Federal Register Vol. 83, No.116,

Federal Register Volume 83, Issue 116 (June 15, 2018)

Page Range27889-28150
FR Document

83_FR_116
Current View
Page and SubjectPDF
83 FR 27981 - Proposed Information Collection Request; Comment Request; Water Quality Standards Regulation (Renewal)PDF
83 FR 27996 - Notice of Intent To Award a Single-Source SupplementPDF
83 FR 28011 - Government in the Sunshine Act Meeting NoticePDF
83 FR 28064 - Oregon International Port of Coos Bay and Coos Bay Rail Line, Inc.-Intra-Corporate Family Transaction ExemptionPDF
83 FR 27938 - Approval and Promulgation of Air Quality Implementation Plans; Arizona; Nonattainment Plan for the Miami SO2PDF
83 FR 27984 - Proposed Information Collection Request; Comment Request; Fuel Use Requirements for Great Lake Steamships (Renewal)PDF
83 FR 27983 - Announcement of the Per- and Polyfluoroalkyl Substances (PFAS) New England Community EngagementPDF
83 FR 27932 - Anchorage Ground; Sabine Pass, TXPDF
83 FR 28012 - Cumulative Report of Rescissions Proposals Pursuant to the Congressional Budget and Impoundment Control Act of 1974PDF
83 FR 27975 - Agency Information Collection Activities: Comment Request; CorrectionPDF
83 FR 27954 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to a Low-Energy Geophysical Survey in the Northwest Atlantic OceanPDF
83 FR 28011 - Citric Acid and Certain Citrate Salts From Thailand; Termination of InvestigationPDF
83 FR 27974 - Procurement List; Addition and DeletionsPDF
83 FR 27972 - Procurement List; Proposed Additions and DeletionsPDF
83 FR 28016 - Aptus Capital Advisors, LLC and ETF Series SolutionsPDF
83 FR 27975 - Defense Intelligence Agency National Intelligence University Board of Visitors; Notice of Federal Advisory Committee MeetingPDF
83 FR 27953 - Large Diameter Welded Pipe From Canada, Greece, India, the People's Republic of China, the Republic of Korea, and the Republic of Turkey: Postponement of Preliminary Determinations in the Less-Than-Fair-Value InvestigationsPDF
83 FR 27949 - Fresh Garlic From the People's Republic of China: Final Results and Partial Rescission of the 22nd Antidumping Duty Administrative Review and Final Result and Rescission, in Part, of the New Shipper Reviews; 2015-2016PDF
83 FR 28006 - Center for Substance Abuse Treatment; Notice of MeetingPDF
83 FR 27936 - Air Plan Approval; Connecticut; Prevention of Significant Deterioration; Revisions to the Prevention of Significant Deterioration Greenhouse Gas Permitting AuthorityPDF
83 FR 27999 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program; Draft Guidance for Industry; AvailabilityPDF
83 FR 27989 - Request for Information From Suppliers Selling on Commercial E-Commerce PortalsPDF
83 FR 27986 - Request for Information From Platform Providers of Commercial e-Commerce PortalsPDF
83 FR 28007 - Agency Information Collection Activities: Proposed Collection; Comment Request; National Flood Insurance Program Call Center and Agent Referral Enrollment FormPDF
83 FR 28008 - Request for Renewal of the Incidental Take Permit and Short-Term Habitat Conservation Plan for Operation and Maintenance of Existing and Limited Future Facilities Associated With the Kauai Island Utility Cooperative on Kauai, HawaiiPDF
83 FR 28006 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Direct Housing Program FormsPDF
83 FR 28011 - Importer of Controlled Substances RegistrationPDF
83 FR 27915 - Suspension of Community EligibilityPDF
83 FR 27953 - Submission for OMB Review; Comment RequestPDF
83 FR 27981 - Western Minnesota Municipal Power Authority; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing ApplicationsPDF
83 FR 27977 - Notice of Application Tendered for Filing With the Commission and Soliciting Additional Study Requests and Establishing Procedural Schedule for Relicensing and a Deadline for Submission of Final Amendments: Aquenergy Systems, LLCPDF
83 FR 27979 - Notice of Request Under Blanket Authorization: Saltville Gas Storage Company, LLCPDF
83 FR 27978 - Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests: Duke Energy Carolinas, LLCPDF
83 FR 27980 - Notice of Effectiveness of Exempt Wholesale Generator and Foreign Utility Company StatusPDF
83 FR 27977 - Pine Prairie Energy Center, LLC; Notice of ApplicationPDF
83 FR 27980 - Combined Notice of Filings #1PDF
83 FR 27922 - Standards of Conduct and Referral of Known or Suspected Criminal Violations; Standards of ConductPDF
83 FR 27891 - Airworthiness Directives; Engine Alliance Turbofan EnginesPDF
83 FR 28058 - Privacy Act of 1974; System of RecordsPDF
83 FR 28062 - Privacy Act of 1974; System of RecordsPDF
83 FR 27894 - The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry; AvailabilityPDF
83 FR 28012 - Submission for OMB Review, Comment Request, Proposed Collection: IMLS Inspire! Grants for Small Museums (IGSM) Notice of Funding OpportunityPDF
83 FR 28003 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
83 FR 28005 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
83 FR 27899 - Safety Zone; Appomattox River, Hopewell, VAPDF
83 FR 28012 - Notice of Lodging of Proposed Consent Decree Under the Clean Air ActPDF
83 FR 27983 - Environmental Impact Statements; Notice of AvailabilityPDF
83 FR 27949 - Submission for OMB Review; Comment RequestPDF
83 FR 27933 - Production or Disclosure of Material or InformationPDF
83 FR 27975 - Charter Renewal of Department of Defense Federal Advisory CommitteesPDF
83 FR 28045 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Security Futures Risk Disclosure Statement To Reflect the T+2 Settlement Cycle, Incorporate Prior Supplements, and Make Other Non-Substantive ChangesPDF
83 FR 28018 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Proposed Rule Change, as Modified by Amendment No. 1, Related to The Options Clearing Corporation's Stress Testing and Clearing Fund MethodologyPDF
83 FR 28039 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Descriptions of Certain Data Feeds Within the Nasdaq Options MarketPDF
83 FR 28048 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Its Price List Related to Co-Location Services in Connection With the Re-Launch of Trading on NYSE National, Inc. and Proposed NYSE National Co-Location ServicesPDF
83 FR 28053 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE Arca Options Fees and Charges and the NYSE Arca Equities Fees and Charges Related to Co-Location Services in Connection With the Re-Launch of Trading on NYSE National, Inc. and Proposed NYSE National Co-Location ServicesPDF
83 FR 28041 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Change To Amend the NYSE American Equities Price List and the NYSE American Options Fee Schedule Related to Co-Location Services in Connection With the Re-Launch of Trading on NYSE National, Inc. and Proposed NYSE National Co-Location ServicesPDF
83 FR 27976 - Submission for OMB Review; Comment RequestPDF
83 FR 28149 - Federal Acquisition Regulation: Federal Acquisition Circular 2005-99; Small Entity Compliance GuidePDF
83 FR 28145 - Federal Acquisition Regulation: Violations of Arms Control Treaties or Agreements With the United StatesPDF
83 FR 28141 - Federal Acquisition Regulation; Use of Products and Services of Kaspersky LabPDF
83 FR 28013 - Investigative HearingPDF
83 FR 28140 - Federal Acquisition Regulation: Federal Acquisition Circular 2005-99; IntroductionPDF
83 FR 28016 - Inbound Parcel Post (at UPU Rates)PDF
83 FR 27912 - Medicare Program; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; CorrectionPDF
83 FR 28014 - Westinghouse Electric Company, LLC; Columbia Fuel Fabrication FacilityPDF
83 FR 27992 - Medicare and Medicaid Programs: Application From the Community Health Accreditation Partner for Continued CMS Approval of Its Hospice Accreditation ProgramPDF
83 FR 28001 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 28002 - Prospective Grant of Exclusive Patent Commercialization License: Streptococcus Pneumonia PSAA Peptide for Treatment of Sepsis and InfectionPDF
83 FR 28003 - National Cancer Institute; Amended Notice of MeetingPDF
83 FR 27985 - Family Voice Communications, LLC, Application for Renewal of License of FM Radio Station KLSX(FM), Rozet, WYPDF
83 FR 27976 - Notice of Availability of Government-Owned Inventions; Available for LicensingPDF
83 FR 27993 - Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-August 22, 2018PDF
83 FR 27889 - Airworthiness Directives; Pratt & Whitney Division Turbofan EnginesPDF
83 FR 27895 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue RemovalPDF
83 FR 28015 - New Postal ProductsPDF
83 FR 27918 - Importation of Fresh Avocado Fruit From Continental Ecuador Into the Continental United StatesPDF
83 FR 27995 - Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Councils on Developmental Disabilities-Annual Program Performance Report (PPR) (OMB Control Number-0985-0033)PDF
83 FR 27998 - Coronary, Peripheral, and Neurovascular Guidewires-Performance Tests and Recommended Labeling; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
83 FR 27996 - Intravascular Catheters, Wires, and Delivery Systems With Lubricious Coatings-Labeling Considerations; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
83 FR 27992 - Final National Occupational Research Agenda for Agriculture, Forestry, and FishingPDF
83 FR 27910 - Air Plan Approval; Wisconsin; Regional Haze Progress ReportPDF
83 FR 27937 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Removal of Department of Environmental Protection Gasoline Volatility Requirements for the Pittsburgh-Beaver Valley AreaPDF
83 FR 27901 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Removal of Department of Environmental Protection Gasoline Volatility Requirements for the Pittsburgh-Beaver Valley AreaPDF
83 FR 27898 - Allocation of Assets in Single-Employer Plans; Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Valuing and Paying BenefitsPDF
83 FR 28068 - Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Commercial and Industrial Solid Waste Incineration Units; Technical AmendmentsPDF

Issue

83 116 Friday, June 15, 2018 Contents Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 27949 2018-12860
Animal Animal and Plant Health Inspection Service PROPOSED RULES Importation of Fresh Avocado Fruit from Continental Ecuador Into the Continental United States, 27918-27922 2018-12827 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 27975 2018-12908 Centers Disease Centers for Disease Control and Prevention NOTICES Final National Occupational Research Agenda for Agriculture, Forestry, and Fishing, 27992 2018-12821 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare Program: Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; Correction, 27912-27915 2018-12843 NOTICES Medicare and Medicaid Programs: Application from the Community Health Accreditation Partner for Continued CMS Approval of its Hospice Accreditation Program, 27992-27993 2018-12840 Meetings: Medicare Evidence Development and Coverage Advisory Committee, 27993-27995 2018-12831 Coast Guard Coast Guard RULES Safety Zones: Appomattox River, Hopewell, VA, 27899-27901 2018-12863 PROPOSED RULES Anchorage Ground: Sabine Pass, TX, 27932-27933 2018-12910 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 27972-27975 2018-12903 2018-12904 Community Living Administration Community Living Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 27995-27996 2018-12826 Award of a Single-Source Supplement: National Limb Loss Resource Center, 27996 2018-12978 Defense Department Defense Department See

Navy Department

RULES Federal Acquisition Regulations: Federal Acquisition Circular 2005-99; Introduction, 28140 2018-12845 Federal Acquisition Circular 2005-99; Small Entity Compliance Guide, 28149-28150 2018-12849 Use of Products and Services of Kaspersky Lab, 28141-28145 2018-12847 Violations of Arms Control Treaties or Agreements with the United States, 28145-28149 2018-12848 NOTICES Charter Renewals: Federal Advisory Committees, 27975-27976 2018-12857 Meetings: Defense Intelligence Agency National Intelligence University Board of Visitors, 27975 2018-12901
Drug Drug Enforcement Administration NOTICES Importers of Controlled Substances; Registrations, 28011-28012 2018-12884 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Pennsylvania; Removal of Department of Environmental Protection Gasoline Volatility Requirements for the Pittsburgh-Beaver Valley Area, 27901-27909 2018-12703 Wisconsin; Regional Haze Progress Report, 27910-27912 2018-12810 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Arizona; Nonattainment Plan for the Miami SO2 Nonattainment Area, 27938-27948 2018-12913 Connecticut; Prevention of Significant Deterioration; Revisions to the Prevention of Significant Deterioration Greenhouse Gas Permitting Authority, 27936-27937 2018-12896 Pennsylvania; Removal of Department of Environmental Protection Gasoline Volatility Requirements for the Pittsburgh-Beaver Valley Area, 27937-27938 2018-12704 Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Commercial and Industrial Solid Waste Incineration Units; Technical Amendments, 28068-28137 2018-12164 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Fuel Use Requirements for Great Lake Steamships, 27984 2018-12912 Water Quality Standards Regulation, 27981-27983 2018-13027 Environmental Impact Statements; Availability, etc., 27983-27984 2018-12861 Per- and Polyfluoroalkyl Substances New England Community Engagement, 27983 2018-12911 Farm Credit Farm Credit Administration PROPOSED RULES Standards of Conduct and Referral of Known or Suspected Criminal Violations; Standards of Conduct, 27922-27932 2018-12874 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Engine Alliance Turbofan Engines, 27891-27894 2018-12873 Pratt and Whitney Division Turbofan Engines, 27889-27891 2018-12830 Federal Communications Federal Communications Commission NOTICES License Renewals; Applications: Family Voice Communications, LLC; FM Radio Station KLSX(FM), Rozet, WY, 27985-27986 2018-12835 Federal Emergency Federal Emergency Management Agency RULES Suspension of Community Eligibility, 27915-27917 2018-12883 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Direct Housing Program Forms, 28006-28007 2018-12888 National Flood Insurance Program Call Center and Agent Referral Enrollment Form, 28007-28008 2018-12890 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Aquenergy Systems, LLC, 27977-27978 2018-12880 Duke Energy Carolinas, LLC, 27978-27979 2018-12878 Pine Prairie Energy Center, LLC, 27977 2018-12876 Combined Filings, 27980 2018-12875 Effectiveness of Exempt Wholesale Generator Status: Midway Wind, LLC; Victoria City Power LLC; Victoria Port Power LLC; et al., 27980-27981 2018-12877 Preliminary Permit Applications: Western Minnesota Municipal Power Authority, 27981 2018-12881 Requests under Blanket Authorizations: Saltville Gas Storage Company, LLC, 27979-27980 2018-12879 Fish Fish and Wildlife Service NOTICES Renewal of Incidental Take Permit and Short-Term Habitat Conservation Plan: Operation and Maintenance of Existing and Limited Future Facilities associated with the Kauai Island Utility Cooperative on Kauai, Hawaii, 28008-28011 2018-12889 Food and Drug Food and Drug Administration RULES Guidance: Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels, 27894-27895 2018-12867 Medical Devices: Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal, 27895-27898 2018-12829 NOTICES Guidance: Coronary, Peripheral, and Neurovascular Guidewires—Performance Tests and Recommended Labeling, 27998-27999 2018-12825 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, 27999-28001 2018-12894 Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations, 27996-27998 2018-12824 General Services General Services Administration RULES Federal Acquisition Regulations: Federal Acquisition Circular 2005-99; Introduction, 28140 2018-12845 Federal Acquisition Circular 2005-99; Small Entity Compliance Guide, 28149-28150 2018-12849 Use of Products and Services of Kaspersky Lab, 28141-28145 2018-12847 Violations of Arms Control Treaties or Agreements with the United States, 28145-28149 2018-12848 NOTICES Requests for Information: Platform Providers of Commercial e-Commerce Portals, 27986-27989 2018-12891 Suppliers Selling on Commercial e-Commerce Portals, 27989-27991 2018-12893 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Community Living Administration

See

Food and Drug Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

Institute of Museum and Library Services Institute of Museum and Library Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: IMLS Inspire! Grants for Small Museums Notice of Funding Opportunity, 28012-28013 2018-12866 Interior Interior Department See

Fish and Wildlife Service

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Fresh Garlic from the People's Republic of China, 27949-27952 2018-12898 Determinations of Sale at Less than Fair Value: Large Diameter Welded Pipe from Canada, Greece, India, the People's Republic of China, the Republic of Korea, and the Republic of Turkey, 27953 2018-12899 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Citric Acid and Certain Citrate Salts from Thailand, 28011 2018-12905 Meetings; Sunshine Act, 28011 2018-12973 Justice Department Justice Department See

Drug Enforcement Administration

NOTICES Proposed Consent Decrees under the Clean Air Act, 28012 2018-12862
Management Management and Budget Office NOTICES Cumulative Report of Rescissions Proposals Pursuant to the Congressional Budget and Impoundment Control Act, 28012 2018-12909 NASA National Aeronautics and Space Administration RULES Federal Acquisition Regulations: Federal Acquisition Circular 2005-99; Introduction, 28140 2018-12845 Federal Acquisition Circular 2005-99; Small Entity Compliance Guide, 28149-28150 2018-12849 Use of Products and Services of Kaspersky Lab, 28141-28145 2018-12847 Violations of Arms Control Treaties or Agreements with the United States, 28145-28149 2018-12848 National Foundation National Foundation on the Arts and the Humanities See

Institute of Museum and Library Services

National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 28001-28002 2018-12836 2018-12839 National Cancer Institute, 28003 2018-12837 Prospective Grant of Exclusive Patent Commercialization License: Streptococcus Pneumonia PSAA Peptide for Treatment of Sepsis and Infection, 28002-28003 2018-12838 National Oceanic National Oceanic and Atmospheric Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 27953-27954 2018-12882 Takes of Marine Mammals Incidental to Specified Activities: Low-Energy Geophysical Survey in the Northwest Atlantic Ocean, 27954-27972 2018-12907 National Transportation National Transportation Safety Board NOTICES Investigative Hearing, 28013-28014 2018-12846 Navy Navy Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 27976 2018-12850 Availability of Government-Owned Inventions; Available for Licensing, 27976 2018-12834 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Environmental Assessments; Availability, etc.: Westinghouse Electric Company, LLC, Columbia Fuel Fabrication Facility, 28014-28015 2018-12841 Pension Benefit Pension Benefit Guaranty Corporation RULES Allocation of Assets in Single-Employer Plans: Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Valuing and Paying Benefits, 27898-27899 2018-12549 Postal Regulatory Postal Regulatory Commission NOTICES Inbound Parcel Post (at UPU Rates), 28016 2018-12844 New Postal Products, 28015-28016 2018-12828 Postal Service Postal Service PROPOSED RULES Production or Disclosure of Material or Information, 27933-27936 2018-12858 Securities Securities and Exchange Commission NOTICES Applications: Aptus Capital Advisors, LLC and ETF Series Solutions, 28016-28018 2018-12902 Self-Regulatory Organizations; Proposed Rule Changes: Financial Industry Regulatory Authority, Inc., 28045-28048 2018-12856 New York Stock Exchange, LLC, 28048-28052 2018-12853 NYSE American, LLC, 28041-28045 2018-12851 NYSE Arca, Inc., 28053-28057 2018-12852 The Nasdaq Stock Market, LLC, 28039-28041 2018-12854 The Options Clearing Corp., 28018-28039 2018-12855 State Department State Department NOTICES Privacy Act; Systems of Records, 28058-28064 2018-12871 2018-12872 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 28003-28006 2018-12864 2018-12865 Meetings: Center for Substance Abuse Treatment, 28006 2018-12897 Surface Transportation Surface Transportation Board NOTICES Intra-Corporate Family Transaction Exemptions: Oregon International Port of Coos Bay and Coos Bay Rail Line, Inc., 28064-28065 2018-12914 Transportation Department Transportation Department See

Federal Aviation Administration

Separate Parts In This Issue Part II Environmental Protection Agency, 28068-28137 2018-12164 Part III Defense Department, 28140-28150 2018-12845 2018-12849 2018-12847 2018-12848 General Services Administration, 28140-28150 2018-12845 2018-12849 2018-12847 2018-12848 National Aeronautics and Space Administration, 28140-28150 2018-12845 2018-12849 2018-12847 2018-12848 Reader Aids

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83 116 Friday, June 15, 2018 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-0817; Product Identifier 2017-NE-30-AD; Amendment 39-19314; AD 2018-13-02] RIN 2120-AA64 Airworthiness Directives; Pratt & Whitney Division Turbofan Engines AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for all Pratt & Whitney Division (PW) PW4052, PW4056, PW4060, PW4062, PW4062A, PW4152, PW4156A, PW4158, PW4460, and PW4462 turbofan engine models, including engines identified with suffixes -1C, -1E, -3, -3A, or -3B. This AD was prompted by the discovery of multiple cracked 4th stage low-pressure turbine (LPT) air seals in the fleet. This AD requires removal from service of certain 4th stage LPT air seals. We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD is effective July 20, 2018.

ADDRESSES:

For service information identified in this final rule, contact Pratt & Whitney Division, 400 Main St., East Hartford, CT 06118; phone: 800-565-0140; fax: 860-565-5442. You may view this service information at the FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA 01803. 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-2017-0817.

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-2017-0817; 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 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:

Jo-Ann Theriault, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7105; fax: 781-238-7199; 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 all Pratt & Whitney Division (PW) PW4052, PW4056, PW4060, PW4062, PW4062A, PW4152, PW4156A, PW4158, PW4460, and PW4462 turbofan engine models, including engines identified with suffixes -1C, -1E, -3, -3A, or -3B. The NPRM published in the Federal Register on October 12, 2017 (82 FR 47405). The NPRM was prompted by the discovery of multiple cracked 4th stage LPT air seals, part number (P/N) 50N346, in the fleet. An investigation determined there is insufficient clearance to the 4th stage LPT vane cluster honeycomb that makes up the other half of the sealing system. Also, the knife edge seals are uncoated so they are more susceptible to overheating if a hard rub with the honeycomb occurs. The NPRM proposed to require the removal from service of certain 4th stage LPT air seals. Replacement of the air seal also requires replacement of the 4th stage LPT vane cluster honeycomb. This condition, if not corrected, could result in failure of the air seal, uncontained air seal release, damage to the engine, and damage to the airplane. 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 Clarify Compliance Time

United Parcel Service, United Airlines, SR Technics, Delta Airlines (DAL), Atlas Air, Federal Express (FedEx), and the Boeing Company requested that we clarify the compliance time requirement specified in the NPRM, paragraph (f)(1), which stated “at the next disassembly of the LPT module, remove 4th stage air seal, P/N 50N346, from service and replace with a part eligible for installation” because the term “disassembly” is subjective and not defined elsewhere in the NPRM. DAL requested that we specify a compliance time in the final rule since paragraph (f)(1) of the NPRM indicates that the compliance actions should be done in accordance with the compliance times specified in the AD.

We agree. We clarified that the compliance in this AD should be performed “the next time the 4th stage LPT vanes are removed from the LPT module.”

Request for Clarification on Installation Prohibition

DAL requested clarification on the acceptability of returning an LPT to service with P/N 50N346 installed if the air seal was not exposed at the piece-part level, because the LPT disassembly was limited.

An LPT module with a 4th stage air seal, P/N 50N346, installed, may be returned to service, if the 4th stage LPT vanes are not removed. However, replacement of the 4th stage air seal is required, when the 4th stage LPT vanes are removed. This would include, if the 4th stage LPT air seal was at the piece-part exposure level.

Request for Clarification on Replacement of Affected Air Seals

Cathay Pacific Airways (CPA) asked if replacing the 4th stage LPT air seal, P/N 50N346, with any of the other 4th stage LPT air seals depicted in the Illustrated Parts Catalog (IPC) fulfills the AD requirement or if P/N 51N113 is the only suitable air seal for replacement. CPA further requested that we define what is “a part eligible for installation” in paragraph (f)(1) of the NPRM which states “at the next disassembly of the LPT module, remove 4th stage air seal, P/N 50N346, from service and replace with a part eligible for installation.”

Currently, P/N 51N113 is the only 4th stage LPT air seal suitable for P/N 50N346 replacement. However, new replacement air seals may be developed in the future. We did not change this AD.

Service Bulletin Comment

CPA stated that PW Service Bulletin (SB) PW4ENG A72-830, Revision No. 1, dated May 2, 2017, listed P/N 51N113 as the only part eligible for installation. However, the service bulletin is not clearly listed in paragraph (f) of the NPRM.

We disagree. We listed PW SB PW4ENG A72-830, Revision No. 1, dated May 2, 2017, in the “Related Service Information” section of the NPRM, which was the appropriate paragraph. We did not change this AD.

Request for Clarification on Applicability of AD

Atlas Air asked if the AD applies to engines with 4th stage LPT air seals, P/N 51N038, 50N478, or 50N478-001, installed.

We determined this AD only applies to engines with 4th stage LPT air seal, P/N 50N346, installed.

Request for Clarification on Repair Limits

Atlas Air asked if PW Clean, Inspect, Repair (CIR) 72-53-40 Inspection/Check-03 limits apply to the 4th stage LPT air seal, P/N 51N113. If so, Atlas Air is concerned that the reduced knife edge might get scrapped due to reduced diameters.

The intent of this AD is to install a 4th stage LPT air seal with reduced knife edge diameters. This AD does not impact the CIR 72-53-40 Inspection/Check-03 limits.

Request for Clarification on Re-Installation Prohibition

Atlas Air asked if 4th stage LPT air seals, P/N 51N038, 50N478, or 50N478-001 are prohibited from re-installation.

We determined that 4th stage LPT air seals, P/N 51N038, 50N478, and 50N478-001, are not applicable to the engines affected by this AD.

Request for Clarification on Effective Date

SR Technics asked when this AD will become effective.

This AD will be effective 35 days after publication in the Federal Register.

Request for Clarification on Part Modification

PW stated that the new part can be obtained by modification of the old part as specified in PW SB PW4ENG A72-830, Revision No. 1, dated May 2, 2017.

We agree. The new 4th stage LPT air seal, P/N 51N113, can be obtained through modification of the old air seal, P/N 50N346, as noted in PW SB PW4ENG A72-830, Revision No. 1, dated May 2, 2017.

Request for Clarification on Honeycomb Replacement

DAL and FedEx note that the NPRM states “Replacement of the air seal also requires replacement of the 4th stage LPT vane cluster honeycomb” in the “Discussion” paragraph. However, paragraph (f) in the NPRM does not address honeycomb replacement. The commenters asked if the FAA intends to require the replacement of the honeycomb.

This AD addresses the unsafe condition created by a cracked 4th stage LPT air seal by replacing the air seal with a part that does not crack. Installation of the new air seal without replacement of the 4th stage LPT vane cluster honeycomb results in an increased radial clearance between the honeycomb and air seals. This is not an approved configuration. Requirements for replacement of the honeycomb when an air seal is replaced are defined in the appropriate service information, such as PW CIR Manual P/N 51A357, Chapter/Section 72-53-24, Repair-02. We did not change this AD.

Supportive Comment

The Air Line Pilots Association International expressed support for this AD.

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 and for minor editorial changes. We have determined that these minor changes:

• Are 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 PW SB PW4ENG A72-830, Revision No. 1, dated May 02, 2017. The SB describes procedures for replacement or modification of the 4th stage LPT air seals.

Costs of Compliance

We estimate that this AD affects 991 engines installed on aircraft 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
  • Replacement of air seal 0 work-hours × $85 per hour = $0 $13,800 $13,800 $13,675,800
    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): 2018-13-02 Pratt & Whitney Division: Amendment 39-19314; Docket No. FAA-2017-0817; Product Identifier 2017-NE-30-AD. (a) Effective Date

    This AD is effective July 20, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all Pratt & Whitney Division (PW) PW4052, PW4056, PW4060, PW4062, PW4062A, PW4152, PW4156A, PW4158, PW4460, and PW4462 turbofan engine models, including engines identified with suffixes -1C, -1E, -3, -3A, or -3B, with 4th stage low-pressure turbine (LPT) air seal, part number (P/N) 50N346, installed.

    (d) Subject

    Joint Aircraft System Component (JASC) Code 7240, Turbine Engine Combustion Section.

    (e) Unsafe Condition

    This AD was prompted by the discovery of multiple cracked air seals. We are issuing this AD to prevent failure of the 4th stage LPT air seal. This unsafe condition, if not addressed, could result in uncontained release of the air seal, damage to the engine, and damage to the airplane.

    (f) Compliance

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

    (g) Required Actions

    The next time the 4th stage LPT vanes are removed from the LPT module, remove 4th stage air seal, P/N 50N346, from service and replace with a part eligible for installation.

    (h) Installation Prohibition

    After the effective date of this AD, do not install any 4th stage LPT air seal, P/N 50N346, into any LPT module.

    (i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO 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 (j) of this AD. You may email your request 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.

    (j) Related Information

    For more information about this AD, contact Jo-Ann Theriault, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7105; fax: 781-238-7199; email: [email protected]

    (k) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on June 11, 2018. Robert J. Ganley, Manager, Engine and Propeller Standards Branch, Aircraft Certification Service.
    [FR Doc. 2018-12830 Filed 6-14-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0501; Product Identifier 2018-NE-19-AD; Amendment 39-19304; AD 2018-11-16] RIN 2120-AA64 Airworthiness Directives; Engine Alliance Turbofan Engines AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule; request for comments.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Engine Alliance (EA) GP7270, GP7272, and GP7277 turbofan engines. This AD requires a one-time eddy current inspection (ECI) of the engine fan hub blade slot bottom and blade slot front edge for cracks, a visual inspection of the engine fan hub for damage, and removal of parts if damage or defects are found that are outside serviceable limits. This AD was prompted by an uncontained failure of the engine fan hub. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective July 2, 2018.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of July 2, 2018.

    We must receive comments on this AD by July 30, 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: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this final rule, contact Engine Alliance, 411 Silver Lane, East Hartford, CT 06118; phone: 800-565-0140; email: [email protected]; website: www.engineallianceportal.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-2018-0501.

    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-2018-0501; 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 street address for the Docket Operations (phone: 800-647-5527) is listed above. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    David Bethka, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7129; fax: 781-238-7199; email: [email protected].

    SUPPLEMENTARY INFORMATION: Discussion

    We received information concerning an uncontained engine fan hub failure that occurred on an EA GP7200-series turbofan engine. AD 2017-23-03 (82 FR 51979, November 9, 2017), requires visual inspections of all engine fan hubs for damage. This AD requires additional visual inspections of the EA GP7200-series engine fan hub beyond those required by AD 2017-23-03. This AD also requires an ECI that was not required by AD 2017-23-03. This condition, if not addressed, could result in an uncontained failure of the engine fan hub, damage to the engine, and damage to the airplane. We are issuing this AD to address the unsafe condition on these products.

    Related Service Information Under 1 CFR Part 51

    We reviewed EA Alert Service Bulletin (ASB) EAGP7-A72-389, Revision No. 2, dated April 17, 2018. The ASB describes procedures for ECI and visual inspection of the GP7270, GP7272, and GP7277 engine fan hub. 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 a one-time ECI of the GP7270, GP7272, and GP7277 engine fan hub blade slot bottom and blade slot front edge for cracks, a visual inspection of the engine fan hub for damage, and removal of the engine fan hub if damage or defects are found that are outside of serviceable limits.

    Interim Action

    We consider this AD interim action. An investigation to determine the cause of the failure is on-going and we may consider additional rulemaking if final action is identified.

    FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to the adoption of this rule because the compliance time for the required action is shorter than the time necessary for the public to comment and for us to publish the final rule. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason stated above, we find 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-2018-0501 and Product Identifier 2018-NE-19-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

    We estimate that this AD affects 0 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
    ECI and visual inspection 14 work-hours × $85 per hour = $1190 $0 $1190 $0
    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): 2018-11-16 Engine Alliance: Amendment 39-19304 ; Docket No. FAA-2018-0501; Product Identifier 2018-NE-19-AD. (a) Effective Date

    This AD is effective July 2, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Engine Alliance (EA) GP7270, GP7272, and GP7277 model turbofan engines with serial numbers (S/Ns) identified in Table 3 in Planning Information of Engine Alliance (EA) Alert Service Bulletin (ASB) EAGP7-A72-389, Revision No. 2, dated April 17, 2018.

    (d) Subject

    Joint Aircraft System Component (JASC) Code 7230, Turbine Engine Compressor Section.

    (e) Unsafe Condition

    This AD was prompted by an uncontained failure of the engine fan hub. We are issuing this AD to detect defects, damage, and cracks that could result in an uncontained failure of the engine fan hub. The unsafe condition, if not addressed, could result in uncontained failure of the engine fan hub, damage to the engine, and damage to the airplane.

    (f) Compliance

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

    (g) Required Actions

    Within 120 days after the effective date of this AD:

    (1) For engine fan hubs at the low-pressure compressor (LPC) module assembly level:

    (i) Perform a visual inspection of the engine fan hub, in accordance with the Accomplishment Instructions, For Fan Hubs at LPC Module Assembly Level, paragraphs 1.A.(1), 1.A.(4), and 1.A.(6)(a), of EA ASB EAGP7-A72-389, Revision No. 2, dated April 17, 2018.

    (ii) Perform an eddy current inspection (ECI) of the engine fan hub blade slot bottoms and front edges, in accordance with the Accomplishment Instructions, For Fan Hubs at LPC Module Assembly Level, paragraphs 2.A and 2.B, of EA ASB EAGP7-A72-389, Revision No. 2, dated April 17, 2018.

    (2) For engine fan hubs at the piece part level:

    (i) Perform a visual inspection of the engine fan hub, in accordance with the Accomplishment Instructions, For Fan Hubs at Piece Part Level, paragraphs 1.A.(1) and 1.A.(3), of EA ASB EAGP7-A72-389, Revision No. 2, dated April 17, 2018.

    (ii) Perform an ECI of the engine fan hub blade slot bottoms and front edges, in accordance with the Accomplishment Instructions, For Fan Hubs at Piece Part Level, paragraphs 2.A and 2.B, of EA ASB EAGP7-A72-389, Revision No. 2, dated April 17, 2018.

    (3) For engine fan hubs installed in an engine (on-wing or off-wing):

    (i) Perform a visual inspection of the engine fan hub, in accordance with the Accomplishment Instructions, For Fan Hubs Installed in an Engine, paragraphs 1.C.(1), 1.C.(5), and 1.C.(7)(a), of EA ASB EAGP7-A72-389, Revision No. 2, dated April 17, 2018.

    (ii) Perform an ECI of the engine fan hub blade slot bottoms and front edges, in accordance with the Accomplishment Instructions, For Fan Hubs Installed in an Engine, paragraphs 1.D.(1) and 1.D.(2), of EA ASB EAGP7-A72-389, Revision No. 2, dated April 17, 2018.

    (4) If the engine fan hub visual inspection reveals defects or damage to the engine fan hub that are found outside the serviceable limits specified in Table 4 in the Accomplishment Instructions of EA ASB EAGP7-A72-389, Revision No. 2, dated April 17, 2018, remove the engine fan hub from service and replace with a part that is eligible for installation, prior to further flight.

    (5) If the fan hub ECI results in a rejectable indication, per the Appendix, Added Data, of EA ASB EAGP7-A72-389, Revision No. 2, dated April 17, 2018, remove the hub from service and replace with a part that is eligible for installation, prior to further flight.

    (h) Credit for Previous Actions

    You may take credit for the inspection required by paragraph (g) of this AD if you performed the inspection before the effective date of this AD, using EA ASB EAGP7-A72-389, dated December 19, 2017, or EA ASB EAGP7-A72-389, Revision No. 1, dated January 19, 2018.

    (i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO 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 (j) of this AD. You may email your request 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.

    (j) Related Information

    For more information about this AD, contact David Bethka, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7129; fax: 781-238-7199; email: [email protected].

    (k) 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) Engine Alliance Alert Service Bulletin EAGP7-A72-389, Revision No. 2, dated April 17, 2018.

    (ii) Reserved.

    (3) For Engine Alliance service information identified in this AD, contact Engine Alliance, 411 Silver Lane, East Hartford, CT 06118; phone: 800-565-0140; email: [email protected]; website: www.engineallianceportal.com.

    (4) You may view this service information at 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.

    (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 Burlington, Massachusetts, on June 8, 2018. Robert J. Ganley, Manager, Engine and Propeller Standards Branch, Aircraft Certification Service.
    [FR Doc. 2018-12873 Filed 6-14-18; 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-2018-D-1323] The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled “The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry.” The guidance identifies eight specific, additional isolated or synthetic non-digestible carbohydrates that we intend to add to our regulatory definition of “dietary fiber” through our regular rulemaking process. In the interim, the guidance also advises manufacturers of our policy for when one or more of these eight non-digestible carbohydrates, present in a food, are included in the declared amount of “dietary fiber,” and for the use of a caloric value for polydextrose of 1 kilocalorie per gram (kcal/g).

    DATES:

    The announcement of the guidance is published in the Federal Register on June 15, 2018.

    ADDRESSES:

    You may submit either electronic or written comments on Agency guidances 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-1323 for “The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; 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.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    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 guidance to the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Paula R. Trumbo, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Campus Dr., College Park, MD 20740, 240-402-2579.

    SUPPLEMENTARY INFORMATION: I. Background

    We are announcing the availability of a guidance for industry entitled “The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry.” We are issuing this guidance consistent with our good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (§ 10.115(g)(2)). We made this determination because this guidance sets out compliance policy that reduces burden and is consistent with the public health. Although this guidance document is immediately in effect, it remains subject to comment in accordance with FDA's GGP regulation.

    Before 2016, FDA regulations did not define the term “dietary fiber” for purposes of the Nutrition Facts and Supplement Facts labels. In the Federal Register of May 27, 2016 (81 FR 33742), we published a final rule amending our Nutrition Facts and Supplement Facts Labels regulations (hereafter referred to as “the final rule”). The final rule, among other things, defines dietary fiber as non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health (§ 101.9(c)(6)(i) (21 CFR 101.9(c)(6)(i))). The final rule also identifies seven isolated or synthetic non-digestible carbohydrates, each of which has a physiological effect that is beneficial to human health and that must be declared as dietary fiber on Nutrition and Supplement Facts labels when present in a food.

    Interested parties can ask us to list additional isolated or synthetic non-digestible carbohydrates in the definition of dietary fiber in § 101.9(c)(6)(i). For example, a manufacturer can request FDA to include another added isolated or synthetic non-digestible carbohydrate in the listing of dietary fibers by submitting a citizen petition under 21 CFR 10.30. FDA would review the scientific evidence to determine whether the evidence supports the non-digestible carbohydrate as having a physiological effect that is beneficial to human health. If so, FDA would propose a rule to include the non-digestible carbohydrate in the listing of dietary fibers.

    Based on our review of citizen petitions that FDA has received requesting that we identify additional isolated or synthetic non-digestible carbohydrates in the listing of dietary fibers, and comments that we have received on a draft guidance entitled “Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30)” and an accompanying document titled “Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates,” the availability of which we announced in the Federal Register of November 23, 2016 (81 FR 84516 and 81 FR 84595), in addition to our independent evaluation of the available scientific data, we intend to add certain isolated or synthetic non-digestible carbohydrates to the dietary fiber definition in § 101.9(c)(6)(i) through our regular rulemaking process. The eight non-digestible carbohydrates that we intend to add are: Mixed plant cell wall fibers; arabinoxylan; alginate, inulin and inulin-type fructans; high amylose starch (resistant starch 2); galactooligosaccharide; polydextrose; and resistant maltodextrin/dextrin. One category of non-digestible carbohydrate that we intend to add to § 101.9(c)(6)(i) through our regular rulemaking process—mixed plant cell wall fibers—encompasses a number of fiber ingredients, such as rice bran fibers, soy fibers, and sugar cane fibers. We have tentatively determined that each of these isolated or synthetic non-digestible carbohydrates has a physiological effect that is beneficial to human health. Several petitions are still pending with FDA and reviewing this information is a very high priority for FDA. Firms also can submit new citizen petitions, and we will review the petitions on a rolling basis. Firms whose non-digestible carbohydrates do not meet our regulatory definition of “dietary fiber” and are not one of the eight non-digestible carbohydrates identified in the guidance can still use those non-digestible carbohydrates in foods. Although those non-digestible carbohydrates cannot be listed as dietary fiber in the Nutrition Facts label, they would still be declared as part of the amount of total carbohydrate and listed by name in the ingredients on the food package. In addition, based on our review of the scientific evidence, including evidence we received in a citizen petition, we intend to establish a caloric value for polydextrose at 1 kcal/g in § 101.9(c)(1)(i)(C).

    Pending completion of the rulemaking process, we are announcing a policy for the eight identified isolated or synthetic non-digestible carbohydrates when one or more are present in food and declared in the amount of “dietary fiber” on Nutrition Facts and Supplement Facts labels and when the caloric value of 1 kcal/g is used to determine the calorie contribution of polydextrose. Section 101.9(g) requires manufacturers to make and keep records to verify the amount of non-digestible carbohydrates added to food that do not meet the definition of dietary fiber. Under our policy, when a mixture of dietary fiber and one or more of these eight added non-digestible carbohydrates (that are not currently listed as a “dietary fiber” in the definition in § 101.9(c)(6)(i)) are present in a food, we do not expect manufacturers to make and keep records in accordance with § 101.9(g)(10) and (11) to verify the declared amount of one or more of these eight added non-digestible carbohydrates in the label and labeling of food.

