Federal Register Vol. 83, No.134,

Federal Register Volume 83, Issue 134 (July 12, 2018)

Page Range32191-32561
FR Document

83_FR_134
Current View
Page and SubjectPDF
83 FR 32293 - Sunshine Act MeetingPDF
83 FR 32213 - National Emission Standards for Hazardous Air Pollutants for Chemical Recovery Combustion Sources at Kraft, Soda, Sulfite, and Stand-Alone Semichemical Pulp MillsPDF
83 FR 32269 - Certain Activated Carbon From the People's Republic of China: Continuation of Antidumping Duty OrderPDF
83 FR 32330 - Sunshine Act Meetings; National Science BoardPDF
83 FR 32283 - Endangered and Threatened Species; Take of Anadromous FishPDF
83 FR 32337 - Open Meeting of the Financial Research Advisory CommitteePDF
83 FR 32211 - Approval of California Air Plan Revisions, Yolo-Solano Air Quality Management DistrictPDF
83 FR 32260 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Animal WelfarePDF
83 FR 32301 - Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; RenewalPDF
83 FR 32310 - Advisory Committee; Allergenic Products Advisory Committee; RenewalPDF
83 FR 32335 - Agency Information Collection Activities: Information Collection Renewal; Submission for OMB Review; Subordinated Debt Licensing RequirementsPDF
83 FR 32215 - Mango Promotion, Research, and Information Order; Reopening and Extension of Comment Period on Amendment To Include Frozen MangosPDF
83 FR 32193 - Cranberries Grown in States of Massachusetts, et al.; Establishment of Handler Diversion and Reporting Requirements and New Information CollectionPDF
83 FR 32191 - Federal Employees Health Benefits Program and Federal Employees Dental and Vision Insurance Program: Expiration of Coverage of Children of Same-Sex Domestic Partners; Federal Flexible Benefits Plan: Pre-Tax Payment of Health Benefits Premiums: Conforming AmendmentsPDF
83 FR 32296 - General Services Administration Acquisition Regulation (GSAR); Information Collection; Environmental Conservation, Occupational Safety, and Drug-Free WorkplacePDF
83 FR 32337 - Creating Options for Veterans Expedited Recovery (COVER) Commission; Notice of MeetingPDF
83 FR 32305 - Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 29 New Drug ApplicationsPDF
83 FR 32301 - Advisory Committee; Psychopharmacologic Drugs Advisory Committee; RenewalPDF
83 FR 32286 - Proposed Collection; Comment RequestPDF
83 FR 32334 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of NebraskaPDF
83 FR 32293 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
83 FR 32299 - Healthcare Infection Control Practices Advisory Committee (HICPAC)PDF
83 FR 32299 - Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)PDF
83 FR 32262 - Production Activity Not Authorized; Foreign-Trade Zone (FTZ) 26-Atlanta, Georgia; PBR, Inc. d/b/a SKAPS Industries (Non-Woven Geotextiles); Athens, GeorgiaPDF
83 FR 32287 - Notice of Availability for an Environmental Assessment Addressing Upgrade of the Main Gate Access Control Point at Defense Distribution Depot, San Joaquin, California, and Surrounding AreaPDF
83 FR 32286 - Notice of Availability of an Environmental Assessment Addressing Hazardous Materials Warehouses and Gas Cylinder Sheds at Naval Station Norfolk and Naval Support Activity Norfolk Naval Shipyard, VirginiaPDF
83 FR 32263 - Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Preliminary Results and Intent To Rescind the Review in Part; 2016-2017PDF
83 FR 32270 - Initiation of Antidumping and Countervailing Duty Administrative ReviewsPDF
83 FR 32262 - Supercalendered Paper From Canada: Notice of Rescission of Countervailing Duty Administrative Review; 2015 and 2016PDF
83 FR 32268 - Supercalendered Paper From Canada: Final Results of Changed Circumstances Review and Revocation of Countervailing Duty OrderPDF
83 FR 32265 - Certain Steel Nails From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review and Partial Rescission of Antidumping Duty Administrative Review; 2016-2017PDF
83 FR 32206 - Special Local Regulation; Marine City Water Ski Show, St. Clair River, Marine City, MIPDF
83 FR 32313 - Accreditation and Approval of Saybolt LP (Nederland, TX) as a Commercial Gauger and LaboratoryPDF
83 FR 32334 - Petition for Exemption; Summary of Petition Received; 3GLP, Inc. dba Precision Flight DevicesPDF
83 FR 32335 - Petition for Exemption; Summary of Petition Received; NextEra Energy, Inc.PDF
83 FR 32261 - Notice of Proposed New Fee Site; Federal Lands Recreation Enhancement ActPDF
83 FR 32261 - Notice of New Fee Sites; Federal Lands Recreation Enhancement ActPDF
83 FR 32312 - Advisory Committee on Heritable Disorders in Newborns and ChildrenPDF
83 FR 32329 - Notice of Lodging of Proposed Consent Decree Under the Oil Pollution ActPDF
83 FR 32221 - Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type SizePDF
83 FR 32315 - Notice of Inventory Completion: State Historic Preservation Office, Lansing, MIPDF
83 FR 32319 - Notice of Inventory Completion: Heard Museum, Phoenix, AZPDF
83 FR 32317 - Notice of Inventory Completion: U.S. Department of Agriculture, Tongass National Forest, Juneau Ranger District, Juneau, AKPDF
83 FR 32320 - Notice of Intent To Repatriate Cultural Items: U.S. Department of the Interior, National Park Service, Grand Canyon National Park, Grand Canyon, AZPDF
83 FR 32316 - Notice of Inventory Completion: St. Joseph Museums, Inc., St. Joseph, MOPDF
83 FR 32322 - Notice of Inventory Completion: Museum of Ojibwa Culture and Marquette Mission Park, City of St. Ignace, MIPDF
83 FR 32318 - Notice of Inventory Completion: University of San Diego, San Diego, CAPDF
83 FR 32323 - Notice of Inventory Completion: San Diego Museum of Man, San Diego, CAPDF
83 FR 32321 - Notice of Inventory Completion: University of Michigan, Ann Arbor, MIPDF
83 FR 32314 - Notice of Intent To Repatriate Cultural Items: Berkshire Museum, Pittsfield, MAPDF
83 FR 32328 - Agency Information Collection Activities: Nomination and Request for Payment Form for OSMRE's National Technical Training CoursesPDF
83 FR 32327 - Agency Information Collection Activities: OSM-76-Abandoned Mine Land Problem Area Description FormPDF
83 FR 32326 - Agency Information Collection Activities: Reclamation on Private LandsPDF
83 FR 32325 - Agency Information Collection Activities: State Regulatory Authority: Inspection and EnforcementPDF
83 FR 32324 - Agency Information Collection Activities: Petition Process for Designation of Federal Lands as Unsuitable for All or Certain Types of Surface Coal Mining Operations and for Termination of Previous DesignationsPDF
83 FR 32326 - Agency Information Collection Activities: GeneralPDF
83 FR 32284 - Submission for OMB Review; Comment RequestPDF
83 FR 32285 - Submission for OMB Review; Comment RequestPDF
83 FR 32329 - Steel Propane Cylinders From China and ThailandPDF
83 FR 32295 - Submission for OMB Review; General Services Administration Acquisition Regulation; Contract Financing Final Payment (GSA Form 1142 Release of Claims)PDF
83 FR 32298 - Information Collection; CDP Supply Chain Climate Change Information RequestPDF
83 FR 32329 - Ammonium Nitrate From Ukraine; Termination of Five-Year ReviewPDF
83 FR 32296 - Information Collection; Background Investigations for Child Care WorkersPDF
83 FR 32255 - New FM Radio Broadcast Class C4 and To Modify the Requirements for Designating Short-Spaced AssignmentsPDF
83 FR 32297 - Submission for OMB Review; General Services Administration Acquisition Regulation; Contractor's Qualifications and Financial Information (GSA Form 527)PDF
83 FR 32331 - Privacy Act of 1974; System of RecordsPDF
83 FR 32333 - New Postal ProductPDF
83 FR 32300 - Notice of Hearing: Reconsideration of Disapproval Washington Medicaid State Plan Amendment (SPA) 17-0027PDF
83 FR 32306 - Human Gene Therapy for Hemophilia; Draft Guidance for Industry; AvailabilityPDF
83 FR 32313 - National Center for Complementary & Integrative Health; Notice of MeetingPDF
83 FR 32313 - National Center for Advancing Translational Sciences; Notice of MeetingsPDF
83 FR 32303 - Human Gene Therapy for Rare Diseases; Draft Guidance for Industry; AvailabilityPDF
83 FR 32302 - Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry; AvailabilityPDF
83 FR 32309 - Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry; AvailabilityPDF
83 FR 32311 - Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry; AvailabilityPDF
83 FR 32307 - Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Draft Guidance for Industry; AvailabilityPDF
83 FR 32293 - ReadyTech Corporation; Analysis To Aid Public CommentPDF
83 FR 32290 - Agency Information Collection Activities: Submission for OMB Review; Comment Request (OMB No. 3064-0109; 0124; and 0162)PDF
83 FR 32208 - Safety Zone; Alaska Marine Highway System Port Valdez Ferry Terminal, Port Valdez; Valdez, AKPDF
83 FR 32219 - Airworthiness Directives; Hoffmann Propeller GmbH & Co. KG PropellersPDF
83 FR 32289 - Open Commission Meeting, Thursday, July 12, 2018PDF
83 FR 32287 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
83 FR 32288 - Information Collections Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
83 FR 32209 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Interstate Transport Requirements for the 2012 Fine Particulate Matter StandardPDF
83 FR 32215 - Airworthiness Directives; Bombardier, Inc., AirplanesPDF
83 FR 32203 - Airworthiness Directives; Rolls-Royce Corporation Turboshaft EnginesPDF
83 FR 32252 - Medicaid Program; Reassignment of Medicaid Provider ClaimsPDF
83 FR 32198 - Airworthiness Directives; The Boeing Company AirplanesPDF
83 FR 32201 - Airworthiness Directives; Bell Helicopter Textron Canada Limited HelicoptersPDF
83 FR 32524 - Inversions and Related TransactionsPDF
83 FR 32227 - Definition of “Waters of the United States”-Recodification of Preexisting RulePDF
83 FR 32340 - Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting OrganizationsPDF

Issue

83 134 Thursday, July 12, 2018 Contents Agricultural Marketing Agricultural Marketing Service RULES Establishment of Handler Diversions, Reporting Requirements, and New Information Collections: Cranberries Grown in States of Massachusetts, et al., 32193-32198 2018-14939 PROPOSED RULES Promotion, Research, and Information Orders: Reopening and Extension of Comment Period on Amendment to Include Frozen Mangos, 32215 2018-14940 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Animal and Plant Health Inspection Service

See

Forest Service

Animal Animal and Plant Health Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Animal Welfare, 32260-32261 2018-14945 Centers Disease Centers for Disease Control and Prevention NOTICES Meetings: Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health, 32299 2018-14929 Healthcare Infection Control Practices Advisory Committee, 32299-32300 2018-14930 Centers Medicare Centers for Medicare & Medicaid Services PROPOSED RULES Medicaid Program: Reassignment of Medicaid Provider Claims, 32252-32255 2018-14786 Medicare and Medicaid Programs: CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; etc., 32340-32522 2018-14443 NOTICES Meetings: Washington Medicaid State Plan Amendment; Reconsideration of Disapproval: Hearing, 32300-32301 2018-14876 Coast Guard Coast Guard RULES Safety Zones: Alaska Marine Highway System Port Valdez Ferry Terminal, Port Valdez; Valdez, AK, 32208-32209 2018-14863 Special Local Regulations: Marine City Water Ski Show, St. Clair River, Marine City, MI, 32206-32207 2018-14919 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Subordinated Debt Licensing Requirements, 32335-32337 2018-14941 Defense Department Defense Department See

Engineers Corps

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 32286 2018-14933 Environmental Assessments; Availability, etc.: Hazardous Materials Warehouses and Gas Cylinder Sheds at Naval Station Norfolk and Naval Support Activity Norfolk Naval Shipyard, Virginia, 32286-32287 2018-14926 Upgrade of the Main Gate Access Control Point at Defense Distribution Depot, San Joaquin, CA, and Surrounding Area, 32287 2018-14927
Engineers Engineers Corps PROPOSED RULES Definition of Waters of the United States—Recodification of Preexisting Rule, 32227-32252 2018-14679 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: California, Yolo-Solano Air Quality Management District, 32211-32213 2018-14946 Delaware; Interstate Transport Requirements for the 2012 Fine Particulate Matter Standard, 32209-32211 2018-14838 National Emission Standards for Hazardous Air Pollutants: Chemical Recovery Combustion Sources at Kraft, Soda, Sulfite, and Stand-Alone Semichemical Pulp Mills, 32213-32214 2018-15023 PROPOSED RULES Definition of Waters of the United States—Recodification of Preexisting Rule, 32227-32252 2018-14679 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Bell Helicopter Textron Canada Limited Helicopters, 32201-32203 2018-14701 Rolls-Royce Corporation Turboshaft Engines, 32203-32206 2018-14801 The Boeing Company Airplanes, 32198-32201 2018-14702 PROPOSED RULES Airworthiness Directives: Bombardier, Inc., Airplanes, 32215-32218 2018-14804 Hoffmann Propeller GmbH and Co. KG Propellers, 32219-32221 2018-14862 NOTICES Petitions for Exemptions; Summaries: 3GLP, Inc. dba Precision Flight Devices, 32334-32335 2018-14913 NextEra Energy, Inc., 32335 2018-14912 Federal Communications Federal Communications Commission PROPOSED RULES New FM Radio Broadcast Class C4 and to Modify the Requirements for Designating Short-Spaced Assignments, 32255-32259 2018-14880 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 32287-32289 2018-14858 2018-14860 Meetings: Open Commission, 32289-32290 2018-14861 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 32290-32293 2018-14864 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 32293 2018-15024 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 32293 2018-14931 Federal Trade Federal Trade Commission NOTICES Proposed Consent Agreements: ReadyTech Corporation, 32293-32295 2018-14865 Food and Drug Food and Drug Administration PROPOSED RULES Food Labeling: Calorie Labeling of Articles of Food Sold from Certain Vending Machines; Front of Package Type Size, 32221-32227 2018-14906 NOTICES Charter Renewals: Advisory Committee; Allergenic Products Advisory Committee, 32310-32311 2018-14942 Advisory Committee; Science Advisory Board to the National Center for Toxicological Research, 32301 2018-14943 Psychopharmacologic Drugs Advisory Committee, 32301-32302 2018-14934 Guidance: Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications, 32307-32308 2018-14866 Human Gene Therapy for Hemophilia, 32306-32307 2018-14875 Human Gene Therapy for Rare Diseases, 32303-32305 2018-14871 Human Gene Therapy for Retinal Disorders, 32302-32303 2018-14870 Long Term Follow-Up After Administration of Human Gene Therapy Products, 32311-32312 2018-14867 Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up, 32309-32310 2018-14868 Withdrawal of Approval of 29 New Drug Applications: Concordia Pharmaceuticals, Inc., et al., 32305-32306 2018-14935 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: PBR, Inc. d/b/a SKAPS Industries, Foreign-Trade Zone 26, Atlanta, GA, 32262 2018-14928 Forest Forest Service NOTICES New Fee Sites, 32261-32262 2018-14910 2018-14911 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Background Investigations for Child Care Workers, 32296-32297 2018-14882 CDP Supply Chain Climate Change, 32298-32299 2018-14884 Contract Financing Final Payment, 32295 2018-14885 Contractor's Qualifications and Financial Information, 32297-32298 2018-14879 Environmental Conservation, Occupational Safety, and Drug-Free Workplace, 32296 2018-14937 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

Health Resources Health Resources and Services Administration NOTICES Meetings: Advisory Committee on Heritable Disorders in Newborns and Children, 32312-32313 2018-14908 Homeland Homeland Security Department See

Coast Guard

See

U.S. Customs and Border Protection

Interior Interior Department See

National Park Service

See

Surface Mining Reclamation and Enforcement Office

Internal Revenue Internal Revenue Service RULES Inversions and Related Transactions, 32524-32561 2018-14693 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Activated Carbon from the People's Republic of China, 32269-32270 2018-15014 Certain Steel Nails from the Republic of Korea, 32265-32268 2018-14920 Initiation of Administrative Reviews, 32270-32283 2018-14923 Supercalendered Paper from Canada, 32262-32263, 32268-32269 2018-14921 2018-14922 Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, from the People's Republic of China, 32263-32265 2018-14924 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Ammonium Nitrate from Ukraine, 32329 2018-14883 Investigations; Determinations, Modifications, and Rulings, etc.: Steel Propane Cylinders from China and Thailand, 32329 2018-14886 Justice Department Justice Department NOTICES Proposed Consent Decrees: Oil Pollution Act, 32329-32330 2018-14907 National Institute National Institutes of Health NOTICES Meetings: National Center for Advancing Translational Sciences, 32313 2018-14873 National Center for Complementary and Integrative Health, 32313 2018-14874 National Oceanic National Oceanic and Atmospheric Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 32284-32286 2018-14887 2018-14888 2018-14889 Endangered and Threatened Species: Take of Anadromous Fish, 32283-32284 2018-14950 National Park National Park Service NOTICES Inventory Completions: Heard Museum, Phoenix, AZ, 32319-32320 2018-14904 Museum of Ojibwa Culture and Marquette Mission Park, City of St. Ignace, MI, 32322-32323 2018-14900 San Diego Museum of Man, San Diego, CA, 32323-32324 2018-14898 St. Joseph Museums, Inc., St. Joseph, MO, 32316-32317 2018-14901 State Historic Preservation Office, Lansing, MI, 32315-32316 2018-14905 Tongass National Forest, Juneau Ranger District, Juneau, AK, 32317-32318 2018-14903 University of Michigan, Ann Arbor, MI, 32321-32322 2018-14897 University of San Diego, San Diego, CA, 32318-32319 2018-14899 Repatriation of Cultural Items: Berkshire Museum, Pittsfield, MA, 32314-32315 2018-14896 Grand Canyon National Park, Grand Canyon, AZ, 32320-32321 2018-14902 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 32330-32331 2018-14984 Occupational Safety Health Rev Occupational Safety and Health Review Commission NOTICES Privacy Act; Systems of Records, 32331-32333 2018-14878 Personnel Personnel Management Office RULES Federal Employees Health Benefits Program and Federal Employees Dental and Vision Insurance Program: Expiration of Coverage of Children of Same-Sex Domestic Partners; Federal Flexible Benefits Plan: Pre-Tax Payment of Health Benefits Premiums, 32191-32193 2018-14938 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 32333-32334 2018-14877 Small Business Small Business Administration NOTICES Disaster Declarations: Nebraska, 32334 2018-14932 Surface Mining Surface Mining Reclamation and Enforcement Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Abandoned Mine Land Problem Area Description Form, 32327-32328 2018-14894 General (Procedures and Requirements), 32326 2018-14890 Nomination and Request for Payment Form for OSMRE's National Technical Training Courses, 32328 2018-14895 Petition Process for Designation of Federal Lands as Unsuitable for All or Certain Types of Surface Coal Mining Operations and for Termination of Previous Designations, 32324-32325 2018-14891 Reclamation on Private Lands, 32326-32327 2018-14893 State Regulatory Authority: Inspection and Enforcement, 32325 2018-14892 Transportation Department Transportation Department See

Federal Aviation Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Internal Revenue Service

NOTICES Meetings: Financial Research Advisory Committee, 32337 2018-14949
Customs U.S. Customs and Border Protection NOTICES Commercial Gaugers and Laboratories; Accreditations and Approvals: Saybolt LP (Nederland, TX), 32313-32314 2018-14918 Veteran Affairs Veterans Affairs Department NOTICES Meetings: Creating Options for Veterans Expedited Recovery Commission, 32337-32338 2018-14936 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 32340-32522 2018-14443 Part III Treasury Department, Internal Revenue Service, 32524-32561 2018-14693 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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83 134 Thursday, July 12, 2018 Rules and Regulations OFFICE OF PERSONNEL MANAGEMENT 5 CFR Parts 890, 892, and 894 RIN 3206-AN34 Federal Employees Health Benefits Program and Federal Employees Dental and Vision Insurance Program: Expiration of Coverage of Children of Same-Sex Domestic Partners; Federal Flexible Benefits Plan: Pre-Tax Payment of Health Benefits Premiums: Conforming Amendments AGENCY:

U.S. Office of Personnel Management.

ACTION:

Final rule.

SUMMARY:

On October 30, 2013, OPM published final regulations in the Federal Register to expand coverage for children of same-sex domestic partners under the Federal Employees Health Benefits (FEHB) Program and the Federal Employees Dental and Vision Insurance Program (FEDVIP). The regulation allowed children of same-sex domestic partners living in states that did not allow same-sex couples to marry to be covered family members under the FEHB and the FEDVIP. Due to a subsequent Supreme Court decision legalizing same-sex marriage in all states, OPM published an interim final regulation on December 2, 2016, that created a regulatory exception that only allowed children of same-sex domestic partners living overseas to maintain their FEHB and FEDVIP coverage until September 30, 2018. OPM recognized that there were additional requirements placed on overseas federal employees that did not apply to other civilian employees with duty stations in the United States making it difficult to travel to the United States to marry their same-sex partners. Understanding that we have provided agencies with additional time for compliance given that overseas federal employees may not have been able to marry immediately following the Supreme Court decision, OPM is issuing a final rule removing references to domestic partners and domestic partnerships from the regulations. Based on the Supreme Court decision and the two additional year's lead time for domestic partners overseas to marry, the current language in the CFR is not needed and may be somewhat confusing. There is no change in coverage for children whose same-sex partners are married.

DATES:

This rule is effective on September 30, 2018.

FOR FURTHER INFORMATION CONTACT:

Michael W. Kaszynski, Senior Policy Analyst, at [email protected] or (202) 606-0004.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

The Federal Employees Health Benefits (FEHB) Program is administered by the Office of Personnel Management (OPM) in accordance with Title 5, Chapter 89 United States Code and our implementing regulations (title 5, parts 890, 892, 894 and title 48, chapter 16). The statute establishes the basic rules for benefits, enrollment, and participation in the Federal insurance programs.

Background

The Federal Employees Health Benefits (FEHB) Program provides health insurance to about 8.2 million Federal employees, retirees, and their dependents each year. It is the largest employer-sponsored health insurance program in the country providing more than $53 billion in health care benefits annually. Coverage options available to eligible individuals include self only, self plus one or self and family coverage in an approved health benefits plan. Eligible family members include the spouse of an employee or annuitant and a child under 26 years of age, including adopted children, stepchildren or foster children or a child regardless of age who is incapable of self-support because of mental or physical disability which existed before age 26.

Effective January 1, 2014, the Office of Personnel Management (OPM) published the “Federal Employees Health Benefits Program and Federal Employees Dental and Vision Insurance Program: Expanding Coverage of Children; Federal Flexible Benefits Plan: Pre-Tax Payment of Health Benefits Premiums: Conforming Amendments” final rule (78 FR 64873) to extend FEHB and FEDVIP coverage to children of same-sex domestic partners of Federal employees and annuitants who would marry their partners but live in states that did not allow same-sex couples to marry. As the result of the June 26, 2015, Supreme Court Obergefell v. Hodges decision, all U.S. states now allow same-sex couples to marry. Accordingly, as of January 2016, coverage of an enrollee's stepchild(ren) is only allowed if the couple is married. OPM also published an interim final regulation (81 FR 86905) on December 2, 2016. The rule amended §§ 890.302 and 894.101 of title 5, Code of Federal Regulations. The amendments allow an employing agency to request, and for OPM to grant, a continued coverage exception for children of an employee's same-sex domestic partner living outside the United States. Any coverage under such an exception will not extend beyond September 30, 2018. The OPM recognized there were additional requirements placed on overseas employees (as compared to civilian employees with duty stations in the United States) making it difficult to travel to the United States to marry same-sex partners. Therefore, OPM created the authority to allow an exception for children of Federal employees in a domestic partnership and living outside of the United States. If requested by an enrollee's agency, coverage of children of same-sex domestic partners can be continued under self and family or self plus one enrollment in the FEHB and FEDVIP Programs. This regulation removes this continued coverage exception which expires for overseas employees on September 30, 2018.

Comments Received on the Interim Rule

We received five comments on the Interim rule. All commenters were in support of the rule. No commenters recommended changes to the rule. Therefore, no changes have been made to this Final rule based on the comments received.

Expected Impact of Changes

This rule eliminates all regulatory language in FEHB, FEDVIP and FedFlex that authorizes coverage for children of same-sex domestic partners, effective September 30, 2018. This rule amends the regulations to remove the language that authorizes coverage of children of same-sex domestic partners since all enrollees now have the right to marry in the United States. The regulatory language that authorized coverage for children of same-sex domestic partners overseas is also being removed from the regulation effective September 30, 2018. There is no change to the population of children who have access to coverage based on this rule.

Executive Order 13563 and 12866 Requirements

Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a not significant regulatory action under Executive Order 12866.

Paperwork Reduction Act Requirements

Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. With this rule there is no change to an existing OMB approved collection of information subject to the PRA—OMB No. 3206-0160, Health Benefits Election Form. The system of record notice for this collection is OPM/Central 1 Civil Service Retirement and Insurance Records, available at https://www.opm.gov/information-management/privacy-policy/sorn/opm-sorn-central-1-civil-service-retirement-and-insurance-records.pdf.

Regulatory Flexibility Act

I certify that these regulations will not have a significant economic impact on a substantial number of small entities.

Executive Order 13771: Reducing Regulation and Controlling Regulatory Costs

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

List of Subjects 5 CFR Part 890

Administration and general provisions, Administrative practice and procedure, Administrative sanctions imposed against health care providers, Benefits for former spouses, Benefits for United States hostages in Iraq and Kuwait and United States hostages captured in Lebanon, Benefits in medically underserved areas, Contributions and withholdings, Department of Defense Federal Employees Health Benefits Program demonstration project, Employee benefit plans, Enrollment, Government employees, Health benefits plans, Limit on inpatient hospital charges, physician charges, and FEHB benefit payments, Reporting and recordkeeping requirements, Retirement, Temporary continuation of coverage, Temporary extension of coverage and conversion, Transfers from retired FEHB Program.

5 CFR Part 892

Administrative practice and procedure, Government employees' health insurance, Pre-tax payment of health benefits premiums, Taxes, Wages.

5 CFR Part 894

Administrative practice and procedure, Government employees, Health insurance, Taxes, Wages.

U.S. Office of Personnel Management. Jeff T.H. Pon, Director.

Accordingly, OPM is amending title 5, Code of Federal Regulations as follows:

PART 890—FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM 1. The authority citation for part 890 continues to read as follows: Authority:

5 U.S.C. 8913; Sec. 890.301 also issued under sec. 311 of Pub. L. 111-03, 123 Stat. 64; Sec. 890.111 also issued under section 1622(b) of Pub. L. 104-106, 110 Stat. 521; Sec. 890.112 also issued under section 1 of Pub. L. 110-279, 122 Stat. 2604; 5 U.S.C. 8913; Sec. 890.803 also issued under 50 U.S.C. 403p, 22 U.S.C. 4069c and 4069c-1; subpart L also issued under sec. 599C of Pub. L. 101-513, 104 Stat. 2064, as amended; Sec. 890.102 also issued under sections 11202(f), 11232(e), 11246 (b) and (c) of Pub. L. 105-33, 111 Stat. 251; and section 721 of Pub. L. 105-261, 112 Stat. 2061; Pub. L. 111-148, as amended by Pub. L. 111-152.

2. In § 890.302, revise paragraphs (a)(2)(iii) and (b)(2) and remove paragraphs (b)(3) through (7) to read as follows:
§ 890.302 Coverage of family members.

(a) * * *

(2) * * *

(iii) Children are entitled to receive benefits under only one enrollment regardless of whether the children qualify as family members under the enrollment of both parents or of a parent and a stepparent and regardless of whether the parents are married, unmarried, divorced, or legally separated. To ensure that no person receives benefits under more than one enrollment, each enrollee must promptly notify the insurance carrier as to which family members will be covered under his or her enrollment. These individuals are not covered under the other enrollment.

(b) * * *

(2) For purposes of this part, the term “stepchild” refers to the child of an enrollee's spouse and shall continue to refer to such child after the enrollee's divorce from the spouse or death of the spouse, so long as the child continues to live with the enrollee in a regular parent-child relationship.

PART 892—FEDERAL FLEXIBLE BENEFITS PLAN: PRE-TAX PAYMENT OF HEALTH BENEFITS PREMIUMS 3. The authority citation for part 892 continues to read as follows: Authority:

5 U.S.C. 8913; 5 U.S.C. 1103(a)(7); 26 U.S.C. 125.

4. In § 892.101, the definition of a “Qualifying life event” is amended by revising the introductory text to read as follows:
§ 892.101 Definitions.

Qualifying life (QLE) event means an event that may permit changes to your FEHB enrollment as well as changes to your premium conversion election as described in Treasury regulations at 26 CFR 1.125-4. Such events include the following:

5. Section 892.102 is revised to read as follows:
§  892.102 What is premium conversion and how does it work?

Premium conversion is a method of reducing your taxable income by the amount of your contribution to your FEHB insurance premium. If you are a participant in the premium conversion plan, Section 125 of the Internal Revenue Code allows you to reduce your salary (through an employer allotment) and provide that portion of your salary back to your employer. Instead of being paid to you as taxable income, this allotted amount is used to purchase your FEHB insurance for you. The effect is that your taxable income is reduced. Because taxable income is reduced, the amount of tax you pay is reduced. You save on Federal income tax, Social Security and Medicare tax and in most States and localities, State and local income taxes.

PART 894—FEDERAL EMPLOYEES DENTAL AND VISION INSURANCE PROGRAM 6. The authority citation for part 894 continues to read as follows: Authority:

5 U.S.C. 8962; 5 U.S.C. 8992; Subpart C also issued under section 1 of Pub. L. 110-279, 122 Stat. 2604.

7. In § 894.101, the definitions for “Domestic partner” and “Domestic partnership” are removed and the definition for “Stepchild” is revised to read as follows:
§ 894.101 Definitions.

Stepchild means your spouse's child born within or outside marriage or his or her adopted child. The child of your spouse shall continue to be considered your stepchild after your divorce from your spouse or the death of your spouse so long as the child continues to live with you in a regular parent-child relationship.

8. In § 894.403, paragraph (a) is revised to read as follows:
§ 894.403 Are FEDVIP premiums paid on a pre-tax basis?

(a) Your FEDVIP premiums are paid on a pre-tax basis (called premium conversion) if you are an active employee, your salary is sufficient to make the premium allotments, and your agency will be able to make pre-tax allotments.

[FR Doc. 2018-14938 Filed 7-11-18; 8:45 am] BILLING CODE 6325-63-P
DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 929 [Doc. No. AMS-SC-17-0066; SC17-929-3 FR] Cranberries Grown in States of Massachusetts, et al.; Establishment of Handler Diversion and Reporting Requirements and New Information Collection AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule.

SUMMARY:

This rule implements a recommendation to establish handler diversion and reporting requirements under the marketing order for cranberries grown in the production area (Order). This action establishes the procedures handlers use to divert fruit through disposal or into noncompetitive outlets. The reporting requirements support the diversion procedures by providing the necessary documentation to help ensure compliance when a volume regulation is established.

DATES:

Effective August 13, 2018.

FOR FURTHER INFORMATION CONTACT:

Doris Jamieson, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email: [email protected] or [email protected]

Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

SUPPLEMENTARY INFORMATION:

This final rule, pursuant to 5 U.S.C. 553, amends regulations used to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under Marketing Agreement and Order No. 929, as amended (7 CFR part 929), regulating the handling of cranberries grown in the states of Massachusetts, Rhode Island, Connecticut, New Jersey, Wisconsin, Michigan, Minnesota, Oregon, Washington, and Long Island in the State of New York. Part 929 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of growers of cranberries operating within the production area, and a public member.

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

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This final rule is not intended to have retroactive effect.

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

This final rule establishes handler diversion and reporting requirements under the Order. This rule establishes procedures handlers use to divert fruit through disposal or into noncompetitive outlets. The reporting requirements support the diversion procedures by providing the necessary documentation to help ensure compliance when a volume regulation is established. This action was recommended by the Committee at its August 31, 2017, September 15, 2017, and October 13, 2017, meetings.

The Order provides for the use of volume regulation to stabilize prices and improve grower returns during periods of oversupply. Section 929.51(a)(2) specifies that a handler withholding program must be recommended by the Committee no later than August 31 and that such recommendation shall include the free and restricted percentages for the crop year. On August 31, 2017, the Committee met and recommended free and restricted percentages of 85 percent free and 15 percent restricted. Handler diversion is one method that handlers can utilize to meet restricted percentage requirements.

Section 929.54 provides, in part, that whenever the Secretary of Agriculture (Secretary) has fixed the free and restricted percentages for any fiscal period, each handler shall withhold from handling a portion of the cranberries acquired during such period. This section also provides the authority for the Committee to establish, with the approval of the Secretary, rules and regulations necessary to administer this section. Section 929.56 provides special provisions relating to withheld (restricted) cranberries, and § 929.57 provides authority for the Committee to establish, with the approval of the Secretary, outlets for withheld cranberries which are noncompetitive with outlets for unrestricted (free percentage) cranberries.

Section 929.62 provides, in part, authority to require handlers to submit reports of cranberries acquired, held in inventory, quantity handled, total cranberries withheld from handling, the portion of such withheld cranberries on hand, and the quantity and manner of disposition of any such withheld cranberries diverted. Section 929.62(f) further provides authority for the Committee, with the approval of the Secretary, to collect other reports and information from handlers needed to perform its duties.

This final rule uses these authorities to establish new §§ 929.157 and 929.162. Section 929.157 establishes the procedures to be used for handler diversion when free and restricted percentages are instituted. Section 929.162 requires handlers of cranberries, during years when free and restricted percentages are applied, to report to the Committee diversion plans and year-end reports, information on cranberries diverted and cranberries shipped to noncompetitive outlets, and other information to verify compliance with the program, using six specific Committee forms.

The Committee recommended establishing free and restricted percentages under a handler withholding volume regulation for the 2017-18 season in response to historically high inventory levels for cranberries. As this is the first time the Committee has used this volume regulation provision under the Order, it recognized the need to establish procedures outlining the diversion requirements for restricted fruit.

Free percentage cranberries can be used to supply any available market, including juice, sweetened dried cranberries, sauce, and frozen cranberries. Restricted percentage cranberries can be diverted through disposal or utilized in markets that are noncompetitive with free cranberries. Possible outlets for restricted cranberries include, in part, for fresh export, except to Canada; charity; research and development projects; and any nonhuman food use. Handlers also have the option to divert processed products in lieu of fresh fruit to meet up to 50 percent of their restricted obligation.

At the 2017 meetings in August, September, and October, the Committee discussed the handler diversion procedures and the associated reporting requirements necessary to help ensure compliance with a free and restricted percentage volume regulation. As a result, the Committee developed and approved six specific forms and related procedures to be used during seasons when free and restricted percentages are established for volume regulation.

Committee members discussed the need for Committee staff to know how handlers plan to meet their restricted percentage obligation and if, at the end of the season, they met their diversion requirement. As a result, the Committee developed two specific forms to be added to the reporting requirements under the Order.

With the first form, the Handler Withholding Report (CMC-JUN), handlers provide information on how they plan to meet their restricted percentage obligation. The form will be submitted to the Committee by June 1 during years with established free and restricted percentages and requires the following information: The name and address of the handler, the amount of cranberries to be acquired, the amount of cranberries to be diverted by disposal, the amount of cranberries to be diverted to noncompetitive outlets, and the types of cranberry products to be withheld. The Committee will use this information to estimate the amount of fruit that will be taken off the market, the proposed disposition of the fruit, and as a starting point for tracking handler compliance.

The second form, the Final Handler Withholding Report (CMC-AUG), will be submitted by the end of the crop year. The report requires the same information as the Handler Withholding Report but provides the Committee with the actual year-end seasonal totals. This form is due by August 31. The final report will be used to verify that handlers met their restricted percentage obligation.

Handlers have several diversion options available to meet their restricted percentage obligation. One method of diversion available to handlers is the disposal of fresh cranberries or cranberry products. In its discussions, Committee members expressed concern regarding verifying the accuracy of the amount of fruit or processed product diverted using this method. The Committee recommended that all disposals take place under the supervision of a non-industry-related third party who will review the handler's disposal documentation, witness the disposal whenever possible, and certify as to the completion of the disposal process. The Committee initially agreed to hire two inspectors to supervise and verify handler compliance. However, due to the size of the production area, the Committee hired four inspectors, one from each of the primary growing regions, who will perform these tasks. The inspection and verification costs will be paid by the handler.

To facilitate this process, the Committee recommended establishing another form. This form, the Handler Disposal Certification (CMC-DISP), will be the primary form used to initiate, track, and certify this method of diversion during years in which a free and restricted percentage volume regulation has been established. The form will be used to notify the Committee of the handler's intent to dispose of cranberries or cranberry products. Information required on the form include the handler's name and address; the amount of fruit to be diverted; the type of cranberry product to be diverted; the amount of processed fruit diverted, if any; and the lot identification information.

Upon receipt of the form, the Committee office will notify the inspector in the handler's growing region. The inspector will contact the handler to schedule a date for the disposal to take place, usually within a week of receipt of the notification. The inspector will meet with the handler on that date to verify the documentation provided and, when possible, witness the disposal.

The Committee recognized that, due to scheduling conflicts, the inspector may not be available to visually witness each disposal of restricted cranberries. Therefore, the Committee agreed that, should the inspector not be available to witness the diversion within seven days, the handler may proceed with the disposal. The inspector will then verify and complete the certification upon the inspector's next visit to the handler's facility. If the cranberries or cranberry product were disposed of at a landfill, through composting, incineration, at a wastewater treatment facility, or any other site, the inspector may request receipts, visual proof, or any other additional information needed to support the disposal as reported on the form. Once the verification process is completed, the inspector will sign the certification section of the form, and return it to the Committee.

Another method of diversion available is to divert cranberries or cranberry products to noncompetitive outlets. Section 929.57 specifies that cranberries withheld from handling may be disposed of only through diversion to such outlets as the Committee, with the approval of the Secretary, finds are noncompetitive to outlets for unrestricted (free percentage) cranberries. The Committee discussed various outlets and recommended the following: Foreign countries, except Canada; charitable institutions; any nonhuman food use; and research and development projects approved by the Committee dealing with the development of foreign and domestic markets, including but not limited to dehydration, radiation, freeze drying, or freezing of cranberries. The Committee further recommended that cranberries may not be converted into canned, frozen, or dehydrated cranberries or other cranberry products by any commercial process when being diverted to foreign countries. The specific outlets are being considered under a separate rulemaking action.

The Agricultural Marketing Service (AMS) submitted and received OMB's approval on the five initial forms. Handlers complete the forms and submit them to the Committee for purposes of tracking compliance with the handler withholding requirement. OMB approved the forms on October 16, 2017, and assigned them OMB No. 0581-0304. Upon full completion of the forms-approval process, AMS will seek to merge the five forms into the OMB-approved 0581-0189 Fruit Crops containing other forms related to the Federal marketing order for cranberries.

Two specific reporting requirements relating to the diversion of fruit to noncompetitive outlets are added to part 929: A Handler Application for Outlets for Withheld Fruit (CMC-OUT) and a Third-Party Confirmation of Receipt of Withheld Fruit (CMC-CONF). Should a handler elect to divert cranberries or cranberry products to noncompetitive outlets, the handler must first request Committee approval of the outlet or research project using the Handler Application for Outlets for Withheld Fruit prior to each disposal activity of this type. Information requested on the form includes, among other things, the handler's name and address, information identifying the noncompetitive outlet, the amount and type of cranberry products to be diverted, and how the cranberries will be utilized. The Committee will review the information and approve or disapprove the diversion request.

If the request is approved and the product is delivered, the receiving outlet needs to acknowledge receipt of the product by completing the Third-Party Confirmation of Receipt of Withheld Fruit form, and the handler then returns the completed form to the Committee.

The two above-described reporting requirements help track the disposition of withheld cranberries in noncompetitive outlets and facilitates the compliance process under the recommended handler withholding.

The last form approved by the Committee provides handlers a method for appealing any decision made by the Committee relating to the diversion process. Should a handler disagree with a Committee decision, such as denying the request for approval of a noncompetitive outlet, or a determination that diversion could not be verified, the handler can appeal the decision by submitting a Handler Withholding Appeal form (CMC-APPL). The handler making the appeal is required to submit the form within 30 days of receiving the determination from the Committee. This form includes information about why the handler is making the appeal and provides additional information to support the appeal. The appeal request is reviewed by an Appeals Subcommittee (Subcommittee) for re-consideration. The Subcommittee consists of two independent growers, two members from the major cooperative, and one public member. The handler will be notified of the Subcommittee's determination within 30 days. If the appeal is denied by the Subcommittee, the handler has the option of appealing the decision to the Secretary within 15 days after the notification of the Subcommittee's findings.

In order to enable the Committee to inform the industry of the information needed for handlers to manage their inventories in a way that complies with the industry-supported handler withholding program, the five initial forms were previously submitted to OMB for approval. These five forms (CMC-JUN, CMC-DISP, CMC-OUT, CMC-CONF and CMC-APPL) were approved by OMB on October 16, 2017, for use for a six-month period, beginning the date of approval. This final rule is necessary for the industry to use the forms beyond the six-month period.

Establishing these handler diversion and reporting requirements facilitates the implementation of, and ensures compliance with, free and restricted percentages when recommended by the Committee.

Final Regulatory Flexibility Analysis

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

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

There are approximately 1,100 cranberry growers in the regulated area and approximately 65 cranberry handlers subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

According to industry and Committee data, the average grower price for cranberries during the 2016-17 crop year was $23.50 per barrel, and total sales were around 9.5 million barrels. The value for cranberries that crop year totaled $223,250,000 ($23.50 per barrel multiplied by 9.5 million barrels). Taking the total value of production for cranberries and dividing it by the total number of cranberry growers (1,100) provides an average return per grower of $202,955. Based on USDA's Market News reports, the average free on board (f.o.b.) price for cranberries was around $30.00 per barrel. Multiplying the f.o.b. price by total utilization of 9.5 million barrels results in an estimated handler-level cranberry value of $285 million. Dividing this figure by the number of handlers (65) yields an estimated average annual handler receipt of $4.3 million, which is below the SBA threshold for small agricultural service firms. Therefore, the majority of growers and handlers of cranberries may be classified as small entities.

This final rule establishes handler diversion and reporting requirements under the Order. This final rule establishes procedures handlers will use to divert fruit through disposal or into noncompetitive outlets. The reporting requirements support the diversion procedures by providing the necessary documentation to help ensure compliance when a volume regulation is established. This rule establishes new §§ 929.157 and 929.162. The authority for this action is provided in §§ 929.54, 929.56, 929.57, and 929.62.

These actions could result in some additional costs to the industry. Specifically, handlers could incur some additional costs as a result of inspector verification and certification of the diversion process. In addition, requiring reports of cranberries acquired, handled, and withheld imposes an increase in the reporting burden on all cranberry handlers. However, the benefits are expected to outweigh the costs and increase in reporting burden. The provisions considered in this action will help facilitate the implementation of any recommended handler withholding volume regulation and help ensure compliance with the recommended regulation. Consequently, these changes will help provide important guidance during times when market conditions support the need for establishing volume regulation.

The impact of this rule will be beneficial to growers and handlers. Establishing diversion procedures benefits the entire industry by ensuring handler diversion is conducted consistently and accurately by all handlers, which also helps ensure compliance with the handler withholding program. Authorizing various diversion outlets means handlers are not required to divert cranberries only through destruction. Instead, fruit can be utilized in noncompetitive outlets, such as for charitable purposes. The benefits of this rule are expected to be equally available to all cranberry growers and handlers, regardless of their size, and are greater than any associated costs.

The Committee discussed other alternatives to this action, including using different methods of ensuring accurate diversion of restricted fruit. One method considered was allowing handlers to self-report their diversion of restricted fruit without a formal verification process. However, the Committee deemed this insufficient verification to ensure compliance with the program. Members were concerned that fruit could be re-routed to a different handling facility for processing, and without established verification procedures, the industry would not have confidence that restricted fruit was being properly diverted. The Committee also considered the value and importance of each of the forms and whether all were required. However, the Committee agreed each of the recommended forms provide important information for the industry and for administering the Order. Therefore, these alternatives were rejected.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this collection has been submitted to OMB for approval. The five currently approved forms in 0581-0304 and one additional form will be merged with forms currently approved under OMB No. 0581-0189, Fruit Crops. This final rule establishes the use of six new reporting requirements and six new Committee forms, which impose a total annual burden increase of 38.4 hours. The forms, “Handler Withholding Report,” “Handler Disposal Certification,” “Handler Application for Outlets for Withheld Fruit,” “Third-Party Confirmation of Receipt of Withheld Fruit,” “Handler Withholding Appeal,” and “Final Handler Withholding Report,” require the minimum information necessary to effectively carry out the requirements of the Order. The information will enable the Committee to ensure compliance when a volume regulation is established.

As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule. Further, the public comment received concerning the proposal did not address the initial regulatory flexibility analysis.

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

Further, the Committee's meetings were widely publicized throughout the cranberry industry, and all interested persons were invited to attend the meetings and participate in Committee deliberations on all issues. Additionally, the Committee's meetings held August 31, September 15, and October 13, 2017, were public meetings, and all entities, both large and small, were able to express views on this issue.

A proposed rule concerning this action was published in the Federal Register on February 15, 2018 (83 FR 6800). Copies of the proposed rule were sent via email to Committee members and cranberry handlers. Finally, the proposed rule was made available through the internet by USDA and the Office of the Federal Register. A 60-day comment period ending April 16, 2018, was provided to allow interested persons to respond to the proposal.

Two comments were received which did not address the merits of the proposed rule. Accordingly, no changes will be made to the rule as proposed based on the comments received.

The proposed rule contained administrative revisions to the Order's subpart headings to bring the language into conformance with the Office of Federal Register requirements. These revisions are not included in this rule as they were included in a final rule published in the Federal Register on April 4, 2018 (83 FR 14350).

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

After consideration of all relevant matter presented, including the information and recommendation of the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

List of Subjects in 7 CFR Part 929

Cranberries, Marketing agreements, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, 7 CFR part 929 is amended as follows:

PART 929—CRANBERRIES GROWN IN STATES OF MASSACHUSETTS, RHODE ISLAND, CONNECTICUT, NEW JERSEY, WISCONSIN, MICHIGAN, MINNESOTA, OREGON, WASHINGTON, AND LONG ISLAND IN THE STATE OF NEW YORK 1. The authority citation for part 929 continues to read as follows: Authority:

7 U.S.C. 601-674.

2. Add § 929.157 to read as follows:
§ 929.157 Handler diversion.

(a) Methods of diversion. Handlers may divert cranberries by disposing of cranberries or cranberry products. Diversion by disposal may take place prior to placing the cranberries into the processing line or after processing. Handlers may also divert cranberries or cranberry products to approved, noncompetitive outlets for withheld fruit. Whole berries or processed products diverted must come from the current crop year. Any information collected of a confidential and/or proprietary nature would be held in confidence pursuant to § 929.65.

(1) Diversion through disposal. This type of diversion is to be carried out under the supervision of the Committee, and the cost of such supervision is to be paid by the handler. Handlers shall notify the Committee of their intent to dispose of cranberries or cranberry products using Form CMC-DISP as specified in § 929.162(c). Following notification, a Committee inspector will meet with the handler to verify the documentation provided and, when possible, witness the destruction. The Committee inspector may request receipts, visual proof, or any other information needed to support the disposal as reported. Once the verification process has been completed, the Committee inspector will sign the certification section of Form CMC-DISP and return it to the Committee.

(2) Diversion through noncompetitive outlets. To divert cranberries or cranberry products to a noncompetitive outlet, handlers must apply to the Committee using Form CMC-OUT as specified in § 929.162(d) prior to each disposal activity of this type. The Committee will review the information and approve or disapprove the diversion request. Once the cranberries or cranberry products are delivered to the approved noncompetitive outlets, the Committee must receive satisfactory documentation of the transaction using Form CMC-CONF as specified in § 929.162(e).

(b) Committee notification and handler plan. Any handler intending to divert cranberries or cranberry products pursuant to § 929.54 must notify the Committee of such intent and provide a plan by June 1 that shows how the handler intends to meet the restricted percentage obligation. The handler shall submit this plan using Form CMC-JUNE as specified in the reporting requirements under § 929.162(a). The handler will have until August 31 to fulfill the plan, by which time the handler shall submit a final report detailing how the restricted percentage obligation was met using Form CMC-AUG as specified in § 929.162(b).

(c) Request for review. (1) If a handler is dissatisfied with a determination made by the Committee which affects such handler, the handler may submit to the Committee within 30 days after receipt of the Committee's determination, a request for a review by an appeals subcommittee composed of two independent growers and two cooperative representatives, as well as a public member. The appeals subcommittee shall be appointed by the Committee chairperson. The handler may forward with the request any pertinent materials for consideration of the appeal.

(2) The subcommittee shall review the information submitted by the handler and render a decision within 30 days of receipt of such appeal. The subcommittee shall notify the handler of its decision, accompanied by the reasons for its conclusions and findings.

(3) The handler may further appeal to the Secretary, within 15 days after notification of the subcommittee's findings, if such handler is not satisfied with the appeals subcommittee's decision. The Committee shall forward a file to the Secretary with all pertinent information related to the handler's appeal. The Secretary shall inform the handler and all interested parties of the Secretary's decision. All decisions by the Secretary are final.

3. Add § 929.162 to read as follows:
§ 929.162 Handler diversion reports.

(a) Handler withholding report. Handlers shall submit to the Committee, by June 1, a handler withholding report. The report shall be submitted using Form CMC-JUN and contain the following information:

(1) The name and address of the handler;

(2) The amount of cranberries acquired;

(3) The amount of cranberries withheld by disposal;

(4) The amount of cranberries diverted to noncompetitive outlets;

(5) The form of cranberry products withheld; and

(6) The total withholding obligation.

(b) Handler Withholding Final Report. Handlers shall submit to the Committee, by August 31, a final handler withholding report. The final report shall be submitted using Form CMC-AUG and contain the following information:

(1) The name and address of the handler;

(2) The seasonal total of cranberries acquired;

(3) The seasonal total of cranberries withheld by disposal;

(4) The seasonal total of cranberries diverted to noncompetitive outlets;

(5) The form of cranberry products withheld during the season; and

(6) The total withholding obligation.

(c) Handler disposal certification. Handlers shall submit to the Committee Form CMC-DISP for each lot of cranberries or cranberry products to be diverted through disposal. The form shall contain the following information:

(1) Name and address of the handler;

(2) Marketable cranberries in whole fruit or processed cranberries converted to whole fruit equivalent disposed of in this lot;

(3) Form of cranberries;

(4) Volume if in processed form;

(5) Lot details;

(6) Disposal site and method; and

(7) Inspector certification of the completion of the disposal.

(d) Handler application for outlets for withheld fruit. Handlers shall submit to the Committee Form CMC-OUT for approval for each lot of cranberries or cranberry products to be diverted to noncompetitive outlets in accordance with § 929.57. The form shall contain the following information:

(1) Name and address of the handler;

(2) Project type;

(3) Product form;

(4) Quantity of cranberries in whole fruit or processed cranberries converted to whole fruit equivalent diverted;

(5) A description of the project and how the cranberries will be used.

(e) Third-party confirmation of receipt of withheld fruit. Handlers shall submit to the Committee Form CMC-CONF for each diversion to a noncompetitive outlet to verify the receipt of the cranberries or cranberry product by the approved outlet. The form shall contain the following information:

(1) Name and address of the handler;

(2) Project type;

(3) Product form;

(4) Quantity of cranberries in whole fruit or processed cranberries converted to whole fruit equivalent utilized; and

(5) Confirmation or documentation of receipt from the receiving outlet.

(f) Handler withholding appeal. Handlers may appeal a determination made by the Committee relating to a handler withholding regulation using the appeals process outlined in § 929.157(c) and Form CMC-APPL, which shall contain the following information:

(1) Name and address of the handler;

(2) Reason for appeal; and

(3) Information in support of appeal.

Dated: July 9, 2018. Bruce Summers, Administrator, Agricultural Marketing Service.
[FR Doc. 2018-14939 Filed 7-11-18; 8:45 am] BILLING CODE 3410-02-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0588; Product Identifier 2017-NM-105-AD; Amendment 39-19328; AD 2018-14-08] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; request for comments.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 777-200LR series airplanes. This AD requires revising certain documents to provide revised operating limitations. For certain airplanes, modification of the water and fuel scavenge systems in the fuel tanks, electrical changes in the main equipment center, and installation of new electrical load management system (ELMS2) software is an acceptable alternative to the documents revision. This AD was prompted by reports of unreliable performance of the water and fuel scavenge systems. We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD is effective July 27, 2018.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of July 27, 2018.

We must receive comments on this AD by August 27, 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 final rule, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet https://www.myboeingfleet.com. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0588.

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-2018-0588; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT:

Kevin Nguyen, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3555; email: [email protected]

SUPPLEMENTARY INFORMATION:

Discussion

Operators have reported unreliable performance of the water and fuel scavenge systems. During flight, any water in the fuel can sink to the bottom of the fuel tank. This water can enter the fuel scavenge inlets and can then freeze as it travels from the body center fuel tank into the colder fuel scavenge tubes in the left and right cheek center fuel tanks (outboard of the side of body ribs). The frozen water can restrict the flow of scavenge fuel from the center fuel tank to the main fuel tanks, causing the fuel flow to decrease or stop. When this occurs, as much as 700 pounds of fuel can remain unavailable during flight. If the flightcrew is not aware that this fuel is unavailable and the fuel quantity decreases to the quantity of the unavailable fuel, then fuel exhaustion will occur, which could lead to subsequent power loss of all engines due to loss of capability to scavenge fuel in the center fuel tank.

Related Rulemaking

We issued AD 2016-11-03, Amendment 39-18530 (81 FR 34867, June 1, 2016) (“AD 2016-11-03”), that applied to certain Boeing Model 777-200LR series airplanes equipped with or without auxiliary fuel tanks. For airplanes with auxiliary fuel tanks, variable numbers WD049-WD053 inclusive only, AD 2016-11-03 requires modification of the water and fuel scavenge systems after removal of the auxiliary fuel tanks. This AD requires incorporation of revised operating limitations for those airplanes, which terminates the associated requirements of AD 2016-11-03. This AD also provides the option of modifying the water and fuel scavenge systems in the fuel tanks, making electrical changes in the main equipment center, and installing new ELMS2 software after removal of the auxiliary fuel tanks. Either compliance method terminates the requirements of paragraphs (g), (h), and (i) of AD 2016-11-03 for those airplanes.

Additionally, paragraph (g) of this AD requires a revision to certain documents to provide revised operating limitations for airplane variable numbers WD011 through WD015 inclusive and WD016 through WD018 inclusive. These airplanes are not affected by AD 2016-11-03, which refers to Boeing Special Attention Service Bulletin 777-28-0078, Revision 1, dated April 27, 2015, for the applicability.

Airplane variable numbers WD011 through WD015 inclusive are included in the effectivity of Boeing Special Attention Service Bulletin 777-28-0078, Revision 3, dated December 19, 2017; therefore, this AD provides a modification of the water and fuel scavenge systems in the fuel tanks, electrical changes in the main equipment center, and installation of new ELMS2 software as an acceptable alternative to the documents revision. However, there is no approved service information for airplane variable numbers WD016 through WD018 inclusive for the modification of the water and fuel scavenge systems in the fuel tanks, electrical changes in the main equipment center, and installation of new ELMS2 software; therefore, there is no alternative to the documents revision specified in this AD for these airplanes.

Related Service Information Under 1 CFR Part 51

We reviewed Boeing Special Attention Service Bulletin 777-28-0078, Revision 3, dated December 19, 2017. The service information describes procedures for the removal of the auxiliary fuel tanks and modification of the water and fuel scavenge systems in the fuel tanks, electrical changes in the main equipment center, and installation of new ELMS2 software. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

FAA's Determination

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

AD Requirements

This AD requires revising certain documents to provide revised operating limitations. For certain airplanes, this AD provides for the optional accomplishment of the actions specified in the service information described previously, as an acceptable alternative to the documents revision.

FAA's Justification and Determination of the Effective Date

There are currently no domestic operators of this product. Therefore, we find that notice and opportunity for prior public comment are unnecessary and that good cause exists for making this amendment effective in less than 30 days.

Comments Invited

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2018-0588 and Product Identifier 2017-NM-105-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. We will consider all comments received by the closing date and may amend this final rule because of those comments.

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

Costs of Compliance

Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, we provide the following cost estimates to comply with this AD:

Estimated Costs for Required Actions Action Labor cost Parts cost Cost per
  • product
  • Revise operating limitations 1 work-hour × $85 per hour = $85 $0 $85
    Estimated Costs for Optional Actions Action Labor cost Parts cost Cost per
  • product
  • Modification Up to 253 work-hours × $85 per hour = up to $21,505 $66,960 Up to $88,465.
    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2018-14-08 The Boeing Company: Amendment 39-19328; Docket No. FAA-2018-0588; Product Identifier 2017-NM-105-AD. (a) Effective Date

    This AD is effective July 27, 2018.

    (b) Affected ADs

    This new AD affects AD 2016-11-03, Amendment 39-18530 (81 FR 34867, June 1, 2016) (“AD 2016-11-03”).

    (c) Applicability

    This AD applies to The Boeing Company Model 777-200LR series airplanes, certificated in any category, variable numbers (V/Ns) WD011 through WD015 inclusive, WD016 through WD018 inclusive, and WD049 through WD053 inclusive.

    (d) Subject

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

    (e) Unsafe Condition

    This AD was prompted by reports of unreliable performance of the water and fuel scavenge systems. We are issuing this AD to prevent fuel exhaustion and subsequent power loss of all engines due to loss of access to fuel in the center fuel tank.

    (f) Compliance

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

    (g) Revision to Operating Limitations

    Except as provided by paragraph (h) of this AD: Within 36 months after the effective date of this AD, revise the applicable section of the documents specified in paragraphs (g)(1) and (g)(2) of this AD to include the information specified in figure 1 to the introductory text of paragraph (g) of this AD.

    ER12JY18.019

    (1) Insert the information specified in figure 1 to the introductory text of paragraph (g) of this AD into the “Fuel-System—Loading” section of the “Certificate Limitations” section of the FAA-approved Boeing Model 777 Airplane Flight Manual.

    (2) Insert the information specified in figure 1 to the introductory text of paragraph (g) of this AD into the “Loading Limitations” section of the “Fuel Loading Procedures” section of the “Fuel Management” section of the FAA-approved Boeing Model 777 Weight and Balance Control and Loading Manual.

    (h) Optional Terminating Action for V/Ns WD049-WD053 Inclusive and WD011-WD015 Inclusive

    For airplane V/Ns WD049 through WD053 inclusive, and WD011 through WD015 inclusive: Accomplishment of the actions specified in paragraphs (h)(1) and (h)(2) of this AD terminates the requirements of paragraph (g) of this AD.

    (1) Remove the auxiliary fuel tanks in accordance with step 1. of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 777-28-0078, Revision 3, dated December 19, 2017.

    (2) Modify the water and fuel scavenge systems in the fuel tanks, make electrical changes in the main equipment center, and install new electrical load management system (ELMS2) software, by doing all applicable actions identified as “RC” (required for compliance) in, and in accordance with, the Accomplishment Instructions of Boeing Special Attention Service Bulletin 777-28-0078, Revision 3, dated December 19, 2017.

    (i) Credit for Previous Actions

    (1) This paragraph provides credit for the actions specified in paragraphs (h)(1) and (h)(2) of this AD, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 777-28-0078, Revision 2, dated October 5, 2016.

    (2) This paragraph provides credit for airplane V/Ns WD049 through WD053 inclusive for the actions specified in paragraphs (h)(1) and (h)(2) of this AD, if those actions were performed before the effective date of this AD using April 27, 2015; or Boeing Special Attention Service Bulletin 777-28-0078, Revision 1, dated April 27, 2015.

    (j) Parts Installation Prohibition

    After completion of the actions specified in paragraph (h) of this AD, no person may install an auxiliary fuel tank on that airplane.

    (k) Terminating Action for AD 2016-11-03 for V/Ns WD049-WD053 Inclusive

    Accomplishment of the actions required by paragraph (g) or (h) of this AD terminates the requirements of paragraphs (g), (h), and (i) of AD 2016-11-03 for that airplane, V/Ns WD049 through WD053 inclusive only.

    (l) Alternative Methods of Compliance (AMOCs)

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

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

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

    (4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (l)(4)(i) and (l)(4)(ii) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

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

    (m) Related Information

    For more information about this AD, contact Kevin Nguyen, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3555; email: [email protected]

    (n) Material Incorporated by Reference

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

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

    (i) Boeing Special Attention Service Bulletin 777-28-0078, Revision 3, dated December 19, 2017.

    (ii) Reserved.

    (3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet https://www.myboeingfleet.com.

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

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

    Issued in Des Moines, Washington, on June 29, 2018. Jeffrey E. Duven, Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-14702 Filed 7-11-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-0757; Product Identifier 2017-SW-022-AD; Amendment 39-19327; AD 2018-14-07] RIN 2120-AA64 Airworthiness Directives; Bell Helicopter Textron Canada Limited Helicopters AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain serial numbered Bell Helicopter Textron Canada Limited (BHTC) Model 429 helicopters. This AD requires marking a serial number on life-limited forward spars and actuator fitting assemblies. The actions of this AD are intended to prevent an unsafe condition on these products.

    DATES:

    This AD is effective August 16, 2018.

    The Director of the Federal Register approved the incorporation by reference of a certain document listed in this AD as of August 16, 2018.

    ADDRESSES:

    For service information identified in this final rule, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; or at http://www.bellcustomer.com/files/. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0757.

    Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0757; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the Transport Canada Civil Aviation (Transport Canada) AD, any incorporated-by-reference service information, the economic evaluation, any comments received, and other information. The street address for Docket Operations (phone: 800-647-5527) is U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Helene Gandy, Aviation Safety Engineer, Regulations & Policy Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5413; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Discussion

    On January 26, 2018, at 83 FR 3628, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 by adding an AD that would apply to Bell Model 429 helicopters, serial number (S/N) 57150, 57168, 57176, 57210 through 57216, 57265, 57266, 57267, and 57287, with a forward spar part number (P/N) 429-031-213-103 or 429-031-213-104 or actuator fitting assembly P/N 429-031-222-101 or 429-031-222-102 installed.

    The NPRM proposed to require marking a serial number on life-limited forward spars and actuator fitting assemblies. The proposed requirements were intended to prevent the forward spar or actuator fitting assembly from remaining in service after reaching its life limit. This condition could result in failure of a forward spar or actuator fitting assembly and subsequent collapse of the landing gear.

    The NPRM was prompted by AD No. CF-2017-02, dated January 16, 2017, issued by Transport Canada, which is the aviation authority for Canada, to correct an unsafe condition for Bell Model 429 helicopters, S/N 57150, 57168, 57176, 57210, 57211 through 57216, 57265, 57266, 57267, and 57287. Transport Canada advises that forward spars P/N 429-031-213-103 and 429-031-213-104 and actuator fitting assembly P/N 429-031-222-101 and 429-031-222-102 have life limits of 30,000 and 19,000 Retirement Index Numbers, respectively. However, Transport Canada states these parts are not serialized, and therefore their accumulated usage is difficult to track, which creates a risk that these parts could remain in service beyond their life limits. This condition could result in failure of the part.

    Comments

    We gave the public the opportunity to participate in developing this AD, but we received no comments on the NPRM.

    FAA's Determination

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

    Differences Between This AD and the Transport Canada AD

    The Transport Canada AD requires compliance within 12 months from its effective date, unless already accomplished. This AD requires compliance within 800 hours time-in-service.

    Related Service Information Under 1 CFR Part 51

    We reviewed Bell Helicopter Alert Service Bulletin 429-16-34, dated November 10, 2016, which specifies procedures for permanently marking each forward spar and actuator fitting assembly with the serial number of the helicopter.

    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.

    Other Related Service Information

    We also reviewed Bell Helicopter Model 429 Maintenance Manual BHT-429-MM-1, Chapter 4, Airworthiness Limitations Schedule, Revision 26, dated September 9, 2016, which specifies airworthiness life limits and inspection intervals for parts installed on Model 429 helicopters.

    Costs of Compliance

    We estimate that this AD affects 6 helicopters of U.S. Registry and that labor costs average $85 per work-hour. We estimate that marking the forward spars and actuator fitting assemblies requires 1 work-hour, and no parts are needed. Based on these estimates, we expect a total cost of $85 per helicopter and $510 for the U.S. fleet.

    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 helicopters identified in this rulemaking action.

    Regulatory Findings

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

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2018-14-07 Bell Helicopter Textron Canada Limited: Amendment 39-19327; Docket No. FAA-2017-0757; Product Identifier 2017-SW-022-AD. (a) Applicability

    This AD applies to Bell Helicopter Textron Canada Limited Model 429 helicopters, serial number (S/N) 57150, 57168, 57176, 57210 through 57216, 57265, 57266, 57267, and 57287, with a forward spar part number (P/N) 429-031-213-103 or 429-031-213-104 or actuator fitting assembly P/N 429-031-222-101 or 429-031-222-102 installed, certificated in any category.

    (b) Unsafe Condition

    This AD defines the unsafe condition as a forward spar or actuator fitting assembly remaining in service after reaching its life limit. This condition could result in failure of a forward spar or actuator fitting assembly and subsequent collapse of the landing gear.

    (c) Effective Date

    This AD becomes effective August 16, 2018.

    (d) Compliance

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

    (e) Required Actions

    (1) Within 800 hours time-in-service, clean and identify each forward spar and actuator fitting assembly with the helicopter serial number in accordance with the Accomplishment Instructions, paragraphs 3 through 5 and with reference to Figure 1 of Bell Helicopter Alert Service Bulletin 429-16-34, dated November 10, 2016.

    (2) After the effective date of this AD, do not install a forward spar P/N 429-031-213-103 or 429-031-213-104 or actuator fitting assembly P/N 429-031-222-101 or 429-031-222-102 on any helicopter unless it has been marked with a serial number in accordance with paragraph (e)(1) of this AD.

    (f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, FAA, may approve AMOCs for this AD. Send your proposal to: Helene Gandy, Aviation Safety Engineer, Regulations & Policy Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5413; email [email protected]

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

    (g) Additional Information

    (1) Bell Helicopter Model 429 Maintenance Manual BHT-429-MM-1, Chapter 4, Airworthiness Limitations Schedule, Revision 26, dated September 9, 2016, which is not incorporated by reference, contains additional information about the subject of this AD. For service information identified in this AD, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; or at http://www.bellcustomer.com/files/. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

    (2) The subject of this AD is addressed in Transport Canada AD No. CF-2017-02, dated January 16, 2017. You may view the Transport Canada AD on the internet at http://www.regulations.gov in Docket No. FAA-2017-0757.

    (h) Subject

    Joint Aircraft Service Component (JASC) Code: 1100, Placards and Markings.

    (i) Material Incorporated by Reference

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

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

    (i) Bell Helicopter Alert Service Bulletin 429-16-34, dated November 10, 2016.

    (ii) Reserved.

    (3) For Bell Helicopter Textron Canada Limited service information identified in this AD, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; or at http://www.bellcustomer.com/files/.

    (4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.

