspection if the batch number of the pipe can be conclusively determined from that review. If the batch number of the oxygen pipe is 19356252, 40008586, 40076689, 40187414, 40292749, 40405164, 40649383, 40724994, 40820410, or 40911832: Within 7,500 flight hours or 26 months, whichever occurs first after the effective date of this AD, replace the oxygen pipe with a serviceable part, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-35-1069, Revision 03, dated December 8, 2017.

    (k) New Parts Installation Prohibition for Certain Airplanes

    For airplanes identified in paragraph (c)(5) of this AD and for Model A320-216 airplanes: As of the effective date of this AD, do not install, on any airplane, a crew oxygen pipe P/N D3511032000640, that is identified as belonging to batch number 19356252, 40008586, 40076689, 40187414, 40292749, 40405164, 40649383, 40724994, 40820410, or 40911832.

    (l) Credit for Previous Actions

    (1) For the airplanes identified in paragraph (g) of this AD: This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before July 21, 2015 (the effective date of AD 2015-12-08) using a service bulletin identified in paragraph (l)(1)(i) or (l)(1)(ii) of this AD.

    (i) Airbus Service Bulletin A320-35-1069, Revision 01, dated March 24, 2014.

    (ii) Airbus Service Bulletin A320-35-1069, Revision 02, dated October 26, 2016.

    (2) For airplanes identified in paragraph (j) of this AD: This paragraph provides credit for actions required by paragraph (j) of this AD, if those actions were performed before the effective date of this AD using a service bulletin identified in paragraph (l)(2)(i), (l)(2)(ii), or (l)(2)(iii) of this AD.

    (i) Airbus Service Bulletin A320-35-1069, dated April 26, 2013.

    (ii) Airbus Service Bulletin A320-35-1069, Revision 01, dated March 24, 2014.

    (iii) Airbus Service Bulletin A320-35-1069, Revision 02, dated October 26, 2016.

    (m) Other FAA AD Provisions

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

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

    (n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2018-0060R1, dated July 19, 2018, for related information. This MCAI may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0806.

    (2) For more information about this AD, contact Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.

    (3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; phone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email: [email protected]; internet: http://www.airbus.com. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    Issued in Des Moines, Washington, on September 23, 2018. John P. Piccola, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-21455 Filed 10-3-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0883; Airspace Docket No. 18-ANE-5] RIN 2120-AA66 Proposed Amendment of Class E Airspace; Bethel, ME AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class E airspace extending upward from 700 feet above the surface at Bethel Regional Airport, Bethel, ME, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures serving this airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.

    DATES:

    Comments must be received on or before November 19, 2018.

    ADDRESSES:

    Send comments on this rule to: U. S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Bldg Ground Floor Rm W12-140, Washington, DC 20590; Telephone: 1-800-647-5527, or (202) 366-9826. You must identify the Docket No. FAA-2018-0883; Airspace Docket No. 18-ANE-5, at the beginning of your comments. You may also submit and review received comments through the internet at http://www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays.

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

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

    FOR FURTHER INFORMATION CONTACT:

    John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Avenue, College Park, GA 30337; telephone (404) 305-6364..

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This proposed 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 would amend Class E airspace extending upward from 700 feet above the surface at Bethel Regional Airport, Bethel, ME, to support standard instrument approach procedures for IFR operations at this airport.

    Comments Invited

    Interested persons are invited to comment on this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

    Communications should identify both docket numbers (Docket No. FAA-2018-0888 and Airspace Docket No. 18-ANE-5) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for the address and phone number.) You may also submit comments through the internet at http://www.regulations.gov.

    Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2018-0883; Airspace Docket No. 18-ANE-5.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this document may be changed in light of the comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket. All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see the ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except federal holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, GA 30337.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend 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 Proposal

    The FAA is considering an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 to amend Class E airspace extending upward from 700 feet above the surface within a 8.6-mile radius (increased from a 6-mile radius) of Bethel Regional Airport, Bethel, ME, providing the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for IFR operations at Bethel Regional Airport.

    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 designations listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed 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

    This proposal would be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.11C, 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. ANE ME E5 Bethel, ME [Amended] Bethel Regional Airport, ME (Lat. 44°25′31″ N, long. 70°48′36″ W)

    That airspace extending upward from 700 feet above the surface within an 8.6-mile radius of Bethel Regional Airport.

    Issued in College Park, Georgia, on September 25, 2018. Christopher Cox, Acting Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2018-21456 Filed 10-3-18; 8:45 am] BILLING CODE 4910-13-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R6-OAR-2018-0386; FRL-9983-94—Region 6] Air Plan Approval; Texas; Control of Air Pollution From Motor Vehicles With Mobile Source Incentive Programs 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 revisions to the Texas State Implementation Plan (SIP) submitted by the State of Texas that pertain to regulations to control air pollution from motor vehicles with mobile source incentive programs.

    DATES:

    Written comments should be received on or before November 5, 2018.

    ADDRESSES:

    Submit your comments, identified by EPA-R6-OAR-2018-0386, at http://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 issue of the Federal Register.

    FOR FURTHER INFORMATION CONTACT:

    Randy Pitre, (214) 665-7299, [email protected]

    SUPPLEMENTARY INFORMATION:

    In the final rules section of this issue of the 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 issue of the Federal Register.

    Dated: September 26, 2018. Anne Idsal, Regional Administrator, Region 6.
    [FR Doc. 2018-21452 Filed 10-3-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Parts 232, 242, and 252 [Docket DARS-2018-0042] RIN 0750-AJ28 Performance-Based Payments and Progress Payments (DFARS Case 2017-D019) AGENCY:

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

    ACTION:

    Proposed rule; withdrawal and cancellation of public meeting.

    SUMMARY:

    DoD is withdrawing the proposed rule on performance-based payments and progress payments that published on August 24, 2018, and is cancelling the public meeting previously scheduled to be held on October 10, 2018.

    DATES:

    As of October 4, 2018, the proposed rule published on August 24, 2018, at 83 FR 42831 is withdrawn.

    The public meeting scheduled for October 10, 2018, as announced on September 21, 2018, at 83 FR 47867, is cancelled.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Amy Williams, OUSD(A&S) DPC/DARS, at 571-372-6106.

    SUPPLEMENTARY INFORMATION:

    This proposed rule is withdrawn in order for DoD to conduct additional outreach with industry regarding contract financing methods. Implementation in the Defense Federal Acquisition Regulation Supplement (DFARS) of section 831 of the National Defense Authorization Act for Fiscal Year 2017 will be addressed in a proposed rule to be published under DFARS Case 2019-D002. Any other changes to contract financing policy will be addressed under DFARS Case 2019-D001.

    List of Subjects in 48 CFR Parts 232, 242, and 252

    Government procurement.

    Jennifer Lee Hawes, Regulatory Control Officer, Defense Acquisition Regulations System.
    [FR Doc. 2018-21714 Filed 10-3-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Part 10 [Docket No. OST-2016-0028] RIN 2105-AE46 Maintenance of and Access to Records Pertaining to Individuals AGENCY:

    Office of the Secretary (OST), U.S. Department of Transportation (DOT).

    ACTION:

    Noticed of proposed rulemaking.

    SUMMARY:

    This proposed rulemaking would amend the Department of Transportation's Privacy Act regulations to exempt the Department of Transportation's new insider threat program system of records from certain requirements of the Privacy Act to protect properly classified information from disclosure, preserve the integrity of insider threat inquiries, and protect the identities of sources in such inquiries and any related investigations.

    DATES:

    Submit comments on or before December 3, 2018.

    ADDRESSES:

    You may file comments identified by the docket number DOT-OST-2016-0028 by any of the following methods:

    Federal Rulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for submitting comments.

    Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Ave. 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 Ave. SE, between 9:00 a.m. and 5:00 p.m. ET, Monday through Friday, except Federal holidays.

    Fax: 202-493-2251.

    Instructions: You must include the agency name and docket number DOT-OST-2016-0028 or the Regulatory Identification Number (RIN) for the rulemaking at the beginning of your comment. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.

    Privacy Act: Anyone is able to search the electronic form of all comments received in any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.) You may review DOT's system of records notice for dockets in the Federal Register notice published on January 17, 2008 (73 FR 3316-3317).

    Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov or to the street address listed above. Follow the online instructions for accessing the docket.

    FOR FURTHER INFORMATION CONTACT:

    Claire Barrett, Departmental Chief Privacy Officer, Office of the Chief Information Officer, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590 or [email protected] or (202) 366-8135.

    SUPPLEMENTARY INFORMATION:

    Executive Order 13587, Structural Reforms to Improve the Security of Classified Networks and the Responsible Sharing and Safeguarding of Classified Information, directs Federal departments and agencies to establish insider threat programs consistent with guidance and standards developed by the National Insider Threat Task Force, which was established under section 6 of Executive Order 13587. The National Insider Threat Policy and Minimum Standards for Executive Branch Insider Threat Programs were issued in November 2012. As described in Executive Order 13587 and the National Insider Threat Policy and Minimum Standards for Executive Branch Insider Threat Programs, insider threat programs are intended to deter and detect insider threats and mitigate the risks associated with an individual using his or her authorized access to Government information and facilities to do harm to the security of the United States. The potential harms posed by an insider threat can include espionage, terrorism, unauthorized disclosure of national security information, or the loss or degradation of Government resources or capabilities.

    The DOT has established an Insider Threat Program within the Office of the Secretary (OST) and the Federal Aviation Administration (FAA). Together, these programs are referred to as the “DOT Insider Threat Program.” The DOT Insider Threat Program will adhere to the requirements of Executive Order 13587, and the National Insider Threat Policy and Minimum Standards for Executive Branch Insider Threat Programs, and include protocols for reporting and responding to potential or suspected insider threat activity.

    The Privacy Act of 1974, 5 U.S.C. 552a, requires that agencies tell the public when they maintain information about a person in a file which is retrieved by reference to that person's name or some other identifying particular. A group of these files is a “system of records,” and the existence of each system must be published in a “system of records notice” (SORN). In accordance with the Privacy Act, DOT proposes to create a new DOT system of records titled, “DOT/ALL 26 Insider Threat Program” for insider threat program records. This notice will be published in the Federal Register.

    The DOT Insider Threat Program will maintain information about DOT employees about whom the DOT Insider Threat Program has received reports of indicia of potential insider threats from other Federal agencies, DOT employees, or any other source. As defined in Executive Order 12968, a DOT employee, for purposes of the DOT Insider Threat Program, means “a person, other than the President and Vice President, employed by, detailed or assigned to, an agency, including members of the Armed Forces; an expert or consultant to an agency; an industrial or commercial contractor, licensee, certificate holder; or any other category of person who acts for or on behalf of an agency, as determined by the” Secretary of Transportation or, for the FAA, the FAA Administrator. A licensee, certificate holder (such an airman), or grantee, who is not also a DOT employee, is generally excluded from the DOT Insider Threat Program; however, such individuals may be included if a determination is made that the nature and extent of an individual's access to DOT personnel, facilities, equipment, systems, networks, operations, and information necessitates their inclusion.

    The DOT Insider Threat Program will review reports of indicia of potential insider threats in accordance with established DOT and FAA Insider Threat Program management policy and procedures, as applicable. Based on this review, an appropriate authorized OST or FAA official will determine whether to proceed with an insider threat inquiry, refer the matter to appropriate law enforcement officials, close the matter, or take other appropriate action. Insider threat inquiries will be comprised primarily of existing DOT information assets, including, but not limited to, records from information security, personnel security, and human resources, and also may include information obtained from other Federal agencies or from publicly available resources (such as internet searches). The DOT Insider Threat Program records also will be used to track reports of indicia of potential insider threats, whether or not an inquiry was opened, the rationale for opening or not opening an inquiry; the disposition of all inquiries, and referrals to law enforcement (such as the DOT Office of the Inspector General or the Federal Bureau of Investigation), and to report on DOT's Insider Threat Program activities.

    An agency wishing to exempt portions of some systems of records from certain provisions of the Privacy Act must notify the public of that exemption in both the SORN and in an exemption rule. This proposed rule would exempt certain records maintained by the DOT Insider Threat Program from the access and notification provisions of the Privacy Act. An exemption from these requirements would be necessary to: Protect classified national security information; preclude the subject of an inquiry from frustrating an inquiry or evading detection; avoid disclosure of insider threat inquiry techniques; protect the identity of confidential informants and third parties; and support DOT and FAA's ability to obtain information relevant to resolving an insider threat concern. The DOT or FAA may take administrative or other appropriate action within scope of their respective legal authorities in response to an insider threat inquiry or, if circumstances indicate a potential violation of law or a national security concern, refer the matter to the appropriate law enforcement or intelligence entity, such as the DOT Office of Inspector General or the Federal Bureau of Investigation. Thus, the system of records may include some classified national security information and, thus, insofar as it does, the subsection (k)(1) exemption (5 U.S.C. 552a(k)(1)) would be applicable. In addition, an insider threat inquiry is comprised of records compiled for law enforcement and the subsection (k)(2) exemption (5 U.S.C. 552a(k)(2) would be applicable to this system of records.

    In appropriate circumstances, where compliance with the request would not appear to interfere with or adversely affect the conduct of an insider threat inquiry or result in the unauthorized disclosure of classified information, OST or FAA may opt to waive these exemptions. In addition, some information may be available under the Freedom of Information Act, 5 U.S.C. 552 (FOIA). Any request for information from this system under the FOIA would be assessed on a case-by-case basis to determine what, if any, information could be released consistent with section (b)(2) of the Privacy Act, 5 U.S.C. 552a(b)(2).

    The DOT identifies a system of records that is exempt from one or more provisions of the Privacy Act (pursuant to 5 U.S.C. 552a(j) or (k)) both in the SORN published in the Federal Register for public comment and in an Appendix to DOT's regulations implementing the Privacy Act (49 CFR part 10, Appendix). This rule would exempt records in the Insider Threat Program system of records from subsections (c)(3) (Accounting of Certain Disclosures), (d) (Access to Records), (e)(1) and (e)(4)(G) through (I) (Agency Requirements) and (f) (Agency Rules) of the Privacy Act to the extent that records are properly classified, in accordance with 5 U.S.C. 552a(k)(1), or consist of investigatory material compiled for law enforcement purposes in accordance with 5 U.S.C. 552a(k)(2).

    Regulatory Analysis and Notices A. Executive Order 12866 (Regulatory Planning and Review) and DOT Regulatory Policies and Procedures

    The DOT has considered the impact of this proposed rulemaking action under Executive Orders 12866 and 13563 (January 18, 2011, “Improving Regulation and Regulatory Review”), and the DOT's regulatory policies and procedures (44 FR 11034; February 26, 1979). The DOT has determined that this action would not constitute a significant regulatory action within the meaning of Executive Order 12866 and within the meaning of DOT regulatory policies and procedures. This rulemaking has not been reviewed by the Office of Management and Budget. This rulemaking is not anticipated to result in any costs. Since these records would be exempt from certain provisions of the Privacy Act, DOT would not have to expend any funds in order to administer those aspects of the Act.

    B. Regulatory Flexibility Act

    DOT has evaluated the effect these changes would have on small entities and does not believe that this rulemaking would impose any costs on small entities because the reporting requirements themselves are not changed and because the rule applies only to information on individuals that is maintained by the Federal Government or that is already publically available. Therefore, I hereby certify that this proposal would not have a significant economic impact on a substantial number of small entities.

    C. National Environmental Policy Act

    The Department has analyzed the environmental impacts of this proposed action pursuant to the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and has determined that it is categorically excluded pursuant to DOT Order 5610.1C, Procedures for Considering Environmental Impacts (44 FR 56420, Oct. 1, 1979). Categorical exclusions are actions identified in an agency's NEPA implementing procedures that do not normally have a significant impact on the environment and therefore do not require either an environmental assessment (EA) or environmental impact statement (EIS). See 40 CFR 1508.4. In analyzing the applicability of a categorical exclusion, the agency must also consider whether extraordinary circumstances are present that would warrant the preparation of an EA or EIS. Id. Paragraph 3.c.5 of DOT Order 5610.1C incorporates by reference the categorical exclusions for all DOT Operating Administrations. This action is covered by the categorical exclusion listed in the Federal Highway Administration's implementing procedures, “[p]romulgation of rules, regulations, and directives.” 23 CFR 771.117(c)(20). The purpose of this rulemaking is to amend the Appendix to DOT's Privacy Act regulations. The Department does not anticipate any environmental impacts and there are no extraordinary circumstances present in connection with this rulemaking.

    D. Executive Order 12898 (Environmental Justice)

    The Department evaluated the environmental effects of this proposed rule in accordance with Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, and DOT Order, 5010.2(a), 91 FR 27534 (May 10, 2012) (available online at www.fhwa.dot.gov/enviornment/environmental_justice/ej_at_dot/order_56102a/index.cfm), which require DOT to achieve environmental justice (EJ) as part of its mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects, including interrelated social and economic effects, of its programs, policies, and activities on minority and low income populations in the United States. The DOT Order requires DOT to address compliance with the Executive Order and the DOT Order in all rulemaking activities. The Department has evaluated this proposed rule under the Executive Order and the DOT Order, and has determined preliminarily that the rule would not cause disproportionately high and adverse human health and environmental effects on minority or low income populations.

    E. Executive Order 13132 (Federalism)

    This proposed action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, Federalism, dated August 4, 1999, and it has been determined that it would not have a substantial direct effect on, or sufficient Federalism implications for, the States, nor would it limit the policymaking discretion of the States. Therefore, the preparation of a Federalism Assessment is not necessary.

    F. Executive Order 13084 (Consultation and Coordination With Indian Tribal Governments)

    This action has been analyzed in accordance with the principles and criteria contained in Executive Order 13084 (“Consultation and Coordination with Indian Tribal Governments”). Because it would not effect on Indian Tribal Governments, the funding and consultation requirements of Executive Order 13084 do not apply.

    G. 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 Office of Management and Budget for each collection of information they conduct, sponsor, or require through regulations. The DOT has determined that this action would not contain a collection of information requirement for the purposes of the PRA.

    H. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4, 109 Stat. 48, March 22, 1995) requires Federal agencies to assess the effects of certain regulatory actions on State, local, and tribal governments; and the private sector. The UMRA requires a written statement of economic and regulatory alternatives for proposed and final rules that contain Federal mandates. A “Federal mandate” is a new or additional enforceable duty, imposed on any State, local, or tribal Government; or the private sector. If any Federal mandate causes those entities to spend, in aggregate, $143.1 million or more in any one year (adjusted for inflation), an UMRA analysis is required. This proposed rule would not impose Federal mandates on any State, local, or tribal governments; or the private sector.

    List of Subjects in 49 CFR Part 10

    Penalties, Privacy.

    In consideration of the foregoing, DOT proposes to amend part 10 of title 49, Code of Federal Regulations, as follows:

    1. The authority citation for part 10 continues to read as follows: Authority:

    5 U.S.C. 552a; 49 U.S.C. 322.

    2. Amend the Appendix to Part 10 by: a. In Part II, adding paragraphs A.10, B.4., F.5., and G.2.

    The revisions and additions read as follows:

    APPENDIX TO PART 10—EXEMPTIONS

    Part II. Specific Exemptions

    A. * * *

    10. Insider Threat Program (DOT/ALL 26),

    B. * * *

    4. Insider Threat Program (DOT/ALL 26).

    F. * * *

    5. Insider Threat Program (DOT/ALL 26).

    G. * * *

    2. Insider Threat Program (DOT/ALL 26).

    Issued in Washington, DC, on August 17, 2018. Elaine L. Chao, Secretary.
    [FR Doc. 2018-21440 Filed 10-3-18; 8:45 am] BILLING CODE 4910-9X-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 395 [Docket No. FMCSA-2018-0248] RIN 2126-AC19 Hours of Service AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Notice of public listening session.

    SUMMARY:

    The FMCSA announces that it will hold a public listening session concerning potential changes to its hours-of-service (HOS) rules for truck drivers. On August 23, 2018, FMCSA published an Advance Notice of Proposed Rulemaking (ANPRM) seeking public comment on four specific aspects of the HOS rules for which the Agency is considering changes: The short-haul HOS limit; the HOS exception for adverse driving conditions; the 30-minute rest break provision; and the split-sleeper berth rule to allow drivers to split their required time in the sleeper berth. In addition, the Agency requested public comment on petitions for rulemaking from the Owner-Operator Independent Drivers Association (OOIDA) and TruckerNation.org (TruckerNation). The Agency encourages vendors of electronic logging devices (ELDs) to participate to address potential implementation issues, should changes to the HOS rules be made. The listening session will be held at the U.S. Department of Transportation in Washington, DC. The listening session will be webcast for the benefit of those not able to attend in person. The listening session will allow interested persons to present comments, views, and relevant research on topics mentioned above. All comments will be transcribed and placed in the rulemaking docket for the FMCSA's consideration.

    DATES:

    The listening session will be October 10, 2018, in Washington, DC, at the U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590. The listening session will begin at 1 p.m. (EDT) and end at 3 p.m., or earlier, if all participants wishing to express their views have done so.

    ADDRESSES:

    The October 10, 2018, meeting will be held at the U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590.

    You may submit comments identified by Docket Number FMCSA-2018-0248 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, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: 202-493-2251.

    Submissions Containing Confidential Business Information (CBI): Mr. Brian Dahlin, Chief, Regulatory Analysis Division, 1200 New Jersey Avenue SE, Washington, DC 20590.

    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, including collection of information comments for the Office of Information and Regulatory Affairs, OMB.

    FOR FURTHER INFORMATION CONTACT:

    For special accommodations for the HOS listening session, such as sign language interpretation, contact Ms. Shannon L. Watson, Senior Advisor to the Associate Administrator for Policy, (202) 385-2395 or at [email protected], [ONE WEEK IN ADVANCE OF THE MEETING], to allow us to arrange for such services. There is no guarantee that interpreter services requested on short notice can be provided. For information concerning the HOS rules, contact Mr. Tom Yager, Chief, Driver and Carrier Operations Division, (202) 366-4325, [email protected]

    SUPPLEMENTARY INFORMATION: I. Public Participation and Request for Comments A. Submitting Comments

    If you submit a comment, please include the docket number for this ANPRM (Docket No. FMCSA-2018-0248), indicate the specific section of this document to which each section 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 phone 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-2018-0248, 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 for the ANPRM. Late comments will be considered to the extent practicable.

    Confidential Business Information

    Confidential Business Information (CBI) is commercial or financial information that is customarily not made available to the public by the submitter. Under the Freedom of Information Act, CBI is eligible for protection from public disclosure. If you have CBI that is relevant or responsive to the ANPRM and this listening session, it is important that you clearly designate the submitted comments as CBI. Accordingly, please mark each page of your submission as “confidential” or “CBI.” Submissions designated as CBI and meeting the definition noted above will not be placed in the public docket for the ANPRM and this listening session. Submissions containing CBI should be sent to Mr. Brian Dahlin, Chief, Regulatory Analysis Division, 1200 New Jersey Avenue SE, Washington, DC 20590 or [email protected] Any commentary that FMCSA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

    FMCSA will consider all comments and material received during the comment period for the ANPRM.

    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-2018-0248, in the keyword box, and click “Search.” Next, click the “Open Docket Folder” button and choose the document to review. If you do not have access to the internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays.

    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.dot.gov/privacy.

    II. Background

    On August 23, 2018 (83 FR 42631), FMCSA published an ANPRM concerning potential changes to its hours-of-service rules. The ANPRM indicated the Agency is considering changes in four areas of the HOS rules: The short-haul HOS limit [49 CFR 395.1(e)(1)(ii)(A)]; the HOS exception for adverse driving conditions [§ 395.1(b)(1)]; the 30-minute rest break provision [§ 395.3(a)(3)(ii)]; and the split-sleeper berth rule to allow drivers to split their required time in the sleeper berth [§ 395.1(g)(1)(i)(A) and (ii)(A)]. In addition, the Agency requested public comment on petitions for rulemaking from the Owner-Operator Independent Drivers Association (OOIDA) and TruckerNation.org (TruckerNation). The ANPRM provides an opportunity for additional discussion of each of these topics. The listening session will provide an opportunity for interested persons to share their views on these topics with representatives of the Agency. The Agency encourages ELD vendors to participate to address potential implementation issues, should changes to the HOS rules be made.

    III. Meeting Participation

    The listening session is open to the public. Speakers' remarks will be limited to 2 minutes each. The public may submit material to the FMCSA staff at the session for inclusion in the public docket, FMCSA-2018-0248. The session will be webcast in its entirety, providing the opportunity for remote participation via the internet. For information on participating in the live webcast, please go to www.fmcsa.dot.gov.

    IV. Questions for Discussion During the Listening Session

    In preparing their comments, meeting participants should consider the questions posed in the ANPRM about the current HOS requirements. Answers to these questions should be based upon the experience of the participants and any data or information they can share with FMCSA.

    Issued on: September 27, 2018. Jim Mullen, Chief Counsel.
    [FR Doc. 2018-21628 Filed 10-3-18; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 RIN 0648-BH92 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Revisions to Sea Turtle Release Gear; Amendment 49 AGENCY:

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

    ACTION:

    Notice of availability (NOA); request for comments.

    SUMMARY:

    The Gulf of Mexico Fishery Management Council (Council) has submitted Amendment 49 to the Fishery Management Plan (FMP) for the Reef Fish Resources of the Gulf of Mexico (Gulf) (Amendment 49) for review, approval, and implementation by NMFS. If approved by the Secretary of Commerce, Amendment 49 would add three new devices as options for fishermen to meet requirements for sea turtle release gear, and would simplify and clarify the requirements for other sea turtle release gear. The new devices would provide additional options to fulfill existing requirements for carrying sea turtle release gear on board vessels with Federal Gulf commercial or charter vessel/headboat reef fish permits. Amendment 49 would also modify the FMP framework procedure to allow for future changes to release gear and handling requirements for sea turtles and other protected resources. The purpose of Amendment 49 is to allow the use of new devices to safely handle and release incidentally captured sea turtles, clarify existing requirements, and streamline the process for making changes to the release devices and handling procedures for sea turtles and other protected species.

    DATES:

    Written comments on Amendment 49 must be received by December 3, 2018.

    ADDRESSES:

    You may submit comments on Amendment 49 identified by “NOAA-NMFS-2018-0087” 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-2018-0087, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit all written comments to Susan Gerhart, 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 Amendment 49 may be obtained www.regulations.gov or from the Southeast Regional Office website at https://sero.nmfs.noaa.gov/sustainable_fisheries/gulf_fisheries/reef_fish/index.html. Amendment 49 includes an environmental assessment, a fishery impact statement, a regulatory impact review, and a Regulatory Flexibility Act analysis.

    FOR FURTHER INFORMATION CONTACT:

    Susan Gerhart, NMFS Southeast Regional Office, telephone: 727-824-5305; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requires each regional fishery management council to submit any FMP or FMP amendment to NMFS for review and approval, partial approval, or disapproval. The Magnuson-Stevens Act also requires that NMFS, upon receiving an FMP or amendment, publish an announcement in the Federal Register notifying the public that the FMP or amendment is available for review and comment.

    The FMP being revised by Amendment 49 was prepared by the Council, and Amendment 49, if approved, would be implemented by NMFS through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Act.

    Background

    The Endangered Species Act (ESA) directs all Federal agencies to insure that any action they authorize, fund, or carry-out does not jeopardize the continued existence of endangered or threatened species, or destroy or adversely modify designated critical habitat. The ESA requires that any Federal agency proposing an action that may adversely affect ESA-listed species or critical habitat formally consult with the U.S. Fish and Wildlife Service or NMFS (i.e., consulting agencies).

    In February 2005, NMFS issued a biological opinion (2005 BiOp), in accordance with section 7 of the ESA, that evaluated the impact of the Gulf reef fish fishery on endangered sea turtles and smalltooth sawfish. The 2005 BiOp concluded that the anticipated incidental take of sea turtles and smalltooth sawfish by the Gulf reef fish fishery was not likely to jeopardize their continued existence, or destroy or adversely modify designated critical habitat; however, the 2005 BiOp required that reasonable and prudent measures be taken to minimize stress and increase the survival rates of any sea turtles and smalltooth sawfish taken in the fishery.

    In response to the 2005 BiOp, the Council developed measures in Amendment 18A to the FMP to increase the likelihood of survival of released sea turtles and smalltooth sawfish caught incidentally in the Gulf reef fish fishery. The final rule implementing Amendment 18A required vessels with Federal commercial or charter vessel/headboat permits for Gulf reef fish to possess a specific set of release gear, and comply with sea turtle and smalltooth sawfish handling and release protocols and guidelines (71 FR 45428, August 9, 2006). Fishermen on these same federally permitted vessels are also required to maintain a reference copy of the NMFS sea turtle handling and release protocols document titled, “Careful Release Protocols for Sea Turtle Release with Minimal Injury” (Release Protocols), in the event a sea turtle is incidentally captured. These Gulf reef fish permit holders are also required to post a NMFS placard of sea turtle handling and release guidelines inside the wheelhouse, or in an easily viewable area on the vessel if there is no wheelhouse.

    Since implementation of Amendment 18A in 2006, the Release Protocols have been revised twice, once in 2008, and again in 2010. Currently, NMFS is drafting a revision to the Release Protocols and would include the recently approved sea turtle release devices if NMFS implements Amendment 49. However, fishermen participating in the reef fish fishery cannot use these devices to meet sea turtle release gear requirements until they are implemented via regulations.

    Actions Contained in Amendment 49

    Amendment 49 would add three new sea turtle handling and release devices, clarify the requirements for other currently required gear, and modify the FMP framework procedure to include future changes to release gear and handling requirements for sea turtles and other protected resources. NMFS and the Council are proposing these changes to provide additional flexibility to fishermen in complying with sea turtle release gear requirements, to aid fishermen and law enforcement with compliance and enforcement efforts by clarifying existing requirements, and to allow for more rapid implementation of regulatory changes to release gear and handling requirements.

    New Sea Turtle Release Gear

    The final rule for Amendment 18A established the requirement for sea turtle release gear to be carried on board vessels with Federal commercial and charter vessel/headboat reef fish permits, and specified the devices allowed to meet this requirement. Amendment 49 would add three new sea turtle release and handling devices that have been approved for use by the NMFS Southeast Fisheries Science Center (SEFSC), providing more options for fishermen to fulfill the sea turtle gear requirements. Details of the construction requirements for these new devices can be found in Amendment 49, and would be included in the new Release Protocols, if subsequently approved by NMFS. NMFS expects the proposed new release devices would increase flexibility for fishermen and regulatory compliance within the fishery, which may result in positive benefits to sea turtles.

    Two of the new sea turtle handling devices are a collapsible hoop net and a sea turtle hoist (net). Both of these devices are more compact versions of the currently required long-handled dip net, and would be used for bringing an incidentally captured sea turtle on board the fishing vessel to remove fishing gear from the sea turtle. For the collapsible hoop net, the net portion is attached to hoops made of flexible stainless steel cable; when the collapsible hoop net is folded over on itself for storage, its size reduces to about half of its original diameter. Additionally, there are two versions of the sea turtle hoist. One version consists of the net portion securely fastened to a frame, providing a relatively taut platform for the sea turtle to be brought on board. Another version creates a basket with the frame and net that holds the sea turtle as it is brought on board. Both the collapsible hoop net and the sea turtle hoist use rope handles attached to either side of the frame, in place of the rigid handle on the dip net. Generally, the collapsible hoop net or hoist would be used to bring sea turtles on board vessels with a high freeboard when it is not feasible to use a dip net.

    The third new device is a dehooker that can be used to remove an externally embedded hook from a sea turtle. This device has a squeeze handle that secures the hook into notches at the end of the shaft of the dehooker, so the hook can be twisted out. This new device would provide another option for fishermen to comply with the regulation for a short-handled dehooker for external hooks.

    Requirements for Existing Sea Turtle Release Gear

    Amendment 49 also would also update the requirements of some currently approved devices for clarity and simplicity, and to aid fishermen and law enforcement with compliance and enforcement efforts. These updates would include more specific measurements for sea turtle release gear. The revisions would provide for either a minimum size dimension or a size range for the short-handled dehookers for external and internal hooks, bite block on the short-handled internal use dehooker, long-nose or needle-nose pliers, bolt cutters, and the block of hard wood and hank of rope when used as mouth openers and gags. Other proposed changes are listed below.