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Electronic Access

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

    Dated: June 8, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-12867 Filed 6-14-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 876 [Docket No. FDA-2018-N-1894] Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is classifying the fluid jet system for prostate tissue removal into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fluid jet system for prostate tissue removal's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

    DATES:

    This order is effective June 15, 2018. The classification was applicable on December 21, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Jessica Cades, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G246, Silver Spring, MD, 20993-0002, 240-402-3900, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Upon request, FDA has classified the fluid jet system for prostate tissue removal as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

    The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

    FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k) and part 807 (21 CFR part 807).

    FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

    Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

    Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

    Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.

    We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or PMA in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

    II. De Novo Classification

    On April 17, 2017, PROCEPT BioRobotics Inc. submitted a request for De Novo classification of the AQUABEAM System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

    We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on December 21, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 876.4350. We have named the generic type of device fluid jet system for prostate tissue removal, and it is identified as a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia. The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.

    FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

    Table 1—Fluid Jet System for Prostate Tissue Removal Risks and Mitigation Measures Identified risks Mitigation measures Injury from device operation causing one or more of the following: Clinical performance testing, Animal testing, Labeling, and Training. • Bleeding • Bruising • Penile or pelvic pain • Dysuria • Incontinence • Bladder or prostate capsule perforation • Sexual dysfunction, including ejaculatory and erectile dysfunction • Transurethral resection syndrome • Urethral damage causing false passage or stricture • Rectal incontinence/perforation • Embolism Adverse tissue reaction Biocompatibility evaluation. Infection Sterilization validation, Reprocessing validation, Shelf life testing, and Labeling. Failure to remove target tissue or removal of non-target tissue Clinical performance testing, Animal testing, Software verification, validation, and hazard analysis, Non-clinical performance testing, Labeling, and Training. Electrical shock or electromagnetic interference Electrical safety testing, Electromagnetic compatibility testing, and Labeling.

    FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

    At the time of classification, fluid jet systems for prostate tissue removal are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).

    III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) 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.

    IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. 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 the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in part 801, regarding labeling, have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

    PART 876—GASTROENTEROLOGY-UROLOGY DEVICES 1. The authority citation for part 876 continues to read as follows: Authority:

    21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    2. Add § 876.4350 to subpart E to read as follows:
    § 876.4350 Fluid jet system for prostate tissue removal.

    (a) Identification. A fluid jet system for prostate tissue removal is a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia. The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.

    (b) Classification. Class II (special controls). The special controls for this device are:

    (1) Clinical performance testing must evaluate the following:

    (i) All adverse events associated with the device, and

    (ii) Improvement in lower urinary tract symptoms (LUTS).

    (2) Physician training must be provided that includes:

    (i) Information on key aspects and use of the device, and

    (ii) Information on how to override or stop resection.

    (3) Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues.

    (4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

    (i) Measurement of targeting accuracy and reproducibility of high velocity fluid jet, and

    (ii) High pressure fluid jet verification testing at target and non-target tissues.

    (5) Software verification, validation, and hazard analysis must be performed.

    (6) The patient-contacting elements of the device must be demonstrated to be biocompatible.

    (7) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device.

    (8) Performance data must demonstrate the sterility of the patient-contacting components of the device.

    (9) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

    (10) Performance data must validate the instructions for reprocessing and reliability of reusable components.

    (11) Labeling must include the following:

    (i) A section that summarizes the clinical testing results, including the adverse event profile and improvement in LUTS;

    (ii) A shelf life for single use components;

    (iii) A use life for reusable components; and

    (iv) Reprocessing instructions for reusable components.

    Dated: June 8, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-12829 Filed 6-14-18; 8:45 am] BILLING CODE 4164-01-P
    PENSION BENEFIT GUARANTY CORPORATION 29 CFR Parts 4022 and 4044 Allocation of Assets in Single-Employer Plans; Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Valuing and Paying Benefits AGENCY:

    Pension Benefit Guaranty Corporation.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule amends the Pension Benefit Guaranty Corporation's regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under the benefit payments regulation for valuation dates in July 2018 and interest assumptions under the asset allocation regulation for valuation dates in the third quarter of 2018. The interest assumptions are used for valuing and paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.

    DATES:

    Effective July 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Hilary Duke ([email protected]), Assistant General Counsel for Regulatory Affairs, Pension Benefit Guaranty Corporation, 1200 K Street NW, Washington, DC 20005, 202-326-4400, ext. 3839. (TTY users may call the Federal relay service toll free at 1-800-877-8339 and ask to be connected to 202-326-4400, ext. 3839.)

    SUPPLEMENTARY INFORMATION:

    PBGC's regulations on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) and Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974 (ERISA). The interest assumptions in the regulations are also published on PBGC's website (http://www.pbgc.gov).

    The interest assumptions in appendix B to part 4044 are used to value benefits for allocation purposes under ERISA section 4044. PBGC uses the interest assumptions in appendix B to part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in appendices B and C of the benefit payment regulation are the same.

    The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the asset allocation regulation are updated quarterly; assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for July 2018 and updates the asset allocation interest assumptions for the third quarter (July through September) of 2018.

    The third quarter 2018 interest assumptions under the allocation regulation will be 2.53 percent for the first 25 years following the valuation date and 2.64 percent thereafter. In comparison with the interest assumptions in effect for the second quarter of 2018, these interest assumptions represent an increase of 5 years in the select period (the period during which the select rate (the initial rate) applies), an increase of 0.26 percent in the select rate, and an increase of 0.05 percent in the ultimate rate (the final rate).

    The July 2018 interest assumptions under the benefit payments regulation will be 1.25 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for June 2018, these interest assumptions represent no change in the immediate rate and no changes in i1, i2, or i3.

    PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

    Because of the need to provide immediate guidance for the valuation and payment of benefits under plans with valuation dates during July 2018, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

    PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

    Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

    List of Subjects 29 CFR Part 4022

    Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements.

    29 CFR Part 4044

    Employee benefit plans, Pension insurance, Pensions.

    In consideration of the foregoing, 29 CFR parts 4022 and 4044 are amended as follows:

    PART 4022—BENEFITS PAYABLE IN TERMINATED SINGLE-EMPLOYER PLANS 1. The authority citation for part 4022 continues to read as follows: Authority:

    29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.

    2. In appendix B to part 4022, Rate Set 297 is added at the end of the table to read as follows: Appendix B to Part 4022—Lump Sum Interest Rates for PBGC Payments Rate set For plans with a valuation date On or after Before Immediate annuity rate
  • (percent)
  • Deferred annuities
  • (percent)
  • i 1 i 2 i 3 n 1 n 2
    *         *         *         *         *         *         * 297 7-1-18 8-1-18 1.25 4.00 4.00 4.00 7 8
    3. In appendix C to part 4022, Rate Set 297 is added at the end of the table to read as follows: Appendix C to Part 4022—Lump Sum Interest Rates for Private-Sector Payments Rate set For plans with a valuation date On or after Before Immediate annuity rate
  • (percent)
  • Deferred annuities
  • (percent)
  • i 1 i 2 i 3 n 1 n 2
    *         *         *         *         *         *         * 297 7-1-18 8-1-18 1.25 4.00 4.00 4.00 7 8
    PART 4044—ALLOCATION OF ASSETS IN SINGLE-EMPLOYER PLANS 4. The authority citation for part 4044 continues to read as follows: Authority:

    29 U.S.C. 1301(a), 1302(b)(3), 1341, 1344, 1362.

    5. In appendix B to part 4044, an entry for “July-September 2018” is added at the end of the table to read as follows: Appendix B to Part 4044—Interest Rates Used To Value Benefits For valuation dates occurring in the month— The values of i t are: i t for t = i t for t = i t for t = *         *         *         *         *         *         * July-September 2018 0.0253 1-25 0.0264 >25 N/A N/A

    Issued in Washington, DC.

    Hilary Duke, Assistant General Counsel, Pension Benefit Guaranty Corporation.
    [FR Doc. 2018-12549 Filed 6-14-18; 8:45 am] BILLING CODE 7709-02-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2018-0330] RIN 1625-AA00 Safety Zone; Appomattox River, Hopewell, VA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone for a marine event on the navigable waters of the Appomattox River at confluence with the James River in Hopewell, VA. This action is necessary to provide for the safety of life on these navigable waters in Hopewell, VA, during a fireworks display on June 30, 2018. This rule prohibits persons and vessels from being in the safety zone unless authorized by the Captain of the Port Hampton Roads or a designated representative.

    DATES:

    This rule is effective from 9 p.m. to 11 p.m. on June 30, 2018.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email LCDR Barbara Wilk, Waterways Management Division Chief, Sector Hampton Roads, U.S. Coast Guard; telephone 757-668-5580, email [email protected]

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

    On March 27, 2018, the Hopewell Recreation and Parks Department notified the Coast Guard that it will be conducting a fireworks display from approximately 9:30 to 9:45 p.m. on June 30, 2018, to serve as the city of Hopewell's Fourth of July celebration. The fireworks are to be launched from a barge in the Appomattox River near City Point in Hopewell, VA. In response, on May 31, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Appomattox River, Hopewell, VA (83 FR 24950). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended June 7, 2018, we received no comments.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable because immediate action is needed to respond to the potential safety hazards associated with fireworks displays including accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Hampton Roads (COTP) has determined that potential hazards associated with the fireworks to be used in this display would be a safety concern for anyone within a 234-yard radius of the barge. The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within a 234-yard radius of the fireworks barge before, during, and after the scheduled event.

    IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published May 31, 2018. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

    This rule establishes a safety zone from 9 to 11 p.m. on June 30, 2018. The safety zone would cover all navigable waters within 234 yards of a barge in the Appomattox River at approximate coordinates: 37°18′52.20″ N, 077°17′12.52″ W. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 9:30 to 9:45 p.m. fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a 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 safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the Appomattox River at confluence with the James River in Hopewell, VA, for 2 hours. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission on-scene to enter the zone.

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security 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 safety zone lasting 2 hours that will prohibit entry within 234 yards of a fireworks barge in the Appomattox River near City Point in Hopewell, VA. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and 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.T05-0330 to read as follows:
    § 165.T05-0330 Safety Zone, Appomattox River; Hopewell, VA.

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

    (1) Captain of the Port means the Commander, Sector Hampton Roads.

    (2) Representative means any Coast Guard commissioned, warrant or petty officer who has been authorized to act on the behalf of the Captain of the Port.

    (3) Participants mean individuals and vessels involved in the fireworks display.

    (b) Location. The following area is a safety zone: All navigable waters in the vicinity of the Appomattox River at confluence with the James River, within a 234 yard radius of the fireworks display barge in approximate position 37°18′52.20″ N, 077°17′12.52″ W (NAD 1983).

    (c) Regulations. (1) Except as provided in paragraph (c)(4) of this section, all persons are required to comply with the general regulations governing safety zones of subpart C of this part.

    (2) With the exception of participants, entry into or remaining in this safety zone is prohibited unless authorized by the Captain of the Port, Hampton Roads or his designated representatives. All vessels within this safety zone at the time it is implemented are to depart the zone immediately.

    (3) The Captain of the Port, Hampton Roads or his representative can be contacted at telephone number (757) 668-5555. The Coast Guard and designated security vessels enforcing the safety zone can be contacted on VHF-FM marine band radio channel 13 (165.65 Mhz) and channel 16 (156.8 Mhz), or by visual or verbal hailing on-scene.

    (4) This section does not apply to participants and vessels that are engaged in the following operations:

    (i) Enforcing laws;

    (ii) Servicing aids to navigation; and

    (iii) Emergency response vessels.

    Dated: June 11, 2018. Richard J. Wester, Captain, U.S. Coast Guard, Captain of the Port, Hampton Roads.
    [FR Doc. 2018-12863 Filed 6-14-18; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2018-0277; FRL-9979-44—Region 3] Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Removal of Department of Environmental Protection Gasoline Volatility Requirements for the Pittsburgh-Beaver Valley Area AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking direct final action to approve a revision to the Commonwealth of Pennsylvania state implementation plan (SIP) submitted by the Pennsylvania Department of Environmental Protection (PADEP) on May 2, 2018. This revision seeks the removal, from the Pennsylvania SIP, of the requirement limiting summertime gasoline volatility to 7.8 pounds per square inch (psi) Reid Vapor Pressure (RVP) to address nonattainment under the 1-hour ozone national ambient air quality standard (NAAQS) in the Pittsburgh-Beaver Valley ozone nonattainment area (hereafter Pittsburgh-Beaver Valley Area). The submitted SIP revision also includes a section 110(l) demonstration as required by the Clean Air Act (CAA) addressing emission impacts associated with the removal of the program. EPA is approving these revisions to the Pennsylvania SIP in accordance with the requirements of the Clean Air Act (CAA).

    DATES:

    This rule is effective on August 14, 2018 without further notice, unless EPA receives adverse written comment by July 16, 2018. If EPA receives such comments, it will publish a timely withdrawal of the direct final rule in the Federal Register and inform the public that the rule will not take effect.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R03-OAR-2018-0277 at http://www.regulations.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be confidential business information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Brian Rehn, (215) 814-2176, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document whenever “we,” “us,” or “our” is used, we refer to EPA. This supplementary information section is arranged as follows:

    I. Background A. Federal Gasoline Volatility Controls Under the CAA B. State Gasoline Volatility Controls for the Pittsburgh-Beaver Valley Area II. What changes have been made to Pennsylvania's gasoline volatility standards? III. What is the historic reason for adoption of gasoline volatility control and the status of air quality in the Pittsburgh-Beaver Valley Area? A. The Status of the Pittsburgh-Beaver Valley Area With Respect to the Ozone NAAQS B. The Status of the Pittsburgh-Beaver Valley Area With Respect to the Fine Particulate Matter NAAQS IV. What is EPA's analysis of the Commonwealth's submittal? A. Pennsylvania's Estimate of the Impacts of Removing the 7.8 psi RVP Requirement B. Pennsylvania's Substitution of Alternative Emissions Reduction Measures for the 7.8 psi Low-RVP Gasoline Program 1. Pennsylvania's Adhesives, Sealants, Primers, and Solvents Rule 2. Shutdown of Guardian Industries Jefferson Hills Facility C. Comparison of Emissions Impacts of Removal of the Commonwealth's 7.8 psi RVP Gasoline Program and the Uncredited Emission Reductions From Substitute Measures V. Impacts on the Boutique Fuels List VI. What action is EPA taking? VII. Statutory and Executive Order Reviews I. Background A. Federal Gasoline Volatility Controls Under the CAA

    Under section 211(c) of the CAA, EPA promulgated regulations on March 22, 1989 (54 FR 11868) that set maximum federal limits for the RVP of gasoline sold during the regulatory control periods that were established on a state-by-state basis in the final rule. The regulatory control periods applied during the summer months when peak ozone concentrations were expected. These regulations constituted Phase I of a two phase nationwide program, which was designed to reduce the volatility of commercial gasoline during the high ozone season. Depending on the state and month, gasoline RVP was not to exceed 10.5 psi, 9.5 psi, or 9.0 psi. Phase I was applicable to calendar years 1989 through 1991. On June 11, 1990 (55 FR 23658), EPA promulgated more stringent volatility controls as Phase II of the volatility control program. These requirements established maximum RVP standards of 9.0 psi or 7.8 psi (depending on the state, the month, and the area's initial ozone attainment designation with respect to the 1-hour ozone NAAQS). Phase II is applicable to 1992 and subsequent years.

    The 1990 amendments to the CAA established a new section, 211(h), to address fuel volatility. Section 211(h)(1) requires EPA to promulgate regulations making it unlawful to sell, offer for sale, dispense, supply, offer for supply, transport, or introduce into commerce gasoline with an RVP level in excess of 9.0 psi during the high ozone season. Section 211(h)(2) prohibits EPA from establishing a volatility standard more stringent than 9.0 psi in an attainment area, except that the Agency may impose a lower (more stringent) standard in any former ozone nonattainment area redesignated to attainment.

    On December 12, 1991 (56 FR 64704), EPA modified the Phase II volatility regulations to make them consistent with section 211(h). The modified regulations prohibited the sale of gasoline, beginning in 1992, with a RVP above 9.0 psi in all areas designated attainment for ozone. For areas designated as nonattainment, the regulations retained the original Phase II standards published on June 11, 1990 (55 FR 23658), which included the 7.8 psi ozone season limitation for certain areas.

    Under these requirements, the Commonwealth of Pennsylvania was required to meet a 9.0 psi RVP standard during the summer RVP control period, with the exception of the Philadelphia Area, which was at that time was designated as severe ozone nonattainment, and as such was subject to more stringent gasoline requirements of the reformulated gasoline program established under CAA section 211(k).

    B. State Gasoline Volatility Controls for the Pittsburgh-Beaver Valley Area

    On November 15, 1990, the CAA amendments of 1990 were signed into law. On November 6, 1991, EPA designated and classified the Pittsburgh-Beaver Valley Area as moderate nonattainment for the 1979 1-hour ozone NAAQS. As part of Pennsylvania's efforts to bring the Pittsburgh-Beaver Valley Area into attainment of the ozone standard, the Commonwealth adopted and implemented a range of ozone precursor emissions control measures for the area, including adoption of a state rule to limit summertime gasoline volatility to 7.8 psi RVP. Pennsylvania's RVP control rule applies to the entire Pittsburgh-Beaver Valley Area—Allegheny, Armstrong, Beaver, Butler, Fayette, Washington, and Westmoreland Counties.

    PADEP promulgated this rule in the November 1, 1997 Pennsylvania Bulletin (27 Pa.B. 5601, effective November 1, 1997), which is codified in Subchapter C of Chapter 126 of the Pennsylvania Code of Regulations (25 Pa. Code Chapter 126, Subchapter C). On April 17, 1998, Pennsylvania submitted this state-adopted rule to EPA as a formal revision to its approved SIP. EPA published a final action approving Pennsylvania's RVP SIP revision in the June 8, 1998 Federal Register (63 FR 31116) and codified in the Code of Federal Regulations at 40 CFR 52.2020(c)(1).

    The local air pollution control agency for Allegheny County, ACHD, later adopted a similar summertime gasoline volatility limit (Allegheny County Order No. 16782, Article XXI, sections 2102.40, 2105.90, and 2107.15; effective May 15, 1998, amended August 12, 1999). On March 23, 2000, PADEP formally submitted a SIP revision to EPA (on behalf of ACHD) to incorporate ACHD's own gasoline RVP summertime requirements into the Pennsylvania SIP. EPA approved that SIP revision establishing an independent ACHD gasoline RVP limit on April 17, 2001 (66 FR 19724), effective June 18, 2001.

    II. What changes have been made to Pennsylvania's gasoline volatility standards?

    In the 2013-14 session of the Pennsylvania General Assembly, the legislature passed and Governor Corbett signed into law Act 50 (Pub. L. 674, No. 50 of May 14, 2014). Act 50 amended the Pennsylvania Air Pollution Control Act to direct PADEP to initiate a process to obtain approval from EPA of a SIP revision that demonstrates continued compliance with the NAAQS, through utilization of substitute, commensurate emissions reductions to balance repeal of the Pittsburgh-Beaver Valley Area RVP limit. Upon approval of that demonstration revision, Act 50 directs PADEP to repeal the summertime gasoline RVP limit provisions of 25 Pa. Code Chapter 126, Subchapter C.

    On May 2, 2018, PADEP submitted a SIP revision requesting that EPA remove from the Pennsylvania SIP Chapter 126, Subchapter C of the Pennsylvania Code (specifically removing 25 Pa. Code sections 126.301, 126.302, and 126.303), based upon a demonstration that the repeal of the RVP requirements rule (coupled with other ozone precursor emission reduction measures) would not interfere with the Pittsburgh-Beaver Valley Area's attainment of any NAAQS, per the requirements for noninterference set forth in section 110(l) of the CAA. Pennsylvania's SIP revision contains a Pennsylvania-specific analysis that the emissions impact from repeal of the 7.8 psi gasoline volatility requirement in Pittsburgh (to be replaced by the federal 9.0 psi summertime gasoline requirement) would be offset by substitution of commensurate benefits from other emission reduction measures enacted by Pennsylvania, but not previously credited in any SIP towards attainment or maintenance of any NAAQS. This analysis is performed through analysis of emission inventory sectors and sources affected by both repeal of gasoline RVP limits and of the substitute measures enacted by Pennsylvania.

    The May 2, 2018 SIP revision references the Commonwealth's regulatory amendment to Chapter 126, Subchapter C, as published in the April 7, 2018 Pennsylvania Bulletin (48 Pa. B. 1932, effective upon publication). This amendment serves to repeal the PADEP requirement for 7.8 psi RVP summer gasoline. The Commonwealth's rule amends 25 Pa. Code Section 126.301 (relating to gasoline volatility requirements) to remove the RVP requirement for the Pittsburgh-Beaver Valley Area RVP upon the effective date of EPA's approval of Pennsylvania's May 2, 2018 SIP revision. As a result, both state and federal repeal of the requirements for summertime RVP in the area will coincide with the effective date of EPA's final action to approve the Commonwealth's related SIP submittals.

    III. What is the historic reason for adoption of gasoline volatility control and the status of air quality in the Pittsburgh-Beaver Valley Area?

    The gasoline volatility limit was originally adopted by Pennsylvania as part of a suite of measures to address ground level ozone pollution in the Pittsburgh-Beaver Valley Area, which has historically been designated nonattainment for the ozone NAAQS. Since passage of the CAA in 1990, portions of the Pittsburgh-Beaver Valley Area have also been designated nonattainment for the daily and annual averaging period fine particulate matter (PM2.5) NAAQS. Since the low-RVP gasoline program affects primarily volatile organic compounds (VOCs) and nitrogen oxides (NOX) emissions, and to some degree directly emitted PM2.5 emissions, our review of the removal of this rule focuses on the NAAQS for which these emissions contribute, either directly or as precursor emissions.

    A. The Status of the Pittsburgh-Beaver Valley Area With Respect to the Ozone NAAQS

    On November 6, 1991 (56 FR 56694), EPA designated and classified the Pittsburgh counties of Allegheny, Armstrong, Beaver, Butler, Fayette, Washington, and Westmoreland Counties as nonattainment for the 1-hour ozone NAAQS promulgated by EPA in 1979. RVP control was one of a suite of measures adopted by Pennsylvania to attain and maintain the 1-hour ozone NAAQS.

    On April 9, 2001, Pennsylvania submitted a request to redesignate the Pittsburgh-Beaver Valley Area to attainment of the 1979 1-hour ozone NAAQS, along with a maintenance plan to demonstrate that the area would continue to attain for a 10-year period—a plan which relied, in part, on emissions reductions attributable to the summertime gasoline volatility control program. Subsequently, EPA determined that the Pittsburgh-Beaver Valley Area had attained the 1979 1-hour ozone NAAQS by its extended attainment date and approved the Commonwealth's 1-hour redesignation request and maintenance plan SIP revision on November 19, 2001 (66 FR 53094).

    On July 18, 1997 (62 FR 38856), EPA issued a revised NAAQS for ozone, strengthening the primary and secondary standards to 0.080 parts per million (ppm) and changing the averaging time from 1-hour to 8-hours. EPA initially designated the Pittsburgh-Beaver Valley Area as nonattainment for the 1997 NAAQS, under the general part D, subpart 1 provisions of the CAA on July 15, 2004. However, in response to litigation, EPA later classified several areas, including Pittsburgh-Beaver Valley, as moderate under the CAA part D, subpart 2 provisions in May of 2012.1

    1 In 2012, EPA finalized revisions to the 2004 Phase 1 Implementation Rule for the 1997 8-hour ozone NAAQS that specified requirements to meet the 1997 ozone NAAQS. (77 FR 28424, May 14, 2012). The revisions were EPA's response to a December 22, 2006 decision in South Coast Air Quality Management District v. EPA, 472 F.3d 882 (D.C. Cir. 2006), directing EPA to classify areas under Part D of the CAA. As a result, EPA reclassified the former subpart 1 nonattainment areas, like the Pittsburgh Beaver Valley Area, under subpart 2. The 1997 8-Hour Ozone NAAQS was eventually revoked on April 6, 2015, coincident with promulgation of the later 2008 ozone NAAQS.

    On April 4, 2013, EPA determined that the Pittsburgh-Beaver Valley Area had attained the 1997 8-hour ozone NAAQS by its applicable attainment date (based on air monitoring data for the 2007-2009 period) and warranted a clean data determination. This latter determination suspended certain CAA planning requirements for the Area, including requirements for an attainment demonstration, associated reasonable further progress plan, contingency measures, reasonably available control measure (RACM) analysis, and other CAA part D planning requirements for moderate ozone nonattainment areas, for as long as the area continued to monitor attainment of the NAAQS.

    On March 27, 2008 (73 FR 16436), EPA strengthened the 8-hour NAAQS from 0.080 to 0.075 ppm in 2008. On March 6, 2015 (77 FR 30088), EPA designated and classified the Pittsburgh-Beaver Valley Area as marginal nonattainment for the 2008 8-hour ozone NAAQS. Also on March 6, 2015 (80 FR 12264), EPA published its ozone implementation rule for the 2008 ozone NAAQS in which established the date of July 20, 2016 as a deadline for attainment of the 2008 NAAQS. On December 6, 2016 (81 FR 87819), EPA determined that the Pittsburgh-Beaver Valley Area had attained the 2008 ozone NAAQS by that July 20, 2016 deadline.2 The Pittsburgh-Beaver Valley Area continues to attain the 2008 ozone NAAQS for the most recent 2015-2017 three-year monitoring period.

    2 On February 16, 2018, the D.C. Circuit Court issued an opinion on the EPA's regulations implementing the 2008 ozone NAAQS, known as the 2008 Ozone SIP Requirements Rule. South Coast Air Quality Mgmt. Dist. v. EPA, No. 15-1115 (D.C. Cir. Feb. 16, 2018). The D.C. Circuit Court found certain provisions from the 2008 Ozone SIP Requirements rule unreasonable including EPA's provision for a “redesignation substitute.” The D.C. Circuit Court vacated these provisions and found redesignations must comply with all required elements in CAA section 107(d)(3) and thus found the “redesignation substitute” which did not require all items in CAA section 107(d)(3)(E) violated the CAA and was thus unreasonable. The D.C. Circuit. Court also vacated other provisions relating to anti-backsliding in the 2008 Ozone SIP Requirements Rule as the Court found them unreasonable. Id. The D.C. Circuit Court found other parts of the 2008 Ozone SIP Requirements Rule unrelated to anti-backsliding and this action reasonable and denied the petition for appeal on those. Id.

    On October 1, 2015 (80 FR 65291), EPA promulgated a revised ozone NAAQS of 0.070 ppm. On November 6, 2017 (82 FR 54232), EPA issued final 2015 ozone NAAQS designations for most U.S. counties, designating all seven Pittsburgh-Beaver Valley Area counties as “attainment/unclassifiable.”

    Pennsylvania's May 2, 2018 SIP revision includes EPA's updated photochemical grid modeling results for the 2008 ozone NAAQS (See Appendix H), based on updated electric generating unit data for 2017.3 This forecast data predicts that the Pittsburgh-Beaver Valley Area will continue to attain the 2008 ozone NAAQS and maintain attainment of the 2015 ozone NAAQS by 2023.

    3 EPA Projected 2023 Ozone Design Values for the Pittsburgh-Beaver Valley Area.

    Source: Notice of Availability—Preliminary Interstate Ozone Transport Modeling Data for the 2015 Ozone NAAQS. Data Spreadsheet is available at: https://www.epa.gov/sites/production/files/2016-12/2015_o3_naaqs_preliminary_transport_assessment_design_values_contributions.xlsx.

    B. The Status of the Pittsburgh-Beaver Valley Area With Respect to the Fine Particulate Matter NAAQS

    On October 17, 2006, EPA published a revised 24-hour PM2.5 NAAQS (71 FR 61144). On November 3, 2009, EPA designated the Pittsburgh-Beaver Valley Area as nonattainment for the 2006 PM2.5 NAAQS (74 FR 58688) under CAA part D, subpart 1. On June 2, 2014, EPA reclassified the Pittsburgh-Beaver Valley Area as moderate nonattainment under CAA part D, subpart 4 (79 FR 31566), including all of Beaver, Butler, Washington, and Westmoreland Counties and portions of Allegheny, Armstrong, Greene, and Lawrence Counties. On May 2, 2014, EPA determined that the Pittsburgh-Beaver Valley area was in attainment of the 2006 annual and 24-hour PM2.5 NAAQS based on 2010-2012 ambient monitoring data (79 FR 25014). On October 2, 2015 (80 FR 59624), EPA approved a request from Pennsylvania to redesignate the Pittsburgh Area to attainment of the 1997 annual and 2006 24-hour PM2.5 NAAQS.

    On January 15, 2015, EPA published a revised annual PM2.5 NAAQS (79 FR 3086). On April 7, 2015, EPA designated Allegheny County as moderate nonattainment of the 2012 annual PM2.5 NAAQS (80 FR 18535).4 Allegheny County continues to be nonattainment for the 2012 annual PM2.5 NAAQS.

    4 This action corrects an initial final designations action for the 2012 PM2.5 NAAQS, which was signed by EPA on December 18, 2014 and published January 15, 2015 (80 FR 2206). This correction included more recently available data for use in designating certain areas of the country.

    IV. What is EPA's analysis of the Commonwealth's submittal? A. Pennsylvania's Estimate of the Impacts of Removing the 7.8 psi RVP Requirement

    EPA's primary consideration for determining the approvability of Pennsylvania's request to rescind the requirements for a gasoline volatility control program is whether this requested action complies with section 110 of the CAA, specifically section 110(l).5 Section 110(l) of the CAA requires that a revision to the SIP not interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in section 171), or any other applicable requirement of the CAA. EPA evaluates each section 110(l) noninterference demonstration on a case-by-case basis considering the circumstances of each SIP revision. EPA interprets CAA section 110(l) as applying to all NAAQS that are in effect, including those that have been promulgated, but for which EPA has not yet made designations.

    5 CAA section 193, with respect to removal of requirements in place prior to enactment of the 1990 CAA Amendments, is not relevant because Pennsylvania's RVP control requirements in the Pittsburgh-Beaver Valley Area were not included in the SIP prior to enactment of the 1990 CAA amendments.

    In the absence of an attainment demonstration to demonstrate no interference with any applicable NAAQS or requirement of the CAA under section 110(l), EPA believes it is appropriate to allow states to substitute equivalent emissions reductions to compensate for any change to a SIP-approved program, if net actual emissions in the air do not increase. “Equivalent” emission reductions mean reductions which are equal to or greater than those reductions achieved by the control measure approved in the SIP. To show that compensating emission reductions are equivalent, modeling or adequate justification must be provided. The compensating, equivalent reductions must represent real, new emissions reductions achieved in a contemporaneous time frame to the change of the existing SIP control measure, in order to preserve the status quo level of emissions in the air. In addition to being contemporaneous, the equivalent emissions reductions must also be permanent, enforceable, quantifiable, and surplus to be approved into the SIP.

    In its May 2, 2018 SIP revision, PADEP includes a section 110(l) demonstration that uses equivalent emission reductions to offset “losses” from emission reductions resulting from the removal of the SIP approved 7.8 psi RVP summertime gasoline requirement in the Pittsburgh-Beaver Valley Area of Pennsylvania. Specifically, PADEP demonstrates the emission reductions associated with the 7.8 psi RVP fuel requirement will be substituted with equivalent or greater emissions reductions from: (1) Reductions from an adopted, implemented Pennsylvania regulation relating to the use and application of adhesives, sealants, primers, and solvents at 25 Pa. Code Section 129.77 and (2) the permanent shutdown of a facility in the Pittsburgh-Beaver Valley Area. These substitute emissions are quantifiable, permanent, surplus, enforceable, and contemporaneous (i.e. occurring at approximately the same period of this demonstration and/or the anticipated cessation of the low RVP fuel program). With removal of the state 7.8 psi summertime RVP requirement, the federal 9.0 psi RVP limit remains as the applicable requirement.

    To determine the emissions impact of removing the 7.8 psi RVP program requirements in the Pittsburgh-Beaver Valley Area, PADEP considered first the pollutants that impact any NAAQS that are controlled through lowering of gasoline RVP: VOCs, NOX, and direct PM2.5. PADEP's analysis focuses on VOC and NOX emissions because low RVP requirements were adopted by the Commonwealth to address the ozone NAAQS and because VOCs and NOX emissions are the primary precursors for ground-level ozone formation. Also, NOX, VOC, and direct PM2.5 emissions also contribute to formation of PM2.5. PADEP limited its analysis to affected portions of the total emissions inventory for the Pittsburgh-Beaver Valley Area such as the highway vehicle emissions sector, nonroad vehicle emissions sector, and gasoline storage and distribution emissions sources within the stationary point source sector. EPA finds the Commonwealth's analysis of the affected universe of emissions sources reasonable, as the 7.8 psi RVP gasoline requirement impacts only emission sources that store, distribute, or combust gasoline. PADEP studied the impacts of low RVP program removal on the emissions inventory at several points in time representing a period just prior to removal of the low RVP program (i.e., 2014), the year of RVP program cessation (i.e., 2018), and a point five years after RVP program removal (i.e., 2023).

    Table 1 summarizes PADEP's estimates of the expected change in highway vehicle emissions from replacement of the Commonwealth's 7.8 psi summertime low RVP program with the federal 9.0 psi RVP limit. To generate these estimates, PADEP used the latest version of EPA's Motor Vehicle Emissions Simulator (MOVES), version MOVES2014a, to characterize motor vehicle emissions. EPA notes that increasing gasoline RVP in and of itself no longer results in an increase in emissions of VOCs in the highway vehicle sector, as increases in VOCs from evaporative loss and permeation through porous materials are offset by improved exhaust emissions reductions from improvements in new motor vehicles (e.g., improved engine control, air/fuel management, timing management, etc.). Thus, as newer vehicles replace older ones in the fleet, the VOC benefits from low RVP gasoline for the highway vehicle sector of the area's total emission inventory are reduced.

    Table 1—Highway Emissions Comparison Between PADEP's 7.8 psi Low-RVP Program and the Federal RVP Program for the Pittsburgh-Beaver Valley Area [In tons per day (tpd) and tons per year (tpy)] Scenario 2014 VOC tpd tpy NOX tpd tpy PM2.5 tpy 2018 VOC tpd tpy NOX tpd tpy PM2.5 tpy 2023 VOC tpd tpy NOX tpd tpy PM2.5 tpy Pennsylvania 7.8 psi RVP Program 38.7 14,134 77.1 28,142 902 25.1 9,082 49.4 17,403 614 18.2 6,650 30.4 10,834 430 Federal 9.0 psi RVP Program 25.0 9,040 49.7 17,446 612 18.0 6,604 30.5 10,847 428 Reduction or Increase in Emissions (−) or (+) −0.18 −41.4 +0.3 +43.5 −2.0 −0.24 −46.5 +0.09 13.1 −2.2

    PADEP modelled nonroad emissions using the MOVES NONROAD model, version 2014a, coupled with the 2014 NEI version 1 emission inventory, to compile a base year scenario. PADEP assumed this portion of the inventory would see an increase of three percent of total VOC emissions from removal of the Commonwealth's 7.8 psi RVP gasoline program. Table 2 summarizes the changes in nonroad vehicle and equipment emissions in the Pittsburgh-Beaver Valley area from repeal of the state low-RVP gasoline program.

    Table 2—Nonroad Mobile Emissions Comparison Between PADEP's 7.8 psi Low-RVP Program Versus the Federal RVP Program for the Pittsburgh-Beaver Valley Area [In tpy and tpd] 2014 VOC tpy 2018 VOC tpd tpy 2023 VOC tpd tpy Pennsylvania 7.8 psi RVP Program 7,221 37.15 5,684 35.10 5,370 Federal 9.0 psi RVP Program 38.15 5,837 36.11 5,525 Reduction or Increase in Emissions (−) or (+) 1.00 153 1.01 155

    Changes in gasoline RVP produce emissions from not only vehicles and equipment that store and combust the fuel, but also from evaporation and permeation from movement, storage, and transportation of the fuel as part of the gasoline distribution system. These sources include gasoline refineries and terminals, pipelines, gasoline tanker trucks, storage tanks, service station tanks, and portable gas cans. These are a combination of large, point sources of emissions and smaller area sources. PADEP estimates emissions from these sources by different means, ranging from use of emission factors (from EPA's AP-42 compendium of emission factors) coupled with activity information (or surrogates for activity like population) or gasoline sales numbers. Some larger sources (e.g., refineries and bulk gasoline terminals) are sufficiently large to be estimated or measured more directly as discreet sources in the Area's periodic point source emission inventory. Table 3 contains a summary of PADEP's estimated emissions from these point and area sources resulting from a change from the Pennsylvania low-RVP gasoline rule to the federal rule. PADEP assumed this portion of the inventory would see an increase of three percent of total VOC emissions from removal of the Commonwealth's 7.8 psi RVP gasoline program.

    Table 3—Gasoline Distribution System Point and Area Sources Increase in VOC Emissions From Removal of Pennsylvania's 7.8 psi RVP Requirement in the Pittsburgh-Beaver Valley Area [In tpy and tpd] Point/area source category 2014 NEI VOC
  • (tpy)
  • Gasoline Terminals 131.3. Bulk Plants 74.9. Tank Truck Transit 10.4. Service Station Unloading 0.1. Total 2014 NEI Point Source RVP-Related Emissions 216.7. 3% of 2014 Point Emissions, Attributable to 7.8 RVP repeal 7 tpy
  • (0.02 tpd).
  • Table 4 summarizes combined highway mobile, nonroad, and point and area source emissions impacts from the removal of the Commonwealth's 7.8 psi low-RVP program for the 2018 and 2023 scenarios.

    Table 4—Summary of Combined Emission Impacts From Removal of the 7.8 psi Program in the Pittsburgh-Beaver Valley Area in 2018 and 2023 [In tpy and tpd] VOC tpy tpd NOX tpy tpd PM2.5 tpy Highway −41.4 −0.18 43.5 0.3 −2.0 Nonroad 153 1 0 0 0 Point/Area 7 −0.02 0 0 0 Total Change in 2018 Emissions +119 +0.84 +43.5 +0.3 −2.0 Highway −46.5 −0.24 13.1 0.09 −2.2 Nonroad 155 1.01 0 0 0 Point/Area 7 0.02 0 0 0 Total Change in 2023 Emissions +116 +0.79 +13.1 +0.09 −2.2

    Based on our review of the information provided, EPA finds that PADEP used reasonable methods and the appropriate tools (e.g., emissions estimation models, emissions factors, and methodologies) in estimating the effect on emissions from removing the 7.8 psi RVP summertime gasoline program. PADEP determined that in 2018 the emissions increase resulting from removal of the 7.8 psi RVP requirement (and replacement with the federal 9.0 RVP gasoline program) would be 0.84 summertime tpd of VOC and 0.3 summertime tpd of NOX in the Pittsburgh-Beaver Valley Area. PADEP's demonstration shows that direct emissions of PM2.5 decrease by 2.0 tpy from removal of the 7.8 psi RVP requirement (and replacement with the federal 9.0 RVP gasoline program). By 2023, the emissions impact of removal of the 7.8 psi RVP requirement would slightly decrease from 2018, to 0.79 tpd of VOCs and 0.09 tpd of NOX, with direct PM2.5 emissions decreasing slightly more than 2018 estimates.

    B. Pennsylvania's Substitution of Alternative Emissions Reduction Measures for the 7.8 psi Low-RVP Gasoline Program

    PADEP has estimated lost and compensating emission reductions for the year of removal of the Commonwealth's low-RVP gasoline program (after considering the benefits from replacement with the federal 9.0 RVP gasoline program). PADEP has also estimated emissions impacts in the year 2023 to examine the future impacts of removal of the 7.8 psi state summertime RVP requirement. To compensate for the emissions impact of repeal of this requirement in the Pittsburgh-Beaver Valley Area, PADEP has analyzed the emission benefits associated with two substitute measures previously implemented but not “claimed” in any prior SIP attainment plan (under CAA section 172) for the Commonwealth. These measures are: (1) Overcontrol of VOC emissions from Pennsylvania's adhesives rule (25 Pa. Code § 129.77) and (2) unclaimed creditable emissions reductions associated with the permanent closure in 2015 of a glass manufacturing facility in Allegheny County, Guardian Industries Jefferson Hills facility.