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

    Issued in Fort Worth, Texas, on June 1, 2018. James A. Grigg, Acting Director, Compliance & Airworthiness Division, Aircraft Certification Service.
    [FR Doc. 2018-14701 Filed 7-11-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-1118; Product Identifier 2017-NE-40-AD; Amendment 39-19313; AD 2018-13-01] RIN 2120-AA64 Airworthiness Directives; Rolls-Royce Corporation Turboshaft Engines AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Rolls-Royce Corporation (RRC) model 250-C turboshaft engines. This AD was prompted by several reports of engine power loss, one of which resulted in a fatal helicopter accident. This AD requires removal of the power turbine governor (PTG) bearing assembly, part number (P/N) 2544198, and its replacement with a bearing assembly eligible for installation. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective August 16, 2018.

    ADDRESSES:

    For service information identified in this final rule, contact Rolls-Royce Corporation, 450 South Meridian Street, Mail Code NB-02-05, Indianapolis, IN 46225; phone: 317-230-3774; email: [email protected]; internet: www.rolls-royce.com. You may view this service information at the FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7759. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-1118.

    Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1118; 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 final rule, the regulatory evaluation, any comments received, and other information. The address for Docket Operations (phone: 800-647-5527) is Docket Operations, U.S. Department of Transportation, Docket Operations,M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    John Tallarovic, Aerospace Engineer, Chicago ACO Branch, FAA, 2300 E. Devon Ave., Des Plaines, IL 60018; phone: 847-294-8180; fax: 847-294-7834; email: [email protected].

    SUPPLEMENTARY INFORMATION: Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Rolls-Royce Corporation (RRC) model 250-C turboshaft engines. The NPRM published in the Federal Register on February 1, 2018 (83 FR 4609). The NPRM was prompted by several reports of loss of engine power on certain RRC model 250-C turboshaft engines installed on single-engine helicopters. One of these instances of power loss resulted in a fatal helicopter accident on May 4, 2016. The NPRM proposed to require removal of the affected PTG bearing assembly and replace it with a bearing assembly with a new design. We are issuing this AD to address the unsafe condition on these products.

    Comments

    We gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.

    Request To Specify the New Bearing Assembly

    The NTSB and Honeywell Aerospace requested that the AD prohibit the installation of bearing assembly, P/N 2544198, and specify the installation of the new bearing assembly, P/N 2526146. The NTSB expressed concern that differences between the proposed AD and the actions described in the Honeywell SB and Rolls-Royce CEBs could lead to the reinstallation of a dual-spool bearing into an affected PTG.

    We partially agree. We agree with the request to prohibit the installation of another bearing assembly, P/N 2544198, because our intent is to remove them from service. We disagree with the request to specify the installation of the new bearing assembly, P/N 2526146, because of the possibility of a new bearing P/N being introduced or the specified P/N being discontinued in the future. We added an installation prohibition paragraph to this AD to prohibit the installation of bearing assembly, P/N 2544198.

    Request To Re-Identify the PTG After Changing the Bearing Assembly

    The NTSB and Honeywell Aerospace requested that the AD require re-identifying the PTG P/N after changing the bearing assembly in accordance with the related service information. Honeywell Aerospace reasoned that maintenance personnel and operators could easily determine if the service bulletin has been accomplished. This increases the efficiency of operations and reduces the potential for misunderstandings about whether the bearing assembly has been replaced.

    We disagree. While re-identifying the PTG after changing the bearing assembly is helpful for maintenance personnel, we are not requiring this action within this AD. During the replacement of the bearing assembly, P/N 2544198, the related service information instructs personnel to re-identify the PTG. We did not change this AD.

    Request To Reduce the Compliance Time

    Honeywell Aerospace requested that we reduce the compliance time to 50 hours or within 90 days for PTGs that have greater than 750 hours. The commenter reasoned that the original compliance schedule was established 10 years ago based on field experience at that time. The fatal accident referenced in the NPRM occurred on a PTG with 1,048.7 hours since new.

    We disagree. The compliance time for removing the bearing assembly, P/N 2544198, in this AD is based on Rolls-Royce Corporation Commercial Engine Bulletin (CEB) 1402, Revision 2, dated February 4, 2009. The failure history shows that the number of bearing assembly failures fell sharply following the initial publication of RRC CEB 1402 in 2008. The replacement strategy has proven successful. As a result, we believe that the majority of the fleet has replaced the bearing assembly, P/N 2544198, and only a few remain in service. Besides the fatal accident, there have not been any other bearing failures noted between 2012 and 2018. We, therefore, find it unnecessary to reduce the compliance time as noted by the commenter. We did not change this AD.

    Request To Increase the Number of Affected Engines

    Honeywell Aerospace noted that only 1,200 engines installed on airplanes of U.S. registry may be affected, compared with the 2,928 mentioned in the NPRM, based on a review of modification records provided to Honeywell by repair stations.

    We disagree. We are estimating the total number of engines affected by this AD based on the data available to us. We did not change this AD.

    Request To Clarify the Affected Engines

    An individual commenter requested that we clarify that only those engine models that have bearing assembly, P/N 2544198, installed are affected.

    We agree. We have updated paragraph (c) of this AD to clarify that engines with bearing assembly, P/N 2544198, installed are affected.

    Request To Identify the Model, Brand, and P/N of the PTG

    Aircraft Maintenance Netherlands requested that this AD identify the model, brand, and P/N of the affected PTG that must be replaced. The commenter reasoned that various PTG models can be installed on the affected engines.

    We disagree. This AD provides the overall engine model applicability. The related service information provides specific information regarding the PTGs, including the manufacturer, model, and P/Ns. We did not change this AD.

    Question on Not Issuing the AD Earlier

    An individual commenter asked why an AD was not issued in 2009 when RRC issued a statement regarding the failure of the bearing assembly.

    The FAA uses a risk-based approach to make continued operational safety decisions. When RRC issued CEB 1402, Revision 2, in 2009, our evaluation of the fleet risk did not support an AD. We update our fleet risk evaluation periodically as new information becomes available and have now determined that an AD is justified. We did not change this AD.

    Question if Replacement Part Verification Testing Was Completed

    An individual commenter asked if tests or procedures were completed to verify that the replacement bearing assembly resolves the failure of bearing assembly, P/N 2544198, due to the lack of lubrication.

    We note that replacement parts, such as this replacement bearing assembly, undergo design analysis and testing before being approved for use by the FAA. No change is requested. We did not change this AD.

    Request for Clarification on the Number of Affected Engines

    An individual commenter noted that the NPRM estimates that 2,928 model 250-C turboshaft engines are affected, however, the RRC website estimates that there are an estimated 16,000 model 250-C engines currently in service.

    This AD applies to all RRC model 250-C turboshaft engines that could have the bearing assembly, P/N 2544198, installed. Many of those engines have already had the bearing assembly, P/N 2544198, replaced when new parts became available. Based on the available data, we estimate that 2,928 engines may still have the bearing assembly, P/N 2544198, installed. We did not change this AD.

    Question on the Availability of a Replacement Bearing Assembly

    An individual commenter asked if RRC still needs to design a new bearing assembly or if a replacement bearing assembly is already available.

    A replacement bearing assembly, P/N 2526146, is available for installation. We did not change this AD.

    Support for the AD

    An individual commenter expressed support for the NPRM as written.

    Conclusion

    We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the changes described previously. We have determined that these minor changes:

    • Αre consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

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

    We also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.

    Related Service Information

    We reviewed Rolls-Royce Corporation Commercial Engine Bulletin (CEB) 1402, Revision 2, dated February 4, 2009. The CEB provides guidance on replacing the PTG bearing assembly, P/N 2544198, with a bearing assembly eligible for installation.

    Costs of Compliance

    We estimate that this AD affects 2,928 engines installed on airplanes of U.S. registry.

    We estimate the following costs to comply with this AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S. operators
    Remove and replace PTG bearing assembly 8 work-hours × $85 per hour = $680 $1,700 $2,380 $6,968,640
    Authority for This Rulemaking

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

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

    This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

    Regulatory Findings

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2018-13-01 Roll-Royce Corporation (Type Certificate previously held by Allison Engine Company): Amendment 39-19313; Docket No. FAA-2017-1118; Product Identifier 2017-NE-40-AD. (a) Effective Date

    This AD is effective August 16, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Rolls-Royce Corporation (RRC) model 250-C10D, 250-C18, 250-C18A, 250-C18B, 250-C18C, 250-C19, 250-C20, 250-C20B, 250-C20C, 250-C20F, 250-C20J, 250-C20R, 250-C20R/1, 250-C20R/2, 250-C20R/4, 250-C20S, 250-C20W, 250-C28, 250-C28B, 250-C28C, 250-C30, 250-C30G, 250-C30G/2, 250-C30M, 250-C30P, 250-C30S, and 250-C30U turboshaft engines with power turbine governor (PTG) bearing assembly, part number (P/N) 2544198, installed.

    (d) Subject

    Joint Aircraft System Component (JASC) Code 7323, Turbine Governor.

    (e) Unsafe Condition

    This AD was prompted by several reports of loss of power, one of which resulted in a fatal helicopter accident. We are issuing this AD to prevent failure of the PTG bearing assembly. The unsafe condition, if not addressed, could result in failure of the PTG, failure of the engine, in-flight shutdown, and forced autorotation landing or accident.

    (f) Compliance

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

    (g) Required Actions

    (1) Remove the bearing assembly, P/N 2544198, from the PTG in accordance with the compliance times in Figure 1 to paragraph (g) of this AD, or within 90 days after the effective date of this AD, whichever occurs later.

    ER12JY18.017

    (2) After such removal, replace the affected PTG bearing assembly with a part eligible for installation before further flight.

    (h) Installation Prohibition

    After the effective date of this AD, do not install PTG bearing assembly, P/N 2544198, on any engine.

    (i) Alternative Methods of Compliance (AMOCs)

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

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

    (j) Related Information

    For more information about this AD, contact John Tallarovic, Aerospace Engineer, Chicago ACO Branch, FAA, 2300 E Devon Ave., Des Plaines, IL 60018; phone: 847-294-8180; fax: 847-294-7834; email: [email protected]

    (k) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on July 6, 2018. Karen M. Grant, Acting Manager, Engine and Propeller Standards Branch, Aircraft Certification Service.
    [FR Doc. 2018-14801 Filed 7-11-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2018-0662] RIN 1625-AA08 Special Local Regulation; Marine City Water Ski Show, St. Clair River, Marine City, MI AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a special local regulation for certain navigable waters of the St. Clair River, Marine City, MI. This action is necessary and is intended to ensure safety of life on navigable waters immediately prior to, during, and immediately after the Marine City Water Ski Show.

    DATES:

    This temporary final rule is effective from 1 p.m. though 5 p.m. on August 4, 2018.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0662 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary rule, call or email Tracy Girard, Prevention Department, Sector Detroit, Coast Guard; telephone (313) 568-9564, or email [email protected]

    SUPPLEMENTARY INFORMATION:

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

    The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The Coast Guard just recently received the final details of this water ski show, which does not provide sufficient time to publish an NPRM prior to the event. Thus, delaying the effective date of this rule to wait for a comment period to run would be contrary to public interest because it would inhibit the Coast Guard's ability to protect participants, mariners and vessels from the hazards associated with this event. It is impracticable to publish an NPRM because we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this rule.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would inhibit the Coast Guard's ability to protect participants, mariners and vessels from the hazards associated with this event.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The Captain of the Port Detroit (COTP) has determined that the likely combination of recreation vessels, commercial vessels, and an unknown number of spectators in close proximity to a water ski show along the water pose extra and unusual hazards to public safety and property. Therefore, the COTP is establishing a special local regulation around the event location to help minimize risks to safety of life and property during this event.

    IV. Discussion of the Rule

    This rule establishes a special local regulation from 1 p.m. though 5 p.m. on August 4, 2018. The special local regulation will encompass all U.S. navigable waters of the St. Clair River, Marine City, MI, bound by: 200 feet seaward of latitude position 42°43.382′ N and 200 feet seaward of latitude position 42°42.983′ N (NAD 83). The special local regulation will be enforced from 1 p.m. to 1:45 p.m. and from 4 p.m. to 4:45 p.m. on August 4, 2018. No vessel or person will be permitted to enter the special local regulation without obtaining permission from the COTP or his designated representative.

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

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

    This regulatory action determination is based on the size, location, duration, and time-of-year of the special local regulation. Vessel traffic will be able to safely transit around this special local regulation zone which will impact a small designated area of the St. Clair River from 1 p.m. until 5 p.m. on August 4, 2018. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the special local regulation and the rule allows vessels to seek permission to enter the area.

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation lasting less than four hours that will prohibit entry into a designated area. It is categorically excluded from further review under paragraph L[61] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 100

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

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

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

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

    2. Add § 100.T09-0662 to read as follows:
    § 100.T09-0662 Special Local Regulation; Marine City Water Ski Show, St. Clair River, Marine City, MI.

    (a) Regulated areas. The following regulated area is established to include all U.S. navigable waters of the St. Clair River, Marine City, MI, bound by: 200 feet seaward of latitude position 42°43.382′ N and 200 feet seaward of latitude position 42°42.983′ N (NAD 83).

    (b) Enforcement date. The regulated area described in paragraph (a) of this section will be in effect from 1 p.m. though 5 p.m. on August 4, 2018. The special local regulation will be enforced from 1 p.m. to 1:45 p.m. and from 4 p.m. to 4:45 p.m. on August 4, 2018.

    (c) Special local regulations. (1) Vessels transiting through the regulated area are to maintain the minimum speeds for safe navigation.

    (2) Vessel operators desiring to operate in the regulated area must contact the Coast Guard Patrol Commander to obtain permission to do so. The Captain of the Port Detroit (COTP) or his on-scene representative may be contacted via VHF Channel 16 or at 313-568-9560. Vessel operators given permission to operate within the regulated area must comply with all directions given to them by the COTP or his on-scene representative.

    (3) The “on-scene representative” of the COTP Detroit is any Coast Guard commissioned, warrant or petty officer or a Federal, State, or local law enforcement officer designated by or assisting the Captain of the Port Detroit to act on his behalf.

    Dated: July 5, 2018. Kevin D. Floyd, Commander, U.S. Coast Guard, Acting Captain of the Port Detroit.
    [FR Doc. 2018-14919 Filed 7-11-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 [Docket Number USCG-2018-0578] Safety Zone; Alaska Marine Highway System Port Valdez Ferry Terminal, Port Valdez; Valdez, AK AGENCY:

    Coast Guard, DHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Coast Guard is republishing its 2014 rule that established a permanent safety zone on the navigable waters of Port Valdez within a 200-yard radius of the Alaska Marine Highway System (AMHS) Port Valdez Ferry Terminal. The safety zone restricts all vessels except AMHS vessels from entering within 200-yards of the AMHS Port Valdez Ferry Terminal whenever an AMHS ferry is underway within 200 yards of the terminal and there is a declared Commercial Salmon Fishery Opener. This safety zone is necessary to provide for the safety of life, property and the environment during periods of vessel traffic congestion during a declared Commercial Salmon Fishery Opener.

    DATES:

    This rule is effective July 12, 2018.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0578 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this rulemaking, call or email LTJG, Carlos M. Quintero, MSU Valdez, U.S. Coast Guard; telephone 907-835-7209, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations AMHS Alaska Marine Highway System CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register § Section U.S.C. United States Code II. Background Information and Regulatory History

    The Coast Guard is issuing this rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are impracticable, unnecessary, or contrary to the public interest. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking with respect to this rule because it is unnecessary to do so. This is a republication, without change, of a previously issued rule.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. The Coast Guard finds that good cause exists because it is unnecessary to do so. This is a republication, without change of a previously issued rule.

    On February 4, 2014, the Coast Guard published a rule that established a permanent safety zone on the navigable waters of Port Valdez within a 200-yard radius of the Alaska Marine Highway System (AMHS) Port Valdez Ferry Terminal (79 FR 6468). The safety zone restricts all vessels except AMHS vessels from entering within 200-yards of the AMHS Port Valdez Ferry Terminal whenever an AMHS ferry is underway within 200 yards of the terminal and there is a declared Commercial Salmon Fishery Opener. That original rule, however, contained a clerical error that prevented the Office of the Federal Register from codifying the rule into the Code of Federal Regulations. The 2014 final rule inadvertently used a pre-existing number assigned to a different regulation. Because the rule could not be codified at the stated location, the Office of the Federal Register, instead, added an editorial note to 33 CFR 165.1712 noting the publication of the 2014 AMHS Port Valdez Ferry Terminal rule.

    The purpose of this rule is to republish that 2014 rule, without change, to a different section number so that it can be codified into the Code of Federal Regulations.

    The authority to re-issue this safety zone is 33 U.S.C. 1231. This safety zone continues to be necessary to provide for the safety of life, property and the environment during periods of vessel traffic congestion during a declared Commercial Salmon Fishery Opener.

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771. This regulatory action determination is based on the fact that this is a republication, without change, of a previously published rule.

    B. Impact on Small Entities

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

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. Small businesses may send comments on the actions of federal employees who enforce, or otherwise determine compliance with, federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the republication, without change, of a previously published rule. It is categorically excluded from further review under paragraph L60a of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    List of Subjects in 33 CFR Part 165

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

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

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

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

    2. Add § 165.1714 to read as follows:
    § 165.1712a Safety Zone; Alaska Marine Highway System Port Valdez Ferry Terminal, Port Valdez; Valdez, AK.

    (a) Location. The following area is a safety zone: All navigable waters of Port Valdez extending 200 yards in all directions from the edges of the Alaska Marine Highway System Terminal dock located in Port Valdez at 61°07′26″ N and 146°21′50″ W.

    (b) Enforcement period. The rule will be enforced whenever there is an Alaska Marine Highway System Ferry vessel transiting within the area described in paragraph (a) of this section and there is a Commercial Salmon Fishery Opener that includes the navigable waters within the safety zone. Each enforcement period will be announced by a broadcast notice to mariners when the Commercial Salmon Fishery Opener is announced.

    (c) Definitions. The following definitions apply to this section:

    (1) The term “designated representative” means any Coast Guard commissioned, warrant or petty officer of the U.S. Coast Guard who has been designated by the Captain of the Port, Prince William Sound, to act on his or her behalf.

    (2) The term “official patrol vessel” may consist of any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement vessels assigned or approved by the COTP, Prince William Sound.

    (3) The term “AMHS vessel” means any vessel owned or operated by the Alaska Marine Highway System, including, but not limited to: M/V AURORA, M/V CHENEGA, M/V COLUMBIA, M/V FAIRWEATHER, M/V KENNICOTT, M/V LECONTE, M/V LITUYA, M/V MALASPINA, M/V MATANUSKA, M/V TAKU and M/V TUSTUMENA.

    (d) Regulations. (1) The general regulations contained in 33 CFR 165.23, as well as the requirements in paragraphs (d)(2) through (5) of this section, apply.

    (2) No vessels, except for AMHS ferries and vessels owned or operated by AMHS will be allowed to transit the safety zone without the permission of the COTP Prince William Sound or the designated representative during periods of enforcement.

    (3) All persons and vessels shall comply with the instructions of the COTP or the designated representative. Upon being hailed by a U.S. Coast Guard vessel or other official patrol vessel by siren, radio, flashing light or other means, the operator of the hailed vessel shall proceed as directed.

    (4) Vessel operators desiring to enter or operate within the regulated area may contact the COTP or the designated representative via VHF channel 16 or 907-835-7205 (Prince William Sound Vessel Traffic Service) to request permission to do so.

    (5) The COTP, Prince William Sound may be aided by other Federal, state, borough, and local law enforcement officials in the enforcement of this regulation. In addition, members of the Coast Guard Auxiliary may be present to inform vessel operators of this regulation.

    Dated: July 6, 2018. M.R. Franklin, Commander, U.S. Coast Guard, Captain of the Port, Prince William Sound.
    [FR Doc. 2018-14863 Filed 7-11-18; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2017-0152; FRL-9980-62—Region 3] Approval and Promulgation of Air Quality Implementation Plans; Delaware; Interstate Transport Requirements for the 2012 Fine Particulate Matter Standard AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving a state implementation plan (SIP) revision submitted by the State of Delaware. This revision pertains to the infrastructure requirement for interstate transport of pollution with respect to the 2012 fine particulate matter (PM2.5) national ambient air quality standards (NAAQS). EPA is approving this revision in accordance with the requirements of the Clean Air Act (CAA).

    DATES:

    This final rule is effective on August 13, 2018.

    ADDRESSES:

    EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2017-0152. 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:

    Joseph Schulingkamp, (215) 814-2021, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    On December 14, 2015, the State of Delaware, through the Department of Natural Resources and Environmental Control (DNREC) submitted a SIP revision addressing the infrastructure requirements under section 110(a)(2) of the CAA for the 2012 PM2.5 NAAQS. On September 22, 2017, EPA approved all portions of Delaware's submittal except for the portion addressing section 110(a)(2)(D)(i)(I) regarding the interstate transport of emissions. See 82 FR 44318. As explained in the final rule, EPA intended to take separate action on that portion of Delaware's submittal and is doing so with today's proposed action. On May 15, 2018 (83 FR 22436), EPA published a notice of proposed rulemaking (NPR) for the State of Delaware. In the NPR, EPA proposed approval of Delaware's submittal to address the infrastructure requirements under section 110(a)(2)(D)(i) of the CAA for the 2012 PM2.5 NAAQS.

    II. Summary of SIP Revision and EPA Analysis

    Delaware's December 14, 2015 SIP submittal asserted that the State's SIP presently contains adequate provisions prohibiting sources from emitting air pollutants in amounts which will contribute significantly to nonattainment or interfere with maintenance of the 2012 PM2.5 NAAQS. Delaware also asserted under Delaware Code, Title 7, Chapter 60, Subsection 6010(c), “Rules and regulations; plans,” that the State has the legal authority to regulate sources whose emission could transport to areas in nonattainment or to areas currently attaining the NAAQS. Delaware also describes ambient air quality data for New Castle, Kent, and Sussex Counties as all being below the NAAQS.

    EPA used the information in the 2016 PM2.5 Memorandum 1 and additional information to evaluate the submittal and came to the same conclusion as Delaware. As discussed in greater detail in the technical support document (TSD) for this action, EPA identified the potential downwind nonattainment and maintenance receptors identified in the 2016 PM2.5 Memorandum, and then evaluated them to determine if Delaware's emissions could potentially contribute to nonattainment and maintenance problems in 2021, the attainment year for moderate PM2.5 nonattainment areas. EPA concluded Delaware was not significantly contributing to nonattainment nor interfering with maintenance with 2012 PM2.5 NAAQS by any other state. A detailed summary of Delaware's submittal and EPA's review and rationale for approval of this SIP revision as meeting CAA section 110(a)(2)(D)(i)(I) for the 2012 PM2.5 NAAQS may be found in the NPR and TSD for this rulemaking action, which are available online at www.regulations.gov, Docket number EPA-R03-OAR-2017-0152.

    1 “Information on the Interstate Transport “Good Neighbor” Provision for the 2012 Fine Particulate Matter National Ambient Air Quality Standards under Clean Air Act Section 110(a)(2)(D)(i)(I),” Memorandum from Stephen D. Page, Director, EPA Office of Air Quality Planning and Standards (March 17, 2016). A copy is included in the docket for this rulemaking action.

    III. Public Comments

    One anonymous public comment was received during the public comment period, but the comment was determined to not be relevant nor specific to this rulemaking action. Thus no response is provided.

    IV. Final Action

    EPA is approving the December 14, 2015 SIP revision addressing the interstate transport requirements for the 2012 PM2.5 NAAQS to the Delaware SIP because the submittal adequately addresses section 110(a)(2)(D)(i)(I) of the CAA.

    V. Statutory and Executive Order Reviews A. General Requirements

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

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

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

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

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

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

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

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

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

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

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

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

    B. Submission to Congress and the Comptroller General

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

    C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 10, 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, addressing Delaware's interstate transport for the 2012 PM2.5 NAAQS, 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, Particulate matter.

    Dated: June 19, 2018. Cosmo Servidio, Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart I—Delaware 2. In § 52.420, the table in paragraph (e) is amended by adding a second entry for Section 110(a)(2) Infrastructure Requirements for the 2012 PM2.5 NAAQS after the first entry. The revised text reads as follows:
    § 52.470 Identification of plan.

    (e) * * *

    Name of non-regulatory SIP revision Applicable
  • geographic
  • area
  • State
  • submittal
  • date
  • EPA
  • approval
  • date
  • Additional explanation
    *         *         *         *         *         *         * Section 110(a)(2) Infrastructure Requirements for the 2012 PM2.5 NAAQS Statewide 12/14/2015 7/12/2018, [Insert Federal Register citation] Docket 2017-0152. This action addresses the infrastructure element of CAA section 110(a)(2)(D)(i)(I). *         *         *         *         *         *         *
    [FR Doc. 2018-14838 Filed 7-11-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2018-0104; FRL-9980-43—Region 9] Approval of California Air Plan Revisions, Yolo-Solano Air Quality Management District AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action to approve a revision to the Yolo-Solano Air Quality Management District (YSAQMD or “District”) portion of the California State Implementation Plan (SIP). This revision concerns emissions of volatile organic compounds (VOCs) from architectural coatings. We are approving a local rule that regulates these emission sources under the Clean Air Act (CAA or the Act).

    DATES:

    This rule is effective on August 13, 2018.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2018-0104. 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:

    Arnold Lazarus, EPA Region IX, (415) 972-3024, [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 May 3, 2018 (83 FR 19495), the EPA proposed to approve the following rule into the California SIP.

    Local agency Rule No. Rule title Revised Submitted YSAQMD 2.14 Architectural Coatings 10/12/2016 01/24/2017

    We proposed to approve this rule because we determined that it complies with the relevant CAA requirements. Our proposed action contains more information on the rule and our evaluation.

    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 in support of regulating VOC emissions, and another that was not germane to this rule.

    III. EPA Action

    No comments were submitted that change our assessment of the rule as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving this rule into the California SIP.

    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 YSAQMD rule 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 September 10, 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, Incorporation by reference, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: June 22, 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)(293)(i)(B)(2) and (c)(497)(i)(D)(2) to read as follows:
    § 52.220 Identification of plan-in part.

    (c) * * *

    (293) * * *

    (i) * * *

    (B) * * *

    (2) Previously approved on January 2, 2004 in paragraph (c)(293)(i)(B)(1) of this section and now deleted with replacement in (c)(497)(i)(D)(2), Rule 2.14, adopted on November 14, 2001.

    (497) * * *

    (i) * * *

    (D) * * *

    (2) Rule 2.14, “Architectural Coatings,” revised on October 12, 2016.

    [FR Doc. 2018-14946 Filed 7-11-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [EPA-HQ-OAR-2014-0741; FRL-9980-84-OAR] National Emission Standards for Hazardous Air Pollutants for Chemical Recovery Combustion Sources at Kraft, Soda, Sulfite, and Stand-Alone Semichemical Pulp Mills AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notification of final action denying petition for reconsideration.

    SUMMARY:

    The U.S. Environmental Protection Agency (EPA) is providing notice that it has responded to a petition for reconsideration of the final National Emission Standards for Hazardous Air Pollutants (NESHAP) for Chemical Recovery Combustion Sources at Kraft, Soda, Sulfite, and Stand-Alone Semichemical Pulp Mills published in the Federal Register on October 11, 2017. The Acting Administrator denied the petition in a separate letter to the petitioners. The letter, which provides a full explanation of the agency's rationale for the denial, is in the rulemaking docket.

    DATES:

    July 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Kelley Spence, Sector Policies and Programs Division (E143-03), Office of Air Quality Planning and Standards, Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-3158; fax number: (919) 541-0516; email address: [email protected]

    SUPPLEMENTARY INFORMATION: I. How can I get copies of this document and other related information?

    This Federal Register document, the petition for reconsideration, and the letter denying the petition for reconsideration are available in the docket the EPA established under Docket ID No. EPA-HQ-OAR-2014-0741. All documents in the docket are listed on the www.regulations.gov website. Although listed, some information is not publicly available, e.g., confidential business information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the EPA Docket Center (EPA/DC), Room 3334, EPA WJC West Building, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744 and the telephone number for the Air Docket is (202) 566-1742.

    II. Judicial Review

    Section 307(b)(1) of the Clean Air Act (CAA) indicates which Federal Courts of Appeals have venue for petitions for review of final EPA actions. This section provides, in part, that the petitions for review must be filed in the United States Court of Appeals for the District of Columbia Circuit if: (1) The agency action consists of “nationally applicable regulations promulgated, or final action taken, by the Administrator,” or (2) such actions are locally or regionally applicable, if “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”

    The EPA has determined that its action denying the petition for reconsideration is nationally applicable for purposes of CAA section 307(b)(1) because the action directly affects the NESHAP for Chemical Recovery Combustion Sources at Kraft, Soda, Sulfite, and Stand-Alone Semichemical Pulp Mills, which are nationally applicable CAA section 112 standards. Any petitions for review of the letter denying the petition for reconsideration must be filed in the United States Court of Appeals for the District of Columbia Circuit by September 10, 2018.

    III. Description of Action

    On October 11, 2017, pursuant to sections 112(d)(6) and (f)(2) of the CAA, the EPA published the final residual risk and technology review (RTR) of the “National Emission Standards for Hazardous Air Pollutants for Chemical Recovery Combustion Sources at Kraft, Soda, Sulfite, and Stand-Alone Semichemical Pulp Mills.” 82 FR 47328. Following publication of the final RTR amendments, the Administrator received a petition for reconsideration of two aspects of the final RTR pursuant to CAA section 307(d)(7)(B). The petitioners, Earthjustice on behalf of Crossett Concerned Citizens for Environmental Justice, Louisiana Environmental Action Network, PT AirWatchers, and Sierra Club, claimed: (1) It was impracticable to object to the EPA's rationale for not setting additional standards for uncontrolled emissions when the EPA was conducting the review required by CAA section 112(d)(6), and their objections on this issue are of central relevance to the outcome of the rule; and (2) it was impracticable to object during the comment period to the EPA's use of census block centroids to account for the residual risk to the most exposed individual, and their objections on this issue are of central relevance to the outcome of the rule.

    CAA section 307(d)(7)(B) requires the EPA to convene a proceeding for reconsideration of a rule if a party raising an objection to the rule “can demonstrate to the Administrator that it was impracticable to raise such objection within [the public comment period] or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule.” The requirement to convene a proceeding to reconsider a rule is, thus, based on the petitioner demonstrating to the EPA both: (1) That it was impracticable to raise the objection during the comment period, or that the grounds for such objection arose after the comment period, but within the time specified for judicial review (i.e., within 60 days after publication of the final rulemaking in the Federal Register, see CAA section 307(b)(1)); and (2) that the objection is of central relevance to the outcome of the rule.

    The EPA carefully reviewed the petition for reconsideration and evaluated the issues raised to determine if they meet the CAA section 307(d)(7)(B) criteria for reconsideration. In a separate letter to the petitioners, the EPA Acting Administrator, Andrew R. Wheeler, denied the petition for reconsideration. The letter is available in the docket for this action.

    Dated: July 9, 2018. Andrew R. Wheeler, Acting Administrator.
    [FR Doc. 2018-15023 Filed 7-11-18; 8:45 am] BILLING CODE 6560-50-P
    83 134 Thursday, July 12, 2018 Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 1206 [Document. No. AMS-SC-17-0002] Mango Promotion, Research, and Information Order; Reopening and Extension of Comment Period on Amendment To Include Frozen Mangos AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Reopening and extension of comment period.

    SUMMARY:

    Notice is hereby given that the comment period on the proposed rule to amend the Mango Promotion, Research, and Information Order to include frozen mangos is reopened and extended. Also, the comment period is extended for the frozen mangos information and collection requirements by the Office of Management and Budget (OMB) which is necessary to include frozen mangos under the current program.

    DATES:

    Comments must be received by August 13, 2018. Pursuant to the Paperwork Reduction Act (PRA), comments on the information collection burden that would result from this proposal must be received by August 13, 2018.

    ADDRESSES:

    Interested persons are invited to submit written comments concerning this proposal. Comments may be submitted on the internet at: http://www.regulations.gov or to the Promotion and Economics Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Room 1406-S, Stop 0244, Washington, DC 20250-0244; facsimile: (202) 205-2800. All comments should reference the docket number and the date and page number of this issue of the Federal Register and will be made available for public inspection, including name and address, if provided, in the above office during regular business hours or it can be viewed at http://www.regulations.gov.

    Pursuant to the PRA, comments regarding the accuracy of the burden estimate, ways to minimize the burden, including the use of automated collection techniques or other forms of information technology, or any other aspect of this collection of information, should be sent to the above address. In addition, comments concerning the information collection should also be sent to the Desk Office for Agriculture, Office of Information and Regulatory Affairs, OMB, New Executive Office Building, 725 17th Street NW, Room 725, Washington, DC 20503.

    FOR FURTHER INFORMATION CONTACT:

    Jeanette Palmer, Marketing Specialist, Promotion and Economics Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Room 1406-S, Stop 0244, Washington, DC 20250-0244; telephone: (202) 720-9915; facsimile: (202) 205-2800; or electronic mail: [email protected]

    SUPPLEMENTARY INFORMATION:

    A proposed rule was published in the Federal Register on April 6, 2018 (83 FR 14771). That rule proposed to amend the Mango Promotion, Research, and Information Order to include frozen mangos.

    The rule also announced the Agricultural Marketing Service's intent to request approval from OMB of new information collection requirements and recordkeeping requirements for the frozen mango industry. Information collection and recordkeeping requirements for the fresh mango program (part 1206) have previously been approved under OMB control nos. 0581-0093 and 0505-0001. Upon approval of this action and associated burden, AMS would submit a Justification for Change to merge this new burden for frozen mangos into the currently approved collection for fresh mangos.

    USDA received a letter from industry requesting that the comment period be extended to allow additional time for interested persons to review the proposal and submit comments.

    USDA is reopening and extending the comment period an additional 30 days to allow interested persons more time to review the proposed rule, perform an analysis, and submit written comments.

    Authority:

    7 U.S.C. 7411-7425; 7 U.S.C. 7401.

    Dated: July 9, 2018. Bruce Summers, Administrator.
    [FR Doc. 2018-14940 Filed 7-11-18; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0634; Product Identifier 2018-NM-050-AD] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc., Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701 & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. This proposed AD was prompted by reports of a fractured main landing gear (MLG) orifice support tube (OST). This proposed AD would require replacing the MLG OST, and revising the maintenance or inspection program, as applicable, to incorporate new or more restrictive maintenance requirements and airworthiness limitations. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by August 27, 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 Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 866-538-1247 or direct-dial telephone 514-855-2999; fax 514-855-7401; email [email protected]; internet http://www.bombardier.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.

    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-2018-0634; 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:

    Aziz Ahmed, Aerospace Engineer, Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7329; fax 516-794-5531; email [email protected].

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0634; Product Identifier 2018-NM-050-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

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

    Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2018-02, dated January 16, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701 & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The MCAI states:

    Five cases of fractured Main Landing Gear (MLG) Orifice Support Tube (OST) have been reported. Subsequent analysis determined that the MLG OST is unable to withstand the loads generated during a hard landing event. A MLG OST fracture cannot be detected during routine maintenance and if not corrected, a fractured MLG OST can lead to aeroplane structural damage and/or collapse of the MLG.

    This [Canadian] AD mandates the replacement of the existing MLG OSTs with a re-designed part, and the implementation of a new airworthiness limitation task.

    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-2018-0634.

    Related Service Information Under 1 CFR Part 51

    Bombardier has issued Service Bulletin SB 670BA-32-058, dated September 26, 2016. The service information describes procedures for replacing each MLG OST.

    Bombardier has also issued Temporary Revision ALI-0593, dated December 18, 2017. The service information describes new life limits for the MLG OSTs.

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

    FAA's Determination

    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.

    This AD requires revisions to certain operator maintenance documents to include new actions (e.g., inspections). Compliance with these actions is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by this proposed AD, the operator may not be able to accomplish the actions described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance according to paragraph (i) of this proposed AD. The request should include a description of changes to the required actions that will ensure the continued damage tolerance of the affected structure.

    Proposed AD Requirements

    This proposed AD would require replacing the MLG OST and revising the maintenance or inspection program, as applicable, to incorporate new or more restrictive maintenance requirements and airworthiness limitations.

    Costs of Compliance

    We estimate that this proposed AD affects 542 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Replacement (left- and right-hand sides) 24 work-hours × $85 per hour = $2,040 * $0 $2,040 $1,105,680 * We have received no definitive data that would enable us to provide cost estimates for the parts cost in this AD.

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

    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Bombardier, Inc.: Docket No. FAA-2018-0634; Product Identifier 2018-NM-050-AD. (a) Comments Due Date

    We must receive comments by August 27, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to the Bombardier, Inc., airplanes specified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD, certificated in any category.

    (1) Model CL-600-2C10 (Regional Jet Series 700, 701 & 702) airplanes, serial numbers 10003 through 10345 inclusive.

    (2) Model CL-600-2D15 (Regional Jet Series 705) airplanes and Model CL-600-2D24 (Regional Jet Series 900) airplanes, serial numbers 15001 through 15429 inclusive.

    (3) Model CL-600-2E25 (Regional Jet Series 1000) airplanes, serial numbers 19001 through 19052 inclusive.

    (d) Subject

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

    (e) Reason

    This AD was prompted by reports of a fractured main landing gear (MLG) orifice support tube (OST). We are issuing this AD to address a fractured MLG OST, which can lead to structural damage to the airplane and collapse of the MLG.

    (f) Compliance

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

    (g) Replacement

    Within the compliance times specified in figure 1 to paragraph (g) of this AD: Replace each MLG OST, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin SB 670BA-32-058, dated September 26, 2016.

    EP12JY18.018 (h) Maintenance or Inspection Program Revision

    Within 90 days after the effective date of this AD, revise the maintenance or inspection program, as applicable, to incorporate Bombardier Temporary Revision ALI-0593, dated December 18, 2017. The initial compliance time for accomplishing the actions is at the applicable time specified in Bombardier Temporary Revision ALI-0593, dated December 18, 2017; or within 90 days after the effective date of this AD; whichever occurs later.

    (i) No Alternative Actions or Intervals

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

    (j) Other FAA AD Provisions

    The following provisions also apply to this AD:

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

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

    (k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian AD CF-2018-02, dated January 16, 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-2018-0634.

    (2) For more information about this AD, contact Aziz Ahmed, Aerospace Engineer, Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7329; fax 516-794-5531; email [email protected]

    (3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 866-538-1247 or direct-dial telephone 514-855-2999; fax 514-855-7401; email [email protected]; internet http://www.bombardier.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 July 3, 2018. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-14804 Filed 7-11-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0281; Product Identifier 2018-NE-06-AD] RIN 2120-AA64 Airworthiness Directives; Hoffmann Propeller GmbH & Co. KG Propellers AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Hoffmann Propeller GmbH & Co. KG model HO-V 62 propellers. This proposed AD was prompted by the failure of the propeller blade lag screws. This proposed AD would require removal of the affected propeller blades and installation of modified propeller blades marked with change letter “A” or “B.” We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by August 27, 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 Hoffmann Propeller GmbH & Co. KG, Sales and Service, Küpferlingstrasse 9, 83022 Rosenheim, Germany; phone: +49 (0) 8031 1878 0; fax: +49 (0) 8031 1878 78; email: [email protected] You may view this service information at the FAA, Engine & Propeller Standards Branch, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7759.

    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-2018-0281; 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 mandatory continuing airworthiness information (MCAI), the regulatory evaluation, any comments received, and other information. The address for Docket Operations (phone: 800-647-5527) is listed above. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Maureen Maisttison, Aerospace Engineer, AIR-7B1, FAA, 1200 District Ave, Burlington, MA 01803; phone: 781-238-7076; fax: 781-238-7151; email: [email protected]

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0281; Product Identifier 2018-NE-06-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

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

    Discussion

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2017-0220, dated November 10, 2017 (referred to hereinafter as “the MCAI”), to address the unsafe condition on these products. The MCAI states:

    In 1983, occurrences were reported of fatigue failure of propeller blade lag screws, at rotation speeds between 2950 and 3250 revolutions per minute (RPM) in flight.

    This condition, if not detected and corrected, could lead to in-flight propeller blade detachment, possibly resulting in damage to the powered sailplane and/or injury to persons on the ground.

    To address this potential unsafe condition, Hoffmann issued Service Bulletin (SB) 4, providing the necessary instructions. Consequently, LBA Germany issued AD 83-150 (later revised), which applied only to HO-V 62 propellers with R/L 160T blades, when in combination with a Limbach L 2000 engine, to require a limitation of continuous operation to 2 900 RPM, to prohibit aerobatic flights, calibrate the tachometer, install a placard, and inspection of the propeller blades. LBA AD 83-150/4 also required overhaul and replacement of the affected propeller blades with modified blades, either having 5 lag screws with 12 mm diameter, or 6 screws, and required implementing a time between overhaul (TBO) of 600 flight hours (FH).

    Since that AD was issued, based on a stress analysis of lag screws on blades with continuous operating speed above 2 900 RPM, it was determined that the 6-screws configuration or the 5 screws configuration with increased strength is necessary to ensure safe propeller operation. In addition, since the LBA AD applied only to a limited population (Limbach engine only), many propellers have not been modified as described in Hoffmann SB 4C. Consequently, Hoffmann issued SB E34 Revision B, to provide blade replacement instructions.

    You may obtain further information by examining the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0281.

    Related Service Information

    We reviewed Hoffmann Propeller GmbH & Co. KG Service Bulletin (SB) E34, Rev. B, dated September 18, 2017. The SB describes the instructions for the removal and installation of the propeller blades.

    FAA's Determination

    This product has been approved by EASA, and is approved for operation in the United States. Pursuant to our bilateral agreement with the European Community, EASA has notified us 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 provided by EASA and determined the unsafe condition previously described is likely to exist or develop in other products of the same type design.

    Proposed AD Requirements

    This proposed AD would require removal of the affected propeller blades and installation of the modified propeller blades marked with change letter “A” or “B” on the blade.

    Differences Between This Proposed AD and the MCAI or Service Information

    EASA AD 2017-0220 partially restates the requirements of AD 83-150, issued on December 21, 1984, by German aviation authority Luftfahrt-Bundesamt (LBA), which is based on Propellerwerk Hoffmann Rosenheim SB 4, Revision C, dated February 20, 1984. EASA AD 2017-0220 also adds new requirements based on the issuance of Hoffmann Propeller GmbH & Co. KG SB E34, Rev. B dated September 18, 2017.

    In restating LBA AD 83-150, EASA AD 2017-0220 maintains a requirement to remove certain propellers from service within 10 flight hours after December 21, 1984, but not later than 31 March 31, 1985. Service Bulletin E34 requires a mandatory immediate maximum propeller rotational speed limitation until the permanent corrective action is completed, within 50 flight hours. The EASA AD 2017-0220 partially restated requirements of SB 4. Additionally, Hoffmann Propeller GmbH & Co. KG SB E34 Revision B and SB 4 Revision C temporarily prohibit acrobatic flight. EASA AD 2017-0220 also adds a new requirement for a mandatory maximum propeller rotational speed limitation within 30 days until the propeller is replaced within 50 flight hours.

    This proposed AD does not require a propeller speed limitation but would require removal of the affected propeller blades and installation of modified propeller blades within 30 days of the effective date of this AD.

    Costs of Compliance

    We estimate that this proposed AD affects 50 propellers installed on airplanes of U.S. registry.

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

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Replace Blades between overhaul 3.0 work-hours × $85 per hour = $255.00 $3,150.00 $3,405.00 $85,125.00 Replace Blades at overhaul 0 work-hours × $85 per hour = $0.00 3,150.00 3,150.00 78,750.00
    Authority for This Rulemaking

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

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

    This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

    Regulatory Findings

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Hoffmann Propeller GmbH & Co. KG: Docket No. FAA-2018-0281; Product Identifier 2018-NE-06-AD. (a) Comments Due Date

    We must receive comments by August 27, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Hoffmann Propeller GmbH & Co. KG model HO-V 62 propellers without modified blades marked with change letter “A” or “B” suffix to the S/N.

    (d) Subject

    Joint Aircraft System Component (JASC) Code 6110, Propeller Assembly.

    (e) Unsafe Condition

    This AD was prompted by the failure of the propeller blade lag screws. We are issuing the AD to prevent failure of the propeller. The unsafe condition, if not addressed, could result in the release of the propeller blade, damage to the aircraft, injury and/or loss of life.

    (f) Compliance

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

    (g) Required Actions

    Within 30 days of the effective date of this AD, remove the applicable propeller blades and install modified propeller blades marked with a change letter “A” or “B” suffix to the S/N marked on the blade.

    (h) Installation Prohibition

    After the effective date of this AD, do not install a propeller blade if it is not marked with a change letter “A” or “B” suffix to the S/N marked on the blade.

    (i) Alternative Methods of Compliance (AMOCs)

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

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

    (j) Related Information

    (1) For more information about this AD, contact Maureen Maisttison, Aerospace Engineer, AIR-7B1, FAA, 1200 District Ave, Massachusetts, 01803; phone: 781-238-7076; fax: 781-238-7151; email: [email protected]

    (2) Refer to European Aviation Safety Agency AD 2017-0220, dated November 10, 2017, for more information. You may examine the EASA AD in the AD docket on the internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2018-0281.

    (3) For service information identified in this proposed AD, contact Hoffmann Propeller GmbH & Co. KG, Sales and Service, Küpferlingstrasse 9, 83022 Rosenheim, Germany; phone: +49 (0) 8031 1878 0; fax: +49 (0) 8031 1878 78; email: [email protected] You may view this referenced service information at the FAA, Engine & Propeller Standards Branch, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7759.

    Issued in Burlington, Massachusetts, on July 6, 2018. Karen M. Grant, Acting Manager, Engine and Propeller Standards Branch, Aircraft Certification Service.
    [FR Doc. 2018-14862 Filed 7-11-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2011-F-0171] RIN 0910-AH83 Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) proposes to revise the type size labeling requirements for front of package (FOP) calorie declarations for packaged food sold from glass front vending machines. We are taking this action in response to requests from the vending and packaged foods industries to reduce the regulatory burden and increase flexibility, while continuing to provide calorie declarations for certain articles of food sold from vending machines.

    DATES:

    Submit either electronic or written comments on the proposed rule by September 25, 2018. Please note that late, untimely filed comments will not be considered.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2011-F-0171 for “Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size.” Received comments, those filed in a timely manner (see DATES), 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.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    FOR FURTHER INFORMATION CONTACT:

    Marjan Morravej, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371, [email protected]

    SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of This Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Background A. Requirements for Calorie Labeling of Articles of Food in Vending Machines and Our Consideration of Front of Package Labeling Issues B. Challenges of Existing Type Size Requirement, and Proposed Change to “150 Percent of the Size of the Net Quantity of Contents Declaration” C. Other Approaches III. Legal Authority IV. Description of the Proposed Rule (Proposed § 101.8(b)(2)) V. Proposed Effective and Compliance Dates VI. Economic Analysis of Impacts A. Introduction B. Summary of Benefits and Costs of the Proposed Rule VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Federalism X. References I. Executive Summary A. Purpose of This Proposed Rule

    We are proposing to amend our vending machine labeling regulations in 21 CFR part 101 by revising § 101.8(b)(2) (21 CFR 101.8(b)(2)), in order to revise the type size requirement when FOP labeling is used to meet the calorie declaration requirements for articles of food sold from certain vending machines. When using FOP labeling, our existing regulations at § 101.8(b)(2) require that the type size of the calorie declaration for articles of food sold from certain vending machines be at least 50 percent of the size of the largest printed matter on the label. We propose, instead, to require that the type size of the calorie declaration on the front of the package be at least 150 percent (one and one-half times) the size of the net quantity of contents (i.e., net weight) declaration on the package of the vended food. We are proposing this change to reduce regulatory burdens that the vending and packaged foods industries shared with us after the final rule implementing the vending machine labeling requirements (79 FR 71259, December 1, 2014) was issued, while continuing to provide calorie declarations for certain articles of food sold from vending machines. Electronic comments must be submitted on or before September 25, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 25, 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.

    B. Summary of the Major Provisions of the Proposed Rule

    This proposed rule would revise the type size requirement for calories labeled on the front of the package of vended foods in § 101.8(b)(2). We are proposing that the type size be anchored to the net quantity of contents statement, such that the minimum type size is 150 percent (one and one-half times) the size of the net quantity of contents, instead of being based on the largest printed matter on the label. The proposed rule would only apply when calories are displayed on the front of the package of foods sold in glass front vending machines.

    C. Legal Authority

    This action is consistent with our authority in section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)(5)(H)). The FD&C Act, at section 403(q)(5)(H), requires certain vending machine operators to provide calorie declarations for certain articles of food sold from vending machines. In addition, we are issuing this proposed rule consistent with our authority in sections 201(n), 403(a)(1), and 403(f), of the FD&C Act (21 U.S.C. 321(n), 343(a)(1), and 343(f)). Further, we are issuing this proposed rule under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), which gives us the authority to issue regulations for the efficient enforcement of the FD&C Act. We discuss our legal authority in greater detail in Section III, “Legal Authority.”

    D. Costs and Benefits

    In response to requests from the vending and packaged foods industries to reduce the regulatory burden and increase flexibility, FDA is proposing to revise the existing type size requirements when calories are displayed on the front of the package of foods sold in glass front vending machines. Because this rule only proposes minor revisions to FOP calorie labeling type size requirements, we estimate there are no costs to vending machine operators and potential costs savings to vending machine operators and packaged food manufacturers. We welcome data that would help us to better estimate these impacts.

    II. Background A. Requirements for Calorie Labeling of Articles of Food in Vending Machines and Our Consideration of Front of Package Labeling Issues

    Section 403(q)(5)(H) of the FD&C Act requires certain vending machine operators to provide calorie declarations for certain articles of food sold from vending machines. Under section 403(q)(5)(H)(viii) of the FD&C Act, if an article of food is sold from a vending machine that does not permit a prospective purchaser to examine the Nutrition Facts label before purchasing the article, or does not otherwise provide visible nutrition information at the point of purchase; and is operated by a person who is engaged in the business of owning or operating 20 or more vending machines, the vending machine operator must “provide a sign in close proximity to each article of food or the selection button that includes a clear and conspicuous statement disclosing the number of calories contained in the article.”

    In the Federal Register of December 1, 2014 (79 FR 71259), we issued a final rule to implement the vending machine labeling requirements in section 403(q)(5)(H) of the FD&C Act. The final rule, which became effective on December 1, 2016, requires vending machine operators that own or operate 20 or more vending machines (or that voluntarily register with us to be subject to the final rule) to provide calorie declarations for certain articles of food sold from vending machines. The final rule describes which foods are subject to the calorie declaration requirement. The final rule also establishes type size, color, and contrast requirements for calorie declarations in, or on, the vending machines and for calorie declarations on signs adjacent to the vending machines. The final rule also clarifies that vending machine operators do not have to provide calorie information for a food if a prospective purchaser can view certain calorie information on the front of the package, in the Nutrition Facts label on the food, or in a reproduction of the Nutrition Facts label for the food, subject to certain requirements. The calorie declaration requirements covered in the final rule are codified at § 101.8.

    In the Federal Register of August 1, 2016 (81 FR 50303), we issued a final rule that extended the compliance date for final calorie declaration requirements for certain food products sold from glass-front vending machines to July 26, 2018. The extended compliance date applies only to those products in glass front vending machines that provide FOP calorie disclosures and that comply with all aspects of the final vending machine labeling rule except that the disclosure is not 50 percent of the size of the largest print on the label.

    In the preamble of the proposed rule (published in the Federal Register of April 6, 2011 (76 FR 19237 at 19244)), we stated that FOP labeling could be a way to provide “visible nutrition information,” as long as the criteria for color, font, and type size are met, and total calories contained in the vended food are included. We also tentatively concluded that the visible nutrition information must be in a type size reasonably related to the most prominent printed matter on the labeling, among other things, such that a purchaser is able to notice and read the information. The preamble to the proposed rule (76 FR 19237 at 19244) explained that we considered “reasonably related” to mean a type size at least 50 percent of the size of the largest print on the label. This type size as specified in the preamble to the proposed rule is consistent with interpretations we have used in food labeling guidance when determining the type size of the statement of identity on packaged foods (Ref. 1).

    In the preamble to the final rule (79 FR 71259 at 71269), we noted that many comments supported the idea that FOP labeling could provide visible nutrition information; these comments said that FOP labeling is the most efficient way to satisfy section 403(q)(5)(H)(viii) of the FD&C Act. Other comments stated that vending machine operators are likely to prefer food products with FOP labeling because operators selling such food products in their vending machines would not have to provide calorie declarations in compliance with section 403(q)(5)(H)(viii)(I)(bb) of the FD&C Act.

    We also discussed several comments that said that interpreting “reasonably related” to mean a type size that is at least 50 percent of the size of the largest print on the label would require a type size that is too large. One comment suggested revising the rule to specify a ratio for the size of the FOP calorie disclosure relative to other printed material on the label. The comment stated that “reasonably related” would be hard to enforce, and we should require the FOP calorie disclosure to be at least two-thirds the size of the largest type size of any other writing on the package, with a minimum size of one-half square inch. Other comments stated we should omit type size or prominence requirements for the FOP calorie disclosure.

    In response to comments to the proposed rule, we revised the rule by removing the words “reasonably related” at § 101.8(b)(2) and instead required the calorie labeling print to be “at least 50 percent of the size of the largest printed matter on the label.” We also noted that vending machine operators had other options for satisfying section 403(q)(5)(H)(viii) of the FD&C Act, including using a vending machine that provides electronic reproductions of Nutrition Facts labels, as provided in § 101.8(b)(1), or posting signs with calorie declarations, as provided in § 101.8(c).

    B. Challenges of Existing Type Size Requirement, and Proposed Change to “150 Percent of the Size of the Net Quantity of Contents Declaration”

    Since the publication of the final rule, several industry representatives indicated that the 50 percent type size requirement for FOP calorie labeling presents significant technical challenges to the packaged foods industry (Refs. 2 and 3). They said it would make the calorie declaration very large on some products and would make label redesign difficult or not practical. They explained that, for glass front vending machines without electronic displays, FOP labeling assures that consumers will get accurate calorie information for vended foods. The industry representatives also said that many packaged food manufacturers who wish to help vending machine operators comply with the regulations by providing packaged foods with FOP labeling will have to redesign their labels at great expense. They noted the existence of several voluntary FOP labeling programs where calorie information is presented in a FOP type size that ranges from 100 to 150 percent of the size of the net quantity of contents statement on the principal display panel. They acknowledged these labeling programs do not meet our type size requirements, and said that complying with the type size requirement for calorie labeling would significantly disrupt their FOP nutrition labeling programs because there would no longer be enough room on the label to accommodate both the voluntary FOP information and our calorie labeling requirement. Thus, they said that the nutrition information beyond calorie labeling that is presently provided under industry FOP programs may no longer be included. Additionally, they said that, while the existing FOP labeling may not be at least 50 percent of the size of the largest printed matter on the label, as required by our rule, the calorie information is nonetheless visible to consumers. Finally, they stated that, in most cases, industry would be able to comply with a rule that linked the FOP type size for calorie labeling if it were no larger than 150 percent of the type size of the net quantity of contents statement. Other industry representatives also have expressed support for using the 150 percent standard for purposes of the FOP type size requirement (Refs. 4-7).

    Consequently, the proposed rule would remove the requirement specifying the FOP labeling be at least 50 percent of the size of the largest printed matter on the label and instead link the type size to the size of the net quantity of contents statement. Specifically, the proposed rule would revise § 101.8(b)(2) pertaining to “articles of food not covered” to state that the visible nutrition information must be in a type size at least 150 percent of the size of the net quantity of contents declaration on the front of the package.

    This revision, if finalized, would allow for greater flexibility for the use of FOP calorie labeling in glass front vending machines, while still ensuring that a FOP calorie declaration would be visible for the consumer, regardless of the size of the package. It also would minimize the need for label changes for foods that currently have voluntary FOP calorie declarations that are 150 percent of the size of the net quantity of content statement provided the calorie declarations meet the other criteria in the final rule. It is our understanding that many packaged food products sold in glass front vending machines that currently bear FOP calorie labeling would meet the 150 percent requirement that we are proposing. However, to more fully understand the current marketplace, we specifically invite comment and data on the percentage of food products commonly sold in glass front vending machines bearing voluntary FOP calorie labeling, and for those products that currently bear voluntary FOP calorie labeling, the type size of the FOP calorie labeling used on the products.

    C. Other Approaches

    Data and information currently available to FDA indicate that the proposed rule is consistent with some existing voluntary FOP calorie declarations currently used on food product labels and it is feasible for other foods that may be sold in vending machines. We also evaluated two other approaches for providing visible nutrition information that would meet the criteria in section 403(q)(5)(H)(viii) of the FD&C Act, such that the food would not be subject to the vending machine calorie labeling requirements. We invite comment on these two alternative approaches, described more fully below.

    1. Alternative Approach A—At Least 100 Percent of the Size of the Net Quantity of Contents Declaration

    The first alternative approach would be to require the visible nutrition information to be in a type size that is at least 100 percent of the size of the net quantity of contents declaration. Our existing food labeling regulations for packaged foods, at 21 CFR 101.7(i), require that the declaration of net quantity be in letters and numerals in a type size that is established in relation to the area of the principal display panel of the package and that the declaration be uniform for all packages of substantially the same size. The regulation prescribes the following size specifications for net quantity declarations:

    • Not less than one-sixteenth inch in height on packages the principal display panel of which has an area of 5 square inches or less;

    • Not less than one-eighth inch in height on packages the principal display panel of which has an area of more than 5 but not more than 25 square inches;

    • Not less than three-sixteenths inch in height on packages the principal display panel of which has an area of more than 25 but not more than 100 square inches; and

    • Not less than one-fourth inch in height on packages the principal display panel of which has an area of more than 100 square inches, except not less than 1/2 inch in height if the area is more than 400 square inches.

    If the declaration is blown, embossed, or molded on a glass or plastic surface rather than by printing, typing, or coloring, then the lettering sizes are to be increased by one-sixteenth of an inch.

    We considered requiring the visible nutrition information to be in a type size that is at least 100 percent of the size of the net quantity of contents declaration on the front of the package; in other words, the visible nutrition information would, at a minimum, be the same size as the net quantity of contents declaration. We invite comment on the impact of meeting the visible nutrition information criteria, required under section 403(q)(5)(H)(viii) of the FD&C Act, especially on food in smaller packages, such as small candy bars or single serve bags of nuts, that are sold in glass front vending machines under this alternative approach where the FOP calorie declaration is at least the same size as the net quantity of contents declaration.

    FDA invites comment on the advantages and disadvantages of this alternative.

    2. Alternative Approach B—Not Specifying Any Size

    The second alternative approach would be to not specify any size for the visible nutrition information. This option would give the packaged food industry considerable flexibility in deciding how large—or how small—voluntary FOP calorie labeling could be, and may reduce the need for packaging changes for some manufacturers. We note that in developing the final vending machine labeling rule, we considered, but disagreed with comments asking that we omit requirements for prominence or type size of FOP calorie disclosures. As we discussed in the preamble to that final rule, “When a vending machine food is in a vending machine, a prospective purchaser cannot handle the product to make it easier for the purchaser to read the nutrition information. Therefore, `visible nutrition information' on the front of package must be large enough, and prominent enough, for prospective purchasers to see and use the information” (79 FR 71259 at 71269).

    We invite comment on the advantages and disadvantages of this alternative.

    III. Legal Authority

    We are proposing to revise the labeling requirements for providing calorie declarations for food sold from certain vending machines, as set forth in this proposed rule, consistent with our authority in section 403(q)(5)(H) of the FD&C Act. Under section 403(q)(5)(H), certain vending machine operators must provide calorie declarations for certain articles of food sold from vending machines. Under section 403(a)(1) of the FD&C Act, such information must be truthful and non-misleading. Under section 403(f) of the FD&C Act, any word, statement, or other information required by or under the FD&C Act to appear on the label or labeling of an article of food must be prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. Under section 403(a), (f), or (q) of the FD&C Act, food to which these requirements apply is deemed misbranded if these requirements are not met. In addition, under section 201(n) of the FD&C Act, the labeling of food is misleading if it fails to reveal facts that are material in light of representations made in the labeling or with respect to consequences that may result from use. Thus, we are issuing this proposed rule under sections 201(n), 403(a)(1), 403(f), and 403(q)(5)(H) of the FD&C Act, as well as under section 701(a) of the FD&C Act, which gives us the authority to issue regulations for the efficient enforcement of the FD&C Act.

    IV. Description of the Proposed Rule (Proposed § 101.8(b)(2))

    The proposed rule would make a change to the existing rule for calorie labeling of food sold from vending machines, in order to reduce the regulatory burden and increase flexibility while continuing to provide calorie declarations for certain articles of food sold from vending machines. We propose to revise § 101.8(b)(2) to remove the requirement that the type size of the visible calorie declaration for articles of food be at least 50 percent of the size of the largest printed matter on the label and, instead, to require the type size to be at least 150 percent (one and one-half times) the size of the net quantity of contents (i.e., net weight) declaration on the package of the vended food. We also would make a minor editorial correction to the same sentence in § 101.8(b)(2), substituting the word “prospective” in place of “perspective.”

    We also would revise the first sentence of § 101.8(b)(2) by inserting a comma after the word “minimum.” This change corrects a punctuation error.

    V. Proposed Effective and Compliance Dates

    We are proposing that any final rule resulting from this rulemaking have an effective date of 30 days after the date of its publication in the Federal Register. We also are proposing that covered vending machine operators comply with any final rule resulting from this rulemaking by January 1, 2020. We are proposing this compliance date in order to provide sufficient time for the packaged food industry to revise their labels, as appropriate, consistent with any new requirements.

    As discussed in section II.A., by July 26, 2018, vending machine operators with glass front vending machines will have to comply with all vending machine requirements of the final rule issued in 2014. However, it is unlikely that we will be able to complete the current rulemaking to revise the type size labeling requirements for FOP calorie declarations before the July 26, 2018 compliance date. Therefore, pending completion of this rulemaking, FDA intends to exercise enforcement discretion with respect to the July 26, 2018 compliance date for products sold in glass front vending machines that provide a FOP calorie disclosure and the product complies with all aspects of the final vending machine labeling rule except that the disclosure is not 50 percent of the size of the largest print on the label.

    Further, as previously noted, vending machine operators with glass front vending machines will have to comply by July 26, 2018, with all vending machine requirements, including complying with calorie disclosure requirements in 21 CFR 101.8(c)(2). Although these requirements cover gums, mints, and roll candy products sold in glass front machines, FDA intends to exercise enforcement discretion, at least until January 1, 2020, with respect to gums, mints, and roll candy products sold in glass front machines in packages that are too small to bear FOP labeling. FDA intends to consider this issue further.

    VI. Economic Analysis of Impacts A. Introduction

    We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13771 requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” This proposed rule has been designated as a significant regulatory action as defined by Executive Order 12866. This proposed rule is expected to be an Executive Order 13771 deregulatory action. Additional details can be found in the proposed rule's preliminary economic analysis.

    The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The vending machine final rule does not impose burdens to the suppliers of vending machine foods. While suppliers are not obliged to engage in FOP calorie labeling, this proposed rule, if finalized, would allow for greater flexibility for the use of FOP calorie labeling in glass front vending machines than the existing regulations, potentially reducing the burden on covered vending machine operators of providing additional calorie labeling. Thus, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.

    The Unfunded Mandates Reform Act of 1995 (section 202(a) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $150 million, using the most current (2017) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

    B. Summary of Benefits and Costs of the Proposed Rule

    FDA proposes to revise the type size labeling requirements for providing FOP calorie declarations for packaged food sold from certain vending machines. We are taking this action in response to requests from the vending and packaged foods industries to reduce the regulatory burden and increase flexibility. The proposed rule would revise the type size requirements for FOP calorie labeling on packaged foods displayed for sale in glass front vending machines.

    There are currently several voluntary FOP labeling programs where calorie information is presented. If finalized, this proposal may provide an increased incentive for packaged food manufacturers to add new or amend current FOP calorie labeling to foods in order to comply with the updated standard. If so, glass front vending machine operators carrying exclusively those products will not have to provide signs with calorie information for the food, providing an opportunity to reduce operator costs. To the extent this occurs, some costs may shift from the vending machine operator to the manufacturer. Packaged food manufacturing firms may choose to incur additional costs associated with amending the FOP label in order to retain revenue streams from current customers, including vending machine operators. If total revenue is greater than total cost, this proposed rule will provide cost savings for packaged food manufacturing firms. We expect the potential cost savings to both vending machine operators and packaged food manufacturers to outweigh the costs to packaged food manufacturers and thus the net effect to be positive, but lack the data to quantify this effect. We welcome data that would help us to better estimate these impacts.

    We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full analysis of economic impacts is available in the docket for this proposed rule (Ref. 8) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

    VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    VIII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no new collection of information beyond what was described in the December 2014 final rule and approved under OMB control number 0910-0782. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

    IX. Federalism

    We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive Order requires Agencies to construe a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute. Federal law includes an express preemption provision that preempts any nutrition labeling requirement of food that is not identical to the requirement of section 403(q) of the FD&C Act, except that this provision does not apply to food that is offered for sale in a restaurant or similar retail food establishment that is not part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items unless such restaurant or similar retail food establishment elects to comply voluntarily with the nutrition information requirements under section 403(q)(5)(H)(ix) of the FD&C Act. The proposed rule would create requirements for nutrition labeling of food under section 403(q) of the FD&C Act that would preempt certain non-identical State and local nutrition labeling requirements.

    Section 4205 of the Patient Protection and Affordable Care Act (ACA), which amended the FD&C Act to require certain vending machine operators to provide calorie declarations for certain articles of food sold from vending machines, also included a Rule of Construction providing that nothing in the amendments made by section 4205 of the ACA shall be construed: (1) To preempt any provision of State or local law, unless such provision establishes or continues into effect nutrient content disclosures of the type required under section 403(q)(5)(H) of the FD&C Act and is expressly preempted under subsection (a)(4) of such section; (2) to apply to any State or local requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food; or (3) except as provided in section 403(q)(5)(H)(ix) of the FD&C Act, to apply to any restaurant or similar retail food establishment other than a restaurant or similar retail food establishment described in section 403(q)(5)(H)(i) of the FD&C Act (see Pub. L. 111-148, section 4205(d) of the ACA, 124 Stat. 119, 576 (2010)).

    We interpret the provisions of section 4205 of the ACA related to preemption to mean that States and local governments may not impose nutrition labeling requirements for food sold from vending machines that must comply with the Federal requirements of section 403(q)(5)(H) of the FD&C Act, unless the State or local requirements are identical to the Federal requirements. In other words, States and localities cannot have additional or different nutrition labeling requirements for food sold either: (1) From vending machines that are operated by a person engaged in the business of owning or operating 20 or more vending machines subject to the requirements of section 403(q)(5)(H)(viii) of the FD&C Act; or (2) from vending machines operated by a person not subject to the requirements of section 403(q)(5)(H)(viii) of the FD&C Act who voluntarily elects to be subject to those requirements by registering biannually under section 403(q)(5)(H)(ix) of the FD&C Act.

    Otherwise, for food sold from vending machines not subject to the nutrition labeling requirements of section 403(q)(5)(H)(viii) of the FD&C Act, States and localities may impose nutrition labeling requirements. Under our interpretation of section 4205(d)(1) of the ACA, nutrition labeling for food sold from these vending machines would not be nutrient content disclosures of the type required under section 403(q)(5)(H)(viii) of the FD&C Act and, therefore, would not be preempted. Under this interpretation, States and localities would be able to continue to require nutrition labeling for food sold from vending machines that are exempt from nutrition labeling under section 403(q)(5) of the FD&C Act. This interpretation is consistent with the fact that Congress included vending machine operators in the voluntary registration provision of section 403(q)(5)(H)(ix) of the FD&C Act. There would have been no need to include vending machine operators in the provision that allows opting into the Federal requirements if States and localities could not otherwise require non-identical nutrition labeling for food sold from any vending machines.