    Current regulations specify that short and long-handled dehookers must be constructed of 316L stainless steel, which is resistant to corrosion from salt water. The SEFSC has also approved 304L stainless steel for the construction of all short-handled and long-handled dehookers. This proposed additional grade of stainless steel is commonly available and is also corrosion resistant.

    Another required device to assist with removing fishing gear from a sea turtle is a pair of monofilament line cutters. Current regulations state that the monofilament line cutters must have cutting blades of 1-inch (2.54 cm) in length (Appendix F to 50 CFR part 622). However, SEFSC has clarified that the blade length must be a minimum of 1 inch (2.54 cm) but could be longer.

    Another required gear type is mouth openers and gags, used to hold a sea turtle's mouth open to remove fishing gear. At least two of the seven types of mouth openers and gags are required on board. Current regulations state the canine mouth gags, an option for this gear requirement, must have the ends covered with clear vinyl tubing, friction tape, or similar, to pad the surface. However, SEFSC determined that this was not necessary and could result in the canine mouth gags not functioning properly. Amendment 49 would remove the requirement to cover the ends of the canine mouth gags with these materials from the regulations.

    Lastly, a life-saving device on a vessel, such as a personal flotation device or life ring buoy, may currently be used as the required cushion or support device for a sea turtle brought on board a vessel to remove fishing gear. However, Amendment 49 would add language to clarify that any life-saving device used to fulfill the sea turtle safe handling requirements cannot also be used to meet U.S. Coast Guard safety requirements of one flotation device per person on board the vessel.

    FMP Framework Procedure

    Currently, adding or changing careful release devices and protocols for incidentally caught sea turtles and other protected species requires an amendment to the FMP. This limits the Council and NMFS' ability to implement new release devices and handling requirements in a timely manner. Amending the FMP through the FMP amendment rulemaking process generally involves more detailed analyses and a lengthier timeline prior to implementation than rulemaking done through a framework procedure. However, the FMP contains a framework procedure to allow the Council to modify certain management measures via an expedited process (see 50 CFR 622.42). The FMP framework procedure was last modified by the final rule implementing Amendment 38 to the FMP (78 FR 6218, January 30, 2013).

    Amendment 49 would allow changes to the sea turtle release gear and handling techniques under the framework procedure. For example, the Council could more quickly add a new release device for sea turtles if approved by the SEFSC. The Council decided that making these changes through an expedited process may have beneficial biological and socio-economic impacts, especially if the changes respond to newer information. The Council concluded that the framework procedure would still allow adequate time for the public to comment on any future proposed regulatory changes.

    Proposed Rule for Amendment 49

    A proposed rule that would implement Amendment 49 has been drafted. In accordance with the Magnuson-Stevens Act, NMFS is evaluating the proposed rule to determine whether it is consistent with the FMP, the Magnuson-Stevens Act, and other applicable laws. If that determination is affirmative, NMFS will publish the proposed rule in the Federal Register for public review and comment.

    Consideration of Public Comments

    The Council has submitted Amendment 49 for Secretarial review, approval, and implementation. Comments on Amendment 49 must be received by December 3, 2018. Comments received during the respective comment periods, whether specifically directed to Amendment 49 or the proposed rule will be considered by NMFS in the decision to approve, disapprove, or partially approve Amendment 49. Comments received after the comment periods will not be considered by NMFS in this decision. All comments received by NMFS on the amendment or the proposed rule during their respective comment periods will be addressed in the final rule.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: October 1, 2018. Margo Schulze-Haugen, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-21635 Filed 10-3-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 180807736-8736-01] RIN 0648-BI41 Fisheries of the Northeastern United States; Framework Adjustment 12 to the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS proposes to approve and implement measures included in Framework Adjustment 12 to the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan that would allow the possession of Atlantic mackerel after 100 percent of the domestic annual harvest is projected to be caught. This action proposes to allow the possession of 5,000 lb of Atlantic mackerel after 100 percent of the domestic annual harvest is caught instead of prohibiting the possession of Atlantic mackerel for the rest of the year. This action is necessary to prevent unintended consequences and negative economic impacts to other fisheries. The intended effect of this rule is to notify the public of this proposed measure and to solicit comment on the proposed change.

    DATES:

    Public comments must be received by October 19, 2018.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2018-0099, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2018-0099, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Michael Pentony, Regional Administrator, NMFS, Greater Atlantic Regional Fisheries Office, 55 Great Republic Drive, Gloucester, MA 01930. Mark the outside of the envelope, “Comments on Mackerel Framework 12.”

    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). Attachments to electronic comments will be accepted in Microsoft Word, Excel, or Adobe PDF formats only.

    The Mid-Atlantic Fishery Management Council prepared a draft supplemental environmental assessment for the Framework 12 that describes the proposed action and other alternatives considered and provides a thorough analysis of the impacts of the proposed action and alternatives considered. Copies of the Framework 12 including the draft SEA and the preliminary Regulatory Impact Review, analysis are available from: Christopher Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 State Street, Dover, DE 19901. The SEA/RIR is accessible via the internet at http://www.greateratlantic.fisheries.noaa.gov/ or http://www.mafmc.org.

    FOR FURTHER INFORMATION CONTACT:

    Alyson Pitts, Fishery Management Specialist, (978) 281-9352, [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    When the Atlantic mackerel fishery starts each year, the various mackerel permit categories start with different trip limits. Tier 1 limited access permit holders have an unlimited trip limit, Tier 2 limited access permit holders have a 135,000-lb (61,235-kg) trip limit, and Tier 3 limited access permit holders have a 100,000-lb (45,359-kg) trip limit. The open access incidental permit has a 20,000-lb (9,072-kg) trip limit. When the fishery reaches 95 percent of the domestic annual harvest (DAH), all permits have 20,000-lb (9,072-kg) trip limits. When the fishery reaches 100 percent of the DAH, no mackerel possession is allowed by vessels with Federal mackerel permits.

    The mackerel fishery also operates under a river herring and shad (RH/S) catch cap, which closes the directed mackerel fishery and implements a 20,000-lb (9,072-kg) trip limit for all permits once the catch cap, currently 82 mt of RH/S, has been projected to be caught in the directed mackerel fishery. In 2018, the RH/S cap closed the mackerel fishery effective February 27, 2018 (83 FR 8635), at which point approximately 88 percent of the mackerel DAH had been harvested. Despite the early mackerel closure due to the RH/S cap, fishery participants, including small-scale mackerel jig fishermen and larger, directed herring fishermen, whose respective fisheries occur late in the year, raised concern to the Council that if mackerel catch reaches 100 percent of its quota and possession goes to zero pounds, they will be negatively impacted. Projections indicate a full closure could occur upon reaching 100 percent of the DAH at some point in November or December of 2018, depending on the pace of mackerel landings.

    There is a management uncertainty buffer for the mackerel fishery, currently 10 percent of the commercial allocation that is primarily designed to account for the difficulty in closing a high volume fishery, such as mackerel. Where the RH/S cap has already effectively closed the high-volume part of the fishery, the buffer is unlikely to be utilized in its original intent this year. Projections from Council staff suggest that if the fishery does not go to a zero possession limit at 100 percent of the DAH but rather a 5,000-lb (2,268-kg) trip limit, then only an additional 384,000-lb (174,180-kg) would be landed, which is a small part (17 percent) of this year's management uncertainty buffer.

    The Atlantic mackerel stock was recently declared overfished, with overfishing occurring in 2016. The Council is preparing a rebuilding plan via a separate action that is on track to be effective in 2019. The projections from the assessment for that action indicate that the stock can be rebuilt in 3-, 5-, or 7-year timelines even if the full management uncertainty buffer is caught this year. The rebuilding plan projections assume that the full management uncertainty buffer will be caught in 2018.

    Under the proposed change to possession limits when the DAH is harvested, at its June 2018 meeting, the Council recommended to change the trip limit once 100 percent of the DAH is landed, from zero pounds to 5,000 lb (2,268 kg) through Framework 12. The New England Fishery Management Council also discussed the issue in June 2018 and expressed support for an action that would avoid the full prohibition of mackerel possession due to impacts on the herring fishery. This action would allow a 5,000-lb (2,269-kg) possession limit after the DAH has been harvested. The Council has reviewed the proposed regulations in this rule as drafted by NMFS and deemed them to be necessary and appropriate as specified in section 303(c) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

    This rule proposes a 15-day comment period to ensure final measures can be effective by early November to avoid adverse economic impacts on the commercial fishing industry. The Council discussed the development of this action in April and May, and made a final recommendation in June, 2018. Because the public had an opportunity to comment on this action at these meetings, an expedited comment period would allow this action to be effective without compromising public input and our goal of implementing this action by early November.

    Proposed Measure

    The proposed measure would allow the possession of 5,000 lb (2,268 kg) of Atlantic mackerel after 100 percent of the DAH has been projected to be harvested.

    Framework 12 proposes to allow the possession of Atlantic mackerel after 100 percent of the DAH is harvested for the remainder of fishing year 2018. Current regulations prohibit the possession of Atlantic mackerel after 100 percent of the DAH is harvested.

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the Assistant Administrator has determined that this proposed rule is consistent with the Framework Adjustment 12, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment. In making a final determination, NMFS will take into account the data, views, and comments received during the comment period.

    This proposed rule has been determined to be not significant for purposes of 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 that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The purpose, context, and statutory basis for this action is described above and not repeated here.

    In determining the significance of the economic impacts of the proposed action, we considered the following two criteria outlined in applicable NMFS guidance: Disproportionality and profitability. The Regulatory Impact Review determined that the proposed measures would not place a substantial number of small entities at a significant competitive disadvantage to large entities. This measure would allow commerce to continue that would otherwise be stopped, and would benefit small business owners and commercial fishing entities. There are no distributional economic effects from this action, as proposed measures would maintain fishing opportunities for Atlantic mackerel and Atlantic herring if 100 percent of the DAH is harvested. The combined mackerel and herring fisheries are worth $50 million or less annually, and only a relatively small portion of the overall fishery may be affected by this action. The proposed measures would allow maintenance of, or a relatively small increase in, fishery landings/revenues. As such, the proposed measures should help maintain the sustainability of the mackerel and herring fisheries, and should positively rather than adversely affect the economy, a sector of the economy, productivity, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.

    List of Subjects in 50 CFR Part 648

    Fisheries, Fishing, Recordkeeping and reporting requirements.

    Dated: October 1, 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 648 is proposed to be amended as follows:

    PART 648—FISHERIES OF THE NORTHEASTERN UNITED STATES 1. The authority citation for part 648 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    2. In § 648.14, revise paragraph (g)(2)(ii)(D) and remove and reserve paragraph (g)(2)(ii)(F).

    The revision reads as follows:

    § 648.14 Prohibitions.

    (g)* * *

    (2)* * *

    (ii)* * *

    (D) Take and retain, possess, or land mackerel, squid, or butterfish in excess of the possession limits specified in § 648.26.

    3. In § 648.24, revise paragraph (b)(1)(i) to read as follows:
    § 648.24 Fishery closures and accountability measures.

    (b) * * *

    (1)(i) Mackerel commercial sector EEZ closure. NMFS will close the commercial Atlantic mackerel fishery in the EEZ when the Regional Administrator projects that 95 percent of the Atlantic mackerel DAH is harvested if such a closure is necessary to prevent the DAH from being exceeded. The closure of the commercial fishery shall be in effect for the remainder of that fishing year, with incidental catches allowed as specified in § 648.26. When the Regional Administrator projects that 100 percent of the Atlantic mackerel DAH will be landed, NMFS will reduce the possession of Atlantic mackerel in the EEZ for the remainder of the fishing year to the amount specified in § 648.26(a)(2)(ii).

    4. In § 648.26, revise paragraphs (a)(1) introductory text and (a)(2) to read as follows:
    § 648.26 Mackerel, squid, and butterfish possession restrictions.

    (a) * * *

    (1) Initial possession limits. A vessel must be issued a valid limited access mackerel permit to fish for, possess, or land more than 20,000 lb (9.08 mt) of Atlantic mackerel from or in the EEZ per trip, provided that the fishery has not been closed, as specified in § 648.24(b)(1).

    (2) Closure possession restrictions—(i) Limited Access Fishery. During a closure of the commercial Atlantic mackerel fishery pursuant to § 648.24(b)(1)(i), when 95 percent of the DAH is harvested, vessels issued a limited access Atlantic mackerel permit may not take and retain, possess, or land more than 20,000 lb (9.08 mt) of Atlantic mackerel per trip at any time, and may only land Atlantic mackerel once on any calendar day, which is defined as the 24-hr period beginning at 0001 hours and ending at 2400 hours. Pursuant to § 648.24(b)(1)(ii), when 90 percent of the Tier 3 allocation is harvested, vessels issued a Tier 3 limited access Atlantic mackerel permit may not take and retain, possess, or land more than 20,000 lb (9.08 mt) of Atlantic mackerel per trip at any time, and may only land Atlantic mackerel once on any calendar day, which is defined as the 24-hr period beginning at 0001 hours and ending at 2400 hours.

    (ii) Entire commercial fishery. During a closure of the directed commercial Atlantic mackerel fishery pursuant to § 648.24(b)(1)(i), when 100 percent of the DAH is harvested, vessels issued an open or limited access Atlantic mackerel permit may not take and retain, possess, or land more than 5,000 lb (2.26 mt) of Atlantic mackerel per trip at any time, and may only land Atlantic mackerel once on any calendar day, which is defined as the 24-hr period beginning at 0001 hours and ending at 2400 hours.

    [FR Doc. 2018-21616 Filed 10-3-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 697 [Docket No. 180709616-8616-01] RIN 0648-BI07 Fisheries of the United States; Regulations for Striped Bass Fishing in the Block Island Transit Zone AGENCY:

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

    ACTION:

    Advance notice of proposed rulemaking; request for comments.

    SUMMARY:

    NMFS issues this advance notice of proposed rulemaking (ANPR) to provide background information and make the public aware of a proposal to remove the current prohibition on recreational Atlantic striped bass fishing in the Block Island Transit Zone (Transit Zone) within the Federal exclusive economic zone (EEZ). The ANPR is in response to the 2018 Omnibus Appropriations Act which included the provision directing NOAA, in consultation with the Atlantic States Marine Fisheries Commission, to consider lifting the ban on striped bass fishing in the Federal Block Island Transit Zone. NMFS communicated the intent to issue this ANPR at the Atlantic States Marine Fisheries Commission's August 2018 public meeting. By this action, NMFS is soliciting public comment on options presented to regulate fishing for striped bass in the Transit Zone. In addition, comments on other options to improve management of Atlantic striped bass in the Transit Zone are welcomed and encouraged.

    DATES:

    Written comments regarding the issues in this ANPR must be received by 5 p.m., local time, on November 19, 2018.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2018-0106, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2018-0106, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Kelly Denit, Division Chief, Office of Sustainable Fisheries, 1315 East-West Highway, SSMC3, Silver Spring, MD 20910.

    Fax: 301-713-1193; Attn: Kelly Denit.

    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).

    FOR FURTHER INFORMATION CONTACT:

    Kelly Denit, Division Chief, Office of Sustainable Fisheries, National Marine Fisheries Service, 301-427-8517.

    SUPPLEMENTARY INFORMATION:

    Background

    Atlantic striped bass occur predominately within 12 nautical miles from shore, an area which includes both waters (0-3 miles from shore) under state jurisdiction, as well as portions of the Exclusive Economic Zone (3-200 miles from shore) under Federal jurisdiction. Management responsibility for Atlantic striped bass resides primarily with the coastal states, and interstate management occurs through the Atlantic State Marine Fisheries Commission's (Commission) Interstate Fisheries Management Plan for the Atlantic Striped Bass (ISFMP), first adopted in 1981. In 1995, the Commission declared the Atlantic striped bass population fully restored and implemented Amendment 5 to the ISFMP to perpetuate the stock so as to allow a commercial and recreational harvest consistent with the long-term maintenance of the striped bass stock. The latest stock assessment update completed in 2016 determined that the Atlantic striped bass stock is not overfished or experiencing overfishing.

    NMFS promulgates regulations in Federal waters that are compatible with the Commission's ISFMP. The Atlantic Striped Bass Conservation Act (Pub. L. 100-589, 16 U.S.C. 5151, et seq.) sets forth the basis for Federal striped bass regulatory authority. Under the act, Federal Atlantic striped bass regulations must comply with the following: (1) Be consistent with the national standards in Section 301 of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) (16 U.S.C. 1851); (2) be compatible with the fishery management plan for managing Atlantic striped bass and each Federal moratorium in effect on fishing for Atlantic striped bass within the coastal waters of a coastal state; (3) ensure the effectiveness of State regulations on fishing for Atlantic striped bass within the coastal waters of a coastal state; and (4) be sufficient to assure the long-term conservation of Atlantic striped bass populations. Further, in developing the regulations, the Secretary is to consult with the Commission, the appropriate Regional Fishery Management Councils (Councils), and each affected Federal, state, and local government entity.

    Existing Federal regulations prohibit recreational and commercial fishing for Atlantic striped bass in the EEZ. The regulations do, however, allow fishers to transport Atlantic striped bass caught in adjoining state fisheries while transiting the Block Island Transit Zone (Transit Zone; 50 CFR 697.7). The Transit Zone is defined in NMFS regulations as the area of Federal waters within Block Island Sound, located between areas south of Montauk Point, New York, and Point Judith, Rhode Island. The Transit Zone area is unique because it is a small area of Federal waters (Block Island Sound) substantially bounded by state waters (Long Island, New York on one side, Block Island, Rhode Island on another, and the mainland of Connecticut and Rhode Island on a third side).

    NMFS is considering revising current regulations to authorize recreational fishing in the Block Island Transit Zone. This would allow recreational fishermen to harvest, retain, and transport striped bass within the Block Island Transit Zone. The ANPR is in response to the 2018 Omnibus Appropriations Act (Pub. L. 115-141) which included the provision directing “NOAA, in consultation with the Atlantic States Marine Fisheries Commission, to consider lifting the ban on striped bass fishing in the Federal Block Island Transit Zone.” NMFS communicated the intent to issue this ANPR to the Atlantic States Marine Fisheries Commission at the August 2018 meeting. NMFS is not proposing to allow commercial striped bass fishing in the Transit Zone, consistent with Executive Order 13449 (October 24, 2007; 72 FR 60531), “Protection of Striped Bass and Red Drum Fish Populations,” which declared it the policy of the United States to prohibit the sale of striped bass caught in the EEZ.

    Public Comments

    To help determine the scope of issues to be addressed and to identify significant issues related to this action, NMFS is requesting public comments on this ANPR. The public is encouraged to submit comments related to the potential regulatory revisions described in this ANPR, as well as additional ideas to improve management of striped bass in the Block Island Transit Zone.

    Authority:

    16 U.S.C. 1827a.

    Dated: September 28, 2018. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
    [FR Doc. 2018-21613 Filed 10-3-18; 8:45 am] BILLING CODE 3510-22-P
    83 193 Thursday, October 4, 2018 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2018-0053] International Sanitary and Phytosanitary Standard-Setting Activities AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with legislation implementing the results of the Uruguay Round of negotiations under the General Agreement on Tariffs and Trade, we are informing the public of the international standard-setting activities of the World Organization for Animal Health, the Secretariat of the International Plant Protection Convention, and the North American Plant Protection Organization, and we are soliciting public comment on the standards to be considered.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0053.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2018-0053, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

    Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0053 or in our reading Room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

    FOR FURTHER INFORMATION CONTACT:

    For general information on the topics covered in this notice, contact Ms. Jessica Mahalingappa, Assistant Deputy Administrator for Trade and Capacity Building, International Services, APHIS, Room 1132, USDA South Building, 14th Street and Independence Avenue SW, Washington, DC 20250; (202) 799-7121.

    For specific information regarding standard-setting activities of the World Organization for Animal Health, contact Dr. Michael David, Director, International Animal Health Standards Team, National Import Export Services, VS, APHIS, 4700 River Road Unit 33, Riverdale, MD 20737; (301) 851-3302.

    For specific information regarding the standard-setting activities of the International Plant Protection Convention, contact Dr. Marina Zlotina, IPPC Technical Director, International Phytosanitary Standards, PPQ, APHIS, 4700 River Road Unit 130, Riverdale, MD 20737; (301) 851-2200.

    For specific information on the North American Plant Protection Organization, contact Ms. Patricia Abad, NAPPO Technical Director, International Phytosanitary Standards, PPQ, APHIS, 4700 River Road Unit 130, Riverdale, MD 20737; (301) 851-2264.

    SUPPLEMENTARY INFORMATION: Background

    The World Trade Organization (WTO) was established as the common international institutional framework for governing trade relations among its members in matters related to the Uruguay Round Agreements. The WTO is the successor organization to the General Agreement on Tariffs and Trade. U.S. membership in the WTO was approved by Congress when it enacted the Uruguay Round Agreements Act (Pub. L. 103-465), which was signed into law on December 8, 1994. The WTO Agreements, which established the WTO, entered into force with respect to the United States on January 1, 1995. The Uruguay Round Agreements Act amended Title IV of the Trade Agreements Act of 1979 (19 U.S.C. 2531 et seq.). Section 491 of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2578), requires the President to designate an agency to be responsible for informing the public of the sanitary and phytosanitary (SPS) standard-setting activities of each international standard-setting organization. The designated agency must inform the public by publishing an annual notice in the Federal Register that provides the following information: (1) The SPS standards under consideration or planned for consideration by the international standard-setting organization; and (2) for each SPS standard specified, a description of the consideration or planned consideration of that standard, a statement of whether the United States is participating or plans to participate in the consideration of that standard, the agenda for U.S. participation, if any, and the agency responsible for representing the United States with respect to that standard.

    “International standard” is defined in 19 U.S.C. 2578b as any standard, guideline, or recommendation: (1) Adopted by the Codex Alimentarius Commission (Codex) regarding food safety; (2) developed under the auspices of the World Organization for Animal Health (OIE, formerly known as the Office International des Epizooties) regarding animal health and welfare and zoonoses; (3) developed under the auspices of the Secretariat of the International Plant Protection Convention (IPPC or the Convention) and the North American Plant Protection Organization (NAPPO) regarding plant health; or (4) established by or developed under any other international organization agreed to by the member countries of the North American Free Trade Agreement (NAFTA) or the member countries of the WTO.

    The President, pursuant to Proclamation No. 6780 of March 23, 1995 (60 FR 15845), designated the Secretary of Agriculture as the official responsible for informing the public of the SPS standard-setting activities of Codex, OIE, IPPC, and NAPPO. The United States Department of Agriculture's (USDA's) Food Safety and Inspection Service (FSIS) informs the public of Codex standard-setting activities, and USDA's Animal and Plant Health Inspection Service (APHIS) informs the public of OIE, IPPC, and NAPPO standard-setting activities.

    FSIS publishes an annual notice in the Federal Register to inform the public of SPS standard-setting activities for Codex. Codex was created in 1962 by two United Nations organizations, the Food and Agriculture Organization and the World Health Organization. It is the major international organization for encouraging international trade in food and protecting the health and economic interests of consumers.

    APHIS is responsible for publishing an annual notice of OIE, IPPC, and NAPPO activities related to international standards for plant and animal health and representing the United States with respect to these standards. Following are descriptions of the OIE, IPPC, and NAPPO organizations and the standard-setting agenda for each of these organizations. We have described the agenda that each of these organizations will address at their annual general sessions, including standards that may be presented for adoption or consideration, as well as other initiatives that may be underway at the OIE, IPPC, and NAPPO.

    The agendas for these meetings are subject to change, and the draft standards identified in this notice may not be sufficiently developed and ready for adoption as indicated. Also, while it is the intent of the United States to support adoption of international standards and to participate actively and fully in their development, it should be recognized that the U.S. position on a specific draft standard will depend on the acceptability of the final draft. Given the dynamic and interactive nature of the standard-setting process, we encourage any persons who are interested in the most current details about a specific draft standard or the U.S. position on a particular standard-setting issue, or in providing comments on a specific standard that may be under development, to contact APHIS. Contact information is provided at the beginning of this notice under FOR FURTHER INFORMATION CONTACT.

    OIE Standard-Setting Activities

    The OIE was established in Paris, France, in 1924 with the signing of an international agreement by 28 countries. It is currently composed of 181 Members, each of which is represented by a delegate who, in most cases, is the chief veterinary officer of that country or territory. The WTO has recognized the OIE as the international forum for setting animal health standards, reporting global animal disease events, and presenting guidelines and recommendations on sanitary measures relating to animal health.

    The OIE facilitates intergovernmental cooperation to prevent the spread of contagious diseases in animals by sharing scientific research among its Members. The major functions of the OIE are to collect and disseminate information on the distribution and occurrence of animal diseases and to ensure that science-based standards govern international trade in animals and animal products. The OIE aims to achieve these through the development and revision of international standards for diagnostic tests, vaccines, and the safe international trade of animals and animal products.

    The OIE provides annual reports on the global distribution of animal diseases, recognizes the free status of Members for certain diseases, categorizes animal diseases with respect to their international significance, publishes bulletins on global disease status, and provides animal disease control guidelines to Members. Various OIE commissions and working groups undertake the development and preparation of draft standards, which are then circulated to Members for consultation (review and comment). Draft standards are revised accordingly and are presented to the OIE World Assembly of Delegates (all the Members) for review and adoption during the General Session, which meets annually every May. Adoption, as a general rule, is based on consensus of the OIE membership.

    The most recent OIE General Session occurred May 20 to May 25, 2018, in Paris, France. The Chief Trade Advisor for APHIS' Veterinary Services program serves as the official U.S. Delegate to the OIE at this General Session. The Deputy Administrator for APHIS' Veterinary Services program serves as the Alternate Delegate. Information about OIE draft Terrestrial and Aquatic Animal Health Code chapters may be found on the internet at http://www.aphis.usda.gov/animal-health/export-animals-oie or by contacting Dr. Michael David (see FOR FURTHER INFORMATION CONTACT above).

    OIE Terrestrial and Aquatic Animal Health Code Chapters Adopted During the May 2018 General Session

    Twenty nine Code chapters were amended, rewritten, or newly proposed and presented for adoption at the General Session. The following Code chapters are of particular interest to the United States:

    1. Chapters 1.7, 1.8, 1.9, 1.10, 1.11, and 1.12., Chapters on the application for official recognition by the OIE of either risk status or free status for various diseases. The United States reminded the Code Commission to respect the process for circulating new and updated chapters to allow member countries the time that is necessary to properly review and comment on such chapters.

    2. Chapter 4.3., Zoning and Compartmentalization. This chapter was significantly revised and either introduced or clarified various concepts regarding zones.

    3. Chapter 4.X., Chapter on vaccination. This is a new chapter that provides member countries with basic guidelines and recommendations when considering the use of vaccines for a control program.

    4. Chapter 6.7., Harmonization of national antimicrobial resistance surveillance and monitoring programmes. References to conducting antimicrobial surveillance on “the animal's immediate environment or the wide environment” was deleted.

    5. Articles 6.81 and 6.8.bis., Monitoring of the quantities and usage patterns of antimicrobial agents used in food producing animals. This is an existing chapter, however definitions for therapeutic use, non-therapeutic use, and growth promotion were introduced. The terms veterinary medical use and non-veterinary medical use were replaced with the terms therapeutic use and non-therapeutic use, respectively.

    6. Chapter 6.13., Prevention and control of Salmonella in pigs. Several articles were revised to improve clarity, particularly with regards to the definition of commercial pigs.

    7. Chapter 6.X., Introduction to recommendations for veterinary public health. This was a newly adopted chapter.

    8. Article 7.1.1., Introduction to the recommendations for animal welfare. This was an amendment to an existing chapter.

    9. Article 7.1.X., Guiding principles for the use of measures to assess animal welfare. The phrase “and other relevant bodies” was reinserted. This was important since entities such as universities and commodity groups often are the ones with the capability to collect data that can be used to set target values.

    10. Chapter 7.X., Animal welfare and pig production systems. The United States supported the adoption of this new chapter, but requested that the Code Commission consider further comments that the United States will be submitting related to some inconsistencies between Articles 7.X.9 and 7.X.10 to address foraging and feeding behavior recommendations.

    OIE Terrestrial Animal Health Code Chapters for Upcoming and Future Review

    Chapter 1.4., Animal health surveillance.

    Chapter 4.Y., Official control of listed disease. This will be a new chapter.

    Chapter 4.Z., Introduction to recommendations for disease prevention and control. This will be a new introductory chapter for section 4.

    Chapter 7.Y., Killing of reptiles for their skins, meat and other products. This will be a new chapter.

    Articles 15.1.1.bis., 15.1.2., 15.1.3., and 15.1.22., Infection with African swine fever virus.

    Articles 1.6.1. to 1.6.4., Procedures for self-declaration and for official recognition by the OIE.

    Chapter 8.14., Infection with rabies virus.

    IPPC Standard-Setting Activities

    The IPPC is a multilateral convention adopted in 1952 to prevent the spread and introduction of pests of plants and plant products and to promote appropriate measures for their control. The WTO recognizes the IPPC as the standard setting body for plant health. Under the IPPC, the understanding of plant protection encompasses the protection of both cultivated and non-cultivated plants from direct or indirect injury by plant pests. The IPPC addresses the following activities: Developing, adopting, and implementing international standards for phytosanitary (plant health) measures (ISPMs); harmonizing phytosanitary activities through adopted standards; facilitating the exchange of official and scientific information among countries; and providing technical assistance to developing countries that are contracting parties to the Convention.

    The IPPC is deposited within the Food and Agriculture Organization of the United Nations, and is an international agreement of 183 contracting parties. National plant protection organizations (NPPOs), in cooperation with regional plant protection organizations, the Commission on Phytosanitary Measures (CPM), and the Secretariat of the IPPC, implement the Convention. The IPPC continues to be administered at the national level by plant quarantine officials, whose primary objective is to safeguard plant resources from injurious pests. In the United States, the NPPO is APHIS' Plant Protection and Quarantine (PPQ) program.

    The 12th Session of the CPM took place from April 16 to 20, 2018, in Rome, Italy, at the Headquarters of the Food and Agriculture Organization of the United Nations. The Deputy Administrator for APHIS' PPQ program was the U.S. delegate to the CPM.

    The CPM adopted the following standards at its 2018 meeting. The United States, represented by the Deputy Administrator for APHIS' PPQ program, participated in deliberations of these standards. The United States developed its position on each of these issues prior to the CPM session, which were based on APHIS' analyses and other relevant information from other U.S. Government agencies and interested stakeholders:

    • Revision of ISPM 6: Surveillance.

    • 2015 and 2016 amendments to ISPM 5: Glossary of phytosanitary terms.

    • Revision of Annex 1 and Annex 2 to ISPM 15, for inclusion of the phytosanitary treatment sulphuryl fluoride fumigation and revision of the dielectric heating section.

    • ISPM 42: Requirements for the use of temperature treatments as a phytosanitary measures.

    • Phytosanitary treatment as Annex to ISPM 28: Phytosanitary treatments for regulated pests: PT 32 Vapour heat treatment for Bactrocera dorsalis on Carica papaya.

    • Diagnostic protocols (DPs) as Annexes to ISPM 27: Diagnostic protocols for regulated pests.

    ○ DP 23: Phytophthora ramorum.

    ○ DP 24: Tomato spotted wilt virus, Impatiens necrotic spot virus, and Watermelon silver mottle virus.

    In addition to adopting these plant health standards, the 2018 Commission meeting also progressed a number of plant health initiatives strategically important to the United States. These initiatives include advancing the development of a new IPPC strategic framework for 2020-2030 to set the top priorities for plant health and trade, launching a pilot of a global electronic certification system to support trade (ePhyto), developing programs aimed at improving the use and implementation of standards around the world, and creating a task force for addressing pests issues associated with the international movement of sea containers.