    1. Pennsylvania's Adhesives, Sealants, Primers, and Solvents Rule

    Pennsylvania adopted emissions limits for adhesives and sealants consistent with the Ozone Transport Commission (OTC) model rule covering 37 categories of products, on December 24, 2010 (40 Pa. B. 7340). On June 25, 2015 (80 FR 36482), EPA approved the adhesives rule (25 Pa. Code Section 129.77) into the Pennsylvania SIP. Although this measure was implemented prior to the Commonwealth's repeal of the 7.8 psi low-RVP gasoline program, the emissions reductions from the adhesives rule have not previously been “credited” in any attainment, reasonable further progress, redesignation, or maintenance plan SIP for any NAAQS. PADEP has quantified the reductions from the OTC adhesives model rule using studies performed by the California Air Resources Board (CARB), upon which the OTC model rule was derived. As an area source measure, PADEP relied upon population based, per capita emission reduction estimates for the 7-county Pittsburgh-Beaver Valley Area. PADEP extrapolated its per capita emission factor estimate prepared when it adopted the adhesives rule (based on 2009 area population) by population data for 2014, 2018, and 2023. For purposes of comparison to the low-RVP rule, PADEP seasonally adjusted its original estimate for the adhesives rule (based on a 3-month June-August summer season) to reflect the longer low-RVP gasoline summertime season (i.e., 5-month May-September control season). Table 5 summarizes the daily and annual VOC emissions benefit provided by the adhesives rule.

    Table 5—Summary of Pennsylvania's Adhesives Rule VOC Emission Reduction Estimates for 2014, 2018, and 2023 2014 2018 2023 Projected Pittsburgh-Beaver Valley Area Population (persons) 2, 358,096 2,346,571 2,338,002 PADEP Adhesives Rule VOC Annual Reduction Emission Factor (tons per person per year) 4.96 × 10−4 4.96 × 10−4 4.96 × 10−4 PADEP Adhesives Rule VOC Daily Reduction Emission Factor (tons per person per day) 1.36 × 10−6 1.36 × 10−6 1.36 × 10−6 VOC Reduction from PADEP Adhesives Rule (in tpy) 1,169 1,163 1,159 VOC Reduction from PADEP Adhesives Rule (in tpd) 3.21 3.20 3.19 2. Shutdown of Guardian Industries Jefferson Hills Facility

    To further aid in offsetting emission reductions lost from the removal of the summertime 7.8 psi low-RVP gasoline requirement (after replacement with the federal 9.0 RVP gasoline program), PADEP is relying upon emission reductions from the permanent closure of a Guardian Industries Corporation glass manufacturing facility located in Jefferson Hills, Allegheny County (Facility ID 4200300342). This facility ceased operations in August 2015, and Guardian Industries did not request that potentially creditable emission reductions be preserved in the inventory within the one year deadline for doing so under 25 Pa. Code Chapter 127, Subchapter E (relating to emission reduction credit generation under Pennsylvania's new source review (NSR) program). Having missed the legal deadline for doing so, the associated emission reductions from the facility shutdown can no longer be used by any facility for complying with the NSR program. Pennsylvania asserts the reductions have not been used and cannot be used in the future by Pennsylvania to meet any other obligation, including attainment demonstration, facility emission limitation, reasonable further progress, or maintenance plan requirements for the area. The facility has been permanently closed and the emission source removed. The plan approvals and operating permits for the facility are no longer valid. Any new source at this facility would be subject to NSR permitting provisions (including securing emission offsets as required by CAA and Pennsylvania SIP) and would not be able to use any emission reductions from this closure for permitting purposes.

    To quantify emission reductions from the Guardian Industries Jefferson Hills facility shutdown, PADEP applied requirements from Pennsylvania's creditable emissions decrease provisions for applicability determination under the NSR program (25 Pa. Code Section 127.203a), used for calculation of lookback periods and baseline credit determinations for emission reduction credit generation. Table 6 summarizes PADEP's estimate of creditable emission reductions from the Guardian Industry Jefferson Hills facility for use in partially offsetting the removal of the 7.8 psi RVP gasoline program.

    Table 6—Summary of Emission Reductions From the Permanent Shutdown of Guardian Industries Jefferson Hills Facility Permanent emission offsets for 24-month annual average
  • (August 2013-July 2015)
  • Pollutant Offsets
  • (in tpy)
  • Offsets
  • (in tpd)
  • NOX 625 1.8 VOC 13.8 0.04 PM2.5 26.5 N/A
    C. Comparison of Emissions Impacts From Removal of the Commonwealth's 7.8 psi RVP Gasoline Program and the Uncredited Emission Reductions From Substitute Measures

    Pennsylvania is relying upon NOX, VOC, and PM2.5 emission reductions from its adoption of the OTC model adhesives rule and from the shutdown of Guardian Industries Jefferson Hills glass manufacturing facility in Allegheny County to offset the emissions impact of removing the Commonwealth's summertime gasoline volatility control rule and to support that its argument that removal of 7.8 psi RVP requirement from the SIP will not interfere with attainment of any NAAQS. Pennsylvania has elected to adjust upward by 25 percent its estimates for the emission impact of the removal of the 7.8 psi RVP gasoline program (as shown in Table 4), to account for uncertainty in its calculation of the estimates for the emissions benefits from that program. Table 7 summarizes the Pittsburgh-Beaver Valley Area emissions increases from repeal of the low-RVP gasoline program compared to the emissions benefits resulting from the alternative emission reduction measures.

    Table 7—Summary of Pittsburgh-Beaver Valley Impacts From Removal of the 7.8 psi Gasoline Volatility Program Compared to Emissions Benefits From Alternative Measures [In 2018 and 2023] VOC tpy tpd NOX tpy tpd PM2.5 tpy tpd 2018: Change in Emissions from RVP Rule Repeal 6 119 0.84 43.5 0.3 −2.0 Emission Adjustment to RVP Change Estimate (25% increase) 30 0.21 11 0.08 −2.0 Total Emissions Requiring Offset 149 1.05 54.5 0.38 Adhesives Rule Reductions for Offset 1,163 3.2 0 0 0 Facility Shutdown Reductions for Offset 13.8 0.04 625 1.8 26.5 Total Available Offset Emissions 1,177 3.24 625 1.8 28.5 Surplus Reductions After Offset (Total Emissions Requiring Offset—Total Available Offsets) 1,029 2.19 570.5 1.0 28.5 2023: Change in Emissions from RVP Rule Repeal 7 116 0.79 13.1 0.09 −2.0 Emission Adjustment to RVP Change Estimate (25% increase) 29 0.20 3.3 0.02 Total Emissions Requiring Offset 144 0.99 16.4 0.11 −2.0 Adhesives Rule Reductions for Offset 1,159 3.19 0 0 0 Facility Shutdown Reductions for Offset 13.8 0.04 625 1.8 26.5 Total Available Offset Emissions 1,173 3.23 625 1.8 28.5 Surplus Reductions After Offset (Total Emissions Requiring Offset—Total Available Offsets) 1,029 2.24 608.6 1.69 28.5

    As indicated in Table 7, Pennsylvania has a surplus of VOC, NOX, and PM2.5 emission reductions from the alternative emission reduction measures after offsetting the emissions reductions lost from repeal of the Commonwealth's low-RVP gasoline program, in both 2018 (the year of repeal of the low-RVP gasoline program) and in the 2023 future case. Although not needed to offset the low-RVP gasoline rule, PADEP is electing to retire all emissions reductions from the facility shutdown and will not use them for any future NSR program purposes. These surplus emission reductions, not previously claimed for any SIP-approved plan, will help to ensure that removal of the low-RVP gasoline program will not interfere with any NAAQS for the Pittsburgh-Beaver Valley Area.

    6 This increase (or decrease) in emissions is the net emission change when comparing the Commonwealth's 7.8 psi requirement for the Pittsburgh-Beaver Valley Area to the federal 9.0 psi RVP program requirement that will remain upon removal of the Commonwealth's program.

    7 This increase (or decrease) in emissions is the net emission change when comparing the Commonwealth's 7.8 psi requirement for the Pittsburgh-Beaver Valley Area to the federal 9.0 psi RVP program requirement that will remain upon removal of the Commonwealth's program.

    EPA believes that the removal of the 7.8 psi low RVP fuel program requirements in the Pittsburgh-Beaver Valley Area does not interfere with Pennsylvania's ability to demonstrate compliance with any of the ozone or PM2.5 NAAQS, which could potentially have been impacted by the NAAQS pollutant precursors that are the subject of the SIP revision. EPA's analyses of the Commonwealth's SIP revision for CAA 110(l) impact is supported by its use of alternate emission reduction measures that ensure permanent, enforceable, contemporaneous, surplus emissions reductions are achieved within the Pittsburgh-Beaver Valley Area which far exceed the slight increase in NOX and VOC pollutants from the removal of low RVP fuel especially as Pennsylvania is still subject to the federal RVP fuel requirement of 9.0 psi. Based on Pennsylvania's CAA 110(l) analysis showing surplus emission reductions (see Table 7), EPA has no reason to believe that the removal of the low RVP fuel requirements in the Pittsburgh-Beaver Valley area will negatively impact the area's ability to attain or maintain any NAAQS including specifically ozone and PM2.5 or interfere with reasonable further progress. In addition, EPA believes that removing the 7.8 psi low RVP program requirements in the Pittsburgh-Beaver Valley Area will not interfere with any other CAA requirement as the Area will remain subject to the federal low RVP fuel requirements.

    V. Impacts on the Boutique Fuels List

    Section 1541(b) of the Energy Policy Act of 2005 required EPA, in consultation with the U.S. Department of Energy, to determine the number of fuels programs approved into all SIPs as of September 1, 2004 and to publish a list of such fuels. On December 28, 2008 (71 FR 78192), EPA published the list of boutique fuels. EPA maintains the current list of boutique fuels on its website at: https://www.epa.gov/gasoline-standards/state-fuels. The final list of boutique fuels was based on a fuel type approach. CAA section 211(c)(4)(C)(v)(III) requires that EPA remove a fuel from the published list if it is either identical to a federal fuel or is removed from the SIP in which it is approved. Under the adopted fuel type approach, EPA interpreted this requirement to mean that a fuel would have to be removed from all SIPs in which it was approved in order for it to be removed from the list. (71 FR 78195).

    The 7.8 psi RVP fuel program (as required by Pa. Code Chapter 126, Subchapter C), as approved into Pennsylvania's SIP, is a fuel type that is included in EPA's boutique fuel list (71 FR 78198-99; https://www.epa.gov/gasoline-standards/state-fuels). The specific counties in the Pittsburgh-Beaver Valley Area where summer low RVP gasoline is required are identified on EPA's Gasoline Reid Vapor Pressure web page (https://www.epa.gov/gasoline-standards/gasoline-reid-vapor-pressure). Subsequent to the final effective date of EPA's approval of Pennsylvania's May 2, 2018 SIP revision to remove Pennsylvania's Chapter 126, Subchapter C RVP requirement from the SIP, EPA will update the State Fuels and Gasoline Reid Vapor Pressure web pages with the effective date of the SIP removal. However, the entry for Pennsylvania will be not be completely deleted from the list of boutique fuels, as Allegheny County remains subject to a separate, SIP-approved 7.8 psi RVP gasoline requirement of ACHD's Rules and Regulations, Article XXI, pending future action by ACHD to repeal that rule and submit a formal SIP revision requesting its repeal from the Pennsylvania SIP. This deletion of Armstrong, Beaver, Butler, Fayette, Washington, and Westmoreland Counties from the list will not result in an opening on the boutique fuels list because the 7.8 psi RVP fuel type remains for one Pennsylvania County, and in other state SIPs.

    VI. What action is EPA taking?

    EPA is approving Pennsylvania's May 2, 2018 SIP revision to remove the low RVP fuel requirements at 25 Pa. Code Chapter 126, Subchapter C from the Pennsylvania SIP. With this action, EPA is also approving the Commonwealth's supporting CAA 110(l) demonstration in its May 2, 2018 submission that removal of the low RVP gasoline program does not interfere with the Commonwealth's ability to attain or maintain any NAAQS in the Pittsburgh-Beaver Valley Area. Our approval of the May 2, 2018 SIP submittal is in accordance with CAA requirements in section 110, including section 110(l) specifically.

    EPA's approval of the May 2, 2018 Pennsylvania SIP revision does not remove the separate SIP requirement applicable requiring use of 7.8 psi RVP gasoline during summertime months in Allegheny County, under requirements set forth in Article XXI, Rules and Regulations of the ACHD, which were approved by EPA as part of the Commonwealth's SIP on April 17, 2001 (66 FR 19724). PADEP will submit a SIP revision, at a later date, on behalf of ACHD to remove or otherwise amend the separate Allegheny County low RVP gasoline program rule. Neither ACHD's rule nor the related approved Pennsylvania SIP for Article XXI are the subject of this action or the Pennsylvania May 2, 2018 low RVP gasoline SIP revision.

    EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on August 14, 2018 without further notice unless EPA receives adverse comment by July 16, 2018. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

    VII. 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 August 14, 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking action. This action to remove from the Pennsylvania SIP requirements for low RVP fuel for the Pittsburgh Area may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

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

    Dated: June 6, 2018. Cecil Rodrigues, Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart NN—Pennsylvania 2. In § 52.2020, the table in paragraph (c)(1) is amended by removing the title and entries for “Subchapter C—Gasoline Volatility Requirements” under Title 25, Chapter 126 Standard for Motor Fuels.
    [FR Doc. 2018-12703 Filed 6-14-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2017-0157; FRL-9979-32—Region 5] Air Plan Approval; Wisconsin; Regional Haze Progress Report AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving the regional haze progress report under the Clean Air Act (CAA) as a revision to the Wisconsin state implementation plan (SIP). Wisconsin has satisfied the progress report requirements of the Regional Haze Rule. Wisconsin has also provided a determination of the adequacy of its regional haze plan with the progress report.

    DATES:

    This final rule is effective on July 16, 2018.

    ADDRESSES:

    EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2017-0157. All documents in the docket are listed on the www.regulations.gov website. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information (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 either through www.regulations.gov or at the Environmental Protection Agency, Region 5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. We recommend that you telephone Gilberto Alvarez, Environmental Scientist, at (312) 886-6143 before visiting the Region 5 office.

    FOR FURTHER INFORMATION CONTACT:

    Gilberto Alvarez, Environmental Scientist, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6143, [email protected].

    SUPPLEMENTARY INFORMATION:

    Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

    I. Background II. What is EPA's response to the comments? III. What action is EPA taking? IV. Statutory and Executive Order Reviews I. Background

    States are required to periodically submit a progress report that evaluates progress towards the Reasonable Progress Goals (RPGs) for each mandatory Class I Federal area within the State and in each mandatory Class I Federal area outside the State which may be affected by emissions from within the state. See 40 CFR 51.308(g). States are also required to submit, at the same time as the progress report, a determination of the adequacy of the State's existing regional haze SIP. See 40 CFR 51.308(h). The first progress report is due five years after the submittal of the initial regional haze SIP.

    Wisconsin submitted its regional haze plan on January 18, 2012. EPA approved Wisconsin's regional haze plan into its SIP on August 7, 2012 (77 FR 46952). Wisconsin submitted its five-year progress report on March 17, 2017. This is a report on the implementation of the regional haze plan and the progress made in the first implementation period towards RPGs for Class I areas outside of Wisconsin. Wisconsin does not have any Class I areas within its borders where visibility is an important value. This progress report SIP included a determination that Wisconsin's existing regional haze SIP requires no substantive revision to achieve the established regional haze visibility improvement and emissions reduction goals for 2018 for Class I areas impacted by Wisconsin emissions. EPA is approving Wisconsin's progress report on the basis that it satisfies the applicable requirements of the rule at 40 CFR 51.308.

    EPA published a direct final rule (DFR) on October 20, 2017 (82 FR 48766), approving the Wisconsin regional haze progress report as a revision to the Wisconsin SIP, along with a proposed rule (82 FR 48780), that provided a 30-day public comment period. The DFR evaluated the Wisconsin submittal assessing its progress in implementing its regional haze plan during the first half of the first implementation period as well as the statutory and regulatory background for EPA's review of Wisconsin's regional haze plan. The DFR also provided a description of the regional haze requirements addressed in the Wisconsin progress report. The DFR serves as the detailed basis for this action. The adverse comments that EPA received are addressed below.

    II. What is EPA's response to the comments?

    EPA received two relevant comments on the DFR. One commenter supported the approval of the regional haze 5-year progress report SIP. A second commenter expressed concern over Cross State Air Pollution Rule (CSAPR) issues and measures not approved into the SIP. We address the second commenter's concerns here.

    Comment—The commenter argued that EPA cannot approve the Wisconsin regional haze 5-year progress report because the State must revise its regional haze SIP to replace reliance on the Clean Air Interstate Rule (CAIR) and CSAPR with reliance on the “CSAPR Update.” The commenter stated that as CAIR and CSAPR are no longer in effect, these rules cannot be relied on for achieving reasonable progress goals, and that states cannot rely on federal implementation plans (FIPs) as measures must be contained in the SIP. The commenter also claimed that Wisconsin is taking credit for consent decrees, an Administrative Order on Consent for Georgia Pacific that is not approved into the SIP, and limits in title V permits that are not approved into the SIP. The commenter argued that because such measures are not federally enforceable, Wisconsin cannot take credit for them in its regional haze SIP. The commenter also argued that EPA cannot allow states to rely on trading programs to meet the source specific requirements for best available retrofit technology (BART).

    EPA's Response—In its regional haze SIP, Wisconsin relied on participation in CSAPR to satisfy certain of the BART requirements for its subject electric generating units and to satisfy reasonable progress requirements for these sources. In its progress report, Wisconsin notes that significant contribution towards reasonable progress has been made through implementation of CAIR and CSAPR in the State. Although EPA promulgated CSAPR on August 8, 2011 (76 FR 48208), the timing of CSAPR's implementation was impacted by several court actions. EPA began implementing CSAPR on January 1, 2015, and CSAPR is now in force. The commenter, however, argues that because CSAPR has been recently modified, ”CSAPR” as referenced in the EPA-approved Wisconsin BART SIP element is no longer in effect. Similarly, the commenter also states that because CAIR is no longer in effect, the State may not rely on CAIR to achieve reasonable progress goals.

    EPA disagrees with the commenter for several reasons. First, although CAIR is no longer in effect, it was in effect during part of the time period addressed by the progress report. Thus, Wisconsin appropriately described reductions from CAIR in summarizing the emissions reductions achieved during the initial years of the first implementation period. Second, contrary to the commenter's assertion, CSAPR remains in effect and will continue to result in emissions reductions in Wisconsin and other states subject to the rule. The D.C. Circuit affirmed CSAPR in most respects in 2015. EME Homer City Generation, L.P. v. EPA, 795 F.3d 118 (D.C. Cir. 2015). In that decision, the court remanded, without vacating, some of the CSAPR budgets for a number of states. At this point, however, EPA has now taken all actions necessary to respond to that remand, and Wisconsin remains subject to CSAPR following EPA's actions. We also note that on September 29, 2017, EPA finalized a determination that the changes to the scope of CSAPR coverage following our actions on the remand do not alter EPA's conclusion that CSAPR remains better-than-BART. (82 FR 45481). Accordingly, we do not agree that Wisconsin erred in relying on CAIR and CSAPR in its progress report for ensuring the necessary emission reductions.

    We also do not agree that States may not rely on FIPs in considering whether a regional haze implementation plan is sufficient to achieve the reasonable progress goals for nearby Class I areas. The Regional Haze Rule defines “implementation plan” for purposes of the visibility program to mean “any [SIP], [FIP], or Tribal Implementation Plan.”. 40 CFR 51.301. Given this, measures in any issued FIP as well as those in a state's regional haze plan may be relied on in assessing the adequacy of the “existing implementation plan” under 40 CFR 51.308(g)(6) and (h).

    The commenter also stated that Wisconsin is inappropriately taking credit in its progress report for consent decrees, an Administrative Consent Order for Georgia Pacific, and title V permits, none of which, the commenter claimed, are approved into the SIP. Again, we disagree with this comment for several reasons. First, with respect to Georgia Pacific, Wisconsin does describe the Admin istrative Consent Order for the source as a key element of its regional haze SIP; however, the Administrative Consent Order is incorporated by reference into the SIP. See 40 CFR 52.2570(c)(124)(i)(A). Second, it is unclear for which other consent decrees or title V permits Wisconsin is “taking credit” or in what way, but states in general are required to consider emission reductions due to ongoing air pollution control programs in developing a long-term strategy. 40 CFR 51.308(d)(3)(v). Given this, it is appropriate for a state to include a discussion in the progress report of the status of measures the state relied on in developing its long-term strategy.

    Finally, the regulations governing progress reports do not include a requirement for states (or EPA) to ensure that all applicable regional haze requirements for the planning period have been met by the existing plan. As such, the comment raising concerns about the reliance on a regional trading program to satisfy the BART requirement raises issues outside the scope of this rulemaking. We do note, however, that 40 CFR 51.308(e)(4) explicitly allows a state to rely on participation in a CSAPR FIP to address the BART requirements for electric generating units (EGUs). See Utility Air Regulatory Group v. EPA, 885 F.3d 714, 721 (D.C. Cir. 2018)(upholding CSAPR as a BART alternative); see also National Parks Conservation Association v. McCarthy, 816 F.3d 989 (8th Cir. 2016).

    In summary, EPA disagrees that the points raised by the commenter prevent approval of the progress report EPA finds that Wisconsin's progress report satisfies 40 CFR 51.308.

    III. What action is EPA taking?

    EPA is approving the Wisconsin regional haze progress report under the CAA as a revision to the Wisconsin SIP. EPA finds that Wisconsin has satisfied the progress report requirements of the Regional Haze Rule. Wisconsin has also met the requirements for a determination of the adequacy of its regional haze plan with its negative declaration submitted with the progress report.

    IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the 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 this action does not involve technical standards; and

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

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

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

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 14, 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, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: June 4, 2018. Cathy Stepp, Regional Administrator, Region 5.

    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.

    2. Section 52.2593 is added to read as follows:
    § 52.2593 Visibility protection.

    (a) Approval. Wisconsin submitted its regional haze plan to EPA on January 18, 2012, supplemented on June 7, 2012. The Wisconsin regional haze plan meets the requirements of Clean Air Act section 169B and the Regional Haze Rule in 40 CFR 51.308.

    (b) Approval. Wisconsin submitted its five-year progress report on March 17, 2017. The Progress Report meets the requirements of Clean Air Act sections 169A and 169B and the Regional Haze Rule in 40 CFR 51.308.

    [FR Doc. 2018-12810 Filed 6-14-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 405, 417, 422, 423, 460, and 498 [CMS-4182-CN2] RIN 0938-AT08 Medicare Program; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; Correction AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Final rule; correction.

    SUMMARY:

    This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on April 16, 2018 titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program.”

    DATES:

    Effective Date: This correcting document is effective June 15, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Marie Manteuffel, (410) 786-3447. Lucia Patrone, (410) 786-8621.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In FR Doc. 2018-07179 of April 16, 2018 (83 FR 16440), there were a number of technical and typographical errors that are identified and corrected in the Correction of Errors section of this correcting document. The provisions in this correction document are effective as if they had been included in the document that appeared in the April 16, 2018 Federal Register. Accordingly, these corrections are effective June 15, 2018.

    II. Summary of Errors A. Summary of Errors in the Preamble

    On page 16498, in our response to a comment regarding default enrollment, we made and error in referencing the Medicare and Medicaid programs.

    On page 16503, in our response to a comment on passive enrollment eligibility, we included footnote that contains a hyperlink to the document by Health Management Associates titled “Value Assessment of the Senior Care Options (SCO) Program” that is no longer valid.

    On pages 16679 through 16684, we made technical and typographical errors in the table numbering and references of the stop-loss insurance deductible tables.

    On page 16684, in summarizing a comment and response regarding stop-loss coverage, we inadvertently included a response as part of the comment and excluded a sentence from part of a response.

    On page 16703, in the regulatory impact analysis section, we erroneously stated the percentages of Medicare health plan organizations and Part D sponsors that are not-for-profit. In addition, we made factual and typographical errors in our discussion of the percentage of Medicare Advantage organizations (MAOs) that meet the minimum threshold for classification as small businesses.

    On page 16710, in our discussion of the percentage of enrollees that are receiving services under capitated arrangements, we made technical and typographical errors in an assumption and our terminology.

    B. Summary of Errors in the Regulations Text

    On pages 16731 and 16732, in the regulations text changes for § 422.208, we made technical and typographical errors in the table numbering and references of the stop-loss insurance deductible tables.

    On pages 16735 and 16754, in the regulations text for §§ 422.2260 and 423.2260, respectively, we made technical errors in the language and paragraph designations for the definitions of “marketing,” “marketing materials,” and “materials that do not include the following are not considered marketing materials.”

    On page 16735, in the regulations text for § 422.2268 we erroneously indicated that we were revising two paragraphs instead of indicating that we were revising the entire section.

    On page 16738, in the regulations text for § 423.120, we made an inadvertent typographical error in punctuating the end of the paragraph.

    On page 16755, in the regulations text for § 423.2262, we inadvertently omitted the asterisks before paragraph (d), indicating that paragraphs (a) through (c) are retained without change.

    III. Waiver of Proposed Rulemaking and Delay in Effective Date

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment. In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the notice and comment and delay in effective date APA requirements; in cases in which these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process are impracticable, unnecessary, or contrary to the public interest. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and an agency includes a statement of support.

    We believe that this correcting document does not constitute a rule that would be subject to the notice and comment or delayed effective date requirements of the APA or section 1871 of the Act. This correcting document corrects technical and typographic errors in the preamble and regulation text of the final rule but does not make substantive changes to the policies that were adopted in the final rule. As a result, this correcting document is intended to ensure that the information in the final rule accurately reflects the policies adopted in that final rule.

    In addition, even if this were a rule to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the final rule or delaying the effective date would be contrary to the public interest because it is in the public's interest to ensure that final rule accurately reflects our policies. Furthermore, such procedures would be unnecessary, as we are not altering payment eligibility or benefit methodologies or policies, but rather, simply implementing correctly the policies that we previously proposed, received comment on, and subsequently finalized. This correcting document is intended solely to ensure that the final rule accurately reflects these policies. Therefore, we believe we have good cause to waive the notice and comment and effective date requirements.

    IV. Correction of Errors

    In FR Doc. 2018-07179 of April 16, 2018 (83 FR 16440), make the following corrections:

    A. Corrections of Errors in the Preamble

    1. On page 16498, third column, first full paragraph, line 19, the phrase “Medicare or Medicare is issued” is corrected to read “Medicaid or Medicare is issued”.

    2. On page 16503, third column, footnote paragraphs (footnote 29), first bulleted paragraph, lines 3 through 5, the hyperlink “http://www.mahp.com/unify-files/HMAFinalSCOWhitePaper_2015_07_21.pdf” is corrected to read “http://www.mahp.com/wp-content/uploads/2017/04/SCO-White-Paper-HMA-2015_07_20-Final.pdf.

    3. On page 16677, third column, first partial paragraph, lines 26 and 27, the parenthetical reference, “(Table PIP-11)” is corrected to read “(Table 1)”.

    4. On page 16679,

    a. Top two-thirds of the page, third column, partial paragraph—

    (1) Lines 22 and 23, the parenthetical reference, “(Table PIP-11)” is corrected to read “(Table 1)”.

    (2) Line 27, the reference, “Table PIP-11” is corrected to read “Table PIP-1”.

    (3) Line 29, the reference, “Table PIP-11” is corrected to read “Table PIP-1”.

    (4) Line 36, the reference, “Table PIP-11” is corrected to read “Table PIP-1”.

    b. Lower third of the page—

    (1) In the table titled “TABLE PIP-11—COMBINED STOP-LOSS INSURANCE DEDUCTIBLES”, the table title is corrected to read as follows: “TABLE PIP-1—COMBINED STOP-LOSS INSURANCE DEDUCTIBLES”

    (2) After the table, first column, partial paragraph, line 2, the reference “Table 1” is corrected to read “Table PIP-1”.

    5. On page 16680,

    a. First column—

    (1) First partial paragraph, line 11, the reference “Table 1” is corrected to read “Table PIP-1”.

    (2) Second partial paragraph, line 4, the phrase “proposed Table 1” is corrected to read “proposed Table PIP-1”.

    b. Second column,

    (1) Line 6, the parenthetical reference, “(Table PIP-12)” is corrected to read “(Table PIP-2)”.

    (2) Line 15, the reference, “Table PIP-12” is corrected to read “Table PIP-2”.

    (3) Line 17, the reference, “Table PIP-11” is corrected to read “Table PIP-1”.

    (4) Line 19, the reference, “Table PIP-12” is corrected to read “Table PIP-2”.

    c. Third column, partial paragraph—

    (1) Line 2, the reference, “Table PIP-11” is corrected to read “Table PIP-1”.

    (2) Line 4, the reference, “Table PIP-12” is corrected to read “Table PIP-2”.

    (3) Line 8, the reference, “Table PIP-11” is corrected to read “Table PIP-1”.

    (4) Lines 13 and 14, the reference, “Table PIP-12” is corrected to read “Table PIP-2”.

    (5) Line 16, the reference, “Table PIP-12” is corrected to read “Table PIP-2”.

    6. On pages 16681 and 16682,

    a. Top of the page, in the table titled “TABLE PIP-12—SEPARATE STOP-LOSS INSURANCE DEDUCTIBLES”, the table title is corrected to read as follows: “TABLE PIP-2—SEPARATE STOP-LOSS INSURANCE DEDUCTIBLES”

    b. Bottom of the page,

    (1) Second column, partial paragraph, line 2, the reference, “Table PIP-12” is corrected to read “Table PIP-2”.

    (2) Third column, partial paragraph, line 2, the reference, “Table PIP-11” is corrected to read “Table PIP-1”.

    7. On page 16683,

    a. First column,

    (1) First partial paragraph,

    (a) Lines 4 and 5, the reference, “Table PIP-11” is corrected to read “Table PIP-1”.

    (b) Line 5, the reference, “Table PIP-12” is corrected to read “Table PIP-2”.

    (c) Line 14, the reference, “Table PIP-12” is corrected to read “Table PIP-2”.

    (d) Lines 18 and 19, the reference, “Table PIP-12” is corrected to read “Table PIP-2”.

    b. Third column—

    (1) Second full paragraph, lines 12 and 13, the parenthetical reference, “(Tables PIP-11 and PIP-12)” is corrected to read “(Tables PIP-1 and PIP-2)”.

    (2) Fourth full paragraph, lines 5 and 6, the parenthetical reference, “(Table PIP-11)” is corrected to read “(Table PIP-1)”.

    (3) Fifth full paragraph, lines 3 and 4 the parenthetical reference, “(Table PIP-11 and Table PIP-12)” is corrected to read “(Tables PIP-1 and PIP-2)”.

    8. On page 16684, lower two-thirds of the page (following the equation), first column—

    a. Third full paragraph, the paragraph, “Comment: We received a comment recommending that CMS consult with stop loss coverage experts in developing this regulation. We believe that this regulation, as finalized, is consistent with the applicable actuarial principles and practices.” is corrected to read “Comment: We received a comment recommending that CMS consult with stop-loss coverage experts in developing this regulation.”

    b. Fourth full paragraph, the paragraph “Response: Over the years, CMS has had numerous discussions with qualified actuaries regarding our method of determining stop-loss insurance requirements.” is corrected to read “Response: We believe that this regulation, as finalized, is consistent with the applicable actuarial principles and practices. Over the years, CMS has had numerous discussions with qualified actuaries regarding our method of determining stop-loss insurance requirements.”

    c. Last paragraph—

    (1) Line 23, the parenthetical reference, “(Table PIP-11)” is corrected to read “(Table PIP-1)”.

    (2) Line 25, the parenthetical reference, “(Table PIP-12)” is corrected to read “(Table PIP-2)”.

    9. On page 16703, first column—

    a. Second full paragraph, lines 5 through 8, the sentence “42% of all Medicare health plan organizations are not-for-profit and 32% of all Part D sponsors and MA plans are not for profit” is corrected to read “Forty-three percent of all Medicare health plan organizations are not-for-profit and 31 percent of all Part D sponsors and MA plans are not-for-profit.”.

    b. Third full paragraph, lines 14 through 16, “which we have actual data on MAO net worth, also shows that 32 percent of all MAO falls” is corrected to read, “which we have complete data on MAO net worth, shows that 33 percent of all MAOs fall.”

    10. On page 16710, first column, last paragraph—

    a. Lines 4 through 8, the phrase “based on CMS observation of managed care industry trends, we believe that the percentage is now higher, and we assume that 11 percent” is corrected to read “based on CMS observation of managed care industry trends, we assume that 11 percent”.

    b. Line 9, the phrase “now paid under” is corrected to read “now receiving services under”.

    c. Line 13, the phrase “MA members are paid under” is corrected to read “MA members are receiving services under”.

    d. Line 21, the phrase “beneficiaries paid under” is corrected to read “beneficiaries receiving services under”.

    B. Correction of Errors in the Regulations Text
    § 422.208 [Corrected]
    1. On page 16731, third column, amendatory instruction 23a, lines 3 and 4, the parenthetical reference “(Table PIP-11)” is corrected to read “(Table PIP-1)”.
    § 422.208 [Corrected]
    2. On page 16732, a. First column—

    (1) First full paragraph, line 2, the parenthetical reference “(Table PIP-11)” is corrected to read “(Table PIP-1)”.

    (2) Second full paragraph, line 9, the reference “Tables PIP-11 and PIP-12” is corrected to read “Tables PIP-1 and PIP-2”.

    (3) Third full paragraph,

    (a) Line 6, the reference “Table PIP-11” is corrected to read “Table PIP-1”.

    (b) Line 8, the reference “Table PIP-12” is corrected to read “Table PIP-2”.

    (4) Sixth full paragraph—

    (a) Lines 12 and 13, the reference “Table PIP-11” is corrected to read “Table PIP-1”.

    (b) Line 14, the reference “Table PIP-11” is corrected to read “Table PIP-1”.

    (c) Line 15, the reference “Table PIP-12” is corrected to read “Table PIP-2”.

    b. Second column,

    (1) First partial paragraph, line 3, the reference “Tables PIP-11 and PIP-12” is corrected to read “Tables PIP-1 and PIP-2”

    (2) First full paragraph, line 1, the reference “Table PIP-11” is corrected to “Table PIP-1”.

    (3) Fourth full paragraph—

    (a) Line 1, the reference “Table 1” is corrected to read “Table PIP-1”.

    (b) Line 3, the reference “Table PIP-11” is corrected to “Table PIP-1”.

    (4) Fifth full paragraph, line 25, the reference “Table PIP-11” is corrected to “Table PIP-1”.

    (5) Last partial paragraph, line 2, the reference “Table PIP-11” is corrected to “Table PIP-1”.

    c. Third column,

    (1) First partial paragraph, line 3, the parenthetical reference “(Table PIP-12)” is corrected to read “(Table PIP-2).”

    (2) Second full paragraph, line 6, the reference “Table 2” is corrected to read “Table PIP-2”.

    (3) Third full paragraph—

    a. Line 5, the reference “Table PIP-11” is corrected to read “Table PIP-1”. b. Line 6, the reference “Table PIP-12” is corrected to read “Table PIP-2”. c. Line 9, the reference “Table PIP-12” is corrected to read “Table PIP-2”. d. Line 11, the reference “Table PIP-11” is corrected to read “Table PIP-1”. e. Line 13, the reference “Table PIP-12” is corrected to read “Table PIP-2”. f. Lines 15 and 16, the reference “Table PIP-11” is corrected to read “Table PIP-1”.

    (4) Fourth full paragraph—

    a. Line 1, the reference “Table PIP-12” is corrected to read “Table PIP-2”. b. Lines 2 and 3, the reference “Table PIP-11” is corrected to read “Table PIP-1”.

    (5) Eighth full paragraph, line 5, the reference “Table PIP-11 and PIP-12” is corrected to read “Table PIP-1 and PIP-2.”

    3. On page 16735, in the first column, § 422.2260 is corrected to read as follows:
    § 422.2260 Definitions.

    As used in this subpart—

    Communications means activities and use of materials to provide information to current and prospective enrollees.

    Communication materials means all information provided to current and prospective enrollees. Marketing materials are a subset of communication material.

    Marketing means activities and use of materials that meet the following:

    (1) Conducted by the MA organization or downstream entities.

    (2) Intended to draw a beneficiary's attention to a MA plan or plans.

    (3) Intended to influence a beneficiary's decision-making process when selecting a MA plan for enrollment or deciding to stay enrolled in a plan (that is, retention-based marketing).

    Marketing materials—(1) Include, but are not limited to following:

    (i) Materials such as brochures; posters; advertisements in media such as newspapers, magazines, television, radio, billboards, or the internet; and social media content.

    (ii) Materials used by marketing representatives such as scripts or outlines for telemarketing or other presentations.

    (iii) Presentation materials such as slides and charts.

    (2) Marketing materials exclude materials that—

    (i) Do not include information about the plan's benefit structure or cost sharing;

    (ii) Do not include information about measuring or ranking standards (for example, star ratings);

    (iii) Mention benefits or cost sharing, but do not meet the definition of marketing in this section;

    (iv) Are required under § 422.111, unless otherwise specified by CMS based on their use or purpose; or

    (v) Are specifically designated by CMS as not meeting the definition of the marketing definition based on their use or purpose.”

    § 422.2268 [Corrected]
    4. On page 16735, in the second column, amendatory instruction 47, the instructions beginning with the phrase “a. Revising the section” and ending with the phrase “read as follows:” are corrected to read as follows:

    “Section 422.2268 is revised to read as follows:”

    § 423.120 [Corrected]
    5. On page 16738, in the third column, sixth full paragraph (§ 423.120(b)(5)(C)(2)), line 7, the phrase “423.578; and” is corrected to read “423.578.”.
    § 423.160 [Corrected]
    6. On page 16743, first column, eighth full paragraph (§ 423.160(b)(1)(iv)), line 1, the date “October 31, 2019” is corrected to read “December 31, 2019”.
    § 423.2260 [Corrected]
    7. Beginning on page 16754, in the third column fourth full paragraph, § 423.2260 is corrected to read as follows:”
    § 423.2260 Definitions.

    As used in this subpart—

    Communications means activities and use of materials to provide information to current and prospective enrollees.

    Communication materials means all information provided to current and prospective enrollees. Marketing materials are a subset of communication materials.

    Marketing means activities and use of materials that meet the following:

    (1) Conducted by the MA organization or downstream entities.

    (2) Intended to draw a beneficiary's attention to a MA plan or plans.

    (3) Intended to influence a beneficiary's decision-making process when selecting a MA plan for enrollment or deciding to stay enrolled in a plan (that is, retention-based marketing).

    Marketing materials—(1) Include, but are not limited to following:

    (i) Materials such as brochures; posters; advertisements in media such as newspapers, magazines, television, radio, billboards, or the internet; and social media content.

    (ii) Materials used by marketing representatives such as scripts or outlines for telemarketing or other presentations.

    (iii) Presentation materials such as slides and charts.

    (2) Marketing materials exclude materials that—

    (i) Do not include information about the plan's benefit structure or cost sharing;

    (ii) Do not include information about measuring or ranking standards (for example, star ratings);

    (iii) Mention benefits or cost sharing, but do not meet the definition of marketing in this section;

    (iv) Are required under § 423.128, unless otherwise specified by CMS based on their use or purpose; or

    (v) Are specifically designated by CMS as not meeting the definition of the marketing definition based on their use or purpose.”

    § 423.2430 [Corrected]
    8. On page 16756, first column, amendatory instruction 113b, line 1, the words “republishing the” are corrected to read “adding a new”. Dated: June 11, 2018. Ann C. Agnew, Executive Secretary to the Department, Department of Health and Human Services.
    [FR Doc. 2018-12843 Filed 6-14-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket ID FEMA-2018-0002; Internal Agency Docket No. FEMA-8533] Suspension of Community Eligibility AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Final rule.