    In addition, the express preemption provisions of 21 U.S.C. 343-1(a)(4) do not preempt any State or local requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food. This is clear from both the literal language of 21 U.S.C. 343-1(a)(4) with respect to the scope of preemption and from the Rule of Construction at section 4205(d)(2) of the ACA.

    X. References

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

    1. FDA, “Guidance for Industry: A Food Labeling Guide (4. Name of Food)”, last updated January 2013. Retrieved from https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM265446.pdf. 2. Letter from Karin F. R. Moore, Vice President and General Counsel, Grocery Manufacturers Association, and cosigned by the American Beverage Association, National Automated Merchandising Association, National Confectioners Association, and SNAC International, to Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition, dated March 31, 2016. 3. Letter from Karin F. R. Moore, Senior Vice President and General Counsel, Grocery Manufacturers Association, and cosigned by the American Beverage Association, National Automated Merchandising Association, National Confectioners Association, and SNAC International, to Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition, dated June 28, 2016. 4. Letter from Karin F. R. Moore, Senior Vice President and General Counsel, Grocery Manufacturers Association, and cosigned by the American Beverage Association, National Automated Merchandising Association, National Confectioners Association, and SNAC International, to Scott Gottlieb, M.D., Commissioner of Food and Drugs, FDA, dated July 19, 2017. 5. Letter from Jason Eberstein, Director, State & Federal Government Affairs, National Automatic Merchandising Association, to Scott Gottlieb, M.D., Commissioner of Food and Drugs, FDA, dated November 21, 2017. 6. Letter from Brad G. Figel, Vice President, North America Public Affairs, Mars, Inc., to Mick Mulvaney, Director, Office of Management and Budget, dated January 30, 2018. 7. Letter from Elizabeth Avery, President and CEO, SNAC International, to Dockets Management Staff, FDA, dated February 12, 2018. 8. FDA, “Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size, Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, Preliminary Small Entity Analysis,” dated June 2018. Also available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR part 101 be amended as follows:

    PART 101—FOOD LABELING 1. The authority citation for part 101 continues to read as follows: Authority:

    15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.

    2. Section 101.8 is amended by revising paragraph (b)(2) to read as follows:
    § 101.8 Vending machines.

    (b) * * *

    (2) The prospective purchaser can otherwise view visible nutrition information, including, at a minimum, the total number of calories for the article of food as sold at the point of purchase. This visible nutrition information must appear on the food label itself. The visible nutrition information must be clear and conspicuous and able to be easily read on the article of food while in the vending machine, in a type size at least 150 percent of the size of the net quantity of contents declaration on the front of the package, and with sufficient color and contrasting background to other print on the label to permit the prospective purchaser to clearly distinguish the information.

    Dated: July 6, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-14906 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers 33 CFR Part 328 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 110, 112, 116, 117, 122, 230, 232, 300, 302, and 401 [EPA-HQ-OW-2017-0203; FRL-9980-52-OW] RIN 2040-AF74 Definition of “Waters of the United States”—Recodification of Preexisting Rule AGENCY:

    Department of Defense, Department of the Army, Corps of Engineers; Environmental Protection Agency (EPA).

    ACTION:

    Supplemental notice of proposed rulemaking.

    SUMMARY:

    The purpose of this supplemental notice is for the Environmental Protection Agency (EPA) and the Department of the Army (agencies) to clarify, supplement and seek additional comment on an earlier proposal, published on July 27, 2017, to repeal the 2015 Rule Defining Waters of the United States (“2015 Rule”), which amended portions of the Code of Federal Regulations (CFR). As stated in the agencies' July 27, 2017 Notice of Proposed Rulemaking (NPRM), the agencies propose to repeal the 2015 Rule and restore the regulatory text that existed prior to the 2015 Rule, as informed by guidance in effect at that time. If this proposal is finalized, the regulations defining the scope of federal Clean Water Act (CWA) jurisdiction would be those portions of the CFR as they existed before the amendments promulgated in the 2015 Rule. Those preexisting regulatory definitions are the ones that the agencies are currently implementing in light of the agencies' final rule published on February 6, 2018, adding a February 6, 2020 applicability date to the 2015 Rule, as well as judicial decisions preliminarily enjoining and staying the 2015 Rule.

    DATES:

    Comments must be received on or before August 13, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2017-0203, at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The agencies may publish any comment received to the 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 agencies will generally not consider comments or comment content located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets.commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Michael McDavit, Office of Water (4504-T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: (202) 566-2428; email address: [email protected]; or Stacey Jensen, Regulatory Community of Practice (CECW-CO-R), U.S. Army Corps of Engineers, 441 G Street NW, Washington, DC 201314; telephone number: (202) 761-6903; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    The agencies propose to repeal the Clean Water Rule: Definition of “Waters of the United States,” 80 FR 37054, and recodify the regulatory definitions of “waters of the United States” that existed prior to the August 28, 2015 effective date of the 2015 Rule. Those preexisting regulatory definitions are the ones that the agencies are currently implementing in light of the agencies' final rule (83 FR 5200, February 6, 2018), which added a February 6, 2020 applicability date to the 2015 Rule. Judicial decisions currently enjoin the 2015 Rule in 24 States as well. If this proposal is finalized, the agencies would administer the regulations promulgated in 1986 and 1988 in portions of 33 CFR part 328 and 40 CFR parts 110, 112, 116, 117, 122, 230, 232, 300, 302, and 401, and would continue to interpret the statutory term “waters of the United States” to mean the waters covered by those regulations, as the agencies are currently implementing those regulations consistent with Supreme Court decisions and longstanding practice, as informed by applicable guidance documents, training, and experience.

    State, tribal, and local governments have well-defined and established relationships with the federal government in implementing CWA programs. Those relationships are not affected by this proposed rule, which would not alter the jurisdiction of the CWA compared to the regulations and practice that the agencies are currently applying. The proposed rule would permanently repeal the 2015 Rule, which amended the longstanding definition of “waters of the United States” in portions of 33 CFR part 328 and 40 CFR parts 110, 112, 116, 117, 122, 230, 232, 300, 302, and 401, and restore the regulations as they existed prior to the amendments in the 2015 Rule.1

    1 While EPA administers most provisions in the CWA, the Department of the Army, Corps of Engineers (Corps) administers the permitting program under section 404. During the 1980s, both agencies adopted substantially similar definitions of “waters of the United States.” See 51 FR 41206, Nov. 13, 1986, amending 33 CFR 328.3; 53 FR 20764, June 6, 1988, amending 40 CFR 232.2.

    The agencies are issuing this supplemental notice of proposed rulemaking (SNPRM) to clarify, supplement and give interested parties an opportunity to comment on certain important considerations and reasons for the agencies' proposal. The agencies clarify herein the scope of the solicitation of comment and the actions proposed. In response to the July 27, 2017 NPRM, (82 FR 34899), the agencies received numerous comments on the impacts of repealing the 2015 Rule in its entirety. Others commented in favor of retaining the 2015 Rule, either as written or with modifications. Some commenters interpreted the proposal as restricting their opportunity to provide such comments either supporting or opposing repeal of the 2015 Rule. In this SNPRM, the agencies reiterate that this regulatory action is intended to permanently repeal the 2015 Rule in its entirety, and we invite all interested persons to comment on whether the 2015 Rule should be repealed.

    The agencies are also issuing this SNPRM to clarify that the rule adding an applicability date to the 2015 Rule does not change the agencies' decision to proceed with this proposed repeal. For the reasons discussed in this notice, the agencies propose to conclude that regulatory certainty would be best served by repealing the 2015 Rule and recodifying the scope of CWA jurisdiction currently in effect. The agencies propose to conclude that rather than achieving its stated objectives of increasing predictability and consistency under the CWA, see 80 FR 37055, the 2015 Rule is creating significant confusion and uncertainty for agency staff, regulated entities, states, tribes, local governments, and the public, particularly in view of court decisions that have cast doubt on the legal viability of the rule. To provide for greater regulatory certainty, the agencies propose to repeal the 2015 Rule and to recodify the pre-2015 regulations, thereby maintaining a longstanding regulatory framework that is more familiar to and better-understood by the agencies, states, tribes, local governments, regulated entities, and the public.

    Further, court rulings against the 2015 Rule suggest that the interpretation of the “significant nexus” standard as applied in the 2015 Rule may not comport with and accurately implement the legal limits on CWA jurisdiction intended by Congress and reflected in decisions of the Supreme Court. At a minimum, the agencies find that the interpretation of the statute adopted in the 2015 Rule is not compelled and raises significant legal questions. In light of the substantial uncertainty associated with the 2015 Rule, including by virtue of a potential stay, injunction, or vacatur of the 2015 Rule in various legal challenges, as well as the substantial experience the agencies already possess implementing the preexisting regulations that the agencies are implementing today, the agencies propose to conclude that administrative goals of regulatory certainty would be best served by repealing the 2015 Rule.

    The agencies also propose to conclude that the 2015 Rule exceeded the agencies' authority under the CWA by adopting such an interpretation of Justice Kennedy's “significant nexus” standard articulated in Rapanos v. United States and Carabell v. United States, 547 U.S. 715 (2006) (“Rapanos”) as to be inconsistent with important aspects of that opinion and to cover waters outside the scope of the Act, even though that concurring opinion was identified as the basis for the significant nexus standard articulated in the 2015 Rule. The agencies also propose to conclude that, contrary to conclusions articulated in support of the rule, the 2015 Rule appears to have expanded the meaning of tributaries and adjacent wetlands to include waters well beyond those regulated by the agencies under the preexisting regulations, as applied by the agencies following decisions of the Supreme Court in Rapanos and Solid Waste Agency of Northern Cook County v. U.S. Army Corps of Engineers, 531 U.S. 159 (2001) (“SWANCC”). The agencies believe that the 2015 Rule may have altered the balance of authorities between the federal and State governments, contrary to the agencies' statements in promulgating the 2015 Rule and in contravention of CWA section 101(b), 33 U.S.C. 1251(b).

    I. Background

    The agencies refer the public to the Executive Summary for the NPRM, 82 FR 34899 (July 27, 2017), and incorporate it by reference herein.

    A. The 2015 Rule

    On June 29, 2015, the agencies issued a final rule (80 FR 37054) amending various portions of the CFR that set forth definitions of “waters of the United States,” a term contained in the CWA section 502(7) definition of “navigable waters,” 33 U.S.C. 1362(7).

    A primary purpose of the 2015 Rule was to “increase CWA program predictability and consistency by clarifying the scope of `waters of the United States' protected under the Act.” 80 FR 37054. The 2015 Rule attempted to clarify the geographic scope of the CWA by placing waters into three categories: (A) Waters that are categorically “jurisdictional by rule” in all instances (i.e., without the need for any additional analysis); (B) waters that are subject to case-specific analysis to determine whether they are jurisdictional, and (C) waters that are categorically excluded from jurisdiction. Waters that are “jurisdictional by rule” include (1) waters which are currently used, were used in the past, or may be susceptible to use in interstate or foreign commerce, including all waters which are subject to the ebb and flow of the tide; (2) interstate waters, including interstate wetlands; (3) the territorial seas; (4) impoundments of waters otherwise identified as jurisdictional; (5) tributaries of the first three categories of “jurisdictional by rule” waters; and (6) waters adjacent to a water identified in the first five categories of “jurisdictional by rule” waters, including wetlands, ponds, lakes, oxbows, impoundments, and similar waters. See id. at 37104.

    The 2015 Rule added new definitions of key terms such as “tributaries” and revised previous definitions of terms such as “adjacent” (by adding a new definition of “neighboring” that is used in the definition of “adjacent”) that would determine whether waters are “jurisdictional by rule.” See id. at 37105. Specifically, a tributary under the 2015 Rule is a water that contributes flow, either directly or through another water, to a water identified in the first three categories of “jurisdictional by rule” waters and that is characterized by the presence of the “physical indicators” of a bed and banks and an ordinary high water mark. “These physical indicators demonstrate there is volume, frequency, and duration of flow sufficient to create a bed and banks and therefore an ordinary high water mark, and thus to qualify as a tributary.” Id. The 2015 Rule does not delineate jurisdiction specifically based on categories with established scientific meanings such as ephemeral, intermittent, and perennial waters that are based on the source of the water and nature of the flow. See id. at 37076 (“Under the rule, flow in the tributary may be perennial, intermittent, or ephemeral.”). Under the 2015 Rule, tributaries need not be demonstrated to possess any specific volume, frequency, or duration of flow, or to contribute flow to a traditional navigable water in any given year or specific time period. Tributaries under the 2015 Rule can be natural, man-altered, or man-made, and they do not lose their status as a tributary if, for any length, there are one or more constructed breaks (such as bridges, culverts, pipes, or dams), or one or more natural breaks (such as wetlands along the run of a stream, debris piles, boulder fields, or a stream that flows underground) so long as a bed and banks and an ordinary high water mark can be identified upstream of the break. Id. at 37105-06.

    In the 2015 Rule, the agencies did not expressly amend the longstanding definition of “adjacent” (defined as “bordering, contiguous, or neighboring”), but the agencies added a new definition of “neighboring” that impacted the interpretation of “adjacent.” The 2015 Rule defined “neighboring” to encompass all waters located within 100 feet of the ordinary high water mark of a category (1) through (5) “jurisdictional by rule” water; all waters located within the 100-year floodplain of a category (1) through (5) “jurisdictional by rule” water and not more than 1,500 feet from the ordinary high water mark of such water; all waters located within 1,500 feet of the high tide line of a category (1) though (3) “jurisdictional by rule” water; and all waters within 1,500 feet of the ordinary high water mark of the Great Lakes. Id. at 37105. The entire water is considered neighboring if any portion of it lies within one of these zones. See id. This regulatory text did not appear in the proposed rule, and thus the agencies did not receive public comment on these numeric measures.

    In addition to the six categories of “jurisdictional by rule” waters, the 2015 Rule identifies certain waters that are subject to a case-specific analysis to determine if they have a “significant nexus” to a water that is jurisdictional. Id. at 37104-05. The first category consists of five specific types of waters in specific regions of the country: Prairie potholes, Carolina and Delmarva bays, pocosins, western vernal pools in California, and Texas coastal prairie wetlands. Id. at 37105. The second category consists of all waters located within the 100-year floodplain of any category (1) through (3) “jurisdictional by rule” water and all waters located within 4,000 feet of the high tide line or ordinary high water mark of any category (1) through (5) “jurisdictional by rule” water. Id. These quantitative measures did not appear in the proposed rule, and thus the agencies did not receive public comment on these specific measures.

    The 2015 Rule defines “significant nexus” to mean a water, including wetlands, that either alone or in combination with other similarly situated waters in the region, significantly affects the chemical, physical, or biological integrity of a category (1) through (3) “jurisdictional by rule” water. 80 FR 37106. “For an effect to be significant, it must be more than speculative or insubstantial.” Id. The term “in the region” means “the watershed that drains to the nearest” primary water.2 Id. This definition is different than the test articulated by the agencies in their 2008 Rapanos Guidance.3 That guidance interpreted “similarly situated” to include all wetlands (not waters) adjacent to the same tributary, a much less expansive treatment of similarly situated waters than in the 2015 Rule.

    2 In this notice, a “primary” water is a category (1) through (3) “jurisdictional by rule” water.

    3See U.S. EPA and U.S. Army Corps of Engineers. Clean Water Act Jurisdiction Following the U.S. Supreme Court's Decision in Rapanos v. United States & Carabell v. United States at 1 (Dec. 2, 2008) (“Rapanos Guidance”), available at https://www.epa.gov/sites/production/files/2016-02/documents/cwa_jurisdiction_following_rapanos120208.pdf. The agencies acknowledge that the Rapanos Guidance did not impose legally binding requirements, see id. at 4 n.17, but believe that this guidance is relevant to the discussion in this notice.

    Under the 2015 Rule, to determine whether a water, alone or in combination with similarly situated waters across a watershed, has such an effect, one must look at nine functions such as sediment trapping, runoff storage, provision of life cycle dependent aquatic habitat, and other functions. It is sufficient for determining whether a water has a significant nexus if any single function performed by the water, alone or together with similarly situated waters in the watershed, contributes significantly to the chemical, physical, or biological integrity of the nearest category (1) through (3) “jurisdictional by rule” water. Id. Taken together, the enumeration of the nine functions and the more expansive consideration of “similarly situated” in the 2015 Rule could mean that the vast majority of water features in the United States may come within the jurisdictional purview of the federal government.4 Indeed, the agencies stated in the 2015 Rule that the “the chemical, physical, and biological integrity of downstream waters is directly related to the aggregate contribution of upstream waters that flow into them, including any tributaries and connected wetlands.” Id. at 37066.

    4 “[T]he vast majority of the nation's water features are located within 4,000 feet of a covered tributary, traditional navigable water, interstate water, or territorial sea.” U.S. EPA and Department of the Army. Economic Analysis of the EPA-Army Clean Water Rule at 11 (May 20, 2015) (“2015 Rule Economic Analysis”) (Docket ID: EPAHQ-OW-2011-0880-20866), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-20866.

    The agencies also retained exclusions from the definition of “waters of the United States” for prior converted cropland and waste treatment systems. Id. at 37105. In addition, the agencies codified several exclusions that reflected longstanding agency practice, and added others such as “puddles” and “swimming pools” in response to concerns raised by stakeholders during the public comment period on the proposed 2015 Rule. Id. at 37096-98, 37105.

    B. Legal Challenges to the 2015 Rule

    Following the 2015 Rule's publication, 31 States 5 and 53 non-state parties, including environmental groups, and groups representing farming, recreational, forestry, and other interests, filed complaints and petitions for review in multiple federal district 6 and appellate 7 courts challenging the 2015 Rule. In those cases, the challengers alleged procedural deficiencies in the development and promulgation of the 2015 Rule and substantive deficiencies in the 2015 Rule itself. Some challengers argued that the 2015 Rule was too expansive while others argued that it excluded too many waters from federal jurisdiction.

    5 Alabama, Alaska, Arizona, Arkansas, Colorado, Florida, Georgia, Idaho, Indiana, Kansas, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Mexico (Environment Department and State Engineer), North Carolina (Department of Environment and Natural Resources), North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, West Virginia, Wisconsin, and Wyoming. Iowa joined the legal challenge later in the process, bringing the total to 32 States.

    6 U.S. District Courts for the Northern and Southern District of Georgia, District of Minnesota, District of North Dakota, Southern District of Ohio, Northern District of Oklahoma, Southern District of Texas, District of Arizona, Northern District of Florida, District of the District of Columbia, Western District of Washington, Northern District of California, and Northern District of West Virginia.

    7 U.S. Court of Appeals for the Second, Fifth, Sixth, Eighth, Ninth, Tenth, Eleventh, and District of Columbia Circuits.

    The day before the 2015 Rule's August 28, 2015 effective date, the U.S. District Court for the District of North Dakota preliminarily enjoined the 2015 Rule in the 13 States that challenged the rule in that court.8 The district court found those States were “likely to succeed” on the merits of their challenge to the 2015 Rule because, among other reasons, “it appears likely that the EPA has violated its Congressional grant of authority in its promulgation of the Rule.” In particular, the court noted concern that the 2015 Rule's definition of tributary “includes vast numbers of waters that are unlikely to have a nexus to navigable waters.” Further, the court found that “it appears likely that the EPA failed to comply with [Administrative Procedure Act (APA)] requirements when promulgating the Rule,” suggesting that certain distance-based measures were not a logical outgrowth of the proposal to the 2015 Rule. North Dakota v. EPA, 127 F. Supp. 3d 1047, 1051, 1056, 1058 (D.N.D. 2015). No party sought an interlocutory appeal.

    8 Alaska, Arizona, Arkansas, Colorado, Idaho, Missouri, Montana, Nebraska, Nevada, New Mexico, North Dakota, South Dakota, and Wyoming. Iowa's motion to intervene in the case was granted after issuance of the preliminary injunction.

    The petitions for review filed in the courts of appeals were consolidated in the U.S. Court of Appeals for the Sixth Circuit. In that litigation, state and industry petitioners raised concerns about whether the 2015 Rule violates the Constitution and the CWA and whether its promulgation violated procedural requirements under the APA and other statutes. Environmental petitioners also challenged the 2015 Rule, including exclusions therein. On October 9, 2015, approximately six weeks after the 2015 Rule took effect in the 37 States that were not subject to the preliminary injunction issued by the District of North Dakota, the Sixth Circuit stayed the 2015 Rule nationwide after finding, among other things, that State petitioners had demonstrated “a substantial possibility of success on the merits of their claims.” In re EPA & Dep't of Def. Final Rule, 803 F.3d 804 (6th Cir. 2015) (“In re EPA”).

    On January 13, 2017, the U.S. Supreme Court granted certiorari on the question of whether the courts of appeals have original jurisdiction to review challenges to the 2015 Rule. See Nat'l Ass'n of Mfrs. v. Dep't of Defense, 137 S. Ct. 811 (2017). The Sixth Circuit granted petitioners' motion to hold in abeyance the briefing schedule in the litigation challenging the 2015 Rule pending a Supreme Court decision on the question of the court of appeals' jurisdiction. On January 22, 2018, the Supreme Court, in a unanimous opinion, held that the 2015 Rule is subject to direct review in the district courts. Nat'l Ass'n of Mfrs. v. Dep't of Def., 138 S. Ct. 617, 624 (2018). Throughout the pendency of the Supreme Court litigation (and for a short time thereafter), the Sixth Circuit's nationwide stay remained in effect. In response to the Supreme Court's decision, on February 28, 2018, the Sixth Circuit lifted the stay and dismissed the corresponding petitions for review. See In re Dep't of Def. & EPA Final Rule, 713 Fed. App'x 489 (6th Cir. 2018).

    Since the Supreme Court's jurisdictional ruling, district court litigation regarding the 2015 Rule has resumed. At this time, the 2015 Rule continues to be subject to a preliminary injunction issued by the District of North Dakota as to 13 States: Alaska, Arizona, Arkansas, Colorado, Idaho, Missouri, Montana, Nebraska, Nevada, North Dakota, South Dakota, Wyoming, and New Mexico. The 2015 Rule also is subject to a preliminary injunction issued by the U.S. District Court for the Southern District of Georgia as to 11 more States: Georgia, Alabama, Florida, Indiana, Kansas, Kentucky, North Carolina, South Carolina, Utah, West Virginia, and Wisconsin. See Georgia v. Pruitt, No. 15-cv-79 (S.D. Ga.). In another action, the U.S. District Court for the Southern District of Texas is considering preliminary injunction motions filed by parties including the States of Texas, Louisiana, and Mississippi. See Texas v. EPA, No. 3:15-cv-162 (S.D. Tex.); Am. Farm Bureau Fed'n et al. v. EPA, No. 3:15-cv-165 (S.D. Tex.). At least three additional States are seeking a preliminary injunction in the U.S. District Court for the Southern District of Ohio as well. See, e.g., States' Supplemental Memorandum in Support of Preliminary Injunction, Ohio v. EPA, No. 2:15-cv-02467 (S.D. Ohio June 20, 2018) (brief filed by the States of Ohio, Michigan, and Tennessee in support of the States' motion for a preliminary injunction against the 2015 Rule).

    C. Executive Order 13778, the Notice of Proposed Rulemaking, and the Applicability Date Rule

    The agencies are engaged in a two-step process intended to review and repeal or revise, as appropriate and consistent with law, the definition of “waters of the United States” as set forth in the 2015 Rule. This process began in response to Executive Order 13778 issued on February 28, 2017, by the President entitled “Restoring the Rule of Law, Federalism, and Economic Growth by Reviewing the `Waters of the United States' Rule.” Section 1 of the Executive Order states, “[i]t is in the national interest to ensure the Nation's navigable waters are kept free from pollution, while at the same time promoting economic growth, minimizing regulatory uncertainty, and showing due regard for the roles of the Congress and the States under the Constitution.” The Order directed the EPA and the Army to review the 2015 Rule for consistency with the policy outlined in Section 1 of the Order and to issue a proposed rule rescinding or revising the 2015 Rule as appropriate and consistent with law (Section 2). The Executive Order also directed the agencies to “consider interpreting the term `navigable waters' . . . in a manner consistent with” Justice Scalia's plurality opinion in Rapanos (Section 3).

    On March 6, 2017, the agencies published a notice of intent to review the 2015 Rule and provide notice of a forthcoming proposed rulemaking consistent with the Executive Order. 82 FR 12532. Shortly thereafter, the agencies announced that they would implement the Executive Order in a two-step approach. On July 27, 2017, the agencies published a NPRM (82 FR 34899) that proposed to rescind the 2015 Rule and restore the regulatory text that governed prior to the promulgation of the 2015 Rule, which the agencies have been implementing since the judicial stay of the 2015 Rule consistent with Supreme Court decisions and informed by applicable guidance documents and longstanding agency practice. The agencies invited comment on the NPRM over a 62-day period.

    Shortly after the Supreme Court decided that the courts of appeals do not have original jurisdiction to review challenges to the 2015 Rule and directed the Sixth Circuit to dismiss the consolidated challenges to the 2015 Rule for lack of jurisdiction, the agencies issued a final rule (83 FR 5200, Feb. 6, 2018), after providing notice and an opportunity for public comment, that added an applicability date to the 2015 Rule. The applicability date was established as February 6, 2020. When adding the applicability date to the 2015 Rule, the agencies clarified that they will continue to implement nationwide the previous regulatory definition of “waters of the United States,” consistent with the practice and procedures the agencies implemented before and immediately following the issuance of the 2015 Rule pursuant to the preliminary injunction issued by the District of North Dakota and the nationwide stay issued by the Sixth Circuit. The agencies further explained that the final applicability date rule would ensure regulatory certainty and consistent implementation of the CWA nationwide while the agencies reconsider the 2015 Rule and potentially pursue further rulemaking to develop a new definition of “waters of the United States.” The applicability date rule was challenged in a number of district courts. Generally, the challenges raise concerns that the agencies' action was arbitrary and capricious because the agencies did not address substantive comments regarding the 2015 Rule, as well as procedural concerns with respect to the length of the public comment period for the proposed applicability date rule. At this time, these challenges remain pending in the district courts where they were filed.

    D. Comments on the Original Notice of Proposed Rulemaking

    The agencies accepted comments on the NPRM from July 27, 2017, through September 27, 2017. The agencies received more than 685,000 comments on the NPRM from a broad spectrum of interested parties. The agencies are continuing to review those extensive comments. Some commenters expressed support for the agencies' proposal to repeal the 2015 Rule, stating, among other things, that the 2015 Rule exceeds the agencies' statutory authority. Other commenters opposed the proposal, stating, among other things, that repealing the 2015 Rule will increase regulatory uncertainty and adversely impact water quality.

    Based on the agencies' careful and ongoing review of the comments submitted in response to the NPRM, the agencies believe that it is in the public interest to provide further explanation and allow interested parties additional opportunity to comment on the proposed repeal of the 2015 Rule. Because some commenters interpreted the NPRM as restricting their ability to comment on the legal and policy reasons for or against the repeal of the 2015 Rule while others submitted comments addressing these topics, the agencies wish to make clear that comments on that subject are solicited. Additionally, some commenters appeared to be confused by whether the agencies proposed a temporary or interim, as opposed to a permanent, repeal of the 2015 Rule. While the agencies did refer to the July 2017 proposal as an “interim action” (82 FR 34902), that was in the context of explaining that the proposal to repeal the 2015 Rule is the first step of a two-step process, as described above, and that the agencies are planning to take the additional, second step of conducting a separate notice and comment rulemaking to propose a new definition of “waters of the United States.” In this notice, the agencies are clarifying that, regardless of the timing or ultimate outcome of that additional rulemaking, the agencies are proposing a permanent repeal of the 2015 Rule at this stage. This was also our intent in the NPRM. Finally, some commenters did not fully understand the precise action the NPRM proposed to take, e.g., repealing, staying, or taking some other action with respect to the 2015 Rule. The agencies are issuing this SNPRM and are inviting all interested persons to comment on whether the agencies should repeal the 2015 Rule and recodify the regulations currently being implemented by the agencies.

    E. Comments on This Supplemental Notice of Proposed Rulemaking

    As discussed in the next sections, the agencies are proposing to permanently repeal the 2015 Rule. The agencies welcome comment on all issues that are relevant to the consideration of whether to repeal the 2015 Rule. In response to the initial NPRM, many commenters have already provided comment on considerations and issues that weigh in favor of or against repeal, including many of the issues articulated below. The agencies will consider all of those previously submitted comments, in addition to any new comments submitted in response to this SNPRM, in taking a final action on this rulemaking. As such, commenters need not resubmit comments already provided in response to the agencies' July 27, 2017 NPRM (82 FR 34899).

    II. Proposal To Repeal the 2015 Rule A. Legal Authority To Repeal

    The agencies' ability to repeal an existing regulation through notice-and-comment rulemaking is well-grounded in the law. The APA defines rulemaking to mean “agency process for formulating, amending, or repealing a rule.” 5 U.S.C. 551(5). The CWA complements this authority by providing the Administrator with broad authority to “prescribe such regulations as are necessary to carry out the functions under this Act.” 33 U.S.C. 1361(a). This broad authority includes regulations that repeal or revise CWA implementing regulations promulgated by a prior administration.

    The Supreme Court has made clear that “[a]gencies are free to change their existing policies as long as they provide a reasoned explanation for the change,” and “[w]hen an agency changes its existing position, it `need not always provide a more detailed justification than what would suffice for a new policy created on a blank slate.' ” Encino Motorcars, LLC v. Navarro, 136 S. Ct. 2117, 2125 (2016) (citations omitted). The NPRM discussed how the agencies may revise or repeal the regulatory definition of “waters of the United States” so long as the agencies' action is based on a reasoned explanation. See 82 FR 34901. The agencies can do so based on changes in circumstance, or changes in statutory interpretation or policy judgments. See, e.g., FCC v. Fox Television Stations, Inc., 556 U.S. 502, 514-15 (2009); Ctr. for Sci. in Pub. Interest v. Dep't of Treasury, 797 F.2d 995, 998-99 & n.1 (D.C. Cir. 1986). The agencies' interpretation of the statutes they administer, such as the CWA, are not “instantly carved in stone”; quite the contrary, the agencies “must consider varying interpretations and the wisdom of [their] policy on a continuing basis, . . . for example, in response to . . . a change in administrations.” Nat'l Cable & Telecommc'ns Ass'n v. Brand X Internet Servs., 545 U.S. 967, 981-82 (2005) (“Brand X”) (internal quotation marks omitted) (quoting Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837, 863-64 (1984)) (citing Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 59 (1983) (Rehnquist, J., concurring in part and dissenting in part)). The Supreme Court and lower courts have acknowledged an agency's ability to repeal regulations promulgated by a prior administration based on changes in agency policy where “the agency adequately explains the reasons for a reversal of policy.” See Brand X, 545 U.S. at 981. A revised rulemaking based “on a reevaluation of which policy would be better in light of the facts” is “well within an agency's discretion,” and “[a] change in administration brought about by the people casting their votes is a perfectly reasonable basis for an executive agency's reappraisal” of its regulations and programs. Nat'l Ass'n of Home Builders v. EPA, 682 F.3d 1032, 1038 & 1043 (D.C. Cir. 2012) (“NAHB”).

    B. Legal Background 1. The Clean Water Act

    Congress amended the Federal Water Pollution Control Act (FWPCA), or Clean Water Act (CWA) as it is commonly called,9 in 1972 to address longstanding concerns regarding the quality of the nation's waters and the federal government's ability to address those concerns under existing law. Prior to 1972, the ability to control and redress water pollution in the nation's waters largely fell to the Corps under the Rivers and Harbors Act of 1899. Congress had also enacted the Water Pollution Control Act of 1948, Public Law 80-845, 62 Stat. 1155 (June 30, 1948), to address interstate water pollution, and subsequently amended that statute in 1956 (giving the statute is current formal name), 1961, and 1965. The early versions of the CWA promoted the development of pollution abatement programs, required states to develop water quality standards, and authorized the federal government to bring enforcement actions to abate water pollution.

    9 The FWPCA is commonly referred to as the CWA following the 1977 amendments to the FWPCA. Public Law 95-217, 91 Stat. 1566 (1977). For ease of reference, the agencies will generally refer to the FWPCA in this notice as the CWA or the Act.

    These early statutory efforts, however, proved inadequate to address the decline in the quality of the nation's waters, see City of Milwaukee v. Illinois, 451 U.S. 304, 310 (1981), so Congress performed a “total restructuring” and “complete rewriting” of the existing statutory framework in 1972, id. at 317 (quoting legislative history of 1972 amendments). That restructuring resulted in the enactment of a comprehensive scheme designed to prevent, reduce, and eliminate pollution in the nation's waters generally, and to regulate the discharge of pollutants into navigable waters specifically. See, e.g., S.D. Warren Co. v. Maine Bd. of Envtl. Prot., 547 U.S. 370, 385 (2006) (“[T]he Act does not stop at controlling the `addition of pollutants,' but deals with `pollution' generally[.]”).

    The objective of the new statutory scheme was “to restore and maintain the chemical, physical, and biological integrity of the Nation's waters.” 33 U.S.C. 1251(a). In order to meet that objective, Congress declared two national goals: (1) “that the discharge of pollutants into the navigable waters be eliminated by 1985;” and (2) “that wherever attainable, an interim goal of water quality which provides for the protection and propagation of fish, shellfish, and wildlife and provides for recreation in and on the water be achieved by July 1, 1983. . . .” Id. at 1251(a)(1)-(2).

    Congress established several key policies that direct the work of the agencies to effectuate those goals. For example, Congress declared as a national policy “that the discharge of toxic pollutants in toxic amounts be prohibited; . . . that Federal financial assistance be provided to construct publicly owned waste treatment works; . . . that areawide waste treatment management planning processes be developed and implemented to assure adequate control of sources of pollutants in each State; . . . [and] that programs for the control of nonpoint sources of pollution be developed and implemented in an expeditious manner so as to enable the goals of this Act to be met through the control of both point and nonpoint sources of pollution.” Id. at 1251(a)(3)-(7).

    Congress envisioned a major role for the states in implementing the CWA, and the CWA also recognizes the importance of preserving the states' independent authority and responsibility in this area. The CWA balances the traditional power of states to regulate land and water resources within their borders with the need for a federal water quality regulation to protect the waters of the United States. For example, the statute reflects “the policy of the Congress to recognize, preserve, and protect the primary responsibilities and rights of States to prevent, reduce, and eliminate pollution” and “to plan the development and use . . . of land and water resources. . . .” Id. at 1251(b). Congress also declared as a national policy that states manage the major construction grant program and implement the core permitting programs authorized by the statute, among other responsibilities. Id. Congress added that “nothing in this Act shall . . . be construed as impairing or in any manner affecting any right or jurisdiction of the States with respect to the waters (including boundary waters) of such States.” Id. at 1370. Congress also pledged to provide technical support and financial aid to the states “in connection with the prevention, reduction, and elimination of pollution.” Id. at 1251(b).

    To carry out these policies, Congress broadly defined “pollution” to mean “the man-made or man-induced alteration of the chemical, physical, biological, and radiological integrity of water,” id. at 1362(19), to parallel the broad objective of the Act “to restore and maintain the chemical, physical, and biological integrity of the Nation's waters,” id. at 1251(a). Congress then crafted a non-regulatory statutory framework to provide technical and financial assistance to the states to prevent, reduce, and eliminate pollution in the broader set of the nation's waters. For example, section 105 of the Act, “Grants for research and development,” authorized EPA “to make grants to any State or States or interstate agency to demonstrate, in river basins or portions thereof, advanced treatment and environmental enhancement techniques to control pollution from all sources, . . . including nonpoint sources, . . . [and] for research and demonstration projects for prevention of pollution of any waters by industry including, but not limited to, the prevention, reduction, and elimination of the discharge of pollutants.” 33 U.S.C. 1255(b)-(c) (emphases added); see also id. at 1256(a) (authorizing EPA to issue “grants to States and to interstate agencies to assist them in administering programs for the prevention, reduction, and elimination of pollution”). Section 108, “Pollution control in the Great Lakes,” authorized EPA to enter into agreements with any state to develop plans for the “elimination or control of pollution, within all or any part of the watersheds of the Great Lakes.” Id. at 1258(a) (emphasis added); see also id. at 1268(a)(3)(C) (defining the “Great Lakes System” as “all the streams, rivers, lakes, and other bodies of water within the drainage basin of the Great Lakes”). Similar broad pollution control programs were created for other major watersheds, including, for example, the Chesapeake Bay, see id. at 1267(a)(3), Long Island Sound, see id. at 1269(c)(2)(D), and Lake Champlain, see id. at 1270(g)(2).

    For the narrower set of the nation's waters identified as “navigable waters” or “the waters of the United States,” id. at 1362(7), Congress created a federal regulatory permitting program designed to address the discharge of pollutants into those waters. Section 301 contains the key regulatory mechanism: “Except as in compliance with this section and sections 302, 306, 307, 318, 402, and 404 of this Act, the discharge of any pollutant by any person shall be unlawful.” Id. at 1311(a). A “discharge of a pollutant” is defined to include “any addition of any pollutant to navigable waters from any point source,” such as a pipe, ditch or other “discernible, confined and discrete conveyance.” Id. at 1362(12), (14) (emphasis added). The term “pollutant,” as compared to the broader term “pollution,” id. at 1362(19), means “dredged spoil, solid waste, incinerator residue, sewage, garbage, sewage sludge, munitions, chemical wastes, biological materials, radioactive materials, heat, wrecked or discarded equipment, rock, sand, cellar dirt and industrial, municipal, and agricultural waste discharged into water.” Id. at 1362(6). Thus, it is unlawful to discharge pollutants into navigable waters (defined in the Act as “the waters of the United States”) from a point source unless the discharge complies with certain enumerated sections of the CWA, including obtaining authorizations to discharge pollutants pursuant to the section 402 National Pollutant Discharge Elimination System (NPDES) permit program and the section 404 dredged or fill material permit program. See id. at 1342 and 1344.

    Under this statutory scheme, the states are responsible for developing water quality standards for waters of the United States within their borders and reporting on the condition of those waters to EPA every two years. Id. at 1313, 1315. States are also responsible for developing total maximum daily loads (TMDLs) for waters that are not meeting established water quality standards and must submit those TMDLs to EPA for approval. Id. at 1313(d). States also have authority to issue water quality certifications or waive certification for every federal permit or license issued within their borders that may result in a discharge to navigable waters. Id. at 1341. A change to the interpretation of “waters of the United States” may change the scope of waters subject to CWA jurisdiction and thus may change the scope of waters for which states may assume these responsibilities under the Act.

    These same regulatory authorities can be assumed by Indian tribes under section 518 of the CWA, which authorizes EPA to treat eligible Indian tribes in a manner similar to states for a variety of purposes, including administering each of the principal CWA regulatory programs. Id. at 1377(e). In addition, states and tribes retain sovereign authority to protect and manage the use of those waters that are not navigable waters under the CWA. See, e.g., id. at 1251(b), 1251(g), 1370, 1377(a). Forty-seven states administer the CWA section 402 permit program for those waters of the United States within their boundaries, and two administer the section 404 permit program. At present, no tribes administer the section 402 or 404 programs.

    The agencies must develop regulatory programs designed to ensure that the full statute is implemented as Congress intended. See, e.g., Hibbs v. Winn, 542 U.S. 88, 101 (2004) (“A statute should be construed so that effect is given to all its provisions, so that no part will be inoperative or superfluous, void or insignificant.”). This includes pursuing the overall “objective” of the CWA to “restore and maintain the chemical, physical, and biological integrity of the Nation's waters,” 33 U.S.C. 1251(a), while implementing the specific “policy” directives from Congress to, among other things, “recognize, preserve, and protect the primary responsibilities and rights of States to prevent, reduce, and eliminate pollution” and “to plan the development and use . . . of land and water resources,” id. at 1251(b). See Webster's II, New Riverside University Dictionary (1994) (defining “policy” as a “plan or course of action, as of a government[,] designed to influence and determine decisions and actions;” an “objective” is “something worked toward or aspired to: Goal”). To maintain that balance, the agencies must determine what Congress had in mind when it defined “navigable waters” in 1972 as simply “the waters of the United States”—and must do so in light of, inter alia, the policy directive to preserve and protect the states' rights and responsibilities.

    Congress' authority to regulate navigable waters derives from its power to regulate the “channels of interstate commerce” under the Commerce Clause. Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1 (1824); see also United States v. Lopez, 514 U.S. 549, 558-59 (1995) (describing the “channels of interstate commerce” as one of three areas of congressional authority under the Commerce Clause). The Supreme Court explained in SWANCC that the term “navigable” indicates “what Congress had in mind as its authority for enacting the Clean Water Act: its traditional jurisdiction over waters that were or had been navigable in fact or which could reasonably be so made.” 531 U.S. 159, 172 (2001). The Court further explained that nothing in the legislative history of the Act provides any indication that “Congress intended to exert anything more than its commerce power over navigation.” Id. at 168 n.3.

    The Supreme Court has cautioned that one must look to the underlying purpose of the statute to determine the scope of federal authority being exercised over navigable waters under the Commerce Clause. See PPL Montana, LLC v. Montana, 132 S. Ct. 1215, 1228 (2012). The Supreme Court did that in United States v. Riverside Bayview Homes, for example, and determined that Congress had intended “to exercise its powers under the Commerce Clause to regulate at least some waters that would not be deemed `navigable' under the classical understanding of that term.” 474 U.S. 121, 133 (1985) (“[T]he evident breadth of congressional concern for protection of water quality and aquatic ecosystems suggests that it is reasonable for the Corps to interpret the term `waters' to encompass wetlands adjacent to waters as more conventionally defined.”); see also SWANCC, 531 U.S. at 167 (noting that the Riverside Bayview “holding was based in large measure upon Congress' unequivocal acquiescence to, and approval of, the Corps' regulations interpreting the CWA to cover wetlands adjacent to navigable waters”).

    The classical understanding of the term navigable was first articulated by the Supreme Court in The Daniel Ball:

    Those rivers must be regarded as public navigable rivers in law which are navigable in fact. And they are navigable in fact when they are used, or are susceptible of being used, in their ordinary condition, as highways of commerce, over which trade and travel are or may be conducted in the customary modes of trade and travel on water. And they constitute navigable waters of the United States within the meaning of the Acts of Congress, in contradistinction from the navigable waters of the States, when they form in their ordinary condition by themselves, or by uniting with other waters, a continued highway over which commerce is or may be carried on with other States or foreign countries in the customary modes in which such commerce is conducted by water.

    77 U.S. (10 Wall.) 557, 563 (1871). Over the years, this traditional test has been expanded to include waters that had been used in the past for interstate commerce, see Economy Light & Power Co. v. United States, 256 U.S. 113, 123 (1921), and waters that are susceptible for use with reasonable improvement, see United States v. Appalachian Elec. Power Co., 311 U.S. 377, 407-10 (1940).

    By the time the 1972 CWA amendments were enacted, the Supreme Court had also made clear that Congress' authority over the channels of interstate commerce was not limited to regulation of the channels themselves, but could extend to activities necessary to protect the channels. See Oklahoma ex rel. Phillips v. Guy F. Atkinson Co., 313 U.S. 508, 523 (1941) (“Congress may exercise its control over the non-navigable stretches of a river in order to preserve or promote commerce on the navigable portions.”). The Supreme Court had also clarified that Congress could regulate waterways that formed a part of a channel of interstate commerce, even if they are not themselves navigable or do not cross state boundaries. See Utah v. United States, 403 U.S. 9, 11 (1971).

    These developments were discussed during the legislative process leading up to the passage of the 1972 CWA amendments, and certain members referred to the scope of the amendments as encompassing waterways that serve as “links in the chain” of interstate commerce as it flows through various channels of transportation, such as railroads and highways. See, e.g., 118 Cong. Rec. 33756-57 (1972) (statement of Rep. Dingell); 118 Cong. Rec. 33699 (Oct. 4, 1972) (statement of Sen. Muskie).10 Other references suggest that congressional committees at least contemplated applying the “control requirements” of the Act “to the navigable waters, portions thereof, and their tributaries.” S. Rep. No. 92-414, 92nd Cong., 1st Sess. at 77 (1971). And in 1977, when Congress authorized State assumption over the section 404 dredged or fill material permitting program, Congress limited the scope of assumable waters by requiring the Corps to retain permitting authority over Rivers and Harbors Act waters (as identified by the Daniel Ball test) plus wetlands adjacent to those waters, minus historic use only waters. See 33 U.S.C. 1344(g)(1).11 This suggests that Congress had in mind a broader scope of waters subject to CWA jurisdiction than waters traditionally understood as navigable. See SWANCC, 531 U.S. at 171; Riverside Bayview, 474 U.S. at 138 n.11.

    10 The agencies recognize that individual member statements are not a substitute for full congressional intent, but they do help provide context for issues that were discussed during the legislative debates. For a detailed discussion of the legislative history of the 1972 CWA amendments, see Albrecht & Nickelsburg, Could SWANCC Be Right? A New Look at the Legislative History of the Clean Water Act, 32 ELR 11042 (Sept. 2002).

    11 For a detailed discussion of the legislative history supporting the enactment of section 404(g), see Final Report of the Assumable Waters Subcommittee (May 2017), App. F.

    Thus, Congress intended to assert federal authority over more than just waters traditionally understood as navigable, and Congress rooted that authority in “its commerce power over navigation.” SWANCC, 531 U.S. at 168 n.3. However, there must necessarily be a limit to that authority and to what water is subject to federal jurisdiction. How the agencies should exercise that authority has been the subject of dispute for decades, but the Supreme Court on three occasions has analyzed the issue and provided some instructional guidance.

    2. U.S. Supreme Court Precedent a. Adjacent Wetlands

    In Riverside Bayview, the Supreme Court considered the Corps' assertion of jurisdiction over “low-lying, marshy land” immediately abutting a water traditionally understood as navigable on the grounds that it was an “adjacent wetland” within the meaning of the Corps' then-existing regulations. 474 U.S. at 124. The Court addressed the question whether non-navigable wetlands may be regulated as “waters of the United States” on the basis that they are “adjacent to” navigable-in-fact waters and “inseparably bound up with” them because of their “significant effects on water quality and the aquatic ecosystem.” See id. at 131-35 & n.9.

    In analyzing the meaning of adjacency, the Court captured the difficulty in determining where the limits of federal jurisdiction end, noting that the line is somewhere between open water and dry land:

    In determining the limits of its power to regulate discharges under the Act, the Corps must necessarily choose some point at which water ends and land begins. Our common experience tells us that this is often no easy task: The transition from water to solid ground is not necessarily or even typically an abrupt one. Rather, between open waters and dry land may lie shallows, marshes, mudflats, swamps, bogs—in short, a huge array of areas that are not wholly aquatic but nevertheless fall far short of being dry land. Where on this continuum to find the limit of “waters” is far from obvious.

    Id. at 132 (emphasis added). Within this statement, the Supreme Court identifies a basic principle for adjacent wetlands: The limits of jurisdiction lie within the “continuum” or “transition” “between open waters and dry land.” Observing that Congress intended the CWA “to regulate at least some waters that would not be deemed `navigable,' ” the Court therefore held that it is “a permissible interpretation of the Act” to conclude that “a wetland that actually abuts on a navigable waterway” falls within the “definition of `waters of the United States.' ” Id. at 133, 135. Thus, a wetland that abuts a navigable water traditionally understood as navigable is subject to CWA permitting because it is “inseparably bound up with the `waters' of the United States.” Id. at 134. “This holds true even for wetlands that are not the result of flooding or permeation by water having its source in adjacent bodies of open water.” Id. The Court also noted that the agencies can establish categories of jurisdiction for adjacent wetlands. See id. at 135 n.9.

    The Supreme Court in Riverside Bayview declined to decide whether wetlands that are not adjacent to navigable waters could also be regulated by the agencies. See id. at 124 n.2 & 131 n.8. In SWANCC, however, the Supreme Court analyzed a similar question in the context of an abandoned sand and gravel pit located some distance from a traditional navigable water, with excavation trenches that ponded—some only seasonally—and served as habitat for migratory birds. 531 U.S. at 162-65. The Supreme Court rejected the government's stated rationale for asserting jurisdiction over these “nonnavigable, isolated, intrastate waters.” Id. at 171-72. In doing so, the Supreme Court noted that Riverside Bayview upheld “jurisdiction over wetlands that actually abutted on a navigable waterway” because the wetlands were “inseparably bound up with the `waters' of the United States.” Id. at 167.12 As summarized by the SWANCC majority:

    12 For additional context, at oral argument during Riverside Bayview, the government attorney characterized the wetland at issue as “in fact an adjacent wetland, adjacent—by adjacent, I mean it is immediately next to, abuts, adjoins, borders, whatever other adjective you might want to use, navigable waters of the United States.” Transcript of Oral Argument at 16, United States v. Riverside Bayview Homes, Inc., 474 U.S. 121 (1985) (No. 84-701).

    It was the significant nexus between the wetlands and “navigable waters” that informed our reading of the CWA in Riverside Bayview Homes. Indeed, we did not “express any opinion” on the “question of authority of the Corps to regulate discharges of fill material into wetlands that are not adjacent to bodies of open water. . . . In order to rule for [the Corps] here, we would have to hold that the jurisdiction of the Corps extends to ponds that are not adjacent to open water. But we conclude that the text of the statute will not allow this.

    Id. at 167-68 (internal citations omitted). That is because the text of section 404(a)—the permitting provision at issue in the case—included the word “navigable” as its operative phrase, and signaled a clear direction to the Court that “Congress had in mind . . . its traditional jurisdiction over waters that were or had been navigable in fact or which could reasonably be so made.” Id. at 172.

    The Court dismissed the argument that the use of the abandoned ponds by migratory birds fell within the power of Congress to regulate activities that in the aggregate have a substantial effect on interstate commerce, or that the targeted use of the ponds as a municipal landfill was commercial in nature. Id. at 173. Such arguments, the Court noted, raised “significant constitutional questions.” Id. “Where an administrative interpretation of a statute invokes the outer limits of Congress' power, we expect a clear indication that Congress intended that result.” Id. at 172-73 (“Congress does not casually authorize administrative agencies to interpret a statute to push the limit of congressional authority.”). This is particularly true “where the administrative interpretation alters the federal-state framework by permitting federal encroachment upon a traditional state power.” Id. at 173; see also Atascadero State Hospital v. Scanlon, 473 U.S. 234, 242-43 (1985) (finding that where Congress intends to alter the “usual constitutional balance between the States and the Federal Government,” it must make its intention to do so “unmistakably clear in the language of the statute”); Gregory v. Ashcroft, 501 U.S. 452, 460-61 (1991) (“[The] plain statement rule . . . acknowledg[es] that the States retain substantial sovereign powers under our constitutional scheme, powers with which Congress does not readily interfere.”). “Rather than expressing a desire to readjust the federal-state balance in this manner, Congress chose [in the CWA] to `recognize, preserve, and protect the primary responsibilities and rights of States . . . to plan the development and use . . . of land and water resources. . . .” SWANCC, 531 U.S. at 174 (quoting 33 U.S.C. 1251(b)). The Court therefore found no clear statement from Congress that it had intended to permit federal encroachment on traditional state power, and construed the CWA to avoid the significant constitutional questions related to the scope of federal authority authorized therein. Id.

    The Supreme Court considered the concept of adjacency again several years later in consolidated cases arising out of the Sixth Circuit. See Rapanos v. United States, 547 U.S. 715 (2006). In one case, the Corps had determined that wetlands on three separate sites were subject to CWA jurisdiction because they were adjacent to ditches or man-made drains that eventually connected to traditional navigable waters several miles away through other ditches, drains, creeks, and/or rivers. Id. at 719-20, 729. In another case, the Corps had asserted jurisdiction over a wetland separated from a man-made drainage ditch by a four-foot-wide man-made berm. Id. at 730. The ditch emptied into another ditch, which then connected to a creek, and eventually connected to Lake St. Clair, a traditional navigable water, approximately a mile from the parcel at issue. The berm was largely or entirely impermeable, but may have permitted occasional overflow from the wetland to the ditch. Id. The Court, in a fractured opinion, vacated and remanded the Sixth Circuit's decision upholding the Corps' asserted jurisdiction over the four wetlands at issue, with Justice Scalia writing for the plurality and Justice Kennedy concurring in the judgment. Id. at 757 (plurality), 787 (Kennedy, J.).

    The plurality determined that CWA jurisdiction only extended to adjacent “wetlands with a continuous surface connection to bodies that are `waters of the United States' in their own right, so that there is no clear demarcation between `waters' and wetlands.” Id. at 742. The plurality then concluded that “establishing that wetlands . . . are covered by the Act requires two findings: first, that the adjacent channel contains a `wate[r] of the United States,' (i.e., a relatively permanent body of water connected to traditional interstate navigable waters); and second, that the wetland has a continuous surface connection with that water, making it difficult to determine where the `water' ends and the `wetland' begins.” Id. (alteration in original).

    In order to reach the adjacency conclusion of this two-part test, the plurality interpreted the Riverside Bayview decision, and subsequent SWANCC decision characterizing Riverside Bayview, as authorizing jurisdiction over wetlands that physically abutted traditional navigable waters. Id. at 740-42. The plurality focused on the “inherent ambiguity” described in Riverside Bayview in determining where on the continuum between open waters and dry land the scope of federal jurisdiction should end. Id. at 740. It was “the inherent difficulties of defining precise bounds to regulable waters,” id. at 741 n.10, according to the plurality, that prompted the Court in Riverside Bayview to defer to the Corps' inclusion of adjacent wetlands as “waters” subject to CWA jurisdiction based on ecological considerations. Id. at 740-41 (“When we characterized the holding of Riverside Bayview in SWANCC, we referred to the close connection between waters and the wetlands they gradually blend into: `It was the significant nexus between the wetlands and `navigable waters' that informed our reading of the CWA in Riverside Bayview Homes.' ”). The plurality also noted that “SWANCC rejected the notion that the ecological considerations upon which the Corps relied in Riverside Bayview . . . provided an independent basis for including entities like `wetlands' (or `ephemeral streams') within the phrase `the waters of the United States.' SWANCC found such ecological considerations irrelevant to the question whether physically isolated waters come within the Corps' jurisdiction.” Id. at 741-42 (emphasis in original).

    Justice Kennedy disagreed with the plurality's determination that adjacency requires a “continuous surface connection” to covered waters. Id. at 772. In reading the phrase “continuous surface connection” to mean a continuous “surface-water connection,” id. at 776, and interpreting the plurality's standard to include a “surface-water-connection requirement,” id. at 774, Justice Kennedy stated that “when a surface-water connection is lacking, the plurality forecloses jurisdiction over wetlands that abut navigable-in-fact waters—even though such navigable waters were traditionally subject to federal authority,” id. at 776, even after the Riverside Bayview Court “deemed it irrelevant whether `the moisture creating the wetlands . . . find[s] its source in the adjacent bodies of water,” id. at 772 (internal citations omitted). This is one reason why Justice Kennedy stated that “Riverside Bayview's observations about the difficulty of defining the water's edge cannot be taken to establish that when a clear boundary is evident, wetlands beyond that boundary fall outside the Corps' jurisdiction.” Id. at 773.

    The plurality did not directly address the precise distinction raised by Justice Kennedy, but did note in response that the “Riverside Bayview opinion required” a “continuous physical connection,” id. at 751 n.13 (emphasis added), and focused on evaluating adjacency between a “water” and a wetland “in the sense of possessing a continuous surface connection that creates the boundary-drawing problem we addressed in Riverside Bayview.” Id. at 757. The plurality also noted that its standard includes a “physical-connection requirement” between wetlands and covered waters. Id. at 751 n.13. In other words, the plurality appeared to be more focused on the abutting nature rather than the source of water creating the wetlands at issue in Riverside Bayview to describe the legal constructs applicable to adjacent wetlands, see id. at 747; see also Webster's II, New Riverside University Dictionary (1994) (defining “abut” to mean “to border on” or “to touch at one end or side of something”), and indeed agreed with Justice Kennedy and the Riverside Bayview Court that “[a]s long as the wetland is `adjacent' to covered waters . . . its creation vel non by inundation is irrelevant.” Id. at 751 n.13.13

    13 The agencies' Rapanos Guidance recognizes the plurality's “continuous surface connection” does not refer to a continuous surface water connection. See, e.g., Rapanos Guidance at 7 n.28 (“A continuous surface connection does not require surface water to be continuously present between the wetland and the tributary.”).

    Because physically disconnected wetlands do not raise the same boundary-drawing concerns presented by actually abutting wetlands, the plurality determined that the rationale in Riverside Bayview does not apply to such features. The plurality stated that “[w]etlands with only an intermittent, physically remote hydrologic connection to `waters of the United States' do not implicate the boundary-drawing problem of Riverside Bayview, and thus lack the necessary connection to covered waters that we described as a `significant nexus' in SWANCC[.]” Id. at 742. The plurality supported this position by referring to the Court's treatment of isolated waters in SWANCC as non-jurisdictional. Id. at 726, 741-42 (“[W]e held that `nonnavigable, isolated, intrastate waters'—which, unlike the wetlands at issue in Riverside Bayview, did not `actually abu[t] on a navigable waterway,'—were not included as `waters of the United States.' ”). The plurality found “no support for the inclusion of physically unconnected wetlands as covered `waters' ” based on Riverside Bayview's treatment of the Corps' definition of adjacent. Id. at 746-47; see also id. at 746 (“[T]he Corps' definition of `adjacent' . . . has been extended beyond reason.”).

    Concurring in the judgment, Justice Kennedy focused on the “significant nexus” between the adjacent wetlands and traditional navigable waters as the basis for determining whether a wetland is a water subject to CWA jurisdiction: “It was the significant nexus between wetlands and navigable waters . . . that informed our reading of the [Act] in Riverside Bayview Homes. Because such a nexus was lacking with respect to isolated ponds, [in SWANCC] the Court held that the plain text of the statute did not permit the Corps' action.” Id. at 767 (internal quotations and citations omitted). Justice Kennedy noted that the wetlands at issue in Riverside Bayview were “adjacent to [a] navigable-in-fact waterway[ ],” while the “ponds and mudflats” considered in SWANCC “were isolated in the sense of being unconnected to other waters covered by the Act.” Id. at 765-66. “Taken together, these cases establish that in some instances, as exemplified by Riverside Bayview, the connection between a nonnavigable water or wetland and a navigable water may be so close, or potentially so close, that the Corps may deem the water or wetland a `navigable water' under the Act. In other instances, as exemplified by SWANCC, there may be little or no connection. Absent a significant nexus, jurisdiction under the Act is lacking.” Id. at 767.

    According to Justice Kennedy, whereas the isolated ponds and mudflats in SWANCC lack the “significant nexus” to navigable waters, it is the “conclusive standard for jurisdiction” based on “a reasonable inference of ecological interconnection” between adjacent wetlands and navigable-in-fact waters that allows for their categorical inclusion as waters of the United States. Id. at 780 (“[T]he assertion of jurisdiction for those wetlands [adjacent to navigable-in-fact waters] is sustainable under the act by showing adjacency alone.”). Justice Kennedy surmised that it may be that the same rationale “without any inquiry beyond adjacency . . . could apply equally to wetlands adjacent to certain major tributaries,” noting that the Corps could establish by regulation categories of tributaries based on volume of flow, proximity to navigable waters, or other factors that “are significant enough that wetlands adjacent to them are likely, in the majority of cases, to perform important functions for an aquatic system incorporating navigable waters.” Id. at 780-81. However, “[t]he Corps' existing standard for tributaries” provided Justice Kennedy “no such assurance” to infer the categorical existence of a requisite nexus between waters traditionally understood as navigable and wetlands adjacent to nonnavigable tributaries. Id. at 781. That is because:

    the breadth of [the tributary] standard—which seems to leave wide room for regulation of drains, ditches, and streams remote from any navigable-in-fact water and carrying only minor water volumes towards it—precludes its adoption as the determinative measure of whether adjacent wetlands are likely to play an important role in the integrity of an aquatic system comprising navigable waters as traditionally understood. Indeed, in many cases wetlands adjacent to tributaries covered by this standard might appear little more related to navigable-in-fact waters than were the isolated ponds held to fall beyond the Act's scope in SWANCC. Id. at 781-82.

    Justice Kennedy stated that, absent development of a more specific regulation, the Corps “must establish a significant nexus on a case-by-case basis when it seeks to regulate wetlands based on adjacency to nonnavigable tributaries. Given the potential overbreadth of the Corps' regulations, this showing is necessary to avoid unreasonable applications of the statute.” Id. at 782. Justice Kennedy explained that “wetlands possess the requisite nexus, and thus come within the statutory phrase `navigable waters,' if the wetlands, either alone or in combination with similarly situated lands in the region, significantly affect the chemical, physical, and biological integrity of other covered waters more readily understood as `navigable.' ” Id. at 780. “Where an adequate nexus is established for a particular wetland, it may be permissible, as a matter of administrative convenience or necessity, to presume covered status for other comparable wetlands in the region.” Id. at 782.

    In describing this significant nexus test, Justice Kennedy relied, in part, on the overall objective of the CWA to “restore and maintain the chemical, physical, and biological integrity of the Nation's waters.” Id. at 779 (quoting 33 U.S.C. 1251(a)). Justice Kennedy also agreed with the plurality that “environmental concerns provide no reason to disregard limits in the statutory text.” Id. at 778. With respect to wetlands adjacent to nonnavigable tributaries, Justice Kennedy therefore determined that “mere adjacency . . . is insufficient. A more specific inquiry, based on the significant-nexus standard, is . . . necessary.” Id. at 786. Not requiring adjacent wetlands to possess a significant nexus with navigable waters, Justice Kennedy noted, would allow a finding of jurisdiction “whenever wetlands lie alongside a ditch or drain, however remote and insubstantial, that eventually may flow into traditional navigable waters. The deference owed the Corps' interpretation of the statute does not extend so far.” Id. at 778-79.

    Based on the agencies' review of this Supreme Court precedent, although the plurality and Justice Kennedy established different standards to determine the jurisdictional status of wetlands adjacent to nonnavigable tributaries, they both appear to agree in principle that the determination must be made using a two-part test that considers: (1) The proximity of the wetland to the tributary; and (2) the status of the tributary with respect to downstream traditional navigable waters. The plurality and Justice Kennedy also agree that the proximity between the wetland and the tributary must be close. The plurality refers to that proximity as a “continuous surface connection” or “continuous physical connection,” as demonstrated in Riverside Bayview. Id. at 742, 751 n.13. Justice Kennedy recognized that “the connection between a nonnavigable water or wetland and a navigable water may be so close, or potentially so close, that the Corps may deem the water or wetland a `navigable water' under the Act.” Id. at 767. The second part of the two-part tests established by the plurality and Justice Kennedy is addressed in the next section.

    b. Tributaries

    The definition of tributaries was not addressed in either Riverside Bayview or SWANCC. And while the focus of Rapanos was on whether the Corps could regulate wetlands adjacent to nonnavigable waters, the plurality and concurring opinions provide some guidance on the regulatory status of tributaries to navigable-in-fact waters.

    The plurality and Justice Kennedy both recognized that the jurisdictional scope of the CWA is not restricted to traditional navigable waters. See id. at 731 (plurality) (“[T]he Act's term `navigable waters' includes something more than traditional navigable waters.”); id. at 767 (Justice Kennedy) (“Congress intended to regulate at least some waters that are not navigable in the traditional sense.”). Both also agree that federal authority under the Act is not without limit. See id. at 731-32 (plurality) (“[T]he waters of the United States . . . cannot bear the expansive meaning that the Corps would give it.”); id. at 778-79 (Justice Kennedy) (“The deference owed to the Corps' interpretation of the statute does not extend” to “wetlands” which “lie alongside a ditch or drain, however remote or insubstantial, that eventually may flow into traditional navigable waters.”).

    With respect to tributaries specifically, both the plurality and Justice Kennedy focus in large part on a tributary's contribution of flow to, and connection with, traditional navigable waters. The plurality would include as waters of the United States “only relatively permanent, standing or flowing bodies of water” and would define such “waters” as including streams, rivers, oceans, lakes and other bodies of waters that form geographical features, noting that all such “terms connote continuously present, fixed bodies of water . . . .” Id. at 732-33, 739. On the other hand, the plurality would likely exclude ephemeral streams and related features. Id. at 733-34, 739, 741. Justice Kennedy would likely exclude some streams considered jurisdictional under the plurality's test. Id. at 769 (noting that under the plurality's test, “[t]he merest trickle, if continuous, would count as a `water' subject to federal regulation, while torrents thundering at irregular intervals through otherwise dry channels would not”).

    In addition, both the plurality and Justice Kennedy would likely include some intermittent streams as waters of the United States. See id. at 732-33 & n.5 (plurality); id. at 769-70 (Justice Kennedy). The plurality noted that its reference to “relatively permanent” waters did “not necessarily exclude streams, rivers, or lakes that might dry up in extraordinary circumstances, such as drought,” or “seasonal rivers, which contain continuous flow during some months of the year but no flow during dry months . . . .” Id. at 732 n.5 (emphasis in original). However, neither the plurality nor Justice Kennedy defined with precision where to draw the line. Nevertheless, the plurality provided that “navigable waters” must have “at bare minimum, the ordinary presence of water,” id. at 734, and Justice Kennedy noted that the Corps can identify by regulation categories of tributaries based on volume of flow, proximity to navigable waters, or other factors that “are significant enough that wetlands adjacent to them are likely, in the majority of cases, to perform important functions for an aquatic system incorporating navigable waters.” Id. at 780-81. And both the plurality and Justice Kennedy agreed that the Corps' assertion of jurisdiction over the wetlands adjacent to the “drains, ditches, and streams remote from any navigable-in-fact water,” id. at 781 (Kennedy), at issue in Rapanos raised significant jurisdictional questions. Id. at 737-38 (plurality); id. at 781-82 (Kennedy).

    3. Principles and Considerations

    From this legal foundation, a few important principles emerge from which the agencies can evaluate their authorities. First, the power conferred on the agencies to regulate the waters of the United States is grounded in Congress' commerce power over navigation. The agencies can choose to regulate beyond waters more traditionally understood as navigable given the broad purposes of the CWA, including some tributaries to those traditional navigable waters, but must provide a reasonable basis grounded in the language and structure of the Act for determining the extent of jurisdiction. The agencies also can choose to regulate wetlands adjacent to the traditional navigable waters and some tributaries, if the wetlands are in close proximity to the tributaries, such as in the transitional zone between open waters and dry land. In the agencies' view, it would not be consistent with Justice Kennedy's Rapanos opinion or the Rapanos plurality opinion to regulate wetlands adjacent to all tributaries, no matter how small or remote from navigable water. The Court's opinion in SWANCC also calls into serious question the agencies' authority to regulate nonnavigable, isolated, intrastate waters that lack a sufficient connection to traditional navigable waters, and suggests that the agencies should avoid regulatory interpretations of the CWA that raise constitutional questions regarding the scope of their statutory authority. The agencies can, however, regulate certain waters by category, which could improve regulatory predictability and certainty and ease administrative burden while still effectuating the purposes of the Act.

    In developing a clear and predictable regulatory framework, the agencies also must respect the primary responsibilities and rights of States and Tribes to regulate their land and water resources. See 33 U.S.C. 1251(b), 1370. The oft-quoted objective of the CWA to “restore and maintain the chemical, physical, and biological integrity of the Nation's waters,” id. at 1251(a), must be implemented in a manner consistent with Congress' policy directives to the agencies. The Supreme Court long ago recognized the distinction between federal waters traditionally understood as navigable and waters “subject to the control of the States.” The Daniel Ball, 77 U.S. (10 Wall.) 557, 564-65 (1871). Over a century later, the Supreme Court in SWANCC reaffirmed the State's “traditional and primary power over land and water use.” 531 U.S. at 174; accord Rapanos, 547 U.S. at 738 (Scalia, J., plurality opinion). Ensuring that States and Tribes retain authority over their land and water resources pursuant to CWA section 101(b) and section 510 helps carry out the overall objective of the CWA, and ensures that the agencies are giving full effect and consideration to the entire structure and function of the Act, including Congress' intent as reflected in dozens of non-regulatory grant, research, nonpoint source, groundwater, and watershed planning programs to assist the states in controlling pollution in the nation's waters, not just its navigable waters.