    New IPPC Standard-Setting Initiatives, Including Those in Development

    A number of expert working group (EWG) meetings or other technical consultations took place October 2017 through July 2018 on the topics listed below. These standard-setting initiatives are under development and may be considered for future adoption. APHIS intends to participate actively and fully in each of these working groups. APHIS developed its position on each of the topics prior to the working group meetings. The APHIS position was based on technical analyses, information from other U.S. Government agencies, and relevant scientific information from interested stakeholders:

    • Expert Working Group on Guidance on Pest Risk Management.

    • Technical Panel for the Glossary of Phytosanitary Terms.

    • Technical Panel on Diagnostic Protocols.

    • Technical Panel on Phytosanitary Treatments.

    For more detailed information on the above, contact Dr. Marina Zlotina (see FOR FURTHER INFORMATION CONTACT above).

    PPQ actively works to achieve broad participation by States, industry, and other stakeholders in the development and use of international and regional plant health standards. Plant health stakeholders are strongly encouraged to comment on draft standards, documents, and specifications during the consultation periods. In 2018, six draft standards and one draft specification were open for consultation. APHIS posts links to draft standards on its website as they become available and provides information on the due dates for comments.1 Additional information on IPPC standards (including the IPPC work program (list of topics 2 ), standard-setting process, and adopted standards) is available on the IPPC website.3 For the most current information on official U.S. participation in IPPC activities, including U.S. positions on standards being considered, contact Dr. Marina Zlotina (see FOR FURTHER INFORMATION CONTACT above). Those wishing to provide comments on any of the areas of work being undertaken by the IPPC may do so at any time by responding to this notice (see ADDRESSES above) or by providing comments through Dr. Zlotina.

    1 For more information on the IPPC draft ISPM consultation: https://www.aphis.usda.gov/aphis/ourfocus/planthealth/sa_international/sa_phytostandards/ct_draft_standards.

    2 IPPC list of topics: https://www.ippc.int/en/core-activities/standards-setting/list-topics-ippc-standards/.

    3 IPPC website: https://www.ippc.int/.

    NAPPO Standard-Setting Activities

    NAPPO, a regional plant protection organization created in 1976 under the IPPC, coordinates the efforts among the United States, Canada, and Mexico to protect their plant resources from the entry, establishment, and spread of harmful plant pests, while facilitating intra- and inter-regional trade. As the NPPO of the United States, APHIS' PPQ is the organization officially identified to participate in NAPPO. Through NAPPO, APHIS works closely with its regional counterparts and industries to develop harmonized regional standards and approaches for managing pest threats. NAPPO conducts its work through priority-driven annual projects approved by the NAPPO Executive Committee and conducted by expert groups, including subject matter experts from each member country and regional industry representatives. Project results and updates are provided during the NAPPO annual meeting. Projects can include the development of positions, policies, or technical documents, or the development or revision of regional standards for phytosanitary measures (RSPMs). Projects can also include implementation of standards or other capacity development activities such as workshops.

    The 41st NAPPO annual meeting was held October 16 to 19, 2017, in Merida, Yucatan, Mexico. The meeting featured several strategic topics, including a 1-day symposium on surveillance in the NAPPO countries and the Americas. The NAPPO Executive Committee meetings took place on October 16 and 20, 2017, and February 15, 2018. The Deputy Administrator for PPQ is the U.S. member of the NAPPO Executive Committee.

    The NAPPO expert groups, including member countries' subject matter experts, finalized the following regional standards, documents, products, and projects in 2017-2018:

    • Completed an English language online training module on RSPM 12-Preparation of a Petition for First Release of a Non-indigenous Entomophagous Biological Control Agent.

    • Organized and delivered the first International Symposium on Risk-Based Sampling in June 2017 in Baltimore, MD, which included 122 government, industry, and academic participants from 27 countries.

    • Completed a NAPPO discussion document on Criteria for Evaluating Phytosanitary Seed Treatments. The NAPPO Executive Committee approved this document during the 2017 October NAPPO annual meeting.

    • Completed a discussion document on Likelihood of Establishment. The NAPPO Executive Committee approved this document during the 2017 October NAPPO annual meeting.

    • Issued via NAPPO's Phytosanitary Alert System (PAS): 29 Official Pest Reports and 6 Emerging Pest Alerts for FY 2018 (from October 2017 to July 2018).

    • Conducted a review of RSPM 36 (Phytosanitary Guidelines for the Movement of Seed) and completed the archiving of RSPM 36 in-light of the newly adopted ISPM 38: International Movement of Seeds.

    New NAPPO Standard-Setting Initiatives, Including Those in Development

    The 2018 work program 4 includes the following topics being worked on by NAPPO expert groups and NAPPO's Advisory and Management Committee. APHIS intends to participate actively and fully in the 2018 NAPPO work program. The APHIS position on each topic will be guided and informed by the best technical and scientific information available, as well as on relevant input from stakeholders. For each of the following, the United States will consider its position on any draft standard after it reviews a prepared draft. Information regarding the following NAPPO projects, assignments, activities, and updates on meeting times and locations may be obtained from the NAPPO website or by contacting Ms. Patricia Abad (see FOR FURTHER INFORMATION CONTACT above).

    4 NAPPO work program: http://nappo.org/english/710/status-current-nappo-projects/.

    1. RSPM 9: Revision of Regional Standard for Phytosanitary Measures 9: Authorization of Laboratories for Phytosanitary Testing.

    2. RSPM 35: Revision of Regional Standard for Phytosanitary Measures 35: Guidelines for the Movement of Stone and Pome Fruit Trees and Grapevines into a NAPPO Member Country.

    3. ISPM 38 Implementation: Design and deliver a hemispheric (Americas focused) workshop to promote the understanding and implementation of ISPM 38: International Movement of Seeds.

    4. Forestry Systems Approaches: Finalize a NAPPO Regional Standard for Phytosanitary Measures (RSPM 41) on the use of systems approaches to manage pest risks associated with the movement of wood.

    5. Lymantriids: Develop a NAPPO Science and Technology document on the risks associated with Lymantriids of concern to the NAPPO region, identifying potential species and pathways of concern.

    6. Khapra Beetle: Develop a discussion document on a harmonized North American approach to preventing the introduction, establishment, and spread of khapra beetle in various pathways.

    7. Biological Control: Develop online training module in Spanish on preparing a petition for first release of an entomophagous biological control agent.

    8. Risk-Based Sampling: Complete and publish proceedings from 2017 International Risk-Based Sampling Symposium (organized by NAPPO) as well as Risk-Based Sampling Manual.

    9. Asian Gypsy Moth: Validate specific risk periods for regulated Asian gypsy moth in countries of origin.

    10. Foundation and Procedure documents: Continue to update and finalize various foundation or procedure documents.

    11. Electronic Phytosanitary Certification: Provide assistance and technical support to the IPPC ePhyto Steering Group.

    12. Phytosanitary Alert System: Continue to manage the NAPPO pest reporting system.

    13. Update to Pest List for RSPM 3: Movement of Potatoes into a NAPPO Member Country.

    14. Regional Collaboration: Collaboration (mainly information exchange) with the Interamerican Coordinating Group in Plant Protection (GICSV), via Technical Working Groups on ePhyto and citrus greening (HLB).

    15. Stakeholder Engagement: Plan, coordinate and execute activities for the October 2018 NAPPO Annual Meeting in Tucson, Arizona, and publish the quarterly newsletter.

    The PPQ Assistant Deputy Administrator, as the official U.S. delegate to NAPPO, intends to participate in the adoption of these regional plant health standards and projects, including the work described above, once they are completed and ready for such consideration.

    The information in this notice contains all the information available to us on NAPPO standards under development or consideration. For updates on meeting times and for information on the expert groups that may become available following publication of this notice, visit the NAPPO website or contact Ms. Patricia Abad (see FOR FURTHER INFORMATION CONTACT above). PPQ actively works to achieve broad participation by States, industry, and other stakeholders in the development and use of international and regional plant health standards. Plant health stakeholders are strongly encouraged to comment on draft standards, documents, and specifications during consultation periods. APHIS posts links to draft standards on the internet as they become available and provides information on the due dates for comments.5 Additional information on NAPPO standards (including the NAPPO Work Program, standard setting process, and adopted standards) is available on the NAPPO website.6 Information on official U.S. participation in NAPPO activities, including U.S. positions on standards being considered, may also be obtained from Ms. Abad. Those wishing to provide comments on any of the topics being addressed in the NAPPO work program may do so at any time by responding to this notice (see ADDRESSES above) or by transmitting comments through Ms. Abad.

    5 For more information on the NAPPO draft RSPM consultation: https://www.aphis.usda.gov/aphis/ourfocus/planthealth/sa_international/sa_phytostandards/ct_draft_standards.

    6 NAPPO website: http://nappo.org/.

    Done in Washington, DC, on September 27, 2018. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2018-21577 Filed 10-3-18; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE National Agricultural Statistics Service Notice of the Advisory Committee on Agriculture Statistics Meeting AGENCY:

    National Agricultural Statistics Service, USDA.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, the National Agricultural Statistics Service (NASS) announces a meeting of the Advisory Committee on Agriculture Statistics.

    DATES:

    The Committee meeting will be held from 8:00 a.m. to 5:30 p.m. on Wednesday, November 14, 2018, and from 8:00 a.m. to 12:30 p.m. on Thursday, November 15, 2018. There will be an opportunity for public questions and comments at 8:15 a.m. on Thursday, November 15, 2018. All times mentioned herein refer to Central Standard Time.

    ADDRESSES:

    The Committee meeting will take place at the Wyndham San Antonio Riverwalk, 111 E Pecan St., San Antonio, TX 78205. Written comments may be filed before or up to two weeks after the meeting with the contact person identified herein at: U.S. Department of Agriculture, National Agricultural Statistics Service, 1400 Independence Avenue SW, Room 5041-A, South Building, Washington, DC, 20250-2000.

    FOR FURTHER INFORMATION CONTACT:

    Kevin Barnes, Associate Administrator, National Agricultural Statistics Service, telephone: 202-720-4333, eFax: 855-493-0445, or email: [email protected] General information about the committee can also be found at https://www.nass.usda.gov/About_NASS/index.php.

    SUPPLEMENTARY INFORMATION:

    The Advisory Committee on Agriculture Statistics, which consists of 20 members appointed from 7 categories covering a broad range of agricultural disciplines and interests, has scheduled a meeting on November 14-15, 2018. During this time the Advisory Committee will discuss topics including the status of NASS programs, Census of Agriculture Updates, Census of Agriculture Program Plans, and the NASS Strategic Plan.

    The Committee meeting is open to the public. The public is asked to pre-register for the meeting at least 10 business days prior to the meeting. Your pre-registration must state the names of each person in your group, organization, or interest represented; the number of people planning to give oral comments, if any; and whether anyone in your group requires special accommodations. Submit registrations to Executive Secretary, Advisory Committee on Agriculture Statistics, via eFax: 855-493-0445, or email: [email protected] Members of the public who request to give oral comments to the Committee must arrive at the meeting site by 8:00 a.m. on Thursday, November 15, 2018. Written comments by attendees or other interested stakeholders will be welcomed for the public record before and up to two weeks following the meeting. The public may file written comments by mail to the Executive Director, Advisory Committee on Agriculture Statistics, U.S. Department of Agriculture, National Agricultural Statistics Service, 1400 Independence Avenue SW, Room 5041-A South Building, Washington, DC, 20250-2000. Written comments can also be sent via eFax: 855-493-0445, or email: [email protected] All statements will become a part of the official records of the USDA Advisory Committee on Agriculture Statistics and will be kept on file for public review in the office of the Executive Director, Advisory Committee on Agriculture Statistics, U.S. Department of Agriculture, Washington, DC, 20250.

    Signed at Washington, DC, September 19, 2018. Kevin Barnes, Associate Administrator, National Agricultural Statistics Service.
    [FR Doc. 2018-21611 Filed 10-3-18; 8:45 am] BILLING CODE 3410-20-P
    DEPARTMENT OF AGRICULTURE National Agricultural Statistics Service Notice of Intent To Request Revision and Extension of a Currently Approved Information Collection AGENCY:

    National Agricultural Statistics Service, USDA.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the National Agricultural Statistics Service (NASS) to request revision and extension of a currently approved information collection, the List Sampling Frame Surveys. Revision to burden hours will be needed due to changes in the size of the target population, sampling design, and questionnaire length. Annually, NASS obtains lists of farm and ranch operators from different crop and livestock organizations. Before adding these names to our list of active operators we will contact the individuals to determine if they qualify as a farm or ranch and then collect basic information from them on the size and type of operation they have. These data will be used to eliminate any duplication we may have with names already on our list.

    In addition to the names of potential operators we receive from different crop and livestock organizations, NASS has been investigating the use of web-scraping as a source of identifying new farm operators to add to our List Frame. This new approach will be conducted under a two stage process. A short screening form will be used first to identify potential agricultural producers who will then receive a more detailed questionnaire. This approach is designed to minimize respondent burden on small or non-farming entities.

    DATES:

    Comments on this notice must be received by December 3, 2018 to be assured of consideration.

    ADDRESSES:

    You may submit comments, identified by docket number 0535-0140, by any of the following methods:

    Email: [email protected] Include docket number above in the subject line of the message.

    eFax: (855) 838-6382.

    Mail: Mail any paper, disk, or CD-ROM submissions to: David Hancock, NASS Clearance Officer, U.S. Department of Agriculture, Room 5336 South Building, 1400 Independence Avenue SW, Washington, DC 20250-2024.

    Hand Delivery/Courier: Hand deliver to: David Hancock, NASS Clearance Officer, U.S. Department of Agriculture, Room 5336 South Building, 1400 Independence Avenue SW, Washington, DC 20250-2024.

    FOR FURTHER INFORMATION CONTACT:

    Kevin L. Barnes, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720-2707. Copies of this information collection and related instructions can be obtained without charge from David Hancock, NASS—OMB Clearance Officer, at (202) 690-2388 or at [email protected]

    SUPPLEMENTARY INFORMATION:

    Title: List Sampling Frame Surveys.

    OMB Control Number: 0535-0140.

    Expiration Date of Approval: January 31, 2019.

    Type of Request: Intent to Seek Approval to Revise and Extend an Information Collection for a period of three years.

    Abstract: The primary objective of the National Agricultural Statistics Service is to prepare and issue State and national estimates of crop and livestock production, economic statistics, environmental statistics related to agriculture and also to conduct the Census of Agriculture. The List Sampling Frame Surveys are used to develop and maintain a complete list of possible farm and ranch operations. The goal is to produce for each State a relatively complete, current, and unduplicated list of names for statistical sampling for agricultural operation surveys and the Census of Agriculture. Data from these agricultural surveys are used by government agencies and educational institutions in planning, farm policy analysis, and program administration. More importantly, farmers and ranchers use NASS data to help make informed business decisions on what commodities to produce and when is the optimal time to market their products. NASS data is useful to farmers in comparing their farming practices with the economic and environmental data published by NASS.

    Authority: These data will be collected under the authority of 7 U.S.C. 2204(a). Individually identifiable data collected under this authority are governed by Section 1770 of the Food Security Act of 1985 as amended, 7 U.S.C. 2276, which requires USDA to afford strict confidentiality to non-aggregated data provided by respondents. This Notice is submitted in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-113) and the Office of Management and Budget regulations at 5 CFR part 1320.

    NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),” Federal Register, Vol. 72, No. 115, June 15, 2007, p. 33376.

    Estimate of Burden: Public reporting burden for this collection of information is estimated to average 10 to 15 minutes per respondent.

    Respondents: Potential Farmers and Ranchers.

    Estimated Number of Respondents: 675,000 (annual average).

    Estimated Total Annual Burden on Respondents: With an estimated response rate of approximately 65% NASS estimates the burden to be approximately 145,000 hours (annually).

    Comments: Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, technological or other forms of information technology collection methods.

    All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.

    Signed at Washington, DC, September 26, 2018. Kevin L. Barnes, Associate Administrator.
    [FR Doc. 2018-21612 Filed 10-3-18; 8:45 am] BILLING CODE 3410-20-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meetings of the Oklahoma Advisory Committee AGENCY:

    U.S. Commission on Civil Rights

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Oklahoma Advisory Committee (Committee) will hold a meeting on Tuesday October 23, 2018 at 3:00 p.m. Central time. The Committee will review a draft project proposal and discuss next steps in their study of the state's 2012 “Civil Rights Initiative,” which bars consideration of race or sex in public employment, admissions to public educational institutions, or public contracts.

    DATES:

    The meeting will take place on Tuesday, October 23, 2018 at 3:00 p.m. Central.

    Public Call Information: Dial: 1-855-719-5012, Conference ID: 5395512.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

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

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

    Agenda I. Welcome and Roll Call II. Discussion: Project Proposal, OK 2012 Civil Rights Initiative III. Public Comment IV. Vote on Proposal V. Next Steps VI. Adjournment Dated: September 28, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-21588 Filed 10-3-18; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Pennsylvania Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA) that a meeting of the Pennsylvania Advisory Committee to the Commission will convene by conference call at 11:30am. (EST) on Tuesday, October 9, 2018. The PA Committee is considering possible topics for its civil rights project. At this meeting Catherine Lhamon, USCCR Chair, will present issues under review by the Commission that the Committee may want to consider when selecting its civil rights project.

    DATES:

    Tuesday, October 9, 2018, at 11:30 a.m. EST.

    Public Call-In Information: Conference call-in number: 855-710-4182 and conference call 5309106.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 855-710-4182 and conference call 5309106. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.

    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-877-8339 and providing the operator with the toll-free conference call-in number: 855-710-4182 and conference call 5309106.

    Members of the public are invited to make statements during the open comment period of the meeting or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Corrine Sanders at [email protected] Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=279, click the “Meeting Details” and “Documents” links.Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meetings. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Eastern Regional Office at the above phone numbers, email or street address.

    Agenda: Tuesday, October 9, 2018 I. Rollcall II. Welcome and Introductions III. Catherine Lhamon Presentation Discussion of Commission Civil Rights Topics IV. Other Business V. Adjourn Dated: September 27, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-21579 Filed 10-3-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-60-2018] Foreign-Trade Zone 64—Jacksonville, Florida; Application for Reorganization (Expansion of Service Area) Under Alternative Site Framework

    An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Jacksonville Port Authority, grantee of Foreign-Trade Zone 64, requesting authority to reorganize the zone to expand its service area under the alternative site framework (ASF) adopted by the FTZ Board (15 CFR Sec. 400.2(c)). The ASF is an option for grantees for the establishment or reorganization of zones and can permit significantly greater flexibility in the designation of new subzones or “usage-driven” FTZ sites for operators/users located within a grantee's “service area” in the context of the FTZ Board's standard 2,000-acre activation limit for a zone. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on September 27, 2018.

    FTZ 64 was approved by the Board on December 29, 1980 (Board Order 170, 46 FR 1330, January 6, 1981), reorganized under the ASF on May 6, 2011 (Board Order 1759, 76 FR 28418, May 17, 2011), and the service area was expanded under the ASF on July 5, 2012 (Board Order 1840, 77 FR 41374, July 13, 2012). The zone currently has a service area that includes Baker, Bradford, Clay, Columbia, Duval, Nassau, Putnam and St. Johns Counties, Florida.

    The applicant is now requesting authority to expand the service area of the zone to include Flagler County, as described in the application. If approved, the grantee would be able to serve sites throughout the expanded service area based on companies' needs for FTZ designation. The application indicates that the proposed expanded service area is adjacent to the Jacksonville Customs and Border Protection Port of Entry.

    In accordance with the FTZ Board's regulations, Qahira El-Amin of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the FTZ Board.

    Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is December 3, 2018. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to December 18, 2018.

    A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's website, which is accessible via www.trade.gov/ftz. For further information, contact Qahira El-Amin at [email protected] or (202) 482-5928.

    Dated: September 27, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-21615 Filed 10-3-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security In the Matter of: Francisco Xavier Martinez, Inmate Number: 21369-470, FCI Bastrop, P.O. Box 1010, Bastrop, TX 78602; Order Denying Export Privileges

    On November 16, 2017, in the U.S. District Court for the Southern District of Texas, Francisco Xavier Martinez (“Martinez”) was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Martinez was convicted of knowingly exporting and attempting to export from the United States to Mexico firearms designated as defense articles on the United States Munitions List, without the required U.S. Department of State licenses. Martinez was sentenced to 41 months in prison, three years of supervised release, and an assessment of $100.

    Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”) 1 provides, in pertinent part, that “[t]he Director of the Office of Exporter Services, in consultation with the Director of the Office of Export Enforcement, may deny the export privileges of any person who has been convicted of a violation of . . . section 38 of the Arms Export Control Act (22 U.S.C. 2778).” 15 CFR 766.25(a). The denial of export privileges under this provision may be for a period of up to 10 years from the date of the conviction. 15 CFR 766.25(d). In addition, Section 750.8 of the Regulations states that the Bureau of Industry and Security's Office of Exporter Services may revoke any Bureau of Industry and Security (“BIS”) licenses previously issued pursuant to the Act or the Regulations in which the person had an interest at the time of his/her conviction.

    1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR parts 730-774 (2018). The Regulations originally issued under the Export Administration Act of 1979, as amended, 50 U.S.C. 4601-4623 (Supp. III 2015) (“the EAA”), which lapsed on August 21, 2001. The President, through Executive Order 13,222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 8, 2018 (83 FR 39,871 (Aug. 13, 2018)), continued the Regulations in full force and effect under the International Emergency Economic Powers Act, 50 U.S.C. 1701, et seq. (2012) (“IEEPA”). On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which includes the Export Control Reform Act of 2018, Title XVII, Subtitle B of Public Law 115-232 (“ECRA”). While Section 1766 of ECRA repeals the provisions of the EAA (except for three sections which are inapplicable here), Section 1768 of ECRA provides, in pertinent part, that all rules and regulations that were made or issued under the EAA, including as continued in effect pursuant to IEEPA, and were in effect as of ECRA's date of enactment (August 13, 2018), shall continue in effect according to their terms until modified, superseded, set aside, or revoked through action undertaken pursuant to the authority provided under ECRA.

    BIS has received notice of Martinez's conviction for violating Section 38 of the AECA, and has provided notice and an opportunity for Martinez to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Martinez.

    Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Martinez's export privileges under the Regulations for a period of seven years from the date of Martinez's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Martinez had an interest at the time of his conviction.

    Accordingly, it is hereby ordered:

    First, from the date of this Order until November 16, 2024, Francisco Xavier Martinez, with a last known address of Inmate Number: 21369-470, FCI Bastrop, P.O. Box 1010, Bastrop, TX 78602, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (“the Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:

    A. Applying for, obtaining, or using any license, license exception, or export control document;

    B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or

    C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.

    Second, no person may, directly or indirectly, do any of the following:

    A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;

    B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;

    C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;

    D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or

    E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.

    Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Martinez by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.

    Fourth, in accordance with Part 756 of the Regulations, Martinez may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

    Fifth, a copy of this Order shall be delivered to Martinez and shall be published in the Federal Register.

    Sixth, this Order is effective immediately and shall remain in effect until November 16, 2024.

    Issued this September 27, 2018. Karen H. Nies-Vogel, Director, Office of Exporter Services.
    [FR Doc. 2018-21651 Filed 10-3-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security In the Matter of Erik Villasana, Inmate Number: 22762-479, FCI Bastrop, P.O. Box 1010, Bastrop, TX 78602; Order Denying Export Privileges

    On November 16, 2017, in the U.S. District Court for the Southern District of Texas, Erik Villasana (“Villasana”) was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Villasana was convicted of knowingly exporting and attempting to export from the United States to Mexico firearms designated as defense articles on the United States Munitions List, without the required U.S. Department of State licenses. Villasana was sentenced to 63 months in prison, three years of supervised release, and an assessment of $100.

    Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”) 1 provides, in pertinent part, that “[t]he Director of the Office of Exporter Services, in consultation with the Director of the Office of Export Enforcement, may deny the export privileges of any person who has been convicted of a violation of . . . section 38 of the Arms Export Control Act (22 U.S.C. 2778).” 15 CFR 766.25(a). The denial of export privileges under this provision may be for a period of up to 10 years from the date of the conviction. 15 CFR 766.25(d). In addition, Section 750.8 of the Regulations states that the Bureau of Industry and Security's Office of Exporter Services may revoke any Bureau of Industry and Security (“BIS”) licenses previously issued pursuant to the Act or the Regulations in which the person had an interest at the time of his/her conviction.

    1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR Parts 730-774 (2018). The Regulations originally issued under the Export Administration Act of 1979, as amended, 50 U.S.C. 4601-4623 (Supp. III 2015) (“the EAA”), which lapsed on August 21, 2001. The President, through Executive Order 13,222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 8, 2018 (83 FR 39,871 (Aug. 13, 2018)), continued the Regulations in full force and effect under the International Emergency Economic Powers Act, 50 U.S.C. 1701, et seq. (2012) (“IEEPA”). On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which includes the Export Control Reform Act of 2018, Title XVII, Subtitle B of Public Law 115-232 (“ECRA”). While Section 1766 of ECRA repeals the provisions of the EAA (except for three sections which are inapplicable here), Section 1768 of ECRA provides, in pertinent part, that all rules and regulations that were made or issued under the EAA, including as continued in effect pursuant to IEEPA, and were in effect as of ECRA's date of enactment (August 13, 2018), shall continue in effect according to their terms until modified, superseded, set aside, or revoked through action undertaken pursuant to the authority provided under ECRA.

    BIS has received notice of Villasana's conviction for violating Section 38 of the AECA, and has provided notice and an opportunity for Villasana to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Villasana.

    Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Villasana's export privileges under the Regulations for a period of 10 years from the date of Villasana's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Villasana had an interest at the time of his conviction.

    Accordingly, it is hereby ordered:

    First, from the date of this Order until November 16, 2027, Erik Villasana, with a last known address of Inmate Number: 22762-479, FCI Bastrop, P.O. Box 1010, Bastrop, TX 78602, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (“the Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:

    A. Applying for, obtaining, or using any license, license exception, or export control document;

    B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or

    C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.

    Second, no person may, directly or indirectly, do any of the following:

    A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;

    B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;

    C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;

    D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or

    E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.

    Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Villasana by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.

    Fourth, in accordance with Part 756 of the Regulations, Villasana may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

    Fifth, a copy of this Order shall be delivered to Villasana and shall be published in the Federal Register.

    Sixth, this Order is effective immediately and shall remain in effect until November 16, 2027.

    Issued this September 27, 2018. Karen H. Nies-Vogel, Director, Office of Exporter Services.
    [FR Doc. 2018-21639 Filed 10-3-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security In the Matter of: Edward Alexander Duenas, Inmate Number: 27317-479, FCI Beaumont Low, P.O. Box 26020, Beaumont, TX 77720; Order Denying Export Privileges

    On November 16, 2017, in the U.S. District Court for the Southern District of Texas, Edward Alexander Duenas (“Duenas”) was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Duenas was convicted of knowingly exporting and attempting to export from the United States to Mexico firearms designated as defense articles on the United States Munitions List, without the required U.S. Department of State licenses. Duenas was sentenced to 27 months in prison, three years of supervised release, and an assessment of $100.

    Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”) 1 provides, in pertinent part, that “[t]he Director of the Office of Exporter Services, in consultation with the Director of the Office of Export Enforcement, may deny the export privileges of any person who has been convicted of a violation of . . . section 38 of the Arms Export Control Act (22 U.S.C. 2778).” 15 CFR 766.25(a). The denial of export privileges under this provision may be for a period of up to 10 years from the date of the conviction. 15 CFR 766.25(d). In addition, Section 750.8 of the Regulations states that the Bureau of Industry and Security's Office of Exporter Services may revoke any Bureau of Industry and Security (“BIS”) licenses previously issued pursuant to the Act or the Regulations in which the person had an interest at the time of his/her conviction.

    1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR parts 730-774 (2018). The Regulations originally issued under the Export Administration Act of 1979, as amended, 50 U.S.C. 4601-4623 (Supp. III 2015) (“the EAA”), which lapsed on August 21, 2001. The President, through Executive Order 13,222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 8, 2018 (83 FR 39,871 (Aug. 13, 2018)), continued the Regulations in full force and effect under the International Emergency Economic Powers Act, 50 U.S.C. 1701, et seq. (2012) (“IEEPA”). On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which includes the Export Control Reform Act of 2018, Title XVII, Subtitle B of Public Law 115-232 (“ECRA”). While Section 1766 of ECRA repeals the provisions of the EAA (except for three sections which are inapplicable here), Section 1768 of ECRA provides, in pertinent part, that all rules and regulations that were made or issued under the EAA, including as continued in effect pursuant to IEEPA, and were in effect as of ECRA's date of enactment (August 13, 2018), shall continue in effect according to their terms until modified, superseded, set aside, or revoked through action undertaken pursuant to the authority provided under ECRA.

    BIS has received notice of Duenas's conviction for violating Section 38 of the AECA, and has provided notice and an opportunity for Duenas to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Duenas.

    Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Duenas's export privileges under the Regulations for a period of five years from the date of Duenas's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Duenas had an interest at the time of his conviction.

    Accordingly, it is hereby ordered:

    First, from the date of this Order until November 16, 2022, Edward Alexander Duenas, with a last known address of Inmate Number: 27317-479, FCI Beaumont Low, P.O. Box 26020, Beaumont, TX 77720, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (“the Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:

    A. Applying for, obtaining, or using any license, license exception, or export control document;

    B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or

    C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.

    Second, no person may, directly or indirectly, do any of the following:

    A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;

    B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;

    C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;

    D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or

    E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.

    Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Duenas by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.

    Fourth, in accordance with Part 756 of the Regulations, Duenas may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

    Fifth, a copy of this Order shall be delivered to Duenas and shall be published in the Federal Register.

    Sixth, this Order is effective immediately and shall remain in effect until November 16, 2022.

    Issued September 27, 2018. Karen H. Nies-Vogel, Director, Office of Exporter Services .
    [FR Doc. 2018-21652 Filed 10-3-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security In the Matter of: Ruben Arnoldo Madrid, Inmate Number: 20727-479, FCI Beaumont Low, P.O. Box 26020, Beaumont, TX 77720; Order Denying Export Privileges

    On December 14, 2017, in the U.S. District Court for the Southern District of Texas, Ruben Arnoldo Madrid (“Madrid”) was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Madrid was convicted of knowingly exporting and attempting to export from the United States to Mexico firearms designated as defense articles on the United States Munitions List, without the required U.S. Department of State licenses. Madrid was sentenced to 51 months in prison, three years of supervised release, and an assessment of $100.

    Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”) 1 provides, in pertinent part, that “[t]he Director of the Office of Exporter Services, in consultation with the Director of the Office of Export Enforcement, may deny the export privileges of any person who has been convicted of a violation of . . . section 38 of the Arms Export Control Act (22 U.S.C. 2778).” 15 CFR 766.25(a). The denial of export privileges under this provision may be for a period of up to 10 years from the date of the conviction. 15 CFR 766.25(d). In addition, Section 750.8 of the Regulations states that the Bureau of Industry and Security's Office of Exporter Services may revoke any Bureau of Industry and Security (“BIS”) licenses previously issued pursuant to the Act or the Regulations in which the person had an interest at the time of his/her conviction.

    1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR parts 730-774 (2018). The Regulations originally issued under the Export Administration Act of 1979, as amended, 50 U.S.C. 4601-4623 (Supp. III 2015) (“the EAA”), which lapsed on August 21, 2001. The President, through Executive Order 13, 222 of August 17, 2001 (3 CFR 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 8, 2018 (83 FR 39, 871 (Aug. 13, 2018)), continued the Regulations in full force and effect under the International Emergency Economic Powers Act, 50 U.S.C. 1701, et seq. (2012) (“IEEPA”). On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which includes the Export Control Reform Act of 2018, Title XVII, Subtitle B of Public Law 115-232 (“ECRA”). While Section 1766 of ECRA repeals the provisions of the EAA (except for three sections which are inapplicable here), Section 1768 of ECRA provides, in pertinent part, that all rules and regulations that were made or issued under the EAA, including as continued in effect pursuant to IEEPA, and were in effect as of ECRA's date of enactment (August 13, 2018), shall continue in effect according to their terms until modified, superseded, set aside, or revoked through action undertaken pursuant to the authority provided under ECRA.