    SUMMARY:

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

    DATES:

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

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

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

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

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

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

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

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

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

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

    List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

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

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

    § 64.6 [Amended]
    2. The tables published under the authority of § 64.6 are amended as follows: State and location Community No. Effective date authorization/cancellation of sale of flood insurance in community Current
  • effective
  • map date
  • Date certain
  • federal
  • assistance
  • no longer
  • available
  • in SFHAs
  • Region II New Jersey: Little Silver, Borough of, Monmouth County 340305 September 29, 1972, Emerg; February 1, 1978, Reg; June 20, 2018, Susp. June 20, 2018 June 20, 2018. Long Branch, City of, Monmouth County 340307 March 17, 1972, Emerg; May 5, 1976, Reg; June 20, 2018, Susp. ......do   Do. Middletown, Township of, Monmouth County 340313 May 20, 1974, Emerg; February 15, 1984, Reg; June 20, 2018, Susp. ......do   Do. Monmouth Beach, Borough of, Monmouth County 340315 July 30, 1971, Emerg; May 16, 1977, Reg; June 20, 2018, Susp. ......do   Do. Oceanport, Borough of, Monmouth County 340320 July 14, 1972, Emerg; February 16, 1977, Reg; June 20, 2018, Susp. ......do   Do. Shrewsbury, Borough of, Monmouth County 340326 July 3, 1975, Emerg; August 1, 1979, Reg; June 20, 2018, Susp. ......do   Do. Region IV Florida: Orlando, City of, Orange County 120186 August 30, 1974, Emerg; September 3, 1980, Reg; June 20, 2018, Susp. ......do   Do. North Carolina: Autryville, Town of, Sampson County 370358 September 29, 1980, Emerg; February 1, 1987, Reg; June 20, 2018, Susp. ......do   Do. Beulaville, Town of, Duplin County 370547 N/A, Emerg; December 29, 2008, Reg; June 20, 2018, Susp. ......do   Do. Clayton, Town of, Johnston County 370139 April 2, 1975, Emerg; April 1, 1982, Reg; June 20, 2018, Susp. ......do   Do. Clinton, City of, Sampson County 370263 July 2, 1975, Emerg; July 2, 1975, Reg; June 20, 2018, Susp. ......do   Do. Cumberland County, Unincorporated Area 370076 November 3, 1975, Emerg; February 17, 1982, Reg; June 20, 2018, Susp. ......do   Do. Duplin County, Unincorporated Area 370083 November 29, 1979, Emerg; July 4, 1989, Reg; June 20, 2018, Susp. ......do   Do. Four Oaks, Town of, Johnston County 370502 N/A, Emerg; September 24, 2002, Reg; June 20, 2018, Susp. June 20, 2018 June 20, 2018. Goldsboro, City of, Wayne County 370255 May 29, 1975, Emerg; June 1, 1982, Reg; June 20, 2018, Susp. ......do   Do. Pine Level, Town of, Johnston County 370505 N/A, Emerg; June 22, 2005, Reg; June 20, 2018, Susp. ......do   Do. Sampson County, Unincorporated Area 370220 March 29, 1982, Emerg; July 16, 1991, Reg; June 20, 2018, Susp. ......do   Do. Wallace, Town of, Duplin and Pender Counties 370084 April 3, 1975, Emerg; April 2, 1986, Reg; June 20, 2018, Susp. ......do   Do. Warsaw, Town of, Duplin County 370633 December 29, 2005, Emerg; July 17, 2006, Reg; June 20, 2018, Susp. ......do   Do. Wayne County, Unincorporated Area 370254 N/A, Emerg; September 16, 1991, Reg; June 20, 2018, Susp. ......do   Do. Region V Ohio: Fort Jennings, Village of, Putnam County 390468 September 26, 1978, Emerg; March 9, 1984, Reg; June 20, 2018, Susp. ......do   Do. Gilboa, Village of, Putnam County 390469 June 20, 1979, Emerg; May 16, 1995, Reg; June 20, 2018, Susp. ......do   Do. Glandorf, Village of, Putnam County 390470 January 16, 1975, Emerg; March 9, 1984, Reg; June 20, 2018, Susp. ......do   Do. Kalida, Village of, Putnam County 390471 May 9, 1978, Emerg; October 5, 1984, Reg; June 20, 2018, Susp. ......do   Do. Ottawa, Village of, Putnam County 390472 December 27, 1974, Emerg; February 15, 1979, Reg; June 20, 2018, Susp. ......do   Do. Ottoville, Village of, Putnam County 390473 June 2, 1975, Emerg; August 1, 1987, Reg; June 20, 2018, Susp. ......do   Do. Pandora, Village of, Putnam County 390474 September 5, 1974, Emerg; November 1, 1978, Reg; June 20, 2018, Susp. ......do   Do. Putnam County, Unincorporated Area 390465 April 18, 1984, Emerg; December 5, 1990, Reg; June 20, 2018, Susp. ......do   Do. Region X Oregon: Cannon Beach, City of, Clatsop County 410029 March 6, 1974, Emerg; September 1, 1978, Reg; June 20, 2018, Susp. June 20, 2018 June 20, 2018. Clatsop County, Unincorporated Area 410027 February 7, 1974, Emerg; July 3, 1978, Reg; June 20, 2018, Susp. ......do   Do. Gearhart, City of, Clatsop County 410030 April 11, 1974, Emerg; May 15, 1978, Reg; June 20, 2018, Susp. ......do   Do. Seaside, City of, Clatsop County 410032 March 25, 1974, Emerg; September 5, 1979, Reg; June 20, 2018, Susp. ......do   Do. Warrenton, City of, Clatsop County 410033 July 16, 1975, Emerg; May 15, 1978, Reg; June 20, 2018, Susp. ......do   Do. Washington: San Juan County, Unincorporated Area 530149 December 8, 1986, Emerg; March 1, 1991, Reg; June 20, 2018, Susp. ......do   Do. -do- = Ditto. Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension.
    Dated: June 4, 2018. Eric Letvin, Deputy Assistant Administrator for Mitigation, Federal Insurance and Mitigation Administration, Department of Homeland Security, Federal Emergency Management Agency.
    [FR Doc. 2018-12883 Filed 6-14-18; 8:45 am] BILLING CODE 9110-12-P
    83 116 Friday, June 15, 2018 Proposed Rules DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 319 [Docket No. APHIS-2016-0099] RIN 0579-AE45 Importation of Fresh Avocado Fruit From Continental Ecuador Into the Continental United States AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    We are proposing to amend the fruits and vegetables regulations to allow the importation into the continental United States of fresh avocado fruit from continental Ecuador. As a condition of entry, fresh avocado fruit from continental Ecuador would have to be produced in accordance with a systems approach that would include production site registration, field sanitation, packinghouse procedures designed to exclude the quarantine pests, and procedures for packing, storing, and shipping the avocado fruit. The fruit would also have to be imported in commercial consignments, with each consignment identified throughout its movement from place of production to port of entry in the continental United States. The systems approach for all fresh avocado fruit from continental Ecuador, except Hass avocados, would also have to include production site pest control measures. Consignments would have to be accompanied by a phytosanitary certificate issued by the national plant protection organization of Ecuador certifying that the fruit was produced in accordance with the systems approach. This proposed rule would allow for the importation of fresh avocados from continental Ecuador into the continental United States while continuing to provide protection against the introduction of quarantine pests.

    DATES:

    We will consider all comments that we receive on or before August 14, 2018.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0099.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2016-0099, 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-2016-0099 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:

    Ms. Claudia Ferguson M.S., Senior Regulatory Policy Specialist, Regulatory Coordination and Compliance, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737-1231; (301) 851-2352.

    SUPPLEMENTARY INFORMATION: Background

    The regulations in “Subpart-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-83, referred to below as the regulations) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are new to or not widely distributed within the United States.

    The national plant protection organization (NPPO) of Ecuador has requested that the Animal and Plant Health Inspection Service (APHIS) amend the regulations to allow fresh avocado (Persea americana Miller) from continental Ecuador to be imported into the continental United States. As part of our evaluation of Ecuador's request, we prepared a pest risk assessment (PRA) and a risk management document (RMD). Copies of the PRA and the RMD may be obtained from the person listed under FOR FURTHER INFORMATION CONTACT or viewed on the Regulations.gov website (see ADDRESSES above for instructions for accessing Regulations.gov).

    The PRA, titled “Importation of Fresh Avocado Fruit (Persea americana Miller) from Continental Ecuador into the Continental United States” (July 18, 2017), evaluates the risks associated with the importation of fresh avocado fruit into the continental United States from continental Ecuador. The RMD draws upon the findings of the PRA to determine the phytosanitary measures necessary to ensure the safe importation into the United States of avocado from continental Ecuador.

    The PRA identified four pests of quarantine significance present in continental Ecuador that could follow the pathway of consignments of fresh avocado imported from continental Ecuador into the continental United States:

    • The Mediterranean fruit fly (Medfly), Ceratitis capitata Wiedemann,

    • The South American fruit fly, Anastrepha fraterculus Wiedemann,

    • The sapote fruit fly, Anastrepha serpentina Wiedemann, and

    • The guava fruit fly, Anastrepha striata Schiner.

    A quarantine pest is defined in § 319.56-2 as a pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and being officially controlled. Plant pest risk potentials associated with the importation of fresh avocado from continental Ecuador into the continental United States were derived by estimating the consequences and likelihood of introduction of each quarantine pest into the United States and ranking the risk potential as High, Medium, or Low. The PRA determined that these four quarantine pests pose a medium risk of following the pathway of fresh avocado from continental Ecuador into the continental United States and having negative effects on U.S. agriculture.

    Based on the conclusions of the PRA, we have determined that Hass avocados are not hosts of the fruit flies present in Ecuador, while other varieties of avocado are considered to be poor hosts to fruit flies. Therefore, based on the conclusions of the PRA and RMD, we are proposing to allow the importation from continental Ecuador of avocados subject to a systems approach. Under a systems approach, a set of phytosanitary conditions, at least two of which have an independent effect in mitigating the pest risk associated with the movement of commodities, is specified, whereby fruits and vegetables may be imported into the United States from countries that are not free of certain plant pests. For Hass avocados from continental Ecuador, the systems approach would be the same as for other varieties of avocado except that fruit fly trapping and treatment would not be required.

    We are proposing to add the systems approach for avocado from continental Ecuador to the regulations in a new § 319.56-84. The specific mitigation measures required in the systems approach for each quarantine pest are discussed below, as well as in the risk management document.

    General Requirements

    Proposed paragraph (a) of § 319.56-84 would require the NPPO of Ecuador to provide an operational workplan to APHIS that details the activities that the NPPO would, subject to APHIS' approval of the workplan, carry out to meet the requirements of proposed § 319.56-84. The operational workplan would have to include and describe in detail the quarantine pest survey intervals and other specific requirements in proposed § 319.56-84.

    An operational workplan is an agreement between APHIS' Plant Protection and Quarantine program, officials of the NPPO of a foreign government, and, when necessary, foreign commercial entities, that specifies in detail the phytosanitary measures that will be carried out to comply with our regulations governing the importation of a specific commodity. Operational workplans apply only to the signatory parties and establish detailed procedures and guidance for the day-to-day operations of specific import/export programs. Operational workplans also establish how specific phytosanitary issues are dealt with in the exporting country and make clear who is responsible for dealing with those issues. The implementation of a systems approach typically requires an operational workplan to be developed.

    Proposed paragraph (b) of § 319.56-84 would require avocado from continental Ecuador to be imported only in commercial consignments. Produce grown commercially is less likely to be infested with plant pests than noncommercial consignments. Noncommercial consignments are more prone to infestations because the commodity is often ripe to overripe, could be of a variety with unknown susceptibility to pests, and is often grown with little or no pest control. Commercial consignments, as defined in § 319.56-2, are consignments that an inspector identifies as having been imported for sale and distribution. Such identification is based on a variety of indicators, including, but not limited to: Quantity of produce, type of packing, identification of grower or packinghouse on the packaging, and documents consigning the fruits or vegetables to a wholesaler or retailer.

    Production Site Requirements

    Paragraph (c)(1) of proposed § 319.56-84 would require that all production sites participating in the avocado export program be approved by and registered with the NPPO of Ecuador in accordance with the requirements of the operational workplan.

    Paragraph (c)(2) of proposed § 319.56-84 would require the NPPO of Ecuador to visit and inspect the production sites monthly starting 2 months before harvest and continue until the end of the shipping season. APHIS may also monitor the places of production if necessary. If APHIS or the NPPO of Ecuador finds that a place of production is not complying with the requirements of the systems approach, no fruit from the place of production will be eligible for export to the United States until APHIS and the NPPO of Ecuador conduct an investigation and appropriate remedial actions have been implemented.

    Paragraph (c)(3) would require that any fallen avocado fruit be removed from the production site at least once every 7 days, starting 2 months before harvest and continuing through the end of the harvest, and that fallen fruit may not be included in field containers of fruit to be packed for export. Fallen fruit is more susceptible to infestation by pests because it may be overripe or damaged.

    Paragraph (c)(4) would require that, for production sites that produce non-Hass variety avocados, no other host of Medfly or Anastrepha spp. can be grown within 100 meters of the edge of the place of production.

    Paragraph (c)(5) would require the NPPO of Ecuador conduct a fruit fly trapping program beginning at least 2 months before the beginning of harvest and continuing for the duration of the harvest period for the detection of Medfly and Anastrepha spp. at each production site that produces non-Hass variety avocados. This program would support efforts for pest-free production sites within a certified low pest prevalence area for fruit flies. Details of the trapping program would be specified in the operational workplan.

    Paragraph (c)(6) would require that the NPPO of Ecuador maintain records of fruit fly detections for each trap in a non-Hass avocado production site and update the records each time the traps are checked. The trapping records would have to be maintained for at least 1 year and made available for APHIS' review upon request.

    Paragraph (c)(7) would state that, if the number of flies per trap per day exceeds levels specified in the operational workplan for more than 2 consecutive weeks, the place of production would be prohibited from exporting avocados to the continental United States until APHIS and the NPPO of Ecuador jointly agree that the risk has been mitigated.

    Paragraph (c)(8) would require that all harvested avocados be placed in field cartons or containers that are marked to identify the production site from which the consignment of fruit originated. Production site registration and container marking would facilitate traceback of a consignment of avocado fruit to the production site in which it was grown in the event that quarantine pests were discovered in the consignment at the port of first arrival into the United States. The fruit would have to be moved to the packinghouse within 3 hours of harvest or it must be protected from fruit fly infestation until moved.

    Packinghouse Requirements

    We are proposing several requirements for packinghouse activities, which would be contained in paragraph (d) of proposed § 319.56-84. Paragraph (d)(1) would require that all avocados be packed for export to the United States in pest-exclusionary packinghouses approved by and registered with the NPPO of Ecuador in accordance with the requirements of the operational workplan.

    Paragraph (d)(2) would provide that consignments of avocados destined for export to the continental United States must be packed within 24 hours of harvest and safeguarded during movement from registered packinghouses to arrival at the port of entry into the continental United States as specified by the operational workplan. Such safeguarding could include the use of pest-proof screens or tarpaulins to cover the lots during transit, or other similar measures approved by APHIS and the NPPO of Ecuador. We would require these safeguards to remain intact until the consignment's arrival in the continental United States or the consignment would be denied entry into the continental United States.

    Paragraph (d)(3) would require that all openings to the outside of the packinghouse must be covered by screening with openings of not more than 1.6 mm or by some other barrier that prevents pests from entering. The packinghouse would have to have double doors at the entrance to the facility and at the interior entrance to the area where the avocados are packed.

    Paragraph (d)(4) would require that, while in use for exporting avocado fruit to the continental United States, the packinghouses may only accept avocados from registered a pproved production sites and the fruit must be segregated from fruit intended for other markets. This requirement would prevent such avocados intended for export to the continental United States from being exposed to or otherwise mixed with avocados that are not produced according to the requirements of the systems approach. Avocados from other places of production may be produced under conditions that are less stringent than those of this proposed rule, and may therefore be a pathway for introduction of quarantine pests into the packinghouses.

    Paragraph (d)(5) would require that the identity and origin of the fruit be maintained from the packinghouse through export of consignments to the United States. This requirement would ensure that APHIS and the NPPO of Ecuador could identify the packinghouse at which the fruit was packed if inspectors find quarantine pests in the fruit either before export or at the port of entry.

    Treatment

    Paragraph (e) would state that, if non-Hass variety avocados are ineligible for export under the systems approach due to the place of production exceeding the trapping threshold for fruit flies as established in the operational workplan, they may still be exported, but only after undergoing an APHIS approved treatment in accordance with 7 CFR part 305.

    Currently, irradiation treatment under treatment schedule T105-a-1 is the only treatment approved for all fruit flies and may be used to export non-Hass avocados from Ecuador. Under this treatment, the fruit must be irradiated with a minimum absorbed dose of 150 Gy to be applied upon arrival in the United States and follow the requirements of 7 CFR part 305. In the future, when irradiation facilities become available in Ecuador, irradiation may be applied in Ecuador as long as the treatment follows all requirements of 7 CFR part 305.

    Phytosanitary Inspection

    Paragraph (f)(1) would require that a biometric sample of avocados, jointly agreed upon by APHIS and the NPPO of Ecuador, be inspected in Ecuador by the NPPO following post-harvest processing. The sample would have to be visually inspected for all quarantine pests and a portion of the fruit would be cut open, if the fruit shows signs of internal pests. If any quarantine pests are found, the entire consignment of avocados would be prohibited from import into the continental United States unless treated using an APHIS-approved treatment in accordance with 7 CFR part 305.

    Paragraph (f)(2) would require that fruit presented for inspection at a U.S. port of entry be identified in the shipping documents accompanying each consignment of fruit that specify the place of production in which the fruit was produced and the packinghouse in which the fruit was processed. This identification would have to be maintained with the consignment until the fruit is released for entry into the continental United States.

    Phytosanitary Certificate

    Paragraph (g) would require that each consignment of avocado fruit be accompanied by a phytosanitary certificate issued by the NPPO of Ecuador that states that the avocados in the consignment have been produced in accordance with the requirements of §§ 319.56-84.

    Executive Orders 12866 and 13771 and Regulatory Flexibility Act

    This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. Further, because this rule is not significant, it is not a regulatory action under Executive Order 13771.

    In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov website (see ADDRESSES above for instructions for accessing Regulations.gov).

    APHIS is proposing to allow the importation of fresh avocados from continental Ecuador into the continental United States under certain pest mitigation measures. This would be the first opportunity Ecuador has had to export fresh avocados to the United States. Over the 6-year period 2010-2015, Ecuador's avocado exports declined precipitously, from over 8,000 metric tons (MT) in 2010 to about 1,000 MT in 2015. Over these 6 years, Ecuador's avocado exports averaged 4,884 MT per year, reportedly valued at about $310,000 for an average price of less than $0.07 per kilogram or $63.50 per MT. This price is inexplicably low and may well indicate data error.

    The United States is a net importer of avocados. Over the same 6-year period, 2010-2015, annual U.S. avocado imports averaged more than 570,000 MT, valued at $1.1 billion. Mexico is the principal source, accounting for 86 percent of U.S. avocado imports.

    If between 5 percent and 20 percent of Ecuador's average fresh avocado exports to the world, 2010-2015, that is, between 244 and 976 MT, were imported by the United States, we estimate that U.S. producer welfare would fall by between $95,000 and $383,000, consumer welfare would rise by between $428,000 to $1.72 million, for a net social welfare gain of between $332,000 and $1.33 million. At the midpoint of this range, the net social gain would be $833,000. In accordance with guidance on complying with Executive Order 13771, the primary estimate of the cost savings of this proposed rule is $833,000, the mid-point estimate of cost savings annualized in perpetuity using a 7 percent discount rate.

    While most U.S. avocado farms are small entities, they would not be significantly affected by this proposed rule. Annual avocado imports by the United States from Ecuador of between 244 and 976 MT would be equivalent to between 0.04 and 0.17 percent of the quantity of avocados imported by the United States annually.

    Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

    Executive Order 12988

    This proposed rule would allow fresh avocado to be imported into the continental United States from continental Ecuador, subject to a systems approach. If this proposed rule is adopted, State and local laws and regulations regarding fresh avocado imported under this rule would be preempted while the fruit is in foreign commerce. Fresh avocados are generally imported for immediate distribution and sale to the consuming public and would remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. If this proposed rule is adopted, no retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.

    Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), reporting and recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send comments on the Information Collection Request (ICR) to OMB's Office of Information and Regulatory Affairs via email to [email protected], Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2016-0099. Please send a copy of your comments to the USDA using one of the methods described under ADDRESSES at the beginning of this document.

    APHIS is proposing to amend the fruit and vegetable regulations to allow the importation of avocados from continental Ecuador into the continental United States. As a condition of entry, the avocados would have to be produced in accordance with a systems approach that would include requirements for importation in commercial consignments, registration and monitoring of places of production, field monitoring and pest-control practices, trapping, and inspection for quarantine pests by the NPPO of Ecuador.

    Implementing this rule will require information collection activities such as an operational workplan, production site and packinghouse registrations, marking of fruit cartons, phytosanitary inspections and certificates, notices of suspension to export, notices of resumption to export, preclearance inspection documentation, import permit applications, notices of arrival, emergency action notifications, and creation and maintenance records.

    We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:

    (1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;

    (2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, 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 information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).

    Estimate of burden: Public reporting burden for this collection of information is estimated to average 0.012 hours per response.

    Respondents: NPPO of Ecuador, production site and packinghouse managers, and importers of avocados from Ecuador.

    Estimated annual number of respondents: 44.

    Estimated annual number of responses per respondent: 1,154.

    Estimated annual number of responses: 50,791.

    Estimated total annual burden on respondents: 623 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.)

    A copy of the information collection may be viewed on the Regulations.gov website or in our reading room. (A link to Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule.) Copies can also be obtained from Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483. APHIS will respond to any ICR-related comments in the final rule. All comments will also become a matter of public record.

    E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to compliance 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. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

    List of Subjects in 7 CFR Part 319

    Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Rice, Vegetables.

    Accordingly, we propose to amend 7 CFR part 319 as follows:

    PART 319—FOREIGN QUARANTINE NOTICES 1. The authority citation for part 319 continues to read as follows: Authority:

    7 U.S.C. 450 and 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

    2. Section 319.56-84 is added to read as follows:
    § 319.56-84 Fresh avocado fruit from continental Ecuador.

    Fresh avocados (Persea americana Miller), may be imported into the continental United States from continental Ecuador only under the conditions described in this section. These conditions are designed to prevent the introduction of the following quarantine pests: Anastrepha fraterculus Wiedemann, Anastrepha serpentina Wiedemann, Anastrepha striata Schiner, and Ceratitis capitata Wiedemann.

    (a) Operational workplan. The national plant protection organization (NPPO) of Ecuador must provide an operational workplan to APHIS that details the activities that the NPPO of Ecuador will, subject to APHIS' approval of the workplan, carry out to meet the requirements of this section. The operational workplan must include and describe the quarantine pest survey intervals and other specific requirements as set forth in this section.

    (b) Commercial consignments. Avocados from continental Ecuador may be imported in commercial consignments only.

    (c)(1) Production site requirements. All production sites that participate in the export program must be approved by and registered with the NPPO of Ecuador in accordance with the requirements of the operational workplan.

    (2) The NPPO of Ecuador will visit and inspect the production sites monthly starting 2 months before harvest and continue until the end of the shipping season. APHIS may also monitor the places of production if necessary. If APHIS or the NPPO of Ecuador finds that a place of production is not complying with the requirements of this section, no fruit from the place of production will be eligible for export to the United States until APHIS and the NPPO of Ecuador conduct an investigation and appropriate remedial actions have been implemented.

    (3) Fallen avocado fruit must be removed from the production site at least once every 7 days, starting 2 months before harvest and continuing through the end of the harvest, and fallen fruit may not be included in field containers of fruit to be packed for export.

    (4) At each non-Hass avocado production site, no other host of A. fraterculus, A. serpentina, A. striata, or C. capitata can be grown within 100 meters of the edge of the place of production.

    (5) At each non-Hass avocado production site, the NPPO of Ecuador must conduct a fruit fly trapping program beginning at least 2 months before the beginning of harvest and continuing for the duration of the harvest period for the detection of A. fraterculus, A. serpentina, A. striata, and C. capitata in accordance with the operational workplan.

    (6) The NPPO of Ecuador must maintain records of fruit fly detections for each trap in a non-Hass avocado production site and update the records each time the traps are checked. The trapping records must be maintained for at least 1 year and provided for APHIS' review, if requested.

    (7) If the number of flies per trap per day exceeds levels specified in the operational workplan for more than 2 consecutive weeks, the place of production will be prohibited from exporting avocados to the continental United States until APHIS and the NPPO of Ecuador jointly agree that the risk has been mitigated.

    (8) All avocados must be placed in field cartons or containers that are marked to identify the production site from which the consignment of fruit originated. The fruit must either be moved to the packinghouse within 3 hours of harvest or protected from fruit fly infestation until moved.

    (d)(1) Packinghouse requirements. Avocados must be packed for export to the continental United States in pest-exclusionary packinghouses that are approved by and registered with the NPPO of Ecuador in accordance with the requirements of the operational workplan.

    (2) The avocados must be packed within 24 hours of harvest in a pest-exclusionary packinghouse in accordance with the requirements of the operational workplan. The avocados must be safeguarded by an insect-proof mesh screen or plastic tarpaulin while in transit to the packinghouse and while awaiting packing. The avocados must be packed in insect-proof cartons or containers, or covered with insect-proof mesh or plastic tarpaulin, for transit into the continental United States. These safeguards must remain intact until arrival at the port of entry into the continental United States or the consignment will be denied entry into the continental United States.

    (3) All openings to the outside of the packinghouse must be covered by screening with openings of not more than 1.6 mm or by some other barrier that prevents pests from entering. The packinghouse must have double doors at the entrance to the facility and at the interior entrance to the area where the avocados are packed.

    (4) During the time the packinghouse is in use for exporting avocados to the continental United States, the packinghouse may only accept avocados from registered approved production sites and the fruit must be segregated from fruit intended for other markets.

    (5) The identity and origin of the fruit must be maintained from the packinghouse through export of consignments to the United States.

    (e) Treatment. If the non-Hass variety avocados are ineligible for export under the systems approach due to the place of production exceeding the trapping threshold for fruit flies as established in the operational workplan, they may still be exported, but only after undergoing an APHIS approved treatment in accordance with part 305 of this chapter.

    (f) Phytosanitary inspection. (1) Inspectors from the NPPO of Ecuador must inspect a biometric sample of the fruit from each avocado consignment jointly agreed upon by APHIS and the NPPO of Ecuador, following post-harvest processing. The inspectors must visually inspect for quarantine pests listed in the operational workplan required by paragraph (a) of this section and must cut fruit if signs of quarantine pests that are internal feeders are observed. If quarantine pests are detected in this inspection, the consignment will be prohibited entry into the United States unless it is treated with an APHIS-approved quarantine treatment in accordance with part 305 of this chapter.

    (2) Fruit presented for inspection at a U.S. port of entry must be identified in the shipping documents accompanying each consignment of fruit that specify the place of production in which the fruit was produced and the packinghouse in which the fruit was processed. This identification must be maintained until the fruit is released for entry into the continental United States.

    (g) Phytosanitary certificate. Each consignment of avocado fruit must be accompanied by a phytosanitary certificate of inspection issued by the NPPO of Ecuador that states that the fruit in the consignment was produced in accordance with the requirements of § 319.56-84.

    Done in Washington, DC, this 11th day of June 2018. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2018-12827 Filed 6-14-18; 8:45 am] BILLING CODE 3410-34-P
    FARM CREDIT ADMINISTRATION 12 CFR Part 612 RIN 3052-AC44 Standards of Conduct and Referral of Known or Suspected Criminal Violations; Standards of Conduct AGENCY:

    Farm Credit Administration.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Farm Credit Administration (FCA, we, or our) proposes to amend our regulations governing standards of conduct of directors and employees of Farm Credit System (FCS or System) institutions, excluding the Federal Agricultural Mortgage Corporation. The proposed rule would replace the original proposed rule, and would require every System institution to have or develop a Standards of Conduct Program based on core principles to put into effect ethical values as part of corporate culture.

    DATES:

    You may send comments on or before September 13, 2018.

    ADDRESSES:

    We offer a variety of methods for you to submit your comments. For accuracy and efficiency reasons, commenters are encouraged to submit comments by email or through FCA's website. As facsimiles (fax) are difficult for us to process and achieve compliance with section 508 of the Rehabilitation Act, we are no longer accepting comments submitted by fax. Regardless of the method you use, please do not submit your comment multiple times via different methods. You may submit comments by any of the following methods:

    Email: Send us an email at [email protected]

    FCA Website: http://www.fca.gov. Select “Public Commenters,” then “Public Comments” and follow the directions for “Submitting a Comment.”

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

    Mail: Barry F. Mardock, Deputy Director, Office of Regulatory Policy, Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102-5090.

    You may review copies of comments we receive at our office in McLean, Virginia, or from our website at http://www.fca.gov. Once you are in the website, select “Public Commenters,” then “Public Comments” and follow the directions for “Reading Submitted Public Comments.” We will show your comments as submitted but, for technical reasons, we may omit items such as logos and special characters. Identifying information that you provide, such as phone numbers and addresses, will be publicly available. However, we will attempt to remove email addresses to help reduce internet spam.
    FOR FURTHER INFORMATION CONTACT:

    Jacqueline R. Melvin, Senior Policy Analyst, Office of Regulatory Policy, (703) 883-4498, TDD (703) 883-4056, [email protected], or Mary Alice Donner, Senior Counsel, Office of General Counsel, (703) 883-4020, TDD (703) 883-4056, [email protected]

    SUPPLEMENTARY INFORMATION: I. Objectives

    The objectives of this proposed rule are to:

    • Establish principles for ethical conduct and recognize each System institution's responsibility for promoting an ethical culture;

    • Provide each System institution flexibility to develop specific guidelines on acceptable practices suitable for its business;

    • Encourage each System institution to foster core ethical values and conduct as part of its corporate culture;

    • Require each System institution to develop strategies and a system of internal controls to promote institution and individual accountability in ethical conduct, including by establishing a Standards of Conduct Program and adopting a Code of Ethics; and

    • Remove prescriptive requirements that do not promote these objectives.

    II. Background

    Our standards of conduct regulations have not been significantly changed since their 1994 publication.1 Over the past few years, there have been increasing concerns with governance, oversight, management practices and standards of conduct in the financial services industry. The proposed rule would update FCA's regulations in view of these concerns, and would address the ethical culture under which System institutions should operate.2

    1 The original proposed regulation was published in the Federal Register on February 20, 2014, (79 FR 9649). The objective was to build on the existing standards of conduct rules by adding a few new provisions, clarifying or augmenting some current provisions, and providing additional flexibility for others. After receiving comments, FCA determined to use a different approach.

    2 “The Directors Role” booklet states that sound ethics and adherence to standards of conduct, among other things, are essential to effective oversight.

    III. The Importance of Ethical Culture

    Public confidence in the integrity and ethical business practices of any financial institution is fundamental to its ongoing viability. Unethical or preferential business practices can damage a financial institution's reputation and lead to earnings and credit risk. Congress granted the Farm Credit System certain attributes that result in Government-sponsored enterprise (GSE) status. This status confers on System institutions additional responsibility to strive for high ethical standards and business practices.

    IV. The Proposed Rule

    This rule would establish core principles for ethical conduct. It would set forth basic tenets of ethical business practices to compel each System institution to foster a culture of loyalty, honesty, integrity and accountability. The proposed rule would set forth principles by which a System institution must do business. The System institution would be responsible for establishing and enforcing policies that expand on these principles, and for clearly communicating expectations for acceptable behavior to directors and employees. FCA believes that the proposed rule would promote ethical conduct. At the same time, because it is less prescriptive than the current rule, it could reduce regulatory burden.

    A. Organization

    The proposed rule would change the organization of the current rule. It would consolidate, rename and assign new numbers to some sections and remove other sections altogether. The following bullets summarize the changes:

    • Proposed § 612.2136 would set forth the principles that serve as the foundation for the rule. It would substantively revise and rename current § 612.2135 “Director and employee responsibilities and conduct—generally”.

    • Proposed § 612.2137 “Elements of a Standards of Conduct Program,” would consolidate current § 612.2160 “Institution responsibilities” and current § 612.2165 “Policies and procedures”.

    • Proposed § 612.2138 “Conflicts of interest, reporting of financial interests” would consolidate current “Director reporting” and current § 612.2155 “Employee reporting”.

    • Proposed § 612.2139 “Prohibited conduct” would consolidate current § 612.2140 “Directors—prohibited conduct” and § 612.2150 “Employees—prohibited conduct”. It would also include the prohibitions in current § 612.2157 “Joint employees” and current § 612.2270 “Purchase of System obligations”.

    • Proposed § 612.2137 would require that institutions develop policies and procedures with respect to agents to avoid conflicts of interests and would replace current § 612.2260 “Standards of conduct for agents”.

    B. Definitions [Proposed § 612.2130]

    The proposed rule would define “Code of Ethics,” “resolved” and “Standards of Conduct Program”. We would change the term “controlled entity and entity controlled by” to “reportable business entity” and modify the definition of “employee”. We would omit the definitions of “officer” and “service corporation” as redundant with the definitions of “employee” and “System institution”, respectively. We would omit the definition of “relative” as redundant with the definition of “family” in the current rule and “immediate family” in § 620.1(e). We would make the definition of System institutions more concise. These and other changes and clarifications are discussed below.

    Agent. We would modify the definition of “agent” to clarify that an agent includes someone who currently represents a System institution as a fiduciary in contacts with third parties. The proposed rule adds the language “as a fiduciary” to the definition of agent to explain that not all outside parties performing services for the System institution require the conflict of interest disclosure required of agents. For example, the contractor responsible for maintaining grounds would not be an agent. However, those with fiduciary responsibilities, such as lawyers, accountants, and those representing the System institution in contacts with third parties would be an agent. Each System institution should review the risks associated with its use of third parties and should expand or elaborate on the definition of agent, depending on the System institution's need for conflict disclosures in those relationships. Special consideration should be given to cyber security issues in third party relationships and information technology specialists should be subject to especially heightened ethical controls and confidentiality requirements.

    Code of Ethics. The proposed rule would define “Code of Ethics” as a written statement of the principles and values the System institution follows to establish a culture of ethical conduct. The Code of Ethics directs professionalism and discourages misconduct so that the best interests of the institution and the System are advanced.

    Conflict of interest. This definition would explain that a conflict can arise whenever a secondary or non-work-related interest might unduly influence or materially impact a director's or employee's work-related decision-making.

    Employee. The proposed rule would define “employee” to mean any individual, including an officer, who works for the System institution. Every individual who works for the System institution, including temporary employees and interns, would be part of the ethical corporate culture, regardless of length or term of employment. System institutions should also consider whether and when third-party contractors should be included in the definition of employee or agent.

    Entity. The proposed rule would add “sole proprietorship” to the definition of “entity” in the current rule and make other non-substantive changes.

    Family. The proposed rule would include “significant others” in the definition of “family”. The System institution could elaborate on this definition, and consider whether to include cousins or civil union partners.

    Material. The definition of “material” in the proposed rule is not substantively different from the definition in the current rule. Each System institution must set its own specific parameters for what would constitute a material financial interest or transaction. The dollar amount or value of material, in the context of a financial interest or transaction, should be determined by the System institution board. This should be based on the institution's needs for tracking and supervising the potentially conflicting business and financial activities of its directors and employees.

    Ordinary course of business. We would clarify that an ordinary course of business transaction is one that is usual and customary “in the business in question”, on terms that are not preferential. Each System institution must determine what activities and transactions are in the ordinary course of business. Generally, a person provides goods or services in the ordinary course of business if the transaction is usual or customary for the kind of business in which the seller or service provider is engaged or with the seller's or service provider's own usual or customary practices. So, for example, a borrower sells crop inputs (seed, fertilizer, etc.), and a System institution director or employee wishes to purchase the crop inputs. A transaction in the ordinary course of business would mean that the borrower sells the crop inputs at the price and terms common to others in the industry. It would mean that the director or employee is typical of an ordinary purchaser of crop inputs in the industry. Also, the terms of the arrangement should be consistent with the other transactions, if any, between this borrower/seller and director or employee/buyer.

    Another example involves services in the ordinary course of business, such as accounting, legal or medical. A System institution director may need a lawyer. The fact that the best lawyer is a borrower, does not preclude the director from engaging that lawyer for personal use, assuming no conflict, if the terms of the engagement are usual or customary practices in the legal field. The director must pay the lawyer at the going rate, the legal services must be of the kind the lawyer typically provides in the business, and the relationship cannot have any preferential terms or discounts.

    Preferential. The proposed rule would not change the definition of “preferential” but would list it separately from the definition of “ordinary course of business”.

    Reportable business entity. The proposed rule would change the term “controlled entity and entity controlled by” and replace it with “reportable business entity”. The proposed rule would provide that a reportable business entity is an entity in which the reporting individual, directly or indirectly or acting through or in concert with one or more persons, owns a material percentage of the equity; owns, controls, or has the power to vote a material percentage of any class of voting securities; or has the power to exercise a material influence over management of policies of such entity. We would make this change to avoid confusion with the term “control” in the corporate context, and to allow the System institution discretion to determine how much interest represents a conflict. This determination may vary depending on whether the entity is private, public, profit, or not for profit. The intent of this provision is to require directors and employees to identify and report any business interest that is significant enough to create a conflict of interest or the appearance of a conflict of interest when considered from the perspective of an ordinarily prudent and reasonable person.

    Resolved. We would define “resolved” to mean an actual or apparent conflict of interest that has been addressed with an action such as recusal, divestiture, approval or exception, job reassignment, employee supervision, employment separation or other action, with the result that a reasonable person with knowledge of the relevant facts would conclude that the conflicting interest is unlikely to adversely affect the person's performance of official duties in an objective and fair manner and in furtherance of the interests and statutory purposes of the Farm Credit System.

    Standards of Conduct Official. The proposed rule would modify the definition of Standards of Conduct Official (or Official). Because of the variety of institution sizes and resources, we do not require the Standards of Conduct Official to be a senior officer. However, the focus of this proposal is on accountability in ethical conduct; therefore, the Official must be an employee who is an officer appointed under § 612.2137(b), and must have the authority to report directly to the System institution board or designated board committee on standards of conduct matters. The Official should be an employee who is able to exert a positive influence in ethical matters on System institution directors and employees. The Official would be independent in his duties related to standards of conduct. It may be practical for some larger System institutions to appoint more than one Standards of Conduct Official.

    Standards of Conduct Program. The proposed rule would define “Standards of Conduct Program” to mean the policies and procedures, internal controls, and other actions a System institution must implement to put into practice the requirements of this rule. The Standards of Conduct Program is the totality of the policies and procedures, internal controls, audit, training, and other activities that promote ethical behavior.

    C. Standards of Conduct—Core Principles [Proposed § 612.2136]

    As mentioned in Section A, we would substantively revise and rename current § 612.2135 “Director and employees responsibilities and conduct—generally” as proposed § 612.2136 “Standards of conduct—core principles.” Proposed § 612.2136 would establish principles that directors and employees must follow in performing official duties. We specifically request comment on the effectiveness of the proposed principles in reaching the objective of fostering a culture of ethical conduct.

    Paragraph (a) would establish core principles. Paragraph (b) would set forth certain basic minimum requirements to comply with the principles.

    Proposed § 612.2136(a)(1) would set forth the first principle: To maintain the highest ethical standards of the financial banking industry, including standards of care, honesty, integrity and fairness. This principle establishes that these standards, important in the financial banking industry, are critical to the conduct expected of a GSE. System institution directors and employees should consider ethical conduct beyond reproach a component of their job responsibilities.

    System institution directors and employees must avoid self-serving practices and hold performance of their duties to the institution above personal concerns. They must not use their position for personal advantage. Proposed § 612.2136(a)(2) would set forth the principle that institution directors and employees must act in the best interest of the institution. Proposed § 612.2136(a)(3) would set forth the principle to preserve the reputation of the institution and the public's confidence in the Farm Credit System. Proposed § 612.2136(a)(4) would set forth the principle to exercise diligence and good business judgment in carrying out duties and responsibilities.

    Proposed § 612.2136(a)(5) would state as a principle the responsibility to report, vet and make all reasonable efforts to resolve conflicts and the appearance of conflicts in business relationships and activities. As a corollary, proposed § 612.2136(a)(6) would set forth the principle that directors and employees must avoid self-dealing and acceptance of gifts or favors that may influence or have the appearance of influencing official actions or decisions. Proposed rules concerning acceptance of gifts are set forth in proposed § 612.2137(d)(6). Proposed § 612.2136(a)(7) would require directors and employees, if applicable, to fulfill fiduciary duties.

    Proposed § 612.2136(b)(1) would require institution directors and employees to comply with their System institution's Standards of Conduct Program and Code of Ethics. Proposed § 612.2136(b)(2) would require institution directors and employees to comply with all applicable laws and regulations when carrying out official duties. Applicable laws and regulations would include all FCA regulations and Federal laws. Proposed § 612.2136(b)(3) would require institution directors and employees to participate in annual standards of conduct training, and to acknowledge participation with a written certification. Section 612.2136(b)(4) would require directors and employees to report, under § 612.2137(e), known or suspected illegal or unethical activities, and known or suspected violations of the institution's rules on standards of conduct and Code of Ethics. Reporting would be made to the Standards of Conduct Official or through the institution's hotline or other method consistent with the institution's procedures for anonymous reporting.

    D. Elements of a Standards of Conduct Program [Proposed § 612.2137]

    The proposed rule would consolidate current § 612.2160 “Institution responsibilities” with current § 612.2165 “Policies and procedures,” in proposed § 612.2137 “Elements of a Standards of Conduct Program.” This section would require each System institution to establish a Standards of Conduct Program that incorporates the principles established in proposed § 612.2136 and provide resources for its implementation. A System institution may continue to use its existing Standards of Conduct Program if it incorporates the core principles and satisfies the requirements of this proposed rule.