    Further, the agencies are cognizant that the “Clean Water Act imposes substantial criminal and civil penalties for discharging any pollutant into waters covered by the Act without a permit. . . .” U.S. Army Corps of Eng'rs v. Hawkes Co., 136 S. Ct. 1807, 1812 (2016); see also Sackett v. EPA, 566 U.S. 120, 132-33 (2012) (Alito, J., concurring) (“[T]he combination of the uncertain reach of the Clean Water Act and the draconian penalties imposed for the sort of violations alleged in this case still leaves most property owners with little practical alternative but to dance to the EPA's tune.”). As the Chief Justice observed in Hawkes, “[i]t is often difficult to determine whether a particular piece of property contains waters of the United States, but there are important consequences if it does.” 136 S. Ct. at 1812; see also id. at 1816-17 (Kennedy, J., concurring) (“[T]he reach and systemic consequences of the Clean Water Act remain a cause for concern,” and the Act “continues to raise troubling questions regarding the Government's power to cast doubt on the full use and enjoyment of private property throughout the Nation.”). Given the significant civil and criminal penalties associated with the CWA, it is important for the agencies to promote regulatory certainty while striving to provide fair and predictable notice of the limits of federal jurisdiction. See, e.g., Sessions v. Dimaya, 138 S. Ct. 1204, 1223-25 (2018) (Gorsuch, J., concurring in part and concurring in the judgment) (characterizing fair notice as possibly the most fundamental of the protections provided by the Constitution's guarantee of due process, and stating that vague laws are an exercise of “arbitrary power . . . leaving the people in the dark about what the law demands and allowing prosecutors and courts to make it up”).

    C. Proposed Reasons for Repeal

    The agencies' proposal is based on our view that regulatory certainty may be best served by repealing the 2015 Rule and recodifying the preexisting scope of CWA jurisdiction. Specifically, the agencies are concerned that rather than achieving their stated objectives of increasing regulatory predictability and consistency under the CWA, retaining the 2015 Rule creates significant uncertainty for agency staff, regulated entities, and the public, which is compounded by court decisions that have increased litigation risk and cast doubt on the legal viability of the rule. To provide for greater regulatory certainty, the agencies propose to revert to the pre-2015 regulations, a regulatory regime that is more familiar to and better-understood by the agencies, States, Tribes, local governments, regulated entities, and the public.

    Further, as a result of the agencies' review and reconsideration of their statutory authority and in light of the court rulings against the 2015 Rule that have suggested that the agencies' interpretation of the “significant nexus” standard as applied in the 2015 Rule was expansive and does not comport with and accurately implement the limits on jurisdiction reflected in the CWA and decisions of the Supreme Court, the agencies are also concerned that the 2015 Rule lacks sufficient statutory basis. The agencies are proposing to conclude in the alternative that, at a minimum, the interpretation of the statute adopted in the 2015 Rule is not compelled, and a different policy balance can be appropriate.

    Considering the substantial uncertainty associated with the 2015 Rule resulting from its legal challenges, and the substantial experience the agencies and others possess with the longstanding regulatory framework currently being administered by the agencies, the agencies conclude that clarity, predictability, and consistency may be best served by repealing the 2015 Rule and thus are proposing to do so. The agencies may still propose changes to the definition of “waters of the United States” in a future rulemaking.

    Further, the agencies are concerned that certain findings and assumptions supporting adoption of the 2015 Rule were not correct, and that these conclusions, if erroneous, may separately justify repeal of the 2015 Rule. The agencies are concerned and seek comment on whether the 2015 Rule significantly expanded jurisdiction over the preexisting regulatory program, as implemented by the agencies, and whether that expansion altered State, tribal, and local government relationships in implementing CWA programs. The agencies therefore propose to repeal the 2015 Rule in order to restore those preexisting relationships and better serve the balance of authorities envisioned in CWA section 101(b).

    1. The 2015 Rule Fails To Achieve Regulatory Certainty

    The agencies are proposing to repeal the 2015 Rule because it does not appear to achieve one of its primary goals of providing regulatory certainty and consistency. When promulgating the 2015 Rule, the agencies concluded the rule would “increase CWA program predictability and consistency by clarifying the scope of `waters of the United States' protected under the Act.” 80 FR 37054. The agencies stated that the 2015 “rule reflect[ed] the judgment of the agencies in balancing the science, the agencies' expertise, and the regulatory goals of providing clarity to the public while protecting the environment and public health, consistent with the law.” Id. at 37065. Since then, developments in the litigation against the 2015 Rule and concerns raised since the rule's promulgation indicate that maintaining the 2015 Rule would produce substantial uncertainty and confusion among state and federal regulators and enforcement officials, the regulated public, and other interested stakeholders. To provide for greater regulatory certainty, the agencies propose to repeal the 2015 Rule and restore a longstanding regulatory framework that is more familiar to and better-understood by the agencies, our co-regulators, and regulated entities, until the agencies propose and finalize a replacement definition.

    a. Litigation to Date

    As noted above, the 2015 Rule has been challenged in legal actions across multiple district courts, in which plaintiffs have raised a number of substantive and procedural claims against the rule. Petitions for review were also filed in multiple courts of appeals and were consolidated in the U.S. Court of Appeals for the Sixth Circuit. To date, all three of the courts that substantively have considered the 2015 Rule—the Sixth Circuit, the District of North Dakota, and the Southern District of Georgia—have found that petitioners seeking to overturn the rule are likely to succeed on the merits of at least some of their claims against the rule.

    In the Sixth Circuit, the court granted a nationwide stay of the 2015 Rule after finding, among other factors, that the petitioners showed a “substantial possibility of success on the merits” of their claims against the 2015 Rule, including claims that the rule was inconsistent with Justice Kennedy's opinion in Rapanos and that the rule's distance limitations were not substantiated by specific scientific support. In re EPA, 803 F.3d 804, 807 (6th Cir. 2015).

    The District of North Dakota made similar findings in issuing a preliminary injunction against the 2015 Rule. There, the court found that the plaintiff-States are “likely to succeed on the merits of their claim” that the rule violated the congressional grant of authority to the agencies under the CWA because the rule “likely fails” to meet Justice Kennedy's significant nexus test. North Dakota v. EPA, 127 F. Supp. 3d 1047, 1055-56 (D.N.D. 2015). The court also found that the plaintiff-States have a fair chance of success on the merits of their procedural claims that the agencies failed to comply with APA requirements in promulgating the rule. Id. at 1056-57.

    The Southern District of Georgia also preliminarily enjoined the 2015 Rule, holding that the State plaintiffs had demonstrated “a likelihood of success on their claims that the [2015] WOTUS Rule was promulgated in violation of the CWA and the APA.” Georgia v. Pruitt, No. 15-cv-79, 2018 U.S. Dist. LEXIS 97223, at *14 (S.D. Ga. June 8, 2018) (“Georgia”) (granting preliminary injunction). The court determined that the 2015 Rule likely failed to meet the standard expounded in SWANCC and Rapanos, and that the rule was likely fatally defective because it “allows the Agencies to regulate waters that do not bear any effect on the `chemical, physical, and biological integrity' of any navigable-in-fact water.” Id. at *17-18. The court also held that the plaintiffs “have demonstrated a likelihood of success on both of their claims under the APA” that the 2015 Rule “is arbitrary and capricious” and “that the final rule is not a logical outgrowth of the proposed rule.” Id. at *18.

    These rulings indicate that substantive or procedural challenges to the 2015 Rule are likely to be successful, particularly claims that the rule is not authorized under the CWA and was promulgated in violation of the APA. A successful challenge to the 2015 Rule could result in a court order vacating the rule in all or part, in all or part of the country, and potentially resulting in different regulatory regimes being in effect in different parts of the country, which would likely lead to substantial regulatory confusion, uncertainty, and inconsistency.

    Notably, the agencies face an increasing risk of a court order vacating the 2015 Rule. The District of North Dakota is proceeding to hear the merits of the plaintiff-States' claims against the 2015 Rule in that case, and the plaintiff-States in the Southern District of Georgia have requested a similar merits-briefing schedule. See Scheduling Order, North Dakota v. EPA, No. 15-cv-59 (D.N.D. May 2, 2018); Response to Defendants' Updated Response to Plaintiff States' Motion for Preliminary Injunction at 11-12, Georgia, No. 15-cv-79 (S.D. Ga. May 29, 2018). Although the applicability date rule ensures that the 2015 Rule will not go into effect until February 6, 2020, the prospect of a court order vacating the 2015 Rule creates additional regulatory uncertainty.

    b. Stakeholder Confusion Regarding the Scope of the 2015 Rule and Extent of Federal CWA Jurisdiction

    Statements made in the litigation against the 2015 Rule and in comments regarding the 2015 Rule indicate that there has been substantial disagreement and confusion as to the scope of the 2015 Rule and the extent of federal CWA jurisdiction more broadly. In the Sixth Circuit, for example, State petitioners asserted that the 2015 Rule covers waters outside the scope of the CWA pursuant to SWANCC and Rapanos and “extends jurisdiction to virtually every potentially wet area of the country.” 14 Industry petitioners contended that the rule's “uncertain standards are impossible for the public to understand or the agencies to apply consistently.” 15 In contrast, environmental petitioners found that SWANCC and Rapanos led to widespread confusion over the scope of the CWA and that the pre-2015 regulatory regime could theoretically apply to “almost all waters and wetlands across the country.” 16 These petitioners asserted that the 2015 Rule violated the CWA by failing to cover certain waters, including waters that may possess a “significant nexus” to traditional navigable waters.17 Whether such comments are accurate or not, they indicate continued widespread disagreement and confusion over the meaning of the 2015 Rule and extent of jurisdiction it entails.

    14 Opening Brief of State Petitioners at 15, 61, In re EPA, No. 15-3751 (6th Cir. Nov. 1, 2016).

    15 Opening Brief for the Business & Municipal Petitioners, In re EPA, No. 15-3751 (6th Cir. Nov. 1, 2016).

    16 Brief of Conservation Groups at 11, In re EPA, No. 15-3751 (6th Cir. Nov. 1, 2016).

    17See, e.g., id. at 22, 43.

    Some comments received on the July 27, 2017 NPRM also demonstrate continued confusion over the scope and various provisions of the 2015 Rule. For example, one commenter found that the rule's definitions of “adjacent,” “significant nexus” and other key terms lack clarity and thus lead to regulatory uncertainty.18 This same commenter contended that the rule could raise constitutional concerns related to the appropriate scope of federal authority and encouraged the agencies to undertake a new rulemaking to more clearly articulate the extent of federal CWA authority. Another commenter echoed these concerns, alleging that the 2015 Rule resulted in a “vague and indecipherable explanation” of the definition of “waters of the United States” that has caused confusion and uncertainty as to the extent of jurisdiction that can be asserted by federal, state and local authorities.19

    18See comments submitted by Oregon Cattlemen's Association (July 27, 2017) (Docket ID: EPA-HQ-OW-2017-0203-0039), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2017-0203-0039.

    19See comments submitted by Skagit County Dike, Drainage and Irrigation District No. 12 and Skagit County Dike District No. 1 (Sept. 27, 2017) (Docket ID: EPA-HQ-OW-2017-0203-11709), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2017-0203-11709.

    The agencies have received comments from numerous other individuals and entities expressing confusion and concern about the extent of federal CWA jurisdiction asserted under the 2015 Rule, and the agencies are continuing to review and consider these comments.

    c. Impact on State Programs

    Like other commenters on the proposal to the 2015 Rule, some States expressed confusion regarding the scope of the proposal and, uniquely, the potential impacts of that uncertainty on States' ability to implement CWA programs. Though some States have stated that the 2015 Rule “more clearly identifies what types of waters would be considered jurisdictional,” 20 others assert that the extent of CWA jurisdiction under the rule remained “fuzzy” and unclear.21 Certain States noted that this uncertainty could “create time delays in obtaining permits which previously were not required” 22 and “result in increased costs to the State and other private and public interests, along with decreased regulatory efficiency.” 23 One State suggested that even if the 2015 Rule established greater regulatory clarity, the rule's case-by-case determinations could result in permitting delays when a jurisdictional determination is required.24

    20See, e.g., comments submitted by State of Washington, Department of Ecology (Nov. 13, 2014) (Docket ID: EPA-HQ-OW-2011-0880-13957), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-13957.

    21See, e.g., comments submitted by State of Oklahoma (Nov. 14, 2014) (Docket ID: EPA-HQ-OW-2011-0880-14625), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-14625; see also comments submitted by National Association of Counties (Nov. 14, 2014) (Docket ID: EPA-HQ-OW-2011-0880-15081), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-15081.

    22See comments submitted by State of Utah, Governor's Office (Nov. 14, 2014) (Docket ID: EPA-HQ-OW-2011-0880-16534), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-16534.

    23See comments submitted by Wyoming Department of Environmental Quality (Nov. 14, 2014) (Docket ID: EPA-HQ-OW-2011-0880-16393), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-16393.

    24See comments submitted by State of Washington, Department of Ecology, supra note 20.

    Similar concerns have been raised in the litigation challenging the 2015 Rule. For example, in the Southern District of Georgia, the State of Indiana has asserted that the 2015 Rule's definition of “waters of the United States” is “vague” and that the rule “imposes . . . unclear regulatory requirements that will result in an inefficient use of limited regulatory resources.” 25 In particular, the State asserts concerns that implementing the 2015 Rule will divert resources by “[d]emanding the time and attention of regulators to make the now-difficult determination of when and whether a feature is a WOTUS” and “[g]enerating unnecessary administrative appeals and lawsuits to resolve jurisdictional disputes.” 26

    25 Statement of Bruno L. Pigott, Georgia, No. 15-cv-79 (S.D. Ga. July 21, 2015).

    26Id.

    d. Agency Experience With the 1986 Regulations

    The agencies have been implementing the pre-2015 regulations (hereinafter referred to as the “1986 regulations”) almost uninterruptedly since 1986. Corps staff are trained on making jurisdictional determinations in the field and through national webinars and classroom or field-based trainings. From June 2007 through June 2018, the Corps issued 241,857 27 approved jurisdictional determinations (AJDs) under their 1986 regulations, as informed by applicable Supreme Court precedent and the agencies' guidance.

    27 U.S. Army Corps of Engineers, OMBIL Regulatory Module (June 5, 2018).

    Through over 30 years of experience, the agencies have developed significant technical expertise with the 1986 regulations and have had the opportunity to refine the application of the rules through guidance and the agencies' experience and federal court decisions. Indeed, the 1986 regulations have been the subject of a wide body of case law, including three significant U.S. Supreme Court decisions 28 and dozens of cases in federal district courts and courts of appeals that have addressed the scope of analysis required. Since 1986, the agencies have issued numerous memoranda, guidance, and question-and-answer documents explaining and clarifying these regulations.29

    28Riverside Bayview, 474 U.S. 121 (1985); SWANCC, 531 U.S. 159 (2001); Rapanos, 547 U.S. 715 (2006).

    29 The Corps maintains many of these documents on its public website, available at https://www.usace.army.mil/Missions/Civil-Works/Regulatory-Program-and-Permits/Related-Resources/CWA-Guidance/. The EPA maintains many of these documents as well; see also https://www.epa.gov/wotus-rule/about-waters-united-states.

    Given the longstanding nature and history of the 1986 regulations, this regulatory regime is more familiar to the agencies, co-regulators, and regulated entities. For this reason, as between the 2015 Rule and the 1986 regulations, the 1986 regulations (as informed by applicable Supreme Court precedent and the agencies' guidance) would appear to provide for greater regulatory predictability, consistency, and certainty, and the agencies seek public comment on this issue. Though the agencies acknowledge that the 1986 regulations have posed certain implementation difficulties and were the subject of court decisions that had the effect of narrowing their scope, the longstanding nature of the regulatory regime—coupled with the agencies' and others' extensive experience with the regulatory scheme—make it preferable to the regulatory uncertainty posed by the 2015 Rule.

    2. The 2015 Rule May Exceed the Agencies' Authority Under the CWA

    The agencies are concerned that the 2015 Rule exceeded EPA's authority under the CWA by adopting an expansive interpretation of the “significant nexus” standard that covers waters outside the scope of the Act and stretches the significant nexus standard so far as to be inconsistent with important aspects of Justice Kennedy's opinion in Rapanos, even though this opinion was identified as the basis for the significant nexus standard articulated in the 2015 Rule. In particular, the agencies are concerned that the 2015 Rule took an expansive reading of Justice Kennedy's significant nexus test and exceeds the agencies' authority under the Act.

    As expounded in Rapanos, Justice Kennedy's significant nexus standard is a test intended to limit federal jurisdiction due to the breadth of the Corps' then-existing standard for tributaries and in order to “prevent[ ] problematic applications of the statute.” 547 U.S. at 783. “Given the potential overbreadth of the Corps' [1986] regulations,” Justice Kennedy found that the showing of a significant nexus “is necessary to avoid unreasonable applications of the statute.” Id. at 782. The agencies are concerned, upon further consideration of the 2015 Rule, that the significant nexus standard articulated in that rule could lead to similar unreasonable applications of the CWA.

    Justice Kennedy wrote that adjacent “wetlands possess the requisite nexus, and thus come within the statutory phrase `navigable waters,' if the wetlands, either alone or in combination with similarly situated lands in the region, significantly affect the chemical, physical, and biological integrity of other covered waters more readily understood as `navigable.' ” 547 U.S. at 780. The opinion did not expressly define the relevant “region” or what was meant by “similarly situated,” but it is reasonable to presume that that the Justice did not mean “similarly situated” to be synonymous with “all” waters in a region. The agencies' Rapanos Guidance, for example, had interpreted the term “similarly situated” more narrowly to “include all wetlands adjacent to the same tributary.” 30 “A tributary . . . is the entire reach of the stream that is of the same order (i.e., from the point of confluence, where two lower order streams meet to form the tributary, downstream to the point such tributary enters a higher order stream).” 31 Thus, under the agencies' 2008 guidance, “where evaluating significant nexus for an adjacent wetland, the agencies will consider the flow characteristics and functions performed by the tributary to which the wetland is adjacent along with the functions performed by the wetland and all other wetlands adjacent to that tributary. This approach reflects the agencies' interpretation of Justice Kennedy's term `similarly situated' to include all wetlands adjacent to the same tributary. . . . Interpreting the phrase `similarly situated' to include all wetlands adjacent to the same tributary is reasonable because such wetlands are physically located in a like manner (i.e., lying adjacent to the same tributary).” 32

    30Rapanos Guidance at 8.

    31Id. at 10.

    32Id.

    The 2015 Rule departed from this interpretation of “similarly situated” wetlands in a “region,” including applying it to other waters, not only wetlands, that were not already categorically jurisdictional as tributaries or adjacent waters. The proposed rule, for example, stated that “[o]ther waters, including wetlands, are similarly situated when they perform similar functions and are located sufficiently close together or sufficiently close to a `water of the United States' so that they can be evaluated as a single landscape unit with regard to their effect on the chemical, physical, or biological integrity of a [primary] water.” 79 FR 22263 (April 21, 2014). The 2015 Rule took it a step further and stated that “the downstream health of larger downstream waters is directly related to the aggregate health of waters located upstream, including waters such as wetlands that may not be hydrologically connected but function together to ameliorate the potential impacts of flooding and pollutant contamination from affecting downstream waters.” 80 FR 37063. The 2015 Rule thus concluded that “[a] water has a significant nexus when any single function or combination of functions performed by the water, alone or together with similarly situated waters in the region, contributes significantly to the chemical, physical, or biological integrity of the nearest [primary] water.” Id. at 37106. The “term `in the region' means the watershed that drains to the nearest [primary] water.” Id.

    An examination of all of the waters in “the watershed” of “the nearest [primary] water” under the 2015 Rule therefore may have materially broadened the scope of aggregation that determines jurisdiction in a “significant nexus” inquiry for waters not categorically jurisdictional from the focus in the proposed rule on waters “located sufficiently close together or sufficiently close to a `water of the United States' so that they can be evaluated as a single landscape unit.” 79 FR 22263. The agencies in finalizing the rule viewed the scientific literature through a broader lens as “the effect of landscape position on the strength of the connection to the nearest `water of the United States,' ” and that “relevant factors influencing chemical connectivity include hydrologic connectivity . . . , surrounding land use and land cover, the landscape setting, and deposition of chemical constituents (e.g., acidic deposition).” 80 FR 37094. The agencies are concerned that this important change in the interpretation of “similarly situated waters” from the proposed 2015 Rule and the 2008 Rapanos Guidance may not be explainable by the scientific literature, including the Connectivity Report 33 cited throughout the preamble to the 2015 Rule, in light of the agencies' view at the time that “[t]he scientific literature does not use the term `significant' as it is defined in a legal context.” 80 FR 37062. The agencies solicit comment on whether the agencies' justification for the 2015 Rule's interpretation of “similarly situated” with reference to an entire watershed for purposes of waters not categorically jurisdictional relied on the scientific literature without due regard for the restraints imposed by the statute and case law, and whether this interpretation of Justice Kennedy's significant nexus standard is a reason, at a minimum because of the legal risk it creates, to repeal the 2015 Rule. As discussed, the 2015 Rule included distance-based limitations that were not specified in the proposal. In light of this, the agencies also solicit comment on whether these distance-based limitations mitigated or affected the agencies' change in interpretation of similarly situated waters in the 2015 Rule.

    33 U.S. EPA. Connectivity of Streams and Wetlands to Downstream Waters: A Review and Synthesis of the Scientific Evidence (Jan. 2015) (EPA/600/R-14/475F).

    The agencies are also concerned that the 2015 Rule does not give sufficient effect to the term “navigable” in the CWA. See South Carolina v. Catawba Indian Tribe, 476 U.S. 498, 510 n.22 (1986) (“It is our duty to give effect, if possible, to every clause and word of a statute[.]” (quoting United States v. Menasche, 348 U.S. 528, 538-39 (1955)) (internal quotation marks omitted)). Justice Kennedy's concurring opinion in Rapanos, on which the 2015 Rule relied heavily for its basis, recognized the term “navigable” must have “some importance” and, if that word has any meaning, the CWA cannot be interpreted to “permit federal regulation whenever wetlands lie along a ditch or drain, however remote and insubstantial, that eventually may flow into traditional navigable waters.” Rapanos, 547 U.S. at 778-79 (Kennedy, J., concurring in judgment). When interpreting the Rapanos decision and its application for determining the scope of CWA jurisdiction in 2008, the agencies wrote “[p]rincipal considerations when evaluating significant nexus include the volume, duration, and frequency of the flow of water in the tributary and the proximity of the tributary to a traditional navigable water.” 34 The agencies are considering whether the 2015 Rule's definitions of “tributary” and “adjacent” were so broad as to eliminate consideration of these factors in a manner consistent with Justice Kennedy's opinion and the CWA.

    34Rapanos Guidance at 10.

    The 2015 Rule stated that the agencies assessed “the significance of the nexus” to navigable water “in terms of the CWA's objective to `restore and maintain the chemical, physical, and biological integrity of the Nation's waters.' ” 80 FR 37056 (quoting 33 U.S.C. 1251(a)). Under the 2015 Rule, a significant nexus may be established by an individual water or by collectively considering “similarly situated” waters across a “region,” defined as “the watershed that drains to the nearest [primary] water identified.” Id. at 37106. The agencies are now concerned that this broad reliance on biological functions, such as the provision of life cycle dependent aquatic habitat, may not comport with the CWA and Justice Kennedy's statement in Rapanos that “environmental concerns provide no reason to disregard limits in the statutory text.” See 547 U.S. at 778. In particular, the agencies are mindful that the Southern District of Georgia's preliminary injunction of the 2015 Rule was based in part on the court's holding that the 2015 Rule likely is flawed for the same reason as the Migratory Bird Rule: “the WOTUS Rule asserts that, standing alone, a significant `biological effect'—including an effect on `life cycle dependent aquatic habitat[s]'—would place a water within the CWA's jurisdiction. Thus, this WOTUS Rule will likely fail for the same reason that the rule in SWANCC failed.” Georgia, 2018 U.S. Dist. LEXIS 97223, at *18 (quoting 33 CFR 328.3(c)(5)). The agencies solicit comment on whether the 2015 Rule is flawed in the same manner as the Migratory Bird Rule, including whether the 2015 Rule raises significant constitutional questions similar to the questions raised by the Migratory Bird Rule as discussed by the Supreme Court in SWANCC.

    Moreover, the 2015 Rule relied on a scientific literature review—the Connectivity Report—to support exerting federal jurisdiction over certain waters based on nine enumerated functions. See 80 FR 37065 (“the agencies interpret the scope of `waters of the United States' protected under the CWA based on the information and conclusions in the [Connectivity] Report”). The report notes that connectivity “occur[s] on a continuum or gradient from highly connected to highly isolated,” and “[t]hese variations in the degree of connectivity are a critical consideration to the ecological integrity and sustainability of downstream waters.” Id. at 37057. In its review of a draft version of the Connectivity Report, EPA's Science Advisory Board (“SAB”) noted, “[s]patial proximity is one important determinant of the magnitude, frequency and duration of connections between wetlands and streams that will ultimately influence the fluxes of water, materials and biota between wetlands and downstream waters.” 35 “Wetlands that are situated alongside rivers and their tributaries are likely to be connected to those waters through the exchange of water, biota and chemicals. As the distance between a wetland and a flowing water system increases, these connections become less obvious.” 36 The Connectivity Report also recognizes that “areas that are closer to rivers and streams have a higher probability of being connected than areas farther away.” Connectivity Report at ES-4.

    35 Science Advisory Board, U.S. EPA. Review of the EPA Water Body Connectivity Report at 60 (Oct. 17, 2014).

    36Id. at 55.

    Yet, the SAB observed that “[t]he Report is a science, not policy, document that was written to summarize the current understanding of connectivity or isolation of streams and wetlands relative to large water bodies such as rivers, lakes, estuaries, and oceans.” 37 “The SAB also recommended that the agencies clarify in the preamble to the final rule that `significant nexus' is a legal term, not a scientific one.” 80 FR 37065. And in issuing the 2015 Rule, the agencies stated, “the science does not provide a precise point along the continuum at which waters provide only speculative or insubstantial functions to downstream waters.” Id. at 37090.

    37Id. at 2.

    The agencies now believe that they previously placed too much emphasis on the information and conclusions of the Connectivity Report when setting jurisdictional lines in the 2015 Rule, relying on its environmental conclusions in place of interpreting the statutory text and other indicia of Congressional intent to ensure that the agencies' regulations comport with their statutory authority to regulate. This is of particular concern to the agencies today with respect to the agencies' broad application of Justice Kennedy's phrase “similarly situated lands. ” As discussed previously, the agencies took an expansive reading of this phrase, in part based on “one of the main conclusions of the [Connectivity Report] . . . that the incremental contributions of individual streams and wetlands are cumulative across entire watersheds, and their effects on downstream waters should be evaluated within the context of other streams and wetlands in that watershed,” see 80 FR 37066. Yet, Justice Kennedy observed in Rapanos that what constitutes a “significant nexus” to the waters of the United States is not a solely scientific question and that it cannot be determined by environmental effects alone. See, e.g., 547 U.S. at 777-78 (noting that although “[s]cientific evidence indicates that wetlands play a critical role in controlling and filtering runoff . . . environmental concerns provide no reason to disregard limits in the statutory text” (citations omitted)). This includes how Congress' use of the term “navigable” in the CWA and how the policies embodied in section 101(b) should inform this analysis. Justice Kennedy wrote that “the Corps deems a water a tributary if it feeds into a traditional navigable water (or a tributary thereof) and possesses an ordinary high-water mark,” defined as a “line on the shore established by the fluctuations of water and indicated by [certain] physical characteristics.” Id. at 781. This “may well provide a reasonable measure of whether specific minor tributaries bear a sufficient nexus with other regulated waters to constitute `navigable waters' under the Act. Yet the breadth of this standard—which seems to leave wide room for regulation of drains, ditches, and streams remote from any navigable-in-fact water and carrying only minor volumes toward it—precludes its adoption as the determinative measure of whether adjacent wetlands are likely to play an important role in the integrity of an aquatic system comprising navigable waters as traditionally understood.” Id. (emphasis added).

    The 2015 Rule, by contrast, asserts jurisdiction categorically over any tributary, including all ephemeral and intermittent streams that meet the rule's tributary definition, as well as all wetlands and other waters that are within certain specified distances from a broadly defined category of tributaries (e.g., all waters located within the 100-year floodplain of a category (1) through (5) “jurisdictional by rule” water and not more than 1,500 feet from the ordinary high water mark of such water). According to the rule, tributaries are characterized by the presence of the physical indicators of a bed and banks and an ordinary high water mark and eventually contribute flow (directly or indirectly) to a traditional navigable water, interstate water, or territorial sea that may be a considerable distance away. See 80 FR 37105. The 2015 Rule defined “ordinary high water mark” as “that line on the shore established by the fluctuations of water and indicated by physical characteristics such as a clear, natural line impressed on the bank, shelving, changes in the character of soil, destruction of terrestrial vegetation, the presence of litter and debris, or other appropriate means that consider the characteristics of the surrounding areas.” Id. at 37106. The 2015 Rule did not require any assessment of flow, including volume, duration, or frequency, when defining the “waters of the United States.” Instead, the 2015 Rule concluded that it was reasonable to presume that “[t]hese physical indicators demonstrate there is volume, frequency, and duration of flow sufficient to create a bed and banks and an ordinary high water mark, and thus to qualify as a tributary.” Id. at 37105. The 2015 Rule thus covers ephemeral washes that flow only in response to infrequent precipitation events if they meet the definition of tributary. These results, particularly that adjacent waters, broadly defined, are categorically jurisdictional no matter how small or frequently flowing the tributary to which they are adjacent, is, at a minimum, in significant tension with Justice Kennedy's understanding of the term significant nexus as explained in Rapanos. See id. at 781-82 (“[I]n many cases wetlands adjacent to tributaries covered by [the Corps' 1986 tributary] standard might appear little more related to navigable-in-fact waters than were the isolated ponds held to fall beyond the Act's scope in SWANCC.”).

    The agencies are mindful that courts that have considered the merits of challenges to the 2015 Rule have similarly observed that the rule may conflict with Justice Kennedy's opinion in Rapanos, particularly the rule's definition of “tributary.” The District of North Dakota found that the definitions in the 2015 Rule raise “precisely the concern Justice Kennedy had in Rapanos, and indeed the general definition of tributary [in the 2015 Rule] is strikingly similar” to the standard for tributaries that concerned Justice Kennedy in Rapanos. North Dakota, 127 F. Supp. 3d at 1056. The Southern District of Georgia also found that the 2015 Rule's definition of “tributary” “is similar to the one” at issue in Rapanos, and that “it carries with it the same concern that Justice Kennedy had there.” Georgia, 2018 U.S. Dist. LEXIS 97223, at *17. Likewise, the Sixth Circuit stated in response to petitioners' “claim that the Rule's treatment of tributaries, `adjacent waters,' and waters having a `significant nexus' to navigable waters is at odds with the Supreme Court's ruling in Rapanos” that “[e]ven assuming, for present purposes, as the parties do, that Justice Kennedy's opinion in Rapanos represents the best instruction on the permissible parameters of `waters of the United States' as used in the Clean Water Act, it is far from clear that the new Rule's distance limitations are harmonious with the instruction.” In re EPA, 803 F.3d at 807 & n.3 (noting that “[t]here are real questions regarding the collective meaning of the [Supreme] Court's fragmented opinions in Rapanos”).

    One example that illustrates this point is the “seasonally ponded, abandoned gravel mining depressions” specifically at issue in SWANCC, 531 U.S. at 164, which the Supreme Court determined were “nonnavigable, isolated, intrastate waters,” id. at 166-72, and not jurisdictional. These depressions are located within 4,000 feet of Poplar Creek, a tributary to the Fox River, and may have the ability to store runoff or contribute other ecological functions in the watershed. Thus, they would be subject to, and might satisfy, a significant nexus determination under the 2015 Rule's case-specific analysis. However, Justice Kennedy himself stated in Rapanos, which informed the significant nexus standard articulated in the rule, that, “[b]ecause such a [significant] nexus was lacking with respect to isolated ponds, the [SWANCC] Court held the plain text of the statute did not permit” the Corps to assert jurisdiction over them. 547 U.S. at 767. Other potential examples of the breadth of the significant nexus standard articulated in the 2015 Rule are provided below in the next section.

    3. Concerns Regarding the 2015 Rule's Effect on the Scope of CWA Jurisdiction

    The agencies asserted in the preamble to the 2015 Rule that “State, tribal, and local governments have well-defined and longstanding relationships with the Federal government in implementing CWA programs and these relationships are not altered by the final rule.” 80 FR 37054. The agencies further noted that “[c]ompared to the current regulations and historic practice of making jurisdictional determinations, the scope of jurisdictional waters will decrease” under the 2015 Rule. Id. at 37101. When compared to more recent practice, however, the agencies determined that the 2015 Rule would result “in an estimated increase between 2.84 and 4.65 percent in positive jurisdictional determinations annually.” Id. The agencies thus concluded that the 2015 Rule would “result in a small overall increase in positive jurisdiction determinations compared to those made under the Rapanos Guidance” and that the “net effect” of the regulatory changes would “be marginal at most.” Brief for Respondents at 32-33 & n.6, In re EPA, No. 15-3571 (6th Cir. Jan. 13, 2017). Since publication of the final rule, the agencies have received information about the impact of these changes, including through filings in litigation against the 2015 Rule and comments received in response to the July 27, 2017 NPRM. After further analysis and reconsideration of how the 2015 Rule is likely to impact jurisdictional determinations, including how the data on those impacts relate to the specific regulatory changes made in the 2015 Rule, the agencies are now considering whether the definitional changes in the 2015 Rule would have a more substantial impact on the scope of jurisdictional determinations made pursuant to the CWA than acknowledged in the analysis for the rule and would thus impact the balance between federal, state, tribal, and local government in a way that gives inadequate consideration to the overarching Congressional policy to “recognize, preserve, and protect the primary responsibilities and rights of States to prevent, reduce, and eliminate pollution” and “to plan the development and use . . . of land and water resources. . . .” 33 U.S.C. 1251(b).

    Between the agencies' “historic” (i.e., 1986 regulations) and “recent” practices of making jurisdictional determinations under the Rapanos Guidance, the Supreme Court held that the agencies' application of the 1986 regulation was overbroad in some important respects. See SWANCC, 531 U.S. at 174 (reversing and remanding the assertion of jurisdiction); Rapanos, 547 U.S. at 715 (vacating and remanding, for further analysis, the assertion of CWA jurisdiction). Throughout the rulemaking process for the 2015 Rule, the agencies stressed in public statements,38 fact sheets,39 blog posts,40 and before Congress 41 that the rule would not significantly expand the jurisdictional reach of the CWA. Some commenters questioned the accuracy of these statements during the rulemaking process for the 2015 Rule and in response to the July 27, 2017 NPRM. The court in North Dakota questioned the scope of waters subject to the 2015 Rule, and based its preliminary injunction in principal part on those doubts, stating, for example, that “the definition of tributary” in the 2015 Rule “includes vast numbers of waters that are unlikely to have a nexus to navigable waters within any reasonable understanding of the term.” 127 F. Supp. 3d at 1056; see also In re EPA, 803 F.3d at 807 (finding that “it is far from clear that the new Rule's distance limitations are harmonious” with Justice Kennedy's significant nexus test in Rapanos); Georgia, 2018 U.S. Dist. LEXIS 97223, at *17 (holding that the 2015 Rule's “tributary” definition “is similar to the one invalidated in Rapanos, and it carries with it the same concern that Justice Kennedy had there”).

    38 Addressing farmers in Missouri in July 2014, then-EPA Administrator Gina McCarthy stated that no additional CWA permits would be required under the proposed 2015 Rule. See: http://www.farmfutures.com/story-epas-mccarthy-ditch-myths-waters-rule-8-114845 (“The bottom line with this proposal is that if you weren't supposed to get a permit before, you don't need to get one now.”).

    39 U.S. EPA. Facts About the Waters of the U.S. Proposal at 4 (July 1, 2014), available at https://www.regulations.gov/contentStreamer?documentId=EPA-HQ-OW-2011-0880-16357&attachmentNumber=38&contentType=pdf (“The proposed rule does not expand jurisdiction.”).

    40 U.S. EPA blog post entitled “Setting the Record Straight on Waters of the US” (June 30, 2014), available at https://blog.epa.gov/blog/2014/06/setting-the-record-straight-on-wous/ (“The proposed rule does not expand jurisdiction.”).

    41 In a hearing before the House Committee on Science, Space, and Technology entitled “Navigating the Clean Water Act: Is Water Wet?” (July 9, 2014), then-Deputy EPA Administrator Bob Perciasepe told the Committee that the agencies are not expanding the jurisdiction of the CWA. See https://science.house.gov/legislation/hearings/full-committee-hearing-navigating-clean-water-act-water-wet.

    Given the concerns raised by some commenters and the federal courts, the agencies have reviewed data previously relied upon to conclude that the 2015 Rule would have no or “marginal at most” impacts on jurisdictional determinations, Brief for Respondents at 32 n.6, In re EPA, No. 15-3571 (6th Cir. Jan. 13, 2017), and are reconsidering the validity of this conclusion. The agencies solicit comment on whether the agencies appropriately characterized or estimated the potential scope of CWA jurisdiction that could change under the 2015 Rule, including whether the documents supporting the 2015 Rule appropriately considered the data relevant to and were clear in that assessment.

    For example, the agencies relied upon an examination of the documents supporting the estimated 2.84 to 4.65 percent annual increase in positive approved jurisdictional determinations (AJDs) to conclude that the 2015 Rule would only “result in a small overall increase in positive jurisdictional determinations compared to those made under the Rapanos Guidance.” See Brief for Respondents at 32, In re EPA, No. 15-3571 (6th Cir. Jan. 13, 2017). However, others have raised concerns that this information and other data show the 2015 Rule may have expanded jurisdiction more significantly, particularly with respect to so-called “other waters” that are not adjacent to navigable waters and their tributaries.

    In developing the 2015 Rule, the agencies examined records in the Corps' Operation and Maintenance Business Information Link, Regulatory Module (ORM2) database that documents jurisdictional determinations associated with various aquatic resource types, including an isolated waters category. “The isolated waters category is used in the Corps' ORM2 database to represent intrastate, non-navigable waters; including wetlands, lakes, ponds, streams, and ditches, that lack a direct surface connection to other waterways. These waters are hereafter referred to as `ORM2 other waters.' ” 42 To examine how assertion of jurisdiction could change under the 2015 Rule, the agencies reviewed ORM2 aquatic resource records from Fiscal Year (FY)13 and FY14 and placed them into three groups: Streams (ORM2 categories of traditionally navigable waters, relatively permanent waters, and non-relatively permanent waters), wetlands adjacent to the stream category group, and other waters. Of the 160,087 records for FY13 and FY14, streams represented 65 percent of the total records available, wetlands represented 29 percent, and other waters represented 6 percent.

    42 2015 Rule Economic Analysis at 7.

    From this baseline, the agencies assumed that 100 percent of the records classified as streams would meet the jurisdictional tests established in the final rule, and 100 percent of the records classified as adjacent wetlands would meet the definition of adjacent in the final rule. These assumptions resulted in a relatively minor projected increase in positive jurisdictional determinations under the final rule for these categories: 99.3 to 100 percent for the streams category, and 98.9 to 100 percent for the wetlands category.

    The agencies also performed a detailed analysis of the other waters category to determine whether jurisdiction might change for those waters under the final rule. In total, “these files represented over 782 individual waters in 32 states.” 43

    43 2015 Rule Economic Analysis at 9.

    Of the existing negative determinations for other waters, the agencies made the following estimates:

    • 17.1 percent of the negative jurisdictional determinations for other waters would become positive under the 2015 Rule because the aquatic resources would meet the new definition of adjacent waters. See 80 FR 37105. These waters fall within the 100-year floodplain and are within 1,500 feet of a stream included in the United States Geological Survey's (USGS) National Hydrography Dataset (NHD).

    • 15.7 percent of the other waters could become jurisdictional under category (7) of the 2015 Rule following a significant nexus analysis. See id. at 37104-05.

    • 1.7 percent of the other waters could become jurisdictional under category (8) of the 2015 Rule following a significant nexus analysis. See id. at 37105.

    In total, the agencies estimated that 34.5 percent of the other waters represented in the FY13 and FY14 ORM2 database could become jurisdictional under the 2015 Rule after having been declared not jurisdictional under the existing regulations and agency guidance. Thus, while the agencies acknowledged in the 2015 Rule Economic Analysis that “[f]ollowing the Supreme Court decisions in SWANCC (2001) and Rapanos (2006), the agencies no longer asserted CWA jurisdiction over isolated waters,” the agencies estimated in the 2015 Rule Economic Analysis that 34.5 percent of the other waters category could become jurisdictional under the 2015 Rule.44 By way of comparison, a similar analysis of this category of other waters performed in support of the proposed rule in 2014 (using FY09 and FY10 data from the ORM2 database) estimated that 17 percent of the negative jurisdictional for other waters would become positive.45

    44 2015 Rule Economic Analysis at 5, 12.

    45 U.S. EPA and U.S. Army Corps of Engineers. Economic Analysis of Proposed Revised Definition of Waters of the United States at 12, Exhibit 3 (Mar. 2014) (Docket ID: EPA-HQ-OW-2011-0880-0003), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-0003.

    While the Economic Analysis for the 2015 Rule estimated that 34.5 percent of negative jurisdictional determinations for other waters would become positive,46 the agencies nevertheless premised the 2015 Rule on assertions that the “scope of jurisdiction in this rule is narrower than that under the existing regulation,” the scope of jurisdiction in the rule would result “in an estimated increase between 2.84 and 4.65 percent in positive jurisdictional determinations annually” based on existing practice, and that such impacts would be “small overall” and “marginal at most.” See 80 FR 37054, 37101; Brief for Respondents at 32-33 & n.6, In re EPA, No. 15-3571 (6th Cir. Jan. 13, 2017). The agencies are examining these statements and how this data relates specifically to the regulatory changes made in the 2015 Rule (as opposed to those provisions which already subjected many streams and wetlands to CWA jurisdiction). The agencies request comment on whether the projected increase for this category is most relevant to measuring the impacts of the 2015 Rule, whether the public had ample notice of the doubling of projected positive jurisdiction over the other waters category from the proposed to final rule, and whether the final rule could expand overall CWA positive jurisdictional determinations by a material amount inconsistent with the findings and conclusions that justified the 2015 Rule.

    46 2015 Rule Economic Analysis at 13, Figure 2.

    In particular, the agencies seek comment on the conclusions that were based on the method that estimated a 2.84 to 4.65 percent increase in overall jurisdiction, including the use of a method whereby the increase in assertion of jurisdiction in a particular category of waters (e.g., streams, wetlands, and other waters) was proportionally applied based on the raw number of records in a category relative to the total number of records across all categories in the ORM2 database, notwithstanding whether the regulatory changes in the 2015 Rule did not materially impact those other categories. For example, of the 160,087 records in the ORM2 database for FY13 and FY14, 103,591 were associated with the streams category, 46,781 were associated with the wetlands category, and 9,715 were related to the other waters category. Thus, although 34.5 percent of previously non-jurisdictional “other waters” would become jurisdictional under the 2015 Rule, the proportional method used in the 2015 Rule Economic Analysis resulted in only an estimated 2.09 percent increase in positive jurisdictional determinations for “other waters” relative to the total number of jurisdictional determinations considered.47

    47 The following summarizes the methodology used to derive the low-end estimated increase in jurisdiction of 2.84 percent: Streams account for 103,591 of the 160,087 total records (64.709 percent of the total ORM2 records) and 100 percent of streams are assumed to be jurisdictional under the final rule compared to 99.3 percent under previous practice (100 percent minus 99.3 percent = 0.7 percent). The relative contribution of streams to the overall change in jurisdictional determinations is thus 64.709 percent multiplied by 0.7 percent for a total of 0.45 percent. Wetlands account for 46,781 of the 160,087 total records (29.222 percent of the total ORM2 records) and 100 percent of wetlands are assumed to be jurisdictional under the final rule compared to 98.9 percent under previous practice (100 percent minus 98.9 percent = 1.1 percent). The relative contribution of wetlands to the overall estimated change in jurisdictional determinations is thus 29.222 percent multiplied by 1.1 percent for a total of 0.32 percent. Other waters account for 9,715 of the 160,087 total records (6.069 percent of the total ORM2 records) and 34.5 percent of other waters are assumed to be jurisdictional under the final rule compared to 0.0 percent under previous practice (34.5 percent minus 0.0 percent = 34.5 percent). The relative contribution of other waters to the overall estimated change in jurisdictional determinations is thus 6.069 percent multiplied by 34.5 percent for a total of 2.09 percent. The agencies then added the relative contribution to the overall estimated change in jurisdictional determinations for each category of waters (i.e., 0.45 percent for streams, 0.32 percent for wetlands, and 2.09 percent for other waters) to get a total projected change in positive jurisdictional determinations of 2.86 percent. The differences between this calculation and the reported 2.84 percent in the 2015 Rule Economic Analysis may be the result of rounding error.

    In addition, the record for the 2015 Rule includes a 57-page document entitled “Supporting Documentation: Analysis of Jurisdictional Determinations for Economic Analysis and Rule,” 48 along with an accompanying 3,695 page document of approved jurisdictional determination (AJD) forms.49 This contains the agencies' assessment conducted in April 2015 of almost two hundred previously performed AJDs to help the agencies better understand how waters might change jurisdictional status based on the distance limitations included in the final 2015 Rule for adjacent and case-specific waters (see 80 FR 37105), including where they might no longer be jurisdictional under the final rule. Certain examples included in the assessment suggest that the 2015 Rule could modify CWA jurisdiction over waters that were deemed not jurisdictional under the 1986 regulatory framework and Supreme Court precedent. The agencies request comment on whether the examples illustrate the concerns expressed by the recent court decisions discussed above that the 2015 Rule may have exceeded the significant nexus standard articulated by Justice Kennedy in the Rapanos opinion and concerns expressed by certain commenters that the 2015 Rule may have created additional regulatory uncertainty over waters that were previously thought beyond the scope of CWA jurisdiction. The examples are intended to be illustrative, and are not intended to attempt to quantify or reassess previous estimates of CWA jurisdiction, as the agencies are not aware of any map or dataset that accurately or with any precision portrays CWA jurisdiction at any point in the history of this complex regulatory program.

    48 U.S. EPA. Supporting Documentation: Analysis of Jurisdictional Determinations for Economic Analysis and Rule (Docket ID: EPA-HQ-OW-2011-0880-20877), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-20877.

    49 U.S. EPA and U.S. Army Corps of Engineers. Supporting Documentation: Jurisdictional Determinations (Docket ID: EPA-HQ-OW-2011-0880-20876), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-20876.

    In the first example, a property in Chesapeake, Virginia, was reviewed by the Corps' Norfolk District in early January 2014 and again in March 2015 and was determined not to contain jurisdictional wetlands because the wetlands on the property lacked a hydrological surface connection of any duration, frequency, or volume of flow to other jurisdictional waters. The Corps noted that the wetlands “appear to be dependent upon groundwater for hydrology, and have no surface connections” to nearby tributaries, the closest one of which was approximately 80 feet from the wetland. The agencies later stated that the wetland features “would be jurisdictional under the new rule” because they are “within 100-feet of a tributary” and would thus meet the rule's definition of “neighboring” and, in turn, “adjacent.” Further information regarding this AJD and property has been added to the docket for the NPRM and is identified as “Case Study A—AJD Number NAO-2014-2269” (see Support Document).

    In another example, the Corps' Buffalo District reviewed a small wetland approximately 583 feet away from the Johlin Ditch near Toledo, Ohio, which eventually leads north to Lake Erie. After conducting a field investigation in September 2014, the Corps determined that the wetlands were not jurisdictional because the “wetlands are isolated and there is no surface water connections [sic] and the only potential jurisdiction would be the [Migratory Bird Rule],” noting that the area previously would have been regulated under the Migratory Bird Rule prior to the Supreme Court's SWANCC decision. The agencies later stated that the wetlands would be jurisdictional under the 2015 Rule. Further information regarding this AJD and property has been added to the docket for the NPRM and is identified as “Case Study B—AJD Number 2004-001914” (see Support Document).

    In another example, the Corps' Memphis District reviewed a borrow pit on a property in Mississippi County, Missouri, and concluded that the borrow pit did not contain jurisdictional wetlands. The project area was described in the AJD as follows:

    The borrow pit has been abandoned for some time. Vegetation consists mainly of black willow (Salix nigra) and poison ivy (Toxicodendron radicans). A site visit was conducted on 8 December 2014. The borrow pit is bordered by agricultural land on three sides and County Road K on the western border. There are no surface water connections to other waters of the U.S. A sample was taken within the site and all three parameters for a wetland are present. The Soil Survey book for Cape Girardeau, Mississippi and Scott Counties Missouri, compiled in 1974 and 1975 from aerial photography indicates no drainage into or out of the project site. The area is an isolated wetland approximately 7.6 acres in size.

    The abandoned pit in this example was 2,184 feet from the nearest “tributary,” a feature that itself appears to be a ditch in an agricultural field. The wetlands in the borrow pit were determined by the Corps to be isolated and non-jurisdictional “with no substantial nexus to interstate (or foreign) commerce” and on the basis that “prior to . . .`'SWANCC,' the review area would have been regulated based solely on the `Migratory Bird Rule.' ” A later review by the agencies, however, stated that these wetlands would be jurisdictional under the 2015 Rule. Further information regarding this property and associated AJD has been added to the docket for the NPRM and is identified as “Case Study C—AJD Number MVM-2014-460” (see Support Document).

    In another example, the Corps' New England District reviewed a “mowed wet meadow within a mowed hayfield” in Greensboro, Vermont, in August 2012 and concluded the site did not contain jurisdictional wetlands. The AJD described the wetlands as “surrounded on all sides by similar upland,” “500′-985′ away” from the nearest jurisdictional waters, and “isolated intrastate waters with no outlet, no hydrological connection to the Lamoille River, no nexus to interstate commerce, and no significant nexus to the Lamoille River (located about 1.7-1.8 miles southeast of the site).” A later review by the agencies, however, stated the wetlands would be jurisdictional under the 2015 Rule. Further information regarding this property and associated AJD has been added to the docket for the NPRM and is identified as “Case Study D—AJD Number NAE-2012-1813” (see Support Document).

    In another example, the Corps' Chicago District completed AJD number LRC-2015-31 for wetlands in agricultural fields in Kane County, Illinois, in January 2015. AJD Number LRC-2015-31 was completed using two separate AJD forms: One form for the features at the project site that were determined to be jurisdictional according to the Rapanos Guidance (“positive AJD form”) and a second form for the features at the site that the Corps determined were not jurisdictional under the Rapanos Guidance (“negative AJD form”). Only the positive AJD form was included in the docket in Supporting Documentation entitled, “Jurisdictional Determinations—Redacted.” 50 The negative AJD form is available on the Chicago District website.51

    50Id. at 2082-83.

    51 Available at: http://www.lrc.usace.army.mil/Portals/36/docs/regulatory/jd/lrcnjd02-2015.pdf (page 1 and 2).

    Using a field determination and desk determinations, the Corps found on the AJD form that there were “no `waters of the U.S.' within Clean Water Act (CWA) jurisdiction (as defined by 33 CFR part 328) in the review area.” The Corps described the project area in the AJD form as follows: “Wetland A is a 1.37 acre high quality closed depressional isolated wetland. Wetlands B and C (0.08 ac and 0.15 ac) are isolated wetlands that formed over a failed drain tile and are over 1,200 feet away from the closest jurisdictional waterway.” The AJD also notes, “Weland [sic] A and the area around Wetlands B and C were previously determined to be isolated in 2008. Wetland C is mapped as Prior Converted in a NRCS certified farmed wetland determination—other areas are mapped as not inventoried.” Upon later reviewing the negative AJD, however, the agencies determined the wetlands would be “now Yes JD” under the 2015 Rule. Further information regarding this property and associated positive and negative AJDs has been added to the docket for the NPRM and is identified as “Case Study E—AJD Number LRC-2015-31” (see Support Document).

    In another example, the Corps' Pittsburgh District visited a property in Butler, Pennsylvania, in October 2014 and determined the site did not contain waters of the United States because the wetland was “completely isolated and has no nexus to a TNW or interstate or foreign commerce.” The Corps noted that the wetland would have been regulated based solely on the Migratory Bird Rule prior to the decision in SWANCC. Upon reviewing the AJD, the agencies later stated the wetland is “[i]solated but would have flood storage function.” The agencies' review notes that the wetland is 1,270 feet from the nearest relatively permanent water (RPW) or traditional navigable water (TNW). Given the wetland is within 4,000 feet of a tributary and the agencies have stated it possesses at least one of the nine functions relevant to the significant nexus evaluation, see 80 FR 37106 (i.e., retention and attenuation of flood waters), the wetland would be subject to a significant nexus evaluation under the 2015 Rule. It is unclear, however, whether the wetland and its flood storage function would contribute significantly to the chemical, physical, or biological integrity of the nearest category (1) through (3) water as required by the 2015 Rule to satisfy the significant nexus test. Further information regarding this property and associated AJD has been added to the docket for the NPRM and is identified as “Case Study F—AJD Number LRP 2014-855” (see Support Document).

    In addition to the projected increase in positive jurisdictional determinations and the above examples of expected JD changes, an examination of the documents supporting the estimated 2.84 to 4.65 percent annual increase in positive AJDs raises concerns that the 2015 Rule may have significantly expanded jurisdiction over tributaries in certain States, particularly those in more arid parts of the country.

    As described previously, to assess how assertion of jurisdiction may change under the 2015 Rule, the agencies reviewed ORM2 aquatic resource records from FY13 and FY14 and placed the aquatic resources into three groups: Streams, wetlands adjacent to the stream category group, and other waters. With respect to the streams category, the agencies assumed that “100 percent of the records classified as streams will meet the definition of tributary in the final rule,” 52 resulting in a relatively minor projected increase in positive jurisdictional determinations under the final rule for streams: 99.3 percent to 100 percent, or a 0.7 percent increase.

    52 2015 Rule Economic Analysis at 8.

    However, the agencies have reexamined the 57-page “Supporting Documentation: Analysis of Jurisdictional Determinations for Economic Analysis and Rule” and have questions regarding the minor projected increase in positive jurisdictional determinations over streams in some states. An untitled table on page 46 of the supporting document lists an analysis of a subset of streams and the number of those streams estimated to be non-jurisdictional by State in the FY13-FY14 ORM2 records for the purpose of estimating stream mitigation costs associated with the 2015 Rule.53

    53 The table includes all states except Hawaii.

    Investigating the percent of streams estimated to be non-jurisdictional on a State-by-State basis coupled with the 2015 Rule Economic Analysis's assumption that 100 percent of the stream jurisdictional determinations will be positive under the 2015 Rule could indicate that there may be a significant expansion of jurisdiction over tributaries in some States beyond current practice. For example, in the FY13-FY14 ORM2 records for Arizona, the table identifies 709 of 1,070 total streams (66.3 percent) were non-jurisdictional. For Arkansas, the table identifies 116 of 213 total streams (54.5 percent) as non-jurisdictional. In South Dakota, North Dakota, Nevada, New Mexico, and Wyoming, 8.5 percent, 9.2 percent, 13.2 percent, 16.7 percent, and 57.1 percent of streams in the FY13-FY14 ORM2 database, respectively, were identified in the table as non-jurisdictional. The agencies are concerned that because the 2015 Rule may assert jurisdiction over 100 percent of streams as the agencies assumed in the 2015 Rule Economic Analysis, certain States, particularly those in the arid West, would see significant expansions of federal jurisdiction over streams. The agencies solicit comment on whether such expansions conflict with the assumptions underlying and statements justifying the 2015 Rule, and if such expansions were consistent with the policy goals of section 101(b) of the CWA.

    Several questions were raised by commenters regarding whether the 2015 Rule expanded CWA jurisdiction over intermittent and ephemeral streams, and whether the agencies accurately identified that potential expansion in the development of the 2015 Rule. Several commenters, for example, suggested that the amount of jurisdictional river and stream miles in the United States may increase from approximately 3.5 million miles to more than 8 million miles in response to the per se jurisdictional treatment of millions of miles of ephemeral and intermittent streams under the tributary definition.54 To frame their analysis, those commenters compared river and stream miles reported in recent CWA section 305(b) reports submitted by States to EPA, and transmitted by EPA to Congress, to the river and stream miles depicted in maps developed by the agencies and the USGS prior to the 2015 Rule's proposal.

    54See comments submitted by Arizona Department of Environmental Quality et al. (Nov. 14, 2014) (Docket ID: EPA-HQ-OW-2011-0880-15096), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-15096; comments submitted by CropLife America (Nov. 14, 2014) (Docket ID: EPA-HQ-OW-2011-0880-14630), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-14630; comments submitted by American Foundry Society (Nov. 14, 2014) (Docket ID: EPA-HQ-OW-2011-0880-15148), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-15148; comments submitted by U.S. Chamber of Commerce et al. (Nov. 12, 2014) (Docket ID: EPA-HQ-OW-2011-0880-14115), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-14115.

    Section 305(b)(1)(A) of the CWA directs each state to “prepare and submit to the Administrator . . . biennially . . . a report which shall include . . . a description of the water quality of all navigable waters in such State during the preceding year. . . .” 33 U.S.C. 1315(b)(1)(A). Section 305(b)(2) additionally directs the Administrator to “transmit such State reports, together with an analysis thereof, to Congress . . . .” Id. at 1315(b)(2). Over the years, those reports to Congress have identified between 3.5 and 3.7 million river and stream miles nationwide (see Support Document). The agencies previously observed that this analysis may not be precise, because of concerns regarding the baseline for comparison and assumptions regarding which intermittent and ephemeral streams may be covered under the 2015 Rule.55

    55See U.S. EPA and U.S. Army Corps of Engineers. Clean Water Rule Response to Comments—Topic 8: Tributaries at 88-89, available at https://www.epa.gov/sites/production/files/2015-06/documents/cwr_response_to_comments_8_tributaries.pdf.

    The agencies are not aware of any national, regional, or state-level map that identifies all “waters of the United States” and acknowledge that there are limitations associated with existing datasets. The agencies, however, developed a series of draft maps using the NHD identifying “rivers and streams and tributaries and other water bodies” in each State, which then-EPA Administrator Gina McCarthy mentioned at a March 27, 2014 hearing before the U.S. House of Representatives Appropriations Committee Subcommittee on Interior, Environment, and Related Agencies.56 The EPA provided a copy of those draft maps to Congress on July 28, 2014,57 and they remain available to the public on the U.S. House of Representatives Committee on Science, Space and Technology website.58 The draft maps identify a total of 8,086,742 river and stream miles across the 50 States (see Support Document).

    56 EPA Administrator Gina McCarthy testimony before the U.S. House of Representatives Appropriations Committee Subcommittee on Interior, Environment, and Related Agencies (March 27, 2014), available at https://www.c-span.org/video/?318438-1/fy2015-epa-budget.

    57 Letter from Nancy Stoner, Acting Asst. Administrator, U.S. EPA Office of Water, to Rep. Lamar Smith, Chairman, U.S. House of Representatives Committee on Science, Space, and Technology (July 28, 2014), available at https://science.house.gov/sites/republicans.science.house.gov/files/documents/epa_releases_maps_letter.pdf.

    58 EPA State and National Maps of Waters and Wetlands, available at https://science.house.gov/epa-state-and-national-maps-waters-and-wetlands.

    Given the significant differences between the CWA section 305(b) reports and the draft NHD maps submitted to Congress, and the possibility that each may represent potential estimates for the relative jurisdictional scope of the 1986 regulations and practice compared to the 2015 Rule, several States have questioned whether the proposed definition of “tributary” for the 2015 Rule would expand federal jurisdiction over State water resources. Eight State departments of environmental quality, for example, stated in joint comments that “comparing the `waters of the United States' reported by States to recent USGS maps released by the EPA shows a 131% increase in federal waters.” 59 Comments filed by the State of Kansas on the proposed rule raised similar concerns and focused on the inclusion of ephemeral streams in the proposed definition of tributary: “In Kansas we have identified approximately 31,000 miles of perennial and intermittent waters that have been treated as WOTUS for several decades. . . . As per the preamble to the Rule and EPA/ACOE statements, the additional 133,000 miles [of ephemeral streams] would result in a 460% increase in the number of Kansas waters presumed to be jurisdictional under the Rule.” 60 Kansas added that the State does “not believe ephemeral waters have always been considered de facto tributaries for CWA jurisdictional purposes.” 61 Referencing a statement made by then-EPA Administrator McCarthy in which she stated, “[u]nfortunately, 60 percent of our nation's streams and millions of acres of wetlands currently lack clear protection from pollution under the Clean Water Act,” 62 Kansas noted that “if those 60 percent that `lack clear protection' are brought under the umbrella of the CWA, [there will be] a significantly larger expansion than estimated in the economic analysis for the Rule.” 63

    59See comments submitted by Alabama Dept. of Environ. Mgmt., Arizona Dept. of Environ. Quality, Indiana Dept. of Environ. Mgmt., Kansas Dept. of Health and Environ., Louisiana Dept. of Environ. Quality, Mississippi Dept. of Environ. Quality, Oklahoma Dept. of Environ. Quality, and Wyoming Dept. of Environ. Quality (Nov. 14, 2014) (Docket ID: EPA-HQ-OW-2011-0880-15096), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-15096.

    60See comments submitted by the State of Kansas at Appendix A (Oct. 23, 2014) (Docket ID: EPA-HQ-OW-2011-0880-16636), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-16636.

    61Id. (emphasis in original).

    62See “Clean Water Drives Economic Growth” by Gina McCarthy (Sept. 29, 2014), available at http://www.huffingtonpost.com/gina-mccarthy/clean-water-act_b_5900734.html.

    63See supra note 60.

    The agencies in 2015 suggested that a feature that flows very infrequently would not form the physical indicators required to meet the 2015 Rule's definitions of “ordinary high water mark” and “tributary.” 64 In response to comments questioning the agencies' characterization of the change in scope of jurisdiction under the 2015 Rule, the agencies stated that the 2015 Rule was narrower in scope than the existing regulations and historical practice, and reiterated that an increase of approximately 3 percent represented the agencies' estimate of the increased positive jurisdictional determinations compared to recent practice.65 In the administrative record for the 2015 Rule and in a brief filed with the Sixth Circuit (based on that record), the agencies asserted that the definition of “waters of the United States” historically has included ephemeral streams and that some federal court decisions after SWANCC upheld assertions of CWA jurisdiction over surface waters that have a hydrologic connection to and that form part of the tributary system of a traditional navigable water, including intermittent or ephemeral streams. 80 FR 37079; Brief for Respondents at 11, 62-64, In re EPA, No. 15-3571 (6th Cir. Jan. 13, 2017).66 The agencies are requesting comment on whether these responses to these issues are adequate. While some ephemeral streams may have been jurisdictional after a case-specific analysis pursuant to the Rapanos Guidance,67 and while challenges to some of those determinations have been rejected by courts, the agencies are requesting public comment on whether these prior conclusions and assertions were correct.

    64See, e.g., U.S. EPA and U.S. Army Corps of Engineers. Clean Water Rule Response to Comments—Topic 11: Cost/Benefits (Volume 2) at 223, available at https://www.epa.gov/sites/production/files/2015-06/documents/cwr_response_to_comments_11_econ_vol2.pdf.

    65See, e.g., id. at 10-13, 17.

    66See also U.S. EPA and Department of the Army. Technical Support Document for the Clean Water Rule: Definition of Waters of the United States at 28 (May 27, 2015), available at https://www.epa.gov/sites/production/files/2015-05/documents/technical_support_document_for_the_clean_water_rule_1.pdf.

    67See Rapanos Guidance at 7 (“ `[R]elatively permanent' waters do not include ephemeral tributaries which flow only in response to precipitation and intermittent streams which do not typically flow year-round or have continuous flow at least seasonally. However, CWA jurisdiction over these waters will be evaluated under the significant nexus standard.”).

    Given the concerns expressed by three federal courts regarding the potential scope of the 2015 Rule and comments raised during the 2015 rulemaking and submitted in response to the July 27, 2017 NPRM, the agencies are re-evaluating the 2015 Rule and the potential change in jurisdiction. While the agencies are not aware of any data that estimates with any reasonable certainty or predictability the exact baseline miles and area of waters covered by the 1986 regulations and preexisting agency practice or data that accurately forecasts of the additional waters subject to jurisdiction under the 2015 Rule, the agencies are examining whether the data and estimates used to support the 2015 Rule's conclusions that the rule would be narrower than preexisting regulations may not have supported those conclusions, and instead the 2015 Rule may have had more than a marginal impact on CWA jurisdictional determinations and may impact well-defined and longstanding relationships between the federal and State governments in implementing CWA programs. The agencies seek comment on this and other data that may be relevant to a proposed finding, and whether such a change in finding would, either independently or in conjunction with other factors, support the agencies' proposal to repeal the 2015 Rule.

    4. Potential Impact on Federal-State Balance

    When promulgating the 2015 Rule, the agencies concluded and prominently stated that “State, tribal, and local governments have well-defined and longstanding relationships with the Federal government in implementing CWA programs and these relationships are not altered by the final rule,” 80 FR 37054. Indeed, it was “the policy of the Congress to recognize, preserve, and protect the primary responsibilities and rights of States to prevent, reduce, and eliminate pollution, to plan the development and use (including restoration, preservation, and enhancement) of land and water resources, and to consult with the Administrator in the exercise of his authority under this Act.” 33 U.S.C. 1251(b).

    In response to the agencies' July 27, 2017 NPRM, some commenters have suggested that the 2015 Rule—including, inter alia, elements of the final rule that commenters were not able to address during the comment period—may not effectively reflect the specific policy that Congress articulated in CWA section 101(b). The agencies are considering whether and are proposing to conclude that the 2015 Rule did not draw the appropriate line, for purposes of CWA jurisdiction, between waters subject to federal and State regulation, on the one hand, and waters subject to state regulation only, on the other. In comments submitted to the agencies in response to the July 27, 2017 NPRM, many States, representatives of entities within many sectors of the regulated community, and numerous other commenters expressed concerns that the 2015 Rule permits federal encroachment upon the States' traditional and primary authority over land and water resources. Such commenters cite the Supreme Court's recognition that “Congress chose to `recognize, preserve, and protect the primary responsibilities and rights of states . . . to plan the development and use' ” of those resources in enacting the CWA rather than “readjust the federal-state balance,” SWANCC, 531 U.S. at 174 (quoting CWA section 101(b), 33 U.S.C. 1251(b)).

    Under the 2015 Rule, commenters have observed that the agencies asserted categorical jurisdiction over water features that may be wholly intrastate and physically remote from navigable-in-fact waters. Such waters “adjacent” to jurisdictional waters are deemed to meet the definition of “waters of the United States” under the 2015 Rule, so long as any portion of the water is located within 100 feet of the ordinary high water mark of a category (1) through (5) “jurisdictional by rule” water; within the 100-year floodplain of a category (1) through (5) “jurisdictional by rule” water but not more than 1,500 feet from the ordinary high water mark of such water; or within 1,500 feet of the high tide line of a primary water or the ordinary high water mark of the Great Lakes. 80 FR 37085-86, 37105. The agencies also established case-specific jurisdiction over water features generally at a greater distance, including waters (including seasonal or ephemeral waters) located within 4,000 feet of the high tide line or ordinary high water mark of a category (1) through (5) water. See 80 FR 37105. For such waters, “the entire water is a water of the United States if a portion is located within the 100-year floodplain of a water identified in paragraphs (a)(1) through (3) . . . or within 4,000 feet of the high tide line or ordinary high water mark” of a category (1) through (5) water.” Id.