    BIS has received notice of Madrid's conviction for violating Section 38 of the AECA, and has provided notice and an opportunity for Madrid to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Madrid.

    Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Madrid's export privileges under the Regulations for a period of 10 years from the date of Madrid's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Madrid had an interest at the time of his conviction.

    Accordingly, it is hereby ordered:

    First, from the date of this Order until December 14, 2027, Ruben Arnoldo Madrid, with a last known address of Inmate Number: 20727-479, FCI Beaumont Low, P.O. Box 26020, Beaumont, TX 77720, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (“the Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:

    A. Applying for, obtaining, or using any license, license exception, or export control document;

    B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or

    C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.

    Second, no person may, directly or indirectly, do any of the following:

    A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;

    B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;

    C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;

    D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or

    E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.

    Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Madrid by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.

    Fourth, in accordance with Part 756 of the Regulations, Madrid may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

    Fifth, a copy of this Order shall be delivered to Madrid and shall be published in the Federal Register.

    Sixth, this Order is effective immediately and shall remain in effect until December 14, 2027.

    Issued: September 27, 2018. Karen H. Nies-Vogel, Director, Office of Exporter Services.
    [FR Doc. 2018-21649 Filed 10-3-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security In the Matter of: Juan Diego Madrid, Inmate Number: 24877-479, FCI Bastrop, P.O. Box 1010, Bastrop, TX 78602; Order Denying Export Privileges

    On November 16, 2017, in the U.S. District Court for the Southern District of Texas, Juan Diego Madrid (“Madrid”) was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Madrid was convicted of knowingly exporting and attempting to export from the United States to Mexico firearms designated as defense articles on the United States Munitions List, without the required U.S. Department of State licenses. Madrid was sentenced to 65 months in prison, three years of supervised release, and an assessment of $100.

    Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”) 1 provides, in pertinent part, that “[t]he Director of the Office of Exporter Services, in consultation with the Director of the Office of Export Enforcement, may deny the export privileges of any person who has been convicted of a violation of . . . section 38 of the Arms Export Control Act (22 U.S.C. 2778).” 15 CFR 766.25(a). The denial of export privileges under this provision may be for a period of up to 10 years from the date of the conviction. 15 CFR 766.25(d). In addition, Section 750.8 of the Regulations states that the Bureau of Industry and Security's Office of Exporter Services may revoke any Bureau of Industry and Security (“BIS”) licenses previously issued pursuant to the Act or the Regulations in which the person had an interest at the time of his/her conviction.

    1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR parts 730-774 (2018). The Regulations originally issued under the Export Administration Act of 1979, as amended, 50 U.S.C. 4601-4623 (Supp. III 2015) (“the EAA”), which lapsed on August 21, 2001. The President, through Executive Order 13222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 8, 2018 (83 FR 39871 (Aug. 13, 2018)), continued the Regulations in full force and effect under the International Emergency Economic Powers Act, 50 U.S.C. 1701, et seq. (2012) (“IEEPA”). On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which includes the Export Control Reform Act of 2018, Title XVII, Subtitle B of Public Law 115-232 (“ECRA”). While Section 1766 of ECRA repeals the provisions of the EAA (except for three sections which are inapplicable here), Section 1768 of ECRA provides, in pertinent part, that all rules and regulations that were made or issued under the EAA, including as continued in effect pursuant to IEEPA, and were in effect as of ECRA's date of enactment (August 13, 2018), shall continue in effect according to their terms until modified, superseded, set aside, or revoked through action undertaken pursuant to the authority provided under ECRA.

    BIS has received notice of Madrid's conviction for violating Section 38 of the AECA, and has provided notice and an opportunity for Madrid to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Madrid.

    Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Madrid's export privileges under the Regulations for a period of 10 years from the date of Madrid's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Madrid had an interest at the time of his conviction.

    Accordingly, it is hereby Ordered:

    First, from the date of this Order until November 16, 2027, Juan Diego Madrid, with a last known address of Inmate Number: 24877-479, FCI Bastrop, P.O. Box 1010, Bastrop, TX 78602, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (“the Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:

    A. Applying for, obtaining, or using any license, license exception, or export control document;

    B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or

    C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.

    Second, no person may, directly or indirectly, do any of the following:

    A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;

    B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;

    C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;

    D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or

    E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.

    Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Madrid by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.

    Fourth, in accordance with Part 756 of the Regulations, Madrid may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

    Fifth, a copy of this Order shall be delivered to Madrid and shall be published in the Federal Register.

    Sixth, this Order is effective immediately and shall remain in effect until November 16, 2027.

    Issued: September 27, 2018. Karen H. Nies-Vogel, Director, Office of Exporter Services.
    [FR Doc. 2018-21640 Filed 10-3-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security In the Matter of: Edgar Garza-Sanchez, Inmate Number: 12512-479, Mid-Valley House, 2520 South Expressway 281, Edinburg, TX 78542; Order Denying Export Privileges

    On March 28, 2017, in the U.S. District Court for the Southern District of Texas, Edgar Garza-Sanchez (“Garza-Sanchez”) was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Garza-Sanchez was convicted of intentionally and knowingly conspiring to knowingly and willfully export and cause to be exported from the United States to Mexico approximately 13,600 rounds of 7.62 × 39 mm caliber ammunition and approximately 200 7.62 × 39 mm caliber magazines, items designated as defense articles on the United States Munitions List, without the required U.S. Department of State licenses. Garza-Sanchez was sentenced to 21 months in prison, three years of supervised release, and an assessment of $100.

    Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”)1 provides, in pertinent part, that “[t]he Director of the Office of Exporter Services, in consultation with the Director of the Office of Export Enforcement, may deny the export privileges of any person who has been convicted of a violation of . . . section 38 of the Arms Export Control Act (22 U.S.C. 2778).” 15 CFR 766.25(a). The denial of export privileges under this provision may be for a period of up to 10 years from the date of the conviction. 15 CFR 766.25(d). In addition, Section 750.8 of the Regulations states that the Bureau of Industry and Security's Office of Exporter Services may revoke any Bureau of Industry and Security (“BIS”) licenses previously issued pursuant to the Act or the Regulations in which the person had an interest at the time of his/her conviction.

    1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR Parts 730-774 (2018). The Regulations originally issued under the Export Administration Act of 1979, as amended, 50 U.S.C. 4601-4623 (Supp. III 2015) (“the EAA”), which lapsed on August 21, 2001. The President, through Executive Order 13222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 8, 2018 (83 FR 39871 (Aug. 13, 2018)), continued the Regulations in full force and effect under the International Emergency Economic Powers Act, 50 U.S.C. 1701, et seq. (2012) (“IEEPA”). On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which includes the Export Control Reform Act of 2018, Title XVII, Subtitle B of Public Law 115-232 (“ECRA”). While Section 1766 of ECRA repeals the provisions of the EAA (except for three sections which are inapplicable here), Section 1768 of ECRA provides, in pertinent part, that all rules and regulations that were made or issued under the EAA, including as continued in effect pursuant to IEEPA, and were in effect as of ECRA's date of enactment (August 13, 2018), shall continue in effect according to their terms until modified, superseded, set aside, or revoked through action undertaken pursuant to the authority provided under ECRA.

    BIS has received notice of Garza-Sanchez's conviction for violating Section 38 of the AECA, and has provided notice and an opportunity for Garza-Sanchez to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Garza-Sanchez.

    Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Garza-Sanchez's export privileges under the Regulations for a period of five years from the date of Garza-Sanchez's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Garza-Sanchez had an interest at the time of his conviction.

    Accordingly, it is hereby ordered:

    First, from the date of this Order until March 28, 2022, Edgar Garza-Sanchez, with a last known address of Inmate Number: 12512-479, Mid-Valley House, 2520 South Expressway 281, Edinburg, TX 78542, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (“the Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:

    A. Applying for, obtaining, or using any license, license exception, or export control document;

    B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or

    C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.

    Second, no person may, directly or indirectly, do any of the following:

    A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;

    B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;

    C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;

    D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or

    E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.

    Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Garza-Sanchez by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.

    Fourth, in accordance with Part 756 of the Regulations, Garza-Sanchez may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

    Fifth, a copy of this Order shall be delivered to Garza-Sanchez and shall be published in the Federal Register.

    Sixth, this Order is effective immediately and shall remain in effect until March 28, 2022.

    Issued: September 27, 2018. Karen H. Nies-Vogel, Director, Office of Exporter Services.
    [FR Doc. 2018-21654 Filed 10-3-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security In the Matter of Rolando Armando Madrid, Inmate Number: 20726-479, FCI Bastrop, P.O. Box 1010, Bastrop, TX 78602; Order Denying Export Privileges

    On November 16, 2017, in the U.S. District Court for the Southern District of Texas, Rolando Armando Madrid (“Madrid”) was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Madrid was convicted of knowingly exporting and attempting to export from the United States to Mexico firearms designated as defense articles on the United States Munitions List, without the required U.S. Department of State licenses. Madrid was sentenced to 51 months in prison, three years of supervised release, and an assessment of $100.

    Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”) 1 provides, in pertinent part, that “[t]he Director of the Office of Exporter Services, in consultation with the Director of the Office of Export Enforcement, may deny the export privileges of any person who has been convicted of a violation of . . . section 38 of the Arms Export Control Act (22 U.S.C. 2778).” 15 CFR 766.25(a). The denial of export privileges under this provision may be for a period of up to 10 years from the date of the conviction. 15 CFR 766.25(d). In addition, Section 750.8 of the Regulations states that the Bureau of Industry and Security's Office of Exporter Services may revoke any Bureau of Industry and Security (“BIS”) licenses previously issued pursuant to the Act or the Regulations in which the person had an interest at the time of his/her conviction.

    1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR Parts 730-774 (2018). The Regulations originally issued under the Export Administration Act of 1979, as amended, 50 U.S.C. 4601-4623 (Supp. III 2015) (“the EAA”), which lapsed on August 21, 2001. The President, through Executive Order 13,222 of August 17, 2001 (3 CFR 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 8, 2018 (83 FR 39,871 (Aug. 13, 2018)), continued the Regulations in full force and effect under the International Emergency Economic Powers Act, 50 U.S.C. 1701, et seq. (2012) (“IEEPA”). On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which includes the Export Control Reform Act of 2018, Title XVII, Subtitle B of Public Law 115-232 (“ECRA”). While Section 1766 of ECRA repeals the provisions of the EAA (except for three sections which are inapplicable here), Section 1768 of ECRA provides, in pertinent part, that all rules and regulations that were made or issued under the EAA, including as continued in effect pursuant to IEEPA, and were in effect as of ECRA's date of enactment (August 13, 2018), shall continue in effect according to their terms until modified, superseded, set aside, or revoked through action undertaken pursuant to the authority provided under ECRA.

    BIS has received notice of Madrid's conviction for violating Section 38 of the AECA, and has provided notice and an opportunity for Madrid to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Madrid.

    Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Madrid's export privileges under the Regulations for a period of 10 years from the date of Madrid's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Madrid had an interest at the time of his conviction.

    Accordingly, it is hereby ordered:

    First, from the date of this Order until November 16, 2027, Rolando Armando Madrid, with a last known address of Inmate Number: 20726-479, FCI Bastrop, P.O. Box 1010, Bastrop, TX 78602, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (“the Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:

    A. Applying for, obtaining, or using any license, license exception, or export control document;

    B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or

    C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.

    Second, no person may, directly or indirectly, do any of the following:

    A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;

    B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;

    C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;

    D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or

    E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.

    Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Madrid by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.

    Fourth, in accordance with Part 756 of the Regulations, Madrid may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

    Fifth, a copy of this Order shall be delivered to Madrid and shall be published in the Federal Register.

    Sixth, this Order is effective immediately and shall remain in effect until November 16, 2027.

    Issued September 27, 2018. Karen H. Nies-Vogel, Director, Office of Exporter Services.
    [FR Doc. 2018-21642 Filed 10-3-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE International Trade Administration Initiation of Antidumping and Countervailing Duty Administrative Reviews AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Commerce) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with August anniversary dates. In accordance with Commerce's regulations, we are initiating those administrative reviews.

    DATES:

    Applicable October 4, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Brenda E. Brown, Office of AD/CVD Operations, Customs Liaison Unit, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-4735.

    SUPPLEMENTARY INFORMATION: Background

    Commerce has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various antidumping and countervailing duty orders and findings with August anniversary dates.

    All deadlines for the submission of various types of information, certifications, or comments or actions by Commerce discussed below refer to the number of calendar days from the applicable starting time.

    Notice of No Sales

    If a producer or exporter named in this notice of initiation had no exports, sales, or entries during the period of review (POR), it must notify Commerce within 30 days of publication of this notice in the Federal Register. All submissions must be filed electronically at http://access.trade.gov in accordance with 19 CFR 351.303.1 Such submissions are subject to verification in accordance with section 782(i) of the Tariff Act of 1930, as amended (the Act). Further, in accordance with 19 CFR 351.303(f)(1)(i), a copy must be served on every party on Commerce's service list.

    1See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011).

    Respondent Selection

    In the event Commerce limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, Commerce intends to select respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports during the period of review. We intend to place the CBP data on the record within five days of publication of the initiation notice and to make our decision regarding respondent selection within 30 days of publication of the initiation Federal Register notice. Comments regarding the CBP data and respondent selection should be submitted seven days after the placement of the CBP data on the record of this review. Parties wishing to submit rebuttal comments should submit those comments five days after the deadline for the initial comments.

    In the event Commerce decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:

    In general, Commerce has found that determinations concerning whether particular companies should be “collapsed” (e.g., treated as a single entity for purposes of calculating antidumping duty rates) require a substantial amount of detailed information and analysis, which often require follow-up questions and analysis. Accordingly, Commerce will not conduct collapsing analyses at the respondent selection phase of this review and will not collapse companies at the respondent selection phase unless there has been a determination to collapse certain companies in a previous segment of this antidumping proceeding (e.g., investigation, administrative review, new shipper review or changed circumstances review). For any company subject to this review, if Commerce determined, or continued to treat, that company as collapsed with others, Commerce will assume that such companies continue to operate in the same manner and will collapse them for respondent selection purposes. Otherwise, Commerce will not collapse companies for purposes of respondent selection. Parties are requested to (a) identify which companies subject to review previously were collapsed, and (b) provide a citation to the proceeding in which they were collapsed. Further, if companies are requested to complete the Quantity and Value (Q&V) Questionnaire for purposes of respondent selection, in general each company must report volume and value data separately for itself. Parties should not include data for any other party, even if they believe they should be treated as a single entity with that other party. If a company was collapsed with another company or companies in the most recently completed segment of this proceeding where Commerce considered collapsing that entity, complete Q&V data for that collapsed entity must be submitted.

    Deadline for Withdrawal of Request for Administrative Review

    Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that Commerce may extend this time if it is reasonable to do so. Determinations by Commerce to extend the 90-day deadline will be made on a case-by-case basis.

    Separate Rates

    In proceedings involving non-market economy (NME) countries, Commerce begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is Commerce's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.

    To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, Commerce analyzes each entity exporting the subject merchandise. In accordance with the separate rates criteria, Commerce assigns separate rates to companies in NME cases only if respondents can demonstrate the absence of both de jure and de facto government control over export activities.

    All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a separate rate application or certification, as described below. For these administrative reviews, in order to demonstrate separate rate eligibility, Commerce requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on Commerce's website at http://enforcement.trade.gov/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the certification, please follow the “Instructions for Filing the Certification” in the Separate Rate Certification. Separate Rate Certifications are due to Commerce no later than 30 calendar days after publication of this Federal Register notice. The deadline and requirement for submitting a Certification applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers who purchase and export subject merchandise to the United States.

    Entities that currently do not have a separate rate from a completed segment of the proceeding 2 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. In addition, companies that received a separate rate in a completed segment of the proceeding that have subsequently made changes, including, but not limited to, changes to corporate structure, acquisitions of new companies or facilities, or changes to their official company name,3 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. The Separate Rate Status Application will be available on Commerce's website at http://enforcement.trade.gov/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the Separate Rate Status Application, refer to the instructions contained in the application. Separate Rate Status Applications are due to Commerce no later than 30 calendar days of publication of this Federal Register notice. The deadline and requirement for submitting a Separate Rate Status Application applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers that purchase and export subject merchandise to the United States.

    2 Such entities include entities that have not participated in the proceeding, entities that were preliminarily granted a separate rate in any currently incomplete segment of the proceeding (e.g., an ongoing administrative review, new shipper review, etc.) and entities that lost their separate rate in the most recently completed segment of the proceeding in which they participated.

    3 Only changes to the official company name, rather than trade names, need to be addressed via a Separate Rate Application. Information regarding new trade names may be submitted via a Separate Rate Certification.

    For exporters and producers who submit a separate-rate status application or certification and subsequently are selected as mandatory respondents, these exporters and producers will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.

    Initiation of Reviews

    In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than August 31, 2019.

    Period to be
  • reviewed
  • Antidumping Duty Proceedings India: Finished Carbon Steel Flanges, A-533-871 2/8/17-7/31/18 Adinath International Allena Group Alloyed Steel Bansidhar Chiranjilal Bebitz Flanges Works Private Limited C.D. Industries CHQ Forge Pvt. Ltd. CHW Forge Citizen Metal Depot Corum Flange DN Forge Industries Echjay Forgings Limited Falcon Valves and Flanges Private Limited Heubach International Hindon Forge Pvt. Ltd. Jai Auto Pvt. Ltd. Kinnari Steel Corporation M F Rings and Bearing Races Ltd. Mascot Metal Manufactures Norma (India) Ltd. OM Exports Punjab Steel Works (PSW) R. D. Forge R.N. Gupta & Co. Ltd. Raaj Sagar Steels Ravi Ratan Metal Industries Rolex Fittings India Pvt. Ltd. Rollwell Forge Pvt. Ltd. SHM (ShinHeung Machinery) Siddhagiri Metal & Tubes Sizer India Steel Shape India Sudhir Forgings Pvt. Ltd. Tirupati Forge Uma Shanker Khandelwal & Co. Umashanker Khandelwal Forging Limited USK Export Private Limited Italy: Finished Carbon Steel Flanges, A-475-835 2/8/17-7/31/18 ASFO S.p.A. ASFO S.p.A—FOMAS Group Assotherm srl Bifrangi S.p.A. CAT Carpenteria Metallica srl Costruzione Ricambi Machine Industriali Filmag Italia S.r.l. FOC Ciscato S.p.Ar. FOMAS Forgia Di Bollate S.p.A. Forgiatura A. Vienna diAntonio Vienna Forgital Italy S.p.A. Franchini Acciai S.p.A. Galperti Forged Products Inox Laghi S.r.l. KIASMA SRL lml Industria Meccanica Ligure Martin Valmore srl M.E.G.A. S.p.A Metalfar Prodotti Industriali, S.p.A. Officine Ambrogio Melesi & C. S.R.L. Officine di Cortabbio s.r.1. OFFICINE MECCANICHE CIOCCA S.p.A. Office SANTAFEDE Siderforgerossi Group S.P.A. UNIGEN Steel Engineering VALVITALIA S.p.A. Malaysia: Polyethylene Retail Carrier Bags, A-557-813 8/1/17-7/31/18 Euro SME Sdn Bhd Mexico: Light-Walled Rectangular Pipe and Tube, A-201-836 8/1/17-7/31/18 Aceros Cuatro Caminos S.A. de C.V. Arco Metal S.A. de C.V. Fabricaciones y Servicios de Mexico Galvak, S.A. de C.V. Grupo Estructuras y Perfiles Hylsa S.A. de C.V. Industrias Monterrery S.A. de C.V. International de Aceros, S.A. de C.V. Maquilacero S.A. de C.V. Nacional de Acero S.A. de C.V. PEASA-Productos Especializados de Acero Perfiles LM, S.A. de C.V. Productos Laminados de Monterrey S.A. de C.V. Regiomontana de Perfiles y Tubos S.A. de C.V. Talleres Acero Rey S.A. de C.V. Ternium Mexico S.A. de C.V. Tuberias Aspe Tuberia Laguna, S.A. de C.V. Tuberias y Derivados S.A de C.V. Republic of Korea: Dioctyl Terephthalate, A-580-889 2/3/17-7/31/18 Aekyung Petrochemical LG Chem, Ltd. Hanwha Chemical Republic of Korea: Large Power Transformers, A-580-867 8/1/17-7/31/18 Hyosung Heavy Industries Corporation Hyosung Corporation Hyundai Electric & Energy Systems Co., Ltd. Hyundai Heavy Industries Co., Ltd. ILJIN Iljin Electric Co., Ltd. LSIS Co., Ltd. Romania: Carbon and Alloy Seamless Standard Line and Pressure Pipe, A-485-805 (under 41/2 Inches) 8/1/17-7/31/18 Silcotub S.A. ArcelorMittal Tubular Products Roman S.A. SC TMK-Artom S.A. SC Tubinox S.A. Socialist Republic of Vietnam: Certain Frozen Fish Fillets, A-552-801 8/1/17-7/31/18 An Giang Agriculture and Food Import-Export Joint Stock Company (also known as Afiex, An Giang Agriculture and Foods Import-Export Joint Stock Company, An Giang Agriculture and Food Import-Export Company, An Giang Agriculture and Foods Import and Export Company, or An Giang Agriculture and Foods Import-Export Company) An Giang Fisheries Import and Export Joint Stock Company (also known as Agifish, AnGiang Fisheries Import and Export, or An Giang Fisheries Import & Export Joint Stock Company) An My Fish Joint Stock Company (also known as Anmyfish or Anmyfishco) An Phat Import-Export Seafood Co., Ltd. (also known as An Phat Seafood Co. Ltd. or An Phat Seafood Co., Ltd.) An Phu Seafood Corporation (also known as ASEAFOOD or An Phu Seafood Corp.) Anvifish Joint Stock Company (also known as Anvifish, Anvifish JSC, or Anvifish Co., Ltd.) Asia Commerce Fisheries Joint Stock Company (also known as Acomfish JSC or Acomfish) Asia Pangasius Company Limited (also known as ASIA) Basa Joint Stock Company (BASACO) Ben Tre Aquaproduct Import and Export Joint Stock Company (also known as Bentre Aquaproduct, Bentre Aquaproduct Import & Export Joint Stock Company, or Aquatex Bentre) Bentre Forestry and Aquaproduct Import Export Joint Stock Company (also known as Bentre Forestry and Aquaproduct Import and Export Joint Stock Company, Ben Tre Forestry and Aquaproduct Import-Export Joint Stock Company, Ben Tre Forestry and Aquaproduct Import-Export Company, Ben Tre Forestry Aquaproduct Import-Export Company, Ben Tre Frozen Aquaproduct Export Company, or Faquimex) Bien Dong Hau Giang Seafood Joint Stock Company (also known as Bien Dong HG or Bien Dong Hau Giang Seafood Joint Stock Co.) Bien Dong Seafood Company Ltd. (also known as Bien Dong, Bien Dong Seafood, Bien Dong Seafood Co., Ltd., Biendong Seafood Co., Ltd., or Biendong Seafood Limited Liabilty Company) Binh An Seafood Joint Stock Company (also known as Binh An or Binh An Seafood Joint Stock Co.) Binh Dinh Import Export Company (also known as Binh Dinh) Cadovimex II Seafood Import-Export and Processing Joint Stock Company (also known as Cadovimex II, Cadovimex II Seafood Import-Export, Cadovimex II Seafood Import Export and Processing Joint Stock Company, or Cadovimex II Seafood Import-Export & Processing Joint Stock Company) Cafatex Corporation (also known as Cafatex) Can Tho Animal Fishery Products Processing Export Enterprise (also known as Cafatex) Cantho Import-Export Seafood Joint Stock Company (also known as CASEAMEX, Cantho Import Export Seafood Joint Stock Company, Cantho Import-Export Joint Stock Company, Can Tho Import Export Seafood Joint Stock Company, Can Tho Import- Export Seafood Joint Stock Company, or Can Tho Import-Export Joint Stock Company) C.P. Vietnam Corporation Cuu Long Fish Import-Export Corporation (also known as CL Panga Fish) Cuu Long Fish Joint Stock Company (also known as CL-Fish, CL-FISH CORP, or Cuu Long Fish Joint Stock Company) Da Nang Seaproducts Import-Export Corporation (also known as Da Nang or Da Nang Seaproducts Import/Export Corp.) Dai Thanh Seafoods Company Limited (also known as DATHACO, Dai Thanh Seafoods, or Dai Thanh Seafoods Co., Ltd.) East Sea Seafoods LLC (also known as ESS LLC, ESS, ESS JVC, East Sea Seafoods Limited Liability Company, East Sea Seafoods Joint Venture Co., Ltd.) Europe Joint Stock Company (also known as Europe JSC or EJS CO.) Fatifish Company Limited (also known as FATIFISH or FATIFISHCO) Go Dang An Hiep One Member Limited Company Go Dang Ben Tre One Member Limited Liability Company GODACO Seafood Joint Stock Company (also known as GODACO, GODACO Seafood J.S.C., GODACO Seafood, or GODOCO_SEAFOOD) Golden Quality Seafood Corporation (also known Golden Quality, GoldenQuality, GoldenQuality Seafood Corporation, or GOLDENQUALITY) Green Farms Seafood Joint Stock Company (also known as Green Farms, GreenFarm SeaFoods Joint Stock Company, Green Farms Seafoods Joint Stock Company, or Green Farms Seafood JSC) Hai Huong Seafood Joint Stock Company (also known as HHFish, HH Fish, or Hai Houng Seafood) Hiep Thanh Seafood Joint Stock Company (also known as Hiep Thanh or Hiep Thanh Seafood Joint Stock Co.) Hoa Phat Seafood Import-Export and Processing J.S.C. (also known as HOPAFISH, Hoa Phat Seafood Import-Export and Processing Joint Stock Company, or Hoa Phat Seafood Import-Export and Processing JSC) Hoang Long Seafood Processing Company Limited (also known as HLS, Hoang Long Seafood, Hoang Long Seafood Processing Co.,Ltd., Hoang Long, or HoangLong Seafood) Hung Vuong Ben Tre Seafood Processing Company Limited (also known as Ben Tre, HVBT, or HVBT Seafood Processing) Hung Vuong—Mien Tay Aquaculture Corporation (also known as HVMT or Hung Vuong Mien Tay Aquaculture Joint Stock Company) Hung Vuong—Sa Dec Co., Ltd. (also known as Hung Vuong Sa Dec Company Limited) Hung Vuong—Vinh Long Co., Ltd. (also known as Hung Vuong Vinh Long Company Limited) Hung Vuong Corporation (as known as HVC or HV Corp.) Hung Vuong Joint Stock Company Hung Vuong Mascato Company Limited Hung Vuong Seafood Joint Stock Company International Development & Investment Corporation (also known as IDI or International Development and Investment Corporation) Lian Heng Investment Co., Ltd. (also known as Lian Heng Investment or Lian Heng) Lian Heng Trading Co., Ltd. (also known as Lian Heng or Lian Heng Trading) Nam Phuong Seafood Co., Ltd. (also known as Nam Phuong, NAFISHCO, Nam Phuong Seafood, or Nam PhuongSeafood Company Ltd.) Nam Viet Corporation (also known as NAVICO) Ngoc Ha Co. Ltd. Food Processing and Trading (also known as Ngoc Ha or Ngoc Ha Co., Ltd. Foods Processing and Trading) Nha Trang Seafoods, Inc. (also known as Nha Trang Seafoods-F89, Nha Trang Seafoods, or Nha Trang Seaproduct Company) NTACO Corporation (also known as NTACO or NTACO Corp.) NTSF Seafoods Joint Stock Company (also known as NTSF or NTSF Seafoods) Quang Minh Seafood Company Limited (also known as Quang Minh, Quang Minh Seafood Co., Ltd., or Quang Minh Seafood Co.) QVD Dong Thap Food Co., Ltd. (also known as Dong Thap or QVD DT) QVD Food Company, Ltd. (also known as QVD, QVD Food Co., Ltd., or QVD Aquaculture) Saigon-Mekong Fishery Co., Ltd. (also known as SAMEFICO or Saigon Mekong Fishery Co., Ltd.) Seafood Joint Stock Company No. 4 Branch Dongtam Fisheries Processing Company (also known as DOTASEAFOODCO or Seafood Joint Stock Company No. 4-Branch Dong Tam Fisheries Processing Company) Seavina Joint Stock Company (also known as Seavina) Southern Fishery Industries Company, Ltd. (also known as South Vina, South Vina Co., Ltd., Southern Fisheries Industries Company, Ltd., Southern Fishery Industries Co., Ltd., or Southern Fisheries Industries Company Limited) Sunrise Corporation TG Fishery Holdings Corporation (also known as TG) Thanh Binh Dong Thap One Member Company Limited (also known as Thanh Binh Dong Thap or Thanh Binh Dong Thap Ltd.) Thanh Hung Co., Ltd. (also known as Thanh Hung Frozen Seafood Processing Import Export Co., Ltd. or Thanh Hung) Thien Ma Seafood Co., Ltd. (also known as THIMACO, Thien Ma, Thien Ma Seafood Company, Ltd., or Thien Ma Seafoods Co., Ltd.) Thuan An Production Trading and Service Co., Ltd. (also known as TAFISHCO, Thuan An Production Trading and Services Co., Ltd., Thuan An Production & Trading Service Co., Ltd., or Thuan An Production & Trading Services Co., Ltd.) Thuan Hung Co., Ltd. (also known as THUFICO) To Chau Joint Stock Company (also known as TOCHAU, TOCHAU JSC, or TOCHAU Joint Stock Company) Van Duc Food Export Joint Stock Company (also known as Van Duc) Van Duc Tien Giang Food Export Company (also known as VDTG) Viet Hai Seafood Company Limited (also known as Viet Hai, Vietnam Fish-One Co., Ltd. Viet Hai Seafood Co., Viet Hai Seafood Co., Ltd., Vietnam Fish One Co., Ltd., or Fish One) Viet Phu Foods and Fish Corporation (also known as Vietphu, Viet Phu, Viet Phu Food and Fish Corporation, or Viet Phu Food & Fish Corporation) Viet Phu Foods & Fish Co., Ltd. Vinh Hoan Corporation (also known as Vinh Hoan, Vinh Hoan Co., or Vinh Hoan Corp.) Vinh Long Import-Export Company (also known as Vinh Long, Imex Cuu Long or Vinh Long Import/Export Company) Vinh Quang Fisheries Corporation (also known as Vinh Quang, Vinh Quang Fisheries Joint Stock Company, Vinh Quang Fisheries Co.,Ltd., or Vinh Quang Fisheries Corp.) The People's Republic of China: Certain Passenger Vehicle and Light Truck Tires, A-570-016 8/1/17-7/31/18 Anhui Jichi Tire Co., Ltd. Bridgestone (Tianjin) Tire Co., Ltd. Bridgestone Corporation Cooper (Kunshan) Tire Co., Ltd. Crown International Corporation Fleming Limited Guangrao Taihua International Trade Co., Ltd. Hankook Tire China Co., Ltd. Haohua Orient International Trade Ltd. Jingsu Hankook Tire Co., Ltd. Kenda Rubber (China) Co., Ltd. Kinforest Tyre Co., Ltd. Macho Tire Corporation Limited Mayrun Tyre (Hong Kong) Limited Pirelli Tyre Co., Ltd. Qingdao Fullrun Tyre Corp., Ltd. Qingdao Jinhaoyang International Co., Ltd. Qingdao Keter International Co., Limited Qingdao Lakesea Tyre Co., Ltd. Qingdao Odyking Tyre Co., Ltd. Qingdao Sunfulcess Tyre Co., Ltd. Qingdao Transamerica Tire Industrial Co., Ltd. Qingzhou Detai International Trading Co., Ltd. Riversun Industry Limited Safe&Well (HK) International Trading Limtied Shandong Achi Tyres Co., Ltd. Shandong Anchi Tryes Co., Ltd. Shandong Duratti Rubber Corporation Co., Ltd. Shandong Guofeng Rubber Plastics Co., Ltd. Shandong Haohua Tire Co., Ltd. Shandong Hengyu Science & Technology Co., Ltd. Shandong Hongsheng Rubber Technology Co., Ltd. Shandong Longyue Rubber Co., Ltd. Shandong New Continent Tire Co., Ltd. Shandong Province Sanli Tire Manufactured Co., Ltd. Shandong Wanda Boto Tyre Co., Ltd. Shengtai Group Co., Ltd. Shouguang Firemax Tyre Co., Ltd. Tianjin Wanda Tyre Group Co., Ltd. Triangle Tyre Co., Ltd. Tyrechamp Group Co., Limited Windforce Tyre Co., Limited Winrun Tyre Co., Ltd. The People's Republic of China: Certain Steel Nails, A-570-909 8/1/17-7/31/18 Air It on Inc. A-Jax Enterprises Ltd. A-Jax International Co. Ltd. Anhui Amigo Imp. & Exp. Co. Ltd. Anhui Tea Imp. & Exp. Co. Ltd. Anjing Caiquing Hardware Co., Ltd. Astrotech Steels Pvt. Ltd. Beijing Catic Industry Ltd. Beijing Qin-Li Jeff Trading Co., Ltd. Bodi Corporation Cana (Rizhou) Hardward Co. Ltd. Cangzhou Xinqiao Int'l Trade Co. Ltd. Certified Products Taiwan Inc. Changzhou Kya Trading Co. Ltd. Chia Pao Metal Co. Ltd. China Dinghao Co. Ltd. China Staple Enterprise Co. Ltd. Chinapack Ningbo Imp. & Exp. Co. Ltd. Chite Enterprise Co. Ltd. Crelux Int'l Co. Ltd. Daejin Steel Co. Ltd. Dezhou Hualude Hardware Products Co. Ltd. Dingzhou Baota Metal Products Co. Ltd. Dong E Fuqiang Metal Products Co. Ltd. Dream Rising Co., Ltd. Eco-Friendly Floor Ltd. Ejen Brother Limited Everglow Inc. Everleading International Inc. Faithful Engineering Products Co. Ltd. Fastening Care Fastgrow International Co. Inc. Foshan Hosontool Development Hardware Co. Ltd. GD CP International Ltd. GDCP International Co., Ltd. Geeky Wires Limited Glori-Industry Hong Kong Inc. Guangdong Meite Mechanical Co. Ltd. Guangdong TC Meite Intelligent Tools Co., Ltd. Hangzhou Orient Industry Co., Ltd. Hangzhou Spring Washer Co. Ltd. Hebei Canzhou New Century Foreign Trade Co. Ltd. Hebei Jindun Trade Co., Ltd. Hebei Minmetals Co., Ltd. Hengtuo Metal Products Co. Ltd. Home International Development Co. Ltd. Hongyi (HK) Hardware Products Co. Ltd. Huaiyang County Yinfeng Plastic Factory Hualude International Development Co. Ltd. Huanghua Yingjin Hardware Products Inmax Industries Sdn. Bhd. ITW Construction Products Jade Shuttle Enterprise Co. Ltd. Jiang Men City Yu Xing Furniture Limited Company Jiangsu General Science Technology Co. Ltd. Jiangsu Holly Corporation Jiangsu Huaiyin Guex Tools Jiangsu Inter-China Group Corp. Jiangu Soho Honry Imp. and Exp. Co. Ltd. Jiaxing TSR Hardware Inc. Jinhai Hardware Co. Ltd. Jinsco International Corp. Jinsheung Steel Corporation Koram Inc. Korea Wire Co. Ltd. Liang's Ind. Corp. Liaocheng Minghui Hardware Products Linyi FlyingArrow Imp. & Exp. Co Ltd. M&M Industries Co., Ltd. Max Co., Ltd. Milkway Chemical Supply Chain Service Co., Ltd. Mingguang Abundant Hardware Products Co. Ltd. Mingguang Ruifeng Hardware Products Co. Ltd. Modern Factory For Metal Products Nailtech Co. Ltd. Nanjing Caiquing Hardware Co. Ltd. Nanjing Nuochun Hardware Co. Ltd. Nanjing Yuechang Hardware Co., Ltd. Nanjing Zeejoe International Trade Nantong Intlevel Trade Co., Ltd. Natuzzi China Limited Nielsen Bainbridge LLC Ningbo Adv. Tools Co. Ltd. Ningbo Angelar Trading Co., Ltd. Ningbo Fine Hardware Production Co. Ltd. Ningbo Freewill Imp. & Exp Co., Ltd. Ningbo Sunrise International Ltd. Ningbo WePartner Imp. & Exp. Co., Ltd. Overseas Distribution Services Inc. Overseas International Steel Industry Paslode Fasteners Co. Ltd. Patek Tool Co. Ltd. President Industrial Inc. Promising Way (Hong Kong) Ltd. Qingda Jisco Co. Ltd. Qingdao Ant Hardware Manufacturing Co. Ltd. Qingdao D&L Hardware Co. Ltd. Qingdao Gold Dragon Co. Ltd. Qingdao Hongyuan Nail Industry Co. Ltd. Qingdao JCD Machinery Co., Ltd. Qingdao Meijialucky Industry and Co. Qingdao MST Industry and Commerce Co. Ltd. Qingdao Top Steel Industrial Co. Ltd. Qingdao Uni-Trend International Quzhou Monsoon Hardware Co. Ltd. Region Industries Co. Ltd. Region System Sdn. Bhd. Rise Time Industrial Ltd. Romp Coil Nail Industries Inc. R-Time Group Inc. Ruifeng Hardware Products Co., Ltd. SDC International Australia Pty. Ltd. Senco Asia Manufacturing Ltd. Shandong Dinglong Imp. & Exp. Co., Ltd. Shandong Liaocheng Minghua Metal Pvt. Ltd. Shandong Liaocheng Minghua Metal Pvt. Ltd. Shandong Oriental Cherry Hardware Group Co. Ltd. Shandong Oriental Cherry Hardware Import & Export Co. Ltd. Shandong Qingyun Hongyi Hardware Co. Ltd. Shanghai Cedargreen Imp. & Exp. Co., Ltd. Shanghai Curvet Hardware Products Co. Ltd. Shanghai Haoray International Trade Co. Ltd. Shanghai Jade Shuttle Hardware Tools Co. Ltd. Shanghai Seti Enterprise Int'l Co. Ltd. Shanghai Sutek Industries Co., Ltd. Shanghai Yiren Machinery Co., Ltd. Shanghai Yueda Fasteners Co., Ltd. Shanghai Yueda Nails Co. Ltd. Shanghai Yueda Nails Co. Ltd. Shanghai Zoonlion Industrial Co., Ltd. Shanxi Easyfix Trade Co. Ltd. Shanxi Hairut Trade Co. Ltd. Shanxi Pioneer Hardware Industrial Co. Ltd. Shanxi Tianli Industries Co. Ltd. Shanxi Xinjintai Hardware Co., Ltd. Shaoxing Chengye Metal Producing Co. Ltd. Shenzhen Xinjintal Hardware Co. Ltd. Stanley Black & Decker, Inc. Sueyi International Ltd. Suntec Industries Co. Ltd. Suzhou Xingya Nail Co. Ltd. Taizhou Dajiang Ind. Co. Ltd. The Stanley Works (Langfang) Fastening Systems Co., Ltd. Theps International Tianji Hweschun Fasteners Manufacturing Co. Ltd. Tianjin Baisheng Metal Products Co. Ltd. Tianjin Bluekin Indusries Ltd. Tianjin Coways Metal Products Co. Ltd. Tianjin Dagang Jingang Nail Factory Tianjin Evangel Imp. & Exp. Co. Ltd. Tianjin Fulida Supply Co. Ltd. Tianjin Huixingshangmao Co. Ltd. Tianjin Huixishangmao Co. Ltd. Tianjin Jin Xin Sheng Long Metal Products Co. Ltd. Tianjin Jinchi Metal Products Co. Ltd. Tianjin Jinghai County Hongli Industry and Business Co. Ltd. Tianjin Jinghai Yicheng Metal Pvt. Tianjin Jinlin Pharmaceutical Factory Tianjin Jinmao Imp. & Exp. Corp. Ltd. Tianjin Lianda Group Co. Ltd. Tianjin Tianhua Environmental Plastics Co. Ltd. Tianjin Universal Machinery Imp. & Exp Tianjin Yong Sheng Towel Mill Tianjin Yongye Furniture Co. Ltd. Tianjin Zhonglian Metals Ware Co. Ltd. Tianjin Zhonglian Times Technology Tianjin Zhongsheng Garment Co. Ltd. Tinjin Liweitian Metal Technology Tinjin Tiaolai Import & Export Company Ltd. Tsugaru Enterprise Co., Ltd. Unicore Tianjin Fasteners Co. Ltd. Verko Incorporated Win Fasteners Manufactory (Thailand) Co. Ltd. Wire Products Manufacturing Co., Ltd. Wulian Zhanpeng Metals Co. Ltd. Xi'An Metals and Minerals Imp. & Exp. Co. Ltd. Xiamen Zhaotai Industrial Corp. Yongchang Metal Product Co. Youngwoo Fasteners Co., Ltd. Yuyao Dingfeng Engineering Co. Ltd. Zhanghaiding Hardware Co., Ltd. Zhangjiagang Lianfeng Metals Products Co. Ltd. Zhangjiagang Longxiang Industries Co. Ltd. Zhaoqing Harvest Nails Co. Ltd. Zhejiang Best Nail Industry Co. Ltd. Zhejiang Jihengkang (JHK) Door Ind. Co. Ltd. Zhejiang Yiwu Yongzhou Imp. & Exp. Co. Ltd. Zhong Shan Daheng Metal Products Co. Ltd. Zhong Shan Shen Neng Metals Products Co. Ltd. Zhucheng Jinming Metal Products Co. Ltd. Zhucheng Runfang Paper Co. Ltd. The People's Republic of China: Hydrofluorocarbon Blends, A-570-028 8/1/17-7/31/18 Arkema Daikin Advanced Fluorochemicals (Changsu) Co., Ltd. Daikin Fluorochemcials (China) Co., Ltd. Dongyang Weihua Refrigerants Co., Ltd. Jinhua Yonghe Fluorochemical Co., Ltd. Shandong Huaan New Material Co., Ltd. Sinochem Environmental Protection Chemicals (Taicang) Co., Ltd. T.T. International Co., Ltd. Weitron, Inc. Weitron International Refrigeration Equipment (Kushan) Co., Ltd. Zhejiang Lantian Environmental Protection Fluoro Material Co. Ltd. Zhejiang Quzhou Lianzhou Refrigerants Co., Ltd. Zhejiang Sanmei Chemica Industry Co., Ltd. Zhejiang Yonghe Refrigerant Co., Ltd. Zhejiang Zhonglan Refrigeration Technology Co., Ltd. The People's Republic of China: Polyethylene Retail Carrier Bags, A-570-886 8/1/17-7/31/18 Crown Polyethylene Products (International) Ltd. Dongguan Nozawa Plastics Products Co., Ltd. and United Power Packaging, Ltd. (collectively Nozawa) High Den Enterprises Ltd. Countervailing Duty Proceedings India: Finished Carbon Steel Flanges, C-533-872 11/29/16-12/31/17 Adinath International Allena Group Alloyed Steel Bansidhar Chiranjilal Bebitz Flanges Works Private Limited C.D. Industries CHW Forge CHW Forge Pvt. Ltd. Citizen Metal Depot Corum Flange DN Forge Industries Echjay Forgings Limited Falcon Valves and Flanges Private Limited Heubach International Hindon Forge Pvt. Ltd. Jai Auto Pvt. Ltd. Kinnari Steel Corporation M F Rings and Bearing Races Ltd. Mascot Metal Manufactures Norma (India) Ltd. OM Exports Punjab Steel Works (PSW) R.D. Forge R.N. Gupta & Co. Ltd. R.N. Gupta & Company Limited Raaj Sagar Steels Ravi Ratan Metal Industries Rolex Fittings India Pvt. Ltd. Rollwell Forge Pvt. Ltd. SHM (ShinHeung Machinery) Siddhagiri Metal & Tubes Sizer India Steel Shape India Sudhir Forgings Pvt. Ltd. Tirupati Forge Uma Shanker Khandelwal & Co. Uma Shanker Khandelwal and Co. Umashanker Khandelwal Forging Limited USK Export Private Limited Republic of Korea: Certain Corrsion-Resistant Steel Products,4 C-580-879 1/1/17-12/31/17 The People's Republic of China: Certain Passenger Vehicle and Light Truck Tires, C-570-017 1/1/17-12/31/17 Anhui Jichi Tire Co., Ltd. Bridgestone (Tianjin) Tire Co., Ltd. Bridgestone Corporation Cooper (Kunshan) Tire Co., Ltd. Dynamic Tire Corp. Fleming Limited Guangrao Taihua International Trade Co., Ltd. Hankook Tire China Co., Ltd. Haohua Orient International Trade Ltd. Husky Tire Corp. Jiangsu Hankook Tire Co., Ltd. Macho Tire Corporation Limited Maxon Int'l Co., Limited Mayrun Tyre (Hong Kong) Limited Pirelli Tyre Co., Ltd. Qingdao Fullrun Tyre Corp., Ltd. Qingdao Jinhaoyang International Co., Ltd. Qingdao Keter International Co., Limited Qingdao Lakesea Tyre Co., Ltd. Qingdao Odyking Tyre Co., Ltd. Qingdao Sunfulcess Trye Co., Ltd. Qinzhou Detai International Trading Co., Ltd. Riversun Industry Limited Safe&Well (HK) International Trading Limited Sailun Jinyu Group Co., Ltd. Sailun Jinyu Group (Hong Kong) Co., Limited Sailun Tire International Corp. Seatex International Inc. Seatex PTE. Ltd. Shandong Achi Tyres Co., Ltd. Shandong Anchi Tyres Co., Ltd. Shandong Duratti Rubber Corporation Co., Ltd. Shandong Guofeng Rubber Plastics Co., Ltd. Shandong Haohua Tire Co., Ltd. Shandong Hengyu Science & Technology Co., Ltd. Shandong Jinyu Industrial Co., Ltd. Shandong Longyue Rubber Co., Ltd. Shandong New Continent Tire Co., Ltd. Shandong Province Sanli Tire Manufactured Co., Ltd. Shandong Wanda Boto Tyre Co., Ltd. Shengtai Group Co., Ltd. Shouguang Firemax Tyre Co., Ltd. Triangle Tyre Co., Ltd. Tyrechamp Group Co., Limited Windforce Tyre Co., Limited Winrun Tyre Co., Ltd. Suspension Agreements Ukraine: Certain Oil Country Tubular Goods,5 A-823-815 7/1/17-6/30/18
    Duty Absorption Reviews