    The Standards of Conduct Program would set forth specific guidelines on acceptable and unacceptable business practices. Policies and procedures should include requirements and prohibitions as necessary to promote public confidence in the institution and the System, and further the objectives of the principles and this proposed rule. Each System institution should enhance these requirements with comprehensive rules as necessary to meet System institution goals. Each System institution would be required to allocate resources to administer the Standards of Conduct Program. This could include hiring personnel in addition to the Standards of Conduct Official, if necessary, to assist in responsibilities such as reviewing reports, providing training, and conducting investigations. It could include use of outside counsel, especially if the Standards of Conduct Official is not an attorney, and whatever additional resources are necessary to implement the Standards of Conduct Program and promote the ethical culture of the System institution.

    The System institution board is ultimately responsible for implementing the principles and for compliance and oversight of the Standards of Conduct Program. Proposed § 612.2137(a) would require each institution to establish a Standards of Conduct Program that sets forth the core principles in § 612.2136. Proposed § 612.2137(b) would require the board of directors to appoint a Standards of Conduct Official, defined as an employee, who would be responsible for carrying out the duties set forth in proposed § 612.2170. To carry out these responsibilities and promote the ethical culture required by the proposed rule, the Standards of Conduct Official should have a close relationship with the employees of the System institution and be in a position of authority and trust. Because the board of directors is ultimately responsible for compliance, the Standards of Conduct Official must have direct access to the board or designated board committee on standards of conduct matters. The Standards of Conduct Official would be required to meet periodically with the board or designated board committee as proposed in § 612.2170(g).

    Proposed § 612.2137(c) would require each System institution to adopt a written Code of Ethics that states the institution's principles and values and guides directors and employees in ethical conduct. These principles and values must include standards for appropriate professional conduct at the workplace and in matters related to employment. The Code of Ethics would be a component of the Standards of Conduct Program. To demonstrate commitment to its values and to provide transparency and accountability in ethical conduct, the proposed rule requires each System institution to post its Code of Ethics on the System institution's external (public) website.

    Proposed § 612.2137(d) would require each System institution to establish policies and procedures to put into operation the Standards of Conduct Program and to comply with the provisions of this proposed rule.

    Proposed § 612.2137(d)(1) would require each System institution to establish policies and procedures for reporting. At a minimum, these would include reporting requirements sufficient to identify any conflicts of interest, actual or apparent; any business transactions with directors, employees, borrowers and agents that are not in the ordinary course of business; any gifts; names of family members; and reportable business entities (or other related party as determined by the System institution).

    As defined in proposed § 612.2130, ordinary course of business means a transaction that is usual and customary in the business in question, on terms that are not preferential. We believe the System institution is in the best position to determine that which is an ordinary course of business transaction and that which is favorable or preferential in its region. Therefore, each System institution should develop policies and procedures to identify transactions that are preferential and not in the ordinary course of business and report the transactions pursuant to § 612.2137(d)(1)(ii).

    Generally, ordinary course of business means business procedures and practices consistent with usual customs and practices in that line of business. Is the transaction of a type that other similar businesses and their customers would engage in as ordinary business? Is the transaction, and its terms, common in the specific industry? From an industry-wide perspective, is the transaction of the sort commonly undertaken? The practices of others in the industry would be helpful in making the determination.

    Another consideration is the parties' own past relationship and past practice. Is the transaction ordinary in the context of the relationship already existing between the parties? A review of the parties' prior conduct and practices would be helpful in making this determination.

    Certain special situations bear discussion. Transactions between a director/employee and that director's/employee's loan officer should be specifically addressed, and the general nature of these transactions should always be reported because of the high potential for conflict, even if the transactions are in the ordinary course of business. System institution policies and procedures should require reporting for other ordinary course of business transactions that may have a high potential for conflict.

    Compliance with proposed § 612.2137(d)(1) would require the System institution to develop a method to monitor related-party transactions and make sure that directors and employees do not transact business on preferential or favorable terms and do not take advantage of their employment or position with the Farm Credit System in their business affairs. The policies and procedures should include specific dollar amounts as appropriate, and other criteria for pre-event versus post-event reporting. Reporting should include, at a minimum, financial transactions (recurring or one-time), and other relationships or arrangements (monetary or non-monetary) between directors, employees, agents or borrower/stockholders.

    Proposed § 612.2137(d)(2) would require each System institution to establish policies and procedures to address how conflicts of interest would be resolved through an action such as recusal, divestiture, approval or exception, job reassignment, employee supervision, employment separation or other action. To resolve conflicts of interest, the director or employee should cooperate with the Standards of Conduct Official. Policies and procedures would include action taken in the event a conflict cannot be resolved. Compliance with proposed § 612.2137 requires that the System institution establish a process to report, vet, and resolve conflicts of interest effectively. It would be read in tandem with proposed § 612.2138, which speaks directly to directors and employees and sets forth their reporting requirements.

    Agents, consultants and other third parties who represent the institution to the public, or upon whom the institution relies for professional services, must be bound by the same ethical responsibilities to the System institution and its borrower/shareholders as directors and employees. Proposed § 612.2137(d)(3) would require each System institution to establish policies and procedures to make sure that agents file conflict of interest disclosures, and that agents, consultants and other third-party contractors avoid misconduct and conflicts of interests. These third parties must be notified that their engagement is conditioned upon their agreement to avoid misconduct and conflicts of interest. These policies and procedures should include a mechanism to report, vet and resolve any conflicts of interest between third parties representing the institution and the System institution itself or its directors and employees. The System institution should also consider having the agent or consultant acknowledge its Code of Ethics, depending on the relative importance of the agent or consultant services to the institution. Consideration should be given to the sensitivity of the services, for example third-party performers of internet technology or cyber security services should be subject to a high degree of scrutiny. Consideration also should be given to whether the third party is covered by a professional code or standard that prescribes ethical conduct.

    The rule provides specific authority to each System institution to monitor and enforce its standards of conduct rules and Code of Ethics. Violators should be subject to specific and appropriate action, as determined by the System institution. Proposed § 612.2137(d)(4) would require each System institution to establish policies and procedures for the enforcement of its Standards of Conduct Program. This would provide the mechanism by which the institution takes action against any person who violates the standards of conduct rules, Code of Ethics, or these regulations. This section places accountability for enforcing the ethical conduct outlined in this proposed rule and fundamental to the health and viability of the System institution directly with the System institution itself.

    Proposed § 612.2137(d)(5) would require each System institution to establish policies and procedures to apply and enforce the prohibitions set forth in proposed § 612.2139 and any other provision in this subpart A.

    Proposed § 612.2137(d)(6) would require policies and procedures to prohibit gifts. These should include a definition of gifts, and explanation of prohibited sources. Directors and employees are prohibited from accepting gifts or favors that could be viewed as offered to influence or give the appearance to influence decision-making or official action or to obtain information. A System institution may determine that certain gifts, for example those valued at $25.00 or less, are so low in value (de minimis) that they could not be perceived as influencing decision-making or official action. The System institution may allow its directors and employees to accept gifts of little or no value. However, it may do so only if it has policies and procedures in place that set forth controls that are consistent with the core principles established in this proposed rule and with the requirements of Federal laws including FCA regulations and the Federal Bank Bribery Act.3 These policies and procedures would set forth the maximum value of any individual gift that a director or employee may accept, and the maximum value of gifts in the aggregate per year that a director or employee may accept. The policies and procedures would include reporting requirements for gifts and rules for disposing of impermissible gifts.

    3See 18 U.S.C. 215 and 18 U.S.C. 20.

    Proposed § 612.2137(e) would set forth minimum requirements for internal controls for all aspects of the System institution's Standards of Conduct Program.

    Proposed § 612.2137(e)(1) would require the System institution to maintain all reports generated under subpart A of the Standards of Conduct regulations including those required by § 612.2137(d)(1) and records on any ethics investigations and determinations, for a minimum of 6 years. Proposed § 612.2137(e)(2) would require internal controls to preserve the confidentiality of reports and other information maintained under the Standards of Conduct Program.

    Proposed § 612.2137(e)(3) would require each System institution to establish a process for anonymous reporting of suspected standards of conduct or Code of Ethics violations. A reporting hotline is most effective when both internal parties (directors and employees) and external parties (agents, borrowers, shareholders, applicants, and others) can report a complaint, misconduct, or tip for corrective action without fear of retribution such as termination of employment, suspension, or other similar action.

    Proposed § 612.2137(e)(4) requires periodic review of the Standards of Conduct Program for consistency with current practices at the System institution, financial banking industry best practices, and FCA regulations.

    Internal controls to prevent self-dealing and conflict situations should be monitored and evaluated with an effective audit program. Proposed § 612.2137(e)(5) would require each System institution to arrange for periodic internal audits of the Standards of Conduct Program. The audit would identify weaknesses, review and measure the effectiveness of the Standards of Conduct Program, and prescribe necessary corrective actions. The audit would cover the entire System institution and include all activities conducted by the System institution including through an unincorporated business entity (UBE), such as those organized for the express purpose of investing in a Rural Business Investment Company pursuant to § 611.1150(b). The audit would test for compliance and recommend corrective action as necessary, and the results should be reported directly to the institution's board or designated board committee. The scope and depth of the audit would be determined by the needs of the institution. The System institution would document the audit process and results.

    Proposed § 612.2137(f) would require each System institution to establish and provide standards of conduct training at least annually. This section should be read in tandem with § 612.2170. The institution's Standards of Conduct Program and ongoing training would encourage directors and employees to obtain counsel from the Standards of Conduct Official prior to engaging in transactions that could be perceived as preferential or not in the ordinary course of business. The Standards of Conduct Official could then provide advice to the director or employee on the permissibility of the transaction under the institution's Standards of Conduct Program and these proposed rules, or prescribe actions that would be necessary before or following the transaction to resolve a conflict of interest or the appearance of a conflict of interest. Training must include updates, if any, to the Standards of Conduct Program and Code of Ethics, and discussion of the System institution's procedures for the anonymous reporting of violations. It must include education on prohibited conduct, conflicts of interest and reporting requirements. Training on fiduciary responsibilities would be required, although the System institution may elect to have that service performed by outside counsel.

    E. Conflicts of Interest, Reporting of Financial Interests [New § 612.2138]

    It is incumbent upon each System institution to adopt the standards of conduct core principles, to make them part of the culture and lexicon of every director and employee. In addition, certain prescriptive rules directed to employees and directors are necessary to realize a baseline ethical standard. The baseline prescriptive requirements are set forth in proposed §§ 612.2138 and 612.2139, and each System institution should expand upon these prescriptive requirements as appropriate.

    Section 612.2138 of the proposed rule would specifically address conflicts of interest and reporting of financial interests. This section would require directors and employees to take affirmative action to identify, report and resolve conflicts or potential conflicts of interest of which they are aware. It is intended to compel each director and employee to take ownership of and invest in ethical responsibilities.

    Proposed § 612.2138(a) would require each director and employee to identify, report and resolve conflicts and potential conflicts. Proposed § 612.2138(b) would require that if a director or employee has a conflict of interest in a matter, transaction or activity that is subject to official action, or that is being considered by the board of directors, then that director or employee must disclose relevant non-privileged information including the existence, nature, and extent of his or her interests; refrain from participating in the official action or board discussion on the matter, activity or transaction (§ 612.2138(b)(2)); and not vote on or influence the decision-making on the matter, transaction or activity (§ 612.2138(b)(3)). Working together with other provisions of the proposed rule, this section is intended to bolster loyalty to the System institution and to reinforce personal responsibility and accountability in avoiding conflicts and acting ethically.

    Proposed § 612.2138(c) would require a director or employee to report conflicts of interest to the Standards of Conduct Official at year-end and at such other times as may be required by the institution. At a minimum, this section would require reporting of information sufficient for a reasonable person to make a conflict of interest determination on any business matter to be considered by the System institution. Reporting consistent with part 620 is also required.

    Proposed § 612.2138(c)(1) would require directors and employees to report any interest that they may have in any business matter before the System institution. This would include any interest in a loan, or in an entity making a loan application, or any other direct or indirect interest in a matter that pertains to the business of the System institution.

    Proposed § 612.2138(c)(2) would require directors and employees to report the names of any family member who has transacted or is currently transacting business with the System institution. The System institution should determine how best to capture reporting of current transactions, and should consider whether to require a director or employee to report the name of a family member who has engaged in a transaction in the past.

    Proposed § 612.2138(c)(3) would require directors and employees to report all material financial interests with any director, employee, agent, borrower or business affiliate of the System institution, supervised institution or supervising institution.

    Proposed § 612.2138(c)(4) would require directors and employees to report any matter required to be disclosed by § 620.6 of this chapter, in accordance with System institution policies and procedures.

    Proposed § 612.2138(c)(5) would require directors and employees to report the names of reportable business entities.

    Proposed § 612.2138(c)(6) would require directors and employees to report the names of any person residing in the home if such person transacts business with the System institution, or any institution supervised by the System institution.

    All the reporting in this section would be based on information the reporting individual knows or has reason to know.

    F. Prohibited Conduct [Proposed § 612.2139]

    As stated in Section A, we would consolidate current § 612.2140 “Directors—prohibited conduct” with current § 612.2150 “Employees—prohibited conduct,” in proposed § 612.2139 “Prohibited conduct.” We would also incorporate current § 612.2157 “Joint employees” and current § 612.2270 “Purchase of System obligations” requirements in this section. Most of our revisions to the prohibited conduct rules are straightforward and provide clarification of an intended prohibition. For example, we would clarify that lending transactions with a party related to the System institution such as a director, employee or a borrower is permitted, but only if on terms that are not favorable or preferential. We would also add a new provision that would prohibit directors and employees from acting inconsistently with the core principles.

    Proposed § 612.2139(a) would set forth the general prohibitions and their related exceptions for directors and employees, and proposed § 612.2139(b) would set forth additional prohibitions specifically for employees with their related exceptions.

    Proposed § 612.2139(a)(1) would prohibit acting inconsistently with the core principles in proposed § 612.2136.

    Proposed § 612.2139(a)(2) restates the director and employee prohibitions on participation in matters affecting financial interests in current §§ 612.2140(a) and 612.4150(a), respectively.

    Proposed § 612.2139(a)(3) restates the director and employee prohibitions on use of information in current §§ 612.2140(b) and 612.4150(b), respectively.

    Proposed § 612.2139(a)(4) would prohibit directors and employees from soliciting, obtaining or accepting, directly or indirectly, any gift, fee or other compensation that could be viewed as offered to influence decision-making, or official action or to obtain information. The System institution may determine that a gift that has an insignificant value would not trigger this prohibition, and may develop rules under which directors and employees may accept de minimis gifts. However, these System institution rules must be consistent with Federal rules and regulations including FCA rules and the Federal Bank Bribery Act. De minimis gifts may be accepted only as set forth under the institution's properly established policies and procedures (see § 612.2137(d)(6)).

    Proposed § 612.2139(a)(5) would provide that, among other things, a director or employee may not knowingly purchase or otherwise acquire, directly or indirectly, unless through inheritance, any interest (including mineral interests) in any real or personal property that is currently owned, or within the 12 past months was owned, by the System institution, supervising institution or any supervised institution as a result of foreclosure, deed in lieu, or similar action. Like the current rule, the proposed rule would allow a director to purchase such property only through public auction or similar open, competitive bidding. By open competitive bidding, we mean bidding that is both competitive, allowing involvement of all interested parties, and open and unsealed. Open competitive bidding affords all interested parties an opportunity to counter-bid. The advantage to open bidding is that it discourages unethical behavior or favoritism. A public auction can be accomplished on-line only if there is an opportunity for all who may be interested in the auction to participate in the bidding process. A director may purchase acquired property through open competitive bidding only if the director did not participate in the decision to foreclose or dispose of the property, including setting the sale terms, and did not receive information that could provide an advantage over other potential bidders or purchasers of the property.

    The proposed acquired property prohibitions do not reflect a substantive change from the current rule. We made revisions because the scope of misunderstanding and misapplication of the original provision warranted further clarification of the current rule's intent. The prohibition would apply to collateral acquired by a System institution, including collateral acquired directly or through use of an acquired property UBE. This provision of the rule does not change or alter any rights a borrower may have under title IV, part C of the Farm Credit Act of 1971, as amended, 12 U.S.C. 2199-2202, or FCA regulations promulgated thereunder.

    Proposed § 612.2139(a)(6) would provide that a director or employee must not directly or indirectly borrow from, lend to, or become financially obligated with or on behalf of a director, employee, or agent of the System institution, supervising institution, or supervised institution or a borrower or loan applicant of the System institution. This section prohibits a director or employee from entering into a lending or borrowing transaction with those who may have a financial relationship with the System institution. Lending and borrowing relationships include providing loan guarantees or stand-by letters of credit and similar forms of financial obligation.

    FCA recognizes that there are many situations in which a director or employee may enter into lending transactions or business relationships that involve other directors, employees, agents, borrowers, or loan applicants in the ordinary course of business. Financing in the ordinary course of business, as discussed earlier, is not a prohibited lending transaction. Each System institution should develop policies and procedures governing ordinary course of business transactions that include rules for reporting.

    The proposed rule requires every System institution to develop policies and procedures for directors and employees to identify, vet, and resolve any lending transactions with prohibited sources that are on preferential terms. Evidence of a director or employee engaging in a preferential business arrangement with a borrower or other party related to the System institution would be a safety and soundness concern and might be evidence of non-compliance.

    Proposed § 612.2139(a)(7) restates the prohibitions in current § 612.2270 on purchasing System obligations; and § 612.2165(b)(14) on purchasing or retiring preferred stock in advance of the release of material non-public information.

    Proposed § 612.2139(b)(1) restates the prohibition in current § 612.2150(d) on serving as an officer or director of an entity other than a System institution, except that the proposed revisions would not include the exception in current § 612.2150(d) that allows an employee of a Farm Credit Bank or association to serve as a director of a cooperative that borrows from a bank for cooperatives. This exception has been dropped because of the conflicts that would arise as a result of merger activity. Proposed § 612.2139(b)(2) and (b)(3) restate the prohibitions in current § 612.2150(j) on acting as a real estate agent or broker; and current § 612.2150(k) on acting as an agent or broker; respectively. Proposed § 612.2139(b)(4) restates the prohibition in current § 612.2157 on joint employees, but allows an employee of a bank to serve as an officer of a supervised association in its district in an extraordinary situation if: Both boards authorize the service, the duties and compensation at each institution are set forth in writing, and reasonable notice prior to the assumption of duties is provided to FCA.

    G. Standards of Conduct Official [Proposed § 612.2170]

    The proposed rule would enhance the role of the Standards of Conduct Official. The System institution board of directors is responsible for creating and fostering the institution culture, and for development of the Standards of Conduct Program. The institution board is also responsible for compliance with the Standards of Conduct Program. Proposed § 612.2170(a) would require that the Standards of Conduct Official must implement the Standards of Conduct Program. The Standards of Conduct Official is the authority to whom directors, employees, agents and consultants turn for advice on conflict of interest situations. Proposed § 612.2170(b) would require the Standards Conduct Official to provide guidance and information to directors and employees on conflicts of interest.

    Proposed § 612.2170(c) should be read in tandem with proposed § 612.2137(f) and would require the Standards of Conduct Official to provide annual and new director and employee training. The training would review the institution's standards of conduct rules and the Code of Ethics and discuss any updates; review and discuss the anonymous reporting hotline or other reporting procedure; prohibited conduct; directors' and employees' fiduciary duties (this training could be separate from the training of employees who do not have fiduciary duties); the importance of identifying conflicts of interests and reporting of financial interests; and annual and ongoing reporting requirements.

    The proposed rule would require the Standards of Conduct Official to report periodically to the board of directors or designated board committee on the Standards of Conduct Program and Code of Ethics matters. Proposed § 612.2170(d) would require the Standards of Conduct Official to help directors and employees identify conflicts of interest and report financial interests, in accordance with proposed § 612.2138. The Official would make written determinations on conflicts of interest and determine how to resolve them including by recusal, divestiture, approval or exception, job reassignment, employee supervision, employment separation, or other action consistent with the institution's Standards of Conduct Program as provided in proposed § 612.2170(e). Proposed § 612.2170(f) would require the Standards of Conduct Official to document all resolved and unresolved material or significant conflicts of interest. The Standards of Conduct Official would be required to maintain documentation that explains how conflicts are handled.

    Proposed § 612.2170(g) would require the Standards of Conduct Official to report to the institution's board of directors or designated board committee any instance of non-compliance with the System institution's standards of conduct rules or Code of Ethics. It would also require periodic reporting on the administration of the Standards of Conduct Program. These reports would include a review of the Standards of Conduct Program required under proposed § 612.2137.

    V. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), FCA hereby certifies that the proposed rule would not have a significant economic impact on a substantial number of small entities. Each of the banks in the System, considered together with its affiliated associations, has assets and annual income in excess of the amounts that would qualify them as small entities. Therefore, System institutions are not “small entities” as defined in the Regulatory Flexibility Act.

    List of Subjects in 12 CFR Part 612

    Agriculture, Banks, banking, Conflict of interests, Crime, Investigations, Rural areas.

    For the reasons stated in the preamble, part 612 of chapter VI, title 12 of the Code of Federal Regulations is proposed to be amended as follows:

    PART 612—STANDARDS OF CONDUCT AND REFERRAL OF KNOWN OR SUSPECTED CRIMINAL VIOLATIONS 1. The authority citation for part 612 continues to read as follows: Authority:

    Secs. 5.9, 5.17, 5.19 of the Farm Credit Act (12 U.S.C. 2243, 2252, 2254).

    2. Subpart A, consisting of §§ 661.2130 through 612.2270, is revised to read as follows: Subpart A—Standards of Conduct Sec. 612.2130 Definitions. 612.2135 [Reserved] 612.2136 Standards of conduct—core principles. 612.2137 Elements of a Standards of Conduct Program. 612.2138 Conflicts of interest, reporting of financial interests. 612.2139 Prohibited conduct. 612.2140-612.2165 [Reserved] 612.2170 Standards of Conduct Official. 612.2260-612.2270 [Reserved] Subpart A—Standards of Conduct
    § 612.2130 Definitions.

    For purposes of this section, the following terms are defined:

    Agent means any person, other than a director or employee, who currently represents a System institution as a fiduciary in contacts with third parties or who currently provides professional services to a System institution, such as legal, accounting, appraisal, cyber-security, internet technology and other similar services.

    Code of Ethics means a written statement of the principles and values the System institution follows to establish a culture of ethical conduct for directors and employees.

    Conflicts of interest means a set of circumstances that creates a risk that actions or judgments regarding a primary interest will be unduly influenced by a secondary interest. A conflict of interest (or the appearance of a conflict of interest) may exist when a person has a financial interest in a transaction, relationship, or activity that could materially impact that person's ability to perform official duties and responsibilities in a totally impartial manner and in the best interest of the institution, when viewed from the perspective of a reasonable person with knowledge of the relevant facts.

    Employee means any individual, including an officer, working part-time, full-time, or on a temporary basis for the System institution.

    Entity means a corporation, company, association, firm, joint venture, partnership, sole proprietorship, trust or other organization whether or not incorporated.

    Family means spouse or significant other and anyone having the following relationship to either: Parent, spouse, son, daughter, sibling, stepparent, stepson, stepdaughter, stepbrother, stepsister, half-brother, half-sister, uncle, aunt, nephew, niece, grandparent, grandson, granddaughter, and the spouses of the foregoing.

    Financial interest means an interest in an activity, transaction, property, or relationship with a person that involves receiving or providing something of monetary value or other present or deferred compensation.

    Financially obligated with means having a legally enforceable joint obligation with, being financially obligated on behalf of (contingently or otherwise), having an enforceable legal obligation secured by property owned by another person, or owning property that secures an enforceable legal obligation of another.

    Material, when applied to a financial interest or transaction (including a series of transactions viewed in the aggregate), means that the interest or transaction is of sufficient magnitude that a reasonable person with knowledge of the relevant facts would question the ability of the person who has the interest or is party to such transaction(s) to perform the person's official duties objectively and impartially and in the best interest of the institution and its statutory purpose.

    Mineral interest means any interest in minerals, oil or gas, including but not limited to, any right derived directly or indirectly from a mineral, oil, or gas lease, deed or royalty conveyance.

    Ordinary course of business, when applied to a transaction, means:

    (1) A transaction that is usual and customary in the business in question on terms that are not preferential; or

    (2) A transaction with a person who is in the business of offering the goods or services that are the subject of the transaction on terms that are not preferential.

    Person means individual or entity.

    Preferential means that the transaction is not on the same terms as those prevailing at the same time for comparable transactions for other persons who are not directors, employees or agents of a System institution.

    Reportable business entity means an entity in which the reporting individual, directly or indirectly, or acting through or in concert with one or more persons:

    (1) Owns a material percentage of the equity;

    (2) Owns, controls, or has the power to vote a material percentage of any class of voting securities; or

    (3) Has the power to exercise a material influence over the management of policies of such entity.

    Resolved means an actual or apparent conflict of interest that has been addressed with an action such as recusal, divestiture, approval or exception, job reassignment, employee supervision, employment separation or other action, with the result that a reasonable person with knowledge of the relevant facts would conclude that the conflicting interest is unlikely to adversely affect the person's performance of official duties in an objective and impartial manner and in furtherance of the interests and statutory purposes of the Farm Credit System.

    Standards of Conduct Official means a System institution employee who is appointed as an officer under § 612.2137(b), and who reports directly to the board of directors or designated board committee on Standards of Conduct and Code of Ethics matters.

    Standards of Conduct Program means the policies and procedures, internal controls and other actions a System institution must implement to put into practice the requirements of this rule and the System institution's Code of Ethics.

    Supervised institution is a term that only applies within the context of a System bank or employee of a System bank and refers to each association supervised by that System bank.

    Supervising institution is a term that only applies within the context of an association or employee of an association and refers to the System bank that supervises that association.

    System institution and institution means any Farm Credit System bank, association, or service corporation chartered under section 4.25 of the Act, and the Federal Farm Credit Banks Funding Corporation. It does not include the Federal Agricultural Mortgage Corporation.

    § 612.2135 [Reserved]
    § 612.2136 Standards of conduct—core principles.

    (a) If you are a System institution director or employee, you must:

    (1) Maintain the highest ethical standards of the financial banking industry, including standards of care, honesty, integrity, and fairness.

    (2) Act in the best interest of the institution.

    (3) Preserve the reputation of the institution and the public's confidence in the Farm Credit System.

    (4) Exercise diligence and good business judgment in carrying out official duties and responsibilities.

    (5) Report, vet, and work with the Standards of Conduct Official to resolve conflicts of interest and the appearance of conflicts of interest in System business relationships and activities.

    (6) Avoid self-dealing and acceptance of gifts or favors that may be deemed as offered, or have the appearance of being offered, to influence official actions or decisions.

    (7) Fulfill your fiduciary duties, as applicable.

    (b) To comply with core principles, all System institution directors and employees must:

    (1) Comply with the institution's standards of conduct and Code of Ethics.

    (2) Comply with all applicable laws and regulations.

    (3) Certify, in writing, participation in the institution's annual standards of conduct training.

    (4) Timely report to the Standards of Conduct Official or through the institution's reporting procedures under § 612.2137(e)(3) known or suspected:

    (i) Illegal or unethical activities; and

    (ii) Violations of the institution's standards of conduct and Code of Ethics.

    § 612.2137 Elements of a Standards of Conduct Program.

    The System institution board is ultimately responsible for the implementation and oversight of, and compliance with, the Standards of Conduct Program. Each System institution board of directors must:

    (a) Establish a Standards of Conduct Program that sets forth the core principles in § 612.2136 and provide adequate resources for its implementation.

    (b) Appoint a Standards of Conduct Official. Provide the Standards of Conduct Official:

    (1) Authority to carry out responsibilities set forth in this subpart A; and

    (2) Direct access to the System institution board of directors or designated board committee on standards of conduct matters.

    (c) Adopt a written Code of Ethics that establishes the System institution's values and expectations for the ethical conduct of directors and employees. Include standards for appropriate professional conduct at the workplace and in matters related to employment. Post the Code of Ethics on the institution's external website with access for the public.

    (d) Establish policies and procedures to:

    (1) Institute requirements for directors and employees to comply with the Standards of Conduct Program, including at a minimum, annual and interim reporting of:

    (i) Actual or apparent conflicts of interest;

    (ii) Transactions not in the ordinary course of business;

    (iii) Names of family members;

    (iv) Reportable business entities; and

    (v) Gifts under paragraph (d)(6) of this section.

    (2) Address how conflicts will be resolved, and provide action(s) to be taken when a conflict cannot be resolved to the satisfaction of the System institution;

    (3) Address third-party relationships. Include policies and procedures to:

    (i) Require agents to disclose conflicts of interest and act in a manner consistent with the ethical standards of the System institution; and

    (ii) Notify agents, consultants and other third parties who represent the institution, or who provide expert or professional services to the System institution that their engagement is conditioned upon their agreement to avoid misconduct and conflicts of interest;

    (4) Enforce and monitor the System institution's Standards of Conduct Program. Take appropriate action against any director or employee who violates the standards of conduct rules, Code of Ethics or the regulations under this subpart A;

    (5) Apply and enforce the prohibited conduct rules set forth in § 612.2139 and any other Farm Credit Administration rules in this subpart A; and

    (6) Set forth rules prohibiting gifts. If the System institution allows directors and employees to accept de minimis gifts, establish a de minimis threshold dollar amount per gift and an aggregate amount per year consistent with applicable laws. Establish rules for disposing of impermissible gifts.

    (e) Provide for Standards of Conduct Program internal controls to include at a minimum, a process to:

    (1) Maintain conflicts of interest and other reports required under this subpart A, including paragraph (d)(1) of this section, along with any investigations, determinations and supporting documentation, for a minimum of 6 years.

    (2) Protect against unauthorized disclosure of confidential information maintained by the institution, pursuant to this subpart A.

    (3) Report anonymously known or suspected violations of the institution's Standards of Conduct Program and Code of Ethics, through a hotline or other reporting procedure.

    (4) Periodically review the Standards of Conduct Program to ensure continued adequacy and consistency with changes in institution practices, financial banking industry best practices and Farm Credit Administration regulations.

    (5) Perform internal audits of the Standards of Conduct Program to:

    (i) Review the effectiveness of advancing the core principles,

    (ii) Identify weaknesses;

    (iii) Recommend and report necessary corrective actions directly to the institution's board or designated board committee; and

    (iv) Cover the entire Standards of Conduct Program across the System institution and include all activities conducted through a System institution unincorporated business entity (UBE), including UBEs organized for the express purpose of investing in a Rural Business Investment Company pursuant to § 611.1150(b) of this chapter. The System institution must determine and document the scope and depth of the audit.

    (f) Establish periodic standards of conduct training required under § 612.2170(c) at least annually.

    § 612.2138 Conflicts of interest, reporting of financial interests.

    (a) If you are a director or employee of a System institution you must, to the best of your knowledge and belief:

    (1) Identify conflicts of interest and potential conflicts of interest;

    (2) Report conflicts of interest and potential conflicts of interest in any matters, transactions or activities pending at the System institution to the Standards of Conduct Official; and

    (3) Cooperate with and provide information requested by the Standards of Conduct Official to resolve conflicts of interest and potential conflicts of interest.

    (b) If you are a director or employee of a System institution and you have a conflict of interest in a matter, transaction or activity subject to official action, or before the board of directors then you must, to the best of your knowledge:

    (1) Disclose relevant information including:

    (i) The existence, nature, and extent of your interest; and

    (ii) The facts known to you as to the matter, transaction or activity under consideration;

    (2) Refrain from participating in the official action or board discussion of the matter, transaction or activity; and

    (3) Not vote on, or influence the vote on, the matter, transaction or activity.

    (c) If you are a director or employee, at least annually and at such other times as may be required by your institution policies and procedures, you must report to the Standards of Conduct Official, in sufficient detail for a reasonable person to make a conflict of interest determination, the following information to the best of your knowledge or belief:

    (1) Any interest you have in any business matter to be considered by the System institution;

    (2) The names of your family members who have transacted or are currently transacting, business with the System institution;

    (3) All material financial interests with any director, employee, agent, borrower or business affiliate of your System institution, or supervised or supervising institution;

    (4) Any matter you are required to disclose under § 620.6(f) of this chapter;

    (5) The names of entities that are reportable business entities to you; and

    (6) The name of any person residing in your home if, you know or have reason to know, such person transacts business with your System institution, or any institution supervised by the System institution.

    § 612.2139 Prohibited conduct.

    (a) If you are a System institution director or employee you must not:

    (1) Act inconsistently with the core principles. You must follow the core principles set forth in § 612.2136.

    (2) Use your position for personal gain or advantage. Do not participate in deliberations on, or the determination of, any matter affecting your financial interest. Matters affecting your financial interest include financial interests of a family member, a person residing in your home, or a reportable business entity. You may participate in matters of general applicability affecting shareholders/borrowers of a particular class in a nondiscriminatory way.

    (3) Divulge confidential information. Do not make use of any fact, information or document not generally available to the public that you acquired by virtue of your position. You may use confidential information in the performance of your official duties.

    (4) Accept gifts. Do not solicit, obtain, or accept, directly or indirectly, any gift, fee or other compensation that could be viewed as offered to influence your decision-making, or official action, or to obtain information.

    (5) Purchase property owned by the institution. Do not knowingly purchase or otherwise acquire, directly or indirectly except through inheritance, any interest (including mineral interests) in any real or personal property that currently is owned, or within the past 12 months was owned, by your employing or supervising institution, or any supervised institution as a result of foreclosure, deed in lieu, or similar action. Exceptions: As a director, in addition to the inheritance exception, you may purchase such property if you:

    (i) Purchase the property through public auction or similar open, competitive bidding process;

    (ii) Did not participate in the decision to foreclose or dispose of the property, including setting the sale terms; and

    (iii) Have not received information as a result of your position that could give you an advantage over other potential bidders or purchasers of the property.

    (6) Enter into loan transactions with prohibited sources. Do not directly or indirectly borrow from, lend to, or become financially obligated with or on behalf of a director, employee, or agent of your employing or supervising institution, supervised institution, or a borrower or loan applicant of the employing institution. Exceptions: You may enter into transactions with family members and transactions in the ordinary course of business as determined and documented by the written policies and procedures of your institution.

    (7) Purchase System obligations.

    (i) Do not purchase any obligation of a System institution, including any joint, consolidated or System-wide obligation, unless such obligation is part of an offering available to the public; and purchased through a dealer or dealer bank affiliated with a member of the selling group designated by the Federal Farm Credit Banks Funding Corporation or purchased in the secondary market.

    (ii) Do not purchase or retire any stock in advance of the release of material non-public information concerning the institution to other stockholders;

    (iii) If you are a director or employee of the Federal Farm Credit Banks Funding Corporation, do not purchase or otherwise acquire, directly or indirectly, except by inheritance, any obligation or equity of a System institution, including any joint, consolidated or System-wide obligations, unless it is a common cooperative equity as defined in § 628.2 of this chapter.

    (b) In addition to the prohibitions under paragraph (a) of this section, if you are a System institution employee you must not:

    (1) Serve as a director or employee of certain entities. Do not serve as a director or employee of an entity that transacts business with your institution, another System institution in the district, or of any commercial bank, savings and loan or other non-System financial institution. For the purpose of this paragraph, “transacts business” does not include System institution loans to a reportable business entity; service on the board of directors of the Federal Agricultural Mortgage Corporation; or transactions with non-profit entities; or entities in which the System institution has an ownership interest. Exceptions: You may serve as a director or employee of an employee credit union, and you may serve as an employee of another System institution as permitted under paragraph (b)(4) of this section.

    (2) Act as a real estate agent or broker. Do not act as a real estate agent or broker, unless you are buying or selling real estate for your own use or for a family member or a person living in your home.

    (3) Act as an insurance agent or broker. Do not act as an insurance agent or broker for the sale and placement of insurance, unless authorized by section 4.29 of the Act.

    (4) Serve as a joint employee.

    (i) If you are currently employed as an officer with a System bank, you cannot serve as an employee of a supervised association.

    (ii) If you are currently employed with a bank, but not as an officer, you may be an officer of a supervised association only if:

    (A) Both boards authorize such service in an extraordinary situation;

    (B) The duties and compensation at each institution is delineated in the board's approval; and

    (C) Reasonable prior notice is provided to the Farm Credit Administration.

    (iii) You may be both a non-officer employee at a System bank and a supervised association, if employee expenses are appropriately reflected in each institution's financial statements.

    §§ 612.2140-612.2165 [Reserved]
    § 612.2170 Standards of Conduct Official.

    The Standards of Conduct Official must:

    (a) Implement and enforce the institution's Standards of Conduct Program.

    (b) Provide guidance and information to directors and employees on conflicts of interest.

    (c) Administer periodic, but at a minimum, annual standards of conduct training to directors and employees that includes:

    (1) Procedures for the review of and recommendation for any revisions to the institution's standards of conduct rules and Code of Ethics;

    (2) Procedures for reporting anonymously known or suspected violations of standards of conduct, Code of Ethics and unethical conduct;

    (3) Rules for prohibited conduct;

    (4) Fiduciary duties;

    (5) Conflicts of interest and apparent conflicts of interest;

    (6) Reporting requirements; and

    (7) New director training within 60 calendar days before the beginning of the director's election or term; and new employee training within 5 business days of the beginning of employment.

    (d) Help all directors and employees identify conflicts of interest and report financial interests in accordance with § 612.2138.

    (e) Make written determinations on how conflicts of interest will be resolved consistent with your institution's Standards of Conduct Program.

    (f) Document resolved and unresolved conflicts of interest that are material or significant. Maintain documentation that explains how conflicts are being handled.

    (g) Report to your institution's board of directors or designated board committee:

    (1) Instances of standards of conduct or Code of Ethics non-compliance, promptly upon completion of any investigation or determination; and

    (2) Administration of the Standards of Conduct Program, periodically as determined by the written policies and procedures of your institution.

    §§ 612.2260-612.2270 [Reserved]
    Dated: June 12, 2018. Dale L. Aultman, Secretary, Farm Credit Administration Board.
    [FR Doc. 2018-12874 Filed 6-14-18; 8:45 am] BILLING CODE 6705-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 110 [Docket Number USCG-2018-0388] Anchorage Ground; Sabine Pass, TX AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of inquiry; request for comments.

    SUMMARY:

    We are requesting your comments on a request we received from Sabine Pass LNG, L.P. for the disestablishment of the Sabine Pass Channel Anchorage Ground in Sabine, TX. The request indicates that deep draft ships do not use the anchorage and that disestablishment of the anchorage would not pose a concern for ship traffic. We seek your comments on whether we should consider a proposed rulemaking disestablishing the Sabine Pass Anchorage Ground based on this request or if other actions, such as reducing the size of the anchorage, should be considered.

    DATES:

    Your comments and related material must reach the Coast Guard on or before July 16, 2018.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2018-0388 using the Federal portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this notice of inquiry, call or email Mr. Scott K. Whalen, Marine Safety Unit Port Arthur, U.S. Coast Guard; telephone 409-719-5086, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security U.S.C. United States Code II. Background and Purpose

    In 1967, the Secretary of the Army transferred responsibility for certain functions, power, and duties to the Secretary of Transportation. Among the responsibilities transferred to the Secretary of Transportation was establishment and administration of water vessel anchorages. On December 12, 1967, the regulations for the Sabine Pass Anchorage Ground were republished in 33 CFR part 110, without change, under this new authority (32 FR 17726). The regulations for the Sabine Pass Channel Anchorage Ground in Sabine, TX are contained in 33 CFR 110.196.

    The legal basis and authorities for this notice of inquiry are found in 33 U.S.C. 471, 1221 through 1236; 33 CFR 1.05-1, and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to propose, establish, and define regulatory anchorages. As reflected in title 33 CFR 109.05, the Commandant of the U.S. Coast Guard has delegated the authority to establish anchorage grounds to U.S. Coast Guard District Commanders. The Coast Guard is now requesting comments on considering a proposed rulemaking based on Sabine Pass LNG L.P.'s request for disestablishing the Sabine Pass Anchorage Ground, or if other actions, such as reducing the size of the anchorage, should also be considered.

    As discussed earlier, administration of the Sabine Pass Anchorage Ground was originally transferred to the Coast Guard in 1967. Under 33 CFR 110.196, the anchorage ground is “for the temporary use of vessels of all types, but especially for naval and merchant vessels awaiting weather and tidal conditions favorable to the resumption of their voyages.” In 2006, Cheniere Energy began construction of a liquefied natural gas terminal on the eastern waterfront of the Sabine Pass Channel, immediately north and adjacent to the Sabine Pass Channel Anchorage Ground. On October 3, 2006, the Coast Guard published a notice of proposed rulemaking proposing to reduce the area of the Sabine Pass Anchorage Ground by 800 feet on the north end of the anchorage in order to reduce the risk of collision between anchored vessels and berthing and unberthing vessels at Cheniere's terminal, as well as to reduce the risk of grounding by providing a larger maneuvering area for vessels calling Cheniere's terminal (71 FR 58330). Both comments we received during that rulemaking process supported the proposed reduction on the basis of enhancing navigation safety. One commenter noted that “the anchorage was infrequently used and would have minimal impact on the economy.” On January 5, 2007, the Coast Guard published the final rule reducing the overall size of the anchorage consistent with the proposal (72 FR 463).