    The agencies are considering whether the 2015 Rule's coverage of waters based, in part, on their location within the 100-year floodplain of a jurisdictional water is consistent with the policy articulated in CWA section 101(b) that States should maintain primary responsibility over land and water resources. The agencies received many comments on the proposal to the 2015 Rule indicating that the potential breadth of this standard could conflict with other federal, State or local laws that regulate development within floodplains.68 In particular, certain local governments expressed concern that the floodplain element of the rule could conflict with local floodplain ordinances or otherwise complicate local land use planning and development.69 Though the agencies added a distance-based threshold to limit the use of the 100-year floodplain as a basis for categorical CWA jurisdiction with respect to adjacent waters, the agencies are concerned that the Rule's use of this standard, including its use as a basis for requiring a case-specific significant nexus determination, could nonetheless interfere with traditional state and local police power, as suggested by some of the comments received in 2014.70 Comments received in response to the July 27, 2017 NPRM also raise concerns about the use of the 100-year floodplain. Specifically, commenters expressed concern about the absence of suitable maps and about the accuracy of existing maps. Given these concerns, the agencies request comment on whether the 2015 Rule's use of the 100-year floodplain as a factor to establish jurisdiction over adjacent waters and case-specific waters interferes with States' primary responsibilities over the planning and development of land and water resources in conflict with CWA section 101(b). The agencies also seek comment on to what extent the 100-year floodplain component of the 2015 Rule conflicts with other federal regulatory programs, and whether such a conflict impacts State and local governments.

    68See, e.g., comments submitted by City of Chesapeake (Sept. 9, 2014) (Docket ID: EPA-HQ-OW-2011-0880-9615), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-9615.

    69See, e.g., comments submitted by National Association of Counties (Nov. 14, 2014) (Docket ID: EPA-HQ-OW-2011-0880-15081), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-15081.

    70See, e.g., comments submitted by Georgia Municipal Association (Nov. 13, 2014) (Docket ID: EPA-HQ-OW-2011-0880-14527), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-14527; comments submitted by City of St. Petersburg (Nov. 13, 2014) (Docket ID: EPA-HQ-OW-2011-0880-18897), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2011-0880-18897.

    The agencies noted in 2015 “that the vast majority of the nation's water features are located within 4,000 feet of a covered tributary, traditional navigable water, interstate water, or territorial sea.” 71 The agencies' broadening of certain key concepts and terms relative to the prior regulatory regime means that the agencies can potentially review the “vast majority” of water features in the country under the 2015 Rule, unless those features have been excluded from the definition. Similar concern was raised in response to the July 27, 2017 NPRM, for example, by the Missouri Department of Natural Resources and Department of Agriculture.72 The agencies seek comment on that analysis and whether the 2015 Rule readjusts the federal-state balance in a manner contrary to the congressionally determined policy in CWA section 101(b). Indeed, when issuing a preliminary injunction of the 2015 Rule, the Southern District of Georgia held that “The [2015] WOTUS Rule asserts jurisdiction over remote and intermittent waters without evidence that they have a nexus with any navigable-in-fact waters.” Georgia, 2018 U.S. Dist. LEXIS 97223, at *19. The agencies thus solicit comment on whether the definitions in the 2015 Rule would subject wholly intrastate or physically remote waters or wetlands to CWA jurisdiction, either categorically or on a case-by-case basis, and request information about the number and scope of such waters of which commenters may be aware.73

    71 2015 Rule Economic Analysis at 11.

    72See comments submitted by the Missouri Department of Natural Resources and Department of Agriculture (Sept. 26, 2017) (Docket ID: EPA-HQ-OW-2017-0203-13869), available at https://www.regulations.gov/document?D=EPA-HQ-OW-2017-0203-13869 (“The broad definition of tributary and the inclusion of a three-quarter mile buffer around every tributary and impoundment, would have cast a very broad jurisdictional umbrella over the state; requiring significant nexus determinations on all but a very few number of waters.”).

    73 This includes whether the 2015 Rule is supported by a “clear and manifest” statement under the CWA to change the scope of traditional state regulatory authority. See BFP v. Resolution Trust Corp., 511 U.S. 531, 544 (1994); see also Bond v. United States, 134 S. Ct. 2077, 2089-90 (2014); SWANCC, 531 U.S. at 172-74.

    Further, the agencies solicit comment about whether these, or any other, aspects of the 2015 Rule as finalized would, as either a de facto or de jure matter, alter federal-state relationships in the implementation of CWA programs and State regulation of State waters, and whether the 2015 Rule appropriately implements the Congressional policy of recognizing, preserving, and protecting the primary rights of states to plan the development and use of land and water resources. Because such findings would, if adopted by the agencies, negate a key finding underpinning the 2015 Rule, the agencies request comment on whether to repeal the 2015 Rule on this basis.

    5. Additional Bases for Repealing the 2015 Rule That the Agencies Are Considering

    In addition to our proposed conclusions that the 2015 Rule failed to provide regulatory certainty and that it exceeded the agencies' authority under the CWA, the agencies are also considering several other supplemental bases for repealing the 2015 Rule. These are discussed below along with requests for public comment.

    Some commenters have suggested that the 2015 Rule may exceed Congress' power under the Commerce Clause. The Supreme Court in SWANCC found that, in enacting the CWA, Congress had in mind as its authority “its traditional jurisdiction over waters that were or had been navigable in fact or which could reasonably be so made.” 531 U.S. at 172. The Court went on to construe the CWA to avoid the significant constitutional questions raised by the agencies' assertion that the “ `Migratory Bird Rule' falls within Congress' power to regulate intrastate activities that `substantially affect' interstate commerce.” Id. at 173. The agencies are evaluating the concerns, reflected in certain comments received by the agencies, that many features that are categorically jurisdictional under the 2015 Rule, such as wetlands that fall within the distance thresholds of the definition of “neighboring,” test the limits of the scope of the Commerce Clause because they may not have the requisite effect on the channels of interstate commerce.74

    74 Though the agencies have previously said that the 2015 Rule is consistent with the Commerce Clause and the CWA, the agencies are in the process of considering whether it is more appropriate to draw a jurisdictional line that ensures that the agencies regulate well within our constitutional and statutory bounds.

    For example, according to certain litigants challenging the 2015 Rule, the “seasonally ponded, abandoned gravel mining depressions” specifically at issue in SWANCC, 531 U.S. at 164, which the Supreme Court determined were “nonnavigable, isolated, intrastate waters,” id. at 166-72, might be subject to case-specific jurisdiction under the 2015 Rule. The depressions appear to be located within 4,000 feet of Poplar Creek, a tributary to the Fox River, and may have the ability to store runoff or contribute other ecological functions in the watershed.

    The agencies request comment, including additional information, on whether the water features at issue in SWANCC or other similar water features could be deemed jurisdictional under the 2015 Rule, and whether such a determination is consistent with or otherwise well-within the agencies' statutory authority, would be unreasonable or go beyond the scope of the CWA, and is consistent with Justice Kennedy's significant nexus test expounded in Rapanos wherein he stated, “[b]ecause such a [significant] nexus was lacking with respect to isolated ponds, the [SWANCC] Court held that the plain text of the statute did not permit” the Corps to assert jurisdiction over them. See 547 U.S. at 767.

    The examples identified in Section II.C.3 above raise similar issues. The abandoned borrow pit, for example, discussed in Case Study C—AJD Number MVM-2014-460, was determined by the Corps in December 2014 to be an isolated water located 2,184 feet from a relatively permanent body of water “with no substantial nexus to interstate (or foreign) commerce” (see Support Document), yet the agencies later stated the feature would be jurisdictional under the 2015 Rule. In addition, the wetlands at issue in Case Study B—AJD Number 2004-001914 (see Support Document) described above in Section II.C.3 were located 583 feet from the Johlin Ditch outside Toledo, Ohio, situated east of an existing medical building and west of an agricultural area. The wetlands were determined by the Corps to be isolated, lacking a surface connection to a water of the United States and a substantial nexus to interstate commerce. Those wetlands, however, were later stated by the agencies to be subject to CWA jurisdiction under the 2015 Rule. The agencies therefore solicit comment on whether the 2015 Rule would cover such wetlands and, if so, whether that would exceed the CWA's statutory limits. See, e.g., SWANCC, 531 U.S. at 171-72, 174 (“[W]e find nothing approaching a clear statement from Congress that it intended § 404(a) to reach an abandoned sand and gravel pit” that is “isolated.”).

    Interested parties are encouraged to provide comment on whether the 2015 Rule is consistent with the statutory text of the CWA and relevant Supreme Court precedent, the limits of federal power under the Commerce Clause as specifically exercised by Congress in enacting the CWA, and any applicable legal requirements that pertain to the scope of the agencies' authority to define the term “waters of the United States.” The agencies also solicit comment on any other issues that may be relevant to the agencies' consideration of whether to repeal the 2015 Rule, such as whether any potential procedural deficiencies limited effective public participation in the development of the 2015 Rule.75

    75See, e.g., Small Refiner Lead Phase-Down Task Force v. EPA, 705 F.2d 506, 549 (DC Cir. 1983).

    D. The Agencies' Next Steps

    In defining the term “waters of the United States” under the CWA, Congress gave the agencies broad discretion to articulate reasonable limits on the meaning of that term, consistent with the Act's text and its policies as set forth in CWA section 101. In light of the substantial litigation risk regarding waters covered under the 2015 Rule, and based on the agencies' experience and expertise in applying the CWA, the agencies propose to repeal the 2015 Rule and put in place the prior regulation. This is based on the concerns articulated above and the agencies' concern that there may be significant disruption to the implementation of the Act and to the public, including regulated entities, if the 2015 Rule were vacated in part. The agencies therefore propose to exercise their discretion and policy judgment by repealing the 2015 Rule permanently and in its entirety because the agencies believe that this approach is the most appropriate means to remedy the deficiencies of the 2015 Rule identified above, address the litigation risk surrounding the 2015 Rule, and restore a regulatory process that has been in place for years.

    The agencies have considered other alternatives that could have the effect of addressing some of the potential deficiencies identified, including proposing revisions to specific elements of the 2015 Rule, issuing revised implementation guidance and implementation manuals, and proposing a further change to the February 6, 2020 applicability date of the 2015 Rule. The agencies are soliciting comments on whether any of these alternative approaches would fully address and ameliorate potential deficiencies in and litigation risk associated with the 2015 Rule. Consistent with the President's Executive Order, the agencies are also evaluating options for revising the definition of “waters of the United States.”

    The agencies are proposing to permanently repeal the 2015 Rule at this time, and are taking comment on whether this proposal is the best and most efficient approach to address the potential deficiencies identified in this notice and to provide the predictability and regulatory certainty that alternative approaches may not provide.

    E. Effect of Repeal

    The 2015 Rule amended longstanding regulations contained in portions of 33 CFR part 328 and 40 CFR parts 110, 112, 116, 117, 122, 230, 232, 300, 302, and 401 by revising, removing, and re-designating certain paragraphs and definitions in those regulations. In this action, the agencies would repeal the 2015 Rule and restore the regulations in existence immediately prior to the 2015 Rule. As such, if the agencies finalize this proposal and repeal the 2015 Rule and thus repeal those amendments, the regulatory definitions of “waters of the United States” in effect would be those portions of 33 CFR part 328 and 40 CFR parts 110, 112, 116, 117, 122, 230, 232, 300, 302, and 401 as they existed immediately prior to the 2015 Rule's amendments. See, e.g., API v. EPA, 883 F.3d 918, 923 (DC Cir. 2018) (regulatory criterion in effect immediately before enactment of criterion that was vacated by the court “replaces the now-vacated” criterion). Thus, if the agencies determine that repeal of the 2015 Rule is appropriate, the agencies concurrently would recodify the prior regulation in the CFR, which would not have the effect of creating a regulatory vacuum, and the agencies need not consider the potential consequences of such a regulatory vacuum in light of this. If this proposed rule is finalized, the agencies propose to apply the prior definition until a new definition of CWA jurisdiction is finalized.

    The current regulatory scheme for determining CWA jurisdiction is “familiar, if imperfect,” In re EPA, 803 F.3d at 808, and the agencies and regulated public have significant experience operating under the longstanding regulations that were replaced by the 2015 Rule. The agencies would continue to implement those regulations, as they have for many years, consistent with Supreme Court decisions and practice, other case law interpreting the rule, and informed by agency guidance documents. Apart from a roughly six-week period when the 2015 Rule was in effect in 37 States, the agencies have continued to implement the preexisting regulatory definitions as a result of the court orders discussed in Section I.B. above, as well as the final rule adding an applicability date to the 2015 Rule (83 FR 5200, Feb. 6, 2018). While the agencies acknowledge that the 1986 and 1988 regulations have been criticized and their application has been narrowed by various legal decisions, including SWANCC and Rapanos, the longstanding nature of the regulatory framework and its track record of implementation makes it preferable until the agencies propose and finalize a replacement definition. The agencies believe that, until a new definition is completed, it is important to retain the status quo that has been implemented for many years rather than the 2015 Rule, which has been and continues to be mired in litigation.

    In other words, restoration of the prior regulatory text in the CFR, interpreted in a manner consistent with Supreme Court decisions, and informed by applicable agency guidance documents and longstanding practice, will ensure that the scope of CWA jurisdiction will be administered in the same manner as it is now; as it was during the Sixth Circuit's lengthy, nationwide stay of the 2015 Rule; and as it was for many years prior to the promulgation of the 2015 Rule. To be clear, the agencies are not proposing a new definition of “waters of the United States” in this specific rulemaking separate from the definition that existed immediately prior to the 2015 Rule. The agencies also are not proposing to take this action in order to fill a regulatory gap because no such gap exists today. See 83 FR 5200, 5204. Rather, the agencies are solely proposing to repeal the 2015 amendments to the above-referenced portions of the CFR and recodify the prior regulatory text as it existed immediately prior to the 2015 Rule's amendments.

    III. Minimal Reliance Interests Implicated by a Repeal of the 2015 Rule

    More than 30,000 AJDs of individual aquatic resources and other features have been issued since August 28, 2015, the effective date of the 2015 Rule. However, less than two percent of the AJDs of individual aquatic resources were issued under the 2015 Rule provisions in the six weeks the rule was in effect in a portion of the country.76 The 2015 Rule was in effect in only 37 States for about six weeks between the 2015 Rule's effective date and the Sixth Circuit's October 9, 2015 nationwide stay order, see In re EPA, 803 F.3d 804 (6th Cir. 2015), and only 540 AJDs for aquatic resources and other features were issued during that short window of time. The remainder of the AJDs issued since August 28, 2015, were issued under the regulations defining the term “waters of the United States” that were in effect immediately before the effective date of the 2015 Rule.

    76See Clean Water Act Approved Jurisdictional Determinations, available at https://watersgeo.epa.gov/cwa/CWA-JDs, as of May 9, 2018. The 2015 Rule was enjoined in 13 States by the U.S. District Court for the District of North Dakota and has never gone into effect in those States.

    “Sudden and unexplained change, . . . or change that does not take account of legitimate reliance on prior [agency] interpretation, . . . may be arbitrary, capricious [or] an abuse of discretion[,] [b]ut if these pitfalls are avoided, change is not invalidating[.]” Smiley v. Citibank (South Dakota), N.A., 517 U.S. 735, 742 (1996) (internal quotation marks and citations omitted). Therefore, in proposing to repeal the 2015 Rule, the agencies are considering any interests that may have developed in reliance on the 2015 Rule, as well as the potential harm to such reliance interests from repealing the Rule against the benefits. The agencies solicit comment on whether the AJDs that were issued under the 2015 Rule's brief tenure (and any ensuing reliance interests that were developed) would be adversely affected by the Rule's repeal. If the potential for such harm exists, the agencies also solicit comment on whether those harms outweigh the potential benefits of repealing the 2015 Rule.

    In staying the 2015 Rule nationwide, the Sixth Circuit found no indication “that the integrity of the nation's waters will suffer imminent injury if the [2015 Rule] is not immediately implemented and enforced.” In re EPA, 803 F.3d at 808. The Sixth Circuit wrote that the “burden—potentially visited nationwide on governmental bodies, state and federal, as well as private parties—and the impact on the public in general, implicated by the Rule's effective redrawing of jurisdictional lines over certain of the nation's waters” was of “greater concern.” Id. As a result, the Sixth Circuit held that “the sheer breadth of the ripple effects caused by the Rule's definitional changes counsels strongly in favor of maintaining the status quo for the time being.” Id. For the reasons expounded in this notice and the NPRM, the agencies believe that any potential adverse reliance interests are outweighed by the benefits of the agencies' proposed action. The agencies therefore propose to repeal the 2015 Rule and request comment on that proposal.

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

    This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review prior to the NPRM and again prior to issuance of the SNPRM. Any changes made in response to OMB recommendations have been documented in the docket.

    While economic analyses are informative in the rulemaking context, the agencies are not relying on the economic analysis performed pursuant to Executive Orders 12866 and 13563 and related procedural requirements as a basis for this proposed action. See, e.g., NAHB, 682 F.3d at 1039-40 (noting that the quality of an agency's economic analysis can be tested under the APA if the “agency decides to rely on a cost-benefit analysis as part of its rulemaking”).

    B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Cost

    This rule is expected to be an Executive Order 13771 deregulatory action. Details on the estimated cost savings of this proposed rule can be found in the economic analysis that was published together with the NPRM.

    C. Paperwork Reduction Act

    This proposed rule does not impose any new information collection burdens under the Paperwork Reduction Act.

    D. Regulatory Flexibility Act

    The Regulatory Flexibility Act generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

    The proposed repeal of the 2015 Rule is a deregulatory action that would effectively maintain the status quo as the agencies are currently implementing it, and avoid the imposition of potentially significant adverse economic impacts on small entities in the future. Details on the estimated cost savings of this proposed rule can be found in the economic analysis that was published together with the NPRM. Accordingly, after considering the potential economic impacts of the proposed repeal action on small entities, we certify that this proposed action will not have a significant economic impact on a substantial number of small entities.

    E. Unfunded Mandates Reform Act

    Under section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), signed into law on March 22, 1995, an agency must prepare a budgetary impact statement to accompany any proposed or final rule that includes a federal mandate that may result in estimated cost to state, local, or tribal governments in the aggregate, or to the private sector, of $100 million or more. Under section 205 of the UMRA, the agency must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires the agency to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule. This proposed action does not contain any unfunded mandate as described in the UMRA, and does not significantly or uniquely affect small governments. The definition of “waters of the United States” applies broadly to CWA programs. The proposed action imposes no enforceable duty on any state, local, or tribal governments, or the private sector, and does not contain regulatory requirements that significantly or uniquely affect small governments.

    F. Executive Order 13132: Federalism

    Executive Order 13132 requires the agencies to develop an accountable process to ensure “meaningful and timely input by state and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implication” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, the agencies may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the federal government provides the funds necessary to pay the direct compliance costs incurred by state and local government, or the agencies consult with state and local officials early in the process of developing the proposed regulation. The agencies also may not issue a regulation that has federalism implications and that preempts state law unless the agencies consult with state and local officials early in the process of developing the proposed regulation.

    This proposed rule will not have substantial direct effects on the states, on the relationship between the national government and states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it merely proposes to repeal a rule that was in effect in only a portion of the country for a short period of time, and does not alter the relationship or the distribution of power and responsibilities established in the CWA. The agencies are proposing to repeal the 2015 Rule in part because the 2015 Rule may have impermissibly and materially affected the states and the distribution of power and responsibilities among the various levels of government and therefore likely should have been characterized as having federalism implications when promulgated in 2015. Thus, the requirements of section 6 of the Executive Order do not apply to this proposed rule because it returns the federal-state relationship to the status quo.

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

    Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, Nov. 9, 2000), requires the agencies to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This proposed rule does not have tribal implications, as specified in Executive Order 13175. This proposed rule will not have substantial direct effects on tribal governments, 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, because it merely preserves the status quo currently in effect today and in effect immediately before promulgation of the 2015 Rule. Thus, Executive Order 13175 does not apply to this proposed rule. Consistent with E.O. 13175, however, the agencies have and will continue to consult with tribal officials, as appropriate, as part of any future rulemaking to define “waters of the United States.”

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

    Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, Apr. 23, 1997), applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that an agency has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency. This proposed rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

    I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

    J. National Technology Transfer and Advancement Act

    Section 12 of the National Technology Transfer and Advancement Act of 1995 requires federal agencies to evaluate existing technical standards when developing a new regulation. The proposed rule does not involve technical standards.

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

    This proposed rule maintains the legal status quo. The agencies therefore believe that this action does not have disproportionately high and adverse human health or environmental effects on minority, low-income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, Feb. 16, 1994).

    List of Subjects 33 CFR Part 328

    Environmental protection, Administrative practice and procedure, Navigation (water), Water pollution control, Waterways.

    40 CFR Part 110

    Environmental protection, Oil pollution, Reporting and recordkeeping requirements.

    40 CFR Part 112

    Environmental protection, Oil pollution, Penalties, Reporting and recordkeeping requirements.

    40 CFR Part 116

    Environmental protection, Hazardous substances, Reporting and recordkeeping requirements, Water pollution control.

    40 CFR Part 117

    Environmental protection, Hazardous substances, Penalties, Reporting and recordkeeping requirements, Water pollution control.

    40 CFR Part 122

    Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous substances, Reporting and recordkeeping requirements, Water pollution control.

    40 CFR Part 230

    Environmental protection, Water pollution control.

    40 CFR Part 232

    Environmental protection, Intergovernmental relations, Water pollution control.

    40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Natural resources, Occupational safety and health, Oil pollution, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.

    40 CFR Part 302

    Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Natural resources, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.

    40 CFR Part 401

    Environmental protection, Waste treatment and disposal, Water pollution control.

    For the reasons stated herein, the agencies propose to amend 33 CFR part 328 and 40 CFR parts 110, 112, 116, 117, 122, 230, 232, 300, 302, and 401 of the Code of Federal Regulations to repeal the amendments that were promulgated in the 2015 Rule and reestablish the regulatory text that was in place immediately prior to promulgation of the 2015 Rule. Dated: June 29, 2018. E. Scott Pruitt, Administrator, Environmental Protection Agency. Dated: June 29, 2018. R.D. James, Assistant Secretary of the Army (Civil Works).
    [FR Doc. 2018-14679 Filed 7-11-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 447 [CMS-2413-P] RIN 0938-AT61 Medicaid Program; Reassignment of Medicaid Provider Claims AGENCIES:

    Centers for Medicare & Medicaid Services, Department of Health and Human Services.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule would remove the regulatory text that allows a state to make payments to third parties on behalf of an individual provider for benefits such as health insurance, skills training, and other benefits customary for employees. We are concerned that these provisions are overbroad, and insufficiently linked to the exceptions expressly permitted by the statute. As we noted in our prior rulemaking, section 1902(a)(32) of the Act provides for a number of exceptions to the direct payment requirement, but it does not authorize the agency to create new exceptions.

    DATES:

    To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 13, 2018.

    ADDRESSES:

    In commenting, please refer to file code CMS-2413-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

    Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

    1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

    2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2413-P, P.O. Box 8016, Baltimore, MD 21244-8016.

    Please allow sufficient time for mailed comments to be received before the close of the comment period.

    3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2413-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    FOR FURTHER INFORMATION CONTACT:

    Christopher Thompson, (410) 786-4044.

    SUPPLEMENTARY INFORMATION:

    Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.

    I. Background

    The Medicaid program was established by the Congress in 1965 to provide health care services for low-income and disabled beneficiaries. Section 1902(a)(32) of the Social Security Act (the Act) requires direct payment to providers who render services to Medicaid beneficiaries. It states that no payment under the plan for care and services provided to an individual shall be made to anyone other than such individual or the person or institution providing such care or service, under an assignment or power of attorney or otherwise.

    We codified § 447.10 implementing section 1902(a)(32) of the Act in the “Payment for Services” final rule published on September 29, 1978 (43 FR 45253). The statute provides several specific exceptions to the general principle of requiring that direct payment be made to the individual provider. The regulations implementing section 1902(a)(32) of the Act have generally tracked the plain statutory language and required direct payments absent a statutory exception.

    In 2012, we proposed a new regulatory exception in the “Provider Payment Reassignment, and Setting Requirements for Community First Choice” proposed rule published on May 3, 2012 (77 FR 26361, 26406) for “a class of practitioners for which the Medicaid program is the primary source of service revenue” such as home health care providers. We recognized in the preamble to the proposed rule that section 1902(a)(32) of the Act does not authorize additional exceptions to the direct payment requirement (See 77 FR 26382).

    We received a total of 7 comments on the proposed regulatory exception, all generally supportive of the proposed rule. This provision was finalized in the “Provider Payment Reassignment, and Home and Community-Based Setting Requirements for Community First Choice and Home and Community-Based Services (HCBS) Waivers” final rule published on January 16, 2014 (79 FR 2947, 3001) and authorized a state to make payments to third parties on behalf of the individual provider “for benefits such as health insurance, skills training, and other benefits customary for employees.”

    We are concerned that § 447.10(g)(4) is overbroad, and insufficiently linked to the exceptions expressly permitted by the statute. As we noted in our prior rulemaking, section 1902(a)(32) of the Act provides for a number of exceptions to the direct payment requirement, but it does not authorize the agency to create new exceptions. Therefore, the regulatory provision grants permissions that Congress has foreclosed, so we are proposing to remove the regulatory exception at § 447.10(g)(4).

    II. Provisions of the Proposed Regulations

    This proposal would remove § 447.10(g)(4), but leave in place the other provisions in § 447.10 including the exceptions at § 447.10(e), (f) and (g)(1) through (3). We seek comments regarding how we might provide further clarification on the types of payment arrangements that would be permissible assignments of Medicaid payments, such as arrangements where a state government withholds payments under a valid assignment. Specifically, we invite comments with examples of payment withholding arrangements between states and providers that we should address.

    With regard to section 1915(c), 1915(i), 1915(j), and 1915(k) authority, this proposed rule will not impact a state's ability to perform Financial Management Services (FMS) or secure FMS through a vendor arrangement. However, we also request comments on whether and how the proposed removal of § 447.10(g)(4) would impact self-directed service models, where the Medicaid beneficiary takes responsibility for retaining and managing his or her own services, and, in some cases, may be performing payroll and other employer-related duties. We are especially interested in comments that describe the additional flexibilities needed to support beneficiaries opting for self-directed service models, which may ensure stable, high-quality care for those beneficiaries.

    III. Collection of Information Requirements

    To the extent a state changes its payment as a result of this rule, the state would be required to notify entities of the pending change in payment and update its payment system. We believe the associated burden is exempt from the Paperwork Reduction Act (PRA) in accordance with 5 CFR 1320.3(b)(2). We believe that the time, effort, and financial resources necessary to comply with the aforementioned requirement would be incurred by the state during the normal course of their activities and, therefore, should be considered usual and customary business practices.

    IV. Response to Comments

    Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

    V. Regulatory Impact Analysis A. Statement of Need

    We are concerned that § 447.10(g)(4) is overbroad, and insufficiently linked to the exceptions expressly permitted by the statute. Therefore, the regulatory provision grants permissions that Congress has foreclosed. As we noted in our prior rulemaking published on January 16, 2014 (79 FR 2947, 3001), section 1902(a)(32) of the Act provides for a number of exceptions to the direct payment requirement, but the language does not explicitly authorize the agency to create new exceptions. Therefore, we are proposing to remove the regulatory exception at § 447.10(g)(4). To the extent a state increased reimbursement levels to reassign portions of a provider's reimbursement to a third party, implementation of this rule may affect the rates that are set by the state in the future.

    B. Overall Impact

    We have examined the impacts of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).

    Executive Orders 12866 and 13563 directs 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). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) create a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

    A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimate that this proposed rule could be “economically significant” as it may have an annual effect on the economy in excess of the $100 million threshold of Executive Order 12866, and hence that this proposed rule is also a major rule under the Congressional Review Act. However there is considerable uncertainty around this estimate and the Department invites public comments to help refine this analysis.

    As discussed above, in the “Provider Payment Reassignment, and Home and Community-Based Setting Requirements for Community First Choice and Home and Community-Based Services (HCBS) Waivers” final rule published on January 16, 2014 (79 FR 2947, 3001), we authorized a state to make payments to third parties on behalf of the individual provider “for benefits such as health insurance, skills training, and other benefits customary for employees.” We lack information with which to quantify the potential impacts of this policy on these types of payments as the Department does not formally track the amount of reimbursement that is being reassigned to third parties by states. To offer one example, one such potential impact of the proposed rulemaking would be that states stop reassigning homecare workers' dues to unions. We estimate that unions may currently collect as much as $71 million from such assignments.1 While we have not similarly quantified the amount of other authorized reassignments, such as health insurance, skills training, or other benefits, we believe that the amount of payments made to third parties on behalf of individual providers for the variety of benefits within the scope of this rulemaking is likely in excess of $100 million. We seek comment on this estimate, and particularly on the type and amount of payments currently being reassigned under the exceptions in § 447.10(g).

    1 Dues payments potentially associated with policies of the type being proposed for revision have been reported to be $8 million in Pennsylvania and $10 million in Illinois (https://www.fairnesscenter.org/cases/detail/protecting-the-vulnerable and https://www.washingtonexaminer.com/illinois-politicians-forced-home-care-workers-into-union-that-donates-heavily-to-them/article/2547368). The total population is approximately 26 million in these two states and 102 million across the states that have been reported by the State Policy Network to have relevant third-party payment policies (California, Connecticut, Illinois, Maryland, Massachusetts, Minnesota, Missouri, New Jersey, Oregon, Vermont and Washington) (https://www2.census.gov/programs-surveys/popest/tables/2010-2017/state/totals/nst-est2017-01.xlsx and https://spn.org/dues-skimming-faqs/). Factoring the $18 million (= $8 million + $10 million) proportionately by population yields a nationwide total of approximately $71 million in union dues payments potentially affected by this proposed rule. This transfer estimate could be over- or understated if other states pay home care workers different average wages than Pennsylvania and Illinois, if dues payments are collected at different rates, or if participation in Medicaid home care programs is not proportionate to total population.

    The potential direct financial impact to providers of this policy change could be affected by many factors, such as the nature and amounts of the types of payments currently being reassigned and decisions made by homecare providers after a final policy takes effect about whether or not to resume payments to third parties for these types of benefits. The Department is unable to quantify these direct financial impacts in the absence of specific information about the types and amount of payments being reassigned. Even where it may be possible to derive such estimates, such as with the example of union dues, the Department lacks information to reliably estimate the proportion of homecare providers likely to stop making payments versus those likely to continue making payments through alternative means. We request comments on the factors that might influence the direct financial impacts to providers and recipients of reassignments of this policy change for the varied types and amount of payments currently being reassigned under the exceptions in § 447.10(g).

    Although states will no longer be able to withhold portions of a provider's payment, states may elect to maintain the same level of payment, thus affording the provider the opportunity to purchase the items that were previously funded through the reassignment of reimbursement. Conversely, states may elect to decrease payment levels because rescission of § 447.10(g)(4) will limit their ability to reassign payment to third parties. In other words, states may have previously factored their ability to reassign provider payments into their payment rates and might choose to revise their rates in response to this regulatory change. We request comments, particularly from states, on potential state behavior under the proposed policy.

    If a state elected to maintain the same level of payment, and if homecare providers opt to continue all voluntary payments presently being reassigned, then the rule may have no impacts. However, if a state elected to reduce payment levels and/or if homecare providers opt to discontinue all voluntary payments, then the impacts of the rule may be close to the full amount of current reassignments, thus making the rule economically significant.

    While it is difficult for us to conduct a detailed quantitative analysis given this considerable uncertainty and lack of data, we believe that without this proposed rulemaking, states may apply the exceptions at § 447.10(g) in ways that do not comport with section 1902(a)(32) of the Act and we welcome comment with regard to the quantitative impact of the elimination of states' ability to reassign Medicaid payment for items such as health insurance, skills training and other benefits customary for employees. We also seek comments identifying impacts to states and the federal government as a result of this proposed rule, including on the assumption that the time, effort and financial resources necessary to comply with the proposed requirement would be incurred by states during the normal course of their activities and, therefore, does not impose incremental costs.

    C. Anticipated Effects

    The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary proposes to certify, that this proposed rule would not have a significant economic impact on a substantial number of small entities.

    In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary proposes to certify, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.

    Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2018, that threshold is approximately $150 million. This rule will have no consequential effect on state, local, or tribal governments or on the private sector.

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.

    D. Alternatives Considered

    We considered issuing guidance to require states to formally document consent to reassign portions of a provider's payment. We also considered limiting the items for which provider reassignment could be made. However, we are concerned that § 447.10(g)(4)) is overbroad, and insufficiently linked to the exceptions expressly permitted by the statute. Therefore, we believe removing the regulatory exception is the best course of action.

    E. Accounting Statement

    As required by OMB Circular A-4 under Executive Order 12866 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf) in Table 1, we have prepared an accounting statement showing the classification of transfers associated with the provisions in this proposed rule. The accounting statement is based on estimates provided in this regulatory impact analysis and omits categories of impacts for which partial quantification has not been possible.

    Table 1—Accounting Statement Category Low estimate High estimate Units Year dollars Discount rate
  • (%)
  • Period
  • covered
  • Transfers: Annualized Monetized $ millions/year 0 $71 2017 3 2019 0 71 2017 7 2019 From whom to whom? From third parties to home health providers.
    F. Regulatory Reform Analysis Under E.O. 13771

    Executive Order 13771, entitled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017 and requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” This proposed rule is not expected to be subject to the requirements of E.O. 13771 because this proposed rule is expected to result in no more than de minimis costs.

    G. Conclusion

    In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget.

    List of Subjects in 42 CFR Part 447

    Accounting, Administrative practice and procedure, Drugs, Grant programs—health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping requirements, Rural areas.

    For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:

    PART 447—PAYMENTS FOR SERVICES 1. The authority citation for part 447 continues to read as follows: Authority:

    Sec. 1102 of the Social Security Act (42 U.S.C. 1302).

    § 447.10 [Amended]
    2. Section 447.10 is amended by removing paragraph (g)(4). Dated: May 3, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. Dated: May 7, 2018. Alex M. Azar II, Secretary, Department of Health and Human Services.
    [FR Doc. 2018-14786 Filed 7-10-18; 11:15 am] BILLING CODE 4120-01-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [MB Docket No. 18-184; FCC 18-69] New FM Radio Broadcast Class C4 and To Modify the Requirements for Designating Short-Spaced Assignments AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice of inquiry.

    SUMMARY:

    In this document, the Commission adopted a Notice of Inquiry (NOI), based on a petition for rulemaking filed by SSR Communications, Inc., in which the Commission sought comment on a proposal to create a new class of FM radio stations, Class C4, and to establish a procedure for designating certain FM stations.

    DATES:

    Comments may be filed on or before August 13, 2018 and reply comments may be filed on or before September 10, 2018.

    ADDRESSES:

    You may submit comments, identified by MB Docket No. 18-184, by any of the following methods:

    Federal Communications Commission's Website: http://www.fcc.gov/cgb/ecfs/. Follow the instructions for submitting comments.

    Mail: Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

    People With Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email: [email protected] or phone: (202) 418-0530 or TTY: (202) 418-0432. For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Albert Shuldiner, Chief, Media Bureau, Audio Division, (202) 418-2721; James Bradshaw, Deputy Division Chief, Media Bureau, Audio Division, (202) 418-2739. Direct press inquiries to Janice Wise at (202) 418-8165.

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's Notice of Inquiry, FCC 18-69, adopted June 4, 2018, and released June 5, 2018. The full text of this document is available electronically via the FCC's Electronic Document Management System (EDOCS) website at http://https://www.fcc.gov/edocs or via the FCC's Electronic Comment Filing System (ECFS) website at http://https://www.fcc.gov/ecfs/. (Documents will be available electronically in ASCII, Microsoft Word, and/or Adobe Acrobat.) This document is also available for public inspection and copying during regular business hours in the FCC Reference Information Center, which is located in Room CY-A257 at FCC Headquarters, 445 12th Street SW, Washington, DC 20554. The Reference Information Center is open to the public Monday through Thursday from 8:00 a.m. to 4:30 p.m. and Friday from 8:00 a.m. to 11:30 a.m. Alternative formats are available for people with disabilities (braille, large print, electronic files, audio format), by sending an email to [email protected] or calling the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

    Synopsis of Notice of Inquiry

    1. Introduction. In this Notice of Inquiry (NOI), the Commission explores the possibility of amending part 73 of the Commission's Rules to create an intermediate class of FM broadcast stations in Zone II between Class A and Class C3, to be designated Class C4. Commission staff estimates that 127 Class C3 stations, or 14 percent of the total number of Class C3 stations, are operating with facilities that are less than the proposed Class C3 minimums and thus could be subject to reclassification to Class C4. It also explores the possibility of establishing a procedure whereby an FM station in the non-reserved band (Channels 221-300), regardless of Zone or station class, could be designated as a Section 73.215 facility, resulting in such station receiving interference protection based on its actual authorized operating parameters rather than the maximum permitted parameters for its station class.

    2. Class C4 proposal. This proceeding was initiated by a petition for rulemaking filed by SSR Communications, Inc. (SSR). SSR advocates the creation of a new Class C4 with an effective radiated power (ERP) that must exceed 6 kilowatts, a maximum ERP of 12 kilowatts, and a reference HAAT of 100 meters. The ERP that Class C3 stations must exceed would increase from 6 kilowatts to 12 kilowatts, but the maximum ERP would remain at 25 kilowatts. In addition, under the current rules, a station can operate below the minimum ERP for its class provided its HAAT allows it to exceed the class contour distance for the next lower class (for example, a Class C3 station must exceed the Class A contour distance of 28 kilometers). Under the SSR proposal, the next lower class for a Class C3 station would be Class C4, with a contour distance of 33 kilometers. SSR proposes amending Sections 73.207(b)(1), 73.210(a), 73.210(b), 73.211(a)(1), 73.211(b), and 73.215(e) of the Rules to implement these changes. SSR argues that a new Class C4 would provide upgrade opportunities for Class A facilities, particularly minority-owned stations, and create consistent ERP intervals between FM classes.

    3. Affected stations and their listeners. Would the creation of a Class C4 materially benefit existing Class A stations by providing them with an opportunity to upgrade that is not possible today based on the current Class C3 parameters? Would Class A stations and their listeners, particularly in rural or underserved areas, benefit from the new Class C4? Is there a significant demand for the rule changes proposed by SSR? How many stations are likely to be affected by such a rule change? As suggested by SSR, would the creation of a Class C4 be particularly beneficial for minority-owned Class A stations by providing them with an opportunity to upgrade? Would this action encourage diversity of ownership in the FM broadcast industry? Would there be a detrimental effect on existing stations and/or their listeners generally, either from increased interference or reclassification (upgrade or downgrade)?

    4. Secondary services. How would a new Class C4 affect secondary services (FM translators and LPFM stations), as well as AM primary stations that rebroadcast on FM translator stations? Are there lawful ways to mitigate or eliminate the impact of this proposal on secondary services, and, if so, what measures would be effective or appropriate? To what extent, if any, does the Local Community Radio Act of 2010 (LCRA) impact the Commission's ability to protect existing FM translator and LPFM stations? In particular, would such protections be consistent with the LCRA directive that the “Federal Communications Commission, when licensing new FM translators, FM booster stations, and low-power FM stations . . . ensure . . . that . . . (3) [these stations] remain equal in status and secondary to existing and modified full-service FM stations”? In this respect, the Commission notes that it would be reluctant to adopt any proposal in this area that would have a significantly negative impact on FM translators and LPFM stations.

    5. Allocation goals. Given the maturity of the FM service, would an increased density of signals resulting from Class A stations upgrading to Class C4 provide improved FM service coverage, or merely contribute to a higher “noise floor” overall while only modestly benefiting individual stations? Would upgrades to Class C4 increase the overall number of radio stations available to listeners or create interference that would degrade reception for stations in areas where there is currently a listenable signal, resulting in fewer listening choices for listeners? More generally, is there a “tipping point” at which increasingly granular station classifications are no longer conducive to efficient signal coverage and, if so, has that point been reached?

    6. Implementation procedures. What is the appropriate balance of interests between the anticipated benefit of creating a new class of FM stations and the disruption entailed in the reclassification of existing stations? If a new class is created, should the Commission implement a blanket reclassification process, as it did in 1983 and 1989, by requiring existing Class C3 stations to file for modification to meet the proposed revised minimum facility requirements for Class C3 stations within a set time frame or be reclassified based on their actual operating facilities? Should the mere filing for a modification be sufficient to avoid reclassification or should the Commission also require construction to be completed by a date certain? If a date certain is set for filing a modification or completing construction, what would be a reasonable amount of time for licensees to comply? Would a blanket reclassification provide more reliable and timely opportunities for upgrade than the show cause procedure outlined in the next paragraph?

    7. Alternatively, should the Commission adopt a show cause procedure similar to that currently in use for Class C0, whereby a Class C3 station operating below the proposed revised minimum facility requirements for Class C3 stations would be reclassified only after the filing of a “triggering” application that requires it to be reclassified to Class C4? Should the affected Class C3 station have the opportunity to preserve its Class C3 status by filing a construction permit application to upgrade its facility to meet Class C3 minimums? The Commission notes that the Commission's licensing staff has found that the Class C0 show cause procedure appears to incentivize delay and contention between the parties. Have licensees experienced delay or other difficulties using the Class C0 show cause procedure? Is the blanket reclassification process described in the preceding paragraph preferable for that reason? Are there other implementation approaches the Commission should consider that might address or avoid problems identified with this show cause procedure?

    8. Other issues. To what extent, if any, does the LCRA impact the Commission's creation of a new class of FM stations or reclassification of existing FM stations; in particular, the provision that the Commission “shall not amend its rules to reduce the minimum co-channel and first- and second-adjacent channel distance separation requirements in effect on [January 4, 2011] between—(A) low-power FM stations; and (B) full-service FM stations”? Are there specific rule changes that would be necessary or advisable to implement any of the foregoing proposals? The Commission also invites commenters to make suggestions as to how the Commission's forms and databases should be modified to implement the above proposals.

    9. Section 73.215 proposal. SSR argues that, by providing interference protection to a station's contours based on maximum class facilities, as opposed to the actual facilities, the Commission's rules overprotect stations operating with facilities below their class maximum. Accordingly, SSR proposes an amendment to Section 73.3573 of the Rules that would require such “sub-maximum” stations to be designated as Section 73.215 facilities using a procedure similar to the existing Class C0 show cause and reclassification procedure. Designation as a Section 73.215 facility would result in the sub-maximum station receiving interference protection based on its actual authorized operating parameters rather than the maximum permitted parameters for its station class. Under SSR's proposed procedure, stations not already authorized under Section 73.215 that, for ten years prior to the filing of a triggering application, have continuously operated with a HAAT or ERP below that of the class maximum (or equivalent class maximum HAAT and ERP combination in the case of station operating with a HAAT exceeding its reference HAAT) would be given an opportunity to upgrade to maximum class facilities or be subject to designation as a Section 73.215 facility.

    10. SSR recommends a show cause procedure to implement its Section 73.215 proposal. Specifically, the procedure would be initiated by the filing of a “triggering” application that specifies facilities that require the designation of the affected sub-maximum station as a Section 73.215 facility. Triggering applications may utilize Section 73.215 and must certify that no alternative channel is available for the proposed service. Copies of a triggering application and related pleadings would be required to be served on the licensee of the affected sub-maximum station. If the staff concludes that a triggering application is acceptable for filing, it would issue an order to show cause why the affected sub-maximum station should not be designated as a Section 73.215 station. The order to show cause would provide the licensee of the sub-maximum station 30 days to express in writing an intention to seek authority to modify its technical facilities to its maximum class HAAT and ERP (or equivalent combination thereof) or to otherwise challenge the triggering application. If no such intention is expressed and the triggering application is not challenged, the affected sub-maximum station would be designated as a Section 73.215 station and processing of the triggering application would be completed. If such intention is expressed within the 30-day period, an additional 180-day period would be provided during which the licensee of the sub-maximum station would be required to file an acceptable construction permit application to increase HAAT and/or ERP to its class maximum values (or equivalent combination thereof). Upon grant of such a construction permit application, the triggering application would be dismissed. As with Class C0 reclassifications, the licensee of the sub-maximum station would be required to serve on triggering applicants copies of any FAA submissions related to the application grant process. If the construction is not completed as authorized, the affected sub-maximum station would be automatically designated as a Section 73.215 facility. SSR's proposal raises issues similar to those posed by the Class C4 proposal, and the Commission seeks comment generally on the costs and benefits of the proposal.

    11. Affected stations and their listeners. Would the proposed Section 73.215 mechanism materially benefit stations seeking to upgrade and their listeners? What is the demand for such upgrades? Would there be a corresponding detrimental effect on listeners regarding loss of existing interference-free service provided by sub-maximum stations? The Commission has explained that its policy of protecting all stations as if they are operating at maximum permitted height or power for their class, even if they are in fact operating at or near the minimum permitted height and power for their class, “permits stations to improve technical facilities over time and provides a certain degree of flexibility for transmitter relocations.” To what extent would adoption of the Section 73.215 proposal undermine this policy? Is this policy still desirable in the mature FM service? What are the relevant factors that might affect the sub-maximum station's ability to upgrade to the class maximums, and have those factors changed due to technological or other developments? If a station has operated below maximum facilities for a sufficient period of time, can the Commission conclude that the station is either unwilling or unable to operate at maximum facilities, thereby justifying protecting such station based on actual operating parameters and allowing for more efficient utilization of FM spectrum? Is ten years of continuous “sub-maximum” operation the appropriate period of time before a station would be subject to involuntary Section 73.215 designation, as suggested by SSR, or is another period of time appropriate? To what extent should transfers of control or assignments of licensees impact the relevant time period? That is, should the time period apply per station or per licensee? For example, if the relevant time period is ten years and a station that has operated below class maximums for nine years is transferred or assigned to a third-party, should the new licensee have ten additional years to upgrade to class maximums free from potential designation as a Section 73.215 facility?

    12. Secondary services. The Commission seeks comment on the likely impact of full service station upgrades using the proposed Section 73.215 procedure on nearby secondary services or AM primary stations that rebroadcast on FM translator stations. Are there lawful ways to mitigate or eliminate the impact of this proposal on secondary services, and, if so, what measures would be effective or appropriate?

    13. Allocation goals. Would SSR's Section 73.215 proposal, if adopted, result in increased interference levels in the FM band? In particular, would the increased density of signals resulting from upgraded stations provide improved FM service coverage, or merely contribute to a higher “noise floor” overall while only modestly benefiting individual stations? Is this proposal in tension with the original purpose of Section 73.215 to afford applicants greater flexibility in the selection of transmitter sites? Should the Commission significantly expand the applicability of Section 73.215 as proposed by SSR, and what would be the policy and legal justifications for doing so? Does the Commission's long history of licensing thousands of stations in the reserved band—using a contour methodology based on stations' authorized facilities—show that expanding eligibility for Section 73.215 processing would result in increased or decreased services for listeners?

    14. Implementation procedures. If the Section 73.215 proposal is adopted, should the Commission follow SSR's suggested procedures, which are based on those currently in use for Class C0? Should the triggering applicant be required to certify that no alternative channel is available for the proposed service? Should the Commission use a show cause procedure, and if so, what deadlines would be appropriate?

    15. Alternatively, should the Commission adopt a more streamlined procedure whereby all sub-maximum stations would be provided a date certain by which they must file an upgrade application or automatically become subject to immediate designation as a Section 73.215 facility upon the filing of an acceptable application from another licensee seeking to upgrade its facilities? What would be a reasonable amount of time to allow sub-maximum stations to file upgrade applications before becoming subject to automatic designation as a Section 73.215 facility? Would such a procedure avoid unnecessary delays in providing new FM service and incentivize more stations to upgrade to their class maximums? Would there be any disadvantages with this approach? Are there other streamlined implementation approaches the Commission should consider?

    16. Other issues. The Commission invites comment on other details of SSR's Section 73.215 proposal. Which applicants should be permitted to use the proposed Section 73.215 procedure? Does “sub-maximum” include all stations operating at less than class maximums, or should the Commission establish a cutoff whereby a station would not be subject to designation as a Section 73.215 facility if it operates at a minimal distance below its class maximum contour distance, such as two kilometers? How would the proposal affect stations that are short-spaced under Section 73.213 of the Rules? Are there specific rule changes that would be necessary to implement the proposal? The Commission also invites commenters to make suggestions as to how its forms and databases should be modified to implement the Section 73.215 proposal.

    17. Federal Rules that May Duplicate, Overlap, or Conflict with the Proposed Rule. None.

    Ex Parte Rules

    18. Permit But Disclose. The proceeding this NOI initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Ex parte presentations are permissible if disclosed in accordance with Commission rules, except during the Sunshine Agenda period when presentations, ex parte or otherwise, are generally prohibited. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. Memoranda must contain a summary of the substance of the ex parte presentation and not merely a listing of the subjects discussed. More than a one or two sentence description of the views and arguments presented is generally required. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with § 1.1206(b) of the rules. In proceedings governed by § 1.49(f) of the rules or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

    Filing Procedures

    19. Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). Electronic Filers: Comments may be filed electronically using the internet by accessing the ECFS: http://apps.fcc.gov/ecfs/.

    Electronic Filers: Comments may be filed electronically using the internet by accessing the ECFS: http://apps.fcc.gov/ecfs/.

    Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

    Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

    All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW, Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.

    Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.

    U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington DC 20554.

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

    Ordering Clause

    20. It is further ordered that, pursuant to the authority contained in Sections 1, 4(i), 4(j), 301, 303, 307, 308, 309, 316, and 319 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 154(j), 301, 303, 307, 308, 309, 316, and 319, this Notice of Inquiry is adopted.

    Federal Communications Commission. Marlene Dortch, Secretary.
    [FR Doc. 2018-14880 Filed 7-11-18; 8:45 am] BILLING CODE 6712-01-P
    83 134 Thursday, July 12, 2018 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2018-0032] Notice of Request for Revision to and Extension of Approval of an Information Collection; Animal Welfare AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Revision to and extension of approval of an information collection; comment request.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the Animal Welfare Act regulations for the humane handling, care, treatment, and transportation of certain animals by dealers, research facilities, exhibitors, carriers, and intermediate handlers.

    DATES:

    We will consider all comments that we receive on or before September 10, 2018.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0032.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2018-0032, 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-2018-0032 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 information on the Animal Welfare Act regulations, contact Dr. Kay Carter-Corker, Director, National Policy Staff, Animal Care, APHIS, 4700 River Road, Unit 84, Riverdale, MD 20737; (301) 851-3748. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

    SUPPLEMENTARY INFORMATION:

    Title: Animal Welfare.

    OMB Control Number: 0579-0036.

    Type of Request: Revision to and extension of approval of an information collection.

    Abstract: Under the Animal Welfare Act (AWA, 7 U.S.C. 2131 et seq.), the Secretary of Agriculture is authorized to promulgate standards and other requirements governing the humane handling, care, treatment, and transportation of certain animals by dealers, exhibitors, operators of auction sales, research facilities, carriers and intermediate handlers. The Secretary has delegated responsibility for administering the AWA to the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS), Animal Care.

    Definitions, regulations, and standards established under the AWA are contained in 9 CFR parts 1, 2, and 3 (referred to below as the regulations). Part 1 contains definitions for terms used in parts 2 and 3. Part 2 provides administrative requirements and sets forth institutional responsibilities for regulated parties, including licensing requirements for dealers, exhibitors, and operators of auction sales. Dealers, exhibitors, and operators of auction sales are required to comply in all respects with the regulations and standards (9 CFR 2.100(a)) and to allow APHIS officials access to their place of business, facilities, animals, and records to inspect for compliance (9 CFR 2.126). Part 3 provides standards for the humane handling, care, treatment, and transportation of covered animals. Part 3 consists of subparts A through E, which contain specific standards for dogs and cats, guinea pigs and hamsters, rabbits, nonhuman primates, and marine mammals, respectively, and subpart F, which sets forth general standards for warmblooded animals not otherwise specified in part 3.

    Administering the AWA requires the use of several information collection activities such as license applications and renewals, which now include a request to identify whether the business mailing address is a personal residence or not a personal residence; registration applications and updates; annual reports; acknowledgement of regulations and standards; inspections; requests; notifications; agreements; plans; written program of veterinary care and health records; itineraries; applications and permits; records of acquisition, disposition, or transport of animals; official identification; variances; protocols; health certificates; complaints; marking requirements; and recordkeeping.

    These information collection activity requirements provide APHIS with the data necessary for the review and evaluation of program compliance by regulated facilities, and they provide a workable enforcement system to carry out the requirements of the AWA and the intent of Congress without resorting to more detailed and stringent regulations and standards that could be more burdensome to regulated facilities.

    We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.

    The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

    (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

    (2) Evaluate the accuracy of our estimate of the burden of the 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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

    Estimate of burden: The public burden for this collection of information is estimated to average 0.31 hours per response.

    Respondents: Individuals or households; businesses or other for-profit entities; not-for-profit institutions; farms; and State, local, and Tribal governments.

    Estimated annual number of respondents: 9,112.

    Estimated annual number of responses per respondent: 128.

    Estimated annual number of responses: 1,164,553.

    Estimated total annual burden on respondents: 366,021 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

    All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

    Done in Washington, DC, this 9th day of July 2018. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2018-14945 Filed 7-11-18; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Forest Service Notice of New Fee Sites; Federal Lands Recreation Enhancement Act AGENCY:

    Bitterroot National Forest, Forest Service, USDA.

    ACTION:

    Notice of new fee sites.

    SUMMARY:

    The Bitterroot National Forest is proposing to implement new fees at two campgrounds and one rental cabin. These fees are only proposed and will be determined upon further analysis and public comment.

    DATES:

    Send any comments about these fee proposals by August 13, 2018 so comments can be compiled, analyzed, and shared with the Western Montana Bureau of Land Management Resource Advisory Committee. The effective date of implementation of proposed new fees will be no earlier than six months after publication of this notice.

    ADDRESSES:

    Julie King, Forest Supervisor, Bitterroot National Forest, 1801 N First, Hamilton, MT 59840 or Email to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Erica Strayer, Recreation Program Manager, Darby Ranger District, at 406-821-4252 or [email protected] Information about proposed fee changes can also be found at www.fs.usda.gov/goto/r1recfee.

    SUPPLEMENTARY INFORMATION:

    The Federal Recreation Lands Enhancement Act (Title VII, Pub. L. 108-447) directed the Secretary of Agriculture to publish a six month advance notice in the Federal Register whenever new recreation fee areas are established. These new fees will be reviewed by the Western Montana Bureau of Land Management Resource Advisory Committee prior to a final decision and implementation.

    The Forest proposes a $50/night fee for Lost Horse Guard Station, which would open this site for public rental. The Forest also proposes a $10/night fee for both Slate Creek and Sam Billings Memorial campgrounds. Lost Horse Guard Station was built in 1935 and listed on the National Register of Historic Places in 1989. It lies at the head of Lost Horse Creek, near the Montana/Idaho divide. It is near a variety of recreation opportunities such as hiking, camping, horseback riding, non-motorized water sports, hunting, backcountry skiing, and snowmobiling at Twin Lakes. The rustic guard station can sleep up to eight people.

    Slate Creek Campground also has a new group gathering area and Sam Billings Memorial Campground has new horse camping sites. Reasonable fees, paid by users of these sites and services, will help ensure that the Forest can continue maintaining and improving the sites for future generations.

    A business analysis of the proposed new fee sites listed has shown that people desire having a variety of recreation opportunities and experiences on the Bitterroot National Forest, such as group camping, cabin and lookout rentals and single family camping. A market analysis of surrounding recreation sites with similar amenities indicates that the proposed fees are comparable and reasonable.

    Advance reservations for the Lost Horse Guard Station will be available through www.recreation.gov or by calling 1-877-444-6777. The National Recreation Reservation Service charges a $10 fee for reservations.

    Dated: May 17, 2018. Glenn Casamassa, Associate Deputy Chief, National Forest System.
    [FR Doc. 2018-14910 Filed 7-11-18; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Notice of Proposed New Fee Site; Federal Lands Recreation Enhancement Act AGENCY:

    Flathead National Forest, Forest Service, USDA.

    ACTION:

    Notice of new fee site.

    SUMMARY:

    The Flathead National Forest is proposing to charge a new fee at the Lindbergh Lake Campground. Funds generated at the site will be used for the operation and maintenance, upkeep of facilities, and improvements as feasible. This fee is only proposed and will be determined upon further analysis and public comment.

    DATES:

    Send any comments about these fee proposals by August 13, 2018 so comments can be compiled, analyzed, and shared with the Western Montana Bureau Land Management (BLM) Resource Advisory Council. The effective date of implementation of this fee would be no earlier than six months after publication of this notice.

    ADDRESSES:

    Chip Weber, Forest Supervisor, Flathead National Forest, 650 Wolfpack Way, Kalispell, MT 59901 or Email to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Chris Prew, Recreation Program Manager, Flathead National Forest, at 406-758-3538 or [email protected] Information about proposed fee changes can also be found at www.fs.usda.gov/goto/r1recfee.

    SUPPLEMENTARY INFORMATION:

    The Federal Recreation Lands Enhancement Act (Title VII, Pub. L. 108-447) directed the Secretary of Agriculture to publish a six month advance notice in the Federal Register whenever new recreation fee areas are established. This new fee will be reviewed by the Western Montana BLM Resource Advisory Council prior to a final decision and implementation.

    The Flathead National Forest is proposing to charge a $10 per night fee at Lindbergh Lake Campground. Lindbergh Lake Campground offers breathtaking views of the Mission and Swan Mountain Ranges and has a concrete boat ramp for ease of lake access and enjoyment. The lake offers boating, swimming, and fishing opportunities and is located in close proximity to the Mission Mountains Wilderness, which offers excellent hiking opportunities. The campground has 21 individual camp sites and features a new toilet facility and other site improvements.

    A business analysis of the proposed new fee site has shown that people desire having a variety of recreation opportunities and experiences on the Flathead National Forest, such as lake-orientated developed campgrounds. A market analysis of surrounding recreation sites with similar amenities indicates that the proposed fee is comparable and reasonable.

    Dated: July 5, 2018. Glenn Casamassa, Associate Deputy Chief, National Forest System.
    [FR Doc. 2018-14911 Filed 7-11-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-18-2018] Production Activity Not Authorized; Foreign-Trade Zone (FTZ) 26—Atlanta, Georgia; PBR, Inc. d/b/a SKAPS Industries (Non-Woven Geotextiles); Athens, Georgia

    On March 9, 2018, PBR, Inc. d/b/a SKAPS Industries (SKAPS) submitted a notification of proposed production activity to the FTZ Board for its facility within FTZ 26—Site 29, in Athens, Georgia.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (83 FR 13473, March 29, 2018). On July 9, 2018 the applicant was notified of the FTZ Board's decision that further review of the activity is warranted. The production activity described in the notification was not authorized. If the applicant wishes to seek authorization for this activity, it will need to submit an application for production authority, pursuant to Section 400.23.

    Dated: July 9, 2018. Elizabeth Whiteman, Acting Executive Secretary.
    [FR Doc. 2018-14928 Filed 7-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-122-854] Supercalendered Paper From Canada: Notice of Rescission of Countervailing Duty Administrative Review; 2015 and 2016 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Commerce) is rescinding the administrative reviews of the countervailing duty (CVD) order on supercalendared paper (SC paper) from Canada for the period of review August 3, 2015, through December 31, 2015, and the period of review January 1, 2016, through December 31, 2016.

    DATES:

    Applicable July 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Emily Halle or Nicholas Czajkowski, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-0176 or (202) 482-1395, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On December 1, 2016, Commerce published in the Federal Register a notice of opportunity to request an administrative review of the CVD order on SC paper from Canada for the period of review (POR) of August 3, 2015, through December 31, 2015.1 Commerce received timely-filed requests from Verso Corporation (Verso); Catalyst Paper Corporation, Catalyst Pulp and Paper Sales Inc., and Catalyst Paper (USA) Inc. (collectively, Catalyst); Irving Paper Limited (Irving); Port Hawkesbury Paper LP (PHP); and Resolute FP Canada Inc and Resolute FP US Inc. (collectively, Resolute), in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), to conduct an administrative review of the CVD order.2 Based upon this request, on February 13, 2017, in accordance with section 751(a) of the Act, Commerce published a notice of initiation.3

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity To Request Administrative Review, 81 FR 86694 (December 1, 2016).

    2See Letter from Verso, “Supercalendered Paper from Canada: Request for Administrative Review,” January 3, 2017; see Letter from Catalyst, “Supercalendered Paper from Canada: Request for Administrative Review,” December 9, 2016; see Letter from Irving, “Supercalendered Paper from Canada, Inv. No. C-122-854—Request for Administrative Review and Request for Expansion of Review Period,” December 23, 2016; see Letter from PHP, “Supercalendered Paper from Canada: Request for Administrative Review,” December 9, 2016; see Letter from Resolute, “Supercalendered Paper from Canada: Request for Administrative Review (8/3/15-12/31/15),” December 19, 2016.

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 82 FR 10457 (February 13, 2017).

    On December 4, 2017, Commerce published in the Federal Register a notice of opportunity to request an administrative review of the CVD order on SC paper from Canada for the period of review (POR) of January 1, 2016, through December 31, 2016.4 Commerce received timely-filed requests from Verso Corporation, Irving Paper Limited, Port Hawkesbury Paper LP, and Resolute FP Canada Inc and Resolute FP US Inc., in accordance with section 751(a) of the Act, to conduct an administrative review of the CVD order.5 Based upon this request, on February 23, 2018, in accordance with section 751(a) of the Act, Commerce published a notice of initiation.6

    4See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity To Request Administrative Review, 83 FR 57219 (December 4, 2017).

    5See Letter from Verso, “Supercalendered Paper from Canada: Request for Administrative Review,” December 29, 2017; see Letter from Irving, “Supercalendered Paper from Canada, Inv. No. C-122-854—Request for Administrative Review,” December 15, 2017; see Letter from PHP, “Supercalendered Paper from Canada: Request for Administrative Review,” December 20, 2017; see Letter from Resolute, “Supercalendered Paper from Canada: Request for Administrative Review (1/1/2016-12/31/2016),” December 21, 2017.

    6See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 83 FR 8058 (February 23, 2018).

    On July 5, 2018, Commerce revoked the CVD order on SC paper.7

    7See Supercalendered Paper from Canada: Final Results of Changed Circumstances Review and Revocation of Countervailing Duty Order, signed July 5, 2018.

    Rescission of Administrative Reviews

    Pursuant to 19 CFR 351.222(g), Commerce revoked the CVD order on SC paper from Canada. The effective date of the revocation of the CVD order is August 3, 2015. As a result of the revocation, we instructed U.S. Customs and Border Protection (CBP) to discontinue the suspension of liquidation and the collection of cash deposits of estimated countervailing duties, to liquidate all unliquidated entries that were entered on or after August 3, 2015, without regard to countervailing duties, and to refund all CVD cash deposits on all such merchandise, with applicable interest. These administrative reviews cover the period August 3, 2015 through December 31, 2015, and the period January 1, 2016 through December 31, 2016. Because the revocation is retroactive to August 3, 2015, the periods covered by these ongoing administrative reviews are no longer subject to the CVD order, and there is no basis for conducting the administrative review. Therefore, Commerce is rescinding these administrative reviews.

    Assessment

    Because we ordered the liquidation of the entries subject to these administrative reviews, as a result of the revocation of the CVD order, there is no need to issue additional instructions to CBP.

    Notification Regarding Administrative Protective Orders

    This notice serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    This notice is issued and published in accordance with section 751 of the Act and 19 CFR 351.213(d)(4).

    Dated: July 5, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2018-14922 Filed 7-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-601] Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Preliminary Results and Intent To Rescind the Review in Part; 2016-2017 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Commerce) is conducting an administrative review (AR) of the antidumping duty order on tapered roller bearings and parts thereof, finished and unfinished (TRBs), from the People's Republic of China (China). The AR covers 20 exporters, of which Commerce selected two exporters for individual examination (i.e., GGB Bearing Technology (Suzhou) Co., Ltd. (GGB); and Luoyang Bearing Corporation (Group) (Luoyang)). The period of review (POR) is June 1, 2016, through May 31, 2017. We preliminarily determine that sales of subject merchandise have been made below normal value (NV). Interested parties are invited to comment on these preliminary results.

    DATES:

    Applicable July 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Andrew Medley, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4987.

    SUPPLEMENTARY INFORMATION: Scope of the Order

    The merchandise covered by the order includes tapered roller bearings and parts thereof. The subject merchandise is currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 8482.20.00, 8482.91.00.50, 8482.99.15, 8482.99.45, 8483.20.40, 8483.20.80, 8483.30.80, 8483.90.20, 8483.90.30, 8483.90.80, 8708.70.6060, 8708.99.2300, 8708.99.4850, 8708.99.6890, 8708.99.8115, and 8708.99.8180. The HTSUS subheadings are provided for convenience and customs purposes only; the written description of the scope of the order is dispositive.1

    1 For a complete description of the scope of the order, see Memorandum, “Decision Memorandum for the Preliminary Results of the 2016-2017 Antidumping Duty Administrative Review of Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, from the People's Republic of China” (Preliminary Decision Memorandum), issued concurrently with and hereby adopted by this notice.

    Methodology

    Commerce is conducting this review in accordance with section 751(a)(1)(B) of the Act. For GGB, we calculated export prices in accordance with section 772 of the Act. Because China is a non-market economy (NME) within the meaning of section 771(18) of the Act, for GGB, NV was calculated in accordance with section 773(c) of the Act. We preliminary find that Luoyang is ineligible for a separate rate and is part of the China-wide entity.

    For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be found at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content. A list of the topics discussed in the Preliminary Decision Memorandum is attached as the Appendix to this notice.

    Rate for Non-Examined Companies Which Are Eligible for a Separate Rate

    As indicated in the “Preliminary Results of Review” section below, we preliminarily determine that a weighted-average dumping margin of 6.87 percent applies to the six firms not selected for individual review which are eligible for a separate rate. For further information, see the Preliminary Decision Memorandum at “Separate Rate Assigned to Non-Selected Companies.”

    Preliminary Results of Review

    Twelve companies involved in the administrative review did not demonstrate that they are entitled to a separate rate.2 Therefore, we preliminarily finds these companies to be part of the China-wide entity.3 The rate previously established for the China-wide entity is 92.84 percent. One additional company, Hangzhou Xiaoshan Dingli Machinery Co., Ltd. (Dingli), could not demonstrate that it had a suspended entry during the POR; thus, we intend to rescind the review with respect to Dingli.

    2 These companies are: (1) Apex Maritime Shanghai Co., Ltd.; (2) Crossroads Global Trading Co., Ltd.; (3) Honour Lane Shipping Ltd.; (4) Kinetsu World Express China Co., Ltd.; (5) Luoyang; (6) Pacific Link Intl Freight Forwarding Co., Ltd.; (7) Shanghai Dizhao Industrial Trading Co., Ltd.; (8) Thi Group Shanghai Ltd.; (9) Weifang Haoxin-Conmet Mechanical Products Co., Ltd.; (10) Yantai Huilong Machinery Parts Co.; Ltd.; (11) Zhejiang Machinery Import & Export Corp.; and (12) Zhejiang Zhaofeng Mechanical & Electronic Co., Ltd.

    3See Preliminary Decision Memorandum, at 8. Pursuant to Commerce's change in practice, Commerce no longer considers the NME entity as an exporter conditionally subject to administrative reviews. See Antidumping Proceedings: Announcement of Change in Department Practice for Respondent Selection in Antidumping Duty Proceedings and Conditional Review of the Nonmarket Economy Entity in NME Antidumping Duty Proceedings, 78 FR 65963, 65970 (November 4, 2013). Under this practice, the NME entity will not be under review unless a party specifically requests, or Commerce self-initiates, a review of the entity. Because no party requested a review of the entity, the entity is not under review and the entity's rate is not subject to change.