    During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under 19 CFR 351.211 or a determination under 19 CFR 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine whether antidumping duties have been absorbed by an exporter or producer subject to the review if the subject merchandise is sold in the United States through an importer that is affiliated with such exporter or producer. The request must include the name(s) of the exporter or producer for which the inquiry is requested.

    4 Dongkuk Steel Mill Co., Ltd. and Union Steel Manufacturing Co., Ltd. are not subject to the countervailing duty order on certain corrosion-resistant steel products (CORE) from the Republic of Korea (see 83 FR 39671 dated August 10, 2018) and were inadvertently included in the initiation notice that published on September 10, 2018 (83 FR 45596). Therefore, these two companies are not subject to the administrative review of the countervailing duty order on CORE from the Republic of Korea that published on September 10, 2018 (83 FR 45596).

    5 In the initiation notice that published on September 10, 2018 (83 FR 45596), the Department inadvertently omitted the case listed above from the July 2018 anniversary cases for which reviews were requested. This notice serves as a correction to the September initiation notice. In accordance with section 751(a)(3)(A) of the Act, Commerce shall issue its preliminary determination within 245 days after the last day of the month in which occurs the anniversary date of the publication of the suspension agreement for which the review is requested (in this case, July 2018).

    Gap Period Liquidation

    For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period, of the order, if such a gap period is applicable to the POR.

    Administrative Protective Orders and Letters of Appearance

    Interested parties must submit applications for disclosure under administrative protective orders in accordance with the procedures outlined in Commerce's regulations at 19 CFR 351.305. Those procedures apply to administrative reviews included in this notice of initiation. Parties wishing to participate in any of these administrative reviews should ensure that they meet the requirements of these procedures (e.g., the filing of separate letters of appearance as discussed at 19 CFR 351.103(d)).

    Factual Information Requirements

    Commerce's regulations identify five categories of factual information in 19 CFR 351.102(b)(21), which are summarized as follows: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). These regulations require any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. The regulations, at 19 CFR 351.301, also provide specific time limits for such factual submissions based on the type of factual information being submitted. Please review the final rule, available at http://enforcement.trade.gov/frn/2013/1304frn/2013-08227.txt, prior to submitting factual information in this segment.

    Any party submitting factual information in an antidumping duty or countervailing duty proceeding must certify to the accuracy and completeness of that information.6 Parties are hereby reminded that revised certification requirements are in effect for company/government officials as well as their representatives. All segments of any antidumping duty or countervailing duty proceedings initiated on or after August 16, 2013, should use the formats for the revised certifications provided at the end of the Final Rule. 7 Commerce intends to reject factual submissions in any proceeding segments if the submitting party does not comply with applicable revised certification requirements.

    6See section 782(b) of the Act.

    7See Certification of Factual Information To Import Administration During Antidumping and Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (Final Rule); see also the frequently asked questions regarding the Final Rule, available at http://enforcement.trade.gov/tlei/notices/factual_info_final_rule_FAQ_07172013.pdf.

    Extension of Time Limits Regulation

    Parties may request an extension of time limits before a time limit established under Part 351 expires, or as otherwise specified by the Secretary. See 19 CFR 351.302. In general, an extension request will be considered untimely if it is filed after the time limit established under Part 351 expires. For submissions which are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Examples include, but are not limited to: (1) Case and rebuttal briefs, filed pursuant to 19 CFR 351.309; (2) factual information to value factors under 19 CFR 351.408(c), or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2), filed pursuant to 19 CFR 351.301(c)(3) and rebuttal, clarification and correction filed pursuant to 19 CFR 351.301(c)(3)(iv); (3) comments concerning the selection of a surrogate country and surrogate values and rebuttal; (4) comments concerning U.S. Customs and Border Protection data; and (5) quantity and value questionnaires. Under certain circumstances, Commerce may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, Commerce will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. This modification also requires that an extension request must be made in a separate, stand-alone submission, and clarifies the circumstances under which Commerce will grant untimely-filed requests for the extension of time limits. These modifications are effective for all segments initiated on or after October 21, 2013. Please review the final rule, available at http://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in these segments.

    These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i).

    Dated: September 28, 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. 2018-21617 Filed 10-3-18; 8:45 am] BILLING CODE 3510-DS-P
    CONSUMER PRODUCT SAFETY COMMISSION Sunshine Act Meetings TIME AND DATE:

    Wednesday, October 10, 2018, 10:00 a.m.-12:00 p.m.

    PLACE:

    Hearing Room 420, Bethesda Towers, 4330 East West Highway, Bethesda, MD.

    STATUS:

    Commission Meeting—Open to the Public.

    MATTERS TO BE CONSIDERED:

    Decisional Matter: Fiscal Year 2019 Operating Plan.

    A live webcast of the Meeting can be viewed at https://www.cpsc.gov/live.

    CONTACT PERSON FOR MORE INFORMATION:

    Rockelle Hammond, Office of the Secretariat, Office of the General Counsel, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, (301) 504-6833.

    Dated: October 1, 2018. Alberta E. Mills, Secretary.
    [FR Doc. 2018-21710 Filed 10-2-18; 11:15 am] BILLING CODE 6355-01-P
    DEPARTMENT OF DEFENSE Department of the Navy Notice of Intent To Grant Exclusive Patent License; Point Semantics Corporation AGENCY:

    Department of the Navy, DoD.

    ACTION:

    Notice.

    SUMMARY:

    The Department of the Navy hereby gives notice of its intent to grant to Point Semantics Corporation of Alexandria, Virginia an exclusive license in the field of use of Displacement and Strain Measurement for Scientific and Engineering Applications, in the United States, to U.S. Patent No. 8,600,147: System and Method for Remote Measurement of Displacement and Strain Fields, Navy Case No. 099,829.//U.S. Patent No. 9,046,353: System and Method for Remote Full Field Three-Dimensional Displacement and Strain Measurements, Navy Case No. 101,258.//U.S. Patent No. 9,311,566: Method and System for Direct Strain Imaging, Navy Case No. 101.954.// and any continuations, divisionals or re-issues thereof. Nonexclusive, royalty free licenses are retained by SAIC under contract N00173-05-C-2062 and under the Agreement between Owners of Patent Rights NRL-IIA-14-047 between NRL and George Mason University.

    DATES:

    Anyone wishing to object to the grant of this license must file written objections along with supporting evidence, if any, not later than October 19, 2018.

    ADDRESSES:

    Written objections are to be filed with the Naval Research Laboratory, Code 1004, 4555 Overlook Avenue SW, Washington, DC 20375-5320.

    FOR FURTHER INFORMATION CONTACT:

    Amanda Horansky McKinney, Head, Technology Transfer Office, NRL Code 1004, 4555 Overlook Avenue SW, Washington, DC 20375-5320, telephone 202-767-1644. Due to U.S. Postal delays, please fax 202-404-7920, email: [email protected] or use courier delivery to expedite response.

    (Authority: 35 U.S.C. 207, 37 CFR part 404.)

    Dated: October 1, 2018. Meredith Steingold Werner, Lieutenant Commander, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer.
    [FR Doc. 2018-21633 Filed 10-3-18; 8:45 am] BILLING CODE 3810-FF-P
    DEFENSE NUCLEAR FACILITIES SAFETY BOARD Sunshine Act Meetings TIME AND DATE:

    2:00 p.m.-4:00 p.m., October 9, 2018.

    PLACE:

    Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW, Suite 700, Washington, DC 20004.

    STATUS:

    Closed. During the closed meeting, the Board Members will discuss issues dealing with potential Recommendations to the Secretary of Energy. The Board is invoking the exemptions to close a meeting described in 5 U.S.C. 552b(c)(3) and (9)(B) and 10 CFR 1704.4(c) and (h). The Board has determined that it is necessary to close the meeting since conducting an open meeting is likely to disclose matters that are specifically exempted from disclosure by statute, and/or be likely to significantly frustrate implementation of a proposed agency action. In this case, the deliberations will pertain to potential Board Recommendations which, under 42 U.S.C. 2286d(b) and (h)(3), may not be made publicly available until after they have been received by the Secretary of Energy or the President, respectively.

    MATTERS TO BE CONSIDERED:

    The meeting will proceed in accordance with the closed meeting agenda which is posted on the Board's public website at www.dnfsb.gov. Technical staff may present information to the Board. The Board Members are expected to conduct deliberations regarding potential Recommendations to the Secretary of Energy.

    CONTACT PERSON FOR MORE INFORMATION:

    Glenn Sklar, General Manager, Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW, Suite 700, Washington, DC 20004-2901, (800) 788-4016. This is a toll-free number.

    Dated: September 28, 2018. Joseph Bruce Hamilton, Acting Chairman.
    [FR Doc. 2018-21703 Filed 10-2-18; 11:15 am] BILLING CODE 3670-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2018-ICCD-0078] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Paul Douglas Teacher Scholarship Performance Report Form AGENCY:

    Office of Postsecondary Education (OPE), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before November 5, 2018.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2018-ICCD-0078. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 550 12th Street SW, PCP, Room 9086, Washington, DC 20202-0023.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Darryl Davis, 202-453-7582.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Paul Douglas Teacher Scholarship Performance Report Form.

    OMB Control Number: 1840-0787.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 10.

    Total Estimated Number of Annual Burden Hours: 120.

    Abstract: The Paul Douglas Teacher Scholarship program was designed to issue grants to the states to provide scholarships to outstanding secondary school graduates who demonstrated an interest in teaching careers at the preschool, elementary, or secondary level. Although the program is no longer funded, the annual performance report is necessary to monitor and evaluate the compliance of the remaining state education agencies.

    Dated: October 1, 2018. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-21607 Filed 10-3-18; 8:45 am] BILLING CODE 4000-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0355] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before December 3, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0355.

    Title: Rate-of-Return Monitoring Reports.

    Form Numbers: FCC Forms 492 and 492-A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 175 respondents; 175 responses.

    Estimated Time per Response: 8 hours.

    Frequency of Response: Annual reporting requirement and recordkeeping requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 160, 161, 209(b) and 220 as amended by the Communications Act of 1934, as amended.

    Total Annual Burden: 1,400 hours.

    Total Annual Cost: No cost.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: In most cases, the rate-of-return reports do not require submission of any confidential or commercially-sensitive data. The areas in which detailed information is required are fully subject to regulation. If a respondent finds it necessary to submit confidential or commercially-sensitive data, they may do so under 47 CFR 0.459 of the Commission's rules.

    Needs and Uses: The filing of FCC Forms 492 and 492-A is required by 47 CFR 65.600 of the Commission's rules. FCC Form 492 is filed by each local exchange carrier (LEC) or groups of carriers who file individual access tariffs or who are not subject to sections 61.41 through 61.49 of the Commission's rules. Each LEC, or group of affiliated carriers, subject to the previously stated sections, file FCC Form 492-A. These data provide the necessary detail to enable the Commission to fulfill its regulatory responsibilities. The Commission has granted AT&T, Verizon, legacy Qwest, and other similarly-situated carriers forbearance from FCC Form 492-A. See Petition of AT&T Inc. for Forbearance under 47 U.S.C. 160 from Enforcement of Certain of the Commission's Cost Assignment Rules, WC Docket Nos. 07-21, 05-342, Memorandum Opinion and Order, 23 FCC Rcd 7302 (2008) (AT&T Cost Assignment Forbearance Order). However, one submission included 56 new entities that had not previously filed Form 492.

    Federal Communications Commission. Marlene Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-21598 Filed 10-3-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0844, OMB 3060-1086, OMB 3060-1183, OMB 3060-1216] Information Collections Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written PRA comments should be submitted on or before December 3, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email to [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0844.

    Title: Carriage of the Transmissions of Television Broadcast Stations: Section 76.56(a), Carriage of qualified noncommercial educational stations; Section 76.57, Channel positioning; Section 76.61(a)(1)-(2), Disputes concerning carriage; Section 76.64, Retransmission consent.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 835 respondents and 14,040 responses.

    Estimated Time per Response: 1 to 5 hours.

    Frequency of Response: On occasion reporting requirement; Third party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in Sections 1, 4(i) and (j), 325, 336, 614 and 615 of the Communications Act of 1934, as amended.

    Total Annual Burden: 14,840 hours.

    Total Annual Cost: No cost.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: Under Section 614 of the Communications Act and the implementing rules adopted by the Commission, commercial TV broadcast stations are entitled to assert mandatory carriage rights on cable systems located within the station's television market. Under Section 325(b) of the Communications Act, commercial TV broadcast stations are entitled to negotiate with local cable systems for carriage of their signal pursuant to retransmission consent agreements in lieu of asserting must carry rights. This system is therefore referred to as “Must- Carry and Retransmission Consent.” Under Section 615 of the Communications Act, noncommercial educational (NCE) stations are also entitled to assert mandatory carriage rights on cable systems located within the station's market; however, noncommercial TV broadcast stations are not entitled to retransmission consent. The information collection requirements for this collection are contained in 47 CFR Sections 76.56(a), 76.57, 76.61(a)(1)-(2) and 76.64.

    OMB Control Number: 3060-1086.

    Title: Section 74.787, Digital Licensing; Section 74.790, Permissible Service of Digital TV Translator and LPTV Stations; Section 74.794, Digital Emissions, Section 74.796, Modification of Digital Transmission Systems and Analog Transmission Systems for Digital Operation; Section 74.798, LPTV Digital Transition Consumer Education Information; Protection of Analog LPTV.

    Form Number: Not applicable.

    Respondents: Business or other for profit entities; not for profit institutions; State, local or Tribal government.

    Number of Respondents/Responses: 8,445 respondents; 27,386 responses.

    Estimated Hours per Response: 0.50-4 hours.

    Frequency of Response: Recordkeeping requirement; One-time reporting requirement; Third party disclosure requirement.

    Total Annual Burden: 56,386 hours.

    Total Annual Cost: $69,033,000.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in section 301 of the Communications Act of 1934, as amended.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Act Assessment: No impact(s).

    Needs and Uses: The information collection requirements approved under this collection are as follows:

    a. 47 CFR 74.787(a)(2)(iii) provides that mutually exclusive LPTV and TV translator applicants for companion digital stations will be afforded an opportunity to submit in writing to the Commission, settlements and engineering solutions to resolve their situation.

    b. 47 CFR 74.787(a)(3) provides that mutually exclusive applicants applying for construction permits for new digital stations and for major changes to existing stations in the LPTV service will similarly be allowed to submit in writing to the Commission, settlements and engineering solutions to rectify the problem.

    c. 47 CFR 74.787(a)(4) provides that mutually exclusive displacement relief applicants filing applications for digital LPTV and TV translator stations may be resolved by submitting settlements and engineering solutions in writing to the Commission.

    d. 47 CFR 74.787(a)(5)(v) states that a license for a digital-to-digital replacement television translator will be issued only to a full-power television broadcast station licensee that demonstrates in its application a loss in the station's pre-auction digital service area as a result of the broadcast television spectrum incentive auction, including the repacking process, conducted under section 6403 of the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96). “Pre-auction digital service area” is defined as the geographic area within the full power station's noise-limited contour (as set forth in Public Notice, DA 15-1296, released November 12, 2015). The service area of the digital-to-digital replacement translator shall be limited to only the demonstrated loss area within the full power station's pre-auction digital service area, provided that an applicant for a digital-to-digital replacement television translator may propose a de minimis expansion of its full power pre-auction digital service area upon demonstrating that the expansion is necessary to replace a loss in its pre-auction digital service area.

    e. 47 CFR 74.790(f) permits digital TV translator stations to originate emergency warnings over the air deemed necessary to protect and safeguard life and property, and to originate local public service announcements (PSAs) or messages seeking or acknowledging financial support necessary for its continued operation. These announcements or messages shall not exceed 30 seconds each, and be broadcast no more than once per hour.

    f. 47 CFR 74.790(e) requires that a digital TV translator station shall not retransmit the programs and signal of any TV broadcast or DTV broadcast station(s) without prior written consent of such station(s). A digital TV translator operator electing to multiplex signals must negotiate arrangements and obtain written consent of involved DTV station licensee(s).

    g. 47 CFR 74.790(g) requires a digital LPTV station who transmits the programming of a TV broadcast or DTV broadcast station received prior written consent of the station whose signal is being transmitted.

    h. 47 CFR 74.794 mandates that digital LPTV and TV translator stations operating on TV channels 22-24, 32-36 and 38 with a digital transmitter not specifically FCC-certificated for the channel purchase and utilize a low pass filter or equivalent device rated by its manufacturer to have an attenuation of at least 85 dB in the GPS band. The licensees must retain with their station license a description of the low pass filter or equivalent device with the manufacturer's rating or a report of measurements by a qualified individual.

    i. 47 CFR 74.796(b)(5) requires digital LPTV or TV translator station licensees that modify their existing transmitter by use of a manufacturer-provided modification kit would need to purchase the kit and must notify the Commission upon completion of the transmitter modifications. In addition, a digital LPTV or TV translator station licensees that modify their existing transmitter and do not use a manufacturer-provided modification kit, but instead perform custom modification (those not related to installation of manufacturer-supplied and FCC-certified equipment) must notify the Commission upon completion of the transmitter modifications and shall certify compliance with all applicable transmission system requirements.

    j. 47 CFR 74.796(b)(6) provides that operators who modify their existing transmitter by use of a manufacturer-provided modification kit must maintain with the station's records for a period of not less than two years, and will make available to the Commission upon request, a description of the nature of the modifications, installation and test instructions, and other material provided by the manufacturer, the results of performance-tests and measurements on the modified transmitter, and copies of related correspondence with the Commission. In addition, digital LPTV and TV translator operators who custom modify their transmitter must maintain with the station's records for a period of not less than two years, and will make available to the Commission upon request, a description of the modifications performed and performance tests, the results of performance-tests and measurements on the modified transmitter, and copies of related correspondence with the Commission.

    k. Protection of Analog LPTV. In situations where protection of an existing analog LPTV or translator station without a frequency offset prevents acceptance of a proposed new or modified LPTV, TV translator, or Class A station, the Commission requires that the existing non-offset station install at its expense offset equipment and notify the Commission that it has done so, or, alternatively, negotiate an interference agreement with the new station and notify the Commission of that agreement.

    l. 47 CFR 74.798 requires all stations in the low power television services to provide notice of their upcoming digital transition to their viewers.