    On November 8, 2017, we received a request from Sabine Pass LNG L.P. to disestablish the Sabine Pass Anchorage Ground in its entirety. The request states that the anchorage is rarely used and its disestablishment would not significantly impact vessels that use the area. A copy of this request is available in the docket where indicated under ADDRESSES.

    A review of Vessel Traffic Service transit reports shows that deep draft ships have not made use of this anchorage during the last decade. It is estimated that the anchorage area is utilized an average of 27 times each year by shallow draft vessels (for example, tows, dredges, and work boats) for shortening tow or for use as a staging area for local work projects such as dredging.

    III. Information Requested

    We seek your comments on whether we should consider a proposed rulemaking to disestablish or otherwise modify the Sabine Pass Anchorage Ground. In particular, the Coast Guard requests your input to determine if there remains a need for a regulated anchorage in this area, and if so, to what extent and for what purpose; if a reduction in size of the anchorage would meet current and anticipated industry needs; or if other options should be considered. Recent U.S. Army Corps of Engineers survey data of the anchorage is available in the docket where indicated under ADDRESSES.

    IV. Public Participation and Request for Comments

    We encourage you to submit comments through the Federal portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. In your submission, please include the docket number for this notice of inquiry and provide a reason for each suggestion or recommendation.

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

    Documents mentioned in this notice of inquiry as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions.

    Dated: June 12, 2018. Paul F. Thomas, Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
    [FR Doc. 2018-12910 Filed 6-14-18; 8:45 am] BILLING CODE 9110-04-P
    POSTAL SERVICE 39 CFR Parts 265 and 266 Production or Disclosure of Material or Information AGENCY:

    Postal ServiceTM.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Postal Service proposes to amend its Freedom of Information Act (FOIA) and Privacy Act regulations. These changes would improve clarity, make technical corrections, and create a definition of “information of a commercial nature” as it pertains to the Postal Reorganization Act's provisions concerning disclosure of information under the Freedom of Information Act.

    DATES:

    Comments must be received on or before July 16, 2018.

    ADDRESSES:

    Mail or deliver written comments to: Associate General Counsel and Chief Ethics & Compliance Officer, 475 L'Enfant Plaza SW, Room 6000, Washington, DC 20260-1135. Email and faxed comments are not accepted. You may inspect and photocopy all written comments, by appointment only, at USPS® Headquarters Library, 475 L'Enfant Plaza SW, 11th Floor North, Washington, DC 20260. These records are available for review on Monday through Friday, 9 a.m.-4 p.m., by calling 202-268-2904.

    FOR FURTHER INFORMATION CONTACT:

    Ruth B. Stevenson, Attorney, Federal Compliance, [email protected], 202-268-6627.

    SUPPLEMENTARY INFORMATION:

    The Postal Service proposes to amend 39 CFR part 265 to make technical corrections to conform to the FOIA and to establish a definition of information of a commercial nature. The amendments to Sections 265.1 and 265.3 correct citations. The amendment to Section 265.6 adds paragraph (e)(2) so as to conform to the FOIA Improvement Act of 2016. (130 Stat. 544). The amendment to Section 265.9 eliminates an internal cross reference to the CFR by stating the dollar amount to be charged by Postal Service personnel when reviewing records in response to a FOIA request. The amendments to Section 265.14 establish a definition of “information of a commercial nature” to comply with applicable case law and to provide examples of the type of information that may be commercial in nature. Section 265.14 is further amended to clarify that the Postal Service will release change of address information submitted by a business. It is further amended to limit the disclosure of change of address information submitted by domestic violence shelters. Finally, the Postal Service proposes to amend 39 CFR part 266 to conform with Privacy Act provisions pertaining to disclosure of information and to define a court of competent jurisdiction.

    List of Subjects 39 CFR Part 265

    Administrative practice and procedure, Courts, Freedom of information, Government employees.

    39 CFR Part 266

    Privacy.

    For the reasons stated in the preamble, the Postal Service proposes to amend 39 CFR chapter I as follows:

    PART 265—PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION 1. The authority citation for part 265 continues to read as follows: Authority:

    5 U.S.C. 552; 5 U.S.C. App. 3; 39 U.S.C. 401, 403, 410, 1001, 2601; Pub. L. 114-185.

    2. Amend § 265.1 to revise paragraph (a)(1) to read as follows:
    § 265.1 General provisions.

    (a) * * *

    (1) This subpart contains the regulations that implement the Freedom of Information Act (FOIA), 5 U.S.C. 552, insofar as the Act applies to the Postal Service. These rules should be read in conjunction with the text of the FOIA and the Uniform Freedom of Information Act Fee Schedule and Guidelines published by the Office of Management and Budget (OMB Guidelines). The Postal Service FOIA Requester's Guide, an easy-to-read guide for making Postal Service FOIA requests, is available at http://about.usps.com/who-we-are/foia/welcome.htm.

    3. Amend § 265.3 to revise paragraphs (d) and (e) to read as follows:
    § 265.3 Procedure for submitting a FOIA request.

    (d) First-party requests. A requester who is making a request for records about himself must provide verification of identity sufficient to satisfy the component as to his identity prior to release of the record. For Privacy Act-protected records, the requester must further comply with the procedures set forth in 39 CFR 266.5.

    (e) Third-party requests. Where a FOIA request seeks disclosure of records that pertain to a third party, a requester may receive greater access by submitting a written authorization signed by that individual authorizing disclosure of the records to the requester, or by submitting proof that the individual is deceased (e.g., a copy of a death certificate or an obituary). As an exercise of administrative discretion, each component can require a requester to supply a notarized authorization, a declaration, a completed Privacy Waiver as set forth in 39 CFR 266.5(b)(2)(iii), or other additional information if necessary in order to verify that a particular individual has consented to disclosure.

    4. Amend § 265.6 to add paragraph (e)(2) to read as follows:
    § 265.6 Responses to requests.

    (e) * * *

    (2) Any component invoking an exclusion must maintain an administrative record of the process of invocation and approval of exclusion by OIP.

    5. Amend § 265.9 to revise paragraph (c)(3) to read as follows:
    § 265.9 Fees.

    (c) * * *

    (3) Review. Commercial-use requesters shall be charged review fees at the rate of $21.00 for each half hour by personnel reviewing the records. Review fees shall be assessed in connection with the initial review of the record, i.e., the review conducted by a component to determine whether an exemption applies to a particular record or portion of a record. No charge will be made for review at the administrative appeal stage of exemptions applied at the initial review stage. However, if a particular exemption is deemed to no longer apply, any costs associated with a component's re-review of the records in order to consider the use of other exemptions may be assessed as review fees.

    6. Amend § 265.14 to revise paragraphs (b), (d)(1), and (d)(2) to read as follows:
    § 265.14 Rules concerning specific categories of records.

    (b) Information not subject to mandatory public disclosure. Certain types of information are exempt from mandatory disclosure under exemptions contained in the Freedom of Information Act and in 39 U.S.C. 410(c). The Postal Service will exercise its discretion, in accordance with the policy stated in § 265.1(c), as implemented by instructions issued by the Records Office with the approval of the General Counsel in determining whether the public interest is served by the inspection or copying of records that are:

    (1) Related solely to the internal personnel rules and practices of the Postal Service.

    (2) Trade secrets, or privileged or confidential commercial or financial information, obtained from any person.

    (3) Information of a commercial nature, including trade secrets, whether or not obtained from a person outside the Postal Service, which under good business practice would not be publicly disclosed. Information is of a commercial nature if it relates to commerce, trade, profit, or the Postal Service's ability to conduct itself in a businesslike manner.

    (i) When assessing whether information is commercial in nature, the Postal Service will consider whether the information:

    (A) Relates to products or services subject to economic competition, including, but not limited to, “competitive” products or services as defined in 39 U.S.C. 3631 and by regulations and decisions of the Postal Regulatory Commission, an inbound international service, or an outbound international service for which rates or service features are treated as nonpublic in regulatory filings;

    (B) Relates to the Postal Service's activities that are analogous to a private business in the marketplace;

    (C) Would be of potential benefit to individuals or entities in economic competition with the Postal Service, its customers, suppliers, affiliates, or business partners or could be used to cause harm to a commercial interest of the Postal Service, its customers, suppliers, affiliates, or business partners;

    (D) Is proprietary or includes conditions or protections on distribution and disclosure, is subject to a nondisclosure agreement, or a third party has otherwise expressed an interest in protecting such information from disclosure;

    (E) Is the result of negotiations, agreements, contracts or business deals between the Postal Service and a business entity; or

    (F) Relates primarily to the Postal Service's governmental functions or its activities as a provider of basic public services.

    (ii) No one factor is determinative. Rather, each factor should be considered in conjunction with the other factors and the overall character of the particular information. Some examples of commercial information include, but are not limited to:

    (A) Information related to methods of handling valuable registered mail.

    (B) Records of money orders except as provided in Section 509.3 of the Domestic Mail Manual.

    (C) Technical information concerning postage meters and prototypes submitted for Postal Service approval prior to leasing to mailers.

    (D) Quantitative data, whether historical or current, reflecting the number of postage meters or PC postage accounts.

    (E) Reports of market surveys conducted by or under contract on behalf of the Postal Service.

    (F) Records indicating carrier or delivery lines of travel.

    (G) Information which, if publicly disclosed, could materially increase procurement costs.

    (H) Information which, if publicly disclosed, could compromise testing or examination materials.

    (I) Service performance data on competitive services.

    (J) Facility specific volume, revenue, and cost information.

    (K) Country-specific international mail volume and revenue data.

    (L) Non-public international volume, revenue and cost data.

    (M) Pricing and negotiated terms in bilateral arrangements with foreign postal operators.

    (N) Information identifying USPS business customers.

    (O) Financial information in or the identities of parties to Negotiated Service Agreements or Package Incentive Agreements.

    (P) Negotiated terms in contracts.

    (Q) Negotiated terms in leases.

    (R) Geolocation data.

    (S) Proprietary algorithms or software created by the Postal Service.

    (T) Sales performance goals, standards, or requirements.

    (U) Technical information or specifications concerning mail processing equipment.

    (d) * * *

    (1) Change of address. The new address of any specific business or organization that has filed a permanent change of address order (by submitting PS Form 3575, a hand written order, or an electronically communicated order) will be furnished to any person upon request. If a domestic violence shelter has filed a letter on official letterhead from a domestic violence coalition stating:

    (i) That such domestic violence coalition meets the requirements of 42 U.S.C. 10410; and

    (ii) That the organization filing the change of address is a domestic violence shelter, the new address shall not be released except pursuant to applicable routine uses. The new address of any individual or family that has filed a permanent or temporary change of address order will be furnished only in those circumstances stated at paragraph (d)(5) of this section. Disclosure will be limited to the address of the specifically identified individual about whom the information is requested (not other family members or individuals whose names may also appear on the change of address order). The Postal Service reserves the right not to disclose the address of an individual for the protection of the individual's personal safety. Other information on PS Form 3575 or copies of the form will not be furnished except in those circumstances stated at paragraphs (d)(5)(i), (d)(5)(iii), or (d)(5)(iv) of this section.

    (2) Name and address of permit holder. The name and address of the holder of a particular bulk mail permit, permit imprint or similar permit (but not including postage meter licenses), and the name of any person applying for a permit on behalf of a holder will be furnished to any person upon request. For the name and address of a postage meter license holder, see paragraph (d)(3) of this section. (Lists of permit holders may not be disclosed to members of the public. See paragraph (e)(1) of this section.)

    PART 266—PRIVACY OF INFORMATION 7. The authority citation for part 266 continues to read as follows: Authority:

    5 U.S.C. 552a; 39 U.S.C. 401.

    8. Amend § 266.3 to revise the introductory text of paragraph (a), paragraphs (a)(1)(iii) and (a)(3), (b)(1) introductory text, (b)(1)(i), (b)(1)(iii), (b)(2) introductory text, (b)(2)(iii), (b)(2)(xi), and the paragraph heading of (b)(5) to read as follows:
    § 266.3 Collection and disclosure of information about individuals.

    (a) This section governs the collection of information about individuals, as defined in the Privacy Act of 1974, throughout the United States Postal Service and across its operations;

    (3) The Postal Service will maintain no record describing how an individual exercises rights guaranteed by the First Amendment unless expressly authorized by statute or by the individual about whom the record is maintained or unless pertinent to and within the scope of an authorized law enforcement activity.

    (b) * * *

    (1) Limitations. The Postal Service will not disclose information about an individual unless reasonable efforts have been made to assure that the information is accurate, complete, timely and relevant to the extent provided by the Privacy Act and unless:

    (i) The individual to whom the record pertains has requested in writing, or with the prior written consent of the individual to whom the record pertains, that the information be disclosed, unless the individual would not be entitled to access to the record under the Postal Reorganization Act, the Privacy Act, or other law;

    (iii) The disclosure is in accordance with paragraph (b)(2) of this section.

    (2) Conditions of Disclosure. Disclosure of personal information maintained in a system of records may be made:

    (iii) For a routine use as contained in the system of records notices published in the Federal Register;

    (xi) Pursuant to the order of a court of competent jurisdiction. A court of competent jurisdiction is defined in Article III of the United States Constitution including, but not limited to any United States District Court, any United States or Federal Court of Appeals, the United States Court of Federal Claims, and the United States Supreme Court. For purposes of this section, state courts are not courts of competent jurisdiction.

    (5) Employment status. * * *

    Ruth Stevenson, Attorney, Federal Compliance.
    [FR Doc. 2018-12858 Filed 6-14-18; 8:45 am] BILLING CODE 7710-12-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R01-OAR-2018-0212; FRL-9978-97—Region 1] Air Plan Approval; Connecticut; Prevention of Significant Deterioration; Revisions to the Prevention of Significant Deterioration Greenhouse Gas Permitting Authority AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Connecticut. This revision affects provisions applicable to greenhouse gases (GHGs) in the EPA's Prevention of Significant Deterioration (PSD) permit program. Connecticut requested the revision in response to the June 23, 2014, U.S. Supreme Court's decision in Utility Air Regulatory Group (UARG) v. EPA and the April 10, 2015, Amended Judgment by the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) in Coalition for Responsible Regulation v. EPA. The intended effect of this action is to clarify that the State's PSD rules do not require a source to obtain a permit solely because the source emits or has the potential to emit (PTE) GHGs: Above the PSD applicability thresholds for new major sources; or for which there is a significant emissions increase from a modification. This action is being taken under the Clean Air Act.

    DATES:

    Written comments must be received on or before July 16, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R01-OAR-2018-0212 at www.regulations.gov, or via email to. For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the For Further Information Contact section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit www.epa.gov/dockets/commenting-epa-dockets. Publicly available docket materials are available at www.regulations.gov or at the U.S. Environmental Protection Agency, EPA New England Regional Office, Office of Ecosystem Protection, Air Quality Planning Unit, 5 Post Office Square—Suite 100, Boston, MA. The EPA requests that if at all possible, you contact the contact listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Donald Dahl, Air Permits, Toxics, and Indoor Programs Unit, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912, tel. (617) 918-1657, email [email protected]

    SUPPLEMENTARY INFORMATION:

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

    Table of Contents I. Background and Purpose II. EPA's Review III. Proposed Action IV. Incorporation by Reference V. Statutory and Executive Order Reviews I. Background and Purpose

    On February 28, 2018, the Connecticut Department of Energy and Environmental Protection (CT DEEP) submitted a revision to its State Implementation Plan (SIP) for the treatment of GHGs in the context of the PSD permit program under the Clean Air Act (CAA). The revision consists of removing the requirement that sources would have to obtain a PSD permit solely due to its GHG emissions, commonly known as “Step 2” sources.

    On January 2, 2011, GHG emissions were, for the first time, covered by the PSD and title V operating permit programs. See 75 FR 17004, (April 2, 2010). To establish a process for phasing in the permitting requirements for stationary sources of GHGs under the CAA PSD and title V programs, on June 3, 2010, the EPA published a final rule entitled “Prevention of Significant Deterioration and Title V Greenhouse Gas Tailoring Rule” (hereinafter referred to as the GHG Tailoring Rule). See 75 FR 31514. In Step 1 of the GHG Tailoring Rule, which began on January 2, 2011, the EPA limited application of PSD and title V requirements to sources of GHG emissions only if they were subject to PSD or title V “anyway” due to their emissions of pollutants other than GHGs. These sources are referred to as “anyway sources.” In Step 2 of the GHG Tailoring Rule, which applied as of July 1, 2011, the PSD and title V permitting program requirements applied to some sources that were classified as major sources based solely on their GHG emissions or potential to emit GHGs. Step 2 also applied PSD permitting requirements to modifications of otherwise major sources that would increase only GHG emissions above the level in the EPA regulations. EPA generally described the sources covered by PSD during Step 2 of the GHG Tailoring Rule as “Step 2 sources” or “GHG-only sources.”

    The United States Supreme Court invalidated the EPA's regulation of Step 2 sources in Utility Air Regulatory Group (UARG) v. EPA, 134 S Ct. 2427 (2014). In accordance with that decision, the United States Court of Appeals for the District of Columbia Circuit vacated the federal regulations that implemented Step 2 of the GHG Tailoring Rule. See Coalition for Responsible Regulation, Inc. v. EPA, 606 Fed. Appx. 6, 7 (D.C. Cir. 2015). Subsequently, the EPA removed the vacated elements from its rules. See 80 FR 50199 (August 19, 2015). The EPA therefore has the authority to approve a state's request to remove Step 2 sources from the SIP.

    II. EPA's Review

    Section 110(l) of the CAA states that the EPA shall not approve a revision to the SIP if the revision would interfere with any applicable requirement concerning attainment (of the NAAQS) and reasonable further progress (as defined in CAA section 7501) or any other requirement of the CAA. The EPA has reviewed the SIP revision and is proposing to find the revision is consistent with Section 110(l) of the CAA.

    The EPA's analysis and rationale for proposing to approve Connecticut's SIP revision request can be found in the Technical Support Document (TSD) associated with this action. In addition to the finding under Section 110(l), the EPA reviewed the SIP revision to ensure it is consistent with the EPA's regulations at 40 CFR 51.166, which contain the requirements for a state's PSD permit program regulations. The EPA's May 15, 2018 TSD (which is included in the docket for this action) includes the state requirements revised or removed, a list of the relevant federal provisions relating to the State's revisions, and a description of how each state provision complies with the federal requirements.

    During the EPA's review, the EPA noted that there was a typographical error in the certified copy of the regulatory changes Connecticut sent to the EPA. The difference between the certified copy and the state-adopted regulations was due to a clerical error. Connecticut subsequently submitted a revised and correct certified copy of the regulatory changes on May 7, 2018.

    III. Proposed Action

    Based on our analysis, the EPA is proposing to approve the Connecticut SIP revision, which was submitted on February 28, 2018, for the removal of the requirement that sources must obtain a PSD permit based solely on a source's GHG emissions. The EPA is soliciting public comments on the issues discussed in this notice or on other relevant matters. These comments will be considered before taking final action. Interested parties may participate in the Federal rulemaking procedure by submitting written comments to this proposed rule by following the instructions listed in the ADDRESSES section of this Federal Register.

    IV. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate revised RSCA Section 22a-174-3a(a)(1) entitled “Applicability,” RSCA Section 22a-174-3a(j)(1) for when control technology applies, and RSCA Sections 22a-174-3a(k)(1) and (2) regarding applicability of GHGs for new major stationary sources and major modifications. All three state regulations were effective February 8, 2018. The EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office.

    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 proposed action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:

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

    • Is not expected to be an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.

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

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

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

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

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

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

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

    • Does not provide 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).

    List of Subjects in 40 CFR Part 52

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

    Dated: June 12, 2018. Alexandra Dunn, Regional Administrator, EPA Region 1.
    [FR Doc. 2018-12896 Filed 6-14-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2018-0277; FRL-9979-43—Region 3] Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Removal of Department of Environmental Protection Gasoline Volatility Requirements for the Pittsburgh-Beaver Valley Area AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) proposes to approve a state implementation plan (SIP) revision submitted by the Commonwealth of Pennsylvania on May 2, 2018. The purpose of this SIP revision is to remove from the Pennsylvania SIP, the Commonwealth's existing requirements limiting summertime gasoline volatility to 7.8 pounds per square inch (psi) Reid Vapor Pressure (RVP) in seven counties in the Pittsburgh-Beaver Valley Area. In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments relevant to this action, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

    DATES:

    Comments must be received in writing by July 16, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R03-OAR-2018-0277 at http://www.regulations.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be confidential business information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Brian Rehn, (215) 814-2176, or by email at [email protected].

    SUPPLEMENTARY INFORMATION:

    For further information on this action to remove requirements related to Pennsylvania Department of Environmental Protection (PADEP) requirements for a low RVP gasoline program in the Pittsburgh-Beaver Valley Area from the SIP, please see the information provided in the direct final action, with the same title, that is located in the “Rules and Regulations” section of this Federal Register publication.

    Dated: June 6, 2018. Cecil Rodrigues, Acting Regional Administrator, Region III.
    [FR Doc. 2018-12704 Filed 6-14-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2017-0621; FRL-9979-49—Region 9] Approval and Promulgation of Air Quality Implementation Plans; Arizona; Nonattainment Plan for the Miami SO2 Nonattainment Area AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve an Arizona state implementation plan (SIP) revision for attaining the 1-hour sulfur dioxide (SO2) primary national ambient air quality standard (NAAQS or “standard”) for the Miami SO2 nonattainment area (NAA). This SIP revision (hereinafter called the “Miami SO2 Plan” or “Plan”) includes Arizona's attainment demonstration and other elements required under the Clean Air Act (CAA or “Act”). In addition to an attainment demonstration, the Plan addresses the requirement for meeting reasonable further progress toward attainment of the NAAQS, reasonably available control measures and reasonably available control technology, base-year and projected emission inventories, enforceable emissions limitations and control measures, and contingency measures. The EPA proposes to conclude that Arizona has appropriately demonstrated that the Plan provides for attainment of the 2010 1-hour primary SO2 NAAQS in the Miami SO2 NAA by the attainment date of October 4, 2018 and that the Plan meets the other applicable requirements under the CAA.

    DATES:

    Comments must be received on or before July 16, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R09-OAR-2017-0621 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Krishna Viswanathan, EPA, Region IX, Air Division, Air Planning Office, (520) 999-7880 or [email protected]

    SUPPLEMENTARY INFORMATION:

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

    Table of Contents I. Why was Arizona required to submit a plan for the Miami SO2 NAA? II. Requirements for SO2 Nonattainment Plans III. Attainment Demonstration and Longer-Term Averaging IV. Review of Modeled Attainment Demonstration V. Review of Other Plan Requirements VI. Conformity VII. The EPA's Proposed Action VIII. Statutory and Executive Order Reviews I. Why was Arizona required to submit a plan for the Miami SO2 NAA?

    On June 22, 2010, the EPA promulgated a new 1-hour primary SO2 NAAQS of 75 parts per billion (ppb). This standard is met at an ambient air quality monitoring site when the 3-year average of the annual 99th percentile of daily maximum 1-hour average concentrations does not exceed 75 ppb, as determined in accordance with appendix T of 40 CFR part 50.1 On August 5, 2013, the EPA designated a first set of 29 areas of the country as nonattainment for the 2010 SO2 NAAQS, including the Miami SO2 NAA within Arizona.2 These area designations became effective on October 4, 2013. Section 191 of the CAA directs states to submit SIPs for areas designated as nonattainment for the SO2 NAAQS to the EPA within 18 months of the effective date of the designation, i.e., by no later than April 4, 2015, in this case (hereinafter called “plans” or “nonattainment plans”). Under CAA section 192, these plans are required to have measures that will help their respective areas attain the NAAQS as expeditiously as practicable, but no later than 5 years from the effective date of designation, which for the Miami SO2 NAA is October 4, 2018.

    1See 75 FR 35520, codified at 40 CFR 50.17(a)-(b).

    2See 78 FR 47191, codified at 40 CFR part 81, subpart C.

    For a number of areas, including the Miami SO2 NAA, the EPA published a document on March 18, 2016, finding that Arizona and other pertinent states had failed to submit the required SO2 nonattainment plan by the submittal deadline.3 This finding, which became effective on April 18, 2016, initiated a deadline under CAA section 179(a) for the potential imposition of new source review offset and highway funding sanctions. Additionally, under CAA section 110(c), the finding triggered a requirement that the EPA promulgate a federal implementation plan (FIP) within two years of the effective date of the finding unless by that time the State had made the necessary complete submittal and the EPA had approved the submittal as meeting applicable requirements.

    3See 81 FR 14736.

    In response to the requirement for SO2 nonattainment plan submittals, the Arizona Department of Environmental Quality (ADEQ) submitted the Miami SO2 Plan on March 9, 2017, and submitted associated final rules on April 6, 2017.4 The EPA issued letters dated July 17, 2017, and September 26, 2017, finding the submittals complete and halting the sanctions clock under CAA section 179(a).5

    4 Letters from Tim Franquist, ADEQ, to Alexis Strauss, EPA, dated March 8, 2017, and April 6, 2017. Although the cover letter for the Miami SO2 Plan was dated March 8, 2017, the Plan was transmitted to the EPA on March 9, 2017.

    5 Letters from Elizabeth Adams, EPA, to Tim Franquist, ADEQ, dated July 17, 2017, and September 26, 2017.

    The remainder of this preamble describes the requirements that nonattainment plans must meet in order to obtain EPA approval, provides a review of the Miami SO2 Plan with respect to these requirements, and describes the EPA's proposed action on the Plan.

    II. Requirements for SO2 Nonattainment Plans

    Nonattainment plans for SO2 must meet the applicable requirements of the CAA, specifically CAA sections 110, 172, 191 and 192. The EPA's regulations governing nonattainment SIP submissions are set forth at 40 CFR part 51, with specific procedural requirements and control strategy requirements residing at subparts F and G, respectively. Soon after Congress enacted the 1990 Amendments to the CAA, the EPA issued comprehensive guidance on SIP revisions in the “General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990.” 6 Among other things, the General Preamble addressed SO2 SIP submissions and fundamental principles for SIP control strategies.7 On April 23, 2014, the EPA issued recommended guidance for meeting the statutory requirements in SO2 SIP submissions, in a document entitled, “Guidance for 1-Hour SO2 Nonattainment Area SIP Submissions” (“2014 SO2 Guidance”). In the 2014 SO2 Guidance, the EPA described the statutory requirements for a complete nonattainment plan, which include: An accurate emissions inventory of current emissions for all sources of SO2 within the NAA; an attainment demonstration; demonstration of RFP; implementation of RACM (including RACT); new source review, enforceable emissions limitations and control measures, and adequate contingency measures for the affected area.

    6See 57 FR 13498 (April 16, 1992) (General Preamble).

    7Id. at 13545-49, 13567-68.

    For the EPA to fully approve a SIP revision as meeting the requirements of CAA sections 110, 172 and 191-192 and the EPA's regulations at 40 CFR part 51, the plan for the affected area needs to demonstrate to the EPA's satisfaction that each of the aforementioned requirements has been met. Under CAA section 110(l), the EPA may not approve a plan that would interfere with any applicable requirement concerning NAAQS attainment and RFP, or any other applicable requirement. Under CAA section 193, no requirement in effect (or required to be adopted by an order, settlement, agreement, or plan in effect before November 15, 1990) in any area that is a NAA for any air pollutant may be modified in any manner unless it insures equivalent or greater emission reductions of such air pollutant.

    III. Attainment Demonstration and Longer-Term Averaging

    Section 172(c)(1) and 172(c)(6) of the CAA direct states with areas designated as nonattainment to demonstrate that the submitted plan provides for attainment of the NAAQS. 40 CFR part 51, subpart G further delineates the control strategy requirements that plans must meet, and the EPA has long required that all SIPs and control strategies reflect four fundamental principles of quantification, enforceability, replicability, and accountability.8 SO2 nonattainment plans must consist of two components: (1) Emission limits and other control measures that assure implementation of permanent, enforceable and necessary emission controls, and (2) a modeling analysis that meets the requirements of 40 CFR part 51, appendix W and demonstrates that these emission limits and control measures provide for timely attainment of the primary SO2 NAAQS as expeditiously as practicable, but by no later than the attainment date for the affected area. In cases where the necessary emission limits have not previously been made a part of the state's SIP, or have not otherwise become federally enforceable, the plan needs to include the necessary enforceable limits in adopted form suitable for incorporation into the SIP in order for the plan to be approved by the EPA. In all cases, the emission limits and control measures must be accompanied by appropriate methods and conditions to determine compliance with the respective emission limits and control measures and must be quantifiable (i.e., a specific amount of emission reduction can be ascribed to the measures), fully enforceable (i.e., specifying clear, unambiguous and measurable requirements for which compliance can be practicably determined), replicable (i.e., the procedures for determining compliance are sufficiently specific and non-subjective so that two independent entities applying the procedures would obtain the same result), and accountable (i.e., source specific limits must be permanent and must reflect the assumptions used in the SIP demonstrations).

    8See 57 FR at 13567-68 (April 16, 1992).

    The EPA's 2014 SO2 Guidance recommends that the emission limits be expressed as short-term average limits not to exceed the averaging time for the applicable NAAQS that the limit is intended to help maintain (e.g., addressing emissions averaged over one or three hours), but it also describes the option to utilize emission limits with longer averaging times of up to 30 days as long as the state meets various suggested criteria.9 The 2014 SO2 Guidance recommends that—should states and sources utilize longer averaging times (such as 30 days)—the longer-term average limit should be set at an adjusted level that reflects a stringency comparable to the 1-hour average limit at the critical emission value shown to provide for attainment.

    9See 2014 SO2 Guidance, pages 22 to 39.

    The 2014 SO2 Guidance provides an extensive discussion of the EPA's rationale for concluding that appropriately set, comparably stringent limitations based on averaging times as long as 30 days can be found to provide for attainment of the 2010 SO2 NAAQS. In evaluating this option, the EPA considered the nature of the standard, conducted detailed analyses of the impact of use of 30-day average limits on the prospects for attaining the standard, and carefully reviewed how best to achieve an appropriate balance among the various factors that warrant consideration in judging whether a state's plan provides for attainment.10

    10Id. pages 22 to 39. See also id. at Appendices B and D.

    As specified in 40 CFR 50.17(b), the 1-hour primary SO2 NAAQS is met at an ambient air quality monitoring site when the 3-year average of the annual 99th percentile of daily maximum 1-hour average concentrations is less than or equal to 75 ppb. In a year with 365 days of valid monitoring data, the 99th percentile would be the fourth highest daily maximum 1-hour value. The 2010 SO2 NAAQS, including this form of determining compliance with the standard, was upheld by the U.S. Court of Appeals for the District of Columbia Circuit in Nat'l Envt'l Dev. Ass'n's Clean Air Project v. EPA, 686 F.3d 803 (D.C. Cir. 2012). Because the standard has this form, a single hourly exceedance does not create a violation of the standard. Instead, at issue is whether a source operating in compliance with a properly set longer-term average could cause hourly exceedances, and if so what the resulting frequency and magnitude of such exceedances would be, and in particular whether the EPA can have reasonable confidence that a properly set longer-term average limit will provide that the three-year average of the annual fourth highest daily maximum hourly value will be at or below 75 ppb. A synopsis of the EPA's review of how to judge whether such plans “provide for attainment,” based on modeling of projected allowable emissions and in light of the NAAQS' form for determining attainment at monitoring sites, follows.

    For SO2 plans based on 1-hour emission limits, the standard approach is to conduct modeling using fixed emission rates. The maximum emission rate that would be modeled to result in attainment (i.e., in an “average year” 11 shows three, not four days with maximum hourly levels exceeding 75 ppb) is labeled the “critical emission value.” The modeling process for identifying this critical emissions value inherently considers the numerous variables that affect ambient concentrations of SO2, such as meteorological data, background concentrations, and topography. In the standard approach, the state would then provide for attainment by setting a continuously applicable 1-hour emission limit at this critical emission value.

    11 An “average year” is used to mean a year with average air quality. While 40 CFR part 50, appendix T provides for averaging three years of 99th percentile daily maximum hourly values (e.g., the fourth highest maximum daily hourly concentration in a year with 365 days with valid data), this discussion and an example below uses a single “average year” in order to simplify the illustration of relevant principles.

    The EPA recognizes that some sources have highly variable emissions due, for example, to variations in fuel sulfur content and operating rate, that can make it extremely difficult, even with a well-designed control strategy, to ensure in practice that emissions for any given hour do not exceed the critical emission value. The EPA also acknowledges the concern that longer-term emission limits can allow short periods with emissions above the critical emissions value, which, if coincident with meteorological conditions conducive to high SO2 concentrations, could in turn create the possibility of a NAAQS exceedance occurring on a day when an exceedance would not have occurred if emissions were continuously controlled at the level corresponding to the critical emission value. However, for several reasons, the EPA believes that the approach recommended in the 2014 SO2 Guidance suitably addresses this concern. First, from a practical perspective, the EPA expects the actual emission profile of a source subject to an appropriately set longer-term average limit to be similar to the emission profile of a source subject to an analogous 1-hour average limit. The EPA expects this similarity because it has recommended that the longer-term average limit be set at a level that is comparably stringent to the otherwise applicable 1-hour limit (reflecting a downward adjustment from the critical emissions value) and that takes the source's emissions profile into account. As a result, the EPA expects either form of emission limit to yield comparable air quality.

    Second, from a more theoretical perspective, the EPA has compared the likely air quality with a source having maximum allowable emissions under an appropriately set longer-term limit, as compared to the likely air quality with the source having maximum allowable emissions under the comparable 1-hour limit. In this comparison, in the 1-hour-average-limit scenario, the source is presumed at all times to emit at the critical emission level, and in the longer-term average limit scenario, the source is presumed occasionally to emit more than the critical emission value but on average, and presumably at most times, to emit well below the critical emission value. In an “average year,” compliance with the 1-hour limit is expected to result in three exceedance days (i.e., three days with hourly values above 75 ppb) and a fourth day with a maximum hourly value at 75 ppb. By comparison, with the source complying with a longer-term limit, it is possible that additional exceedances would occur that would not occur in the 1-hour limit scenario (if emissions exceed the critical emission value at times when meteorology is conducive to poor air quality). However, this comparison must also factor in the likelihood that exceedances that would be expected in the 1-hour limit scenario would not occur in the longer-term limit scenario. This result arises because the longer-term limit requires lower emissions most of the time (because the limit is set well below the critical emission value). Therefore, a source complying with an appropriately set longer-term limit is likely to have lower emissions at critical times than would be the case if the source were emitting as allowed with a 1-hour limit.

    The following hypothetical example illustrates the aforementioned points. Suppose there is a source that always emits 1000 pounds of SO2 per hour and these emissions result in air quality at the level of the NAAQS (i.e., a design value of 75 ppb).12 For this source, in an “average year”, these emissions cause the five highest maximum daily average 1-hour concentrations to be 100 ppb, 90 ppb, 80 ppb, 75 ppb, and 70 ppb. Subsequently, the source becomes subject to a 30-day average emission limit of 700 (lb/hr). It is theoretically possible for a source meeting this limit to have emissions that occasionally exceed 1000 lb/hr, but with a typical emissions profile, emissions would much more commonly be between 600 and 800 lb/hr. In this simplified example, assume a zero-background concentration, which allows one to assume a linear relationship between emissions and air quality.13 Air quality will depend on what emissions happen on what critical hours, but suppose that emissions at the relevant times on these five days are 800 lb/hr, 1100 lb/hr, 500 lb/hr, 900 lb/hr, and 1200 lb/hr, respectively. (This is a conservative example because the average of these emissions, 900 lb/hr, is well over the 30-day average emission limit.) These emissions would result in daily maximum 1-hour concentrations of 80 ppb, 99 ppb, 40 ppb, 67.5 ppb, and 84 ppb. In this example, the fifth day would have an exceedance that would not otherwise have occurred, but the third and fourth days would not have exceedances that otherwise would have occurred. In this example, the fourth highest maximum daily concentration under the 30-day average would be 67.5 ppb.

    12 Design values are the metrics (i.e., statistics) that are compared to the NAAQS levels to determine compliance. The design value for the primary 1-hour SO2 NAAQS is the 3-year average of annual 99th percentile daily maximum 1-hour values for a monitoring site, calculated as specified in 40 CFR part 50, appendix T, section 5.

    13 A nonzero background concentration would make the mathematics more difficult but would give similar results.

    This simplified example illustrates the findings of a more complicated statistical analysis that the EPA conducted using a range of scenarios using actual plant data. As described in Appendix B of the 2014 SO2 Guidance, the EPA found that the requirement for lower average emissions is highly likely to yield better air quality than is required with a comparably stringent 1-hour limit. Based on analyses described in appendix B of the 2014 SO2 Guidance, the EPA expects that an emission profile with maximum allowable emissions under an appropriately set comparably stringent 30-day average limit is likely to have the net effect of having a lower number of exceedances and better air quality than an emission profile with maximum allowable emissions under a 1-hour emission limit at the critical emission value.

    The EPA must evaluate whether a longer-term average emission limit approach, which is likely to produce a net lower number of overall exceedances of 75 ppb even though it may produce some exceedances of 75 ppb on occasions when emissions are above the critical emission value, meets the requirements in sections 110(a)(1) and 172(c)(1) and (6) for state implementation plans to “provide for attainment” of the NAAQS. For SO2, as for other pollutants, it is generally impossible to design a nonattainment plan in the present that will guarantee that attainment will occur in the future. A variety of factors can cause a well-designed nonattainment plan to fail and unexpectedly not result in attainment (e.g., if meteorology occurs that is more conducive to poor air quality than was anticipated in the plan). Therefore, in determining whether a plan meets the requirement to provide for attainment, the EPA's task is commonly to judge not whether the plan provides absolute certainty that attainment will in fact occur, but rather whether the plan provides an adequate level of confidence of prospective NAAQS attainment. From this perspective, in evaluating use of a 30-day average limit, the EPA must weigh the likely net effect on air quality. Such an evaluation must consider the risk that occasions with meteorology conducive to high concentrations will have elevated emissions leading to exceedances that would not otherwise have occurred, and it must also weigh the likelihood that the requirement for lower emissions on average will result in days not having exceedances that would have been expected with emissions at the critical emissions value. Additional policy considerations, such as in this case the desirability of accommodating real-world emissions variability without significant risk of violations, are also appropriate factors for the EPA to weigh in judging whether a plan provides a reasonable degree of confidence that the plan will lead to attainment. Based on these considerations, especially given the high likelihood that a continuously enforceable limit averaged over as long as 30 days, determined in accordance with the 2014 SO2 Guidance, will result in attainment, the EPA believes as a general matter that such limits, if appropriately determined, can reasonably be considered to provide for attainment of the 2010 SO2 NAAQS.

    The 2014 SO2 Guidance offers specific recommendations for determining an appropriate longer-term average limit. The recommended method starts with determination of the 1-hour emission limit that would provide for attainment (i.e., the critical emission value) and applies an adjustment factor to determine the (lower) level of the longer-term average emission limit that would be estimated to have a stringency comparable to the otherwise necessary 1-hour emission limit. This method uses a database of continuous emission data reflecting the type of control that the source will be using to comply with the SIP emission limits, which may require use of an emission database from another source (e.g., if compliance requires new controls). The recommended method involves using these data to compute a complete set of emission averages, calculated according to the averaging time and averaging procedures of the prospective emission limitation. In this recommended method, the ratio of the 99th percentile among these long-term averages to the 99th percentile of the 1-hour values represents an adjustment factor that may be multiplied by the candidate 1-hour emission limit to determine a longer-term average emission limit that may be considered comparably stringent.14 The guidance also addresses a variety of related topics, such as the potential utility of setting supplemental emission limits (e.g., mass-based limits) to reduce the likelihood and/or magnitude of elevated emission levels that might occur under the longer-term emission rate limit.

    14 For example, if the critical emission value is 1000 pounds of SO2 per hour, and a suitable adjustment factor is determined to be 70 percent, the recommended longer-term average limit would be 700 pounds per hour.

    Preferred air quality models for use in regulatory applications are described in appendix A of the EPA's Guideline on Air Quality Models (40 CFR part 51, appendix W (“appendix W”)).15 In general, nonattainment SIP submissions must demonstrate the adequacy of the selected control strategy using the applicable air quality model designated in appendix W.16 However, where an air quality model specified in appendix W is inappropriate for the particular application, the model may be modified or another model substituted, if the EPA approves the modification or substitution.17 In 2005, the EPA promulgated the American Meteorological Society/Environmental Protection Agency Regulatory Model (AERMOD) as the Agency's preferred near-field dispersion modeling for a wide range of regulatory applications addressing stationary sources (e.g., in estimating SO2 concentrations) in all types of terrain based on extensive developmental and performance evaluation. Supplemental guidance on modeling for purposes of demonstrating attainment of the SO2 standard is provided in appendix A to the 2014 SO2 Guidance. Appendix A provides extensive guidance on the modeling domain, the source inputs, assorted types of meteorological data, and background concentrations. Consistency with the recommendations in the 2014 SO2 Guidance is generally necessary for the attainment demonstration to offer adequately reliable assurance that the plan provides for attainment.