    We preliminarily determine that the following weighted-average dumping margins exist for the period June 1, 2016, through May 31, 2017:

    Exporter Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • GGB Bearing Technology (Suzhou) Co., Ltd 6.87 CNH Industrial Italia SpA * 6.87 GSP Automotive Group Wenzhou Co. Ltd * 6.87 Hangzhou Hanji Auto Parts Co., Ltd * 6.87 Hangzhou Radical Energy-Saving Technology Co., Ltd * 6.87 Ningbo Xinglun Bearings Import & Export Co., Ltd * 6.87 Zhejiang Sihe Machine Co., Ltd * 6.87 * This company was not selected as a mandatory respondent but is subject to this administrative review and demonstrated that it qualified for a separate rate during the POR.
    Disclosure and Public Comment

    Commerce will disclose calculations performed for these preliminary results to the parties within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties may submit case briefs no later than 30 days after the date of publication of these preliminary results of review.4 Rebuttals to case briefs may be filed no later than five days after case briefs are filed and all rebuttal briefs must be limited to comments raised in the case briefs.5 Parties who submit comments are requested to submit with the argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.6

    4See 19 CFR 351.309(c)(1)(ii).

    5See 19 CFR 351.309(d).

    6See 19 CFR 351.309(c)(2).

    Any interested party may request a hearing within 30 days of publication of this notice.7 Hearing requests should contain the following information: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations will be limited to issues raised in the briefs.8 If a request for a hearing is made, parties will be notified of the time and date for the hearing to be held at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.9

    7See 19 CFR 351.310(c).

    8Id.

    9See 19 CFR 351.310(d).

    All submissions, with limited exceptions, must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety by 5 p.m. Eastern Time (ET) on the due date.10 Documents excepted from the electronic submission requirements must be filed manually (i.e., in paper form) with the APO/Dockets Unit in Room 18022 and stamped with the date and time of receipt by 5 p.m. ET on the due date.11

    10See 19 CFR 351.103(c).

    11See 19 CFR 351.303(b) and “ACCESS Handbook on Electronic Filing Procedures Enforcement and Compliance International Trade Administration U.S. Department of Commerce,” dated October 24, 2017, available at https://access.trade.gov/help/Handbook_on_Electronic_Filing_Procedures.pdf.

    Unless otherwise extended, Commerce intends to issue the final results of this administrative review, which will include the results of its analysis of all issues raised in the case briefs, within 120 days of publication of these preliminary results, pursuant to section 751(a)(3)(A) of the Act.

    Assessment Rates

    Upon issuance of the final results of the administrative review, Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.12 For each examined respondent which is eligible for a separate rate and which has a weighted-average dumping margin which is not zero or de minimis (i.e., less than 0.5 percent), we will calculate importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those sales, in accordance with 19 CFR 351.212(b)(1).

    12See 19 CFR 351.212(b)(1).

    Pursuant to Commerce's assessment practice, for entries that were not reported in the U.S. sales data submitted by an examined respondent, we will instruct CBP to liquidate such entries at the China-wide rate. Additionally, if we determine that an exporter had no shipments of the subject merchandise, any suspended entries that entered under that exporter's case number (i.e., at that exporter's cash deposit rate) will be liquidated at the China-wide rate.13

    13See Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011).

    For the respondents which were not selected for individual examination in this administrative review and which qualified for a separate rate, the assessment rate will be equal to the weighted-average dumping margin determined for the non-examined respondents in the final results of this administrative review. For the final results, if we continue to treat the 12 exporters preliminarily found not to qualify for separate rates as part of the China-wide entity, we will instruct CBP to apply an ad valorem assessment rate of 92.84 percent, the current rate established for the China-wide entity, to all entries of subject merchandise during the POR which were exported by those companies. In addition, if Commerce continues to find that Dingli had no suspended entries during the POR, we will rescind the review for that company.14

    14 For a full discussion of this practice, see Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011).

    We intend to issue assessment instructions to CBP 15 days after the publication of the final results of these reviews.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For the exporters listed above which have a separate rate, the cash deposit rate will be equal to the weighted-average dumping margin established in the final results of this review (except, if the rate is zero or de minimis, then a cash deposit rate of zero will be established for that company); (2) for previously investigated or reviewed Chinese and non-Chinese exporters not listed above that have separate rates, the cash deposit rate will continue to be equal to the exporter-specific weighted-average dumping margin published for the most recently completed segment of this proceeding; (3) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the cash deposit rate established for the China-wide entity, 92.84 percent; and (4) for all exporters of subject merchandise which are not located in China and which are not eligible for a separate rate, the cash deposit rate will be the rate applicable to the Chinese exporter(s) that supplied that non-Chinese exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Notification to Interested Parties

    We are issuing and publishing these preliminary results of review in accordance with sections 751(a)(l), 751(a)(2)(B) and 777(i)(l) of the Act, and 19 CFR 351.221(b)(4).

    Dated: July 3, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix—List of Topics Discussed in the Preliminary Decision Memorandum 1. Summary 2. Background 3. Scope of the Order 4. Discussion of the Methodology a. Non-Market Economy Country Status b. Separate Rates i. Separate Rates Applicants with No Evidence of Suspended Entries ii. Separate Rate Recipients 1. Wholly Foreign-Owned Companies 2. Wholly China-Owned Companies and Joint Ventures a. Absence of De Jure Control b. Absence of De Facto Control 3. Companies Not Receiving a Separate Rate c. Separate Rate Assigned to Non-Selected Companies d. The China-Wide Entity e. Application of Facts Available and Use of Adverse Interferences f. Application of Partial AFA for GGB g. Surrogate Country h. Date of Sale i. Normal Value Comparisons j. Determination of Comparison Method k. Constructed Export Price i. Irrecoverable Value-Added Tax (VAT) ii. GGB l. Normal Value i. Factor Valuations ii. Currency Conversion 5. Recommendation
    [FR Doc. 2018-14924 Filed 7-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-580-874] Certain Steel Nails From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review and Partial Rescission of Antidumping Duty Administrative Review; 2016-2017 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Commerce) preliminarily determines that Daejin Steel Co. (Daejin), Koram Inc. (Koram), and Korea Wire Co., Ltd. (Kowire), producers/exporters of merchandise subject to this administrative review, made sales of subject merchandise at less than normal value. The period of review (POR) is July 1, 2016, through June 30, 2017.

    DATES:

    Applicable July 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Robert Galantucci (Kowire), Maliha Khan (Daejin), or Trisha Tran (Koram), AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2923, (202) 482-0895, or (202) 482-4852, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On July 3, 2017, Commerce published in the Federal Register a notice of opportunity to request an administrative review of the antidumping duty (AD) order on certain steel nails (steel nails) from Korea.1 On July 31, 2017, Daejin 2 and Kowire 3 each requested an administrative review, and Mid Continent Steel & Wire, Inc.4 (the petitioner) requested an administrative review of 206 producers and/or exporters, including Daejin, Koram, Koram Steel Co. Ltd., and Kowire. On September 28, 2017, the petitioner withdrew its administrative review request with respect to 202 of the 206 companies identified as producers/exporters in the petitioner's July 31, 2017 letter. The petitioner maintained its administrative review request with respect to: Daejin, Koram, Koram Steel Co. Ltd., and Kowire. As such, Commerce issued its AD questionnaire to these companies on October 10, 2017.5

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 82 FR 30833 (July 3, 2017).

    2See Letter from Daejin, “Administrative Review of the Antidumping Duty Order on Certain Steel Nails from Korea—Request for Review,” dated July 31, 2017.

    3See Letter from Kowire, “Steel Nails from the Republic of Korea—Request for Administrative Review,” dated July 31, 2017.

    4See Letter from the petitioner, “Certain Steel Nails from Korea: Request for Administrative Reviews,” dated July 31, 2017.

    5See Commerce's Letter, “Administrative Review of Certain Steel Nails from Korea: Antidumping Duty Questionnaire,” dated October 10, 2017.

    Partial Rescission of Administrative Review

    Commerce received timely requests to conduct an administrative review of certain exporters covering the POR. Because the petitioner timely withdrew its request for review of all of the companies listed in the Initiation Notice, with the exception of Daejin, Koram, Koram Steel Co. Ltd., and Kowire, we are rescinding this administrative review with respect to the remaining companies on which we initiated a review pursuant to 19 CFR 351.213(d)(1). For a list of the companies for which we are rescinding this review, see Appendix II to this notice.

    As discussed in the Preliminary Decision Memorandum, we preliminarily determine that Koram is the successor-in-interest to Koram Steel Co. Ltd.; therefore, we will not calculate a separate dumping margin for Koram Steel Co., Ltd.6 Accordingly, the three companies subject to the instant review are: Daejin, Koram, and Kowire.

    6See Memorandum, “Decision Memorandum for Preliminary Results of the 2016-2017 Antidumping Duty Administrative Review of Certain Steel Nails from the Republic of Korea,” dated concurrently with, and hereby adopted by this notice (Preliminary Decision Memorandum) at 2.

    The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Preliminary Decision Memorandum are identical in content.

    Scope of the Order

    The merchandise covered by this order is certain steel nails having a nominal shaft length not exceeding 12 inches.7 Merchandise covered by the order is currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7317.00.55.02, 7317.00.55.03, 7317.00.55.05, 7317.00.55.07, 7317.00.55.08, 7317.00.55.11, 7317.00.55.18, 7317.00.55.19, 7317.00.55.20, 7317.00.55.30, 7317.00.55.40, 7317.00.55.50, 7317.00.55.60, 7317.00.55.70, 7317.00.55.80, 7317.00.55.90, 7317.00.65.30, 7317.00.65.60 and 7317.00.75.00. Certain steel nails subject to this order also may be classified under HTSUS subheadings 7907.00.60.00, 8206.00.00.00 or other HTSUS subheadings. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this order is dispositive. For a full description of the scope of the order, see the Preliminary Decision Memorandum.8

    7 The shaft length of certain steel nails with flat heads or parallel shoulders under the head shall be measured from under the head or shoulder to the tip of the point. The shaft length of all other certain steel nails shall be measured overall.

    8See Preliminary Decision Memorandum.

    Methodology

    Commerce is conducting this review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). Export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act.

    For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.9 A list of topics included in the Preliminary Decision Memorandum is included as Appendix I to this notice.

    9Id.

    Preliminary Results of Review

    As a result of this review, we preliminarily determine the following weighted-average dumping margins for the period July 1, 2016, through June 30, 2017:

    Exporter and/or producer Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Daejin Steel Co 3.02 Koram Inc 10.59 Korea Wire Co., Ltd 1.10
    Assessment Rates

    Upon completion of the administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries. Commerce intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of this review.

    For any individually examined respondents whose weighted-average dumping margin is above de minimis (i.e., 0.50 percent), we will calculate importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1).10 For entries of subject merchandise during the POR produced by each respondent for which it did not know its merchandise was destined for the United States, we will instruct CBP to liquidate un-reviewed entries at the all-others rate if there is no rate for the intermediate company involved in the transaction.11 We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific assessment rate calculated in the final results of this review is above de minimis. Where either the respondent's weighted-average dumping margin is zero or de minimis, or an importer-specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

    10 In these preliminary results, Commerce applied the assessment rate calculation methodology adopted in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101 (February 14, 2012).

    11See Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003).

    For the 202 companies for which this review is rescinded, antidumping duties will be assessed at rates equal to the cash deposit of estimated antidumping duties in effect at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions directly to CBP 15 days after publication of this notice. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable.

    Cash Deposit Requirement

    The following deposit requirements will be effective upon publication of the notice of the final results of administrative review for all shipments of steel nails from Korea entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the companies under review will be the rate established in the final results of this review (except, if the rate is zero or de minimis, no cash deposit will be required); (2) for merchandise exported by manufacturers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the manufacturer or exporter participated; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently completed segment of the proceeding for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 11.80 percent ad valorem, the all-others rate established in the less-than-fair value investigation.12

    12See Certain Steel Nails from the Republic of Korea: Final Determination of Sales at Less Than Fair Value, 80 FR 28955 (May 20, 2015).

    Disclosure and Public Comment

    Commerce intends to disclose the calculations used in our analysis to interested parties in this review within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties are invited to comment on the preliminary results of this review. Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed no later than five days after the time limit for filing case briefs.13 Parties who submit case briefs or rebuttal briefs in this proceeding are requested to submit with each brief: (1) A statement of the issues, (2) a brief summary of the argument, and (3) a table of authorities.14 Executive summaries should be limited to five pages total, including footnotes.15 Case and rebuttal briefs should be filed using ACCESS.16

    13See 19 CFR 351.309(d)(1).

    14See 19 CFR 351.309(c)(2) and (d)(2).

    15Id.

    16See 19 CFR 351.303.

    Pursuant to 19 CFR 351.310(c), any interested party may request a hearing within 30 days of the publication of this notice in the Federal Register. If a hearing is requested, Commerce will notify interested parties of the hearing schedule. Interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs.

    We intend to issue the final results of this administrative review, including the results of our analysis of issues raised by the parties in the written comments, within 120 days of publication of these preliminary results in the Federal Register, unless otherwise extended.17

    17See section 751(a)(3)(A) of the Act.

    Notification to Importers

    This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Notification to Interested Parties

    We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(4).

    Dated: July 5, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix I—List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope of the Order IV. Rescission of Review, In Part V. Affiliation VI. Duty Absorption Inquiry VII. Discussion of the Methodology A. Comparisons to Normal Value B. Product Comparisons C. Date of Sale D. Level of Trade E. Export Price F. Normal Value G. Successor-In-Interest Determination—Koram VIII. Currency Conversions IX. Recommendation Appendix II Airlift Trans Oceanic Pvt. Ltd. Aironware Enterprise (China) Ltd. AM Global Shipping Lines Ansing Rich Tech & Trade Co. Ltd. Apex Maritime Co., Ltd. Apex Shipping Co. Ltd. Astrotech Steels Private Limited Baoding Jieboshun Trading Corp. Ltd. Beijing Jin Heung Co. Ltd. Beijing Kang Jie Kong Int'l Cargo Co. Ltd. Beijing Qin Li Jeff Trading Co., Ltd. Bestbond International Limited Bipex Co., Ltd. Bollore Logistics Co. Ltd. Bolung International Trading Co., Ltd. Bon Voyage Logistics Inc. Bonuts Hardware Logistics Co. Ltd. Brilliant Group Logistics Corp. C&D International Freight Forwarding C.H. Robinson Freight Services Ltd. Caesar International Logistics Co. Ltd. Cana (Rizhao) Hardware Co. Ltd. Cangzhou Xinqiao Int'l Trade Co. Ltd. Capital Freight Management Inc. Cargo Services Co. Ltd. Caribbean International Co. Ltd. Casia Global Logistics Co Ltd China Container Line Northern Ltd. China Dinghao Co., Ltd. China International Freight Co., Ltd. China Staple Enterprise Co. Ltd Chinatrans International Limited Chongqing Welluck Trading Co. Ltd. Chosun Shipping Co. Ltd. CJ Korea Express Corp. CKX Co. Ltd. Cohesion Freight (HK) Ltd. Consolidated Shipping Services L.L.C. Crelux International Co. Ltd. Dahnay Logistics Private Ltd. Dalian Sunny International Logistics DCS Dah Star Logistics Co., Ltd. De Well Container Shipping Inc. Dezhou Hualude Hardware Products Co., Ltd. Dong E Fuqiang Metal Products Co. Ltd. DT Logistics Hong Kong Ltd Duo-Fast Korea Co., Ltd. Dynamic Network Container Line Limited E&E Transport International Co., Ltd. ECI Taiwan Co., Ltd. Eco Steel Co., Ltd. Ejem Brothers Limited Eumex Line Shenzhen Limited Eunsan Shipping & Aircargo Co., Ltd. Euroline Global Co., Ltd. Expeditors Korea Ltd. Faithful Engineering Products Co. Ltd. Fastgrow International Co. Fastic Transportation Co., Ltd. Flyjac Logistics Pvt. Ltd. G Link Express Logistics (Korea) Ltd GCL Logistics Co., Ltd. Global Container Line, Inc. Globelink Weststar Shipping Glovis America Grandee Logistics Ltd. Hanbit Logistics Co., Ltd. Hanjin Logistics India Private Ltd. Hanmi Staple Co., Ltd. Hanon Systems Hebei Minmetals Co., Ltd. Hebei Tuohua Metal Products Co., Ltd. Hecny Shipping Ltd. Hecny Transportation Ltd. Hengtuo Metal Products Co Ltd High Link Line Inc. Hong Kong Hong Xing Da Trading Co. Ltd. Hongyi Hardware Products Co., Ltd. Honour Lane Logistics Company Honour Lane Shipping Limited Huanghua Yingjin Hardware Products Co., Ltd. Hyundai Logistics Co. Ltd. Inmax Industries Sdn. Bhd. Integral Building Products Inc. International Maritime and Aviation LLC JAS Forwarding Co. Ltd. Je-il Wire Production Co., Ltd. Jeil Tacker Co. Ltd. Jiangsu Soho Honry Import Export Co. Ltd. Jiaxing Slk Import & Export Co., Ltd. Jinhai Hardware Co., Ltd. Jinheung Steel Corporation Jinkaiyi International Industry Co. Jinsco International Corp. Joo Sung Sea Air Co., Ltd. K Logistics Corp. K Logistics Inc. Kasy Logistics (Tianjin) Co., Ltd. King Shipping Company Korchina International Logistics Co. Ltd. Korea Total Logistics Co. Ltd. Kousa International Logistics Co. Ltd. Kuehne Nagel Ltd. LF Logistics Co. Ltd. Linyi Flying Arrow Imp. & Exp. Ltd. MR Forwarding China Ltd. Maxspeed International Transport Co. Ltd. Mingguang Ruifeng Hardware Products Co., Ltd. Nailtech Co. Ltd. Nanjing Caiqing Hardware Co., Ltd. Nauri Logistics Co. Ltd. NCL Container Lines Co. Ltd. Neo Gls Neptune Shipping Limited Nexen L&C Corp. OEC Freight Worldwide Korea Co. Ltd. OEC Logistics Co., Ltd. OEC World Wide Korea Co. Ltd. Oman Fasteners LLC Orient Express Container Co., Ltd. Oriental Power Logistics Co. Ltd. Overseas Distribution Services Inc. Overseas International Steel Industry Panalpina World Transport (PRC) Ltd. Paslode Fasteners (Shanghai) Co. Ltd. Promising Way (Hong Kong) Limited Pudong Prime International Logistics, Inc. Qingdao Chesire Trading Co. Ltd. Qingdao D&L Group Ltd. Qingdao Hongyuan Nail Industry Co. Ltd. Qingdao Master Metal Products Co. Ltd. Qingdao Meijialucky Industry and Commerce Co., Ltd. Qingdao Mst Industry and Commerce Co., Ltd. Qingdao Tiger Hardware Co., Ltd. Ramses Logistics Company Limited Regency Global Logistics Co., Ltd. Ricoh Logistics System Co., Ltd. Rise Time Industrial Co. Ltd. Sam Un Co. Ltd. Scanwell Container Line Ltd. Schenker Schenker & CO AG SDC International Australia PTY Ltd Seamaster Global Forwarding Seamaster Logistics Sdn Bhd Sejung (China) Sea & Air Co., Ltd. Shandong Dinglong Imp. & Exp. Co. Ltd. Shandong Liaocheng Minghua Metal PR Shandong Oriental Cherry Hardware Group Co. Ltd. Shanghai Haoray International Trade Co. Ltd. Shanghai Jade Shuttle Hardware Tools Co., Ltd. Shanghai Line Feng Int'l Transportation Co. Ltd. Shanghai Pinnacle International Trading Co., Ltd. Shanghai Pudong International Transportation Shanxi Pioneer Hardware Industry Co., Ltd. Shanxi Tianli Industries Co., Ltd. Shijiazhuang Shuangjian Tools Co. Ltd. Shipping Imperial Co., Ltd. Sino Connections Logistics Inc. S-Mart (Tianjin) Technology Development Co., Ltd. Sparx Logistics China Limited Speedmark International Ltd. Suntec Industries Co., Ltd. Swift Freight (India) Pvt Ltd. T.H.I. Group Ltd. The Stanley Works (Langfang) Fastening System Co., Ltd. Tianjin Bluekin Industries Limited Tianjin Coways Metal Products Co. Tianjin Free Trade Service Co. Ltd. Tianjin Fulida Supply Co. Ltd. Tianjin Huixinshangmao Co. Ltd. Tianijn Hweschun Fasteners Manufacturing Co. Ltd. Tianjin Jinchi Metal Products Co., Ltd. Tianjin Long Sheng Tai Tianjin M&C Electronics Co., Ltd. Tianjin Wonderful International Trading Tianjin Zehui Hardware Co. Ltd. Tianjin Zhonglian Metals Ware Co. Ltd. Tianjin Zhonglian Times Technology Toll Global Forwarding Ltd. Top Logistics Korea Ltd. Top Ocean Consolidated Service Ltd. Toyo Boeki Co. Ltd. Trans Knights, Inc. Translink Shipping, Inc. Transwell Logistics Co. Ltd. Transworld Transportation Co. Ltd. Trim International Inc. TTI Freight Forwarder Co. Ltd. Unicorn (Tianjin) Fasteners Co., Ltd. UPS SCS (China) Limited Vanguard Logistics Services W&K Corporation Limited Weida Freight System Co. Ltd. Woowon Sea & Air Co. Ltd. Xi'an Metals and Minerals Imp. Exp. Co. Xinjiayuan International Trade Co. Xinjiayuan Trading Co., Limited Youngwoo Fasteners Co., Ltd. You-One Fastening Systems Yumark Enterprises Corp. Zhaoqing Harvest Nails Co. Ltd.
    [FR Doc. 2018-14920 Filed 7-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-122-854] Supercalendered Paper From Canada: Final Results of Changed Circumstances Review and Revocation of Countervailing Duty Order AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Commerce) is revoking the countervailing duty (CVD) order on supercalendered paper (SC paper) from Canada.

    DATES:

    Applicable August 3, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Emily Halle or Nicholas Czajkowski, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-0176 or (202) 482-1395, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On December 10, 2015, Commerce published the CVD Order on SC paper from Canada.1 On March 21, 2018, Verso Corporation (Verso) (i.e., the petitioner) requested that Commerce conduct a changed circumstances review (CCR), pursuant to section 782(h)(2) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.222(g)(l)(i). Verso expressed a lack of interest in the enforcement or existence of the CVD Order, and requested the retroactive revocation of the CVD Order, effective August 3, 2015.2 Commerce published the initiation of this CCR on May 14, 2018.3 The parties to this proceeding provided comments on May 21, 2018.4 On June 21, 2018, pursuant to 19 CFR 351.302(b), Commerce extended the time limit for completing this CCR.5

    1See Supercalendered Paper from Canada: Countervailing Duty Order, 80 FR 76668 (December 10, 2015) (CVD Order).

    2See Letter from Verso, “Supercalendered Paper from Canada/Request for Changed Circumstances Review,” March 21, 2018 (Verso Request).

    3See Supercalendered Paper from Canada: Initiation of Changed Circumstances Review, 83 FR 22249 (May 14, 2018) (Initiation Notice).

    4See Letter from Verso, et. al., “Supercalendered Paper from Canada (C-122-854): Joint Comments on Initiation of Changed Circumstances Review,” May 21, 2018.

    5See Letter to Verso Corporation, “Countervailing Duty Order on Supercalendered Paper from Canada: Changed Circumstances Review; Extension of Deadline for Final Results,” dated June 21, 2018.

    Final Results of Changed Circumstances Review, and Revocation of the Order

    Pursuant to section 751(d)(1) of the Act, and 19 CFR 351.222(g), Commerce may revoke an antidumping duty or CVD order, in whole or in part, based on a review under section 751(b) of the Act (i.e., a CCR). Section 751(b)(1) of the Act requires a CCR to be conducted upon receipt of a request which shows changed circumstances sufficient to warrant a review. Section 782(h)(2) of the Act gives Commerce the authority to revoke an order if producers accounting for substantially all of the production of the domestic like product have expressed a lack of interest in the order. Section 351.222(g) of Commerce's regulations provides that Commerce will conduct a CCR under 19 CFR 351.216, and may revoke an order (in whole or in part), if it concludes that: (i) Producers accounting for substantially all of the production of the domestic like product to which the order pertains have expressed a lack of interest in the relief provided by the order, in whole or in part; or (ii) if other changed circumstances sufficient to warrant revocation exist. Both the Act and Commerce's regulations require that “substantially all” domestic producers express a lack of interest in the order for Commerce to revoke the order, in whole or in part.6 Commerce has interpreted “substantially all” to represent producers accounting for at least 85 percent of U.S. production of the domestic like product.7 In the Initiation Notice, we stated that Verso's request indicated it accounts for at least 85 percent of domestic production.8 We received no comments concerning Verso's claim regarding its production or otherwise indicating a lack of industry support with respect to this CCR.

    6See section 782(h) of the Act and 19 CFR 351.222(g).

    7See Honey from Argentina; Antidumping and Countervailing Duty Changed Circumstances Reviews; Preliminary Intent to Revoke Antidumping and Countervailing Duty Orders, 77 FR 67790, 67791 (November 14, 2012), unchanged in Honey from Argentina; Final Results of Antidumping and Countervailing Duty Changed Circumstances Reviews; Revocation of Antidumping and Countervailing Duty Orders, 77 FR 77029 (December 31, 2012).

    8See Initiation Notice, 83 FR at 22249.

    As noted in the Initiation Notice, Verso requested the revocation of this CVD Order because it is no longer interested in maintaining the CVD Order or in the imposition of duties on the subject merchandise as of August 3, 2015.9 We conclude that producers accounting for substantially all of the production of the domestic like product, to which this CVD Order pertains, lack interest in the relief provided by the CVD Order. We find that the petitioner's affirmative statement of no interest in the CVD Order constitutes good cause for the conduct of this review.

    9Id.

    On May 21, 2018, Commerce received comments from Verso, the Government of Canada, the Government of New Brunswick, the Government of Nova Scotia, the Government of Ontario, the Government of Quebec, Irving Paper Limited, Port Hawkesbury Paper L.P., Resolute FP Canada Inc., and Resolute FP US Inc. In a joint filing, these parties, who represent all of the interested parties to this proceeding, stated their agreement with the outcome proposed in the Initiation Notice. Moreover, the parties cited to 19 CFR 351.216(e), which provides that, when all parties agree to the outcome, Commerce will issue its final results of CCR within 45 days of the initiation.

    Accordingly, we are notifying the public that we are revoking the CVD Order, in whole. Based on Verso's request that revocation be retroactive to August 3, 2015, and because we have not completed any administrative reviews of the CVD Order, we will instruct U.S. Customs and Border Protection (CBP) to discontinue the suspension of liquidation and the collection of cash deposits of estimated countervailing duties, to liquidate all unliquidated entries that were entered on or after August 3, 2015, without regard to countervailing duties, and to refund all CVD cash deposits on all such merchandise, with applicable interest.

    Scope of the Order

    The product covered by the order is SC paper. SC paper is uncoated paper that has undergone a calendering process in which the base sheet, made of pulp and filler (typically, but not limited to, clay, talc, or other mineral additive), is processed through a set of supercalenders, a supercalender, or a soft nip calender operation.10

    10 Supercalendering and soft nip calendering processing, in conjunction with the mineral filler contained in the base paper, are performed to enhance the surface characteristics of the paper by imparting a smooth and glossy printing surface. Supercalendering and soft nip calendering also increase the density of the base paper.

    The scope of this order covers all SC paper regardless of basis weight, brightness, opacity, smoothness, or grade, and whether in rolls or in sheets. Further, the scope covers all SC paper that meets the scope definition regardless of the type of pulp fiber or filler material used to produce the paper.

    Specifically excluded from the scope are imports of paper printed with final content of printed text or graphics.

    Subject merchandise primarily enters under Harmonized Tariff Schedule of the United States (HTSUS) subheading 4802.61.3035, but may also enter under subheadings 4802.61.3010, 4802.62.3000, 4802.62.6020, and 4802.69.3000. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the order is dispositive.

    Instructions to U.S. Customs and Border Protection

    Because we determine that there are changed circumstances that warrant the revocation of the CVD Order, in whole, we will instruct CBP to discontinue the suspension of liquidation and the collection of cash deposits of estimated countervailing duties, to liquidate all unliquidated entries that were entered on or after August 3, 2015, without regard to countervailing duties, and to refund all CVD cash deposits on all such merchandise, with applicable interest.

    Notification to Interested Parties

    This notice serves as a reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

    We are issuing and publishing these final results and revocation, in whole, and notice in accordance with sections 751(b) and 777(i) of the Act and 19 CFR 351.216, 19 CFR 351.221(c)(3), and 19 CFR 351.222.

    Dated: July 5, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2018-14921 Filed 7-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-904] Certain Activated Carbon From the People's Republic of China: Continuation of Antidumping Duty Order AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    As a result of the determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC) that revocation of the antidumping duty order on certain activated carbon from the People's Republic of China (China) would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, Commerce is publishing a notice of continuation of the antidumping duty order.

    DATES:

    Applicable July 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Robert Palmer, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-9068.

    SUPPLEMENTARY INFORMATION: Background

    On April 27, 2007, Commerce published in the Federal Register notice of the antidumping duty order on certain activated carbon from China.1 On February 1, 2018, Commerce published the notice of initiation of the second five-year (sunset) review of the antidumping duty order on certain activated carbon from China, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).2

    1See Notice of Antidumping Duty Order: Certain Activated Carbon from the People's Republic of China, 72 FR 20988 (April 27, 2007).

    2See Initiation of Five-Year (Sunset) Reviews, 83 FR 4681 (February 1, 2018).

    Commerce conducted this sunset review on an expedited basis, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), because it received a complete, timely, and adequate response from a domestic interested party but no substantive responses from respondent interested parties. As a result of its review, Commerce determined in accordance with section 751(c) of the Act that revocation of the antidumping duty order would likely lead to a continuation or recurrence of dumping.3 Commerce, therefore, notified the ITC of the magnitude of the margins likely to prevail should the antidumping duty order be revoked. On July 6, 2018, the ITC published notice of its determination, pursuant to section 751(c) of the Act, that revocation of the antidumping duty order on certain activated carbon from China would likely lead to a continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.4

    3See Certain Activated Carbon from the People's Republic of China: Final Results of the Expedited Second Sunset Review of the Antidumping Duty Order, 83 FR 26949 (June 11, 2018) (Final Results) and accompanying Issues and Decision Memorandum.

    4See Certain Activated Carbon from China: Investigation No. 731-TA-1103 (Second Review), USITC Publication 4776 (June 2018); see also Certain Activated Carbon from China: Determination, 83 FR 31568 (July 6, 2018).

    Scope of the Order

    The merchandise subject to the order is certain activated carbon. Certain activated carbon is a powdered, granular, or pelletized carbon product obtained by “activating” with heat and steam various materials containing carbon, including but not limited to coal (including bituminous, lignite, and anthracite), wood, coconut shells, olive stones, and peat. The thermal and steam treatments remove organic materials and create an internal pore structure in the carbon material. The producer can also use carbon dioxide gas (CO2) in place of steam in this process. The vast majority of the internal porosity developed during the high temperature steam (or CO2 gas) activated process is a direct result of oxidation of a portion of the solid carbon atoms in the raw material, converting them into a gaseous form of carbon.

    The scope of the order covers all forms of activated carbon that are activated by steam or CO2, regardless of the raw material, grade, mixture, additives, further washing or post-activation chemical treatment (chemical or water washing, chemical impregnation or other treatment), or product form. Unless specifically excluded, the scope of the order covers all physical forms of certain activated carbon, including powdered activated carbon (PAC), granular activated carbon (GAC), and pelletized activated carbon.

    Excluded from the scope of the order are chemically activated carbons. The carbon-based raw material used in the chemical activation process is treated with a strong chemical agent, including but not limited to phosphoric acid, zinc chloride, sulfuric acid, or potassium hydroxide that dehydrates molecules in the raw material, and results in the formation of water that is removed from the raw material by moderate heat treatment. The activated carbon created by chemical activation has internal porosity developed primarily due to the action of the chemical dehydration agent. Chemically activated carbons are typically used to activate raw materials with a lignocellulosic component such as cellulose, including wood, sawdust, paper mill waste and peat.

    To the extent that an imported activated carbon product is a blend of steam and chemically activated carbons, products containing 50 percent or more steam (or CO2 gas) activated carbons are within the scope, and those containing more than 50 percent chemically activated carbons are outside the scope. This exclusion language regarding blended material applies only to mixtures of steam and chemically activated carbons.

    Also excluded from the scope are reactivated carbons. Reactivated carbons are previously used activated carbons that have had adsorbed materials removed from their pore structure after use through the application of heat, steam and/or chemicals.

    Also excluded from the scope is activated carbon cloth. Activated carbon cloth is a woven textile fabric made of or containing activated carbon fibers. It is used in masks and filters and clothing of various types where a woven format is required.

    Any activated carbon meeting the physical description of subject merchandise provided above that is not expressly excluded from the scope is included within the scope. The products subject to the order are currently classifiable under the HTSUS subheading 3802.10.00. Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the scope of the order is dispositive.

    Continuation of the Order

    As a result of the determinations by Commerce and the ITC that revocation of the antidumping duty order would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), Commerce hereby orders the continuation of the antidumping duty order on certain activated carbon from China. U.S. Customs and Border Protection will continue to collect antidumping duty cash deposits at the rates in effect at the time of entry for all imports of subject merchandise.

    The effective date of the continuation of the order will be the date of publication in the Federal Register of this notice of continuation. Pursuant to section 751(c)(2) of the Act, Commerce intends to initiate the next sunset review of the order not later than 30 days prior to the fifth anniversary of the effective date of continuation.

    This sunset review and this notice are in accordance with section 751(c) and 751(d)(2) of the Act and published pursuant to section 777(i)(1) of the Act and 19 CFR 351.218(f)(4).

    Dated: July 6, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2018-15014 Filed 7-11-18; 8:45 am] BILLING CODE 3510-DS-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 May anniversary dates. In accordance with Commerce's regulations, we are initiating those administrative reviews.

    DATES:

    Applicable July 12, 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 May 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.

    Respondent Selection—Aluminum Extrusions From the People's Republic of China

    In the event Commerce limits the number of respondents for individual examination in the administrative review of the antidumping duty order on aluminum extrusions from the People's Republic of China (“China”), Commerce intends to select respondents based on volume data contained in responses to Q&V questionnaires. Further, Commerce intends to limit the number of Q&V questionnaires issued in the review based on CBP data for U.S. imports of aluminum extrusions from the China. The extremely wide variety of individual types of aluminum extrusion products included in the scope of the order on aluminum extrusions would preclude meaningful results in attempting to determine the largest China exporters of subject merchandise by volume. Therefore, Commerce will limit the number of Q&V questionnaires issued based on the import values in CBP data which will serve as a proxy for imported quantities. Parties subject to the review to which Commerce does not send a Q&V questionnaire may file a response to the Q&V questionnaire by the applicable deadline if they desire to be included in the pool of companies from which Commerce will select mandatory respondents. The Q&V questionnaire will be available on Commerce's website at http://trade.gov/enforcement/news.asp on the date of publication of this notice in the Federal Register. The responses to the Q&V questionnaire must be received by Commerce within 14 days of publication of this notice. Please be advised that due to the time constraints imposed by the statutory and regulatory deadlines for antidumping duty administrative reviews, Commerce does not intend to grant any extensions for the submission of responses to the Q&V questionnaire. Parties will be given the opportunity to comment on the CBP data used by Commerce to limit the number of Q&V questionnaires issued. We intend to release the CBP data under APO to all parties having an APO within seven days of publication of this notice in the Federal Register. Commerce invites comments regarding CBP data and respondent selection within five days of placement of the CBP data on the record.

    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 May 31, 2019.

    Period to be reviewed Antidumping Duty Proceedings AUSTRIA: Carbon and Alloy Steel Cut-to-Length Plate, A-433-812 11/14/16-4/30/18 Bohler Edelstahl GmbH & Co KG Bohler Bleche GmbH & Co KG BELGIUM: Carbon and Alloy Steel Cut-to-Length Plate, A-423-812 11/14/16-4/30/18 Henegelhoef Concrete Joints NV Industeel Belgium S.A. NLMK Clabecq S.A./NLMK Plate Sales S.A./NLMK Sales Europe S.A./NLMK Manage Steel Center S.A./NLMK La Louviere S.A. Sarens NV Thyssenkrupp Materials Belgium N.V. Universal Eisen und Stahl GmbH Valvan Baling Systems Voestalpine Belgium NV. CANADA: Citric Acid and Citrate Salt, A-122-853 5/1/17-4/30/18 Jungbunzlauer Canada Inc. CANADA: Polyethylene Terephthalate Resin, A-122-855 5/1/17-4/30/18 Compagnie Selenis Canada FRANCE: Carbon and Alloy Steel Cut-To-Length Plate, A-427-828 11/14/16-4/30/18 Industeel France S.A.S. GERMANY: Carbon and Alloy Steel Cut-To-Length Plate, A-428-844 11/14/16-4/30/18 AG der Dillinger Huttenwerke Ilsendburger Grobblech GmbH Perficon Steel GmbH Reiner Brach GmbH & Co. KG Rudolf Rafflenbeul Stahlwarenfabrik GmBH & Co. Salzgitter Mannesmann Grobblech GmbH Salaigitter Flachstahl GmbH Salzgitter Mannesmann International GmbH Tenova (TAKRAF GmbH Lauchhammer) ThyssenKrupp Steel Europe AG ThyssenKrupp Schulte GmbH UPC Universal Piping GmbH VETTER Umformtechnik GmbH INDIA: Certain Frozen Warmwater Shrimp,4 A-533-840 2/1/17-1/31/18 INDIA: Certain Welded Carbon Steel Standard Pipes and Tubes, A-533-502 5/1/17-4/30/18 Apl Apollo Tubes Ltd. Asian Contec Ltd. Bhandari Foils & Tubes Ltd. Bhushan Steel Ltd. Blue Moon Logistics Pvt. Ltd. CH Robinson Worldwide Ess-Kay Engineers, Manushi Enterprise & Nishi Boring Corporation Fiber Tech Composite Pvt. Ltd. Garg Tube Export LLP GCL Private Limited Goodluck India Ltd. GVN Fuels Ltd. Hydromatik Jindal Quality Tubular Ltd. KLT Automatic & Tubular Products Ltd. Lloyds Line Pipes Ltd. MARINEtrans India Private Ltd. Patton International Ltd. SAR Transport Systems Pvt. Ltd. Surya Global Steel Tubes Ltd. Surya Roshni Ltd. Welspun India Ltd. Zenith Birla (India) Ltd. Zenith Birla Steels Private Ltd. Zenith Dyeintermediates Ltd. ITALY: Carbon and Alloy Steel Cut-To-Length Plate, A-475-834 11/14/16-4/30/18 Euroflex SpA Evarz Palini e Bertoil SpA Ilva SpA Metalcam SpA Modelleria di Modini Renato NLMK Verona SpA Officine Tecnosider srl Ondulit Italiana SpA Padana Tubi e Profilati Acciaio SpA Riva Fire SpA JAPAN: Diffusion-Annealed Nickel-Plated Flat-Rolled Steel Products, A-588-869 5/1/17-4/30/18 Nippon Steel & Sumitomo Metals Corporation Toyo Kohan Co., Ltd. OMAN: Polyethylene Terephthalate Resin, A-523-810 5/1/17-4/30/18 Octal Saoc FZC REPUBLIC OF KOREA: Carbon and Alloy Steel Cut-To-Length Plate, A-580-887 11/14/16-4/30/18 Buma Ce Co., Ltd. Dong Yang Steel Pipe Co., Ltd. Dongkuk Steel Mill Co., Ltd. Expeditors Korea Ltd. Haem Co., Ltd. Hyundai Glovis Co., Ltd. Hyundia Steel Company J.I. Sea & Air Express Co., Ltd. Maxpeed Co., Ltd. POSCO POSCO Daewoo Corporation POSCO Processing & Service Co., Ltd. Rames Logistics Co., Ltd. Sumitomo Corp. Korea Ltd. REPUBLIC OF KOREA: Polyester Staple Fiber, A-580-839 5/1/17-4/30/18 Huvis Corporation Toray Chemical Korea, Inc. TAIWAN: Carbon and Alloy Steel Cut-To-Length Plate, A-583-858 11/14/16-4/30/18 Broad Hand Enterprise Co., Ltd. C.H. Robinson Freight Services China Steel Corporation Chun Chi Grating Co., Ltd. Eci Taiwan Co., Ltd. Locksure Inc. Nan Hoang Traffic Instrument Co. New Marine Consolidator Co., Ltd. North America Mining Group Co., Ltd.. Oriental Power Logistics Co., Ltd. Product Depot International Corp. Scanwell Logistics (Taiwan) Shang Chen Steel Co., Ltd. Shin Yang Steel Co., Ltd. Shye Yao Steel Co., Ltd. Speedmark Consolidation Sumeeko Industries Co., Ltd. Triple Merits Ltd. UKI Enterprise Co., Ltd. TAIWAN: Certain Circular Welded Carbon Steel Pipes and Tubes, A-583-008 5/1/17-4/30/18 Chung Hung Steel Corp. Far East Machinery Co., Ltd. Far East Machinery Group Fine Blanking & Tool Co., Ltd. Hou Lih Co., Ltd. Kao Hsing Chang Iron & Steel Corp. Lang Hwang Corp. Locksure Inc. New Chance Products Co., Ltd. Pat & Jeff Enterprise Co., Ltd. Pin Tai Metal Inc. Shang Jouch Industrial Co., Ltd. Shengyu Steel Co., Ltd. Shin Yang Steel Co., Ltd. Shuan Hwa Industrial Co., Ltd. Tension Steel Industries Co., Ltd. Titan Fastech Ltd. Yeong Shien Industrial Co., Ltd. Yieh Hsing Enterprise Co., Ltd. Yousing Precision Industry Co., Ltd. TAIWAN: Stilbenic Optical Brightening Agents, A-583-848 5/1/17-4/30/18 Teh Fong Min International Co., Ltd. THE PEOPLE'S REPUBLIC OF CHINA: 1-Hydroxyethylidene-1,1-Diphoshonic Acid (Hedp), A-570-045 11/14/16-4/30/18 Henan Qingshuiyuan Technology Co., Ltd. THE PEOPLE'S REPUBLIC OF CHINA: Aluminum Extrusions, A-570-967 5/1/17-4/30/18 Acro Import and Export Co. Activa International Inc. Activa Leisure Inc. Allied Maker Limited Alnan Aluminum Co., Ltd. Alnan Aluminum Ltd. Aluminicaste Fundicion de Mexico AMC Ltd. AMC Limited Anji Chang Hong Chain Manufacturing Anshan Zhongjda Industry Co., Ltd. Aoda Aluminium (Hong Kong) Co., Limited AsiaAlum GroupAtlas Integrated Manufacturing Ltd. Belton (Asia) Development Limited Belton (Asia) Development Ltd. Birchwoods (Lin'an) Leisure Products Co., Ltd. Bolnar Hong Kong Ltd. Bracalente Metal Products (Suzhou) Co., Ltd. Brilliance General Equipment Co., Ltd. Changshu Changshen Aluminum Products Co., Ltd. Changshu Changsheng Aluminum Products Co., Ltd. Changzhou Changzhen Evaporator Co., Ltd. Changzhou Changzheng Evaporator Co., Ltd. Changzhou Tenglong Auto Accessories Manufacturing Co. Ltd Changzhou Tenglong Auto Parts Co., Ltd. Changzhou Tenglong Auto Parts Co. Ltd. China Square China Square Industrial Co. China Square Industrial Ltd. China Zhongwang Holdings, Ltd. Chiping One Stop Industrial & Trade Co., Ltd. Classic & Contemporary Inc. Clear Sky Inc. Cosco (J.M.) Aluminum Co., Ltd. Cosco (JM) Aluminum Development Co. Ltd. Dalian Huacheng Aquatic Products Dalian Liwang Trade Co., Ltd. Danfoss Micro Channel Heat Exchanger (Jia Xing) Co., Ltd. Daya Hardware Co. Ltd. Dongguan Dazhan Metal Co., Ltd. Dongguang Aoda Aluminum Co., Ltd. Dongguan Golden Tiger Hardware Industrial Co., Ltd. Dragonluxe Limited Dynabright International Group (HK) Ltd. Dynamic Technologies China ETLA Technology (Wuxi) Co. Ltd. Ever Extend Ent. Ltd. Fenghua Metal Product Factory First Union Property Limited FookShing Metal & Plastic Co. Ltd. Foreign Trade Co. of Suzhou New & High-Tech Industrial Development Zone Foshan City Nanhai Hongjia Aluminum Alloy Co., Ltd. Foshan Golden Source Aluminum Products Co., Ltd. Foshan Guangcheng Aluminium Co., Ltd. Foshan Jinlan Aluminum Co. Ltd. Foshan JinLan Aluminum Co., Ltd. Foshan JMA Aluminum Company Limited Foshan Nanhai Niu Yuan Hardware Product Co., Ltd. Foshan Shanshui Fenglu Aluminum Co., Ltd. Foshan Shunde Aoneng Electrical Appliances Co., Ltd. Foshan Yong Li Jian Aluminum Co., Ltd. Fujian Sanchuan Aluminum Co., Ltd. Fukang Aluminum & Plastic Import and Export Co., Ltd. Fuzhou Sunmodo New Energy Equipment Gaotang Xinhai Economy & Trade Co., Ltd. Genimex Shanghai, Ltd. Global Hi-Tek Precision Co. Ltd. Global PMX Dongguan Co., Ltd. Global Point Technology (Far East) Limited Gold Mountain International Development, Ltd. Golden Dragon Precise Copper Tube Group, Inc. Gran Cabrio Capital Pte. Ltd. Gree Electric Appliances GT88 Capital Pte. Ltd. Guang Ya Aluminium Industries Co. Ltd. Guang Ya Aluminum Industries Company Ltd Guang Ya Aluminium Industries (HK) Ltd. Guangcheng Aluminum Co., Ltd. Guangdong Hao Mei Aluminum Co., Ltd. Guangdong Jianmei Aluminum Profile Company Limited Guangdong JMA Aluminum Profile Factory (Group) Co., Ltd. Guangdong Midea Guangdong Midea Microwave and Electrical Appliances Guangdong Nanhai Foodstuffs Imp. & Exp. Co., Ltd. Guangdong Weiye Aluminum Factory Co., Ltd. Guangdong Whirlpool Electrical Appliances Co., Ltd. Guangdong Xingfa Aluminum Co., Ltd. Guangdong Xin Wei Aluminum Products Co., Ltd. Guangdong Yonglijian Aluminum Co., Ltd. Guangdong Zhongya Aluminum Company Ltd. Guangzhou Jangho Curtain Wall System Engineering Co., Ltd. Guangzhou Mingcan Die-Casting Hardware Products Co., Ltd. Hangzhou Xingyi Metal Products Co., Ltd. Hanwood Enterprises Limited Hanyung Alcoba Co., Ltd. Hanyung Alcobis Co., Ltd. Hanyung Metal (Suzhou) Co., Ltd. Hao Mei Aluminum Co., Ltd. Hao Mei Aluminum International Co., Ltd. Hebei Xusen Wire Mesh Products Co., Ltd. Henan New Kelong Electrical Appliances Co., Ltd. Henan Zhongduo Aluminum Magnesium New Material Co, Ltd. Hong Kong Gree Electric Appliances Sales Limited Hong Kong Modern Non-Ferrous Metal Honsense Development Company Houztek Architectural Products Co., Ltd. Hui Mei Gao Aluminum Foshan Co., Ltd. Huixin Aluminum IDEX Dinglee Technology (Tianjin) Co., Ltd. IDEX Health IDEX Technology Suzhou Co., Ltd. Innovative Aluminum (Hong Kong) Limited iSource Asia Jackson Travel Products Co., Ltd. Jangho Curtain Wall Hong Kong Ltd. Jiangmen Jianghai District Foreign Economic Enterprise Corp. Ltd. Jiangmen Jianghai Foreign Ent. Gen. Jiangmen Qunxing Hardware Diecasting Co., Ltd. Jiangsu Changfa Refrigeration Co. Jiangyin Suncitygaylin Jiangyin Trust International Inc. Jiangyin Xinhong Doors and Windows Co., Ltd. Jiaxing Jackson Travel Products Co., Ltd. Jiaxing Taixin Metal Products Co., Ltd. Jiuyan Co., Ltd. JMA (HK) Company Limited Johnson Precision Engineering (Suzhou) Co., Ltd. Justhere Co., Ltd. Kam Kiu Aluminum Products Sdn Bhd Kanal Precision Aluminum Product Co., Ltd. Karlton Aluminum Company Ltd. Kong Ah International Company Limited Kromet International Inc. Kromet Intl Inc. Kromet International Kunshan Giant Light Metal Technology Co., Ltd. Liaoning Zhong Da Industrial Aluminum Co., Ltd. Liaoning Zhongwang Group Co., Ltd. Liaoyang Zhongwang Aluminum Profile Co. Ltd. Longkou Donghai Trade Co., Ltd. Metal Tech Co. Ltd. Metaltek Group Co., Ltd. Metaltek Metal Industry Co., Ltd. Midea Air Conditioning Equipment Co., Ltd. Midea Electric Trading Co., Pte Ltd. Midea International Trading Co., Ltd. Midea International Training Co., Ltd. Miland Luck Limited Nanhai Textiles Import & Export Co., Ltd. New Asia Aluminum & Stainless Steel Product Co., Ltd. New Zhongya Aluminum Factory Nidec Sankyo (Zhejang) Corporation Nidec Sankyo Zhejiang Corporation Nidec Sankyo Singapore Pte. Ltd. Ningbo Coaster International Co., Ltd. Ningbo Hi Tech Reliable Manufacturing Company Ningbo Innopower Tengda Machinery Ningbo Ivy Daily Commodity Co., Ltd. Ningbo Yili Import and Export Co., Ltd. North China Aluminum Co., Ltd. North Fenghua Aluminum Ltd. Northern States Metals PanAsia Aluminum (China) Limited Pengcheng Aluminum Enterprise Inc. Permasteelisa Hong Kong Limited Permasteelisa South China Factory Pingguo Aluminum Company Limited Pingguo Asia Aluminum Co., Ltd. Popular Plastics Company Limited Precision Metal Works Ltd. Press Metal International Ltd. Samuel, Son & Co., Ltd. Sanchuan Aluminum Co., Ltd. Sanhua (Hangzhou) Micro Channel Heat Exchanger Co., Ltd. Shandong Fukang Aluminum & Plastic Co. LTD. Shandong Huajian Aluminum Group Shangdong Huasheng Pesticide Machinery Co. Shangdong Nanshan Aluminum Co., Ltd. Shanghai Automobile Air-Conditioner Accessories Co. Ltd. Shanghai Automobile Air Conditioner Accessories Ltd. Shanghai Canghai Aluminum Tube Packaging Co., Ltd. Shanghai Dofiberone Composites Co. Ltd. Shanghai Dongsheng Metal Shanghai Shen Hang Imp & Exp Co., Ltd. Shanghai Tongtai Precise Aluminum Alloy Manufacturing Co. Ltd. Shanghai Top-Ranking Aluminum Products Co., LTD. Shanghai Top-Ranking New Materials Co., Ltd. Shenyang Yuanda Aluminum Industry Engineering Co. Ltd. Shenzhen Hudson Technology Development Co. Shenzhen Jiuyuan Co., Ltd. Sihui Shi Guo Yao Aluminum Co., Ltd. Sincere Profit Limited Skyline Exhibit Systems (Shanghai) Co. Ltd. Southwest Aluminum (Group) Co., Ltd. Summit Heat Sinks Metal Co., Ltd. Summit Plastics Nanjing Co. Ltd. Suzhou JRP Import & Export Co., Ltd. Suzhou New Hongji Precision Part Co. Tai-Ao Aluminum (Taishan) Co. Ltd. Taishan City Kam Kiu Aluminium Extrusion Co., Ltd. Taizhou Lifeng Manufacturing Co., Ltd. Taitoh Machinery Shanghai Co. Ltd. Taizhou United Imp. & Exp. Co., Ltd. tenKsolar (Shanghai) Co., Ltd. Tianjin Ganglv Nonferrous Metal Materials Co., Ltd. Tianjin Jinmao Import & Export Corp., Ltd. Tianjin Ruxin Electric Heat Transmission Technology Co., Ltd. Tianjin Xiandai Plastic & Aluminum Products Co., Ltd. Tiazhou Lifeng Manufacturing Corporation Top-Wok Metal Co., Ltd. Traffic Brick Network, LLC Union Aluminum (SIP) Co. Union Industry (Asia) Co., Ltd. USA Worldwide Door Components (Pinghu) Co., Ltd. Wenzhou Shengbo Decoration & Hardware Wenzhou Yongtai Electric Co., Ltd. Whirlpool (Guangdong) Whirlpool Canada L.P. Whirlpool Microwave Products Development Ltd. Worldwide Door Components, Inc. WTI Building Products, Ltd. Wuxi Lutong Fiberglass Doors Co., Ltd, Xin Wei Aluminum Co. Xin Wei Aluminum Company Limited Xinya Aluminum & Stainless Steel Product Co., Ltd. Yuyao Haoshen Import & Export Yuyao Fanshun Import & Export Co., Ltd. Zahoqing China Square Industry Limited Zhaoqing Asia Aluminum Factory Company Ltd. Zhaoqing China Square Industry Limited Zhaoqing China Square Industrial Ltd. Zhaoqing New Zhongya Aluminum Co., Ltd. Zhejiang Anji Xinxiang Aluminum Co., Ltd. Zhejiang Lilies Industrial and Commercial Co. Zhejiang Yili Automobile Air Condition Co., Ltd. Zhejiang Yongkang Listar Aluminum Industry Co., Ltd. Zhejiang Zhengte Group Co., Ltd. Zhenjiang Xinlong Group Co., Ltd. Zhongshan Daya Hardware Co., Ltd. Zhongshan Gold Mountain Aluminum Factory Ltd. Zhongya Shaped Aluminum (HK) Holding Limited Zhuhai Runxingtai Electrical Equipment Co., Ltd. THE PEOPLE'S REPUBLIC OF CHINA: Oil Country Tubular Goods, A-570-943 5/1/17-4/30/18 Baoshan Iron & Steel Hengyang Steel Tube Group International Trading Inc. Hubei Xinyegang Steel Co., Ltd. Hubei Xin Yegang Special Tube THE PEOPLE'S REPUBLIC OF CHINA: Pure Magnesium, A-570-832 5/1/17-4/30/18 Tianjin Magnesium International Co., Ltd. Tianjin Magnesium Metal Co., Ltd. TURKEY: Circular Welded Carbon Steel Pipes and Tubes, A-489-501 5/1/17-4/30/18 Borusan Birlesik Boru Fabrikalari San ve Tic. Borusan Gemlik Boru Tesisleri A.S. Borusan Holding Borusan Ihracat Ithalat ve Dagitim A.S. Borusan Istikbal Ticaret T.A.S. Borusan Ithicat ve Dagitim A.S. Borusan Mannesmann Boru Sanayi ve Ticaret A.S. Borusan Mannesmann Yatirim Holding Cayirova Boru Sanayi ve Ticaret A.S. Cinar Boru Profil San. Ve Tic. As Erbosan Erciyas Boru Sanayi ve Ticaret A.S. Kale Baglanti Teknolojileri San. ve Tic. Noksel Celik Boru Sanayi A.S. Toscelik Metal Ticaret A.S. Toscelik Profil ve Sac Endustrisi A.S. Tosyali Dis Ticaret A.S. Tubeco Pipe and Steel Corporation Yucel Boru ve Profil Endustrisi A.S. Yucelboru Ihracat Ithalat ve Pazarlama A.S. TURKEY: Light-Walled Rectangular Pipe and Tube, A-489-815 5/1/17-4/30/18 Noksel Celik Boru Sanayi A.S. Countervailing Duty Proceedings REPUBLIC OF KOREA: Carbon and Alloy Steel Cut-To-Length Plate, C-580-888 9/14/16- 12/31/17 BDP International Blue Track Equipment Boxco Bukook Steel Co., Ltd. Buma CE Co., Ltd. Daelim Industrial Co., Ltd. Daesam Industrial Co., Ltd. Daesin Lighting Co., Ltd. Daewoo International Corp. Dong Yang Steel Pipe Dongkuk Industries Co., Ltd. Dongkuk Steel Mill Co., Ltd. Dongbu Steel Co., Ltd. EAE Automotive Equipment EEW KHPC Co., Ltd. Eplus Expo Inc. GS Global Corp. Haem Co., Ltd. Han Young Industries Hyosung Corp. Hyundai Steel Co. Jinmyung Frictech Co., Ltd. Korean Iron and Steel Co., Ltd. Kyoungil Precision Co., Ltd. POSCO Samsun C&T Corp. SK Netwoks Co., Ltd. Steel N People Ltd. Summit Industry Sungjin Co., Ltd. Young Sun Steel THE PEOPLE'S REPUBLIC OF CHINA: 1-Hydroxyethylidene-1,1-Diphoshonic Acid (Hedp), C-570-046 9/8/16-12/31/17 Changzhou Kewei Fine Chemicals Co., Ltd. Changzhou Yao's Tongde Chemical Co., Ltd. Hebei Longke Water Treatment Co., Ltd. Henan Qinshuiyuan Technology Co., Ltd. Jinghai Environmental Protection Co., Ltd. (Jianghai) Nanjing University of Chemical Technology Changzhou Wujin Water Quality Stabilizer Factory Nantong Uniphos Chemicals Co., Ltd. Shandong Huayou Chemistry Co., Ltd. Shandong Taihe Chemicals Co., Ltd. Shandong Taihe Water Treatment Technologies Co., Ltd. Shandong Xintai Water Treatment Technology Wujin Fine Chemical Factory Co., Ltd. Zaozhuang Fuxing Water Treatment Technology Zaozhuang YouBang Chemicals Co., Ltd. Zouping Dongfang Chemical Industry Co., Ltd. THE PEOPLE'S REPUBLIC OF CHINA: Aluminum Extrusions, C-570-968 1/1/17-12/31/17 Acro Import and Export Co. Activa International Inc. Activa Leisure Inc. Allied Maker Limited Alnan Aluminum Co., Ltd. Alnan Aluminum Ltd. Aluminicaste Fundicion de Mexico AMC Ltd. AMC Limited Anji Chang Hong Chain Manufacturing Anshan Zhongjda Industry Co., Ltd. Aoda Aluminium (Hong Kong) Co., Limited AsiaAlum Group Atlas Integrated Manufacturing Ltd. Belton (Asia) Development Limited Belton (Asia) Development Ltd. Birchwoods (Lin'an) Leisure Products Co., Ltd. Bolnar Hong Kong Ltd. Bracalente Metal Products (Suzhou) Co., Ltd. Brilliance General Equipment Co., Ltd. Changshu Changshen Aluminum Products Co., Ltd. Changshu Changsheng Aluminum Products Co., Ltd. Changzhou Changzhen Evaporator Co., Ltd. Changzhou Changzheng Evaporator Co., Ltd. Changzhou Tenglong Auto Accessories Manufacturing Co. Ltd Changzhou Tenglong Auto Parts Co., Ltd. Changzhou Tenglong Auto Parts Co Ltd China Square China Square Industrial Co. China Square Industrial Ltd. China Zhongwang Holdings, Ltd. Chiping One Stop Industrial & Trade Co., Ltd. Classic & Contemporary Inc. Clear Sky Inc. Cosco (J.M.) Aluminum Co., Ltd. Cosco (JM) Aluminum Development Co. Ltd Dalian Huacheng Aquatic Products Dalian Liwang Trade Co., Ltd. Danfoss Micro Channel Heat Exchanger (Jia Xing) Co., Ltd. Daya Hardware Co. Ltd. Dongguan Dazhan Metal Co., Ltd. Dongguang Aoda Aluminum Co., Ltd. Dongguan Golden Tiger Hardware Industrial Co., Ltd. Dragonluxe Limited Dynabright International Group (HK) Ltd. Dynamic Technologies China ETLA Technology (Wuxi) Co. Ltd. Ever Extend Ent. Ltd. Fenghua Metal Product Factory First Union Property Limited FookShing Metal & Plastic Co. Ltd. Foreign Trade Co. of Suzhou New & High-Tech Industrial Development Zone Foshan City Nanhai Hongjia Aluminum Alloy Co., Ltd. Foshan Golden Source Aluminum Products Co., Ltd. Foshan Guangcheng Aluminium Co., Ltd Foshan Jinlan Aluminum Co. Ltd. Foshan JinLan Aluminum Co., Ltd. Foshan JMA Aluminum Company Limited Foshan Nanhai Niu Yuan Hardware Product Co., Ltd. Foshan Shanshui Fenglu Aluminum Co., Ltd. Foshan Shunde Aoneng Electrical Appliances Co., Ltd Foshan Yong Li Jian Aluminum Co., Ltd. Fujian Sanchuan Aluminum Co., Ltd. Fukang Aluminum & Plastic Import and Export Co., Ltd. Fuzhou Sunmodo New Energy Equipment Gaotang Xinhai Economy & Trade Co., Ltd. Genimex Shanghai, Ltd. Global Hi-Tek Precision Co. Ltd Global PMX Dongguan Co., Ltd. Global Point Technology (Far East) Limited Gold Mountain International Development, Ltd. Golden Dragon Precise Copper Tube Group, Inc. Gran Cabrio Capital Pte. Ltd. Gree Electric Appliances GT88 Capital Pte. Ltd. Guang Ya Aluminium Industries Co. Ltd. Guang Ya Aluminum Industries Company Ltd Guang Ya Aluminium Industries (HK) Ltd. Guangcheng Aluminum Co., Ltd. Guangdong Hao Mei Aluminum Co., Ltd. Guangdong Jianmei Aluminum Profile Company Limited Guangdong JMA Aluminum Profile Factory (Group) Co., Ltd. Guangdong Midea Guangdong Midea Microwave and Electrical Appliances Guangdong Nanhai Foodstuffs Imp. & Exp. Co., Ltd. Guangdong Weiye Aluminum Factory Co., Ltd. Guangdong Whirlpool Electrical Appliances Co., Ltd. Guangdong Xingfa Aluminum Co., Ltd. Guangdong Xin Wei Aluminum Products Co., Ltd. Guangdong Yonglijian Aluminum Co., Ltd. Guangdong Zhongya Aluminum Company Ltd. Guangzhou Jangho Curtain Wall System Engineering Co., Ltd. Guangzhou Mingcan Die-Casting Hardware Products Co., Ltd. Hangzhou Xingyi Metal Products Co., Ltd. Hanwood Enterprises Limited Hanyung Alcoba Co., Ltd. Hanyung Alcobis Co., Ltd. Hanyung Metal (Suzhou) Co., Ltd. Hao Mei Aluminum Co., Ltd. Hao Mei Aluminum International Co., Ltd. Hebei Xusen Wire Mesh Products Co., Ltd. Henan New Kelong Electrical Appliances Co., Ltd. Henan Zhongduo Aluminum Magnesium New Material Co., Ltd. Hong Kong Gree Electric Appliances Sales Limited Hong Kong Modern Non-Ferrous Metal Honsense Development Company Houztek Architectural Products Co., Ltd. Hui Mei Gao Aluminum Foshan Co., Ltd. Huixin Aluminum IDEX Dinglee Technology (Tianjin) Co., Ltd. IDEX Health IDEX Technology Suzhou Co., Ltd. Innovative Aluminum (Hong Kong) Limited iSource Asia Jackson Travel Products Co., Ltd. Jangho Curtain Wall Hong Kong Ltd. Jiangmen Jianghai District Foreign Economic Enterprise Corp. Ltd. Jiangmen Jianghai Foreign Ent. Gen. Jiangmen Qunxing Hardware Diecasting Co., Ltd. Jiangsu Changfa Refrigeration Co. Jiangyin Suncitygaylin Jiangyin Trust International Inc. Jiangyin Xinhong Doors and Windows Co., Ltd. Jiaxing Jackson Travel Products Co., Ltd. Jiaxing Taixin Metal Products Co., Ltd. Jiuyan Co., Ltd. JMA (HK) Company Limited Johnson Precision Engineering (Suzhou) Co., Ltd. Justhere Co., Ltd. Kam Kiu Aluminum Products Sdn Bhd Kanal Precision Aluminum Product Co., Ltd. Karlton Aluminum Company Ltd. Kong Ah International Company Limited Kromet International Inc. Kromet Intl Inc. Kromet International Kunshan Giant Light Metal Technology Co., Ltd. Liaoning Zhong Da Industrial Aluminum Co., Ltd. Liaoning Zhongwang Group Co., Ltd. Liaoyang Zhongwang Aluminum Profile Co. Ltd. Longkou Donghai Trade Co., Ltd. Metal Tech Co Ltd. Metaltek Group Co., Ltd. Metaltek Metal Industry Co., Ltd. Midea Air Conditioning Equipment Co., Ltd. Midea Electric Trading Co., Pte Ltd. Midea International Trading Co., Ltd. Midea International Training Co., Ltd. Miland Luck Limited Nanhai Textiles Import & Export Co., Ltd. New Asia Aluminum & Stainless Steel Product Co., Ltd. New Zhongya Aluminum Factory Nidec Sankyo (Zhejang) Corporation Nidec Sankyo Zhejiang Corporation Nidec Sankyo Singapore Pte. Ltd. Ningbo Coaster International Co., Ltd. Ningbo Hi Tech Reliable Manufacturing Company Ningbo Innopower Tengda Machinery Ningbo Ivy Daily Commodity Co., Ltd. Ningbo Yili Import and Export Co., Ltd. North China Aluminum Co., Ltd. North Fenghua Aluminum Ltd. Northern States Metals PanAsia Aluminum (China) Limited Pengcheng Aluminum Enterprise Inc. Permasteelisa Hong Kong Limited Permasteelisa South China Factory Pingguo Aluminum Company Limited Pingguo Asia Aluminum Co., Ltd. Popular Plastics Company Limited Precision Metal Works Ltd. Press Metal International Ltd. Samuel, Son & Co., Ltd. Sanchuan Aluminum Co., Ltd. Sanhua (Hangzhou) Micro Channel Heat Exchanger Co., Ltd. Shandong Fukang Aluminum & Plastic Co. LTD. Shandong Huajian Aluminum Group Shangdong Huasheng Pesticide Machinery Co. Shangdong Nanshan Aluminum Co., Ltd. Shanghai Automobile Air-Conditioner Accessories Co Ltd. Shanghai Automobile Air Conditioner Accessories Ltd. Shanghai Canghai Aluminum Tube Packaging Co., Ltd. Shanghai Dofiberone Composites Co. Ltd. Shanghai Dongsheng Metal Shanghai Shen Hang Imp & Exp Co., Ltd. Shanghai Tongtai Precise Aluminum Alloy Manufacturing Co. Ltd. Shanghai Top-Ranking Aluminum Products Co., LTD. Shanghai Top-Ranking New Materials Co., Ltd. Shenyang Yuanda Aluminum Industry Engineering Co. Ltd. Shenzhen Hudson Technology Development Co. Shenzhen Jiuyuan Co., Ltd. Sihui Shi Guo Yao Aluminum Co., Ltd. Sincere Profit Limited Skyline Exhibit Systems (Shanghai) Co. Ltd. Southwest Aluminum (Group) Co., Ltd. Summit Heat Sinks Metal Co., Ltd. Summit Plastics Nanjing Co. Ltd. Suzhou JRP Import & Export Co., Ltd. Suzhou New Hongji Precision Part Co. Tai-Ao Aluminum (Taishan) Co. Ltd. Taishan City Kam Kiu Aluminium Extrusion Co., Ltd. Taitoh Machinery Shanghai Co. Ltd. Taizhou Lifeng Manufacturing Co., Ltd. Tiazhou Lifeng Manufacturing Corporation Taizhou United Imp. & Exp. Co., Ltd. tenKsolar (Shanghai) Co., Ltd. Tianjin Ganglv Nonferrous Metal Materials Co., Ltd. Tianjin Jinmao Import & Export Corp., Ltd. Tianjin Ruxin Electric Heat Transmission Technology Co., Ltd. Tianjin Xiandai Plastic & Aluminum Products Co., Ltd. Top-Wok Metal Co., Ltd. Traffic Brick Network, LLC Union Aluminum (SIP) Co. Union Industry (Asia) Co., Ltd. USA Worldwide Door Components (Pinghu) Co., Ltd. Wenzhou Shengbo Decoration & Hardware Wenzhou Yongtai Electric Co., Ltd. Whirlpool (Guangdong) Whirlpool Canada L.P. Whirlpool Microwave Products Development Ltd. Worldwide Door Components, Inc. WTI Building Products, Ltd. Wuxi Lutong Fiberglass Doors Co., Ltd. Xin Wei Aluminum Co. Xin Wei Aluminum Company Limited Xinya Aluminum & Stainless Steel Product Co., Ltd. Yuyao Fanshun Import & Export Co., Ltd. Yuyao Haoshen Import & Export Zahoqing China Square Industry Limited Zhaoqing Asia Aluminum Factory Company Ltd. Zhaoqing China Square Industrial Ltd. Zhaoqing China Square Industry Limited Zhaoqing New Zhongya Aluminum Co., Ltd. Zhejiang Anji Xinxiang Aluminum Co., Ltd. Zhejiang Lilies Industrial and Commercial Co. Zhejiang Yili Automobile Air Condition Co., Ltd. Zhejiang Yongkang Listar Aluminum Industry Co., Ltd. Zhejiang Zhengte Group Co., Ltd. Zhenjiang Xinlong Group Co., Ltd. Zhongshan Daya Hardware Co., Ltd. Zhongshan Gold Mountain Aluminum Factory Ltd. Zhongya Shaped Aluminum (HK) Holding Limited Zhuhai Runxingtai Electrical Equipment Co., Ltd. Suspension Agreements

    4 On April 16, 2018, Commerce initiated the 2017-2018 administrative review of Certain Frozen Warmwater Shrimp from India. See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 83 FR 16298, 16300-16304. In the notice of initiation, Commerce inadvertently made the following errors: (1) We included Premier Marine Products Private Limited twice; (2) we made typographical errors in the names of two companies (i.e., Triveni Fisheries P Ltd. and U & Company Marine Exports, listed as Triveni Fisheries P Ltd.U & Company Marine Exports); and (3) we failed to limit the review for Devi Sea Foods to shrimp produced in India where Devi Sea Foods acted as either the manufacturer or exporter (but not both), because shrimp produced and exported by this company is not covered by the antidumping duty order. See Certain Frozen Warmwater Shrimp from India: Final Results of Antidumping Duty Administrative Review, Partial Rescission of Review, and Notice of Revocation of Order in Part, 75 FR 41813, 41814 (July 19, 2010). Accordingly, we are initiating this administrative review for: (1) Premier Marine Products Private Limited only once; (2) Triveni Fisheries P Ltd. and U & Company Marine Exports (instead of Triveni Fisheries P Ltd.U & Company Marine Exports); and (3) Devi Sea Foods, but only with respect to shrimp for which Devi Sea Foods is either the manufacturer or exporter, but not both.