    OMB Control Number: 3060-1183.

    Title: Establishment of a Public Safety Answering Point Do-Not-Call Registry, CG Docket No. 12-129.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities; Federal Government; Not-for-profit institutions; State, local or Tribal Government.

    Number of Respondents and Responses: 106,500 respondents; 1,446,333 responses.

    Estimated Time per Response: 30 minutes (.50 hours) to 1 hour.

    Frequency of Response: Recordkeeping requirement; Annually, monthly, on occasion and one-time reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for the information collection requirements is found in the Middle Class Tax Relief and Job Creation Act of 2012, Public Law 112-96, February 22, 2012.

    Total Annual Burden: 792,667 hours.

    Total Annual Cost: None.

    Nature and Extent of Confidentiality: An assurance of confidentiality is not offered because this information collection does not require the collection of personally identifiable information from individuals.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: The rules adopted herein establish recordkeeping requirements for a large variety of entities, including small business entities. First, each Public Safety Answering Point (PSAP) may designate a representative who shall be required to file a certification with the administrator of the PSAP registry that they are authorized to place numbers onto that registry. The designated PSAP representative shall provide contact information including the PSAP represented, name, title, address, telephone number and email address. Verified PSAPs shall be permitted to upload to the registry any PSAP telephone associated with the provision of emergency services or communications with other public safety agencies. On an annual basis designated PSAP representatives shall access the registry, review their numbers and remove any ineligible numbers from the registry. Second, an operator of automatic dialing equipment (OADE) is prohibited from contacting any number on the PSAP registry. Each OADE must register for access to the PSAP registry by providing contact information which includes name, business address, contact person, telephone number, email, and all outbound telephone numbers used to place autodialed calls. All such contact information must be updated within 30 days of any change. In addition, the OADE must certify that it is accessing the registry solely to prevent autodialed calls to numbers on the registry. An OADE must access and employ a version of the PSAP registry obtained from the registry administrator no more than 31 days prior to the date any call is made, and maintain record documenting this process. No person or entity may sell, rent, lease, purchase, share, or use the PSAP registry for any purpose expect to comply with our rules prohibiting contact with numbers on the registry.

    OMB Control No.: 3060-1216.

    Title: Media Bureau Incentive Auction Implementation, Sections 73.3700(b)(4)(i)-(ii), (c), (d), (h)(5)-(6) and (g)(4).

    Form No.: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities; Not for profit institutions.

    Number of Respondents and Responses: 1,950 respondents and 174,219 responses.

    Estimated Time per Response: .004-15 hours.

    Frequency of Response: One-time reporting requirement; on occasion reporting requirement; recordkeeping requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for these collections are contained in 47 U.S.C. 151, 154, 301, 303, 307, 308, 309, 310, 316, 319, 325(b), 332, 336(f), 338, 339, 340, 399b, 403, 534, 535, 1404, 1452, and 1454.

    Total Annual Burden: 24,932 hours.

    Annual Cost Burden: $1,214,400.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection.

    Needs and Uses: The information gathered in this collection will be used to require broadcasters transitioning to a new station following the Incentive Auction, or going off the air as a result of a winning bid in the Incentive Auction, to notify their viewers of the date the station will terminate operations on its pre-Auction channel by running public service announcements, and allow these broadcasters to inform MVPDs of their relinquishment or change in channel. It requires channel sharing agreements enter into by television broadcast licensees to contain certain provisions regarding access to facilities, financial obligations and to define each party's rights and responsibilities; the Commission will review each channel sharing agreement to ensure it comports with general rules and policies regarding license agreements. The provisions contained in this collection also require wireless licensees to notify low-power television and TV translator stations commence wireless operations and the likelihood of receiving harmful interference from the low power TV or TV translator station to such operations within the wireless licensee's licensed geographic service area. Finally, it requires license relinquishment stations and channel sharing stations to comply with notification and cancellation procedures as they terminate operations on their pre-Auction channel.

    Federal Communications Commission. Marlene Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-21595 Filed 10-3-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0170, 3060-0546, 3060-1034] Information Collections Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before December 3, 2018. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email: [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0170.

    Title: Section 73.1030, Notifications Concerning Interference to Radio Astronomy, Research and Receiving Installations.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Businesses or other for-profit entities.

    Number of Respondents and Responses: 57 respondents; 57 responses.

    Estimated Hours per Response: 0.5 hours.

    Frequency of Response: On occasion reporting requirement; Third party disclosure requirement.

    Total Annual Cost: $14,250.

    Total Annual Burden: 29 hours.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in Section 154(i) of the Communications Act of 1934, as amended.

    Nature and Extent of Confidentiality: There is need for confidentiality required with this collection of information.

    Privacy Impact Assessment(s): No impact(s).

    Needs and Uses: The information collection requirements contained in 47 CFR 73.1030 state in order to minimize harmful interference at the National Radio Astronomy Observatory site located at Green, Pocahontas County, West Virginia, and at the Naval Radio Research Observatory at Sugar Grove, Pendleton County, West Virginia, a licensee proposing to operate a short-term broadcast auxiliary station pursuant to § 74.24, and any applicant for authority to construct a new broadcast station, or for authority to make changes in the frequency, power, antenna height, or antenna directivity of an existing station within the area bounded by 39°15′ N on the north, 78°30′ W on the east, 37°30′ N on the south, and 80°30′ W on the west, shall notify the Interference Office, National Radio Astronomy Observatory, P.O. Box 2, Green Bank, West Virginia 24944. Telephone: (304) 456-2011. The notification shall be in writing and set forth the particulars of the proposed station, including the geographical coordinates of the antenna, antenna height, antenna directivity if any, proposed frequency, type of emission and power. The notification shall be made prior to, or simultaneously with, the filing of the application with the Commission. After receipt of such applications, the FCC will allow a period of 20 days for comments or objections in response to the notifications indicated. If an objection to the proposed operation is received during the 20-day period from the National Radio Astronomy Observatory for itself, or on behalf of the Naval Radio Research Observatory, the FCC will consider all aspects of the problem and take whatever action is deemed appropriate.

    (2) Any applicant for a new permanent base or fixed station authorization to be located on the islands of Puerto Rico, Desecheo, Mona, Vieques, and Culebra, or for a modification of an existing authorization which would change the frequency, power, antenna height, directivity, or location of a station on these islands and would increase the likelihood of the authorized facility causing interference, shall notify the Interference Office, Arecibo Observatory, HC3 Box 53995, Arecibo, Puerto Rico 00612, in writing or electronically, of the technical parameters of the proposal. Applicants may wish to consult interference guidelines, which will be provided by Cornell University. Applicants who choose to transmit information electronically should email to: [email protected]

    (i) The notification to the Interference Office, Arecibo Observatory shall be made prior to, or simultaneously with, the filing of the application with the Commission. The notification shall state the geographical coordinates of the antenna (NAD-83 datum), antenna height above ground, ground elevation at the antenna, antenna directivity and gain, proposed frequency and FCC Rule Part, type of emission, and effective radiated power.

    (ii) After receipt of such applications, the Commission will allow the Arecibo Observatory a period of 20 days for comments or objections in response to the notification indicated. The applicant will be required to make reasonable efforts to resolve or mitigate any potential interference problem with the Arecibo Observatory and to file either an amendment to the application or a modification application, as appropriate. The Commission shall determine whether an applicant has satisfied its responsibility to make reasonable efforts to protect the Observatory from interference.

    OMB Control Number: 3060-0546.

    Title: Section 76.59 Definition of Markets for Purposes of the Cable Television Mandatory Television Broadcast Signal Carriage Rules.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business and other for-profit entities.

    Number of Respondents and Responses: 180 respondents and 200 responses.

    Estimated Time per Response: 0.5 to 40 hours.

    Frequency of Response: On occasion reporting requirement; Third party disclosure requirement; Recordkeeping requirement.

    Total Annual Burden: 1,486 hours.

    Total Annual Cost: $1,387,950.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in 47 U.S.C. 151, 154(i), 303(r), 338 and 534.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Impact Assessment(s): No impact(s).

    Needs and Uses: Market modification allows the Commission to modify the local television market of a particular commercial television broadcast station to enable commercial television stations, cable operators and satellite carriers to better serve the interests of local communities. Market modification provides a means to avoid rigid adherence to DMA designations and to promote consumer access to in-state and other relevant television programming. Section 338(l) of the Communications Act (the satellite market modification provision) and Section 614(h)(1)(C) of the Communications Act (the corresponding cable provision) permit the Commission to add communities to or delete communities from a station's local television market following a written request. Furthermore, the Commission may determine that particular communities are part of more than one television market.

    OMB Control Number: 3060-1034.

    Title: Digital Audio Broadcasting Systems and their Impact on the Terrestrial Radio Broadcast Service; Digital Notification Form, FCC Form 335.

    Form Number: FCC Form 335.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for profit.

    Number of Respondents and responses: 250 respondents, 250 responses.

    Frequency of Response: On occasion reporting requirement.

    Obligation to Respond: Required to obtain benefits—Statutory authority for this collection of information is contained in 154(i), 303, 310 and 533 of the Communications Act of 1934, as amended.

    Estimated Time per Response: 1 hour-8 hours.

    Total Annual Burden: 450 hours.

    Total Annual Cost: $192,000.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: On January 29, 2010, the Commission released the Order, Digital Audio Broadcasting Systems and Their Impact on the Terrestrial Radio Broadcast Service (Order), DA 10-208, MM Docket 99-325. The Order allowed: (1) Eligible authorized FM stations to commence operation of FM digital facilities with digital effective radiated power (ERP) up to-14 dBc upon notice to the Commission on Form 335 (the licensee of a super-powered FM station must file an informal request for any increase in the station's FM Digital ERP). (2) Licensees to submit an application to the Media Bureau, in the form of an informal request, for any increase in FM Digital ERP beyond 6 dB. (3) Licensees submitting such a request must use a simplified method set forth in the Order to determine the proponent station's maximum permissible FM Digital ERP. (4) In situations where the simplified method is not applicable due to unusual terrain or other environmental or technical considerations or when it produces anomalous FM Digital ERP results, the Bureau will accept applications for FM Digital ERP in excess of -14 dBc on a case-by-case basis when accompanied by a detailed showing containing a complete explanation of the prediction methodology used as well as data, maps and sample calculations. These information collection requirements have not changed since they were last approved by the Office of Management and Budget (OMB). These information collection requirements are also a part of this collection and remain unchanged:

    47 CFR 73.404(b) states in situations where interference to other stations is anticipated or actually occurs, AM licensees may, upon notification to the Commission, reduce the power of the primary Digital Audio Broadcasting (DAB) sidebands by up to 6 dB. Any greater reduction of sideband power requires prior authority from the Commission via the filing of a request for special temporary authority or an informal letter request for modification of license.

    47 CFR 73.404(e) states licensees (commercial and noncommercial AM and FM radio stations) must provide notification to the Commission in Washington, DC, within 10 days of commencing in-band, on channel (IBOC) digital operation. The notification must include the following information: (1) Call sign and facility identification number of the station; (2) date on which IBOC operation commenced; (3) certification that the IBOC DAB facilities conform to permissible hybrid specifications; (4) name and telephone number of a technical representative the Commission can call in the event of interference; (5) FM digital effective radiated power used and certification that the FM analog effective radiated power remains as authorized; (6) transmitter power output; if separate analog and digital transmitters are used, the power output for each transmitter; (7) if applicable, any reduction in an AM station's primary digital carriers; (8) if applicable, the geographic coordinates, elevation data, and license file number of the auxiliary antenna employed by an FM station as a separate digital antenna; (9) if applicable, for FM systems employing interleaved antenna bays, a certification that adequate filtering and/or isolation equipment has been installed to prevent spurious emissions in excess of the limits specified in § 73.317; (10) a certification that the operation will not cause human exposure to levels of radio frequency radiation in excess of the limits specified in § 1.1310 of the Commission's rules and is therefore categorically excluded from environmental processing pursuant to § 1.1306(b). Any station that cannot certify compliance must submit an environmental assessment (“EA”) pursuant to § 1.1311 and may not commence IBOC operation until such EA is ruled upon by the Commission.

    Federal Communications Commission. Marlene Dortch, Secretary.
    [FR Doc. 2018-21599 Filed 10-3-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meetings TIME AND DATE:

    Tuesday, October 9, 2018 at 10:00 a.m.

    PLACE:

    1050 First Street NE, Washington, DC

    STATUS:

    This Meeting Will be Closed to the Public.

    MATTERS TO BE CONSIDERED:

    Compliance matters pursuant to 52 U.S.C. 30109.

    Matters concerning participation in civil actions or proceedings or arbitration.

    CONTACT PERSON FOR MORE INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Laura E. Sinram, Deputy Secretary of the Commission.
    [FR Doc. 2018-21763 Filed 10-2-18; 4:15 pm] BILLING CODE 6715-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Agency for Healthcare Research and Quality, HHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project “Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician and Group Survey Database.” This proposed information collection was previously published in the Federal Register on July 16th, 2018 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

    DATES:

    Comments on this notice must be received by November 5, 2018.

    ADDRESSES:

    Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by email at [email protected] (attention: AHRQ's desk officer).

    FOR FURTHER INFORMATION CONTACT:

    Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Proposed Project Renewal of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician and Group Survey Database

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. The CAHPS Database is a repository for data from selected CAHPS surveys. The primary purpose of the CAHPS Database is to facilitate comparisons of CAHPS survey results by survey users. This voluntary compilation of survey results from a large pool of data into a single database enables survey users to compare their own results to relevant Database results. The CAHPS Database also offers an important source of primary data for research related to consumer assessments of quality as measured by CAHPS surveys.

    The CAHPS Clinician & Group Survey (CG-CAHPS) Database is the newest component of the CAHPS Database. It was developed in response to the growing demand for Database results for the various versions of the CG-CAHPS Survey, including the 12-month and Visit versions. In May 2011, the first set of Database results for both the 12-month and Visit versions was released through the CAHPS Database Online Reporting System.

    AHRQ developed the database for CAHPS CG Survey data following the CAHPS Health Plan Database as a model. The CAHPS Health Plan Database was developed in 1998 in response to requests from health plans, purchasers, and CMS for survey data to support public reporting of health plan ratings, health plan accreditation and quality improvement (OMB Control Number 0935-0165, expiration 5/31/2020). Demand for survey results from the CG Survey has grown as well, and therefore AHRQ developed a dedicated Clinician and Group Database to support benchmarking, quality improvement, and research (OMB Control Number 0935-0197, expiration 02/28/2019).

    The CAHPS Database contains data from AHRQ's standardized CAHPS Surveys which provide survey measures of quality to health care purchasers, consumers, regulators, and policy makers. The Health Plan Database also provides data for AHRQ's annual National Healthcare Quality and Disparities Reports. The goal of this project is to renew the CAHPS CG Survey Database. This database will continue to update the CAHPS CG Database with the latest results of the CAHPS CG Survey. These results consist of 31 items that measure 5 areas or composites of patients' experiences with physicians and staff in outpatient medical practices. This database can be used to do the following:

    (1) Improve care provided by individual providers, sites of care, medical groups, or provider networks.

    (2) Offer several products and services, including providing survey results presented through an Online Reporting System, summary chartbooks, custom analyses, private reports in Excel format, and data for research purposes.

    (3) Provides information to help identify strengths and areas with potential for improvement in patient care. The five composite measures are:

    Getting Timely Appointments, Care, and Information How Well Providers Communicate With Patients Helpful, Courteous, and Respectful Office Staff Providers' Use of Information to Coordinate Patient Care Patients' Rating of the Provider

    This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to quality measurement and improvement, and health surveys and database development. 42 U.S.C 299a(a)(1), (2), and (8).

    Method of Collection

    To achieve the goal of this project, the following activities and data collections will be implemented:

    (1) Registration Form—The purpose of this form is to determine the eligibility status and initiate the registration process for participating organizations seeking to submit their CAHPS CG survey data voluntarily to the CAHPS CG Survey Database. The point of contact (POC) at the participating organization (or parent organization) will complete the form. The POC is either a corporate-level health manager or a survey vendor who contracts with a participating organization to collect the CAHPS CG survey data.

    (2) Data Use Agreement—The purpose of the Data Use Agreement (DUA) is to obtain authorization from participating organizations to use their voluntarily submitted CAHPS CG survey data for analysis and reporting according to the terms specified in the DUA. The DUA states how data submitted by participating organizations will be used and provides confidentiality assurances. The POC at the organization will complete the form. Vendors do not sign the DUA.

    (3) Data Submission—The number of submissions to the database may vary each year because medical groups and practices may not administer the survey and submit data each year. Data submission is typically handled by one POC who is either a health system, a medical group or practice or a survey vendor who contracts with the medical group or practice to collect data on their behalf. After the POC has completed the Registration Form and the DUA, they will submit patient-level data collected from the CAHPS CG survey to the CAHPS CG Survey Database. Data on organizational characteristics such as ownership, number of patient visits per week, provider specialty, and information related to survey administration such as mode, dates of survey administration, sample size, and response rate, which are collected as part of CAHPS CG survey operations are also submitted.

    Each submission will consist of 3 data files: (1) A Group File that contains information about the group ownership, (2) a Practice File containing the practice ownership and affiliation (i.e., commercial, hospital or health system, university or academic medical center, community health center, military or county), number of providers working each week, sampling information, number of patient visits per week, contact information and (3) a Sample File that contains one record for each patient surveyed, the date of visit, survey disposition code, information about survey completion, and survey responses.

    Survey data from the CAHPS CG Database is used to produce four types of products: (1) An online reporting of results available to the public on the CAHPS Database website; (2) individual participant reports (in Excel format), used for comparing a participating organization's CAHPS survey results to the database averages, that are confidential and customized for each participating organization that submits their data, (3) an annual Chartbook that presents summary-level results in a downloadable file in PDF format; and (4) a de-identified dataset that is made available to researchers for additional analyses.

    Information for the CAHPS CG Database has been collected by AHRQ on an annual basis since 2010. Participating organizations are asked to submit their data voluntarily to the database each year. The data are cleaned with standardized programs, then aggregated and used to produce summarized results. In addition, reports in Excel format are produced that compare the participating organizations' results to the overall database results. These reports are sent via a secured FTP site upon the participating organization's request.

    Database results and individual participant reports can serve a variety of purposes:

    • Identifying areas for quality improvement at multiple levels, including medical group, practice site, and individual practitioner. • Briefing senior leadership on patients' views of the health care they receive • Supporting public reporting of patients' assessments of care • Combining with other quality measures to examine health care outcomes

    The CAHPS CG Database supports research by providing a de-identified analytic database. Much like the CAHPS Health Plan Database developed in 1998 (OMB Control Number 0935-0165, Expiration Date 5/31/2020), researchers can use the CAHPS CG Survey Database to examine:

    • Disparities in CAHPS satisfaction scores by racial and ethnic characteristics of patients • Comparisons of adult and child CAHPS survey results • Analysis of case-mix factors affecting CAHPS scores, such as patient age, education, and self-reported health status Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated burden hours for the participating in the CG database. The 11 POCs in exhibit 1 are the number of estimated vendors. Survey vendors assist the Health/Medical entities with submitting data submission materials. Survey vendors generally submit all required survey data and other materials other than the DUA. The 86 POCs in exhibit 1 are the number of estimated participating Health/Medical entities based on 2017 submission.

    Each vendor will register online for submission. The online Registration Form will require about 5 minutes to complete. The DUA will be completed by the 86 participating Health/Medical entities. Vendors do not sign DUAs. The DUA process requires about 15 minutes to sign and return by fax, mail or to upload directly to the submission system and includes an accompanying practice site excel file that is uploaded to the submission system. Each submitter will provide a copy of their questionnaire and the survey data file in the required file format. Survey data files must conform to the data file layout specifications provided by the CAHPS Database. The average number of data submissions per vendor is estimated to be 10. Once a data file is uploaded, the file will be automatically checked to ensure it conforms to the specifications and a data file status report will be produced and made available to the submitter. Submitters will review each report and will be expected to fix any errors in their data file and resubmit if necessary. It will take about one hour to complete each file submission. The total burden is estimated to be 133 hours annually.

    Exhibit 1—Estimated Annualized Burden Hours Form name Number of
  • respondents/POCs
  • Number of
  • responses for each POC
  • Hours per
  • response
  • Total burden hours
    Registration Form 11 1 5/60 1 Data Use Agreement 86 1 15/60 22 Data Submission 11 10 1 110 Total 108 NA NA 133

    Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to complete the submission process. The cost burden is estimated to be $6,602 annually.

    Exhibit 2—Estimated Annualized Cost Burden Form name Number of
  • respondents/POCs
  • Total burden hours Average hourly wage rate * Total cost
  • burden
  • Registration Form 11 1 a 40.95 $41 Data Use Agreement 86 22 b 93.44 2,056 Data Files Submission 11 110 c 40.95 4,505 Total 108 133 NA 6,602 * National Compensation Survey: Occupational wages in the United States May 2016, “U.S. Department of Labor, Bureau of Labor Statistics.” (a) and (c) Based on the mean hourly wages for Computer Programmer (15-1131). (b) Based on the mean hourly wage for Chief Executives (11-1011). https://www.bls.gov/oes/current/oes_nat.htm.
    Request for Comments

    In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

    Francis D. Chesley, Jr., Acting Deputy Director.
    [FR Doc. 2018-21618 Filed 10-3-18; 8:45 am] BILLING CODE 4160-90-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-18-0850; Docket No. CDC-2018-0088] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Laboratory Response Network to maintain an integrated national and international network of laboratories that can respond to suspected acts of biological, chemical, or radiological terrorism and other public health emergencies.

    DATES:

    CDC must receive written comments on or before December 3, 2018.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2018-0088 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

    Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    The OMB is particularly interested in comments that will help:

    1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    3. Enhance the quality, utility, and clarity of the information to be collected; and

    4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    5. Assess information collection costs.

    Proposed Project

    Laboratory Response Network Information Collection (OMB Control No. 0920-0850, Exp. Date: 4/30/2019)—Extension—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    CDC is requesting a 3-year extension without change to the data collection plan or tools for Laboratory Response Network (OMB Control No. 0920-0850, Exp. Date: April 30, 2019). The only change is a decrease in the estimated burden from 2,382,300 to 2,064,660 annual hours. The decrease is due to a decrease in the number of LRN member laboratories from 150 to 130 laboratories.

    The Laboratory Response Network (LRN) was established by the Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC) in accordance with Presidential Decision Directive 39, which outlined national anti-terrorism policies and assigned specific missions to federal departments and agencies. The LRN's mission is to maintain an integrated national and international network of laboratories that can respond to suspected acts of biological, chemical, or radiological terrorism and other public health emergencies.

    Federal, state and local public health laboratories join the LRN voluntarily. When laboratories join, they assume specific responsibilities and are required to provide information to the LRN Program Office at CDC. Each laboratory must submit and maintain complete information regarding the testing capabilities of the laboratory. Biennially, laboratories are required to review, verify and update their testing capability information. This information is needed so that the LRN Program Office can determine the ability of the Network to respond to a biological or chemical terrorism event. The sensitivity of all information associated with the LRN requires that CDC obtain personal information about all individuals accessing the LRN website. Since CDC must be able to contact all laboratory personnel during an event, each laboratory staff member who obtains access to the restricted LRN website must provide his or her contact information to the LRN Program Office.

    As a requirement of membership, LRN laboratories must report all biological and chemical testing results to the LRN Program using a CDC developed software tool called the LRN Results Messenger, or through the laboratory information management system (LIMS) which CDC refers to as Data Integration. CDC supplies this software to LRN laboratories at no charge. This information obtained from LRN laboratories is essential for surveillance of anomalies, to support response to an event that may involve multiple agencies, and to manage limited resources.

    LRN laboratories are also required to participate in Proficiency Testing Challenges or Validation Studies and report their results to CDC. LRN laboratories participate in multiple Proficiency Testing Challenges, Exercises and/or Validation Studies every year. These activities consist of 5-500 simulated samples provided by CDC. These challenges are necessary to verify the testing capability of the LRN laboratories. Because biological or chemical agents perceived to be of bioterrorism concern can occur rarely, some LRN laboratories may not be maintaining proficiency in certain testing methods as a result of day-to-day testing. Thus, simulated samples are distributed to ensure proficiency across LRN member laboratories. LRN laboratories also enter the results of these simulated samples into the LRN Results Messenger or through Data Integration for evaluation by CDC.

    During a surge event resulting from a bioterrorism or chemical terrorism attack, or during an emerging infectious disease outbreak, LRN Laboratories must submit all testing results using LRN Results Messenger or through Data Integration. CDC uses these results in order to track the progression of a bioterrorism event, responds in the most efficient and effective way possible, and shares this data with other Federal partners involved in the response.

    Data is collected via two primary avenues, the program LRN Results Messenger or through Data Integration and the LRN website. Laboratories belonging to the Laboratory Response Network utilize the CDC developed software tool LRN Results Messenger to submit testing results to CDC. Data Integration through the Laboratory Information Management System Integration (LIMSi) is an effort parallel to the LRN Results Messenger, which will ultimately allow laboratories to submit data to CDC using their own data collection systems. Results include details about the type and source of samples as well as the tests performed and the numerical and empirical results of those tests. The LRN website is used by laboratories to provide their complete testing capabilities to CDC. All individuals who use the LRN website must provide their contact information to the LRN Program Office during registration.

    An LRN laboratory must provide its testing capabilities, physical and shipping addresses, United States Department of Agriculture (USDA) and Select Agent Permits, and specified responsible individuals' names, phone numbers and email addresses. After registering with the LRN website, a user must provide his/her first and last name, work phone number, alternate phone number, email address, and month and day of birth. During reporting of results, sample details, tests performed, results obtained, and conclusions of tests are required.

    Accomplishments during the last three years include the requalification of labs. The requalification occurred between October 24, 2014 and November 7, 2016 and December 12, 2016. We had 130 domestic LRN labs tasked with completing the requalification. We had a 96% response rate. The LRN website has remained the same, and has only undergone routine maintenance since 2015 to keep it in working order. This data collection is authorized under the Public Health Service Act, (42 U.S.C. 241) Section 301. CDC has estimated the annualized burden for this project to be 2,064,660 hours, a decrease of 317,640 hours per year. There is no cost to respondents other than the time to participate.

    Estimated Annualized Burden Hours Respondents Forms Number of
  • respondents
  • Average
  • number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (hours)
  • Total burden
  • hours
  • Public Health Laboratories Biennial Requalification 130 1 2 260 General Surveillance Testing Results 130 25 24 78,000 Proficiency Testing/Validation Testing Results 130 5 56 36,400 Surge Event Testing Results 130 625 24 1,950,000 Total 2,064,660
    Jeffrey M. Zirger, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2018-21570 Filed 10-3-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-18-1090; Docket No. CDC-2018-0089] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed revision of information collection project titled Formative and Summative Evaluation of Scaling the National Diabetes Prevention Program (National DPP) in Underserved Areas. This revision is to allow CDC to continue collecting the information needed to assess the effectiveness of its program, “Scaling the National DPP in Underserved Areas”, and to collect more targeted information on CDC grantees' success in reaching both general and priority populations in underserved areas.

    DATES:

    CDC must receive written comments on or before December 3, 2018.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2018-0089 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

    Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    The OMB is particularly interested in comments that will help:

    1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    3. Enhance the quality, utility, and clarity of the information to be collected; and

    4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    5. Assess information collection costs.

    Proposed Project

    Formative and Summative Evaluation of Scaling the National Diabetes Prevention Program in Underserved Areas (OMB No. 0920-1090, exp. 12/31/2018)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    The CDC-led National Diabetes Prevention Program (National DPP) is a partnership of public and private organizations working collectively to build the infrastructure for nationwide delivery of an evidence-based lifestyle change program to prevent or delay Type 2 diabetes among adults with prediabetes. The National DPP lifestyle change program is founded on the science of the Diabetes Prevention Program research study, and several translation studies that followed, which showed that making modest behavior changes helped people with prediabetes lose 5% to 7% of their body weight and reduce their risk of developing Type 2 diabetes by 58% (71% for people over 60 years old). From 2012 to 2017, CDC funded six national organizations through a cooperative agreement to establish and expand multistate networks of over 200 program delivery organizations that are able to meet national standards and achieve the outcomes proven to prevent or delay onset of Type 2 diabetes. CDC has conducted a formative and summative evaluation of this program and used the evaluation findings and lessons learned to provide data-driven technical assistance to the grantees and other organizations delivering the National DPP lifestyle change program. The data and lessons learned from DP12-1212 were also used to inform decision-making and policy, including the development of the Centers for Medicare & Medicaid Services (CMS) Medicare Diabetes Prevention Program (MDPP). As of April 1, 2018, the MDPP Expanded Model provides coverage for the National DPP lifestyle change program for eligible Medicare beneficiaries.

    Despite the fact that over 1800 CDC-recognized organizations in 50 states, the District of Columbia, Puerto Rico, and the Virgin Islands offer the National DPP lifestyle change program, there are still many geographic areas with few or no in-person delivery programs. In addition, some populations, including Medicare beneficiaries, men, African-Americans, Asian-Americans, Hispanics, American Indians, Alaska Natives, Pacific Islanders, and people with visual impairment or physical disabilities, are under-enrolled relative to their estimated numbers and disease burden. To address these gaps, CDC funded a new, five-year cooperative agreement with ten new national organizations in September 2017, “Scaling the National DPP in Underserved Areas” (DP17-1705). CDC funded ten national organizations with affiliate program delivery sites in at least three states, each to start new CDC-recognized organizations in underserved areas and to enroll both general and priority populations in new or existing CDC-recognized organizations. The DP17-1705 grantees will work on activities designed to accomplish three main goals:

    (1) Build the infrastructure in underserved areas necessary to deliver the National DPP lifestyle change program to the general population and to priority populations, including Medicare beneficiaries, men, African-Americans, Asian-Americans, Hispanics, American Indians, Alaska Natives, Pacific Islanders, and non-institutionalized people with visual or physical disabilities;

    (2) Tailor and adapt the program to address the unique needs and challenges of the enrolled participants; and

    (3) Provide participants with specialized support needed to successfully complete the program and achieve 5-7% weight loss. Through this new cooperative agreement, it is anticipated that enrollment, retention, and achievement of 5-7% weight loss goals for the targeted populations will increase.

    At this time, CDC requests an additional three years of OMB approval to continue collecting information needed to evaluate the effectiveness of CDC's funding for the new grantees. The data collection will allow CDC to continue to provide data-driven, tailored programmatic technical assistance to ensure continuous quality improvement for each year of the cooperative agreement. A number of changes to the evaluation forms are proposed to ensure that reporting and evaluation requirements are consistent with the aims of the new cooperative agreement and reflect the lessons learned from the original funded national organizations and their affiliate delivery sites. Evaluation data elements have been added or modified accordingly. Also, the method of data collection has converted from using an Excel spreadsheet to a web-based data system to allow for real-time feedback and technical assistance.

    The reporting burden of this collection of information is estimated to vary between two and four hours with an average of three hours per grantee response (decreased from 12 hours), and between four and six hours with an average of five hours per affiliate delivery site response (increased from an average of 45 minutes per response). These estimated burden hours include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information by the grantee and affiliate delivery site to submit information directly to the web-based data system. The number of respondents will increase with the increased number of grantees. These changes result in a net increase of 368 annualized burden hours. There are no costs to respondents other than their time.

    Estimated Annualized Burden Hours Type of
  • respondents
  • Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden
  • (in hours)
  • National DPP Affiliate Delivery Sites Evaluation Form for Sites 100 1 5 500 National DPP Grantees Evaluation Form for Grantees 10 1 3 30 Total 530
    Jeffrey M. Zirger, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2018-21571 Filed 10-3-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10391] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments must be received by December 3, 2018.