    15 The EPA published revisions to appendix W on January 17, 2017, 82 FR 5182.

    16 40 CFR 51.112(a)(1).

    17 40 CFR 51.112(a)(2); appendix W, section 3.2.

    As stated previously, attainment demonstrations for the 2010 1-hour primary SO2 NAAQS must demonstrate future attainment and maintenance of the NAAQS in the entire area designated as nonattainment (i.e., not just at the violating monitor) by using air quality dispersion modeling (see appendix W) to show that the mix of sources and enforceable control measures and emission rates in an identified area will not lead to a violation of the SO2 NAAQS. For a short-term (i.e., 1-hour) standard, the EPA believes that dispersion modeling, using allowable emissions and addressing stationary sources in the affected area (and in some cases those sources located outside the NAA which may affect attainment in the area) is technically appropriate. This approach is also efficient and effective in demonstrating attainment in NAAs because it takes into consideration combinations of meteorological and source operating conditions that may contribute to peak ground-level concentrations of SO2.

    The meteorological data used in the analysis should generally be processed with the most recent version of AERMET, which is the meteorological data preprocessor for AERMOD. Estimated concentrations should include ambient background concentrations, follow the form of the standard, and be calculated as described in the EPA's August 23, 2010 clarification memo.18

    18 “Applicability of Appendix W Modeling Guidance for the 1-hr SO2 National Ambient Air Quality Standard” (August 23, 2010).

    IV. Review of Modeled Attainment Demonstration

    The following discussion evaluates various features of the modeling that Arizona used in its attainment demonstration.

    A. Model Selection

    Arizona's attainment demonstration used a combination of AERMOD and the Buoyant Line and Point Source model (BLP).19 The State used AERMOD version 14134 (“v14134”), the regulatory version at the time it conducted its nonattainment planning, for all emission sources except for those over the Freeport-McMoRan Miami Incorporated (FMMI) smelter (“Miami Smelter” or “Smelter”) building roofline. For AERMOD-only sources, the State used regulatory default options. To represent emissions from the Smelter roofline, the State used a combination of AERMOD v14134 and BLP (“BLP/AERMOD Hybrid Approach”). BLP was used to estimate hourly final plume rise and sigma-z (a measure of vertical size of the plume), which were then used to define volume sources in AERMOD. The State later repeated the simulation using AERMOD version 16216r, the current regulatory version, and showed no difference in predicted annual 4th high daily SO2 hourly concentrations from the previous version.20

    19See Appendix C to Miami SO2 Plan, “Modeling Technical Support Document for the Miami Sulfur Dioxide (SO2) Nonattainment Area” (Modeling TSD).

    20 See letter from Farah Mohammadesmaeili, ADEQ, to Rynda Kay, EPA Region 9, dated March 16, 2018.

    The copper smelting process produces large amounts of excess heat. Fugitive SO2 is released from the Miami Smelter building roofline at an elevated temperature and velocity, leading to enhanced plume rise. AERMOD v14134 does not account for buoyant plume rise from line sources. At the time of preparation of the Miami SO2 Plan, BLP was identified in appendix W as the preferred model for representing buoyant line sources.21 As noted above, where an air quality model specified in appendix W is inappropriate for the particular application, the model may be modified or another model substituted if the EPA approves the modification or substitution.22 Appendix W also specifies that for all such approvals, the EPA regional office will coordinate and seek the concurrence of the EPA's Model Clearinghouse.23 Arizona has sought approval to use the BLP/AERMOD Hybrid Approach under appendix W, paragraph 3.2.2(b), condition (2), which allows for use of an alternative model where “a statistical performance evaluation has been conducted using measured air quality data and the results of that evaluation indicate the alternative model performs better for the given application than a comparable model in appendix A.” The State provided a statistical performance evaluation using measured air quality data that demonstrates the alternative model performs better than the preferred model for this application. Additionally, the State provided technical justification for the validity of the approach for the meteorology and topography affecting this area. EPA Region 9 requested and received concurrence from the EPA's Model Clearinghouse that the alternative model is appropriate for this particular application.24 25 For the reasons described in the concurrence documents, the EPA finds this selection appropriate and proposes to approve use of this alternative under 40 CFR 51.112(a)(2).

    21 The EPA has since approved AERMOD, with newly incorporated BLP algorithms, as the preferred model for buoyant line sources. See 82 FR 5182.

    22 40 CFR 51.112(a)(2); Appendix W, section 3.2.

    23Id. section 3.0(b).

    24 Further details can be found in “Concurrence Request for Approval of Alternative Model: BLP/AERMOD Hybrid Approach for Modeling Buoyant Roofline Sources at the FMMI Copper Smelter in Miami, AZ” (March 12, 2018).

    25 “Model Clearinghouse Review of a BLP/AERMOD Hybrid Alternative Model Approach for Modeling Buoyant Roofline Sources at the FMMI Copper Smelter in Miami, AZ” (March 26, 2018).

    The modeling domain was centered on the Miami Smelter facility and extended to the edges of the Miami SO2 NAA. A grid spacing of 25 meters was used to resolve AERMOD model concentrations along the ambient air boundary surrounding the Smelter and increased toward the edges of the NAA. Receptors were excluded within the ambient air boundary, which is defined by the facility's physical fence line, except in several segments where there is no fence and the State inspected and concluded steep topography precludes public access. We agree with the State's conclusion that the model receptors placed by the State correspond to ambient air.

    B. Meteorological Data

    Arizona conducted its modeling using three years of on-site surface meteorological data collected by FMMI between 2010 and 2013 at a 30.5-meter tower located approximately 0.32 kilometer (km) southwest of the Smelter. The State provided annual audit reports for the monitoring station to document that the station's installation and data collection were consistent with the EPA recommendations.26 27 Cloud cover and relative humidity were not measured at the onsite location and were taken from the National Weather Service (NWS) station at Safford Airport (Weather Bureau Army Navy (WBAN) 93084), which is 132 km to the southeast of the Smelter and representative of cloud cover and relative humidity to the Miami SO2 NAA. The State used upper air data from the NWS station in Tucson, Arizona (WBAN 23160), which is 146 km south of the Smelter. The State used AERMET v14134 to process meteorological data for use with AERMOD and the Meteorological Processor for Regulatory Models for use with BLP.

    26 See email from Farah Mohammadesmaeili, ADEQ, to Rynda Kay, EPA Region 9, dated March 16, 2018.

    27 “EPA Meteorological Monitoring Guidance for Regulatory Modeling Applications.” Publication No. EPA-454/R-99-005 (February 2000).

    The State used AERSURFACE version 13016 using data from the onsite location and the NWS Safford site to estimate the surface characteristics (i.e., albedo, Bowen ratio, and surface roughness (zo)). The State estimated zo values for 12 spatial sectors out to 1 km at a seasonal temporal resolution for dry conditions. We conclude that the State appropriately selected meteorological sites, properly processed meteorological data, and adequately estimated surface characteristics.

    The State used the Auer (1978) land use method, with land cover data from the United States Geological Survey National Land Cover Data 1992 archives, to determine that the 3-km area around the Miami Smelter is composed of 97.3% rural land types. Therefore, the State selected rural dispersion coefficients for modeling. We agree with the State's determination that the facility should be modeled as a rural source.

    C. Emissions Data

    Arizona completed a modeling emissions inventory for sources within the Miami SO2 NAA and a 50-km buffer zone extending from the NAA boundary based on 2009-2011 data. In 2011, the Miami Smelter emitted 2,545 tpy SO2, accounting for more than 99.5% of SO2 emissions in the NAA. Other SO2 sources in the NAA include the Carlota Copper Pinto Valley Mine (2011 SO2 emissions of 32 tpy) and the Freeport McMoRan Miami Mine Smelter (2011 SO2 emissions of 7 tpy), located 13 km and 3.3 km southwest of the Miami Smelter, respectively. No other sources had 2011 SO2 emissions greater than 1 tpy SO2 in the NAA. The ASARCO LLC (ASARCO) copper smelter is located 46 km south of the Miami Smelter and had 2011 SO2 emissions of 21,747 tpy. The two smelters are separated by large mountains, making these two airsheds distinct. The State modeled the ASARCO stack emissions and determined that the modeled concentrations from that source were negligible in the Miami SO2 NAA. The State determined that other than the Miami Smelter, no sources were drivers of nonattainment. The State also determined that no other sources have the potential to cause significant concentration gradients in the vicinity of the Miami SO2 NAA affected by the Miami Smelter. Additionally, the State determined that all nearby sources are sufficiently captured by background monitored concentrations. We agree with the State's determination that only Miami Smelter emissions need to be included in the attainment modeling.

    FMMI is undertaking substantial upgrades to the Smelter that will reduce SO2 and other pollutant emissions (see section 4.3 of the Miami SO2 Plan). The State estimated post-upgrade maximum 1-hour SO2 emissions and used those estimates to model all facility emission sources subject to additional control. The State provided a justification for the control efficiencies assumed in the adjustments, which we reviewed and agree are reasonable.28 The State also modeled additional sources within the Smelter complex, including intermittent emergency generators, smelter building leaks, slag storage area, and other small sources, which will not be subject to further control. These sources collectively account for an additional 8 pounds per hour (lb/hr) of SO2 emissions, which we agree were appropriately calculated.29 The resulting hourly emission rates used in the attainment modeling are shown in Table 1. Together these emissions accounted for a facility-wide critical emission value of 393 lb/hr (rounded to nearest whole number). The facility-wide critical emission value was used to derive a single facility-wide 30-day average emission limit, as described in section IV.D below.

    28See “FmmiReponseToEpaReview—20160721—Final w Signature.pdf” and “FMMI—Emissions-Inventory—2015-07-13—Past-Actuals-Using-Sulfur-Balance.xlsx.”

    29See Appendix K of Modeling TSD.

    Table 1—Projected Maximum Smelter SO2 Emissions After Additional Controls Source SO2
  • Emissions
  • (lb/hr)
  • Acid Plant Tail Gas Stack 3.2 Vent Fume Stack 13.0 Aisle Scrubber Stack—Normal Operations 14.3 Aisle Scrubber Stack—Bypass Operations 275.0 Isa Roof Vent 31.8 ELF Roof Vent 14.2 Converter Roof Vent 25.6 Anode Roof Vent 8.0 Additional Sources 8.0 Total 393

    The State asserts that a single facility-wide emission limit will adequately regulate emissions from each Smelter source. The State provided an analysis of the Smelter's emissions variability, which showed that, due to the batch nature of the smelting process, emissions are independent of one another and therefore do not peak at the same time. This analysis indicates that the collection of future maximum potential emission rates for each source listed in Table 1 is a conservative estimate of the worst-case emission distribution at the Smelter.30 Additionally, the State conducted a sensitivity analysis increasing the modeled emission rate of each source (except the bypass stack) by 21%, while proportionally decreasing the emission rate of the remaining sources so that total facility-wide emissions remained constant.31 The resulting modeled design values were within 1% of those predicted by the attainment modeling and all below the NAAQS. These analyses suggest that variations in the location of peak emissions will not affect attainment so that a facility-wide limit would be sufficiently protective. We agree with the State that a facility-wide emission limit is appropriate in this case.

    30See Appendix E of Modeling TSD.

    31See Appendix I of Modeling TSD.

    The State also adequately characterized source parameters for the emissions described above, as well as the Miami Smelter's building layout and location in its modeling. Where appropriate, the AERMOD component Building Profile Input Program for Plume Rise Model Enhancements (BPIPPRM) was used to assist in addressing building downwash.

    D. Emission Limits

    An important prerequisite for approval of a nonattainment plan is that the emission limits that provide for attainment be quantifiable, fully enforceable, replicable, and accountable.32 The numeric emission limit on which Arizona's Plan relies is expressed as a 30-day average limit. Therefore, part of the review of Arizona's Plan must address the use of longer-term average limits, both with respect to the general suitability of using such limits for this purpose and with respect to whether the particular numeric emission limit included in the Plan has been suitably demonstrated to provide for attainment. The first subsection that follows addresses the enforceability of the limits in the Plan (including both the numeric 30-day emission limit as well as operation and maintenance requirements, which also constitute emission limits),33 and the second subsection that follows addresses the 30-day limit in particular.

    32See 57 FR at 13567-68.

    33See CAA section 302(k)(defining “emission limit” to include “any requirement relating to the operation or maintenance of a source to assure continuous emission reduction.”).

    1. Enforceability

    The emission limits for the Miami Smelter are codified in the Arizona Administrative Code, Title 18, Chapter 2, Article 13, Section R18-2-C1302 (“Rule C1302”). After following proper public notice procedures, Rule C1302 was adopted by the State of Arizona through a final rulemaking in the Arizona Administrative Register. To ensure that the regulatory document was consistent with procedures for incorporating by reference, the EPA subsequently requested that ADEQ provide the version of this regulation that was codified in the Arizona Administrative Code as a supplement to the original SIP revision.

    Subsection (A)(2) of Rule C1302 (“Effective Date”) states that, “(e)xcept as otherwise provided, the provisions of this Section shall take effect on the later of the effective date of the Administrator's action approving it as part of the state implementation plan or January 1, 2018.” Accordingly, the majority of the rule's requirements will come into effect upon final approval by the EPA of the rule. We proposed to approve Rule C1302 into the Arizona SIP on March 30, 2018 34 and we intend to finalize action on the rule prior to taking final action on the Miami SO2 Plan.

    34 83 FR 13716.

    Rule C1302's 30-day rolling average emission limit of 142.45 lbs/hr applies to emissions from the tail gas stack, vent fume stack, aisle scrubber stack, and bypass stack, as well as any fugitives that may come from the roofline of the smelter structure. To ensure that all emission sources subject to the facility-wide limit are accurately monitored and reported, the rule also requires that continuous monitoring systems be installed on each of the aforementioned stacks and at the roofline to measure fugitive emissions. In addition, under subsection (E)(8) of Rule C1302, FMMI is required to develop and implement a roofline fugitive emissions monitoring plan for review and approval by ADEQ and the EPA. Furthermore, FMMI is required to develop and submit for EPA review and approval an Operations & Maintenance plan for capture and control systems at the smelter to ensure that these systems are functioning properly and are adequately maintained in order to minimize fugitive emissions. The rule also includes provisions for determining compliance with the emission limit, and the necessary monitoring, recordkeeping, and reporting requirements to ensure that the regulation as a whole is enforceable. As noted above, the EPA proposed to approve this regulation into the Arizona SIP in a separate action. Further discussion on the enforceability for Rule C1302 is included in the Technical Support Document (TSD) for that action.35

    35 “Technical Support Document for the EPA's Rulemaking for the Arizona State Implementation Plan; Arizona Administrative Code, Title 18, Chapter 2, Article 13, Part C—Miami, Arizona, Planning Area; R18-2-C1302—Limits on SO2 Emissions from the Miami Smelter” (March 2018) (Rule C1302 TSD).

    In accordance with EPA guidance on the use of federally enforceable limits, we find that the limits in Rule C1302 will be enforceable upon our approval of the rule, are supportive of attainment, and are suitable for inclusion into the Arizona SIP. We also find that the 30-day average limit is set at a lower level than the critical emission value used in the attainment demonstration; this relationship is discussed in detail in the following section.

    2. Longer-Term Average Limits

    The State modeled emissions from the Miami Smelter as described in Section IV.C of this notice to determine a facility-wide critical emission value of 393 lb/hr. Arizona demonstrated that the Smelter's “Additional Sources” listed in Table 1, which account for 8 lb/hr, have a negligible contribution to the predicted design value concentration and asserted that these emissions need not be a part of the facility's enforceable emission limit.36 As such, Arizona used an adjusted critical emission value of 385 lb/hr (i.e., 393 lb/hr minus 8 lb/hr) in the calculation of the facility's longer-term average limit.

    36See Appendix K of the Modeling TSD.

    To derive a longer-term average emission limit, the State used hourly SO2 data collected using continuous emission monitors from May 2013 to October 2014, adjusted to account for facility upgrades and increased production capacity, as a representative emission distribution for the Smelter's future configuration. The State summed the emissions from all point and fugitive sources, which yielded the hourly emissions data that provided for calculation of the 30-day average emission rates used to determine an appropriate adjustment factor. The 99th percentile of the 30-day and 1-hour SO2 emission rates were 102.4 lb/hr and 276.7 lb/hr, respectively. The ratio of these two values (i.e., the computed adjustment factor) was 0.37. Compared to the national average adjustment factors (i.e., 0.63-0.79) estimated for Electrical Generating Units (EGUs) and listed in Table 1 of Appendix D of the 2014 SO2 Guidance, the ratio reflects the high variability in Smelter emissions. Although the adjustment factor is out of the range derived for EGUs, this is expected, as smelters exhibit a greater range of variability due to feed and operational variability. In general, we expect operations with large variability to require bigger adjustments (lower adjustment factors) and result in lower longer-term average emissions limits relative to the 1-hour critical emission value. The adjustment factor was multiplied by the adjusted critical emission value (i.e., 385 lb/hr) to derive a longer-term 30-day average emission limit of 142.45 lb/hr. Based on a review of the State's submittal, the EPA believes that the 30-day average limit for the Miami Smelter provides a justified alternative to establishing a 1-hour average emission limit for this source.

    The 2014 SO2 Guidance does not directly address the establishment of limits governing the sum of emissions from multiple units, and the it provides no specific recommendations for a methodology for determining appropriate adjustment factors for deriving comparably stringent longer-term limits in such cases. Nevertheless, the 2014 SO2 Guidance recommends computing adjustment factors based on emissions data that have been determined in accordance with the methods used to determine compliance with the limit. Therefore, in this case, it is appropriate to use facility total emissions data as the basis for a statistical analysis of the degree of adjustment warranted in determining a 30-day facility-wide emission limit that is comparably stringent to the plant total 1-hour emission limit that would otherwise have been set.

    The State has used an appropriate data base and the methodology specified in the 2014 SO2 Guidance to derive an emission limit that has comparable stringency to the 1-hour average limit that the State determined would otherwise have been necessary to provide for attainment. While the 30-day average limit allows occasions in which emissions may be higher than the level that would be allowed with the 1-hour limit, the State's limit compensates by requiring average emissions to be lower than the level that would otherwise have been required by a 1-hour average limit. For reasons described above and explained in more detail in the 2014 SO2 Guidance, the EPA finds that appropriately set longer-term average limits provide a reasonable basis by which nonattainment plans may provide for attainment. Based on our review of this general information as well as the particular information in Arizona's Plan, the EPA finds that the 30 day-average limit will provide for attainment of the SO2 standard in the Miami SO2 NAA.

    E. Background Concentrations

    Arizona selected background SO2 concentrations using ambient air measurements recorded between 2009 and 2013 during Smelter shutdown periods at the Jones Ranch (Air Quality System (AQS) ID: 04-007-0011), Townsite (AQS ID: 04-007-0012) and Ridgeline (AQS ID: 04-007-0009) monitors. The State calculated the 5-year averages of the daily maximum 99th percentile 1-hour average SO2 during Smelter shutdowns at each site, which were 8.1, 6.7, and 7.2 ppb, respectively. The State chose to use the Jones Ranch value of 8.1 ppb (21.2 micrograms per cubic meter (µg/m3)) as background concentrations of SO2 to add to modeled design values. We agree that the State appropriately and conservatively calculated background concentrations.

    F. Summary of Results

    The EPA has reviewed Arizona's submitted modeling supporting the attainment demonstration for the Miami SO2 NAA and has preliminarily determined that this modeling is consistent with CAA requirements, appendix W and the 2014 SO2 Guidance. The State's modeling indicates that with a critical emission value of 393 lb/hr, the highest predicted 99th percentile daily maximum 1-hour concentration within the Miami SO2 NAA would be 194.1 μg/m3, below the NAAQS level of 196.4 μg/m3 (75 ppb). This modeled concentration includes the background concentration of SO2 of 21.2 µg/m3. The modeling indicates that the Smelter upgrades and resulting 30-day emission limit of 142.45 lb/hr are sufficient for the Miami SO2 NAA to attain the 2010 SO2 NAAQS.

    V. Review of Other Plan Requirements A. Emissions Inventory

    The emissions inventory and source emission rate data for an area serve as the foundation for air quality modeling and other analyses that enable states to estimate the degree to which different sources within a NAA contribute to violations within the affected area and assess the expected improvement in air quality within the NAA due to the adoption and implementation of control measures. As noted above, the state must develop and submit to the EPA a comprehensive, accurate and current inventory of actual emissions from all sources of SO2 emissions in each NAA, as well as any sources located outside the NAA which may affect attainment in the area.37

    37See CAA section 172(c)(3).

    The base year inventory establishes a baseline that is used to evaluate emission reductions achieved by the control strategy and to assess reasonable further progress requirements. Arizona used 2011 as the base year for emission inventory preparation. At the time of preparation of the Plan, 2011 reflected the most recent triennial National Emission Inventory, supported the requirement for timeliness of data, and was also representative of a year with violations of the primary SO2 NAAQS. Arizona reviewed and compiled actual emissions of all sources of SO2 in the NAA in the 2011 base year emission inventory. In addition to developing an emission inventory of SO2 emission sources within the NAA, Arizona also provided an SO2 emission inventory for those emission sources within a 50 kilometer buffer zone of the NAA. Table 2 below summarizes 2011 base year SO2 emissions inventory data for the NAA, categorized by emission source type (rounded to the nearest whole number).

    Table 2—2011 Base Year SO2 Emission Inventory for the Miami SO2 NAA [Tons/year] Year Point source Nonpoint source Mobile source
  • (onroad)
  • Mobile source
  • (non-road)
  • Total
    2011 2,583 13 2 >1 2,598

    As seen above, the majority of SO2 emissions in the 2011 base year inventory can be attributed to the point source category. Emissions for this category are provided in further detail in Table 3 below.

    Table 3—2011 Base Year SO2 Emission Inventory [Point sources] Point source Emissions
  • (tons/year)
  • Freeport McMoRan Miami Smelter 2,545 Freeport McMoRan Miami Mine 7 BHP Copper Pinto Valley Miami Unit >1 BHP Copper Pinto Valley Mine >1 Carlota Copper Pinto Valley Mine 31 Total 2,583

    A projected attainment year emission inventory should also be included in the SIP submission according to the 2014 SO2 Guidance. This emission inventory should include, in a manner consistent with the attainment demonstration, estimated emissions for all SO2 emission sources that were determined to have an impact on the affected NAA for the projected attainment year. Table 4 below summarizes Arizona's projected 2018 SO2 emissions inventory data for the NAA, categorized by source type. 2011 base year emissions, as well as the projected change between base year and projected year emissions, are also summarized below (rounded to nearest whole number).

    Table 4—Projected 2018 SO2 Emission Inventory for the Miami SO2 NAA [Tons/year] Year Point source Nonpoint source Mobile source
  • (onroad)
  • Mobile source
  • (non-road)
  • Total
    2011 2,583 13 2 >1 2,598 2018 685 13 2 >1 700 Change −1,898 0 0 0 −1,898

    As seen above, both the majority of SO2 emissions in the projected 2018 emission inventory, as well as the majority of projected SO2 emission reductions, can be attributed to point sources. Emissions for this category are provided in further detail in Table 5 below.

    Table 5—Projected 2018 SO2 Emission Inventory [Point sources] Point source 2011
  • Base year
  • emissions
  • (tons/year)
  • 2018
  • Projected
  • year emissions
  • (tons/year)
  • Change
    Freeport McMoRan Miami Smelter 2,545 660 −1,885 Freeport McMoRan Miami Mine 7 8 1 BHP Copper Pinto Valley Miami Unit >1 >1 0 BHP Copper Pinto Valley Mine >1 14 13 Carlota Copper Pinto Valley Mine 31 3 −28 Total 2,583 685 −1,898

    As seen above, the single largest decrease in emissions is attributed to the Miami Smelter. The projected 2018 SO2 emissions for the Miami Smelter are consistent with allowable emission limits for the Miami Smelter that Arizona is requesting that the EPA approve into the SIP. For other point sources, projected 2018 SO2 emissions were determined by Arizona based on existing permit allowable SO2 limits or other federally enforceable SO2 emission limits.

    The EPA has evaluated Arizona's 2011 base year inventory and projected 2018 emission inventory for the Miami SO2 NAA, and considers these inventories to have been developed consistent with EPA guidance. As a result, the EPA is proposing to determine that the Miami SO2 Plan meets the requirements of CAA Section 172(c)(3) and (4) for the Miami SO2 NAA.

    B. Reasonably Available Control Measures and Reasonably Available Control Technology

    Arizona's Plan for attaining the 1-hour SO2 NAAQS in the Miami SO2 NAA is based on implementation of controls at the Miami Smelter. ADEQ conducted a reasonably available control measures and reasonably available control technology (RACM/RACT) analysis in the Miami SO2 Plan, comparing the requirements at the Miami Smelter with controls in use at other large sources of SO2 to identify potentially available control measures, eliminating any measures that were not feasible at the Miami Smelter or not more stringent than those measures already being implemented. ADEQ then compared the proposed control measures for the Miami Smelter with the measures not eliminated in the first step of the RACM/RACT analysis, and concluded that the proposed control measures would be more stringent. We provide an assessment below of whether ADEQ's RACM/RACT analysis is consistent with EPA guidance.

    The State's RACM/RACT analysis can be found in section 4.4.3 of the Miami SO2 Plan. ADEQ compared SO2 controls at eight different facilities and found that all of these units used an acid plant to recover or reduce SO2 emissions. Some of these facilities also used acid absorption equipment (wet and dry scrubbers) to further control SO2. ADEQ also noted that enhanced capture systems (such as additional hooding, improved ventilation systems and enhanced ductwork) at the Miami Smelter would contribute to reducing uncontrolled fugitive emissions from the smelter structure. While enhanced capture does not inherently reduce SO2 emissions, these capture systems will route a greater amount of gas to control devices that do reduce SO2 emissions.

    The State concluded that upgrades to the acid plant, the installation of additional and improved scrubbers, and the installation of improved capture systems at the IsaSmelt furnace, electric furnace, converter department, and anode casting operations at the Miami Smelter constituted RACM/RACT and would allow the facility to meet the 142.45 lb/hr emission limit and other requirements outlined in Rule C1302. As explained in the Rule C1302 TSD, we agree that Rule C1302 generally requires implementation of reasonable controls for the Miami Smelter. We also find that it was appropriate for Arizona to focus its RACM/RACT analysis solely on this source, given that the Miami Smelter accounted for more than 99.5 percent of SO2 emissions in the NAA during the 2011 base year.38

    38 Miami SO2 Plan, Section 3.1.1, page 33.

    As noted above, most of the requirements of Rule C1302 will become enforceable only after final approval of the rule by the EPA. However, the Plan itself provides that the owner or operator of the Miami Smelter will complete construction of the relevant control measures no later than January 1, 2018, including steps that ADEQ will undertake if the owner or operator failed to complete construction by January 1, 2018.39 On December 19, 2017, FMMI notified the EPA and ADEQ that it had completed construction of the SO2 capture and control system upgrades and had initiated associated commissioning activities.40

    39Id., page 84.

    40 Letter from Byron Belew, FMMI, to Alexis Strauss, EPA, and Timothy Franquist, ADEQ (December 19, 2017).

    As explained above, we find that Arizona has demonstrated that implementation of the control measures required under the Plan are sufficient to provide for attainment of the NAAQS. Given that these controls have already been installed and will be fully operational prior to October 4, 2018, we propose to conclude that the State has satisfied the requirement in section 172(c)(1) and (6) to adopt and submit all RACM and emissions limitations and control measures as needed to attain the standards as expeditiously as practicable and the requirement in section 192(b) to provide for attainment by October 4, 2018.

    C. New Source Review

    On November 2, 2015, the EPA published a final limited approval and limited disapproval of revisions to ADEQ's new source review (NSR) rules.41 On May 4, 2018, the EPA approved additional rule revisions to address many of the deficiencies identified in the 2015 action.42 Collectively these rule revisions will ensure that ADEQ's rules provide for appropriate NSR for SO2 sources undergoing construction or major modification in the Miami SO2 NAA without need for further modification. Therefore, the EPA concludes that the NSR requirement has been met for this area. We note that Rule C1302 subsection (I) indicates that the smelter emission limits contained in the rule shall be determined to be SO2 RACT for purposes of minor NSR requirements. This provision does not interfere with or adversely affect existing nonattainment NSR rules.

    41 80 FR 67319 (November 2, 2015).

    42 83 FR 19631 (May 4, 2018).

    D. Reasonable Further Progress

    In the Miami SO2 Plan, Arizona explained its rationale for concluding that the Plan meets the requirement for reasonable further progress (RFP) in accordance with EPA guidance. Specifically, Arizona's rationale is based on EPA guidance interpreting the RFP requirement being satisfied for SO2 if the Plan requires “adherence to an ambitious compliance schedule” that “implement[s] appropriate control measures as expeditiously as practicable.” Arizona noted that its Plan provides for attainment as expeditiously as practicable, i.e., by October 4, 2018, and finds that the Plan thereby satisfies the requirement for RFP.

    Arizona finds that the Miami SO2 Plan requires affected sources to implement appropriate control measures as expeditiously as practicable in order to ensure attainment of the standard by the applicable attainment date. Arizona concludes that the Plan therefore provides for RFP in accordance with the approach to RFP described in the 2014 SO2 Guidance. The EPA concurs and proposes to conclude that the Plan provides for RFP.

    E. Contingency Measures

    In the Miami SO2 Plan, Arizona explained its rationale for concluding that the Plan meets the requirement for contingency measures. Specifically, Arizona relies on the 2014 SO2 Guidance, which notes the special circumstances that apply to SO2 and explains on that basis why the contingency requirement in CAA section 172(c)(9) is met for SO2 by having a comprehensive program to identify sources of violations of the SO2 NAAQS and to undertake an aggressive follow-up for compliance and enforcement of applicable emissions limitations. Arizona stated that it has such an enforcement program pursuant to state law in Arizona Revised Statutes (ARS) sections 49-461, 49-402, 49-404 and 49-406. Arizona also describes the process under State law to apply contingency measures for failure to make RFP and/or for failure to attain the SO2 NAAQS by the attainment date and concludes that Arizona's Plan satisfies contingency measure requirements. The EPA concurs with this assessment. We note that the EPA has approved ARS 49-402, 49-404, 49-406 and 49-461 into the Arizona SIP.43 In addition, we have approved ARS 49-422(A) (“Powers and Duties”), which authorizes ADEQ to require sources of air contaminants to “monitor, sample or perform other studies to quantify emissions of air contaminants or levels of air pollution that may reasonably be attributable to that source” for purposes of determining whether the source is in violation of a control requirement. We have also approved ARS 49-460 through 49-463, which authorize ADEQ to request compliance-related information from sources, to issue orders of abatement upon reasonable cause to believe a source has violated or is violating an air pollution control requirement, to establish injunctive relief, to establish civil penalties of up to $10,000 per day per violation, and to conduct criminal enforcement, as appropriate through the Attorney General.44 Therefore, we agree that the Arizona SIP establishes a comprehensive enforcement program, allowing for the identification of sources of SO2 NAAQS violations and aggressive compliance and enforcement follow-up. We propose to approve Arizona's Plan as meeting the contingency measure requirement in this manner.

    43See 40 CFR 52.120(e), Table 3.

    44 77 FR 66398 (November 5, 2012).

    VI. Conformity

    Generally, as set forth in section 176(c) of the CAA, conformity requires that actions by federal agencies do not cause new air quality violations, worsen existing violations, or delay timely attainment of the relevant NAAQS. General conformity applies to federal actions, other than certain highway and transportation projects, if the action takes place in a nonattainment area or maintenance area (i.e., an area which submitted a maintenance plan that meets the requirements of section 175A of the CAA and has been redesignated to attainment) for ozone, particulate matter, nitrogen dioxide, carbon monoxide, lead, or SO2. The EPA's General Conformity Rule establishes the criteria and procedures for determining if a federal action conforms to the SIP.45 With respect to the 2010 SO2 NAAQS, federal agencies are expected to continue to estimate emissions for conformity analyses in the same manner as they estimated emissions for conformity analyses under the previous NAAQS for SO2. The EPA's General Conformity Rule includes the basic requirement that a federal agency's general conformity analysis be based on the latest and most accurate emission estimation techniques available.46 When updated and improved emissions estimation techniques become available, the EPA expects the federal agency to use these techniques.

    45 40 CFR 93.150 to 93.165.

    46 40 CFR 93.159(b).

    Transportation conformity determinations are not required in SO2 nonattainment and maintenance areas. The EPA concluded in its 1993 transportation conformity rule that highway and transit vehicles are not significant sources of SO2. Therefore, transportation plans, transportation improvement programs and projects are presumed to conform to applicable implementation plans for SO2.47

    47See 58 FR 3776 (January 11, 1993).

    VII. The EPA's Proposed Action

    The EPA is proposing to approve the Miami SO2 Plan, which includes Arizona's attainment demonstration for the Miami SO2 NAA and addresses requirements for RFP, RACT/RACM, base-year and projected emission inventories, and contingency measures. The EPA proposes to determine that the Miami SO2 Plan meets applicable requirements of sections 110, 172, 191 and 192 of the CAA for the 2010 SO2 NAAQS.

    The EPA is taking public comments for thirty days following the publication of this proposed action in the Federal Register. We will take all relevant comments into consideration in our final action.

    VIII. Statutory and Executive Order Reviews

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

    • Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 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 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).

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur oxides.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: June 4, 2018. Michael B. Stoker, Regional Administrator, EPA Region IX.
    [FR Doc. 2018-12913 Filed 6-14-18; 8:45 am] BILLING CODE 6560-50-P
    83 116 Friday, June 15, 2018 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request June 12, 2018.

    The Department of Agriculture will submit the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13 on or after the date of publication of this notice. Comments are requested regarding: (1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, Washington, DC; New Executive Office Building, 725 17th Street NW, Washington, DC, 20503. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602.

    Comments regarding these information collections are best assured of having their full effect if received by July 16, 2018. Copies of the submission(s) may be obtained by calling (202) 720-8681.

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

    National Agricultural Statistics Service

    Title: Census of Aquaculture.

    OMB Control Number: 0535-0237.

    Summary of Collection: The primary objective of the 2018 Census of Aquaculture is to obtain a comprehensive and detailed picture of the aquaculture sector of the economy. The census of agriculture is required by law under the “Census of Agriculture Act of 1997,” Public Law 105-113 (Title 7, United States Code, Section 2204g). The census of aquaculture will be the only source of data comparable and consistent at the national and State levels for the aquaculture industry. It will cover all operations, commercial or noncommercial, for which $1,000 or more of aquaculture products were sold or normally would have been sold during the census year. The census of aquaculture is one of a series of special study programs that comprise the follow-on study to the Census of Agriculture and is designed to provide detailed statistics on the aquaculture industry.

    Need and Use of the Information: The National Agricultural Statistics Service will collect data to provide a comprehensive inventory on the number of operations, freshwater and saltwater acreage used for aquaculture production, water sources used for production, methods of production, total production, sales outlets, value of aquaculture products sold and sales by aquaculture species, products distributed for recreation, restoration, or conservation by species. These data will provide information on the aquaculture industry necessary for farmers, government, and various groups, concerned with the aquaculture industry to evaluate policy and programs, make marketing decisions, and determine the economic impact on the economy.

    Description of Respondents: Farms; Business or other for-profit.

    Number of Respondents: 6,100.

    Frequency of Responses: Reporting: One-time (Every 5-years).

    Total Burden Hours: 3,073.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-12860 Filed 6-14-18; 8:45 am] BILLING CODE 3410-20-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-831] Fresh Garlic From the People's Republic of China: Final Results and Partial Rescission of the 22nd Antidumping Duty Administrative Review and Final Result and Rescission, in Part, of the New Shipper Reviews; 2015-2016 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Commerce) published the Preliminary Results of the 22nd administrative review and two concurrent new shipper reviews of the antidumping duty order on fresh garlic from the People's Republic of China (China) on December 7, 2017. The period of review (POR) is November 1, 2015, through October 31, 2016. We made no changes to the margin calculated for mandatory respondent Shandong Jinxiang Zhengyang Import & Export Co., Ltd. (Zhengyang), or for new shipper respondent Zhengzhou Yudi Shengjin Agricultural Trade Co., Ltd. (Yudi), and continue to find that they made sales below normal value. In addition, we are rescinding the new shipper review with respect to Qingdao Joinseafoods Co., Ltd. and Join Food Ingredient Inc.'s (collectively, Join).

    DATES:

    Applicable June 15, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Kathryn Wallace or Alexander Cipolla, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone 202-482-6251 or 202-482-4956, respectively.

    SUPPLEMENTARY INFORMATION:

    The mandatory respondents in this administrative review are: Zhengzhou Harmoni Spice Co., Ltd. (Harmoni), and Zhengyang. The new shipper review (NSR) respondents are Join and Yudi. Commerce published the Preliminary Results on December 7, 2017, in which it preliminarily determined that Zhengyang, Join, and Yudi sold merchandise to the United States at less than normal value.1 We also preliminarily granted a separate rate to six companies which demonstrated their eligibility for separate rate status, but were not selected for individual examination.2 We preliminarily rescinded the review with respect to the seven companies, including Harmoni, for which a valid review request did not exist.3 In accordance with 19 CFR 351.309, we invited parties to comment on our Preliminary Results. The petitioners,4 the CFTG,5 Zhengyang, Join, and Yudi timely filed case briefs, pursuant to our regulations.6 Additionally, the petitioners, Join, and Harmoni timely filed rebuttal briefs.7 The deadline for the final results of this review was originally April 9, 2018. On March 14, 2018, Commerce extended the deadline in this proceeding by 60 days to June 8, 2018.8

    1See Fresh Garlic from the People's Republic of China: Preliminary Results, Preliminary Rescission, and Final Rescission, in Part, of the 22nd Antidumping Duty Administrative Review and Preliminary Results of the New Shipper Reviews; 2015-2016, 82 FR 57718 (December 7, 2017) (Preliminary Results) and accompanying Issues and Decision Memorandum (PDM).

    2Id.

    3Id.

    4 The petitioners are the Fresh Garlic Producers Association (FGPA) and its individual members: Christopher Ranch LLC, The Garlic Company, Valley Garlic, and Vessey and Company, Inc.

    5 The CFTG, at the time of initiation, consisted of Mr. Avrum Katz of Boxcar Farm, Mr. Stanley Crawford of El Bosque Farm, Ms. Susanne Sanford of Sanford Farm, and Mr. Alex Pino of Revolution Farm.

    6See CFTG's Letter, “Case Brief: Filed on Behalf of the Coalition for Fair Trade in Garlic in the 22nd Administrative Review of Fresh Garlic from China,” dated April 25, 2018 (CFTG's Case Brief); see also Zhengyang's Letter, “Fresh Garlic from the People's Republic of China—Case Brief,” dated April 25, 2018. (Commerce rejected Zhengyang's Case Brief for containing unsolicited new factual information. see Commerce's Letter, “22nd Antidumping Duty Administrative Review of Fresh Garlic from the People's Republic of China: Request for Removal of Untimely New Factual Information” dated May 15, 2018. Memorandum); see also Yudi's Letter, “Case Brief” dated April 25, 2018 (Yudi's Case Brief); see also Join's Letter, “Case Brief” dated April 25, 2018 (Join's Case Brief); see also the Petitioners' Letter, “Petitioners' Case Brief” dated April 25, 2018 (Petitioners' NSR Case Brief).

    7See the Petitioners' Letter, “Petitioners' Rebuttal Brief,” dated May 2, 2018 (Petitioners' NSR Rebuttal Brief); see also Join's Letter, “Rebuttal Case Brief” dated May 2, 2018 (Join's Rebuttal Brief); see also the Petitioners' Letter, “Fresh Garlic from the People's Republic of China: Petitioners' Rebuttal Brief,” dated May 2, 2018 (the Petitioners' Rebuttal Brief); see also Harmoni's Letter, “Harmoni Administrative Review Reply Brief: 22nd Administrative Review of the Antidumping Duty Order on Fresh Garlic from the People's Republic of China (A-570-831),” dated May 2, 2018 (Harmoni's Rebuttal Brief).

    8See Memorandum, “Fresh Garlic from the People's Republic of China—22nd Administrative Review (2015-2016): extension of Deadline for the Final Results of the Review,” dated March 15, 2017.