    None.

    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.

    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.5 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. 6 Commerce intends to reject factual submissions in any proceeding segments if the submitting party does not comply with applicable revised certification requirements.

    5See section 782(b) of the Act.

    6See 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: July 6, 2018. Wendy J. Frankel, Director, Customs and Border Protection Liaison Unit, Antidumping and Countervailing Duty Operations, Enforcement and Compliance.
    [FR Doc. 2018-14923 Filed 7-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG310 Endangered and Threatened Species; Take of Anadromous Fish AGENCY:

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

    ACTION:

    Notice of final determination and discussion of underlying biological and environmental analyses; notice of availability of Finding of No Significant Impact.

    SUMMARY:

    NMFS has evaluated the joint resource management plan (RMP) submitted to NMFS by the Sauk-Suiattle Indian Tribe, Swinomish Indian Tribal Community, Upper Skagit Indian Tribe, the Skagit River System Cooperative, and the Washington Department of Fish and Wildlife, pursuant to the limitation on take prohibitions for actions conducted under Limit 6 of the 4(d) Rule for salmon and steelhead promulgated under the Endangered Species Act (ESA). The RMP specifies harvest of ESA-listed, Skagit River steelhead in Treaty Indian fisheries and non-treaty recreational fisheries in the Skagit River terminal area of Washington State. This document serves to notify the public that NMFS, by delegated authority from the Secretary of Commerce, had determined pursuant to Limit 6 of the 4(d) rule for salmon and steelhead that implementing and enforcing the RMP will not appreciably reduce the likelihood of survival and recovery of Puget Sound steelhead. In compliance with the National Environmental Policy Act (NEPA), NMFS also announces the availability of its Finding of No Significant Impact for the Skagit River steelhead fisheries determination.

    DATES:

    The final determination of take prohibition limitation under the ESA was made on April 12, 2018. The Finding of No Significant Impact was signed on April 12, 2018.

    ADDRESSES:

    Requests for copies of the decision documents or any of the other associated documents should be directed to NOAA's National Marine Fisheries Service, West Coast Region, Sustainable Fisheries Division, 510 Desmond Drive, Suite 103, Lacey, WA 98503. The documents are also available online at www.westcoast.fisheries.noaa.gov.

    FOR FURTHER INFORMATION CONTACT:

    James Dixon at (360) 534-9329 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    ESA-Listed Species Covered in This Notice

    Steelhead (Oncorhynchus mykiss): threatened, naturally produced and artificially propagated Puget Sound.

    Chinook salmon (O. tshawytscha): threatened, naturally produced and artificially propagated Puget Sound.

    Background

    The Sauk-Suiattle Indian Tribe, Swinomish Indian Tribal Community, Upper Skagit Indian Tribe, and the Skagit River System Cooperative and the Washington Department of Fish and Wildlife have jointly submitted a steelhead fishery RMP to NMFS pursuant to the limitation on take prohibitions for actions conducted under Limit 6 of the 4(d) Rule for salmon and steelhead promulgated under the Endangered Species Act (ESA). The plan was submitted in November of 2016, pursuant to limit 6 of the 4(d) Rule for ESA-listed salmon and steelhead. The RMP would manage the harvest of Skagit River natural-origin steelhead in the Skagit River and in the terminal marine area of the Skagit River. As required, NMFS took public comments on its recommended determination for how the plans address the criteria in § 223.203(b)(5) prior to making its final determination.

    Discussion of the Biological Analysis Underlying the Determination

    The goal of the Skagit RMP is to provide steelhead fishing opportunities for the Skagit River Treaty Tribes and for recreational fishers, in a manner that is conservative at higher run sizes and increasingly so at lower run sizes. For a period of five years, the Skagit RMP will implement annual steelhead fisheries in the Skagit terminal management area consistent with the impact limits, management framework, enforcement, and monitoring requirements, as described in the RMP. The Skagit RMP utilizes an abundance-based, stepped harvest regime to determine annual harvest rates, based on the annual forecasted run size. These stepped harvest rates range from a 4 percent total allowable harvest rate at low run sizes (<4,001 adults) to 25 percent for runs greater than 8,001 adults.

    NMFS has analyzed the Skagit RMP's proposed abundance-based, stepped harvest regime, along with the conservation measures proposed in the plan. We have concluded that the Skagit RMP would provide effective protection to the Skagit River steelhead populations based on parameters defining a viable salmonid population; in terms of overall abundance and productivity, as well as the diversity and spatial structure of the individual populations within the Skagit River basin. The Skagit RMP will provide for the proposed harvest opportunities while not appreciably slowing the population's achievement of viable function.

    NMFS' determination on the Skagit RMP depends upon implementation of all of the monitoring, evaluation, reporting tasks or assignments, and enforcement activities included in the RMP. Reporting and inclusion of new information derived from research, monitoring, and evaluation activities described in the plan provide assurance that performance standards will be achieved in future seasons.

    Summary of Comments Received in the Response to the Proposed Evaluation and Pending Determination

    NMFS published notice of its Proposed Evaluation and Pending Determination (PEPD) on the plan for public review and comment on December 7, 2017 (82 FR 57729). The PEPD was available for public review and comment for 30 days.

    During the public comment period, 121 comments were received, all by email. These came in the form of: Individual, unique comments; individuals who submitted form-letter communications, some with added comments; and letters from fish conservation organizations. NMFS thoroughly reviewed and considered all of the substantive comments received from the public and the additional literature and studies submitted. This review of new information and data informed NMFS' subsequent analysis, in its biological opinion, but did not lead to any changes to the Skagit RMP, as submitted, or to NMFS' determination that the plan adequately addresses the 4(d), Limit 6 criteria. A section summarizing and responding to the substantive comments received during the public comment period on the PEPD is included as part of the final evaluation document, available on the West Coast Region website. Based on its evaluation and recommended determination and taking into account the public comments, NMFS issued its final determination on the joint state-tribal plan.

    Authority

    Under section 4 of the ESA, the Secretary of Commerce is required to adopt such regulations as he deems necessary and advisable for the conservation of species listed as threatened. The ESA salmon and steelhead 4(d) rule (50 CFR 223.203(b)) specifies categories of activities that contribute to the conservation of listed salmonids and sets out the criteria for such activities. The rule further provides that the prohibitions of paragraph (a) of the rule do not apply to actions undertaken in compliance with a plan developed jointly by a state and a tribe and determined by NMFS to be in accordance with the salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000).

    Angela Somma, Chief, Endangered Species Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-14950 Filed 7-11-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: National Oceanic and Atmospheric Administration's Papahanaumokuakea Marine National Monument and University of Hawaii Research Internship Program.

    OMB Control Number: 0648-0719.

    Form Number(s): None.

    Type of Request: Regular (extension of a currently approved information collection).

    Number of Respondents: 80.

    Average Hours per Response: 1 hour or less, for each application, reference letter and support letter.

    Burden Hours: 80.

    Needs and Uses: This request is for extension of a currently approved information collection.

    The National Oceanic and Atmospheric Administration's (NOAA's) Papahānaumokuākea Marine National Monument (PMNM) would like to collect student data and information for the purposes of selecting candidates for its research internship program in partnership with the University of Hawaii. The application package would contain: (1) A form requesting information on academic background and professional experiences, (2) reference forms in support of the internship application by two educational or professional references, and (3) a support letter from one academic professor or advisor.

    Affected Public: Individuals or households.

    Frequency: One time.

    Respondent's Obligation: Voluntary.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: July 8, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-14889 Filed 7-11-18; 8:45 am] BILLING CODE 3510-NK-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: NOAA Marine Debris Program Performance Progress Report and Data Collection Form.

    OMB Control Number: 0648-0718.

    Form Number(s): None.

    Type of Request: Regular (revision and extension of a currently approved information collection).

    Number of Respondents: 70.

    Average Hours per Response: 2.

    Burden Hours: 1,400.

    Needs and Uses: This request is for revision and extension of an existing information collection.

    The NOAA Marine Debris Program (MDP) supports national and international efforts to research, prevent, and reduce the impacts of marine debris. The MDP is a centralized office within NOAA that coordinates and supports activities, both within the bureau and with other federal agencies, which address marine debris and its impacts. In addition to inter-agency coordination, the MDP uses partnerships with state and local agencies, tribes, non-governmental organizations, academia, and industry to investigate and solve the problems that stem from marine debris through research, prevention, and reduction activities, in order to protect and conserve our nation's marine environment and ensure navigation safety.

    The Marine Debris Research, Prevention, and Reduction Act (33 U.S.C. 1951 et seq.) as amended by the Marine Debris Act Amendments of 2012 (Pub. L. 112-213, Title VI, Sec. 603, 126 Stat. 1576, December 20, 2012) outlines three central program components for the MDP to undertake: (1) Mapping, identification, impact assessment, removal, and prevention; (2) reducing and preventing fishing gear loss; and (3) outreach to stakeholders and the general public. To address these components, the Marine Debris Act authorized the MDP to establish several competitive grant programs on marine debris research, prevention and removal that provide federal funding to non-federal applicants throughout the coastal United States and territories.

    The terms and conditions of the financial assistance awarded through these grant programs require regular progress reporting and communication of project accomplishments to MDP. Progress reports contain information related to, among other things, the overall short and long-term goals of the project, project methods and monitoring techniques, actual accomplishments (such as pounds of debris removed from an ecosystem, numbers of volunteers participating in a cleanup project, etc.), status of approved activities, challenges or potential roadblocks to future progress, and lessons learned. This information collection enables MDP to monitor and evaluate the activities supported by federal funds to ensure accountability to the public and to ensure that funds are used consistent with the purpose for which they were appropriated. It also ensures that reported information is standardized in such a way that allows for it to be meaningfully synthesized across a diverse set of projects and project types. MDP uses the information collected in a variety of ways to communicate with federal and non-federal partners and stakeholders on individual project and general program accomplishments.

    Revision: A section has been added to the report form, but there is no change to burden.

    Affected Public: Not-for-profit institutions; business or other for-profit organizations; state, local or tribal government.

    Frequency: Semiannual.

    Respondent's Obligation: Required to obtain or retain benefits.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: July 8, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-14888 Filed 7-11-18; 8:45 am] BILLING CODE 3510-JE-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Highly Migratory Species Dealer, Importer, and Exporter Reporting Family of Forms.

    OMB Control Number: 0648-0040.

    Form Number(s): None.

    Type of Request: Regular (revision and extension of a currently approved information collection).

    Number of Respondents: 10,391.

    Average Hours per Response: 15 minutes for catch document/statistical document/re-export certificate validation by government official; 120 minutes for authorization of non-governmental catch document/statistical document/re-export certificate validation; 2 minutes for daily Atlantic bluefin tuna landing reports; 3 minutes for daily Atlantic bluefin tuna landing reports from pelagic longline and purse seine vessels; 1 minute for Atlantic bluefin tuna tagging; 15 minutes for biweekly Atlantic bluefin tuna dealer landing reports; 15 minutes for HMS international trade biweekly reports; 15 minutes for weekly electronic HMS dealer landing reports (e-dealer); 5 minutes for negative weekly electronic HMS dealer landing reports (e-dealer); 15 minutes for voluntary fishing vessel and catch forms; 2 minutes for provision of HMS dealer email address.

    Burden Hours: 18,552.

    Needs and Uses: This request is for revision and extension of a currently approved information collection.

    Under the provisions of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.), the National Marine Fisheries Service (NMFS) is responsible for management of the Nation's marine fisheries. NMFS must also promulgate regulations, as necessary and appropriate, to carry out obligations the United States (U.S.) undertakes internationally regarding tuna management through the Atlantic Tunas Convention Act (ATCA, 16 U.S.C. 971 et seq.).

    This collection serves as a family of forms for Atlantic highly migratory species (HMS) dealer reporting, including purchases of HMS from domestic fishermen, and the import, export, and/or re-export of HMS, including federally managed tunas, sharks, and swordfish.

    Transactions covered under this collection include purchases of Atlantic HMS from domestic fishermen; and the import/export of all bluefin tuna, frozen bigeye tuna, southern bluefin tuna or swordfish under the HMS International Trade Program, regardless of geographic area of origin. This information is used to monitor the harvest of domestic fisheries, and/or track international trade of internationally managed species.

    The domestic dealer reporting covered by this collection includes weekly electronic landing reports and negative reports (i.e., reports of no activity) of Atlantic swordfish, sharks, bigeye tuna, albacore, yellowfin, and skipjack tunas (collectively referred to as BAYS tunas), and biweekly and electronic daily landing reports for bluefin tuna, including tagging of individual fish. Because of the recent development of an individual bluefin quota (IBQ) management system (RIN 0648-BC09), electronic entry of IBQ-related landing data is required for Atlantic bluefin tuna purchased from Longline and Purse seine category vessels. NMFS intends to consider integrating the electronic dealer reporting for bluefin tuna and electronic reporting for the IBQ system; however, at this time, dealers must submit limited bluefin tuna landings data to both NMFS systems for purse seine and pelagic longline vessels.

    International trade tracking programs are required by both the International Commission for the Conservation of Atlantic Tunas (ICCAT) and the Inter-American Tropical Tuna Commission (IATTC) to account for all international trade of covered species. The U.S. is a member of ICCAT and IATTC and required by ATCA and the Tunas Convention Act (16 U.S.C. 951 et. seq., consecutively) to promulgate regulations as necessary and appropriate to implement ICCAT and IATTC recommendations. These programs require that a statistical document or catch document accompany each export from and import to a member nation, and that a re-export certificate accompany each re-export. The international trade reporting requirements covered by this collection include implementation of catch document, statistical document, and re-export certificate trade tracking programs for bluefin tuna, frozen bigeye tuna, and swordfish. An electronic catch document program for bluefin tuna (EBCD) was recommended by ICCAT and implemented by the United States in 2016 (0648-BF17). U.S. regulations implementing ICCAT statistical document and catch document programs require statistical documents and catch documents for international transactions of the covered species from all ocean areas, so Pacific imports and exports must also be accompanied by statistical documents and catch documents. Since there are statistical document programs in place under other international conventions (e.g., the Indian Ocean Tuna Commission), a statistical document or catch document from another program may be used to satisfy the statistical document requirement for imports into the United States. Revision: These statistical and catch documents are now covered under OMB Control No. 0648-0732, but their validation is still part of this information collection.

    Dealers who internationally trade Southern bluefin tuna are required to participate in a trade tracking program to ensure that imported Atlantic and Pacific bluefin tuna will not be intentionally mislabeled as “southern bluefin” to circumvent reporting requirements. This action is authorized under ATCA, which provides for the promulgation of regulations as may be necessary and appropriate to carry out ICCAT recommendations.

    In addition to statistical document, catch document, and re-export certificate requirements, this collection includes biweekly reports to complement trade tracking statistical documents by summarizing statistical document data and collecting additional economic information.

    Affected Public: Business or other for-profit organizations.

    Frequency: Weekly and biweekly.

    Respondent's Obligation: Mandatory.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: July 8, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-14887 Filed 7-11-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2018-OS-0043] Proposed Collection; Comment Request AGENCY:

    Office of the Under Secretary of Defense for Personnel and Readiness, DoD.

    ACTION:

    Information collection notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Office of the Deputy Assistant Secretary of Defense for Military Personnel Policy announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: 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; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by September 10, 2018.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    Mail: Department of Defense, Office of the Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Suite 08D09, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Office of the Deputy Assistant Secretary of Defense for Military Personnel Policy, ATTN: Accession Policy (3D1066), 1500 Defense Pentagon, Washington, DC 20301-1500, or call 703-695-5525.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Police Records Check; DD Form 369; OMB Control Number 0704-0007.

    Needs and Uses: The information collection requirement is necessary, per Sections 504, 505 Title 10 U.S.C, to identify persons who may be undesirable for military service. Applicants for enlistment must be screened to identify any discreditable involvement with police or other law enforcement agencies. The DD Form 369, “Police Records Check,” is forwarded to law enforcement agencies to identify if an applicant has a criminal record.

    Affected Public: State, Local or Tribal Government.

    Annual Burden Hours: 78,750.

    Number of Respondents: 175,000.

    Responses per Respondent: 1.

    Annual Responses: 175,000.

    Average Burden per Response: 27 minutes.

    Frequency: On occasion.

    Dated: July 9, 2018. Shelly E. Finke, Alternate OSD Federal Register, Liaison Officer, Department of Defense.
    [FR Doc. 2018-14933 Filed 7-11-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2018-OS-0041] Notice of Availability of an Environmental Assessment Addressing Hazardous Materials Warehouses and Gas Cylinder Sheds at Naval Station Norfolk and Naval Support Activity Norfolk Naval Shipyard, Virginia AGENCY:

    Defense Logistics Agency (DLA), Department of Defense.

    ACTION:

    Notice of availability (NOA).

    SUMMARY:

    DLA announces the availability of an Environmental Assessment (EA) documenting the potential environmental effects associated with the proposed action to construct and operate hazardous materials warehouses and gas cylinder sheds at Naval Station Norfolk and Naval Support Activity Norfolk Naval Shipyard, Virginia. The EA has been prepared as required under the National Environmental Policy Act (NEPA) and DLA Regulation, Environmental Considerations in Defense Logistics Agency Actions.

    DATES:

    The public comment period will end on August 13, 2018.

    ADDRESSES:

    You may submit comments, identified by DOD-2018-OS-0041, to one of the following:

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

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, Regulatory and Advisory Committee Division, 4800 Mark Center Drive, Mailbox #24, Suite 08D09, Alexandria, VA 22350-1700.

    FOR FURTHER INFORMATION CONTACT:

    Ira Silverberg at 571-767-0705 during normal business hours Monday through Friday, from 8:00 a.m. to 4:30 p.m. (EDT) or by email: [email protected]

    Dated: July 9, 2018. Shelly E. Finke, Alternate OSD Federal Register, Liaison Officer, Department of Defense.
    [FR Doc. 2018-14926 Filed 7-11-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2018-OS-0042] Notice of Availability for an Environmental Assessment Addressing Upgrade of the Main Gate Access Control Point at Defense Distribution Depot, San Joaquin, California, and Surrounding Area AGENCY:

    Defense Logistics Agency (DLA), Department of Defense.

    ACTION:

    Notice of availability (NOA).

    SUMMARY:

    DLA announces the availability of an Environmental Assessment (EA) documenting the potential environmental effects associated with the proposed action to upgrade the main gate access control point at Defense Distribution Depot, San Joaquin, California, and surrounding area.

    DATES:

    The public comment period will end on August 13, 2018.

    ADDRESSES:

    You may submit comments, identified by DOD-2018-OS-0042, to one of the following:

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

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, Regulatory and Advisory Committee Division, 4800 Mark Center Drive, Mailbox #24, Suite 08D09, Alexandria, VA 22350-1700.

    FOR FURTHER INFORMATION CONTACT:

    Ira Silverberg at 571-767-0705 during normal business hours Monday through Friday, from 8:00 a.m. to 4:30 p.m. (EDT) or by email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The EA has been prepared as required under the National Environmental Policy Act (NEPA) and DLA Regulation 1000.22, Environmental Considerations in Defense Logistics Agency Actions.

    The EA posted to the docket provides additional information about the proposed action.

    The EA is available in hardcopy at the Tracy Branch Library, 20 East Eaton Avenue, Tracy, CA 95376.

    Dated: July 9, 2018. Shelly E. Finke, Alternate OSD Federal Register, Liaison Officer, Department of Defense.
    [FR Doc. 2018-14927 Filed 7-11-18; 8:45 am] BILLING CODE 5001-06-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1048] 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 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 PRA comments should be submitted on or before September 10, 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: 3060-1048.

    Title: Section 1.929(c)(1), Composite Interference Contour (CIC).

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities, not-for-profit institutions and state, local or tribal government.

    Number of Respondents and Responses: 50 respondents; 50 responses.

    Estimated Time per Response: 2 hours.

    Frequency of Response: On occasion reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 309(j).

    Total Annual Burden: 100 hours.

    Total Annual Cost: No cost.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Needs and Uses: The Commission will submit this expiring information collection to the Office of Management and Budget (OMB) for approval of an extension request.

    Under 47 CFR 1.929(c)(1) of the Commission's rules, any increase in the composite interference contour (CIC) of a site-based licensee in the Paging and Radiotelephone Service, Rural Radiotelephone Service, or 800 MHz Specialized Mobile Radio Service is a major modification of a license that requires prior Commission approval.

    However, in February 2005, the Commission adopted and released final rules which amended section 1.929(c)(1) to specify that expansion of a composite interference contour (CIC) of a site-based licensee in the Paging and Radiotelephone Service—as well as the Rural Radiotelephone Service and 800 MHz Specialized Mobile Radio Service—over water on a secondary, non-interference basis should be classified as a minor (rather than major) modification of a license. Such reclassification has eliminated the filing requirements associated with these license modifications, but requires site-based licensees to provide the geographic area licensee (on the same frequency) with the technical and engineering information necessary to evaluate the site-based licensee's operations over water.

    Federal Communications Commission. Marlene Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-14860 Filed 7-11-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0009, OMB 3060-0594, OMB 3060-0601 and OMB 3060-0609] 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 PRA comments should be submitted on or before August 13, 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: 3060-0009.

    Title: Application for Consent to Assignment of Broadcast Station Construction Permit or License or Transfer of Control of Corporation Holding Broadcast Station Construction Permit or License, FCC Form 316.

    Form Number: FCC Form 316.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities; Not-for-profit institutions; State, local or tribal government.

    Number of Respondents and Responses: 750 respondents, 750 responses.

    Estimated Time per Response: 1.5-4.5 hours.

    Frequency of Response: On occasion reporting requirement.

    Obligation To Respond: Required to obtain benefits. Statutory authority for this collection of information is contained in Sections 154(i) and 310(d) of the Communications Act of 1934, as amended.

    Total Annual Burden: 1,231 hours.

    Total Annual Cost: $711,150.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: Confidentiality is not required with this collection of information.

    Needs and Uses: FCC Form 316 is required when applying for authority for assignment of a broadcast station construction permit or license, or for consent to transfer control of a corporation holding a broadcast station construction permit or license where there is little change in the relative interest or disposition of its interests; where transfer of interest is not a controlling one; there is no substantial change in the beneficial ownership of the corporation; where the assignment is less than a controlling interest in a partnership; where there is an appointment of an entity qualified to succeed to the interest of a deceased or legally incapacitated individual permittee, licensee or controlling stockholder; and, in the case of LPFM stations, where there is a voluntary transfer of a controlling interest in the licensee or permittee entity. In addition, the applicant must notify the Commission when an approved transfer of control of a broadcast station construction permit or license has been consummated.

    OMB Control Number: 3060-0594.

    Title: Cost of Service Filing for Regulated Cable Services, FCC Form 1220.

    Form Number: FCC Form 1220.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities; State, Local, or Tribal Government.

    Number of Respondents and Responses: 20 respondents; 10 responses.

    Estimated Hours per Response: 4-80 hours.

    Frequency of Response: On occasion and annual reporting requirements; Third party disclosure requirement.

    Total Annual Burden: 1,220 hours.

    Total Annual Cost: $100,000.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained is Sections 154(i) and 623 of the Communications Act of 1934, as amended.

    Nature and Extent Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: The Cable Television Consumer Protection and Competition Act of 1992 required the Commission to prescribe rules and regulations for determining reasonable rates for basic tier cable service and to establish criteria for identifying unreasonable rates for cable programming services and associated equipment.

    OMB Control Number: 3060-0601.

    Title: Setting Maximum Initiated Permitted Rates for Regulated Cable Services, FCC Form 1200.

    Form Number: FCC Form 1200.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities; State, Local, or Tribal Government.

    Number of Respondents and Responses: 100 respondents; 50 responses.

    Estimated Hours per Response: 2-10 hours.

    Frequency of Response: One time and annual reporting requirements; Third party disclosure requirement.

    Total Annual Burden: 800 hours.

    Total Annual Cost: $62,500.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in Section 623 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 Impact Assessment: No impact(s).

    Needs and Uses: Cable operators and local franchise authorities file FCC Form 1200 to justify the reasonableness of rates in effect on or after May 15, 1994. The FCC uses the data to evaluate cable rates the first time they are reviewed on or after May 15, 1994, so that maximum permitted rates for regulated cable service can be determined.

    OMB Control Number: 3060-0609.

    Title: Section 76.934(e), Petitions for Extension of Time.

    Form Number: Not applicable.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities; and State, local, or tribal governments.

    Number of Respondents and Responses: 20 respondents; 10 responses.

    Frequency of Response: On occasion reporting requirement; Third party disclosure requirement.

    Estimated Time per Response: 4 hours.

    Total Annual Burden: 80 hours.

    Total Annual Cost: None.

    Privacy Impact Assessment: No impact(s).

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority is contained in Sections 4(i) and 623 of the Communications Act of 1934, as amended.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Needs and Uses: The information collection requirements contained under 47 CFR 76.934(e) states that small cable systems may obtain an extension of time to establish compliance with rate regulations provided that they can demonstrate that timely compliance would result in severe economic hardship. Requests for the extension of time should be addressed to the local franchising authorities (“LFAs”) concerning rates for basic service tiers.

    Federal Communications Commission. Marlene Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-14858 Filed 7-11-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION Open Commission Meeting, Thursday, July 12, 2018 July 5, 2018.

    The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, July 12, 2018 which is scheduled to commence at 10:30a.m. in Room TW-C305, at 445 12th Street SW, Washington, DC.

    Item No. Bureau Subject 1 WIRELESS TELE-COMMUNICATIONS, INTERNATIONAL AND OFFICE OF ENGINEERING & TECHNOLOGY Title: Expanding Flexible Use of the 3.7 to 4.2 GHz Band (GN Docket No. 18-122); Expanding Flexible Use in Mid-Band Spectrum Between 3.7 and 24 GHz (GN Docket No. 17-183); Petition for Rulemaking to Amend and Modernize Parts 25 and 101 of the Commission's Rules to Authorize and Facilitate the Deployment of Licensed Point-to-Multipoint Fixed Wireless Broadband Service in the 3.7-4.2 GHz Band (RM-11791); Fixed Wireless Communications Coalition, Inc., Request for Modified Coordination Procedures in Band Shared Between the Fixed Service and the Fixed Satellite Service (RM-11778)
  • Summary: The Commission will consider an Order and Notice of Proposed Rulemaking that would continue the Commission's efforts to make mid-band spectrum in the 3.7-4.2 GHz band available for expanded flexible use, primarily by seeking comment on mechanisms for clearing for mobile use and whether to allow point-to-multipoint use on a shared basis in portions of the band. To inform the Commission's decision-making on the future of the band, it would also collect information about FSS earth stations and space stations to provide a clear understanding of the operations of current users.
  • 2 WIRELESS TELE-COMMUNICATIONS Title: Amendment of Parts 1 and 22 of the Commission's Rules with Regard to the Cellular Service, Including Changes in Licensing of Unserved Area (WT Docket No. 12-40); Amendment of the Commission's Rules with Regard to Relocation of Part 24 to Part 27; Interim Restrictions and Procedures for Cellular Service Applications (RM-11510); Amendment of Parts 0, 1, and 22 of the Commission's Rules with Regard to Frequency Coordination for the Cellular Service; Amendment of Part 22 of the Commission's Rules Regarding Certain Administrative and Filing Requirements; Amendment of the Commission's Rules Governing Radiated Power Limits for the Cellular Service (RM-11660); Amendment of Parts 1, 22, 24, 27, 74, 80, 90, 95, and 101 to Establish Uniform License Renewal, Discontinuance of Operation, and Geographic Partitioning and Spectrum Disaggregation Rules and Policies for Certain Wireless Radio Services (WT Docket No. 10-112); 2016 Biennial Review of Telecommunications Regulations (WT Docket No. 16-138)
  • Summary:The Commission will consider a Report and Order eliminating unnecessary rules that apply to cellular service and other licensees.
  • 3 MEDIA Title: Children's Television Programming Rules (MB Docket No. 18-202); Modernization of Media Regulation Initiative (MB Docket No. 17-105)
  • Summary: The Commission will consider a Notice of Proposed Rulemaking seeking comment on proposed revisions to the children's television programming rules to provide broadcasters greater flexibility in meeting their children's programming obligations.
  • 4 PUBLIC SAFETY & HOMELAND SECURITY Title: Amendment of Part 11 of the Commission's Rules Regarding the Emergency Alert System (PS Docket No. 15-94); Wireless Emergency Alerts (PS Docket No. 15-91)
  • Summary: The Commission will consider a Report and Order and Further Notice of Proposed Rulemaking to improve emergency alerting, including facilitating more effective EAS tests and preventing false alerts.
  • 5 WIRELINE COMPETITION Title: Nationwide Number Portability (WC Docket No. 17-244); Numbering Policies for Modern Communications (WC Docket No. 13-97)
  • Summary: The Commission will consider a Report and Order that forbears from legacy requirements and amends rules to facilitate the move toward complete nationwide number portability to promote competition between all service providers and increase network routing efficiencies.
  • 6 ENFORCEMENT Title: Amendment of Procedural Rules Governing Formal Complaint Proceedings Delegated to the Enforcement Bureau (EB Docket No. 17-245)
  • Summary: The Commission will consider a Report and Order that consolidates and streamlines the rules governing formal complaint proceedings delegated to the Enforcement Bureau.
  • The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to: [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the internet from the FCC Live web page at www.fcc.gov/live.

    For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the internet. To purchase these services, call (703) 993-3100 or go to www.capitolconnection.gmu.edu.

    Federal Communications Commission. Marlene Dortch, Secretary.
    [FR Doc. 2018-14861 Filed 7-11-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Agency Information Collection Activities: Submission for OMB Review; Comment Request (OMB No. 3064-0109; 0124; and 0162) AGENCY:

    Federal Deposit Insurance Corporation (FDIC).

    ACTION:

    Notice and request for comment.

    SUMMARY:

    The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the renewal of existing information collections, as required by the Paperwork Reduction Act of 1995. The FDIC published notices of its intent to renew the information collections described below in the Federal Register and requested comment for 60 days. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of these collections, and again invites comment on the renewal.

    DATES:

    Comments must be submitted on or before August 13, 2018.

    ADDRESSES:

    Interested parties are invited to submit written comments to the FDIC by any of the following methods:

    https://www.FDIC.gov/regulations/laws/federal.

    Email: [email protected] Include the name and number of the collection in the subject line of the message.

    Mail: Manny Cabeza, Counsel, Room MB-3007, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429.

    Hand Delivery: Comments may be hand-delivered to the guard station at the rear of the 17th Street Building (located on F Street), on business days between 7:00 a.m. and 5:00 p.m.

    All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.

    FOR FURTHER INFORMATION CONTACT:

    Manny Cabeza, Counsel, 202-898-3767, [email protected], MB-3007, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429.

    SUPPLEMENTARY INFORMATION:

    Proposal to renew the following currently approved collections of information:

    1. Title: Notice of Branch Closure.

    OMB Number: 3064-0109.

    Form Number: None.

    Affected Public: Insured depository institutions.

    Burden Estimate:

    Summary of Annual Burden Type of burden Obligation
  • to respond
  • Estimated
  • number of
  • respondents
  • Estimated
  • time per
  • response
  • (hours)
  • Frequency
  • of response
  • Average
  • total
  • annual
  • estimated
  • burden
  • (hours)
  • Adoption of Closure Policy Recordkeeping Mandatory 23 8 One time 184 Notice of Closure Disclosure Mandatory 683 2 On occasion 1,366 Total Estimated Annual Burden 1,550

    General Description of Collection: Section 42 of the Federal Deposit Insurance Act mandates that an insured depository institution closing a branch notify its primary federal regulator not later than 90 days prior to the closing. The statute also provides that a notice be posted on the premises of the branch for the 30-day period immediately prior to the closing and that the customers be notified in a mailing at least 90 days prior to the closing. Each insured depository institution that has one or more branches is required to adopt a written policy for branch closings.

    Burden Estimate Methodology and Assumptions:

    There are no changes in the methodology or substance of this information collection. FDIC believes that the existing estimate of the time required to develop a written branch closure policy and to provide the required branch closure notices is accurate. The number of branch closure notifications is closely related to the number of branches closed, while the number of closure policy adoptions equals the number newly chartered branch banking institutions and the number of existing banking institutions that transition from having no branches to having at least one branch. To derive an estimate of average annual branch closure notifications, FDIC Risk Management Supervision (RMS) staff counted the number of full-service standalone and in-store branches that closed between 2015 and 2017. In addition, FDIC staff count the number of newly chartered branch banking institutions and the number of institutions that transitioned from having no branches to having at least one branch. To derive an estimate of average annual branch closure notifications, FDIC Risk Management Supervision (RMS) staff counted the number of full-service standalone and in-store branches that closed between 2015 and 2017. In addition, FDIC staff counted the number of newly chartered branch banking institutions and the number of institutions that transitioned from having no branches to having at least one branch. FDIC records reflect that there were 683 branch closures, on average, each year between 2015 and 2017. FDIC estimates that an average of 23 institutions each year will transition from having no branches to having at least one branch.

    2. Title: Notification of Change of Insured Status.

    OMB Number: 3064-0124.

    Form Number: None.

    Affected Public: Insured depository institutions.

    Burden Estimate:

    Summary of Annual Burden Type of burden Obligation
  • to respond
  • Estimated
  • number of
  • respondents
  • Estimated
  • time per
  • response
  • (hours)
  • Frequency
  • of response
  • Average
  • total
  • annual
  • estimated
  • burden
  • (hours)
  • Certification Reporting Mandatory 150 .25 On Occasion 37.5 Notification Disclosure Mandatory 2 1 On Occasion 2 Total Estimated Annual Burden 39.5

    General Description of Collection:

    This information collection consists of two parts: (1) A certification that insured depository institutions provide the FDIC when all deposit liabilities from one insured depository institution are assumed from another insured depository institution, with the latter institution responsible for providing the certification, and (2) a notification that an insured depository institution provides to its depositors when it seeks to voluntarily terminate its insured status. The certification is necessary to implement the provisions of section 8(q) of the Federal Deposit Insurance Act, 12 U.S.C. 1818(q), regarding termination of the insured status of the transferring institution and termination of the separate deposit insurance coverage provided on deposit accounts assumed by the assuming institution. The depositor notification is required by section 8(a) (6) of the Federal Deposit Insurance Act, 12 U.S.C. 1818(a) (6). This provision ensures that the institution's depositors receive appropriate information regarding the institution's intent to terminate its insured status and that, prior to the termination of the institution's insured status, depositors receive appropriate information concerning federal deposit insurance coverage of their accounts once the institution's insured status is terminated.

    There is no change in the methodology or substance of this information collection. The number of certifications submitted under this information collection is closely related to the number of insured depository institutions that are acquired by another depository institution through mergers or as a result of the closing of the institution by its chartering authority. The number of depositor notifications is driven by the number of institutions that elect to voluntarily terminate its insured status without having its deposits assumed by another insured depository institution. The change in burden is due to economic fluctuation reflected in a lower number of certifications following mergers or closures and a reduction in the number of notifications due to voluntary terminations of insured status.

    3. Title: Large Bank Deposit Insurance Program.

    OMB Number: 3064-0162.

    Form Number: None.

    Affected Public: Insured depository institutions having at least $2 billion in deposits and at least either: (a) 250,000 Deposit accounts; or (b) $20 billion in total assets, regardless of the number of deposit accounts (a “covered institution”).

    Burden Estimate:

    Summary of Annual Burden Type of burden Obligation to
  • respond
  • Average
  • estimated number of
  • respondents
  • Estimated
  • time per
  • response
  • (hours)
  • Frequency of
  • response
  • Average
  • total annual
  • estimated burden
  • (hours)
  • Implementation Posting and removing provisional holds—360.9(c)(1) and (2) Recordkeeping Mandatory 8 150 One time 1,200 Providing standard data format for deposit account and customer information—360.9(d)(1) Recordkeeping Mandatory 8 110 One time 880 Notification of identity of person responsible for producing standard data downloads—360.9(c)(3) Reporting Mandatory 8 8 One time 64 Request for exemption from provisional hold requirements—360.9(c)(9) Reporting Voluntary 1 20 On occasion 20 Provide deposit account and customer information in required standard format—360.9(d)(3) Reporting Mandatory 8 40 On occasion 320 Request for extension of compliance deadline—360.9(e)(7) Reporting Voluntary 1 20 On occasion 20 Request for exemption—360.9(f) Reporting Voluntary 1 20 On occasion 20 Total Implementation Burden 2,524 Ongoing Notification of identity of person responsible for producing standard data downloads—360.9(c)(3) Reporting Mandatory 153 8 On occasion 1,224 Request for exemption from provisional hold requirements—360.9(c)(9) Reporting Voluntary 1 20 On occasion 20 Request for exemption—360.9(f) Reporting Voluntary 1 20 On occasion 20 Test compliance with 360.9(c)-(d) pursuant to 360.9(h) Reporting Mandatory 81 80 On occasion 6,480 Total Ongoing Burden 7,744 Total Estimated Annual Burden 10,268

    General Description of Collection: Upon the failure of an FDIC-insured depository institution, the FDIC is required to pay insured deposits as soon as possible.1 To do so, the FDIC must be able to quickly determine the total insured amount for each depositor. To make this determination, the FDIC must ascertain the balances of all deposit accounts owned by the same depositor in the same ownership capacity at a failed institution as of the day of failure. The FDIC issued a regulation (12 CFR 360.9) to modernize the process of determining the insurance status of each depositor in the event of failure of a covered institution. The regulation requires covered institutions to adopt mechanisms that would, in the event of the institution's failure (1) provide the FDIC with standard deposit account and other customer information, and (2) allow the placement and release of holds on liability accounts, including deposits. The regulation applies only to covered institutions and imposes the following recordkeeping and reporting requirements:

    1 The FDIC can meet its obligation to pay insured deposits either by payment in cash or by making available to each depositor a transferred deposit in a another insured depository institution. 12 U.S.C § 1821(f)(1).

    Recordkeeping

    360.9(c)(1) and (2)—Posting and Removing Provisional Holds. Covered institutions must have an automatic process for placing a provisional hold on deposit accounts within timeframes specified in FDIC regulations.

    360.9(d)(1) and (2)—Providing Standard Data Format for Deposit Account and Customer Information. Covered institutions must produce information in the specified standard data format.

    Reporting

    360.9(c)(3)—Covered institutions must notify the FDIC of the person(s) responsible for producing required standard data downloads and for administering provisional holds.

    360.9(c)(9)—A covered institution may request an exemption from the provisional hold requirements for certain account systems servicing a relatively small number of accounts where manual application of provisional holds is feasible.

    360.9(d)(3)—Upon request by the FDIC, a covered institution must submit the data required by 360.9(d)(1) .

    360.9(e)(7)—A covered institution may request an extension of the deadline to comply with provisional hold and standard data format requirements.

    360.9(f)—A covered institution may request an exemption from the provisional hold and standard data format requirements due to high concentration of deposits incidental to credit card operations.

    360.9(h)—A covered institution's compliance with the recordkeeping and reporting requirements set forth in the rule will be tested by the FDIC.

    Burden Estimate Methodology and Assumptions:

    The FDIC is revising its burden estimate because the number of covered institutions has decreased due to economic fluctuations and most covered institutions have already implemented the requirements of the regulation and will only face reduced ongoing compliance burdens. Based on FDIC Call Report data,2 the regulation currently applies to 145 institutions. The FDIC has determined that in the past, between 1 and 3 new institutions per quarter have become covered under the regulation. FDIC estimates that on average, 2 new institutions per quarter (8 new institutions per year) will become covered and be subject to initial implementation burden. The following table reflects the FDCI's estimate of the breakdown of covered institutions facing implementation and ongoing burden during the next three years:

    2 FDIC Call Report, September 30, 2017.

    Number of Institutions Year 1 Year 2 Year 3 Average Implementation 8 8 8 8 Ongoing 145 153 161 153 Total 153 161 169 161

    All covered institutions will be required to comply with the requirements of 360.9(h). FDIC estimates that half of the covered institutions will be tested for compliance each year. As a result, it is estimated that an average of 81 covered institutions will be affected by this reporting burden annually. No institutions have requested an extension under section 360.9(e)(7), or exemptions under sections 360.9(c)(9) or 360.9(f). The “Summary of Annual Burden” table above lists a respondent count of 1 for these requests as placeholders to preserve the burden estimates for these activities.

    Request for Comment: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; 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. All comments will become a matter of public record.

    Dated at Washington, DC, on July 6, 2018. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2018-14864 Filed 7-11-18; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meeting Time and Date:

    Tuesday, July 17, 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. 2018-15024 Filed 7-10-18; 4:15 pm] BILLING CODE 6715-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 6, 2018.

    A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. Platte Valley Financial Service Companies, Inc., Scottsbluff, Nebraska; to acquire 100 percent of the voting shares of The American Bank of Sidney, Sidney, Nebraska.

    Board of Governors of the Federal Reserve System, July 9, 2018. Ann Misback, Secretary of the Board.
    [FR Doc. 2018-14931 Filed 7-11-18; 8:45 am] BILLING CODE P
    FEDERAL TRADE COMMISSION [File No. 182 3100] ReadyTech Corporation; Analysis To Aid Public Comment AGENCY:

    Federal Trade Commission.

    ACTION:

    Proposed consent agreement.

    SUMMARY:

    The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.

    DATES:

    Comments must be received on or before August 1, 2018.

    ADDRESSES:

    Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write: “ReadyTech Corporation” on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc/readytechconsent by following the instructions on the web-based form. If you prefer to file your comment on paper, write “ReadyTech; File No. 1823100” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580; or deliver your comment to: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024.

    FOR FURTHER INFORMATION CONTACT:

    Monique Einhorn (202-326-2575), Bureau of Consumer Protection, 600 Pennsylvania Avenue NW, Washington, DC 20580.

    SUPPLEMENTARY INFORMATION:

    Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for July 2, 2018), on the World Wide Web, at https://www.ftc.gov/news-events/commission-actions.

    You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before August 1, 2018. Write “ReadyTech; File No. 1823100” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission website, at https://www.ftc.gov/policy/public-comments.

    Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/readytechconsent by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that website.

    If you prefer to file your comment on paper, write “ReadyTech; File No. 1823100” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

    Because your comment will be placed on the publicly accessible FTC website at https://www.ftc.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any sensitive personal information, such as your or anyone else's Social Security number; date of birth; driver's license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “trade secret or any commercial or financial information which . . . is privileged or confidential”—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

    Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on the public FTC website—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from the FTC website, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request.

    Visit the FTC website at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before August 1, 2018. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

    Analysis of Proposed Consent Order To Aid Public Comment

    The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, a consent agreement applicable to ReadyTech Corporation (“ReadyTech”).

    The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.

    This matter concerns alleged false or misleading representations that ReadyTech made to consumers concerning its participation in the Privacy Shield framework agreed upon by the U.S. and the European Union (“EU”). The Privacy Shield framework allows U.S. companies to transfer data outside the EU consistent with EU law. To join the EU-U.S. Privacy Shield framework, a company must self-certify to the U.S. Department of Commerce (“Commerce”) that it complies with a set of principles and related requirements that have been deemed by the European Commission as providing “adequate” privacy protection. These principles include notice; choice; accountability for onward transfer; security; data integrity and purpose limitation; access; and recourse, enforcement, and liability. Commerce maintains a public website, https://www.privacyshield.gov/list, where it posts the names of companies that have self-certified to the EU-U.S. Privacy Shield framework. The listing of companies indicates whether their self-certification is current. Companies are required to re-certify every year in order to retain their status as current members of the EU-U.S. Privacy Shield framework.

    ReadyTech provides online and instructor-led training. According to the Commission's complaint, ReadyTech has set forth on its website, www.readytech.com/policies/privacy-policy/, privacy policies and statements about its practices, including statements related to the status of its participation in the EU-U.S. Privacy Shield framework.

    The Commission's complaint alleges that ReadyTech deceptively represented that it was actively in the process of certifying compliance with the EU-U.S. Privacy Shield framework when, in fact, ReadyTech never completed the necessary steps to finalize its application, and was not certified to participate in the EU-U.S. Privacy Shield framework.

    Part I of the proposed order prohibits ReadyTech from making misrepresentations about its membership in any privacy or security program sponsored by the government or any other self-regulatory or standard-setting organization, including, but not limited to, the EU-U.S. Privacy Shield framework and the Swiss-U.S. Privacy Shield framework.

    Parts II through VI of the proposed order are reporting and compliance provisions. Part II requires acknowledgement of the order and dissemination of the order now and in the future to persons with responsibilities relating to the subject matter of the order. Part III ensures notification to the FTC of changes in corporate status and mandates that ReadyTech submit an initial compliance report to the FTC. Part IV requires ReadyTech to retain documents relating to its compliance with the order for a five-year period.

    Part V mandates that ReadyTech make available to the FTC information or subsequent compliance reports, as requested. Part VI is a provision “sunsetting” the order after twenty (20) years, with certain exceptions.

    The purpose of this analysis is to facilitate public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed complaint or order or to modify the order's terms in any way.

    By direction of the Commission.

    Donald S. Clark, Secretary.
    [FR Doc. 2018-14865 Filed 7-11-18; 8:45 am] BILLING CODE 6750-01-P
    GENERAL SERVICES ADMINISTRATION [OMB Control No. 3090-0080: Docket No. 2018-0001; Sequence No. 3] Submission for OMB Review; General Services Administration Acquisition Regulation; Contract Financing Final Payment (GSA Form 1142 Release of Claims) AGENCY:

    Office of Acquisition Policy, General Services Administration (GSA).

    ACTION:

    Notice of request for public comments regarding an extension to an existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement and the reinstatement of GSA Form 1142, Release of Claims, regarding final payment under construction and building services contract. GSA Contracting Officers have used this form to achieve uniformity and consistency in the release of claims process.

    DATES:

    Submit comments on or before: August 13, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Leah Price, Procurement Analyst, General Services Acquisition Policy Division, GSA, by phone at 202-714-9482 or by email at [email protected]

    ADDRESSES:

    Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching for Information Collection 3090-0080. Select the link “Comment Now” that corresponds with “Information Collection 3090-0080, Contract Financing Final Payment; GSA Form 1142, Release of Claims”. Follow the instructions on the screen. Please include your name, company name (if any), and “Information Collection 3090-0080, Contract Financing Final Payment; GSA Form 1142, Release of Claims” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405. ATTN: Ms. Mandell/IC 3090-0080, Contract Financing Final Payment; GSA Form 1142, Release of Claims.

    Instructions: Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two-to-three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    SUPPLEMENTARY INFORMATION:

    A. Purpose

    The General Services Administration Acquisition Regulation (GSAR) clause 552.232-72 requires construction and building services contractors to submit a release of claims before final payment is made to ensure contractors are paid in accordance with their contract requirements and for work performed. GSA Form 1142, Release of Claims is used to achieve uniformity and consistency in the release of claims process.

    B. Annual Reporting Burden

    Respondents: 7,500.

    Responses per Respondent: 1.

    Annual Responses: 7,500.

    Hours per Response: .10.

    Total Burden Hours: 750.

    C. Public Comments

    A notice published in the Federal Register at 83 FR 13280 on March 28, 2018. No comments were received. Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; and ways to enhance the quality, utility, and clarity of the information to be collected.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 3090-0080, Contract Financing Final Payment; GSA Form 1142, Release of Claims, in all correspondence.

    Dated: July 2, 2018. Jeffrey A. Koses, Director, Office of Acquisition Policy, Office of Government-wide Policy.
    [FR Doc. 2018-14885 Filed 7-11-18; 8:45 am] BILLING CODE 6820-61-P
    GENERAL SERVICES ADMINISTRATION [OMB Control No. 3090-0205; Docket No. 2018-0001; Sequence No. 12] General Services Administration Acquisition Regulation (GSAR); Information Collection; Environmental Conservation, Occupational Safety, and Drug-Free Workplace AGENCY:

    Office of Acquisition Policy, General Services Administration (GSA).

    ACTION:

    Notice of request for comments regarding the extension of a previously existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the General Services Administration will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding Environmental Conservation, Occupational Safety, and Drug-Free Workplace.

    DATES:

    Submit comments on or before: September 10, 2018.

    ADDRESSES:

    Submit comments identified by Information Collection 3090-0205 by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Comment Now” that corresponds with “Information Collection 3090-0205, Environmental Conservation, Occupational Safety, and Drug-Free Workplace”. Follow the instructions provided on the screen. Please include your name, company name (if any), and “Information Collection 3090-0205, Environmental Conservation, Occupational Safety, and Drug-Free Workplace” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405. ATTN: Ms. Mandell/IC 3090-0205, Environmental Conservation, Occupational Safety, and Drug-Free Workplace.

    Instructions: Please submit comments only and cite Information Collection 3090-0205, Environmental Conservation, Occupational Safety, and Drug-Free Workplace, in all correspondence related to this collection. Comments received generally will be posted without change to regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check regulations.gov, approximately two-to-three business days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Ms. Johnnie McDowell, Procurement Analyst, General Services Acquisition Policy Division, GSA, at telephone 202-718-6112, or via email to [email protected]

    SUPPLEMENTARY INFORMATION:

    A. Purpose

    The Federal Hazardous Substance Act and Hazardous Material Transportation Act prescribe standards for packaging of hazardous substances. To meet the requirements of the Acts, the General Services Administration Regulation prescribes provision 552.223-72, Hazardous Material Information, to be inserted in solicitations and contracts that provides for delivery of hazardous materials on a Free On Board (FOB) origin basis.

    This information collection will be accomplished by means of the provision which requires the contractor to identify for each National Stock Number (NSN), the DOT Shipping Name, Department of Transportation (DOT) Hazards Class, and whether the item requires a DOT label. Contracting Officers and technical personnel use the information to monitor and ensure contract requirements based on law and regulation.

    Properly identified and labeled items of hazardous material allows for appropriate handling of such items throughout GSA's supply chain system. The information is used by GSA, stored in an NSN database and provided to GSA customers. Non-Collection and/or a less frequently conducted collection of the information resulting from GSAR provision 552.223-72 would prevent the Government from being properly notified. Government activities may be hindered from apprising their employees of; (1) All hazards to which they may be exposed; (2) Relative symptoms and appropriate emergency treatment; and (3) Proper conditions and precautions for safe use and exposure.

    B. Annual Reporting Burden

    Respondents: 563.

    Responses per Respondent: 3.

    Total Responses: 1689.

    Hours per Response: .67.

    Total Burden Hours: 1111.

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary, whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division, 1800 F Street NW, Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 3090-0205, Environmental Conservation, Occupational Safety, and Drug-Free Workplace, in all correspondence.

    Dated: July 9, 2018. Jeffrey Koses, Senior Procurement Executive, Office of Acquisition Policy, Office of Government-wide Policy.
    [FR Doc. 2018-14937 Filed 7-11-18; 8:45 am] BILLING CODE 6820-61-P
    GENERAL SERVICES ADMINISTRATION [OMB Control No. 3090-0287; Docket No. 2018-0001; Sequence No. 10] Information Collection; Background Investigations for Child Care Workers AGENCY:

    Office of Mission Assurance, General Services Administration (GSA).

    ACTION:

    Notice of request for comments regarding an existing OMB information collection.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a previously approved information collection requirement regarding the collection of personal data for background investigations for child care workers accessing GSA owned and leased controlled facilities

    DATES:

    Submit comments on or before: September 10, 2018.

    ADDRESSES:

    Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally, submit a copy to GSA by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 3090-0287, Background Investigations for Child Care Workers”. Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 3090-0287, Background Investigations for Child Care Workers” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405. ATTN: Ms. Mandell/IC 3090-0287, Background Investigations for Child Care Workers.

    Instructions: Please submit comments only and cite Information Collection 3090-0287, Background Investigations for Child Care Workers, in all correspondence related to this collection. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Mr. Phil Ahn, Security Officer, Office of Mission Assurance, GSA, by telephone at XXX-XXX-XXXX or email [email protected]

    SUPPLEMENTARY INFORMATION:

    A. Purpose

    Homeland Security Presidential Directive (HSPD) 12 “Policy for a Common Identification Standard for Federal Employees and Contractors” requires the implementation of a governmentwide standard for secure and reliable forms of identification for Federal employees and contractors. OMB's implementing instructions requires all contract employees requiring routine access to federally controlled facilities for greater than six (6) months to receive a background investigation. The minimum background investigation is Tier 1 and the Office of Personnel Management offers a Tier 1C for child care.

    However, there is no requirement in the law or HSPD-12 that requires child care employees to be subject to the Tier 1C since employees of child care providers are neither government employees nor government contractors. The child care providers are required to complete the criminal history background checks mandated in the Crime Control Act of 1990, Public Law 101-647, dated November 29, 1990, as amended by Public Law 102-190, dated December 5, 1991. These statutes require that each employee of a child care center located in a Federal building or in leased space must undergo a background check.

    According to GSA policy, child care workers (as described above) will need to submit the following:

    1. An original signed copy of a Basic National Agency Check Criminal History, GSA Form 176; and

    2. Two sets of fingerprints on FBI Fingerprint Cards, for SF-87 and/or electronic prints from an enrollment center.

    3. Electronically submit the e-qip (SF85) application for completion of the Tier 1C.

    This is not a request to collect new information; this is a request to change the form that is currently being used to collect this information.

    B. Annual Reporting Burden

    Respondents: 1,200.

    Responses per Respondent: 1.

    Hours per Response: 1.

    Total Burden Hours: 1,200.

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202-501-4755. Please cite Background Investigations for Child Care Workers, in all correspondence.

    Dated: July 2, 2018. David A. Shive, Chief Information Officer.
    [FR Doc. 2018-14882 Filed 7-11-18; 8:45 am] BILLING CODE 6820-23-P
    GENERAL SERVICES ADMINISTRATION [OMB Control No. 3090-0007; Docket No. 2018-0001; Sequence No. 1] Submission for OMB Review; General Services Administration Acquisition Regulation; Contractor's Qualifications and Financial Information (GSA Form 527) AGENCY:

    Office of Acquisition Policy, General Services Administration (GSA).

    ACTION:

    Notice of request for comments regarding an extension to an existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding Contractor's Qualifications and Financial Information (GSA Form 527).

    DATES:

    Submit comments on or before: August 13, 2018.

    ADDRESSES:

    Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC, 20503. Additionally submit a copy to GSA by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal searching Information Collection 3090-0007. Select the link “Comment Now” that corresponds with “Information Collection 3090-0007, Contractor's Qualifications and Financial Information”. Follow the instructions provided on the screen. Please include your name, company name (if any), and “Information Collection 3090-0007, Contractor's Qualifications and Financial Information” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405. ATTN: Ms. Mandell/IC 3090-0007, Contractor's Qualifications and Financial Information.

    Instructions: Please submit comments only and cite Information Collection 3090-0007, Contractor's Qualifications and Financial Information, in all correspondence related to this collection. Comments received generally will be posted without change to regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check regulations.gov, approximately two-to-three business days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Johnnie McDowell, Policy Analyst, Office of Governmentwide Policy, at 202-718-6112, or via email at [email protected]

    SUPPLEMENTARY INFORMATION:

    A. Purpose

    The General Services Administration will be requesting that OMB extend information collection 3090-0007, concerning GSA Form 527, Contractor's Qualifications and Financial Information. This form is used to determine the financial capability of prospective contractors as to whether they meet the financial responsibility standards in accordance with the Federal Acquisition Regulation (FAR) 9.103(a) and 9.104-1 and also the General Services Administration Acquisition Manual (GSAM) 509.105-1(a).

    B. Annual Reporting Burden

    Respondents: 2,542.

    Responses per Respondent: 1.2.

    Total Responses: 3,050.

    Hours per Response: 1.5.

    Total Burden Hours: 4,575.

    The estimated annual burden has decreased since GSA's 2014 submission from 5,292 to 4,575 burden hours to reflect the continued use of the widespread option for potential contractors to submit financial statements and balance sheets in lieu of completing the applicable fields on GSA Form 527. The alternate submission of financial statements and balance sheets significantly reduces the burden on prospective contractors, as these documents are generally readily available. The average estimated hours to complete a response remained at the optimal rate of 1.5 hours.

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected. A request for public comments was issued in the Federal Register at 83 FR 7184, on February 20, 2018. No comments were received.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202-501-4755.

    Please cite OMB Control No. 3090-0007, Contractor's Qualifications and Financial Information (GSA Form 527), in all correspondence.

    Dated: July 2, 2018. Jeffrey A. Koses, Senior Procurement Executive, Office of Acquisition Policy, Office of Government-wide Policy.
    [FR Doc. 2018-14879 Filed 7-11-18; 8:45 am] BILLING CODE 6820-61-P
    GENERAL SERVICES ADMINISTRATION [OMB Control No. 3090-XXXX; Docket No. 2018-0001; Sequence No. 17] Information Collection; CDP Supply Chain Climate Change Information Request AGENCY:

    Office of Government-Wide Policy (OGP), General Services Administration.

    ACTION:

    Notice of request for comments regarding a new request for an Office of Management and Budget (OMB) clearance.

    SUMMARY:

    The Office of Government-wide Policy, General Services Administration (GSA) will submit a request to the Office of Management and Budget (OMB) for review and clearance for the CDP Supply Chain Climate Change Information Request. As required by the Paperwork Reduction Act of 1995.

    DATES:

    Submit comments on or before September 10, 2018.

    ADDRESSES:

    Submit comments identified by Information Collection 3090-XXXX; CDP Supply Chain Climate Change Information Request, by any of the following methods:

    ADDRESSES:

    Submit comments on this collection by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching for “Information Collection 3090-XXXX; CDP Supply Chain Climate Change Information Request.” Select the link “Submit a Comment” that corresponds with “Information Collection 3090-XXXX; CDP Supply Chain Climate Change Information Request.” Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 3090-XXXX; CDP Supply Chain Climate Change Information Request” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405. ATTN: Ms. Mandell/IC 3090-XXXX; CDP Supply Chain Climate Change Information Request.

    Instructions: Please submit comments only and cite Information Collection 3090-XXXX; CDP Supply Chain Climate Change Information Request, in all correspondence related to this collection. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    SUPPLEMENTARY INFORMATION:

    A. Purpose

    The CDP Supply Chain Climate Change Information Request is an electronic questionnaire designed to collect information pertinent to organizations' exposure to energy market and environmental risks. The questionnaire is administered by CDP North America, Inc., a 501(c)(3) nonprofit organization (“CDP”). CDP administers the questionnaire annually to companies on behalf of over 650 institutional investors and over 100 major purchasing corporations and governmental purchasing organizations. In accordance with 31 U.S. Code § 3512(c)(1)(b), GSA will use the information collected via this questionnaire to inform and develop purchasing policies and contract requirements necessary to safeguard Federal assets against waste, loss, and misappropriation resulting from unmitigated exposure to energy market and environmental risks.

    B. Annual Burden Hours

    Frequency: Annual.

    Affected Public: Federal contractors.

    Number of Respondents: 250.

    Responses per Respondent: 1.

    Total Annual Responses: 250.

    Estimated Time per Respondent: 4.8 hrs.

    Total Burden Hours: 1,210.

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary, whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

    Dated: July 2, 2018. David A. Shive, Chief Information Officer.
    [FR Doc. 2018-14884 Filed 7-11-18; 8:45 am] BILLING CODE 6820-61-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH) AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice of meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, limited only by the space available. The meeting space accommodates approximately 150 people and the audio conference line has 150 ports for callers. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below).

    DATES:

    The meeting will be held on August 22, 2018 from 8:30 a.m. to 5:00 p.m., EDT, and August 23, 2018, 8:30 a.m. to 12:00 p.m., EDT. A public comment session will be held on August 22, 2018 at 5:00 p.m. and conclude at 6:00 p.m. or following the final call for public comment, whichever comes first.

    ADDRESSES:

    Hilton Providence, 21 Atwells Avenue, Providence, RI 02903; Phone: (401)-831-3900, Fax: (401)-274-1562 and audio conference call via FTS Conferencing. The USA toll-free dial-in number is 1-866-659-0537; the pass code is 9933701. Web conference by Skype: meeting CONNECTION: https://webconf.cdc.gov/zab6/yzdq02pl?sl=1.

    FOR FURTHER INFORMATION CONTACT:

    Theodore Katz, MPA, Designated Federal Officer, NIOSH, CDC, 1600 Clifton Road, Mailstop E-20, Atlanta, Georgia 30333, Telephone (513) 533-6800, Toll Free 1 (800) CDC-INFO, Email [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Advisory Board include providing advice on the development of probability of causation guidelines which have been promulgated by the Department of Health and Human Services (HHS) as a final rule, advice on methods of dose reconstruction which have also been promulgated by HHS as a final rule, advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program, and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC.

    The charter was issued on August 3, 2001, renewed at appropriate intervals, rechartered under Executive Order 13811 on February 12, 2018, and will terminate on September 30, 2019.

    Purpose: This Advisory Board is charged with (a) providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advising the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class.

    Matters to be Considered: The agenda will include discussions on the following: NIOSH Program Update; Department of Labor Program Update; Department of Energy Program Update; SEC Petitions Update; possible discussion of a site profile review (dose reconstruction methods for Feed Materials Production Center (Fernald, Ohio); SEC Petitions for: Sandia National Laboratory (Albuquerque, New Mexico), Metals and Controls Corporation (Attleboro, Massachusetts, Idaho National Laboratory (Scoville, Idaho), and DeSoto Facility (Los Angeles, California); continued review of dose reconstruction methods associated with estimating skin doses; and a Board Work Session. Agenda items are subject to change as priorities dictate.

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Sherri A. Berger, Chief Operating Officer, Centers for Disease Control and Prevention.
    [FR Doc. 2018-14929 Filed 7-11-18; 8:45 am] BILLING CODE 4163-19-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee (HICPAC) AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice of meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, limited only by audio phone lines available. The public is also welcome to listen to the meeting by dialing 888-790-3409, passcode: 3250534. A total of 200 lines will be available. To register for this call, please go to www.cdc.gov/hicpac.

    DATES:

    The meeting will be held on August 29, 2018, 3:00 p.m. to 5:00 p.m., EDT.

    ADDRESSES:

    Teleconference Number: 1-888-790-3409, passcode: 3250534.

    FOR FURTHER INFORMATION CONTACT:

    Erin Stone, M.A., HICPAC, Division of Healthcare Quality Promotion, NCEZID, CDC, 1600 Clifton Road NE, Mailstop A-31, Atlanta, Georgia 30333; Telephone (404) 639-4045, Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose: The Committee is charged with providing advice and guidance to the Director, Division of Healthcare Quality Promotion (DHQP), the Director, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), the Director, CDC, the Secretary, Health and Human Services regarding (1) the practice of healthcare infection prevention and control; (2) strategies for surveillance, prevention, and control of infections, antimicrobial resistance, and related events in settings where healthcare is provided; and (3) periodic updating of CDC guidelines and other policy statements regarding prevention of healthcare-associated infections and healthcare-related conditions.

    Matters to be Considered: The agenda will include discussions on updates from the guidelines for infection prevention in healthcare personnel workgroup and the guidelines for infection prevention in patients of neonatal intensive care units workgroup. Agenda items are subject to change as priorities dictate.

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Sherri A. Berger, Chief Operating Officer, Centers for Disease Control and Prevention.
    [FR Doc. 2018-14930 Filed 7-11-18; 8:45 am] BILLING CODE 4163-19-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Notice of Hearing: Reconsideration of Disapproval Washington Medicaid State Plan Amendment (SPA) 17-0027 AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Notice of hearing: Reconsideration of disapproval.

    SUMMARY:

    This notice announces an administrative hearing to be held on August 9, 2018, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid & Children's Health, Seattle Regional Office, 701 Fifth Avenue, Suite 1600, Seattle, WA 98104 to reconsider CMS' decision to disapprove Washington's Medicaid SPA 17-0027.

    DATES:

    Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by July 27, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Benjamin R. Cohen, Presiding Officer, CMS, 2520 Lord Baltimore Drive, Suite L, Baltimore, Maryland 21244, Telephone: (410) 786-3169.

    SUPPLEMENTARY INFORMATION:

    This notice announces an administrative hearing to reconsider CMS' decision to disapprove Washington's Medicaid state plan amendment (SPA) 17-0027, which was submitted to the Centers for Medicare & Medicaid Services (CMS) on August 22, 2017 and disapproved on May 14, 2018. This SPA requested CMS approval to add coverage and reimbursement of services provided by Dental Health Aide Therapists (DHATs) under the Other Licensed Practitioner (OLP) benefit. Specifically, SPA 17-0027 proposed the coverage and reimbursement of services provided by DHATs only when furnished in a practice setting within the boundaries of a tribal reservation and only when operated by an Indian health program, and proposed to make coverage of DHAT services available only to members of a federally recognized tribe or those otherwise eligible for services under Indian Health Service criteria. Washington would, therefore, not permit Medicaid beneficiaries to receive Medicaid coverage for DHAT services if they are not members of a federally recognized tribe or otherwise eligible for services under Indian Health Service criteria.