    ADDRESSES:

    When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

    1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

    2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number _____, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    William Parham at (410) 786-1326.

    SUPPLEMENTARY INFORMATION:

    Contents

    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

    CMS-10391 Methods for Assuring Access to Covered Medicaid Services Under 42 CFR 447.203 and 447.204

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

    Information Collection

    1. Title of Information Collection: Methods for Assuring Access to Covered Medicaid Services Under 42 CFR 447.203 and 447.204; Type of Information Collection Request: Extension of a currently approved collection; Use: Current regulations at 42 CFR 447.203(b) require states to develop an access monitoring review plan (AMRP) that is updated at least every three years for: Primary care services, physician specialist services, behavioral health services, pre and post-natal obstetric services (including labor and delivery), and home health services. When states reduce rates for other Medicaid services, they must add those services to the AMRP and monitor the effects of the rate reductions for 3 years. If access issues are detected, a state must submit a corrective action plan to CMS within 90 days and work to address the issues within 12 months. Section 447.203(b)(7) requires that states have mechanisms to obtain ongoing beneficiary and provider feedback. A state is also required to maintain a record of data on public input and how the state responded to the input. Prior to submitting proposals to reduce or restructure Medicaid service payment rates, states must receive input from beneficiaries, providers, and other affected stakeholders on the extent of beneficiary access to the affected services.

    The information is used by states to document that access to care is in compliance with section 1902(a)(30)(A) of the Social Security Act, to identify issues with access within a state's Medicaid program, and to inform any necessary programmatic changes to address issues with access to care. CMS uses the information to make informed approval decisions on State plan amendments that propose to make Medicaid rate reductions or restructure payment rates and to provide the necessary information for CMS to monitor ongoing compliance with section 1902(a)(30)(A). Beneficiaries, providers and other affected stakeholders may use the information to raise access issues to state Medicaid agencies and work with agencies to address those issues. Form Number: CMS-10391 (OMB control number: 0938-1134); Frequency: Annually; Affected Public: State, Local, or Tribal Governments); Number of Respondents: 51; Number of Responses: 212; Total Annual Hours: 12,262. (For questions regarding this collection contact Jeremy Silanskis at 410-786-1592.)

    Dated: September 28, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2018-21587 Filed 10-3-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10008, CMS-R-234, and CMS-R-194] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments on the collection(s) of information must be received by the OMB desk officer by November 5, 2018.

    ADDRESSES:

    When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 or Email: [email protected]

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' website address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    William Parham at (410) 786-4669.

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

    1. Type of Information Collection Request: Reinstatement with a change of a previously approved collection; Title of Information Collection: Eligibility of Drugs, Biologicals, and Radiopharmaceutical Agents for Transitional Pass-Through Status Under the Hospital Outpatient Prospective Payment System (OPPS); Use: Section 201(b) of the BBRA 1999 amended section 1833(t) of the Act by adding new section 1833(t)(6). This provision requires the Secretary to make additional payments to hospitals for a period of 2 to 3 years for certain drugs, radiopharmaceuticals, biological agents, medical devices and brachytherapy devices. Section 1833(t)(6)(A)(iv) establishes the criteria for determining the application of this provision to new items. Section 1833(t)(6)(C)(i) provides that the additional payment for drugs and biologicals be the amount by which the amount determined under section 1842(o) of the Act exceeds the portion of the otherwise applicable hospital outpatient department fee schedule amount that the Secretary determines to be associated with the drug or biological. Section 1833(t)(6)(D)(i) of the Act sets the payment rate for pass-through eligible drugs and biologicals (assuming that no pro rata reduction in pass-through payment is necessary) as the amount determined under section 1842(o) of the Act. Section 303(c) of Pub. L. 108-173 amended Title XVIII of the Act by adding new section 1847A. This new section establishes the use of the average sales price (ASP) methodology for payment for drugs and biologicals described in section 1842(o)(1)(C) of the Act furnished on or after January 1, 2005. Therefore, as we stated in the November 15, 2004 Federal Register (69 FR 65776), in CY 2005, we will pay under the OPPS for drugs, biologicals and radiopharmaceuticals with pass-through status consistent with the provisions of section 1842(o) of the Act as amended by Public Law 108-173 at a rate that is equivalent to the payment these drugs and biologicals will receive in the physician office setting, and established in accordance with the methodology described in the CY 2005 Physician Fee Schedule final rule. Information on Average Sales Price is found at http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/. The intent of these provisions is to ensure that timely beneficiary access to new pharmacological technologies is not jeopardized by inadequate payment levels. Form Number: CMS-10008 (OMB control number 0938-0802); Frequency: Yearly; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 30; Total Annual Responses: 30; Total Annual Hours: 480. (For policy questions regarding this collection contact Raymond Bulls at 410-786-7267).

    2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Subpart D—Private Contracts; Use: Section 4507 of the Balanced Budget Act of 1997 (BBA 1997) amended section 1802 of the Social Security Act (the Act) to permit certain physicians and practitioners to opt-out of Medicare and to provide through private contracts services that would otherwise be covered by Medicare. Under such contracts the mandatory claims submission and limiting charge rules of section 1848(g) of the Act would not apply. Subpart D and the supporting regulations contained in 42 CFR 405.410, 405.430, 405.435, 405.440, 405.445, and 405.455, counters the effect of certain provisions of Medicare law that, absent section 1802 of the Act, preclude physicians and practitioners from contracting privately with Medicare beneficiaries to pay without regard to Medicare limits. The most recent approval of this information collection request (ICR) was issued by the Office of Management and Budget on March 2, 2016. We are now seeking to renew this approval before it expires on March 31, 2019. We have made no changes to the information being collected. We updated our burden estimate to reflect changes in the number of physicians and practitioners who have opted out and refinements to our methodology for estimating the burden associated with contracts. We have also updated the cost estimate to account for the current Bureau of Labor Statistics (BLS) wage estimates and to include the estimated costs for Medicare Advantage plans. Form Number: CMS-R-234 (OMB control number 0938-0730); Frequency: Yearly; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 57,722; Total Annual Responses: 57,722; Total Annual Hours: 23,557. (For policy questions regarding this collection contact Frederick Grabau at 410-786-0206).

    3. Type of Information Collection Request: Reinstatement without a change of a previously approved collection; Title of Information Collection: Medicare Disproportionate Share Adjustment Procedures and Criteria; Use: Section 1886(d)(5)(F) of the Social Security Act established the Medicare disproportionate share adjustment (DSH) for hospitals, which provides additional payment to hospitals that serve a disproportionate share of the indigent patient population. This payment is an add-on to the set amount per case the Centers for Medicare and Medicaid Services (CMS) pays to hospitals under the Medicare Inpatient Prospective Payment System (IPPS). Under current regulations at 42 CFR 412.106, in order to meet the qualifying criteria for this additional DSH payment, a hospital must prove that a disproportionate percentage of its patients are low income using Supplemental Security Income (SSI) and Medicaid as proxies for this determination. This percentage includes two computations: (1) The “Medicare fraction” or the “SSI ratio” which is the percent of patient days for beneficiaries who are eligible for Medicare Part A and SSI and (2) the “Medicaid fraction” which is the percent of patient days for patients who are eligible for Medicaid but not Medicare. Once a hospital qualifies for this DSH payment, CMS also determines a hospital's payment adjustment based on these two fractions. 42 CFR 412.106 allows hospitals to request that the Medicare fraction of the DSH adjustment be calculated on a cost reporting basis rather than a federal fiscal year. Once requested, the hospital must accept the result irrespective of whether it increases or decreases their DSH payment. The routine use procedure and the DUA allows hospitals to request the detailed Medicare data so they can make an informed choice before deciding whether to request that the Medicare fraction be calculated on the basis of a cost reporting period rather than a federal fiscal year. Form Number: CMS-R-194 (OMB control number 0938-0691); Frequency: Yearly; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 800; Total Annual Responses: 800; Total Annual Hours: 400. (For policy questions regarding this collection contact Emily Lipkin at 410-786-3633.)

    Dated: September 28, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2018-21590 Filed 10-3-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1721] Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Applications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on regulations under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted.

    DATES:

    Submit either electronic or written comments on the collection of information by December 3, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 3, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 3, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2014-N-1721 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Applications.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Investigational New Drug Application—21 CFR Part 312 OMB Control Number 0910-0014—Extension

    This information collection supports FDA regulations in 21 CFR part 312 covering Investigational New Drugs. Part 312 implements provisions of section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) to issue regulations under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted.

    FDA is charged with implementing statutory requirements that ensure drug products marketed in the United States are shown to be safe and effective, properly manufactured, and properly labeled for their intended uses. Section 505(a) of the FD&C Act (21 U.S.C. 355(a)) provides that a new drug may not be introduced or delivered for introduction into interstate commerce in the United States unless FDA has previously approved a new drug application (NDA). FDA approves an NDA only if the sponsor of the application first demonstrates that the drug is safe and effective for the conditions prescribed, recommended, or suggested in the product's labeling. Proof must consist, in part, of adequate and well-controlled studies, including studies in humans, that are conducted by qualified experts.

    The investigational new drug application (IND) regulations under 21 CFR part 312 establish reporting requirements that include an initial application as well as amendments to that application, reports on significant revisions of clinical investigation plans, and information on a drug's safety or effectiveness. In addition, the sponsor is required to give FDA an annual summary of the previous year's clinical experience. The regulations also include recordkeeping requirements pertaining to the disposition of drugs, records pertaining to individual case histories, and certain other documentation verifying the fulfillment of responsibilities by clinical investigators.

    Submissions are reviewed by medical officers and other Agency scientific reviewers assigned responsibility for overseeing a specific study. The details and complexity of these requirements are dictated by the scientific procedures and human subject safeguards that must be followed in the clinical tests of investigational new drugs.

    The IND information collection requirements provide the means by which FDA can monitor the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products, including the following: (1) Monitor the safety of ongoing clinical investigations; (2) determine whether the clinical testing of a drug should be authorized; (3) ensure production of reliable data on the metabolism and pharmacological action of the drug in humans; (4) obtain timely information on adverse reactions to the drug; (5) obtain information on side effects associated with increasing doses; (6) obtain information on the drug's effectiveness; (7) ensure the design of well-controlled, scientifically valid studies; and (8) obtain other information pertinent to determining whether clinical testing should be continued and information related to the protection of human subjects. Without the information provided by industry as required under the IND regulations, FDA cannot authorize or monitor the clinical investigations that must be conducted before authorizing the sale and general use of new drugs. These reports enable FDA to monitor a study's progress, to ensure the safety of subjects, to ensure that a study will be conducted ethically, and to increase the likelihood that the sponsor will conduct studies that will be useful in determining whether the drug should be marketed and available for use in medical practice.

    To assist respondents with certain reporting requirements under part 312, we have developed two forms: Form FDA 1571 entitled, “Investigational New Drug Application (IND)” and Form FDA 1572 entitled, “Statement of Investigator.” Anyone who intends to conduct a clinical investigation must submit Form FDA 1571 as instructed. The reporting elements include: (1) A cover sheet containing background information on the sponsor and investigator; (2) a table of contents; (3) an introductory statement and general investigational plan; (4) an investigator's brochure describing the drug substance; (5) a protocol for each planned study; (6) chemistry, manufacturing, and control information for each investigation; (7) pharmacology and toxicology information for each investigation; and (8) previous human experience with the investigational drug. Form FDA 1572 is executed and submitted by the IND sponsor before an investigator may participate in an investigation. It includes background information on the investigator as well as the investigation, and a general outline of the planned investigation and study protocol.

    Below, we estimate the burden of the information collection as reported by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) as follows:

    Table 1—Estimated Annual Reporting Burden for Human Drugs (CDER) 1 21 CFR section Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total
  • annual
  • responses
  • Average
  • burden per
  • response
  • Total hours
    § 312.2(e); Requests for FDA advice on the applicability of part 312 to a planned clinical investigation 400 1 400 24 9,600 § 312.8; Requests to charge for an investigational drug 74 1.23 91 48 4,368 § 312.10; Requests to waive a requirement in part 312 86 1.84 158 24 3,792 § 312.23(a) through (f); IND content and format (including Form FDA 1571) 2,187 1.7 3,718 1,600 5,948,800 § 312.30(a) through (e); Protocol amendments 4,418 5.52 24,387 284 6,925,908 § 312.31(b); Information amendments 6,691 3.32 22,214 100 2,221,400 § 312.32(c) and (d); IND safety reports 867 15.78 13,681 32 437,792 § 312.33(a) through (f); IND annual reports 3,376 2.86 9,655 360 3,475,800 § 312.38(b) and (c); Notifications of withdrawal of an IND 930 1.61 1,497 28 41,916 § 312.42; Sponsor requests that a clinical hold be removed, including sponsor submission of a complete response to the issues identified in the clinical hold order 198 1.38 273 284 77,532 § 312.44(c) and (d); Sponsor responses to FDA when IND is terminated 12 1.16 14 16 224 § 312.45(a) and (b); Sponsor requests for or responses to an inactive status determination of an IND by FDA 231 1.84 425 12 5,100 § 312.47; Meetings, including “End-of-Phase 2” meetings and “Pre-NDA” meetings 122 1.51 184 160 29,440 § 312.54(a); Sponsor submissions to FDA concerning investigations involving an exception from informed consent under § 50.24 15 2.4 36 48 1,728 § 312.54(b); Sponsor notifications to FDA and others concerning an IRB determination that it cannot approve research because it does not meet the criteria in the exception from informed consent in § 50.24(a) 2 1 2 48 96 § 312.56(b), (c), and (d); Sponsor notifications to FDA and others resulting from: (1) The sponsor's monitoring of all clinical investigations and determining that an investigator is not in compliance with the investigation agreements; (2) the sponsor's review and evaluation of the evidence relating to the safety and effectiveness of the investigational drug; and (3) the sponsor's determination that the investigational drug presents an unreasonable and significant risk to subjects 6,100 7 42,700 80 3,416,000 § 312.58(a); Sponsor's submissions of clinical investigation records to FDA on request during FDA inspections 73 1 73 8 584 § 312.70; During the disqualification process of a clinical investigator by FDA, the number of investigator responses or requests to FDA following FDA's notification to an investigator of its failure to comply with investigation requirements 4 1 4 40 160 § 312.110(b)(4) and (b)(5); Written certifications and written statements submitted to FDA relating to the export of an investigational drug 11 26.28 289 75 21,675 § 312.120(b); Submissions to FDA of “supporting information” related to the use of foreign clinical studies not conducted under an IND 1,414 8.62 12,189 32 390,048 § 312.120(c); Waiver requests submitted to FDA related to the use of foreign clinical studies not conducted under an IND 35 2.34 82 24 1,968 § 312.130; Requests for disclosable information in an IND and for investigations involving an exception from informed consent under § 50.24 3 1 3 8 24 §§ 312.310(b) and 312.305(b); Submissions related to expanded access and treatment of an individual patient 935 2.77 2,590 8 20,720 § 312.310(d); Submissions related to emergency use of an investigational new drug 480 2.15 1,032 16 16,512 §§ 312.315(c) and 312.305(b); Submissions related to expanded access and treatment of an intermediate-size patient population 118 2.52 297 120 35,640 § 312.320(b); Submissions related to a treatment IND or treatment protocol 10 12.9 129 300 38,700 Total 23,125,527 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 2—Estimated Annual Recordkeeping Burden for Human Drugs (CDER) 1 21 CFR section Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total
  • annual
  • records
  • Average
  • burden per
  • recordkeeping
  • Total hours
    § 312.52(a); Sponsor records for the transfer of obligations to a contract research organization 1,300 1 1,300 2 2,600 § 312.57; Sponsor recordkeeping showing the receipt, shipment, or other disposition of the investigational drug and any financial interests 13,000 1 13,000 100 1,300,000 § 312.62(a); Investigator recordkeeping of the disposition of drugs 13,000 1 13,000 40 520,000 § 312.62(b); Investigator recordkeeping of case histories of individuals 13,000 1 13,000 40 520,000 § 312.160(a)(3); Records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests 547 1.43 782 * 0.50 391 § 312.160(c); Shipper records of alternative disposition of unused drugs 547 1.43 782 * 0.50 391 Total 2,343,382 1 There are no capital costs or operating and maintenance costs associated with this collection of information. * 30 minutes.
    Table 3—Estimated Annual Third-Party Disclosure Burden for Human Drugs (CDER) 1 21 CFR section Number of
  • respondents
  • Number of
  • disclosures per
  • respondent
  • Total
  • annual
  • disclosures
  • Average
  • burden per
  • disclosure
  • Total hours
    § 312.53(c); Investigator reports submitted to the sponsor, including Form FDA 1572, curriculum vitae, clinical protocol, and financial disclosure 1,732 7.94 13,752 80 1,100,160 § 312.55(a); Investigator brochures submitted by the sponsor to each investigator 995 4 3,980 48 191,040 § 312.55(b); Sponsor reports to investigators on new observations, especially adverse reactions and safe use 995 4 3,980 48 191,040 § 312.64; Investigator reports to the sponsor, including progress reports, safety reports, final reports, and financial disclosure reports 13,000 1 13,000 24 312,000 Total 1,794,240 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 4—Estimated Annual Reporting Burden for Biologics (CBER) 1 21 CFR section Number of

  • respondents
  • Number of
  • responses per
  • respondent
  • Total
  • annual
  • responses
  • Average
  • burden per
  • response
  • Total hours 312.2(e) Requests for FDA advice on the applicability of part 312 to a planned clinical investigation 217 1.18 256 24 6,144 312.8 Requests to charge for an investigational drug 20 1.50 30 48 1,440 312.10 Requests to waive a requirement in part 312 2 1 2 24 48 312.23(a) through (f) IND content and format 335 1.35 452 1,600 723,200 312.30(a) through (e) Protocol amendments 694 5.84 4,053 284 1,151,052 312.31(b) Information amendments 77 2.43 187 100 18,700 312.32(c) and (d) IND Safety reports 161 8.83 1,422 32 45,504 312.33(a) through (f) IND Annual reports 745 2.14 1,594 360 573,840 312.38(b) and (c) Notifications of withdrawal of an IND 134 1.69 226 28 6,328 312.42 Sponsor requests that a clinical hold be removed, including sponsor submission of a complete response to the issues identified in the clinical hold order 67 1.30 87 284 24,708 312.44(c) and (d) Sponsor responses to FDA when IND is terminated 34 1.15 39 16 624 312.45(a) and (b) Sponsor requests for or responses to an inactive status determination of an IND by FDA 55 1.38 76 12 912 312.47 Meetings, including “End-of-Phase 2” meetings and “Pre-NDA” meetings 88 1.75 154 160 24,640 312.53(c) Investigator reports submitted to the sponsor, including Form FDA-1572, curriculum vitae, clinical protocol, and financial disclosure 453 6.33 2,867 80 229,360 312.54(a) Sponsor submissions to FDA concerning investigations involving an exception from informed consent under 21 CFR 50.24 1 1 1 48 48 312.54(b) Sponsor notifications to FDA and others concerning an IRB determination that it cannot approve research because it does not meet the criteria in the exception from informed consent in 50.24(a) 1 1 1 48 48 312.55(a) Number of investigator brochures submitted by the sponsor to each investigator 239 1.91 456 48 21,888 312.55(b) Number of sponsor reports to investigators on new observations, especially adverse reactions and safe use 243 4.95 1,203 48 57,744 312.56(b), (c), and (d) Sponsor notifications to FDA and others resulting from: (1) The sponsor's monitoring of all clinical investigations and determining that an investigator is not in compliance with the investigation agreements; (2) the sponsor's review and evaluation of the evidence relating to the safety and effectiveness of the investigational drug; and (3) the sponsor's determination that the investigational drug presents an unreasonable and significant risk to subjects 108 2.21 239 80 19,120 312.58(a) Number of sponsor's submissions of clinical investigation records to FDA on request during FDA inspections 7 1 7 8 56 312.64 Number of investigator reports to the sponsor, including progress reports, safety reports, final reports, and financial disclosure reports 2,728 3.82 10,421 24 250,104 312.70 During the disqualification process of a clinical investigator by FDA, the number of investigator responses or requests to FDA following FDA's notification to an investigator of its failure to comply with investigation requirements 5 1 5 40 200 312.110(b)(4) and (b)(5) Number of written certifications and written statements submitted to FDA relating to the export of an investigational drug 18 1 18 75 1,350 312.120(b) Number of submissions to FDA of “supporting information” related to the use of foreign clinical studies not conducted under an IND 280 9.82 2,750 32 88,000 312.120(c) Number of waiver requests submitted to FDA related to the use of foreign clinical studies not conducted under an IND 7 2.29 16 24 384 312.130 Number of requests for disclosable information in an IND and for investigations involving an exception from informed consent under § 50.24 350 1.34 469 8 3,752 312.310(b) and 312.305(b) Number of submissions related to expanded access and treatment of an individual patient 78 1.08 84 8 672 312.310(d) Number of submissions related to emergency use of an investigational new drug 76 2.76 210 16 3,360 312.315(c) and 312.305(b) Number of submissions related to expanded access and treatment of an intermediate-size patient population 9 1 9 120 1,080 312.320(b) Number of submissions related to a treatment IND or treatment protocol 1 1 1 300 300 Total 3,254,606 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Table 5—Estimated Annual Recordkeeping Burden for Biologics (CBER) 1 21 CFR section Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total
  • annual
  • records
  • Average
  • burden per
  • recordkeeping
  • Total hours
    312.52(a) Sponsor records for the transfer of obligations to a contract research organization 75 1.40 105 2 210 312.57 Sponsor recordkeeping showing the receipt, shipment, or other disposition of the investigational drug, and any financial interests 335 2.70 904 100 90,400 312.62(a) Investigator recordkeeping of the disposition of drugs 453 1 453 40 18,120 312.62(b) Investigator recordkeeping of case histories of individuals 453 1 453 40 18,120 312.160(a)(3) Records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests 111 1.40 155 * 0.5 78 312.160(c) Shipper records of alternative disposition of unused drugs 111 1.40 155 * 0.5 78 Total 127,006 1 There are no capital costs or operating and maintenance costs associated with this collection of information. * 30 minutes.

    Because we have received an increased number of IND submissions since the last OMB approval of the information collection, we have increased our estimate of the associated burden accordingly.

    Dated: September 28, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-21610 Filed 10-3-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1021] Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2019 Proposed Guidance Development AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in fiscal year (FY) 2019. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. This feedback is critical to the CDRH guidance program to ensure that we meet stakeholder needs.

    DATES:

    Submit either electronic or written comments by December 3, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 3, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 3, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2012-N-1021 for “Notice to Public of website Location of CDRH Fiscal Year 2019 Proposed Guidance Development.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Erica Takai, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.

    SUPPLEMENTARY INFORMATION:

    I. Background

    During negotiations on the Medical Device User Fee Amendments of 2012, Title II, Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), FDA agreed to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly. Among these commitments included:

    • Annually posting a list of priority medical device guidance documents that the Agency intends to publish within 12 months of the date this list is published each fiscal year (the “A-list”), and

    • Annually posting a list of device guidance documents that the Agency intends to publish, as the Agency's guidance-development resources permit each fiscal year (the “B-list”).

    The Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA Reauthorization Act of 2017 (Pub. L. 115-52) maintained these commitments.

    FDA welcomes comments on any or all of the guidance documents on the lists as explained in 21 CFR 10.115(f)(5). FDA has established Docket No. FDA-2012-N-1021 where comments on the FY 2019 lists, draft language for guidance documents on those topics, suggestions for new or different guidances, and relative priority of guidance documents may be submitted and shared with the public (see ADDRESSES). FDA believes this docket is a valuable tool for receiving information from interested persons. FDA anticipates that feedback from interested persons will allow CDRH to better prioritize and more efficiently draft guidances to meet the needs of the Agency and our stakeholders.

    In addition to posting the lists of prioritized device guidance documents, FDA has committed to updating its website in a timely manner to reflect the Agency's review of previously published guidance documents, including the withdrawal of guidance documents that no longer represent the Agency's interpretation of or policy on a regulatory issue.

    Fulfillment of these commitments will be reflected through the issuance of updated guidance on existing topics, withdrawal of guidances that no longer reflect FDA's current thinking on a particular topic, and annual updates to the A-list and B-list announced in this notice.

    II. CDRH Guidance Development Initiatives A. Finalization of Draft Guidance Documents

    CDRH has identified as a priority, and has devoted resources to, finalization of draft guidance documents. To assure the timely completion or reissuance of draft guidances, in FY 2015 CDRH committed to performance goals for current and future draft guidance documents. For draft guidance documents issued after October 1, 2014, CDRH committed to finalize, withdraw, reopen the comment period, or issue new draft guidance on the topic for 80 percent of the documents within 3 years of the close of the comment period and for the remaining 20 percent, within 5 years. As part of MDUFA IV commitments, FDA reaffirmed this commitment, as resources permit. In addition, in FY 2018, CDRH withdrew two draft guidances and reopened the comment period for two draft guidances of six draft guidances issued prior to October 1, 2012, and has been continuing to work towards taking an action on the remaining draft guidances. Looking forward, in FY 2019, CDRH will strive to finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2013.

    B. Applicability of Previously Issued Final Guidance

    CDRH has issued over 450 final guidance documents to provide stakeholders with the Agency's thinking on numerous topics. Each guidance reflected the Agency's current position at the time that it was issued. However, the guidance program has issued these guidances over a period of 30 years, raising the question of how current previously issued final guidances remain. CDRH has resolved to address this concern through a staged review of previously issued final guidances in collaboration with stakeholders. At the website where CDRH has posted the “A-list” and “B-list” for FY 2019, CDRH has also posted a list of final guidance documents that issued in 2009, 1999, 1989, and 1979.1 CDRH is interested in external feedback on whether any of these final guidances should be revised or withdrawn. In addition, for guidances that are recommended for revision, information explaining the need for revision, such as the impact and risk to public health associated with not revising the guidance, would also be helpful as the Center considers potential action with respect to these guidances. CDRH intends to provide these lists of previously issued final guidances annually through FY 2025 so that by 2025, FDA and stakeholders will have assessed the applicability of all guidances older than 10 years. For instance, in the annual notice for FY 2020, CDRH expects to provide a list of the final guidance documents that issued in 2010, 2000, 1990, and 1980; the annual notice for FY 2021 is expected to provide a list of the final guidance documents that issued in 2011, 2001, 1991, and 1981, and so on. CDRH will consider the comments received from this retrospective review when determining priorities for updating guidance documents and will revise these as resources permit.

    1 The retrospective list of final guidances does not include special controls documents.

    In FY 2018, CDRH received comments regarding guidances issued in 2008, 1998, and 1988, and has withdrawn fourteen guidance documents in response to comments received and because these guidance documents were determined to no longer represent the Agency's current thinking. One guidance has been revised and issued as a draft guidance, and the revision of several guidance documents is also being considered as resources permit.

    Consistent with the Good Guidance Practices regulation at 21 CFR 10.115(f)(4), CDRH would appreciate suggestions that CDRH revise or withdraw an already existing guidance document. We request that the suggestion clearly explain why the guidance document should be revised or withdrawn and, if applicable, how it should be revised. While we are requesting feedback on the list of previously issued final guidances located in the annual agenda website, feedback on any guidance is appreciated and will be considered.

    III. Website Location of Guidance Lists

    This notice announces the website location of the document that provides the A and B lists of guidance documents, which CDRH is intending to publish during FY 2019. To access these two lists, visit FDA's website at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm529396.htm. We note that the topics on this and past guidance priority lists may be removed or modified based on current priorities, as well as comments received regarding these lists. Furthermore, FDA and CDRH priorities are subject to change at any time (e.g., newly identified safety issues). The Agency is not required to publish every guidance on either list if the resources needed would be to the detriment of meeting quantitative review timelines and statutory obligations. In addition, the Agency is not precluded from issuing guidance documents that are not on either list.

    Stakeholder feedback on guidance priorities is important to ensure that the CDRH guidance program meets the needs of stakeholders. The feedback received on the FY 2018 list was mostly in agreement, and CDRH continued to work toward issuing the guidances on this list. In FY 2018, CDRH issued sixteen of twenty guidances on the FY 2018 list (fourteen from the A-list, two from the B-list).

    Dated: September 28, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-21596 Filed 10-3-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2310] Process To Request a Review of the Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability; extension of comment period.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of August 17, 2018. FDA requested comments on the draft guidance for industry and FDA staff entitled “Process To Request a Review of FDA's Decision Not To Issue Certain Export Certificates for Devices.” The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

    DATES:

    FDA is extending the comment period on the document published August 17, 2018 (83 FR 41078). Submit either electronic or written comments on the draft guidance by November 15, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

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

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2018-D-2310 for “Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled “Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Joann Belt, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3658, Silver Spring, MD 20993-0002, [email protected], 301-796-6836; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In the Federal Register of August 17, 2018, FDA published a notice of availability with a 60-day comment period to request comments on the draft guidance for industry and FDA staff entitled “Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices.”

    The Agency has received a request for a 30-day extension of the comment period. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response.

    FDA has considered the request and is extending the comment period for the notice of availability for 30 days, until November 15, 2018. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying guidance on these important issues.

    II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the process to request a review of FDA's decision not to issue certain export certificates for devices. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of “Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 17044 to identify the guidance you are requesting.

    IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in sections 801(e) and 802 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 381(e) and 382) have been approved under OMB control number 0910-0498; the collections of information in 21 CFR part 807, subparts A through E, have been approved under OMB control number 0910-0625; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; and the collections of information in the guidance “Center for Devices and Radiological Health Appeals Processes” have been approved under OMB control number 0910-0738.

    Dated: September 28, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-21597 Filed 10-3-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3636] United States Food and Drug Administration and Health Canada Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public meeting and webcast; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The purpose of this public meeting is to provide information and solicit public input on the current activities of ICH as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Charlotte, NC, scheduled for November 11 through 15, 2018. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Charlotte, NC.

    DATES:

    The public meeting will be held on October 17, 2018, from 9 a.m. to 12 p.m., Eastern Time. Submit either electronic or written comments on this public meeting by October 31, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information.

    ADDRESSES:

    The public meeting will be held at the Sir Frederick G. Banting Research Centre, 251 Sir Frederick Banting Dr., Ottawa, ON K1Y 0M1, Canada. It will also be broadcast on the web, allowing participants to join in person or via the web.

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 31, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 31, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2018-N-3636 for “U.S. Food and Drug Administration and Health Canada Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    William Lewallen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6304, Silver Spring, MD 20993-0002, 301-796-3810, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    The ICH, formerly known as the International Conference on Harmonisation, was established in 1990 as a joint regulatory/industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States without compromising the regulatory obligations of safety and effectiveness. In 2015, the ICH was reformed to establish ICH as a true global initiative that expands beyond the previous ICH members. More involvement from regulators around the world is expected, as they will join their counterparts from Europe, Japan, the United States, Canada, and Switzerland as ICH regulatory members. Expanded involvement is also anticipated from global regulated pharmaceutical industry parties, joining as ICH observers and industry members. The reforms build on a 25-year track record of successful delivery of harmonized guidelines for global pharmaceutical development and regulation.

    ICH guidelines are developed following a five-step process. In Step 1, experts from the different ICH regions work together to prepare a consensus draft of the Step 1 Technical Document. The Step 1 Technical Document is submitted to the ICH Assembly to request endorsement under Step 2a of the process. Step 2b is a “Regulators only” step in which the ICH regulatory members review the Step 2a Final Technical Document and take any actions, which might include revisions that they deem necessary, to develop the draft “Guideline.” Step 3 of the process begins with the public consultation process conducted by each of the ICH regulatory members in their respective regions, and this step concludes with completion and acceptance of any revisions that need to be made to the Step 2b draft guideline in response to public comments. Adoption of the new guideline occurs in Step 4. Following adoption, the harmonized guideline moves to Step 5, the final step of the process, when it is implemented by each of the regulatory members in their respective regions. The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the ICH regions since 1990. More information on the current ICH process and structure can be found at the following website: http://www.ich.org.

    II. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting must register online by October 12, 2018. To register to attend the public meeting either in person or via webcast, please visit the following website: https://www.eventbrite.ca/e/health-canada-us-fda-ich-consultation-tickets-47713713000. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

    Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by October 12, 2018, 11:59 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, the number of participants from each organization may be limited. The agenda for the public meeting will be made available on the internet at https://www.fda.gov/Drugs/NewsEvents/ucm612657.htm approximately 2 weeks in advance of the meeting.

    If you need special accommodations due to a disability, please contact William Lewallen (see FOR FURTHER INFORMATION CONTACT) no later than October 12, 2018.

    Requests for Oral Presentations: If you wish to make a presentation during the public comment session, please contact William Lewallen (see FOR FURTHER INFORMATION CONTACT) no later than October 12, 2018. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation. All requests to make presentations must be received by the close of registration on October 12, 2018. If selected for presentation, any presentation materials must be emailed to William Lewallen (see FOR FURTHER INFORMATION CONTACT) no later than October 12, 2018. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.

    Streaming Webcast of the Public Meeting: This public meeting will also be webcast. To register to attend via webcast, please visit the following website: https://www.eventbrite.ca/e/health-canada-us-fda-ich-consultation-tickets-47713713000. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

    Dated: September 28, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-21594 Filed 10-3-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; CTSA Collaborative Innovation Awards Review Meeting (U01).

    Date: October 24, 2018.

    Time: 2:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, One Democracy Plaza, Room 1068, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: M. Lourdes Ponce, Ph.D., Scientific Review Officer, Office of Scientific Review, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, 6701 Democracy Blvd., Democracy 1, Room 1073, Bethesda, MD 20892, 301-435-0810, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS)
    Dated: September 28, 2018. David D. Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-21567 Filed 10-3-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting Allergy, Immunology, and Transplantation Research Committee.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Allergy, Immunology, and Transplantation Research Committee AITC January 2019 Council.

    Date: October 23-24, 2018.

    Time: 9:30 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: James T. Snyder, Ph.D., Scientific Review Officer Scientific Review Program, Division of Extramural Activities/Room 3G31B, National Institutes of Health, NIAID, 5601 Fishers Lane MSC 9834, Bethesda, MD 20892-9834, (240) 669-5060, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)
    Dated: September 28, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-21572 Filed 10-3-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; RFA-DK-18-003: Elucidating the Effect of Glycemic Excursions on Patient Well-being and Cognitive Status in People with Type 1 Diabetes.

    Date: October 18, 2018.

    Time: 11:30 a.m. to 3:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Charlene J. Repique, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7347, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 451-3638, [email protected].

    This notice is being published less than 15 days prior to the meeting due to the timing limitations Imposed by the review and funding cycle.

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Patient-Reported Outcomes in Diabetes.

    Date: October 25, 2018.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, (301) 594-8898, [email protected].

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; NIDDK-RC2-Telephone Review.

    Date: November 7, 2018.

    Time: 2:30 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Xiaodu Guo, MD, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7023, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-4719, [email protected].

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Clinical Trial Review.

    Date: November 13, 2018.

    Time: 10:30 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, (301) 594-8898, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS)
    Dated: September 28, 2018. David D. Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-21568 Filed 10-3-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; Mentored Career Development (K) Award Application Review (2019/01).

    Date: October 25, 2018.

    Time: 9:30 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, National Institute of Biomedical Imaging and Bioengineering, Two Democracy Plaza, Suite 920, 6707 Democracy Boulevard, Bethesda, MD 20892, (Virtual Meeting).

    Contact Person: John P Holden, Ph.D., Scientific Review Officer, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Blvd., Suite 920, Bethesda, MD 20892, 301-496-8775, [email protected]

    Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; Conference Award (R13) Application Review (2019/01).

    Date: October 25, 2018.

    Time: 2:00 p.m. to 5:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, National Institute of Biomedical Imaging and Bioengineering, Two Democracy Plaza, Suite 920, 6707 Democracy Boulevard, Bethesda, MD 20892, (Virtual Meeting).

    Contact Person: John P. Holden, Ph.D., Scientific Review Officer, National Institute of Biomedical Imaging and Bioengineering, 6707 Democracy Blvd., Suite 920, Bethesda, MD 20892, (301) 496-8775, [email protected]

    Dated: September 28, 2018. David D. Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-21569 Filed 10-3-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA Panel: Cellular and Molecular Biology of Complex Brain Disorders.

    Date: October 29-30, 2018.

    Time: 8:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Villa Florence Hotel, 225 Powell Street, San Francisco, CA 94102.

    Contact Person: Brian H Scott, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301-827-7490, [email protected]

    Name of Committee: Genes, Genomes, and Genetics Integrated Review Group; Genetics of Health and Disease Study Section.

    Date: October 29-30, 2018.

    Time: 8:30 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Cheryl M. Corsaro, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2204, MSC 7890, Bethesda, MD 20892, (301) 435-1045, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Stress and Sleep Neuroscience.

    Date: October 29, 2018.

    Time: 12:00 p.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Jasenka Borzan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive Room 4214 MSC 7814, Bethesda, MD 20892, 301-435-1787, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Integrative Neuroscience.

    Date: October 31, 2018.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Ying-Yee Kong, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5185, Bethesda, MD 20892, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowship: Oncological Sciences.

    Date: November 1-2, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Nikko San Francisco, 222 Mason Street, San Francisco, CA 94102.

    Contact Person: Jian Cao, MD, Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301-827-5902, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Topics in Bacterial Pathogenesis.

    Date: November 1, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW, Washington, DC 20015.

    Contact Person: Richard G Kostriken, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3192, MSC 7808, Bethesda, MD 20892, 240-519-7808, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR-17-094: Maximizing Investigators' Research Award (R 35).

    Date: November 1-2, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Michael L Bloom, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6187, MSC 7804, Bethesda, MD 20892, 301-451-0132, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; BRAIN Initiative: Targeted BRAIN Circuits Projects.

    Date: November 1, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Westgate Hotel, 1055 Second Avenue, San Diego, CA 92101.

    Contact Person: Kirk Thompson, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5184, MSC 7844, Bethesda, MD 20892, 301-435-1242, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test Challenge: Step 2.

    Date: November 1, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate prize.

    Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852.

    Contact Person: Gagan Pandya, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, RM 3200, MSC 7808, Bethesda, MD 20892, 301-435-1167, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Drug Abuse and HIV Infection.

    Date: November 1, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Jingsheng Tuo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5207, Bethesda, MD 20892, 301-451-8754, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Topics in Gastroenterology.

    Date: November 1-2, 2018.

    Time: 8:00 a.m. to 8:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Alexandrian, 480 King Street, Alexandria, VA 22314.

    Contact Person: Terez Shea-Donohue, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2180, MSC 7818, Bethesda, MD 20892, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: AIDS and AIDS-related applications.

    Date: November 1, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Jingsheng Tuo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3196, Bethesda, MD 20892, 301-451-5953, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Brain Disorders and Related Neurosciences.

    Date: November 1-2, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: SpringHill Suites, 900 Bayfront Ct, San Diego, CA 92101.

    Contact Person: Vilen A Movsesyan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040M, MSC 7806, Bethesda, MD 20892, 301-402-7278, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowship: Immunology.

    Date: November 1-2, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Liying Guo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4016F, Bethesda, MD 20892, 301-435-0908, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Health Services and Health Informatics.

    Date: November 1, 2018.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Ping Wu, Ph.D., Scientific Review Officer, HDM IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3166, Bethesda, MD 20892, 301-451-8428, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Endocrinology, Metabolism and Reproductive Biology.

    Date: November 1, 2018.

    Time: 1:00 p.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Hui Chen, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6164, Bethesda, MD 20892, 301-435-1044, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR-16-089: Imaging and Biomarkers for Early Cancer Detection (U01).

    Date: November 1, 2018.

    Time: 1:00 p.m. to 4:15 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Xiang-Ning Li, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5112, MSC 7854, Bethesda, MD 20892, 301-435-1744, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR-18-011: Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R01 Clinical Trial Required).

    Date: November 1-2, 2018.

    Time: 12:00 p.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Yuanna Cheng, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4138, MSC 7814, Bethesda, MD 20892, (301) 435-1195, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: September 28, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-21574 Filed 10-3-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research: Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Dental and Craniofacial Research.

    The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Dental & Craniofacial Research, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Board of Scientific Counselors, National Institute of Dental and Craniofacial Research.

    Date: November 29, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators.

    Place: National Institutes of Health, Building 30, Room 117, 30 Center Drive, Bethesda, MD 20892.

    Contact Person: Alicia J. Dombroski, Ph.D., Director, Division of Extramural Activities, National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD 20892.

    Information is also available on the Institute's/Center's home page: http://www.nidcr.nih.gov/about/CouncilCommittees.asp, where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS)
    Dated: September 28, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-21575 Filed 10-3-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflicts: Disease and Pathophysiology of the Visual System.

    Date: October 24, 2018.

    Time: 9:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Alessandra C Rovescalli, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Rm 5205 MSC7846, Bethesda, MD 20892, (301) 435-1021, [email protected]

    Name of Committee: Cardiovascular and Respiratory Sciences Integrated Review Group; Myocardial Ischemia and Metabolism Study Section.

    Date: October 25-26, 2018.

    Time: 8:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Melrose Hotel, 2430 Pennsylvania Ave. NW, Washington, DC 20037

    Contact Person: Kimm Hamann, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4118A, MSC 7814, Bethesda, MD 20892, 301-435-5575, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA-AI-18-016: Gene Therapeutics for HIV Cure.

    Date: October 25, 2018.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Jingsheng Tuo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5207, Bethesda, MD 20892, 301-451-8754, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR-17-316: Biomedical Technology Research Resource (P41).

    Date: October 30, 2018.

    Time: 10:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Joseph Thomas Peterson, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4118, MSC 7814, Bethesda, MD 20892, 301-408-9694, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Methodology and Measurement in Behavioral and Social Sciences.

    Date: October 30, 2018.

    Time: 10:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Marc Boulay, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, MSC 7808, Bethesda, MD 20892, (301) 300-6541, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Immune System Plasticity in Dental, Oral, and Craniofacial Diseases.

    Date: October 30, 2018.

    Time: 1:00 p.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Rajiv Kumar, Ph.D., Chief, MOSS IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4216, MSC 7802, Bethesda, MD 20892, 301-435-1212, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Immune System Plasticity in Dental, Oral, and Craniofacial Diseases.

    Date: October 30, 2018.

    Time: 2:00 p.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Yi-Hsin Liu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301-435-1781, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Linking Provider Recommendation to Adolescent HPV Uptake.

    Date: October 30, 2018.

    Time: 12:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Tasmeen Weik, DRPH, MPH, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3141, Bethesda, MD 20892, 301-827-6480, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; SBIB Clinical Pediatric and Fetal Applications.

    Date: October 31, 2018.

    Time: 11:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Donald Scott Wright, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5108, MSC 7854, Bethesda, MD 20892, (301) 435-8363, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: September 28, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-21573 Filed 10-3-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed project or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276-1243.

    Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Proposed Project: State Opioid Response (SOR) and Tribal Opioid Response (TOR) Program Data Collection and Performance Measurement—NEW

    The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Treatment (CSAT) is requesting approval from the Office of Management and Budget (OMB) for data collection activities associated with the State Opioid Response (SOR) and Tribal Opioid Response (TOR) discretionary grant programs. Approval of this information collection will allow SAMHSA to continue to meet the Government Performance and Results Modernization Act of 2010 (GPRMA) reporting requirements that quantify the effects and accomplishments of its discretionary grant programs which are consistent with OMB guidance. Information collected through this request will be used to monitor performance throughout the grant period.

    There will be up to 359 award recipients (states, territories, and tribal entities) in these grant programs. Grantee-level data will include information related to naloxone purchases and distribution. This grantee-level information will be collected quarterly.

    All funded states/territories and tribal entities will also be required to collect and report client-level data on individuals who are receiving opioid treatment services to ensure program goals and objectives are being met. Client-level data will include information such as: Demographic information, services planned/received, mental health/substance use disorder diagnoses, medical status, employment status, substance use, legal status, and psychiatric status/symptoms. Client-level data will be collected at intake/baseline, three months post intake, six months post intake, and at discharge.

    CSAT anticipates that the time required to collect and report the grantee-level data is approximately 10 minutes per response, and the time required to collect and report the client-level data is approximately 47 minutes per response. CSAT's estimate of the burden associated with the client-level instrument includes an adjustment for data elements that are currently being collected by entities that are likely to be funded by the SOR/TOR grant programs.

    Table 1—Estimate of Annualized Hour Burden for SOR/TOR Grantees SAMHSA data
  • Collection
  • Number of
  • respondents
  • Responses per
  • respondent
  • Total number
  • of
  • responses
  • Burden hours
  • per
  • response
  • Total burden
  • Hours
  • Grantee-Level Instrument 359 4 1,436 .17 244 Client Level Instrument: Baseline Interview 165,000 1 165,000 .78 128,700 Client-Level Instrument: Follow-up Interview 1 132,000 2 264,000 .78 205,920 Client-Level Instrument: Discharge Interview 2 85,800 1 85,800 .78 66,924 CSAT Total 165,359 516,236 401,788 Notes: 1 It is estimated that 80% of baseline clients will complete the three month and six month follow-up interviews. 2 It is estimated that 52% of baseline clients will complete this interview.

    Send comments to Summer King, SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E57-B, Rockville, Maryland 20857, OR email a copy to [email protected] Written comments should be received by December 3, 2018.

    Summer King, Statistician.
    [FR Doc. 2018-21576 Filed 10-3-18; 8:45 am] BILLING CODE 4162-20-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [18X.LLAK941000 L14100000.ET0000; AA-61299, F-16304, AA-64307, F-85667, AA-61301] Public Land Order No. 7874; Partial Revocation of Public Land Orders No. 5179, 5180, 5181, 5184, and 5188, Alaska AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Public Land Order.

    SUMMARY:

    This Order partially revokes five Public Land Orders (PLO) insofar as they affect approximately 229,715 acres of public lands. The lands were reserved for study and classification as appropriate by the Department of the Interior (DOI). The purposes for which these lands were withdrawn no longer exist as described in the analysis and decisions made through the Bay Resource Management Plan (RMP) and associated Environmental Impact Statement. Of the lands described within the Orders being revoked, approximately 83.30 acres have been conveyed out of Federal ownership and the revocation of the Order on these lands is a record-clearing action only.

    DATES:

    This Public Land Order takes effect on October 4, 2018.

    FOR FURTHER INFORMATION CONTACT:

    David V. Mushovic, Bureau of Land Management (BLM) Alaska State Office, 222 West Seventh Avenue, Mailstop #13, Anchorage, AK 99513-7504, 907-271-4682, or [email protected] People who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    This Order follows the recommendations made in the BLM's 2008 Bay RMP which serves as the detailed statement required under the National Environmental Policy Act, Section 102(2)(C). PLO No. 5179 withdrew lands in aid of legislation concerning addition to or creation of units of the National Park, National Forest, Wildlife Refuge, and Wild and Scenic Rivers systems, and to allow for classification of the lands. Any additions to or creation of new units of National Parks, National Forests, Wildlife Refuges, or Wild and Scenic Rivers from the land withdrawn by Public Land Order No. 5179 were met by the Alaska National Interest Lands Conservation Act (ANILCA). The classification of the lands withdrawn by PLO No. 5179 has been satisfied by the analysis conducted during the development of the BLM's 2008 Bay RMP. PLO No. 5180 withdrew lands to allow for classification and for the protection of the public interest in these lands. The classification and protection of the public interest in the lands withdrawn by PLO No. 5180 has been satisfied by the analysis conducted during the development of the BLM's 2008 Bay RMP. PLO No. 5181 withdrew lands to allow for classification and study as possible additions to the National Wildlife Refuge System. The purposes of PLO No. 5181 were satisfied by both the ANILCA and the analysis conducted during the development of the BLM's 2008 Bay RMP. PLO No. 5184 withdrew lands to allow for classification or reclassification of some of areas withdrawn by Section 11 of the Alaska Native Claims Settlement Act (ANCSA). These purposes were satisfied by the analysis conducted during the development of the BLM's 2008 Bay RMP. PLO No. 5188 withdrew lands to allow for classification and protection of the public interest in the lands in former reservations for use and benefit of Alaska Natives. These purposes were satisfied by the analysis conducted during the development of the BLM's 2008 Bay RMP. In addition, PLO No. 5418, effective March 1974, amends PLO No. 5180 to add all unreserved public lands in Alaska, or those which may become unreserved unless specified by order at that time. Upon revocation, the lands in this Order will not be subject to the terms and conditions of PLO No. 5418, which amended PLO No. 5180, but will continue to be subject to the terms and conditions of any other withdrawal, segregation of record, and other applicable law. Some lands covered by the revocation of the above listed withdrawals have been top filed by the State of Alaska per the Alaska Statehood Act. Upon revocation of the above listed withdrawals, the top filings will convert to selections. Lands validly selected or conveyed to the State of Alaska are not subject to Sec. 810 of the ANLICA as they no longer fit the definition of public lands. The Sec. 810 analysis for the approved Bay RMP found no significant restriction on subsistence uses.

    Order

    By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714, and Section 22(h)(4) of the Alaska Native Claims Settlement Act of 1971, 43 U.S.C. 1621(h)(4), it is ordered as follows:

    1. Subject to valid existing rights, Public Land Orders Nos. 5179 (37 FR 5579 (1972)); 5180 (37 FR 5583 (1972)); 5181 (37 FR 5584 (1972)); 5184 (37 FR 5588 (1972)) and any amendments, modifications or corrections to these Orders, if any, are hereby revoked insofar as they affect the following described Federal lands or interests in lands:

    a. Those lands within PLO No. 5179, as amended, modified, or corrected:

    Seward Meridian, Alaska T. 8 S, R. 71 W, partly unsurveyed, Secs. 1, 2, 12, 13, and 24. T. 9 S, R. 71 W, partly unsurveyed, Sec. 20, W1/2NW1/4NE1/4 and E1/2NE1/4NW1/4. T. 9 S, R. 72 W, unsurveyed.

    The area described contains 26,076 acres.

    b. Those lands within PLO No. 5180 as amended by PLO No. 5418:

    Seward Meridian, Alaska T. 10 S, R. 76 W, Secs. 1 and 12, Sec. 13, those portions lying outside Alaska Maritime National Wildlife Refuge, excepting U.S. Survey No. 13740, Secs. 14, 23, 24, 26, 27, and 34, those portions lying outside Alaska Maritime National Wildlife Refuge.

    The area described contains 516.54 acres.

    c. Those lands within PLO No. 5181, including those lands amended by PLO No. 5388:

    Seward Meridian, Alaska T. 8 S, R. 72 W, partly unsurveyed, Secs. 4 thru 9, secs. 16 thru 21, and secs. 25 thru 36. Tps. 9 S, Rs. 72 and 73 W, unsurveyed. T. 9 S, R. 74 W, unsurveyed, Secs. 1 thru 5; Sec. 6, excepting U.S. Survey No. 9603, lots 1 and 2; Sec. 7, excepting U.S. Survey No. 9757, lots 1 and 2; Secs. 8 thru 36. T. 9 S, R. 75 W, unsurveyed, Sec. 1, excepting U.S. Survey No. 9603, lot 2, those portions lying outside Alaska Maritime National Wildlife Refuge; Sec. 2, those portions lying outside Alaska Maritime National Wildlife Refuge; Secs. 11 thru 16, those portions lying outside Alaska Maritime National Wildlife Refuge; Secs. 20 and 21, those portions lying outside Alaska Maritime National Wildlife Refuge; Sec. 22, excepting U.S. Survey No. 9604, those portions lying outside Alaska Maritime National Wildlife Refuge; Secs. 23 thru 27, those portions lying outside Alaska Maritime National Wildlife Refuge; Sec. 28, excepting U.S. Survey No. 9605, those portions lying outside Alaska Maritime National Wildlife Refuge; Sec. 29, those portions lying outside Alaska Maritime National Wildlife Refuge; Secs. 32 thru 36, those portions lying outside Alaska Maritime National Wildlife Refuge.

    The area described contains approximately 94,871.37 acres.

    d. Those lands within PLO No. 5184, as amended, modified or corrected:

    Seward Meridian, Alaska T. 10 S, R. 71 W, tracts A and B. T. 11 S, R. 71 W, tracts A and B. T. 12 S, R. 71 W, partly unsurveyed, Secs. 3 thru 36. T. 10 S, R. 72 W, Secs. 3, 6, 7, and 24. T. 11 S, R. 72 W, Secs.1, 12, 13, 24, 33, 34, and 35. T. 12 S, R. 72 W, Sec. 13; Secs. 22 thru 36, excepting U.S. Survey Nos. 9851 and 9649. T. 10 S, R. 73 W, Secs. 19 and 30. T. 13 S, R. 73 W, Secs. 1 thru 5; Secs. 7 thru 18, excepting U.S. Survey Nos. 9640 and 9641. T. 10 S, R. 74 W, Secs. 1 thru 9, 13, secs. 16 thru 21, secs. 23 thru 27, secs. 34, and 35. T. 11 S, R. 74 W, Secs. 3, 6, 7, 18, 19, 30, 31, and 32. T. 12 S, R. 74 W, Secs. 5 thru 8; Secs. 17 thru 20, excepting U.S. Survey Nos. 2495, 9455, 9473, and 9760. T. 14 S, R. 74 W, Secs. 28 and 33; M.S. No. 2436. T. 10 S, R. 75 W, Secs. 1 thru 3, secs. 10 thru 15, and secs. 22 thru 24; T. 14 S, R. 75 W, Sec. 11, those portions lying within Federal mining claims AA031603 thru AA031606, AA031608 thru AA031610 and AA031665 only; Sec. 12, those portions lying within Federal mining claims AA031518, AA031607 thru AA031609, AA031663 and AA031664 only; Sec. 13, those portions lying within Federal mining claims AA031603, AA031607, AA031608, AA032237 thru AA032242, AA032271, AA032275, AA032276, AA032278, and AA032279 only; Sec. 14, those portions lying within Federal mining claims AA031603 thru AA031606, AA031608, AA031665, AA032276 and AA032279 only; Sec. 22, those portions lying within Federal mining claims AA031527, AA031528, and AA031620 only; Ssec. 24, those portions lying within Federal mining claims AA032240 and AA032241 only; Sec. 26, those portions lying within Federal mining claims AA031527, AA031616 thru AA031619, AA031627, AA031636 and AA031637 only; Sec 27, those portions lying within Federal mining claims AA031527, AA31528, AA031617 thru AA031620, AA031626 thru AA031631, AA031636 thru AA031642, and AA031646 thru AA031650 only; Sec. 34, those portions lying within Federal mining claims AA031636, AA031637, and AA031646 thru AA031650 only; Sec. 35, those portions lying within Federal mining claim AA031636 only; M.S. Nos. 2436, 2440 and 2442, those portions lying outside Alaska Maritime National Wildlife Refuge. T. 15 S, R. 75 W, M.S. Nos. 2442 and 2443, those portions lying outside Togiak National Wildlife Refuge, Cape Newenham National Wildlife Refuge, and Alaska Maritime National Wildlife Refuge. T. 11 S, R. 76 W, Secs. 2 and 3; those portions lying outside Alaska Maritime National Wildlife Refuge; Secs. 11 thru 14 excepting U.S. Survey Nos. 9495 and 9488, Lot 1, those portions lying outside Alaska Maritime National Wildlife Refuge; Secs. 23, 24, 25, and 36, excepting U.S. Survey Nos. 9487 and 9485, those portions lying outside Alaska Maritime National Wildlife Refuge. T. 12 S, R. 76 W, Sec. 1, excepting U.S. Survey No. 9485, those portions lying outside Alaska Maritime National Wildlife Refuge.

    The area described contains 108,167.99 acres.

    Total areas described in paragraph 1 aggregate 229,632 acres.

    2. Subject to valid existing rights, PLO No. 5184 (37 FR 5588 (1972)), and PLO No. 5188 (37 FR 5591 (1972)) as amended, modified, or corrected, are hereby revoked insofar as they affect the following described Federal interests in land: Public Land Order No. 5184, as amended, modified, or corrected, which withdrew public lands located in Tps. 14 S, Rs. 74 and 75 W, Seward Meridian, Alaska, is hereby revoked insofar as it affects Federal interests in the following described lands:

    U.S. Survey No. 9501, lots 2 and 3.

    The area described contains 79.95 acres.

    Public Land Order No. 5188, as amended, modified, or corrected, which withdrew public lands located in T. 12 S, R. 73 W, Seward Meridian, Alaska, is hereby revoked insofar as it affects Federal interests in the following described lands:

    U.S. Survey No. 2024.

    The area described contains 3.35 acres.

    The area described in paragraph 2 aggregates 83.30 acres.

    The area described in paragraphs 1 and 2 aggregate 229,715 acres.

    3. The lands subject to revocation in this Order will not be subject to additional withdrawal by PLO 5418.

    4. At 8 a.m. AKST on November 5, 2018, the lands described in Paragraph 1 shall be open to all forms of appropriation under the public land laws, including selection by the State of Alaska under the Alaska Statehood Act, location and entry under the mining laws, leasing under the Mineral Leasing Act of February 25, 1920, as amended, and selection by Regional Corporations under section 12 of the ANCSA, subject to valid existing rights, the provisions of existing withdrawals, other segregations of record, and the requirements of applicable law. All valid applications received at or prior to 8 a.m. AKST on November 5, 2018, shall be considered as simultaneously filed at that time. Those received thereafter shall be considered in the order of filing. Appropriation of any of the lands referenced in this order under the mining laws prior to the date and time of restoration is unauthorized. Any such attempted appropriation, including attempted adverse possession under 30 U.S.C. 38, shall vest no rights against the United States. State law governs acts required to establish a location and to initiate a right of possession where not in conflict with Federal law. The BLM will not intervene in disputes between rival locators over possessory rights since Congress has provided for such determinations in local courts.

    5. The lands described in paragraph 2 have been conveyed out of Federal ownership. For those lands this is a record clearing action only.

    Dated: September 26, 2018. Joseph R. Balash, Assistant Secretary, Land and Minerals Management.
    [FR Doc. 2018-21641 Filed 10-3-18; 8:45 am] BILLING CODE 4310-JA-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLNVS01000 L5105.0000.EA0000 LVRCF1806160 241A 18X; MO# 4500125059] Notice of Temporary Closure of Public Land in Clark County, NV AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of temporary closure.

    SUMMARY:

    The Las Vegas Field Office announces the temporary closure of certain public lands under its administration in Clark County, NV. This temporary closure is being made in the interest of public safety in relation to the authorized 2018 Rise Lantern Festival. This temporary closure controls access to multiple points of entry to the festival located on the Jean Dry Lake bed in order to minimize the risk of vehicle collisions with festival participants and workers. The temporary closure also ensures adequate time to conduct clean-up of the festival location.

    DATES:

    The temporary closure takes effect at 12:01 a.m. on October 5, 2018, and remains in effect until 11:59 p.m. on October 6, 2018.

    ADDRESSES:

    The temporary closure order, communications plan, and map of the temporary closure area will be posted at the BLM Las Vegas Field Office, 4701 North Torrey Pines Drive, Las Vegas, Nevada 89130 and on the BLM website: www.blm.gov. These materials will also be posted at the access point of Jean Dry Lake Bed and the surrounding areas.

    FOR FURTHER INFORMATION CONTACT:

    Kenny Kendrick, Outdoor Recreation Planner, (702) 515-5073, [email protected]v. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    The Las Vegas Field Office announces the temporary closure of selected public lands under its administration. This action is being taken to help ensure public safety and prevent unnecessary environmental degradation during the official Special Recreation Permit of the 2018 Rise Lantern Festival. The public lands affected by this temporary closure are described as follows:

    Mount Diablo Meridian, Nevada T. 24 S., R. 60 E., Sec. 21, that portion lying easterly and southerly of the easterly and southerly right-of-way boundary of State Route 604; Sec. 22; Secs. 27 thru 28; Sec. 29, and 32 that portion lying easterly and southerly of the easterly and southerly right-of-way boundary of State Route 604; Secs. 33, and 34. T. 25 S., R. 60 E., Sec. 2, W1/2; Secs. 3 thru 5; Secs. 8 thru 10; Sec. 11, W1/2; Sec. 14, W1/2; Secs. 15 thru 17.

    Roads leading into the public lands under the temporary closure will be posted to notify the public of the temporary closure. The temporary closure area includes the Jean Dry Lake Bed and is bordered by Hidden Valley to the east, the Sheep Mountain to the southwest, and the right-of-way boundary of State Route 604. Under the authority of Section 303(a) of the Federal Lands Policy and Management Act of 1976 (43 U.S.C. 1733(a)), 43 CFR 8360.0-7 and 43 CFR 8364.1, the BLM will enforce the following rules in the area described above:

    The entire area as listed in the legal description above is closed to all vehicles and personnel except Law Enforcement, Emergency Vehicles, event personnel, and ticketed festival participants. Access routes leading to the temporarily closed area are closed to vehicles. No vehicle stopping or parking in the closed area except for designated parking areas will be permitted. Festival participants are required to remain within designated spectator areas only.

    The following restrictions will be in effect for the duration of the temporary closure to ensure public safety of festival participants. Unless otherwise authorized, the following activities within the closure area are prohibited:

    • Camping.

    • Possession and/or consuming any alcoholic beverage unless the person has reached the age of 21 years.

    • Discharging, or use of firearms, or other weapons.

    • Possession and/or discharging of fireworks.

    • Allowing any pet or other animal in their care to be unrestrained at any time. Animals must be on a leash or other restraint no longer than 3 feet.

    • Operation of any vehicle including any off-highway vehicle (OHV) and Golf Carts within the closure area, except along designated event routes to and from entrance/exit points and parking areas; or designated event vehicles and official vehicles.

    • Parking any vehicle in violation of posted restrictions, or in such a manner as to obstruct or impede normal or emergency traffic movement or the parking of other vehicles, create a safety hazard, or endanger any person, property or feature. Vehicles so parked are subject to citation, removal and impoundment at the owner's expense.

    • Operating a vehicle through, around or beyond a restrictive sign, recognizable barricade, fence or traffic control barrier or device.

    Signs and maps directing the public to designated spectator areas will be provided by the event sponsor.

    Exceptions: Temporary closure restrictions do not apply to activities conducted under contract with the BLM, agency personnel monitoring the event, or activities conducted under an approved plan of operation. Authorized users must have in their possession, a written permit or contract from BLM signed by the authorized officer.

    Enforcement: Any person who violates this temporary closure may be tried before a United States Magistrate and fined in accordance with 18 U.S.C. 3571, imprisoned no more than 12 months under 43 U.S.C. 1733(a) and 43 CFR 8360.0-7, or both. In accordance with 43 CFR 8365.1-7, State or local officials may also impose penalties for violations of Nevada law.

    (Authority: 43 CFR 8360.0-7 and 8364.1) Gayle Marrs-Smith, Field Manager—Las Vegas Field Office.
    [FR Doc. 2018-21650 Filed 10-3-18; 8:45 am] BILLING CODE 4310-HC-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-1135] Certain Strength-Training Systems and Components Thereof Institution of Investigation AGENCY:

    U.S. International Trade Commission

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 4, 2018, under section 337 of the Tariff Act of 1930, as amended, on behalf of Hoist Fitness Systems, Inc. of Poway, California. A supplement to the Complaint was filed on September 14, 2018. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain strength-training systems and components thereof by reason of infringement of certain claims of U.S. Patent No. 7,549,949 (“the ’949 patent”); U.S. Patent No. 7,563,209 (“the ’209 patent”); U.S. Patent No. 7,594,880 (“the ’880 patent”); U.S. Patent No. 7,654,938 (“the ’938 patent”); and U.S. Patent No. 7,976,440 (“the ’440 patent”). The complaint, as supplemented, further alleges that an industry in the United States exists as required by the applicable Federal Statute.

    The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

    ADDRESSES:

    The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.

    FOR FURTHER INFORMATION CONTACT:

    Katherine Hiner, Office of the Secretary, Docket Services Division, U.S. International Trade Commission, telephone (202) 205-1802.

    SUPPLEMENTARY INFORMATION:

    Authority: The authority for