    The issues to be considered at the hearing are whether Washington SPA 17-0027 is inconsistent with the requirements of:

    • Section 1902(a)(23) of the Social Security Act (the Act) because it would restrict access to services provided by a DHAT to a limited group of beneficiaries, and it would also prevent beneficiaries from receiving DHAT services from similarly qualified dental services providers that provide services outside the boundaries of a tribal reservation or that are not Indian health programs.

    • Section 1902(a)(10)(A) of the Act because it was unclear whether DHATs must be supervised by a licensed professional consistent with the requirements of the OLP benefit, and because CMS was therefore unable to determine whether DHAT services are “medical assistance” consistent with 1902(a)(10)(A) and 1905 of the Act.

    Section 1116 of the Act and federal regulations at 42 CFR part 430 establish Department procedures that provide an administrative hearing for reconsideration of a disapproval of a state plan or plan amendment. CMS is required to publish in the Federal Register a copy of the notice to a state Medicaid agency that informs the agency of the time and place of the hearing, and the issues to be considered. If we subsequently notify the state Medicaid agency of additional issues that will be considered at the hearing, we will also publish that notice in the Federal Register.

    Any individual or group that wants to participate in the hearing as a party must petition the presiding officer within 15 days after publication of this notice, in accordance with the requirements contained at 42 CFR 430.76(b)(2). Any interested person or organization that wants to participate as amicus curiae must petition the presiding officer before the hearing begins in accordance with the requirements contained at 42 CFR 430.76(c). If the hearing is later rescheduled, the presiding officer will notify all participants.

    The notice to Washington announcing an administrative hearing to reconsider the disapproval of its SPA reads as follows:

    Ms. MaryAnne Lindeblad Director State of Washington, Health Care Authority 626 8th Avenue PO Box 45502 Olympia, WA 98504-5050 Dear Ms. Lindeblad:

    I am responding to your June 8, 2018 request for reconsideration of the decision to disapprove Washington's State Plan amendment (SPA) 17-0027. Washington SPA 17-0027 was submitted to the Centers for Medicare & Medicaid Services (CMS) on August 22, 2017, and disapproved on May 14, 2018. I am scheduling a hearing on your request for reconsideration to be held on August 9, 2018, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid & Children's Health, Seattle Regional Office, 701 Fifth Avenue, Suite 1600, Seattle, WA 98104.

    I am designating Mr. Benjamin R. Cohen as the presiding officer. If these arrangements present any problems, please contact Mr. Cohen at (410) 786-3169. In order to facilitate any communication that may be necessary between the parties prior to the hearing, please notify the presiding officer to indicate acceptability of the hearing date that has been scheduled and provide names of the individuals who will represent the State at the hearing. If the hearing date is not acceptable, Mr. Cohen can set another date mutually agreeable to the parties. The hearing will be governed by the procedures prescribed by federal regulations at 42 CFR Part 430.

    This SPA requested CMS approval to add coverage and reimbursement of services provided by Dental Health Aide Therapists (DHATs) under the Other Licensed Practitioner (OLP) benefit. Specifically, SPA 17-0027 proposed the coverage and reimbursement of services provided by DHATs only when furnished in a practice setting within the boundaries of a tribal reservation and only when operated by an Indian health program, and proposed to make coverage of DHAT services available only to members of a federally recognized tribe or those otherwise eligible for services under Indian Health Service criteria. Washington would, therefore, not permit Medicaid beneficiaries to receive Medicaid coverage for DHAT services if they are not members of a federally recognized tribe or otherwise eligible for services under Indian Health Service criteria.

    The issues to be considered at the hearing are whether Washington SPA 17-0027 is inconsistent with the requirements of:

    • Section 1902(a)(23) of the Social Security Act (the Act) because it would restrict access to services provided by a DHAT to a limited group of beneficiaries, and it would also prevent beneficiaries from receiving DHAT services from similarly qualified dental services providers that provide services outside the boundaries of a tribal reservation or that are not Indian health programs.

    • Section 1902(a)(10)(A) of the Act because it was unclear whether DHATs must be supervised by a licensed professional consistent with the requirements of the OLP benefit, and because CMS was therefore unable to determine whether DHAT services are “medical assistance” consistent with 1902(a)(10)(A) and 1905 of the Act.

    In the event that CMS and the State come to agreement on resolution of the issues which formed the basis for disapproval, this SPA may be moved to approval prior to the scheduled hearing.

    Sincerely, Seema Verma Administrator Section 1116 of the Social Security Act (42 U.S.C. section 1316; 42 CFR section 430.18) (Catalog of Federal Domestic Assistance program No. 13.714. Medicaid Assistance Program.)
    Dated: July 6, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services.
    [FR Doc. 2018-14876 Filed 7-6-18; 4:15 pm] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2642] Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Renewal AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; renewal of advisory committee.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the renewal of the Science Advisory Board (the Board) to the National Center for Toxicological Research (NCTR) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Board to the NCTR for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 2, 2020.

    DATES:

    Authority for the Board to the NCTR expired on June 2, 2018; however, the Commissioner formally determined that renewal is in the public interest.

    FOR FURTHER INFORMATION CONTACT:

    Donna L. Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301-796-8892, [email protected]

    SUPPLEMENTARY INFORMATION:

    Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Board to the NCTR. The Board is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Board to the NCTR advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Board advises the NCTR Director in establishing, implementing, and evaluating the research programs that assist the Commissioner in fulfilling regulatory responsibilities. The Board provides an extra-agency review in ensuring that the research programs at NCTR are scientifically sound and pertinent.

    The Board shall consist of a core of nine voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of toxicological research. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this Board serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons.

    Further information regarding the most recent charter and other information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ToxicologicalResearch/ucm148166.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

    This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: July 9, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-14943 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2565] Advisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewal AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; renewal of advisory committee.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the renewal of the Psychopharmacologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Psychopharmacologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 4, 2020.

    DATES:

    Authority for the Psychopharmacologic Drugs Advisory Committee will expire on June 4, 2020, unless the Commissioner formally determines that renewal is in the public interest.

    FOR FURTHER INFORMATION CONTACT:

    Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Psychopharmacologic Drugs Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner.

    The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility.

    The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the practice of psychiatry and related fields and makes appropriate recommendations to the Commissioner.

    The Committee shall consist of a core of nine voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of psychopharmacology, psychiatry, epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests.

    Further information regarding the most recent charter and other information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/default.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

    This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: July 9, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-14934 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2236] Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.” The draft guidance provides recommendations to stakeholders developing human gene therapy (GT) products for retinal disorders affecting adult and pediatric patients. The draft guidance focuses on issues specific to GT products for retinal disorders and provides recommendations related to product development, preclinical testing, and clinical trial design for such GT products.

    DATES:

    Submit either electronic or written comments on the draft guidance by October 10, 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-2236 for “Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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 the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Angela Moy, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft document entitled “Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.” The draft guidance provides recommendations to stakeholders developing GT products for retinal disorders affecting adult and pediatric patients. These disorders vary in etiology, prevalence, diagnosis, and management, and include genetic as well as age-related diseases. These disorders manifest with central or peripheral visual impairment and often with progressive visual loss. The draft guidance focuses on issues specific to GT products for retinal disorders and provides recommendations related to product development, preclinical testing, and clinical trial design for such GT products.

    Elsewhere in this issue of the Federal Register, FDA is announcing the availability of two other human gene therapy draft guidance documents entitled “Human Gene Therapy for Hemophilia; Draft Guidance for Industry” and “Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.”

    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 “Human Gene Therapy for Retinal Disorders.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 50 have been approved under OMB control number 0910-0755; the collections of information in 21 CFR part 58 have been approved under OMB control number 0910-0119; the collections of information in 21 CFR part 211 have been approved under OMB control number 0910-0139; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; the collections of information in the guidance entitled “Expedited Programs for Serious Conditions—Drugs and Biologics” have been approved under OMB control number 0910-0765; and the collections of information in the guidance entitled “Formal Meetings Between the FDA and Sponsors or Applicants” have been approved under OMB control number 0910-0429.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: July 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-14870 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2258] Human Gene Therapy for Rare Diseases; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.” The draft guidance document provides recommendations to stakeholders developing a human gene therapy (GT) product intended to treat a rare disease in adult and/or pediatric patients regarding the manufacturing, preclinical, and clinical trial design issues for all phases of the clinical development program. Such information is intended to assist sponsors in designing clinical development programs for such products, where there may be limited study population size and potential feasibility and safety issues as well as issues relating to the interpretability of bioactivity/efficacy outcomes that may be unique to rare diseases or to the nature of the GT product itself.

    DATES:

    Submit either electronic or written comments on the draft guidance by October 10, 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-2258 for “Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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 the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Background

    The Orphan Drug Act of 1983 (Pub. L. 97-414) defines a rare disease as a disease or condition that affects fewer than 200,000 persons in the United States. Since most rare diseases have no approved therapies, there is a significant unmet need for effective treatments. However, developing safe and effective products to treat rare diseases can be challenging. For example, it may be more difficult to find and recruit such patients into clinical trials, and many rare diseases exhibit a number of variations or subtypes. Consequently, patients may have highly diverse clinical manifestations and rates of disease progression with unpredictable clinical courses. Despite these challenges, GT-related research and development continue to grow at a rapid rate, with several products advancing in clinical development.

    FDA is announcing the availability of a document entitled “Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.” The draft guidance provides recommendations to stakeholders developing a GT product intended to treat a rare disease in adult and/or pediatric patients regarding the manufacturing, preclinical, and clinical trial design issues for all phases of the clinical development program. Such information is intended to assist sponsors in designing clinical development programs for such products, where there may be limited study population size and potential feasibility and safety issues as well as issues relating to the interpretability of bioactivity/efficacy outcomes that may be unique to rare diseases or to the nature of the GT product itself.

    Elsewhere in this issue of the Federal Register, FDA is announcing the availability of two other human gene therapy draft guidance documents entitled “Human Gene Therapy for Hemophilia; Draft Guidance for Industry” and “Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.”

    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 “Human Gene Therapy for Rare Diseases.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 50 have been approved under OMB control number 0910-0755; the collections of information in 21 CFR part 58 have been approved under OMB control number 0910-0119; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; the collections of information in the guidance entitled “Expedited Programs for Serious Conditions—Drugs and Biologics” have been approved under OMB control number 0910-0765; and the collections of information in the guidance entitled “Formal Meetings Between the FDA and Sponsors or Applicants” have been approved under OMB control number 0910-0429.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: July 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-14871 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2180] Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is withdrawing approval of 29 new drug applications (NDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

    DATES:

    Approval is withdrawn as of August 13, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.

    SUPPLEMENTARY INFORMATION:

    The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

    Application No. Drug Applicant NDA 011287 Kayexalate (sodium polystyrene sulfonate) Powder for Suspension, 453.6 gram (g)/bottle Concordia Pharmaceuticals, Inc., c/o Mapi USA, Inc., 2343 Alexandria Dr., Lexington, KY 40504. NDA 012249 Librium (chlordiazepoxide hydrochloride (HCl)) Capsules, 5 milligram (mg), 10 mg, and 25 mg Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. NDA 016211 Miochol (acetylcholine chloride) for Ophthalmic Solution, 20 mg/vial Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ 07936. NDA 018674 Metro I.V. (metronidazole) Injection, 500 mg/100 milliliter (mL) B. Braun Medical, Inc., 901 Marcon Blvd., Allentown, PA 18109. NDA 018852 Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg; 80 mg Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. NDA 018854 Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg; 160 mg Do. NDA 018988 Vasocidin (prednisolone sodium phosphate and sulfacetamide sodium) Ophthalmic Solution, equivalent to (EQ) 0.23% phosphate/10% Novartis Pharmaceuticals Corp. NDA 019844 Isolyte H in Dextrose 5% in Plastic Container Injection B. Braun Medical, Inc. NDA 019870 Isolyte M in Dextrose 5% in Plastic Container Injection Do. NDA 019964 Terazol 3 (terconazole) Vaginal Cream, 0.8% Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., Titusville, NJ 08560. NDA 020000 Dextrose 5% in Ringer's in Plastic Container Injection B. Braun Medical, Inc. NDA 020393 Atrovent (ipratropium bromide) Nasal Spray, 0.021 mg/spray Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368. NDA 020394 Atrovent (ipratropium bromide) Nasal Spray, 0.042 mg/spray Do. NDA 021180 Ortho Evra (ethinyl estradiol; norelgestromin) Transdermal Patch, 0.035 mg/24 h; 0.15 mg/24 h Janssen Pharmaceuticals, Inc., 1000 U.S. Route 202, P.O. Box 300, Raritan, NJ 08869-0602. NDA 021633 Femtrace (estradiol acetate) Tablets, 0.45 mg, 0.9 mg, and 1.8 mg Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC, 2525 Dupont Dr., Irvine, CA 92612. NDA 022033 Luvox CR (fluvoxamine maleate) Extended-Release Capsules, 100 mg and 150 mg Jazz Pharmaceuticals, Inc., 3180 Porter Dr., Palo Alto, CA 94304. NDA 022106 Doribax (doripenem) for Injection, 250 mg/vial and 500 mg/vial Shionogi, Inc., 300 Campus Dr., Florham Park, NJ 07932. NDA 022386 PrandiMet (metformin HCl; repaglinide) Tablets, 500mg; 1 mg and 500 mg; 2 mg Novo Nordisk, Inc., P.O. Box 846, Plainsboro, NJ 08536. NDA 050201 Ophthocort (chloramphenicol, hydrocortisone acetate, polymyxin B sulfate) Ophthalmic Ointment USP, 10 mg/g; 5 mg/g; 10,000 units/g Parkedale Pharmaceuticals, Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017. NDA 050344 Statrol (neomycin sulfate; polymyxin B sulfate) Ophthalmic Ointment, EQ 3.5 mg base/g; 10,000 units/g Alcon Laboratories, Inc., 6201 South Freeway, TC-45, Fort Worth, TX 76134. NDA 050442 Vibramycin (doxycycline hyclate) Injection, EQ to 200 mg base/vial and EQ 100 mg base/vial Pfizer, Inc., 235 East 42nd St., New York, NY 10017. NDA 050497 Ticar (ticarcillin disodium) Injection, EQ 1 g base/vial, EQ 3 g base/vial, EQ 6 g base/vial, EQ 20 g base/vial, and EQ 30 g base/vial GlaxoSmithKline, 1250 Collegeville Rd., Collegeville, PA 19426. NDA 050512 Duricef (cefadroxil monohydrate) USP Capsules, EQ 500 mg base and EQ 250 mg base Warner Chilcott Co., LLC, 100 Enterprise Dr., Rockaway, NJ 07866. NDA 050527 Duricef (cefadroxil monohydrate) USP For Oral Suspension, EQ 125 mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mL Do. NDA 050593 Eryc Sprinkles (erythromycin) Capsules, 125 mg Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045. NDA 050646 Ceptaz (ceftazidime) Injection, 500 mg/vial, 1 g/vial, 2 g/vial, and 10 g/vial GlaxoSmithKline. NDA 050668 Lorabid (loracarbef) Capsules USP, 200 mg and 400 mg King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620. NDA 050792 Cefotaxime and Dextrose 2.4% in Plastic Container, EQ 2 g base, and Cefotaxime and Dextrose 3.9% in Plastic Container, EQ 1 g base B. Braun Medical, Inc. NDA 050807 Epirubicin HCl for Injection, 50 mg/vial, 200 mg/vial Hospira, Inc.

    Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of August 13, 2018. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on August 13, 2018 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.

    Dated: July 9, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-14935 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2018-D-2238] Human Gene Therapy for Hemophilia; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Human Gene Therapy for Hemophilia; Draft Guidance for Industry.” The draft guidance document provides recommendations to stakeholders developing human gene therapy (GT) products for the treatment of hemophilia. The draft guidance provides recommendations on the clinical trial design and related development of coagulation factor VIII (hemophilia A) and IX (hemophilia B) activity assays, including how to address discrepancies in factor VIII and factor IX activity assays. The draft guidance also includes recommendations regarding preclinical considerations to support development of GT products for the treatment of hemophilia.

    DATES:

    Submit either electronic or written comments on the draft guidance by October 10, 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-2238 for “Human Gene Therapy for Hemophilia; Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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 the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Jessica Walker Udechukwu, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft document entitled “Human Gene Therapy for Hemophilia; Draft Guidance for Industry.” The draft guidance document provides recommendations to stakeholders developing GT products for the treatment of hemophilia. The draft guidance provides recommendations on the clinical trial design and related development of coagulation factor VIII (hemophilia A) and IX (hemophilia B) activity assays, including how to address discrepancies in factor VIII and factor IX activity assays. The draft guidance also includes recommendations regarding preclinical considerations to support development of GT products for the treatment of hemophilia. Hemophilia therapy in the United States has progressed from replacement therapies for on-demand treatment of bleeding to prophylaxis to reduce the frequency of bleeding. GT products for hemophilia are being developed as single-dose treatments that may provide long-term expression of the missing or abnormal coagulation factor in the patient at steady levels to reduce or eliminate the need for exogenous factor replacement.

    Elsewhere in this issue of the Federal Register, FDA is announcing the availability of two other human gene therapy draft guidance documents entitled “Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry” and “Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.”

    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 “Human Gene Therapy for Hemophilia.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 58 have been approved under OMB control number 0910-0119; the collections of information in 21 CFR part 211 have been approved under OMB control number 0910-0139; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; the collections of information in the guidance entitled “Expedited Programs for Serious Conditions—Drugs and Biologics” have been approved under OMB control number 0910-0765; and the collections of information in the guidance entitled “Formal Meetings Between the FDA and Sponsors or Applicants” have been approved under OMB control number 0910-0429.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: July 5, 2018. Leslie Kux. Associate Commissioner for Policy.
    [FR Doc. 2018-14875 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0205] Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry.” The draft guidance document provides sponsors of a human gene therapy IND with recommendations regarding CMC information required to assure product safety, identity, quality, purity, and strength (including potency) of the investigational product. The draft guidance applies to human gene therapy products and to combination products that contain a human gene therapy in combination with a drug or device.

    The draft guidance, when finalized, is intended to supersede the document entitled “Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),” dated April 2008 (April 2008 guidance).

    DATES:

    Submit either electronic or written comments on the draft guidance by October 10, 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. Since 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-2008-D-0205 for “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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 the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Gretchen Opper, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft document entitled “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry.” The draft guidance provides sponsors of a human gene therapy IND with recommendations regarding CMC information required to assure product safety, identity, quality, purity, and strength (including potency) of the investigational product (21 CFR 312.23(a)(7)(i)). The draft guidance applies to human gene therapy products and to combination products that contain a human gene therapy in combination with a drug or device. The field of gene therapy has progressed rapidly since FDA issued the April 2008 guidance. Therefore, FDA is updating the guidance to provide current FDA recommendations regarding the CMC content of a gene therapy IND. In addition, the draft guidance is organized to follow the structure of the FDA guidance on the Common Technical Document.

    The draft guidance, when finalized, is intended to supersede the April 2008 guidance. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of two other draft guidances. In a separate document, FDA is announcing the availability of a draft document entitled “Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry” and the availability of a draft document entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry.”

    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 CMC information for human gene therapy INDs. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 211 have been approved under OMB control number 0910-0139; the collections of information in 21 CFR part 312 and Form FDA 1571 have been approved under OMB control number 0910-0014; and the collections of information in 21 CFR part 1271 have been approved under OMB control number 0910-0543.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: July 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-14866 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0081] Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry.” The draft guidance document provides sponsors of retroviral vector-based human gene therapy products recommendations regarding the testing for replication competent retrovirus (RCR) during the manufacture of retroviral vector-based products, and during follow-up monitoring of patients who have received retroviral vector-based products. Recommendations include the identification and amount of material to be tested, and general testing methods. In addition, recommendations are provided on monitoring patients for evidence of retroviral infection after administration of retroviral vector-based gene therapy products. The draft guidance, when finalized, is intended to supersede the document entitled “Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors,” dated November 2006. The draft guidance, when finalized, is also intended to supplement the documents entitled “Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry” and “Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Draft Guidance for Industry,” when these draft guidance documents are finalized.

    DATES:

    Submit either electronic or written comments on the draft guidance by October 10, 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-1999-D-0081 for “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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 the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Melissa Segal, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft document entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry.” The draft guidance document provides sponsors of retroviral vector-based human gene therapy products recommendations regarding the testing for RCR during the manufacture of retroviral vector-based products, and during follow-up monitoring of patients who have received retroviral vector-based products. Recommendations are also provided for RCR testing during manufacture, including identification and amount of material to be tested, and general testing methods. In addition, recommendations are provided on monitoring patients for evidence of retroviral infection after administration of retroviral vector-based gene therapy products. The draft guidance, when finalized, is intended to supersede the document entitled “Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors,” dated November 2006. The draft guidance, when finalized, is also intended to supplement the “Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry” and “Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Draft Guidance for Industry,” when these draft guidance documents are finalized. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of these other two draft guidance documents.

    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 FDA's current thinking on testing of retroviral vector-based human gene therapy products for replication competent retrovirus during product manufacture and patient follow-up. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; and the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: July 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-14868 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2475] Advisory Committee; Allergenic Products Advisory Committee; Renewal AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; renewal of advisory committee.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the renewal of the Allergenic Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Allergenic Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until July 9, 2020.

    DATES:

    Authority for the Allergenic Products Advisory Committee expired on July 9, 2018; however, the Commissioner formally determined that renewal is in the public interest.

    FOR FURTHER INFORMATION CONTACT:

    Serina Hunter-Thomas, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002; 240-402-5771, [email protected]

    SUPPLEMENTARY INFORMATION:

    Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Allergenic Products Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility.

    The Committee reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease, and makes appropriate recommendations to the Commissioner of its findings regarding the affirmation or revocation of biological product licenses; on the safety, effectiveness, and labeling of the products; on clinical and laboratory studies of such products; on amendments or revisions to regulations governing the manufacture, testing, and licensing of allergenic biological products; and on the quality and relevance of FDA's research programs that provide the scientific support for regulating these agents.

    The Committee shall consist of a core of nine voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests.

    Further information regarding the most recent charter and other information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/AllergenicProductsAdvisoryCommittee/ucm129360.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

    This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: July 9, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-14942 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2173] Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry.” The draft guidance provides sponsors, who are developing a human gene therapy (GT) product, recommendations regarding the design of long term follow-up (LTFU) observational studies for the collection of data on delayed adverse events following administration of a GT product. The draft guidance, when finalized, is intended to supersede the document entitled “Guidance for Industry: Gene Therapy Clinical Trials—Observing Participants for Delayed Adverse Events” dated November 2006. This draft guidance, when finalized, is also intended to supplement the guidance entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus during Product Manufacture and Patient Follow-up; Draft Guidance for Industry.”

    DATES:

    Submit either electronic or written comments on the draft guidance by October 10, 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-2173 for “Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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 the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft document entitled “Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry.” The draft guidance provides a brief introduction of the product characteristics, patient-related factors, and the preclinical and clinical data that should be considered when assessing the need for LTFU observations for your GT product. The draft guidance also describes the Agency's current recommendations for the conduct of LTFU studies, specifically the information/data to support a sponsor's rationale for the duration and design of a LTFU protocol when clinical trials are initiated. Also included in the draft guidance are GT product-specific clinical considerations for monitoring subjects under a LTFU protocol and recommendations on patient monitoring for licensed GT products. The draft guidance, when finalized, is intended to supersede the guidance entitled “Guidance for Industry: Gene Therapy Clinical Trials—Observing Participants for Delayed Adverse Events” dated November 2006. The draft guidance, when finalized, is also intended to supplement the guidance entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus during Product Manufacture and Patient Follow-up; Draft Guidance for Industry,” published elsewhere in this issue of the Federal Register. Also, elsewhere in this issue of the Federal Register, FDA is announcing the availability of another draft guidance entitled “Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Draft Guidance for Industry.”

    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 long term follow-up after administration of human gene therapy products. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910-0755; the collections of information in 21 CFR part 58 have been approved under OMB control number 0910-0119; and the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: July 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-14867 Filed 7-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Heritable Disorders in Newborns and Children AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice of meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) will hold a public meeting.

    DATES:

    Thursday, August 2, 2018, from 9:30 a.m. to 5:00 p.m. Eastern Time (ET).

    ADDRESSES:

    This meeting is a webinar only and requires advanced registration. Please register online at http://www.achdncmeetings.org/ by 12:00 p.m. ET on July 30, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Ann Ferrero, Maternal and Child Health Bureau (MCHB), HRSA, in one of three ways: (1) Send a request to the following address: Ann Ferrero, MCHB, HRSA 5600 Fishers Lane, Room 18N100C, Rockville, MD 20857; (2) call 301-443-3999; or (3) send an email to [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: The ACHDNC provides advice and recommendations to the Secretary of HHS on the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. In addition, ACHDNC's recommendations regarding inclusion of additional conditions for screening, following adoption by the Secretary, are evidence-informed preventive health services provided for in the comprehensive guidelines supported by HRSA through the Recommended Uniform Screening Panel (RUSP) pursuant to section 2713 of the Public Health Service Act (42 U.S.C. 300gg-13). Under this provision, non-grandfathered group health plans and health insurance issuers offering group or individual health insurance are required to provide insurance coverage without cost-sharing (a co-payment, co-insurance, or deductible) for preventive services for plan years (i.e., policy years) beginning on or after the date that is one year from the Secretary's adoption of the condition for screening.

    Agenda: During the August 2, 2018, meeting, the ACHDNC will discuss issues related to long-term follow-up, timeliness, education and training, the evidence-based review process, and risk assessment in newborn screening. Information about the ACHDNC, a roster of members, and the meeting agenda, as well as past meeting summaries, is located on the ACHDNC website: https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html.

    Public Participation: Members of the public will have the opportunity to provide comments, which are part of the official Committee record. To submit written comments or request time for an oral comment at the meeting, please register online by 12:00 p.m. ET on July 27, 2018, at http://www.achdncmeetings.org. Oral comments will be honored in the order they are requested and may be limited as time allows. Individuals associated with groups or who plan to provide comments on similar topics may be asked to combine their comments and present them through a single representative. No audiovisual presentations are permitted. Written comments should identify the individual's name, address, email, telephone number, professional or organization affiliation, background or area of expertise (i.e., parent, family member, researcher, clinician, public health, etc.) and the topic/subject matter.

    Amy P. McNulty, Acting Director, Division of the Executive Secretariat.
    [FR Doc. 2018-14908 Filed 7-11-18; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Notice of Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of meetings of the National Center for Advancing Translational Sciences.

    The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

    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 and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Cures Acceleration Network Review Board.

    Date: September 27, 2018.

    Time: 8:30 a.m. to 3:00 p.m.

    Agenda: Report from the Institute Director.

    Place: National Institutes of Health, Building 31, Conference Room 6, 31 Center Drive, Bethesda, MD 20892.

    Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive Secretary, National Center for Advancing Translational Sciences, 1 Democracy Plaza, Room 1072, Bethesda, MD 20892, 301-435-0809, [email protected].

    Name of Committee: National Center for Advancing Translational Sciences Advisory Council.

    Date: September 27, 2018.

    Open: 8:30 a.m. to 3:00 p.m.

    Agenda: Report from the Institute Director and other staff.

    Place: National Institutes of Health, Building 31, Conference Room 6, 31 Center Drive, Bethesda, MD 20892.

    Closed: 3:15 p.m. to 4:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Building 31, Conference Room 6, 31 Center Drive, Bethesda, MD 20892.

    Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive Secretary, National Center for Advancing Translational Sciences, 1 Democracy Plaza, Room 1072, Bethesda, MD 20892, 301-435-0809, [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: July 5, 2018. David D. Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-14873 Filed 7-11-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Integrative Health; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the ZAT1 PJ (02) 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 Complementary and Integrative Health Special Emphasis Panel; Mechanisms of Mind and Body Interventions (MMB).

    Date: August 1, 2018.

    Time: 11:00 a.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 (Virtual Meeting).

    Contact Person: Pamela Eugenia Jeter, Ph.D., Scientific Review Officer, Office of Scientific Review, Division of Extramural Activities, NCCIH, NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, MD 20892, 301-435-2591, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.213, Research and Training in Complementary and Integrative Health, National Institutes of Health, HHS)
    Dated: July 6, 2018. Michelle D. Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-14874 Filed 7-11-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Accreditation and Approval of Saybolt LP (Nederland, TX) as a Commercial Gauger and Laboratory AGENCY:

    U.S. Customs and Border Protection, Department of Homeland Security.

    ACTION:

    Notice of accreditation and approval of Saybolt LP (Nederland, TX) as a commercial gauger and laboratory.

    SUMMARY:

    Notice is hereby given, pursuant to CBP regulations, that Saybolt LP (Nederland, TX) has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of August 8, 2017.

    DATES:

    Saybolt LP (Nederland, TX) was approved and accredited as a commercial gauger and laboratory as of August 8, 2017. The next triennial inspection date will be scheduled for August 2020.

    FOR FURTHER INFORMATION CONTACT:

    Christopher J. Mocella, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW, Suite 1500N, Washington, DC 20229, tel. 202-344-1060.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Saybolt LP, 4144 N Twin City Hwy., Nederland, TX 77627, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Saybolt LP (Nederland, TX) is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):

    API chapters Title 3 Tank gauging. 7 Temperature determination. 8 Sampling. 12 Calculations. 17 Maritime measurement.

    Saybolt LP (Nederland, TX) is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):

    CBPL No. ASTM Title 27-03 D4006 Standard Test Method for Water in Crude Oil by Distillation. 27-05 D4928 Standard Test Method for Water in Crude Oils by Coulometric Karl Fischer Titration. 27-06 D473 Standard Test Method for Sediment in Crude Oils and Fuel Oils by the Extraction Method. 27-13 D4294 Standard Test Method for Sulfur in Petroleum and Petroleum Products by Energy-Dispersive X-ray Fluorescence Spectrometry. 27-48 D4052 Standard Test Method for Density and Relative Density of Liquids by Digital Density Meter. Pending D4007 Standard Test Method for Water and Sediment in Crude Oil by the Centrifuge Method (Laboratory Procedure).

    Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to [email protected] Please reference the website listed below for a complete listing of CBP approved gaugers and accredited laboratories. http://www.cbp.gov/about/labs-scientific/commercial-gaugers-and-laboratories.

    Dated: July 2, 2018. Dave Fluty, Executive Director, Laboratories and Scientific Services.
    [FR Doc. 2018-14918 Filed 7-11-18; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-NPS0025701; PPWOCRADN0-PCU00RP14.R50000] Notice of Intent To Repatriate Cultural Items: Berkshire Museum, Pittsfield, MA AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The Berkshire Museum, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural item listed in this notice meets the definition of sacred object and object of cultural patrimony. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request to the Berkshire Museum. If no additional claimants come forward, transfer of control of the cultural item to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

    DATES:

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request with information in support of the claim to the Berkshire Museum at the address in this notice by August 13, 2018.

    ADDRESSES:

    Jason Vivori, Collections Experience Manager, Berkshire Museum, 39 South Street, Pittsfield, MA 01201, telephone (413) 443-7171 ext. 341, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3005, of the intent to repatriate a cultural item under the control of the Berkshire Museum, Pittsfield, MA, that meets the definitions of sacred objects and objects of cultural patrimony under 25 U.S.C. 3001.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American cultural items. The National Park Service is not responsible for the determinations in this notice.

    History and Description of the Cultural Item

    In 1903, one cultural item was removed from Pine Point in Becker County, MN, by John K. West, an entrepreneur from western Massachusetts, who arrived in Detroit Lakes in 1881 with his wife, Ms. Jessie Campbell West. Both individuals spent considerable time in Detroit Lakes and other areas within Becker County and acquired numerous objects from White Earth Reservation. Shortly after Ms. West's death in January 1903, several objects were sent to Massachusetts and were acquired by the Berkshire Museum. The one sacred object/object of cultural patrimony is described as an “Ojibwa large drum” (#C1992.53) otherwise referred to as a “Big Drum” or “Manidoo Dewe'igan” (meaning “Spirit Drum”).

    The Pine Point community, where this particular drum originated, is within the boundaries of Becker County on the White Earth Reservation. From the creation of the White Earth Reservation in 1867 through the mid-1900s, the people of White Earth existed often under great hardship due to significant economic, cultural, and religious oppression combined with well-documented dispossession of land and other resources. Historically, the Big Drum served an important role in maintaining peace between communities and such drums continue to hold a spiritual and healing role with ceremonies that are still held on the White Earth Reservation. In addition, the ongoing historical and spiritual importance of these drums is that they are central to the White Earth people as a whole and could never have been alienated, appropriated, or conveyed by any individual regardless of whether or not the individual was a member of the tribe. Thomas Vennum wrote in The Ojibwa Dance Drum, “Because song and dance are traditionally considered to be sacred in origin they are for Native Americans a form of prayer . . . and because most song is accompanied by percussion of some sort—drums more often than not—the instruments themselves become sacred through their associations.” This feeling was reaffirmed by the White Earth Band of the Minnesota Chippewa Tribe during consultation with the Berkshire Museum. In a letter dated April 5, 2017, the White Earth Band of the Minnesota Chippewa Tribe requested the return of the Big Drum due to its substantial cultural and religious significance.

    Determinations Made by the Berkshire Museum

    Officials of the Berkshire Museum have determined that:

    • Pursuant to 25 U.S.C. 3001(3)(C), the one cultural item described above is a specific ceremonial object needed by traditional Native American religious leaders for the practice of traditional Native American religions by their present-day adherents.

    • Pursuant to 25 U.S.C. 3001(3)(D), the one cultural item described above has ongoing historical, traditional, or cultural importance central to the Native American group or culture itself, rather than property owned by an individual.

    • Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the sacred object and object of cultural patrimony and the White Earth Band of the Minnesota Chippewa Tribe.

    Additional Requestors and Disposition

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to Jason Vivori, Collections Experience Manager, Berkshire Museum, 39 South Street, Pittsfield, MA 01201, telephone (413) 443-7171 ext. 341, email [email protected], by August 13, 2018. After that date, if no additional claimants have come forward, transfer of control of the sacred object and object of cultural patrimony to the White Earth Band of the Minnesota Chippewa Tribe may proceed.

    The Berkshire Museum is responsible for notifying the White Earth Band of the Minnesota Chippewa Tribe that this notice has been published.

    Dated: June 1, 2018. Melanie O'Brien, Manager, National NAGPRA Program.
    [FR Doc. 2018-14896 Filed 7-11-18; 8:45 am] BILLING CODE 4312-52-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-NPS0025846; PPWOCRADN0-PCU00RP14.R50000] Notice of Inventory Completion: State Historic Preservation Office, Lansing, MI AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The State Historic Preservation Office (SHPO), Michigan State Housing Development Authority, has completed an inventory of human remains and associated funerary objects in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Michigan State Historic Preservation Office. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

    DATES:

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the State Historic Preservation Office at the address in this notice by August 13, 2018.

    ADDRESSES:

    Dean L. Anderson, State Historic Preservation Office, Michigan State Housing Development Authority, 735 East Michigan Avenue, Lansing, MI 48909, telephone: (517) 373-1618, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the State Historic Preservation Office, Lansing, MI. The human remains and associated funerary objects were removed from a highway construction project on US-12, Lenawee County, MI.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.

    Consultation

    A detailed assessment of the human remains was made during 1993-1995 by the former Office of the State Archaeologist (OSA) professional staff and by a physical anthropologist. According to documents held by the SHPO, in 1995 the OSA initiated consultation on the human remains and funerary objects with the Citizen Potawatomi Nation, Oklahoma; Forest County Potawatomi Community, Wisconsin; Hannahville Indian Community, Michigan; Pokagon Band of Potawatomi Indians, Michigan and Indiana; and Prairie Band Potawatomi Nation (previously listed as the Prairie Band of Potawatomi Nation, Kansas).

    History and Description of the Remains

    In the 1920s, human remains representing nine individuals were removed from a highway construction project in Lenawee County, MI. In 1925, the remains were re-interred on the grounds of the Walker Tavern historic site, located a few miles from the highway construction project. The Walker Tavern structure was built around 1832, as a farmhouse, and then became a tavern and inn along the Detroit to Chicago stagecoach route. In 1921, Frederic Hewitt converted the tavern into a museum, and in 1965, the structure was sold to the Michigan Department of Natural Resources. The Parks and Recreation Division of the Michigan Department of Conservation operated the historic site until 1975, when the Michigan Historical Museum, which was part of the Michigan Historical Center (MHC), took responsibility for the Walker Tavern museum and its collections.

    In the mid-1990s, Barbara Mead, Assistant State Archaeologist, did the NAGPRA reporting for the Office of the State Archaeologist (OSA) and for the state museum. At that time, the state museum turned over to Ms. Mead a single cranium and associated funerary objects that she determined had been part of the group of human remains that was re-interred on the grounds of the Walker Tavern site in 1925.

    In 2009, the Department of History, Arts, and Libraries, which included both the OSA and the state museum, was eliminated. The state museum was moved into the Department of Natural Resources, and the OSA was moved into the Michigan State Housing Development Authority. Soon after that, the OSA was eliminated, and the archaeology staff were moved into the SHPO. Consequently, the archaeological collections, including the Walker Tavern materials, are now held by the SHPO.

    The human remains in the Walker Tavern collection include a single cranium with no teeth present and lacking the mandible. The cranium was examined by a physical anthropologist who stated that the individual was approximately 10-15 years of age, and that no determination of sex or ethnic identity of the individual could be made. No known individuals were identified.

    When the state museum assumed responsibility for the Walker Tavern collection in 1975, the cranium was recorded under Michigan Department of Conservation accession number A1253. The state museum assigned catalog number FA-155-75 to the cranium.

    The state museum also cataloged a group of 18 funerary objects associated with the human remains disinterred during road construction in the 1920s. The 18 associated funerary objects are: One pewter spoon, one bottle, one oval stone, one deer mandible, three loose teeth, one lot of fur pieces with tassels wrapped in porcupine quill, one silver armband, one wooden bowl or toy canoe, one lot of wool scraps, one lot of linen scraps, one silver armband, one copper or brass kettle fragment, one iron knife blade, one lot of very small bone chips, one lot of shell and glass beads and one pewter bowl.

    Based on the funerary objects, it is estimated that the original interment of the objects and the human remains took place between approximately 1760 and 1810. A typescript in the MHC Walker Tavern files identified as an article in the Lenawee County Exponent dated November 22, 1923, describes the discovery of Indian graves and artifacts during road construction work in the Irish Hills area. The article mentions some of the same funerary objects described above and associated with the cranium. This assemblage of funerary objects, including trade silver and beads, together with the cranium, represent a Native American interment.

    The inventory that Assistant State Archaeologist Barbara Mead compiled in 1995 included the following information on cultural affiliation: Probably Potawatomi. Early in the eighteenth century, the Potawatomi, Miami, Ottawa, Huron/Wyandotte and Kickapoo were present in southern Michigan. Most of the reports for tribes other than the Potawatomi are from the pre-1720 era. By the 1760s, the Potawatomi territory included Lenawee County; no other tribes seemed to be present, except perhaps as travelers or temporary residents. (Cleland, Charles E., 1992, Rites of Conquest, the University of Michigan Press; Tanner, Helen Hornbeck (ed.), 1987, Atlas of Great Lakes Indian History, University of Oklahoma Press; Trigger, Bruce G. (ed.), 1978, Handbook of North American Indians, Vol. 15: Northeast, Smithsonian Institution).

    Determinations Made by the State Historic Preservation Office

    Officials of the State Historic Preservation Office have determined that:

    • Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.

    • Pursuant to 25 U.S.C. 3001(3)(A), the 18 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.

    • Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and the Citizen Potawatomi Nation, Oklahoma; Forest County Potawatomi Community, Wisconsin; Hannahville Indian Community, Michigan; Pokagon Band of Potawatomi Indians, Michigan and Indiana; and Prairie Band Potawatomi Nation (previously listed as the Prairie Band of Potawatomi Nation, Kansas).

    Additional Requestors and Disposition

    Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Dean L. Anderson, State Historic Preservation Office, Michigan State Housing Development Authority, 735 East Michigan Avenue, P.O. Box 30044, Lansing, MI 48909, telephone (517) 373-1618, email [email protected], by August 13, 2018. After that date, if no additional requestors have come forward, transfer of control of the human remains and associated funerary objects to the Citizen Potawatomi Nation, Oklahoma; Forest County Potawatomi Community, Wisconsin; Hannahville Indian Community, Michigan; Pokagon Band of Potawatomi Indians, Michigan and Indiana; and Prairie Band Potawatomi Nation (previously listed as the Prairie Band of Potawatomi Nation, Kansas) may proceed.

    The State Historic Preservation Office is responsible for notifying the Citizen Potawatomi Nation, Oklahoma; Forest County Potawatomi Community, Wisconsin; Hannahville Indian Community, Michigan; Pokagon Band of Potawatomi Indians, Michigan and Indiana; and Prairie Band Potawatomi Nation (previously listed as the Prairie Band of Potawatomi Nation, Kansas) that this notice has been published.

    Dated: June 21, 2018. Melanie O'Brien, Manager, National NAGPRA Program.
    [FR Doc. 2018-14905 Filed 7-11-18; 8:45 am] BILLING CODE 4312-52-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-NPS0025769; PPWOCRADN0-PCU00RP14.R50000] Notice of Inventory Completion: St. Joseph Museums, Inc., St. Joseph, MO AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The St. Joseph Museum has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the St. Joseph Museum. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

    DATES:

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the St. Joseph Museum at the address in this notice by August 13, 2018.

    ADDRESSES:

    Trevor Tutt, Collections Manager, St. Joseph Museums, Inc., St. Joseph, MO 64506, telephone (816) 232-8471, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the St. Joseph Museums, Inc., St. Joseph, MO. The human remains were removed from Kake, AK.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.

    Consultation

    A detailed assessment of the human remains was made by the St. Joseph Museum professional staff in consultation with representatives of the Organized Village of Kake.

    History and Description of the Remains

    Prior to 1910, human remains representing, at minimum, one individual were removed from Kake, AK. Subsequently, William H. Case transferred these human remains to Harry L. George, who, in turn donated them to the St. Joseph Museum. The human remains—a jaw bone—belonged to a Medicine Man who had died and was buried in a grave house, in accordance with Native custom. When a sickness, attributed to evil spirits, fell upon the village the Medicine Man's bones were thrown in salt water. A white missionary from Kake was said to have retrieved the jaw bone from the Pacific Ocean several years later, accounting for the barnacles found on the teeth. As Russian missionaries first arrived in Kake in the 1790s, the retrieval of the jaw by a white missionary would have occurred between the 1790s and early 1910, when Case photographed it and sent the images to George. George had purchased the jawbone along with a series of ivory buttons and a jade axe head for $30.00 no later than July 14, 1911.

    The Harry George collection was originally meant to be donated to the St. Joseph Museum prior to George's death in 1923, but due to lack of storage space, it was on loan to the Missouri State Museum in Jefferson City until it transferred to the St. Joseph Museum in October 1944. The bulk of the collection was stored in the basement of the St. Joseph City Hall while select items were displayed at the AJ August House, the second location of the St. Joseph Museum. After the St. Joseph Museum received the Wyeth-Tootle Mansion as their main display site in 1946, the vast majority of the items went on display there. That same year, funds were provided for the St. Joseph Museum to purchase the George Collection outright. The human remains in the collection have remained in storage since at least the 1970s. When the St. Joseph Museum, now the St. Joseph Museums, Inc., moved to the Glore Psychiatric Museum in 2004, much of the George Collection was moved as well, including the jaw bone. In 2017, it, and other human remains were returned to storage at the Wyeth-Tootle Mansion for processing under NAGPRA.

    Research into the Harry George Collection, specifically the William H. Case photographs, began around 2017. Zachary Jones, Archivist at the Alaska State Archives, assisted in identifying objects in the collection and initiated consultation with the Organized Village of Kake. Frank Hughes, the NAGPRA Coordinator for the Organized Village of Kake, contacted Trevor Tutt, the Collections Manager for the St. Joseph Museums, Inc., and began correspondence related to items of cultural patrimony and remains related to Kake, Alaska. Through correspondence, the oral tradition of human remains being thrown in salt water in retaliation against a sickness in the village was confirmed. As research indicates that missionary activity in Kake peaked during the 1890s-1910 period, the jaw might have been removed during that two decade span.

    Determinations Made by the St. Joseph Museum

    Officials of the St. Joseph Museum have determined that:

    • Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.

    • Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and the Organized Village of Kake.

    Additional Requestors and Disposition

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Trevor Tutt, Collections Manager, St. Joseph Museums, Inc., St. Joseph, MO 64506, telephone (816) 232-8471, email [email protected], by August 13, 2018. After that date, if no additional requestors have come forward, transfer of control of the human remains to the Organized Village of Kake may proceed.

    The St. Joseph Museum is responsible for notifying the Organized Village of Kake that this notice has been published.

    Dated: June 12, 2018. Melanie O'Brien, Manager, National NAGPRA Program.
    [FR Doc. 2018-14901 Filed 7-11-18; 8:45 am] BILLING CODE 4312-52-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-NPS0025692; PPWOCRADN0-PCU00RP14.R50000] Notice of Inventory Completion: U.S. Department of Agriculture, Tongass National Forest, Juneau Ranger District, Juneau, AK AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The U.S. Department of Agriculture, Tongass National Forest, Juneau Ranger District, (Tongass National Forest) has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of the human remains and associated funerary objects should submit a written request to the Tongass National Forest. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

    DATES:

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the Tongass National Forest at the address in this notice by August 13, 2018.

    ADDRESSES:

    M. Earl Stewart, Forest Supervisor, Tongass National Forest, 648 Mission Street, Ketchikan, AK 99901-6591, telephone (907) 228-6281, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of the human remains and associated funerary objects under the control of the USDA Tongass National Forest, Juneau Ranger District, Juneau, AK. The human remains and associated funerary objects were removed from Entrance Island, near Hobart Bay, AK, on two separate occasions by two separate collectors.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.

    Consultation

    A detailed assessment of the human remains was made by Tongass National Forest archeologists in partnership with the professional staff of the Alaska State Museum and in consultation with representatives of Douglas Indian Association and the Organized Village of Kake.

    History and Description of the Remains

    In the summer of 1961, funerary objects, in several pieces, were removed from a small cave on Entrance Island near Hobart Bay, AK. An individual exploring the island reported that he found a small cave that contained human remains and portions of a bentwood box, as well as some other burial items believed to have been placed there at the time of burial. He collected a basket of a type that reportedly was used to cradle a baby and sometimes was used to bury the deceased. Additional items collected include a piece of leather cordage, a portion of a woven cedar mat, and a piece of wood with evidence of a kerf corner, all of which were connected with either the basket or the bentwood box. The human remains and the bentwood box were not removed from the cave at that time. The individual returned the four burial items to the Tongass National Forest in 2017. Subsequently, it was determined that these funerary objects are associated with the below described human remains and funerary object that were separately collected by a different individual.

    In 1961, the desiccated remains of an infant inside a bentwood box that had been wrapped in a cedar mat were removed from a small burial cave on Entrance Island, near Hobart Bay. In November 1961, these human remains and funerary objects were sent to the Alaska State Museum for curation. Based on oral testimony, this burial site and the above described burial cave are determined to be one and the same. The human remains consist of a single individual, a mummified infant, estimated to be between the ages of 6 and 9 months. Determination of sex or affinity based on skeletal features was not possible. The bentwood box containing the infant's remains was painted and uncarved. It was recovered from beneath the cedar bark mat. When found, the infant had ermine skins tied in its hair.

    The human remains and associated funerary objects are believed to be of pre-contact or first contact date, as after contact, the Christian burial practice of underground internment became widespread. The human remains are reasonably believed to be associated with the Kéex Kwáan, who have traditionally used and occupied the island. The cultural affiliation of the human remains was determined by consulting Haa Aaní Our Land Tlingit and Haida Land Rights and Use, by Walter R. Goldschmidt and Theodore H. Haas, edited by Thomas F. Thorton (1998). Additional cultural affiliation information was provided by the Organized Village of Kake and the Douglas Indian Association. The Kéex Kwáan continue to live in their traditional territory and use the Hobart Bay area. Their present-day descendants are the Organized Village of Kake.

    Determinations Made by the Tongass National Forest

    Officials of the Tongass National Forest have determined that:

    • Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.

    • Pursuant to 25 U.S.C. 3001(3)(A), the seven objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.

    • Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the human remains and associated funerary objects and the Organized Village of Kake.

    Additional Requestors and Disposition

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to M. Earl Stewart, Forest Supervisor, Tongass National Forest, 648 Mission Street, Ketchikan, AK 99901-6591, telephone (907) 228-6281, email [email protected], by August 13, 2018. After that date, if no additional requestors have come forward, transfer of control of the human remains and associated funerary objects to the Organized Village of Kake may proceed.

    The Tongass National Forest is responsible for notifying the Douglas Indian Association and the Organized Village of Kake that this notice has been published.

    Dated: May 31, 2018. Melanie O'Brien, Manager, National NAGPRA Program.
    [FR Doc. 2018-14903 Filed 7-11-18; 8:45 am] BILLING CODE 4312-52-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-NPS0025756; PPWOCRADN0-PCU00RP14.R50000] Notice of Inventory Completion: University of San Diego, San Diego, CA AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The University of San Diego has completed an inventory of human remains in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and any present-day Indian Tribes or Native Hawaiian organizations. Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the University of San Diego. If no additional requestors come forward, transfer of control of the human remains to the Indian Tribes or Native Hawaiian organizations stated in this notice may proceed.

    DATES:

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the University of San Diego, at the address in this notice by August 13, 2018.

    ADDRESSES:

    Derrick R. Cartwright, Ph.D., University of San Diego, 5998 Alcala Park, San Diego, CA 92110, telephone (619) 260-7632, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the University of San Diego, San Diego, CA. The human remains were removed from Squaw Point, near Dove Creek, Delores County, CO.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3) and 43 CFR 10.11(d). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.

    Consultation

    A detailed assessment of the human remains were made by the University of San Diego professional staff in consultation with representatives of the Hopi Tribe of Arizona; Kewa Pueblo, New Mexico (previously listed as the Pueblo of Santo Domingo); Navajo Nation, Arizona, New Mexico & Utah; Ohkay Owingeh, New Mexico (previously listed as the Pueblo of San Juan); Pueblo of Acoma, New Mexico; Pueblo of Cochiti, New Mexico; Pueblo of Isleta, New Mexico; Pueblo of Jemez, New Mexico; Pueblo of Laguna, New Mexico; Pueblo of Nambe, New Mexico; Pueblo of Picuris, New Mexico; Pueblo of Pojoaque, New Mexico; Pueblo of San Felipe, New Mexico; Pueblo of San Ildefonso, New Mexico; Pueblo of Sandia, New Mexico; Pueblo of Santa Ana, New Mexico; Pueblo of Santa Clara, New Mexico; Pueblo of Taos, New Mexico; Pueblo of Tesuque, New Mexico; Pueblo of Zia, New Mexico; Southern Ute Indian Tribe of the Southern Ute Reservation, Colorado; Ute Indian Tribe of the Uintah & Ouray Reservation, Utah; Ute Mountain Ute Tribe (previously listed as the Ute Mountain Tribe of the Ute Mountain Reservation, Colorado, New Mexico & Utah);Ysleta del Sur Pueblo (previously listed as the Ysleta Del Sur Pueblo of Texas); and Zuni Tribe of the Zuni Reservation, New Mexico (hereafter referred to as “The Consulted Tribes”).

    History and Description of the Remains

    At an unknown time, human remains representing, at minimum, one individual were removed from Squaw Point, near Dove Creek, CO. No information regarding the circumstances surrounding the removal is known. Rose Tyson, a physical anthropologist, received the human remains from Dr. Spencer L. Rogers, also a physical anthropologist, and gave them to the Anthropology Department at the University of San Diego in 2002. The human remains—one cranium and mandible—belong to a male and have been cradleboard flattened. Printed in ink on the left side of the cranium is “PII 7/55 Squaw Point near Dove Creek Colorado prop. S. L. Rogers. Dimensions: maximum length 143 mm, maximum width 168 mm.” No known individual was identified. No associated funerary objects are present.

    Determinations Made by the University of San Diego

    Officials of the University of San Diego have determined that:

    • Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.

    • Pursuant to 25 U.S.C. 3001(2), a relationship of shared group identity cannot be reasonably traced between the Native American human remains and any present-day Indian Tribe.

    • Treaties, Acts of Congress, or Executive Orders, indicate that the land from which the Native American human remain was removed is the aboriginal land of the Southern Ute Indian Tribe of the Southern Ute Reservation, Colorado; Ute Indian Tribe of the Uintah & Ouray Reservation, Utah; and the Ute Mountain Ute Tribe (previously listed as the Ute Mountain Tribe of the Ute Mountain Reservation, Colorado, New Mexico & Utah).

    • Pursuant to 43 CFR 10.11(c)(1), the disposition of the human remains may be to the Southern Ute Indian Tribe of the Southern Ute Reservation, Colorado; Ute Indian Tribe of the Uintah & Ouray Reservation, Utah; and the Ute Mountain Ute Tribe (previously listed as the Ute Mountain Tribe of the Ute Mountain Reservation, Colorado, New Mexico & Utah).

    Additional Requestors and Disposition

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Dr. Derrick R. Cartwright, University of San Diego, 5998 Alcala Park, San Diego, CA 92110, telephone (619) 260-7632, email [email protected] by August 13, 2018. After that date, if no additional requestors have come forward, transfer of control of the human remain to the Southern Ute Indian Tribe of the Southern Ute Reservation, Colorado; Ute Indian Tribe of the Uintah & Ouray Reservation, Utah; and the Ute Mountain Ute Tribe (previously listed as the Ute Mountain Tribe of the Ute Mountain Reservation, Colorado, New Mexico & Utah) may proceed.

    The University of San Diego is responsible for notifying The Consulted Tribes that this notice has been published.

    Dated: June 11, 2018. Melanie O'Brien, Manager, National NAGPRA Program.
    [FR Doc. 2018-14899 Filed 7-11-18; 8:45 am] BILLING CODE 4312-52-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-NPS0025845; PPWOCRADN0-PCU00RP14.R50000] Notice of Inventory Completion: Heard Museum, Phoenix, AZ AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The Heard Museum has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Heard Museum. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

    DATES:

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the Heard Museum at the address in this notice by August 13, 2018.

    ADDRESSES:

    David Roche, Director/CEO, Heard Museum, 2301 North Central Avenue, Phoenix, AZ 85004, telephone (602) 252-8840, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the Heard Museum, Phoenix, AZ. The human remains were removed from Camp Verde, Yavapai County, AZ.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.

    Consultation

    A detailed assessment of the human remains was made by the Heard Museum professional staff in consultation with representatives of Cheyenne River Sioux Tribe of the Cheyenne River Reservation, South Dakota; Hopi Tribe of Arizona; Hualapai Indian Tribe of the Hualapai Indian Reservation, Arizona; Three Affiliated Tribes of the Fort Berthold Reservation, North Dakota; Yavapai-Apache Nation of the Camp Verde Indian Reservation, Arizona; Yavapai-Prescott Indian Tribe (previously listed as the Yavapai-Prescott Tribe of the Yavapai Reservation, Arizona); and Zuni Tribe of the Zuni Reservation, New Mexico.

    History and Description of the Remains

    Sometime prior to 1991, human remains representing, at minimum, one individual were removed from Camp Verde in Yavapai County, AZ. The circumstances surrounding the removal are unknown. In 1991, the human remains were in the collection of the Heard Museum and were assigned the catalog number NA-SW-PR-T-1. The human remains are those of an adult. No known individuals were identified. No associated funerary objects are present.

    Based on consultation, the Camp Verde provenience, the type of burial (inhumation), and the presence of copper oxide stains which are often found on burials in the Tuzigoot area (Caywood and Spicer 1935:99-100; Wilcox 1987:128), the Heard Museum has determined that these human remains belong to the Sinagua culture. The Sinagua period was from A.D. 600 to A.D. 1450. The following present-day Indian Tribes descend from the Sinagua culture: Ak-Chin Indian Community (previously listed as the Ak Chin Indian Community of the Maricopa (Ak Chin) Indian Reservation, Arizona); Fort McDowell Yavapai Nation, Arizona; Gila River Indian Community of the Gila River Indian Reservation, Arizona; Havasupai Tribe of the Havasupai Reservation, Arizona; Hopi Tribe of Arizona; Hualapai Indian Tribe of the Hualapai Indian Reservation, Arizona; Salt River Pima-Maricopa Indian Community of the Salt River Reservation, Arizona; Tohono O'odham Nation of Arizona; Yavapai-Apache Nation of the Camp Verde Indian Reservation, Arizona; Yavapai-Prescott Indian Tribe (previously listed as the Yavapai-Prescott Tribe of the Yavapai Reservation, Arizona); and Zuni Tribe of the Zuni Reservation, New Mexico (hereafter referred to as “The Tribes”).

    Determinations Made by the Heard Museum

    Officials of the Heard Museum have determined that:

    • Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.

    • Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and The Tribes.

    Additional Requestors and Disposition

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to David Roche, Director/CEO, Heard Museum, 2301 North Central Avenue, Phoenix, AZ 85004, telephone (602) 252-8840, email [email protected], by August 13, 2018. After that date, if no additional requestors have come forward, transfer of control of the human remains to The Tribes may proceed.

    The Heard Museum is responsible for notifying The Tribes that this notice has been published.

    Dated: June 21, 2018. Melanie O'Brien, Manager, National NAGPRA Program.
    [FR Doc. 2018-14904 Filed 7-11-18; 8:45 am] BILLING CODE 4312-52-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-NPS0025827; PPWOCRADN0-PCU00RP14.R50000] Notice of Intent To Repatriate Cultural Items: U.S. Department of the Interior, National Park Service, Grand Canyon National Park, Grand Canyon, AZ AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The U.S. Department of the Interior, National Park Service, Grand Canyon National Park, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural items listed in this notice meet the definition of unassociated funerary objects. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request to Grand Canyon National Park. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

    DATES:

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to Grand Canyon National Park at the address in this notice by August 13, 2018.

    ADDRESSES:

    Christine Lehnertz, Superintendent, Grand Canyon National Park, P.O. Box 129, Grand Canyon, AZ 86023, telephone (928) 638-7945, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3005, of the intent to repatriate cultural items under the control of Grand Canyon National Park, Grand Canyon, AZ, that meet the definition of unassociated funerary objects under 25 U.S.C. 3001.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the Superintendent, Grand Canyon National Park.

    History and Description of the Cultural Items

    In 1935, three cultural items were removed from GC 62 in Coconino County, AZ, during a vegetation project by the Works Progress Administration and the National Park Service. The three objects were kept by Claude A. Wagner Jr. until 1974 when he donated them to Grand Canyon National Park. The three unassociated funerary objects are one copper bracelet and two metal bells.

    GC 62 is described as a cremation site, about six feet in diameter with evidence of a large fire. No human remains were collected from GC 62. The site is located in an area traditionally used by the Havasupai Tribe and cremation was a Havasupai burial practice. The Havasupai Tribal Council has identified the items as likely coming from a tribal cremation.

    Determinations Made by Grand Canyon National Park

    Officials of Grand Canyon National Park have determined that:

    • Pursuant to 25 U.S.C. 3001(3)(B), the three cultural items described above are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony and are believed, by a preponderance of the evidence, to have been removed from a specific burial site of a Native American individual.

    • Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the unassociated funerary objects and the Havasupai Tribe of the Havasupai Reservation, Arizona.

    Additional Requestors and Disposition

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to Christine Lehnertz, Superintendent, Grand Canyon National Park, P.O. Box 129, Grand Canyon, AZ 86023, telephone (928) 638-7945, email [email protected], by August 13, 2018. After that date, if no additional claimants have come forward, transfer of control of the unassociated funerary objects to the Havasupai Tribe of the Havasupai Reservation, Arizona may proceed.

    Grand Canyon National Park is responsible for notifying the Havasupai Tribe of the Havasupai Reservation, Arizona that this notice has been published.

    Dated: June 18, 2018. Melanie O'Brien, Manager, National NAGPRA Program.
    [FR Doc. 2018-14902 Filed 7-11-18; 8:45 am] BILLING CODE 4312-52-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-NPS0025702; PPWOCRADN0-PCU00RP14.R50000] Notice of Inventory Completion: University of Michigan, Ann Arbor, MI AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The University of Michigan has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the University of Michigan. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

    DATES:

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the University of Michigan at the address in this notice by August 13, 2018.

    ADDRESSES:

    Dr. Ben Secunda, NAGPRA Project Manager, University of Michigan, Office of Research, 4080 Fleming Building, 503 South Thompson Street, Ann Arbor, MI 48109-1340, telephone (734) 647-9085, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the University of Michigan, Ann Arbor, MI. The human remains were removed from the Garry site (20AC19), Arenac County, MI.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.

    Consultation

    A detailed assessment of the human remains was made by the University of Michigan Museum of Anthropological Archaeology (UMMAA) professional staff in consultation with representatives of the Bay Mills Indian Community, Michigan; Chippewa Cree Indians of the Rocky Boy's Reservation, Montana (previously listed as the Chippewa-Cree Indians of the Rocky Boy's Reservation, Montana); Minnesota Chippewa Tribe, Minnesota (Six component reservations: Bois Forte Band (Nett Lake); Fond du Lac Band; Grand Portage Band; Leech Lake Band; Mille Lacs Band; White Earth Band); Saginaw Chippewa Indian Tribe of Michigan; Sault Ste. Marie Tribe of Chippewa Indians, Michigan; and Sokaogon Chippewa Community, Wisconsin (hereafter referred to as “The Consulted Tribes”).

    Requests for consultation were also sent to the Bad River Band of the Lake Superior Tribe of Chippewa Indians of the Bad River Reservation, Wisconsin; Grand Traverse Band of Ottawa and Chippewa Indians, Michigan; Keweenaw Bay Indian Community, Michigan; Lac Courte Oreilles Band of Lake Superior Chippewa Indians of Wisconsin; Lac du Flambeau Band of Lake Superior Chippewa Indians of the Lac du Flambeau Reservation of Wisconsin; Lac Vieux Desert Band of Lake Superior Chippewa Indians of Michigan; Red Cliff Band of Lake Superior Chippewa Indians of Wisconsin; Red Lake Band of Chippewa Indians, Minnesota; St. Croix Chippewa Indians of Wisconsin; and Turtle Mountain Band of Chippewa Indians of North Dakota (hereafter referred to as “The Tribes Invited to Consult”).

    History and Description of the Remains

    In August of 1971, human remains representing, at minimum, one individual were removed from the Garry site (20AC19) in Arenac County, MI. Workers contacted the Michigan State Police after encountering human remains while digging a trench for a water main on private land. The human remains were taken to the State Crime Lab for analysis and subsequently transferred to the UMMAA. After analyzing the human remains, archaeologists from the UMMAA and Indiana State Museum returned to the burial site to excavate the remaining portion of the trench. The individual had been buried in a semi-prone position within a bell-shaped pit. Several Post-Contact Period objects were found in association with the burial but were transferred to the Arenac County Historical Society instead of the UMMAA. The human remains are of one adolescent, indeterminate sex, 17-18 years old. Copper staining is present on the right ulna and radius. Peri-mortem sharp force trauma, possibly from a knife or blade, on some of the human remains may be the cause of death as there is no evidence of healing from this trauma. No known individuals were identified. There are no associated funerary objects under the control of UMMAA.

    The human remains have been determined to be Native American based on burial treatment and diagnostic artifacts. A relationship of shared group identity can be reasonably traced between the Native American human remains from this site and the Chippewa based on multiple lines of evidence. The associated funerary objects noted from the site are typical of the types of goods traded in the region from approximately A.D. 1760 to 1820. Additionally, according to historical records, when the burial occurred, the Chippewa were the predominant tribe in the area. This is further evinced by a treaty creating two Chippewa reservations in the vicinity of the Garry site in 1837.

    Determinations Made by the University of Michigan

    Officials of the University of Michigan have determined that:

    • Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.

    • Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and The Consulted Tribes and The Tribes Invited to Consult.

    Additional Requestors and Disposition

    Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Dr. Ben Secunda, NAGPRA Project Manager, University of Michigan, Office of Research, 4080 Fleming Building, 503 South Thompson Street, Ann Arbor, MI 48109-1340, telephone (734) 647-9085, email [email protected], by August 13, 2018. After that date, if no additional requestors have come forward, transfer of control of the human remains to The Consulted Tribes and The Tribes Invited to Consult may proceed.

    The University of Michigan is responsible for notifying The Consulted Tribes and The Tribes Invited to Consult that this notice has been published.

    Dated: June 1, 2018. Melanie O'Brien, Manager, National NAGPRA Program.
    [FR Doc. 2018-14897 Filed 7-11-18; 8:45 am] BILLING CODE 4312-52-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-NPS0025758; PPWOCRADN0-PCU00RP14.R50000] Notice of Inventory Completion: Museum of Ojibwa Culture and Marquette Mission Park, City of St. Ignace, MI AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The Museum of Ojibwa Culture and Marquette Mission Park, City of St. Ignace, has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and any present-day Indian Tribes or Native Hawaiian organizations. Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Museum of Ojibwa Culture and Marquette Mission Park, City of St. Ignace. If no additional requestors come forward, transfer of control of the human remains to the Indian Tribes or Native Hawaiian organizations stated in this notice may proceed.

    DATES:

    Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the Museum of Ojibwa Culture and Marquette Mission Park, City of St. Ignace at the address in this notice by August 13, 2018.

    ADDRESSES:

    Shirley Sorrels, Director, Museum of Ojibwa Culture and Marquette Mission Park, c/o Bernstein & Associates, 1041 N Lafayette Street, Denver, CO 80218, telephone (303) 894-0648, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the Museum of Ojibwa Culture and Marquette Mission Park, City of St. Ignace. The human remains were removed from Marquette Mission Site (20MK82), Mackinac County, MI.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3) and 43 CFR 10.11(d). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.

    Consultation

    A detailed assessment of the human remains was made by the Museum of Ojibwa Culture and Marquette Mission Park, City of St. Ignace professional staff in consultation with representatives of the Forest County Potawatomi Community, Wisconsin; Little Traverse Bay Bands of Odawa Indians, Michigan; Saginaw Chippewa Indian Tribe of Michigan; and Sault Ste. Marie Tribe of Chippewa Indians, Michigan.

    History and Description of the Remains

    In 1983, 1997, and 2001, (during excavations by Michigan State University archeologists), human remains representing, at minimum, three individuals were removed with faunal remains from the Marquette Mission site (20MK82) in St. Ignace, Mackinac County, MI. After each excavation season, the excavated material were transported to the Michigan State University Museum, where they were curated. In early 2017, during an examination of the faunal remains, three human teeth were identified: A child's worn shovel-shaped maxillary incisor (5810.005.02 box 8), an adult shovel-shaped incisor (5810.169.91.01), and an adult molar (5810.123.03.03). No known individuals were identified. No associated funerary objects are present.

    The archeological site is within Marquette Mission Park. The Museum of Ojibwa Culture and Marquette Mission Park manages the Park. Both the Park and the Museum are under the auspices of the City of St. Ignace. Based on the archaeological context, the human remains date to A.D. 17th century, when Native Americans representing many different cultures, including but not limited to, the Wendat (Huron), Anishinaabek [Ojibwa/Ojibwe (Chippewa), Odawa (Ottawa)], Bodéwadmi (Potawatomi), and Haudenosaunee (Iroquois), lived in proximity to the Marquette Mission site.

    Determinations Made by the Museum of Ojibwa Culture and Marquette Mission Park, City of St. Ignace

    Officials of the Museum of Ojibwa Culture and Marquette Mission Park, City of St. Ignace have determined that:

    • Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice are Native American based on the biological and archeological evidence.

    • Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of three individuals of