    Based upon our analysis of the comments and information received, Commerce continues to find that the review request made by the Coalition for Fair Trade in Garlic (the CFTG) was not valid, and accordingly have rescinded the review with respect to seven companies, including the other mandatory respondent Harmoni, for which a valid review request does not exist. As discussed below, Commerce finds that Join withheld requested information, significantly impeded the new shipper review, and did not cooperate to the best of its ability. Accordingly, pursuant to sections 776(a) and (b) of the Tariff Act of 1930, as amended (the Act), we have used an adverse inference in selecting from among the facts otherwise available, and have found Join's sale not bona fide, and have rescinded the review of Join.

    Scope of the Order

    The merchandise covered by the order includes all grades of garlic, whole or separated into constituent cloves. Fresh garlic that are subject to the order are currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) 0703.20.0000, 0703.20.0005, 0703.20.0010, 0703.20.0015, 0703.20.0020, 0703.20.0090, 0710.80.7060, 0710.80.9750, 0711.90.6000, 0711.90.6500, 2005.90.9500, 2005.90.9700, 2005.99.9700. Although the HTSUS numbers are provided for convenience and customs purposes, the written product description remains dispositive. For a full description of the scope of this order, please see “Scope of the Order” in the accompanying Issues and Decision Memorandum.9

    9See Memorandum, “Issues and Decision Memorandum for the Final Results and Final Rescission of the Antidumping Duty Administrative Review and New Shipper Reviews: Fresh Garlic from the People's Republic of China; 2014-2015,” dated concurrently with this notice (IDM).

    Partial Rescission of Administrative Review

    As discussed in the IDM,10 Commerce is rescinding the review with respect to seven companies, including mandatory respondent Harmoni, based on Commerce's determination that the CFTG's request for review was not valid. See Appendix IV for the companies for which administrative reviews have been rescinded in these final results.

    10See IDM at 6, 24.

    Analysis of Comments Received

    We addressed all issues raised in the case and rebuttal briefs by parties in this review in the IDM. Appendix I provides a list of the issues which parties raised. The IDM is a public document and is on file in the Central Records Unit (CRU), Room B8024 of the main Department of Commerce building, as well as electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and in the CRU. In addition, a complete version of the IDM can be accessed directly on the internet at http://enforcement.trade.gov/frn/index.html. The signed IDM and the electronic versions of the IDM are identical in content.

    Changes Since the Preliminary Results

    Based on a review of the record and comments received from interested parties regarding our Preliminary Results, and for the reasons explained in the IDM, including the application of facts available with an adverse inference, we revised our decision regarding Join's cooperation and have rescinded the new shipper review, as discussed below. Further, we have determined that the QTF-Entity is eligible for a separate rate.

    Rescission of New Shipper Review

    As discussed in the IDM, Commerce has analyzed the bona fides of Join's single sale and found that it was not a bona fide sale, and thus not reviewable pursuant to section 751(a)(2)(B)(iv) of the Act.11 Commerce reached this conclusion based on its consideration of the totality of circumstances, including: The timing of the payment, the parties' implementation of the terms of sale, incomplete information concerning the affiliates involved with the sale, missing or underreported expenses related to the sale, and the single sale. For a complete discussion see the IDM at 10-15, and Comment 5.

    11See IDM at 10-15, and Comment 5.

    For the foregoing reasons, Commerce finds that Join's sale is not bona fide, and that the sale does not provide a reasonable or reliable basis for calculating a dumping margin. Accordingly, Commerce is rescinding the NSR with respect to Join.

    Final Determination of No Shipments

    In the Preliminary Results, Commerce preliminarily determined that the companies listed in Appendix III timely filed “no shipment” certifications and did not have any reviewable transactions during the POR. Consistent with Commerce's assessment practice in non-market economy (NME) cases, we completed the review with respect to the companies listed in Appendix III. For the companies listed in Appendix III, CBP provided no evidence to contradict the claims of these companies of no shipments.

    As noted in the “Assessment Rates” section below, Commerce intends to issue appropriate instructions to CBP for the companies listed below based on the final results of this review.

    PRC-Wide Entity

    As discussed in the Preliminary Results, Commerce's policy regarding conditional review of the PRC-wide entity applies to this administrative review.12 Under this policy, the PRC-wide 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 PRC-wide entity, the entity is not under review and the entity's rate (i.e., $4.71/kg) is not subject to change. Aside from the no shipment companies discussed below, Commerce considers all other companies for which a review was requested, and which did not qualify for a separate rate, to be part of the PRC-wide entity. See Appendix II.

    12See 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 (November 4, 2013).

    Separate Rates

    In the Preliminary Results, Commerce found that non-selected companies Jining Shunchang Import & Export Co., Ltd., Jinxiang Feiteng Import & Export Co., Ltd., Qingdao Sea-Line International Trading Co., Ltd., Shenzhenn Bainon Co., Ltd., Shenzhen Xinboda Industrial Co., Ltd., and Weifang Hongqiao International Logistics Co., Ltd., demonstrated their eligibility for a separate rate. We continue to find that those six companies are eligible for a separate rate.13 As discussed in the IDM, Commerce granted the QTF-Entity separate status in these final results.14

    13See Preliminary Results at Appendix II.

    14See IDM at 7-8.

    In the Preliminary Results, we assigned the non-selected separate rate companies the dumping margin calculated for Zhengyang. No parties commented on this. We continue to use Zhengyang's margin as the margin for the non-selected separate rate companies in these final results.

    Final Results of Administrative Review

    The weighted-average dumping margins for the administrative review are as follows:

    15 The QTF-Entity includes: Qingdao Tiantaixing Foods Co., Ltd.; Qingdao Tianhefeng Foods Co., Ltd.; Qingdao Beixing Trading Co., Ltd.; Qingdao Lianghe International Trade Co., Ltd.; Qingdao Xintianfeng Foods Co., Ltd.; Hebei Golden Bird Trading Co., Ltd.; and Huamei Consulting; see Fresh Garlic from the People's Republic of China: Final Results and Partial Rescission of the 21st Antidumping Duty Administrative Review; 2014-2015, 82 FR 27230 (June 14, 2017), and accompanying Issues and Decision Memorandum at Comment 4.

    Exporter Weighted-
  • average
  • margin
  • (dollars per
  • kilogram)
  • Shandong Jinxiang Zhengyang Import & Export Co., Ltd $2.69 Jining Shunchang Import & Export Co., Ltd 2.69 Jinxiang Feiteng Import & Export Co., Ltd 2.69 Qingdao Sea-Line International Trading Co., Ltd 2.69 QTF-Entity 15 2.69 Shenzhen Bainong Co., Ltd 2.69 Shenzhen Xinboda Industrial Co., Ltd 2.69 Weifang Hongqiao International Logistics Co., Ltd 2.69
    Final Results of New Shipper Review

    The weighted-average dumping margin for the new shipper review:

    Exporter Weighted-
  • average
  • margin
  • (dollars per
  • kilogram)
  • Zhengzhou Yudi Shengjin Agricultural Trade Co., Ltd $3.19
    Assessment Rates

    Pursuant to section 751(a)(2)(A) and (C) of the Act, and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of these reviews. We intend to issue appropriate assessment instructions directly to CBP 15 days after publication of the final results of this administrative review, and the new shipper reviews.

    Where the respondent reported reliable entered values, we calculated importer- (or customer-) specific ad valorem rates by aggregating the dumping margins calculated for all U.S. sales to each importer (or customer) and dividing this amount by the total entered value of the sales to each importer (or customer).16 Where we calculated a weighted-average dumping margin by dividing the total amount of dumping for reviewed sales to that party by the total sales quantity associated with those transactions, we will direct CBP to assess importer-specific assessment rates based on the resulting per-unit rates.17 Where an importer- (or customer-) specific ad valorem or per-unit rate is greater than de minimis, we will instruct CBP to collect the appropriate duties at the time of liquidation.18 Where an importer- (or customer-) specific ad valorem or per-unit rate is zero or de minimis, we will instruct CBP to liquidate appropriate entries without regard to antidumping duties.19 We intend to instruct CBP to liquidate entries containing subject merchandise exported by the PRC-wide entity at the PRC-wide rate.

    16See 19 CFR 351.212(b)(1).

    17Id.

    18Id.

    19See 19 CFR 351.106(c)(2).

    Pursuant to Commerce's assessment practice, for entries that were not reported in the U.S. sales databases submitted by companies individually examined during this review, we will instruct CBP to liquidate such entries at the PRC-wide entity 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 rate) will be liquidated at the PRC-wide entity rate.20

    20See Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011).

    As Commerce is rescinding the NSR with respect to Join, we are not making a determination as to whether or not Join qualifies for a separate rate. Therefore, Join remains part of the PRC-wide entity. The PRC-wide entity is not under review in the ongoing administrative review. Accordingly, Join's entry will be assessed at the rate equal to the cash deposit of estimated antidumping duties required on its merchandise at the time of entry, or withdrawal from warehouse, for consumption. We intend to issue liquidation instructions for any entries during the relevant period made by Join 15 days after publication of this notice.

    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 exporter listed above, the cash deposit rate will be the rate established in the final results of review (except, if the rate is zero or de minimis, i.e., less than 0.5 percent, a zero cash deposit rate will be required for that company); (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recent period; (3) for all PRC exporters of subject merchandise which have not been found to be entitled to a separate rate, the cash deposit rate will be the PRC-wide rate of $4.71 per kilogram; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporters that supplied that non-PRC exporter. The deposit requirements shall remain in effect until further notice.

    Disclosure

    We intend to disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).

    Notification to Importers

    This notice also serves as a final 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 POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

    Administrative Protective Orders

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    Notification to Interested Parties

    We are issuing and publishing these final results of administrative review in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.213.

    Dated: June 8, 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 Issues Discussed in the Issues and Decision Memorandum Administrative Review 1. Whether Section 751 of the Act Requires Commerce to Conduct an AR of Harmoni Following the CFTG's Request for Review 2. Whether the CFTG's Review Request was Valid, and Whether the Members of the CFTG are Producers or Wholesalers of a Domestic Like Product 3. Whether Harmoni and the FGPA Obstructed or Impaired Legitimate Government Activity New Shipper Reviews 4. Whether Yudi's Sale was Made on a Bona Fide Basis 5. Whether Join's Sale was Made on a Bona Fide Basis 6. Whether Commerce Properly Selected Romania as the Surrogate Country Appendix II List of Companies Under Review Subject to the PRC-Wide Rate 1. China Union Agri. (Qingdao) Co., Ltd. 2. Juxian Huateng Organic Ginger Co., Ltd. 3. Qingdao Jiashan Trading Co., Ltd. 4. Shandong Helu International Trade Co., Ltd. 5. Weifang Wangyuan Food Co., Ltd. 6. Zhengzhou Yudishengjin Farm Products Co., Ltd. Appendix III Companies That Have Certified No Shipments 1. Jinan Farmlady Trading Co., Ltd. 2. Jining Shengtai Fruits & Vegetables Co., Ltd. 3. Jining Yifa Garlic Produce Co., Ltd. 4. Jinxiang Richfar Fruits & Vegetables Co., Ltd. 5. Shijiazhuang Goodman Trading Co., Ltd. Appendix IV Companies for Which Administrative Reviews Have Been Rescinded 1. Jinxiang Jinma Fruits Vegetables Products Co., Ltd. 2. Juxian Huateng Food Co., Ltd. 3. Qingdao Hailize (Sea-Line) International Trading Co., Ltd. 4. Qingdao Jiuyihongrun Foods Co., Ltd. 5. Qingdao Ritai Food Co., Ltd. 6. Zhengzhou Harmoni Spice Co., Ltd. 7. Zhonglian Nongchan Co., Ltd.
    [FR Doc. 2018-12898 Filed 6-14-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-122-863, A-570-077, A-484-803, A-533-881, A-580-897, A-489-833] Large Diameter Welded Pipe From Canada, Greece, India, the People's Republic of China, the Republic of Korea, and the Republic of Turkey: Postponement of Preliminary Determinations in the Less-Than-Fair-Value Investigations AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    DATES:

    Applicable June 15, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Susan Pulongbarit at (202) 482-4031 (Canada); Brittany Bauer at (202) 482-3860 (Greece); Jaron Moore at (202) 482-3640 (India); Kabir Archuletta at (202) 482-8024 (the People's Republic of China (China)); Jesus Saenz at (202) 482-8184 (the Republic of Korea (Korea)); and Rebecca Janz at (202) 482-2972 (the Republic of Turkey (Turkey)), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.

    SUPPLEMENTARY INFORMATION: Background

    On February 9, 2018, the U.S. Department of Commerce (Commerce) initiated less-than-fair-value (LFTV) investigations of imports of large diameter welded pipe from Canada, China, Greece, India, Korea, and Turkey.1 Currently, the preliminary determinations are due no later than June 29, 2018.2

    1See Large Diameter Welded Pipe from Canada, Greece, India, the People's Republic of China, the Republic of Korea, and the Republic of Turkey: Initiation of Less-Than-Fair-Value Investigations, 83 FR 7154 (February 20, 2018).

    2 Commerce has exercised its discretion to toll deadlines for the duration of the closure of the Federal Government from January 20 through 22, 2018. See Memorandum, “Deadlines Affected by the Shutdown of the Federal Government,” dated January 23, 2018 (Tolling Memorandum). Accordingly, all deadlines in this segment of the proceeding have been extended by 3 days.

    Postponement of Preliminary Determinations

    Section 733(b)(1)(A) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in an LTFV investigation within 140 days after the date on which Commerce initiated the investigation. However, section 733(c)(1) of the Act permits Commerce to postpone the preliminary determination until no later than 190 days after the date on which Commerce initiated the investigation if: (A) The petitioner makes a timely request for a postponement; or (B) Commerce concludes that the parties concerned are cooperating, that the investigation is extraordinarily complicated, and that additional time is necessary to make a preliminary determination. Pursuant to 19 CFR 351.205(e), the petitioner must submit a request to postpone 25 days or more before the scheduled date of the preliminary determination, and must state the reasons for postponement. Commerce will grant the request unless it finds compelling reasons to deny the request. See 19 CFR 351.205(e).

    On May 23, 2018, the petitioners 3 submitted a timely request that Commerce postpone the preliminary determinations in these LTFV investigations.4 The petitioners stated that the purpose of their request is to provide Commerce with adequate time to solicit information from the respondents and to allow Commerce sufficient time to analyze respondents' questionnaire responses.5

    3 American Cast Iron Pipe Company, Berg Steel Pipe Corp., Berg Spiral Pipe Corp., Dura-Bond Industries, and Stupp Corporation, individually and as members of the American Line Pipe Producers Association; Greens Bayou Pipe Mill, LP; JSW Steel (USA) Inc.; Skyline Steel; and Trinity Products LLC (collectively, the petitioners).

    4See Petitioners' Letters, “Large Diameter Welded Pipe from Canada: Petitioners' Request for Postponement of the Preliminary Determination,” dated May 23, 2018; “Large Diameter Welded Pipe from China: Petitioners' Request for Postponement of the Preliminary Determination,” dated May 23, 2018; “Large Diameter Welded Pipe from Greece: Petitioners' Request for Postponement of the Preliminary Determination,” dated May 23, 2018; “Large Diameter Welded Pipe from India: Petitioners' Request for Postponement of the Preliminary Determination,” dated May 23, 2018; “Large Diameter Welded Pipe from Korea: Petitioners' Request for Postponement of the Preliminary Determination,” dated May 23, 2018; “Large Diameter Welded Pipe from Turkey: Petitioners' Request for Postponement of the Preliminary Determination,” dated May 23, 2018.

    5Id.

    In accordance with 19 CFR 351.205(e), there are no compelling reasons to deny the request. Therefore, in accordance with section 733(c)(1)(A) of the Act and 19 CFR 351.205(e), we are postponing the preliminary determinations in these LTFV investigations by 50 days (i.e., 190 days after the date on which these investigations were initiated). Additionally, Commerce exercised its discretion to toll deadlines affected by the closure of the Federal Government from January 20 through 22, 2018.6 Accordingly, Commerce is postponing the deadline for the preliminary determinations to August 20, 2018.7 Pursuant to section 735(a)(1) of the Act and 19 CFR 351.210(b)(1), the deadline for the final determinations of these investigations will continue to be 75 days after the date of the preliminary determinations, unless postponed.

    6See Tolling Memorandum.

    7 Note that the revised deadline reflects a full postponement to 190 days after the date on which this investigation was initiated, in addition to a 3-day extension due to closure of the Federal Government. As this new deadline falls on a Saturday, the deadline moves to the next business day. See Notice of Clarification: Application of “Next Business Day” Rule for Administrative Determination Deadlines Pursuant to the Tariff Act of 1920, as Amended, 70 FR 24533 (May 10, 2005).

    This notice is issued and published pursuant to section 733(c)(2) of the Act and 19 CFR 351.205(f)(1).

    Dated: June 8, 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. 2018-12899 Filed 6-14-18; 8:45 am] BILLING CODE 3510-DS-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.

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Western Pacific Community Development Program.

    OMB Control Number: 0648-0612.

    Form Number(s): None.

    Type of Request: Regular (extension of a currently approved information collection).

    Number of Respondents: 5.

    Average Hours per Response: 6.

    Burden Hours: 30.

    Needs and Uses: This request is for extension of a current information collection.

    The Federal regulations at 50 CFR part 665 authorize the Regional Administrator of the National Marine Fisheries Service (NMFS), Pacific Island Region to provide eligible western Pacific communities with access to fisheries that they have traditionally depended upon, but may not have the capabilities to support continued and substantial participation, possibly due to economic, regulatory, or other barriers. To be eligible to participate in the western Pacific community development program, a community must meet the criteria set forth in 50 CFR part 665.20, and submit a community development plan that describes the purposes and goals of the plan, the justification for proposed fishing activities, and the degree of involvement by the indigenous community members, including contact information.

    This collection of information provides NMFS and the Western Pacific Fishery Management Council (Council) with data to determine whether a community that submits a community development plan meets the regulatory requirements for participation in the program, and whether the activities proposed under the plan are consistent with the intent of the program, the Magnuson-Stevens Fishery Conservation and Management Act, and other applicable laws. The information is also important for evaluating potential impacts of the proposed community development plan activities on fish stocks, endangered species, marine mammals, and other components of the affected environment for the purposes of compliance with the National Environmental Policy Act, the Endangered Species Act and other applicable laws.

    Affected Public: Individuals or households; business or other for-profit organizations; not for profit institutions.

    Frequency: On occasion.

    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: June 12, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-12882 Filed 6-14-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF986 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to a Low-Energy Geophysical Survey in the Northwest Atlantic Ocean AGENCY:

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

    ACTION:

    Notice; issuance of an incidental harassment authorization.

    SUMMARY:

    In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to the Scripps Institution of Oceanography (SIO) to take marine mammals incidental to a low-energy marine geophysical survey in the Northwest Atlantic Ocean.

    DATES:

    This authorization is valid for one year from the date of issuance.

    FOR FURTHER INFORMATION CONTACT:

    Jordan Carduner, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at: www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-research-and-other-activities. In case of problems accessing these documents, please call the contact listed above.

    SUPPLEMENTARY INFORMATION: Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

    An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.

    NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

    The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

    National Environmental Policy Act

    To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq.) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action (i.e., the issuance of an incidental harassment authorization) with respect to potential impacts on the human environment. This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental harassment authorizations with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review.

    Summary of Request

    On November 20, 2017, NMFS received a request from SIO for an IHA to take marine mammals incidental to conducting a low-energy marine geophysical survey in the Northwest Atlantic Ocean. On February 8, 2018, we deemed SIO's application for authorization to be adequate and complete. SIO's request is for take of a small number of 35 species of marine mammals by Level B harassment and Level A harassment. Neither SIO nor NMFS expects mortality to result from this activity, and, therefore, an IHA is appropriate. The planned activity is not expected to exceed one year, hence, we do not expect subsequent MMPA incidental harassment authorizations would be issued for this particular activity.

    Description of Specified Activity Overview

    SIO plans to conduct a low-energy marine seismic survey in the Northwest Atlantic Ocean for approximately 25 days during June-July 2018. The survey would occur in International Waters, between ~33.5° and 53.5° N, and 37° and 49° W, at water depths ranging from 1,800 to over 5,000 meters (m) (see Figure 1 in the IHA application) and would entail one source vessel, the R/V Atlantis, which would tow a pair of 45 cubic inch (in3) GI airguns at a depth of 2-4 m with a total discharge volume of approximately 90 in3 as an energy source along predetermined lines. The receiving system would consist of one hydrophone streamer, either 200 or 600 m in length. The program consists of a site survey in support of a potential future International Ocean Discovery Program project and would examine regional seismic stratigraphy and provide seismic images of changing sediment distributions from deepwater production changes. The Principal Investigators are Drs. M. Lyle (Oregon State University), G. Mountain (Rutgers University), and K. Miller (Rutgers University).

    The survey would use two different types of airgun array configurations. The first would entail a pair of 45-in3 airguns spaced 8 m apart at a water depth of 2-4 m with a 200 m hydrophone streamer and with the vessel traveling at 8 knots (kt). The second would entail a pair of 45-in3 airguns, but with airguns spaced 2 m apart at a depth of 2-4 m with a 600 m hydrophone streamer and with the vessel traveling at 5 kt to achieve especially high-quality seismic reflection data. Data would be collected within six grids, and also along track lines between the six grid locations (see Figure 1 in the IHA application). A total of 7,911 kilometers (km) of seismic acquisition would occur, including 4,334 km of data collected within the survey grids (2667 km at 8 kt and 1667 km at 5 kt) and an additional 3,577 km of track lines connecting the grids. There could be additional seismic operations in the project area associated with equipment testing, re-acquisition due to equipment malfunction, data degradation during poor weather, or interruption due to shutdown or track deviation in compliance with IHA requirements.

    In addition to the operations of the airgun array, a multibeam echosounder (MBES) and a sub-bottom profiler (SBP) would also be operated continuously throughout the survey, but not during transits to and from the project area. The MBES (a Kongsberg EM122) operates at 10.5-13 (usually 12) kilohertz (kHz) and is hull-mounted, with the transmitting beamwidth 1 or 2° fore-aft and 150° athwartship. The SBP (a Knudsen 3260) is normally operated to provide information about the near seafloor sedimentary features and the bottom topography that is mapped simultaneously by the MBES. The beam of the SBP is transmitted as a 27° cone, which is directed downward by a 3.5-kHz transducer in the hull of the vessel.

    Table 1—Specifications of the R/V Atlantis Airgun Array Number of airguns 2. Gun positions used Two inline airguns 2- or 8-m apart. Tow depth of energy source 2-4 m. Dominant frequency components 0-188 Hz. Air discharge volume Approximately 90 in3. Shot interval 9.72 seconds (2 m airgun separation survey) and 12.15 seconds (8 m airgun separation survey).

    A detailed description of SIO's planned survey is provided in the Federal Register notice for the proposed IHA (83 FR 18644; April 27, 2018). Since that time, no changes have been made to SIO's planned survey activities. Therefore, a detailed description is not provided here. Please refer to that Federal Register notice for the description of the specific activity. Mitigation, monitoring, and reporting measures are described in detail later in this document (please see “Mitigation” and “Monitoring and Reporting”).

    Comments and Responses

    NMFS published a notice of proposed IHA in the Federal Register on April 27, 2018 (83 FR 18644). During the 30-day public comment period, NMFS received a comment letter from the Marine Mammal Commission (Commission). NMFS has posted the comments online at: www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-research-and-other-activities. NMFS addresses any comments specific to SIO's application related to the statutory and regulatory requirements or findings that NMFS must make under the MMPA in order to issue an Authorization. The following is a summary of the public comments and NMFS' responses.

    Comment 1: The Commission expressed concerns regarding SIO's method to estimate the extent of the Level A and Level B harassment zones and the numbers of marine mammal takes. The Commission stated that the model is not the best available science because it assumes spherical spreading, a constant sound speed, and no bottom interactions for surveys in deep water, and that the model provides results to a water depth of 2,000 m while SIO's planned survey would occur in waters from 1,800 to more than 5,000 m in depth. In light of their concerns, the Commission recommended that NMFS require SIO, in collaboration with Lamont-Doherty Earth Observatory of Columbia University (LDEO) (which performed the modeling of Level A and Level B harassment zones) to re-estimate the Level A and Level B harassment zones and associated takes of marine mammals using (1) operational (including number/type/spacing of airguns, tow depth, source level/operating pressure, operational volume) and site-specific environmental (including sound speed profiles, bathymetry, and sediment characteristics at a minimum) parameters; (2) a comprehensive source model (i.e., Gundalf Optimizer or AASM) and (3) an appropriate sound propagation model for the proposed IHA. Specifically, the Commission states that LDEO should be using the ray-tracing sound propagation model BELLHOP, rather than the MATLAB code currently used.

    NMFS Response: NMFS acknowledges the Commission's concerns about LDEO's current modeling approach for estimating Level A and Level B harassment zones and takes. SIO's application (LGL, 2018) and the Federal Register notice of the proposed IHA (83 FR 18644; April 27, 2018) describe the applicant's approach to modeling Level A and Level B harassment zones. The model LDEO currently uses does not allow for the consideration of environmental and site-specific parameters as requested by the Commission.

    SIO's application (LGL, 2018) describes their approach to modeling Level A and Level B harassment zones. In summary, LDEO acquired field measurements for several array configurations at shallow, intermediate, and deep-water depths during acoustic verification studies conducted in the northern Gulf of Mexico in 2007 and 2008 (Tolstoy et al., 2009). Based on the empirical data from those studies, LDEO developed a sound propagation modeling approach that predicts received sound levels as a function of distance from a particular airgun array configuration in deep water. For this survey, LDEO modeled Level A and Level B harassment zones based on the empirically-derived measurements from the Gulf of Mexico calibration survey (Appendix H of NSF-USGS 2011). LDEO used the deep-water radii obtained from model results down to a maximum water depth of 2,000 m (Figure 2 and 3 in Appendix H of NSF-USGS 2011).

    In 2015, LDEO explored the question of whether the Gulf of Mexico calibration data described above adequately informs the model to predict exclusion isopleths in other areas by conducting a retrospective sound power analysis of one of the lines acquired during L-DEO's seismic survey offshore New Jersey in 2014 (Crone, 2015). NMFS presented a comparison of the predicted radii (i.e., modeled exclusion zones) with radii based on in situ measurements (i.e., the upper bound [95th percentile] of the cross-line prediction) in a previous notice of issued Authorization for LDEO (see 80 FR 27635, May 14, 2015, Table 1). Briefly, the analysis presented in Crone (2015), specific to the survey site offshore New Jersey, confirmed that in-situ, site specific measurements and estimates of 160 decibel (dB) and 180 dB isopleths collected by the hydrophone streamer of the R/V Marcus Langseth in shallow water were smaller than the modeled (i.e., predicted) zones for two seismic surveys conducted offshore New Jersey in shallow water in 2014 and 2015. In that particular case, Crone's (2015) results showed that LDEO's modeled 180 dB and 160 dB zones were approximately 28 percent and 33 percent smaller, respectively, than the in-situ, site-specific measurements, thus confirming that LDEO's model was conservative in that case.

    The following is a summary of two additional analyses of in-situ data that support LDEO's use of the modeled Level A and Level B harassment zones in this particular case. In 2010, LDEO assessed the accuracy of their modeling approach by comparing the sound levels of the field measurements acquired in the Gulf of Mexico study to their model predictions (Diebold et al., 2010). They reported that the observed sound levels from the field measurements fell almost entirely below the predicted mitigation radii curve for deep water (i.e., greater than 1,000 m; 3280.8 ft) (Diebold et al., 2010). In 2012, LDEO used a similar process to model distances to isopleths corresponding to Level A and Level B harassment thresholds for a shallow-water seismic survey in the northeast Pacific Ocean offshore Washington State. LDEO conducted the shallow-water survey using a 6,600 in3 airgun configuration aboard the R/V Marcus Langseth and recorded the received sound levels on both the shelf and slope using the Langseth's 8 km hydrophone streamer. Crone et al. (2014) analyzed those received sound levels from the 2012 survey and confirmed that in-situ, site specific measurements and estimates of the 160 dB and 180 dB isopleths collected by the Langseth's hydrophone streamer in shallow water were two to three times smaller than LDEO's modeling approach had predicted. While the results confirmed the role of bathymetry in sound propagation, Crone et al. (2014) were also able to confirm that the empirical measurements from the Gulf of Mexico calibration survey (the same measurements used to inform LDEO's modeling approach for the planned surveys in the northwest Atlantic Ocean) overestimated the size of the exclusion and buffer zones for the shallow-water 2012 survey off Washington State and were thus precautionary, in that particular case.

    NMFS continues to work with LDEO to address the issue of incorporating site-specific information for future authorizations for seismic surveys. However, LDEO's current modeling approach (supported by the three data points discussed previously) represents the best available information for NMFS to reach determinations for this IHA. As described earlier, the comparisons of LDEO's model results and the field data collected at multiple locations (i.e., the Gulf of Mexico, offshore Washington State, and offshore New Jersey) illustrate a degree of conservativeness built into LDEO's model for deep water, which NMFS expects to offset some of the limitations of the model to capture the variability resulting from site-specific factors. Based upon the best available information (i.e., the three data points, two of which are peer-reviewed, discussed in this response), NMFS finds that the Level A and Level B harassment zone calculations are appropriate for use in this particular IHA.

    LDEO has conveyed to NMFS that additional modeling efforts to refine the process and conduct comparative analysis may be possible with the availability of research funds and other resources. Obtaining research funds is typically accomplished through a competitive process, including those submitted to U.S. Federal agencies. The use of models for calculating Level A and Level B harassment zones and for developing take estimates is not a requirement of the MMPA incidental take authorization process. Further, NMFS does not provide specific guidance on model parameters nor prescribe a specific model for applicants as part of the MMPA incidental take authorization process at this time, although we do review methods to ensure adequate for prediction of take. There is a level of variability not only with parameters in the models, but also the uncertainty associated with data used in models, and therefore, the quality of the model results submitted by applicants. NMFS considers this variability when evaluating applications and the take estimates and mitigation measures that the model informs. NMFS takes into consideration the model used, and its results, in determining the potential impacts to marine mammals; however, it is just one component of the analysis during the MMPA authorization process as NMFS also takes into consideration other factors associated with the activity (e.g., geographic location, duration of activities, context, sound source intensity, etc.).

    Comment 2: The Commission recommended that NMFS better evaluate the numbers of Level A and B harassment takes it plans to propose for authorization by considering both ecological/biological information and implementation of mitigation measures for all proposed authorizations prior to submitting them for publication in the Federal Register. The Commission specifically questioned the proposed authorization of 42 Level A takes of harbor porpoises and recommended that NMFS reduce the numbers of Level A takes for that particular species.

    NMFS Response: We appreciate the Commission's concern with authorizing appropriate numbers of take and their suggestion regarding the specific number of Level A takes that it deems appropriate in this instance. We base take analyses on the best available information; in this case, as SIO's survey is planned in a geographic area where data on marine mammal abundance and density is relatively limited, the best available information on cetacean density (including harbor porpoise density) was represented by density modeling by Mannocci et al. (2017). We relied on this information to calculate the estimated numbers of takes (including Level A takes of harbor porpoise), as described in the proposed IHA. We also acknowledged in the proposed IHA that harbor porpoises would be expected to be relatively uncommon in the proposed survey area, and that take estimates are conservative. That said, given the fact that Mannocci et al. (2017) predict relatively high densities of harbor porpoises in offshore waters north of ~40° N (where much of the survey would occur) and given the relative lack of information regarding the marine mammals that may be encountered by SIO's survey, we do not think a reduction in the number of Level A takes of harbor porpoises is necessary in this instance, given the applicant's request.

    Comment 3: the Commission questioned the necessity of the 100 m exclusion zone, specifically for mid-frequency (MF) cetaceans, noting that the Level A harassment zone is estimated to be less than 1 m for MF cetaceans. The Commission stated that NMFS should ensure that marine mammals are sufficiently protected from Level A harassment and that activities can be completed in an appropriate manner and within an appropriate timeframe, and recommended that NMFS more thoroughly assess the proposed exclusion zones that are to be implemented for this authorization and for future proposed incidental take authorizations, prior to publication in the Federal Register.

    NMFS Response: NMFS agrees with the Commission that mitigation measures should ensure sufficient protection of marine mammals while facilitating the timely completion of the specified activities so as to minimize the overall duration of those activities and their impacts on marine mammals. It is for this reason that NMFS has included a waiver to the shutdown requirement specifically for small delphinoids (which are expected to constitute the vast majority of MF cetaceans encountered by SIO's survey) that would otherwise result in a shutdown of SIO's survey. The shutdown requirement referenced by the Commission will be in place for marine mammals with the exception of small delphinoids (which are all in the MF functional hearing group) under certain circumstances. The small delphinoid group is intended to encompass those members of the Family Delphinidae most likely to voluntarily approach the source vessel for purposes of interacting with the vessel and/or airgun array (e.g., bow riding). The exception to the shutdown requirement applies solely to specific genera of small dolphins—Tursiops, Steno, Stenella, Lagenorhynchus and Delphinus. We have included this exception because shutdown requirements for small delphinoids under all circumstances represent practicability concerns without likely commensurate benefits for the animals in question, as referenced by the Commission. Small delphinoids are generally the most commonly observed marine mammals in the specific geographic region and would typically be the only marine mammals likely to intentionally approach the vessel. As referenced by the Commission, auditory injury is extremely unlikely to occur for MF cetaceans (e.g., delphinids), as this group is relatively insensitive to sound produced at the predominant frequencies in an airgun pulse while also having a relatively high threshold for the onset of auditory injury. We refer the reader to the Federal Register notice for the proposed IHA (83 FR 18644; April 27, 2018) for further discussion of sound metrics and thresholds and marine mammal hearing.

    A large body of anecdotal evidence indicates that small delphinoids commonly approach vessels and/or towed arrays during active sound production for purposes of bow riding, with no apparent effect observed in those delphinoids (e.g., Barkaszi et al., 2012). As referenced by the Commission, the potential for increased shutdowns resulting from such a measure would require the Atlantis to revisit the missed track line to reacquire data, potentially resulting in an increase in the total duration over which the survey is active in a given area and an overall increase in the total sound energy input to the marine environment. Although other mid-frequency hearing specialists (e.g., large delphinoids) are no more likely to incur auditory injury than are small delphinoids, they are much less likely to approach vessels. Therefore, contrary to the Commission's concerns, retaining a shutdown requirement for large delphinoids would not have similar impacts in terms of either practicability for the applicant or corollary increase in sound energy output and time on the water. We also anticipate some benefit for a shutdown requirement for large delphinoids in that it simplifies somewhat the total range of decision-making for protected species observers (PSOs) and may preclude any potential for physiological effects other than to the auditory system as well as some more severe behavioral reactions for any such animals in close proximity to the source vessel. Shutdown requirements, including the waiver to shutdown requirements for small delphinoids, are discussed in greater detail in the Mitigation section below.

    Comment 4: The Commission expressed concern that the method used to estimate the numbers of takes, which summed fractions of takes for each species across project days, does not account for and negates the intent of NMFS' 24-hour reset policy, and recommended that NMFS provide the draft criteria for take calculation in a timely manner.

    NMFS Response: We appreciate the Commission's ongoing concern in this matter. Calculating predicted takes is not an exact science and there are arguments for taking different mathematical approaches in different situations, and for making qualitative adjustments in other situations. We believe, however, that the methodology used for take calculation in this IHA remains appropriate and is not at odds with the 24-hour reset policy the Commission references. We will share draft guidance on this issue as soon as possible with the Commission.

    Comment 5: The Commission expressed concern that information was missing or incorrect in the proposed IHA and SIO's application, including information on the proposed activities related to the proposed source levels, shot intervals, and source velocities and mitigation measures. Therefore the Commission recommended that NMFS review more thoroughly applications prior to deeming them complete and NMFS' draft notices prior to submitting them for publication in the Federal Register.

    NMFS Response: We appreciate the Commission pointing out the deficiencies in the notice of proposed IHA. In response to the Commission's concerns we have ensured source levels, shot intervals, source velocities and mitigation measures are accurately described in this notice and are accurately factored into harassment zones and authorized take numbers. Resultant changes to harassment zones and take estimates are minimal and are described in the Take Estimate section below. NMFS thoroughly reviews all applications prior to deeming them complete, and thoroughly reviews draft notices prior to publishing in the Federal Register, and will continue to do so.

    Comment 6: The Commission requested clarification regarding certain issues associated with NMFS' notice that one-year renewals could be issued in certain limited circumstances and expressed concern that the process would bypass the public notice and comment requirements. The Commission recommended that NMFS refrain from implementing its proposed renewal process and instead use abbreviated Federal Register notices and reference existing documents to streamline the incidental harassment authorization process. The Commission suggested that NMFS should discuss the possibility of renewals through a more general route, such as a rulemaking, instead of notice in a specific authorization. The Commission further recommended that if NMFS did not pursue a more general route, that the agency provide the Commission and the public with a legal analysis supporting our conclusion that this process is consistent with the requirements of section 101(a)(5)(D) of the MMPA.

    NMFS Response: The process of issuing a renewal IHA does not bypass the public notice and comment requirements of the MMPA. The notice of the proposed IHA expressly notifies the public that under certain, limited conditions an applicant could seek a renewal IHA for an additional year. The notice describes the conditions under which such a renewal request could be considered and expressly seeks public comment in the event such a renewal is sought. Importantly, such renewals would be limited to circumstances where: The activities are identical or nearly identical to those analyzed in the proposed IHA; monitoring does not indicate impacts that were not previously analyzed and authorized; and, the mitigation and monitoring requirements remain the same, all of which allow the public to comment on the appropriateness and effects of a renewal at the same time the public provides comments on the initial IHA. NMFS has, however, modified the language for future proposed IHAs to clarify that all IHAs, including renewal IHAs, are valid for no more than one year and that the agency would consider only one renewal for a project at this time. In addition, notice of issuance or denial of a renewal IHA would be published in the Federal Register, as they are for all IHAs. The option for issuing renewal IHAs has been in NMFS's incidental take regulations since 1996. We will provide any additional information to the Commission and consider posting a description of the renewal process on our website before any renewal is issued utilizing this process.

    Description of Marine Mammals in the Area of Specified Activity

    Sections 3 and 4 of SIO's IHA application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history, of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SAR; www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports-region) and more general information about these species (e.g., physical and behavioral descriptions) may be found on NMFS' website (www.fisheries.noaa.gov/species-directory).

    The populations of marine mammals considered in this document do not occur within the U.S. exclusive economic zone (EEZ) and are therefore not assigned to stocks and are not assessed in NMFS' Stock Assessment Reports (SAR). As such, information on potential biological removal (PBR; defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population) and on annual levels of serious injury and mortality from anthropogenic sources are not available for these marine mammal populations. Abundance estimates for marine mammals in the survey location are lacking; therefore the abundance estimates presented here are based on the U.S. Atlantic SARs (Hayes et al., 2017) and on the Canadian Trans-North Atlantic Sighting Survey which provided full coverage of the Atlantic Canadian coast (Lawson and Gosselin, 2009), as these sources are considered the best available information on potential abundance of marine mammals in the area. However, as described above, the marine mammals encountered by the proposed survey are not assigned to stocks. All abundance estimate values presented in Table 2 are the most recent available at the time of publication and are available in the 2017 U.S. Atlantic draft SARs (e.g., Hayes et al. 2017) available online at: www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments, except where noted otherwise.

    Table 2 lists all species with expected potential for occurrence in the survey area and with the potential to be taken as a result of the proposed survey, and summarizes information related to the population, including regulatory status under the MMPA and ESA. For taxonomy, we follow Committee on Taxonomy (2016).

    Table 2—Marine Mammal Species Potentially Present in the Project Area and That May be Affected by the Specified Activities Species Stock ESA/
  • MMPA
  • status; strategic
  • (Y/N) 1
  • Abundance 2 Relative
  • occurrence in
  • project area
  • Order Cetartiodactyla—Cetacea—Superfamily Mysticeti (baleen whales) Family: Balaenopteridae Humpback whale 3 (Megaptera novaeangliae) n/a -/-; N 12,312 Uncommon. Minke whale 4 (Balaenoptera acutorostrata) n/a -/-; N 20,741 Uncommon. Bryde's whale (Balaenoptera brydei) n/a -/-; N unknown Uncommon. Sei whale (Balaenoptera borealis) n/a E/D; Y 357 Uncommon. Fin whale 4 (Balaenoptera physalus) n/a E/D; Y 3,522 Uncommon. Blue whale (Balaenoptera musculus) n/a E/D; Y 440 Uncommon. Order Cetartiodactyla—Cetacea—Superfamily Odontoceti (toothed whales, dolphins, and porpoises) Family: Physeteridae Sperm whale (Physeter macrocephalus) n/a E/D; Y 2,288 Uncommon. Order Cetartiodactyla—Cetacea—Superfamily Odontoceti (toothed whales, dolphins, and porpoises) Family: Kogiidae Pygmy sperm whale 5 (Kogia breviceps) n/a -/-; N 3,785 Rare. Dwarf sperm whale 5 (Kogia sima) n/a -/-; N 3,785 Rare. Order Cetartiodactyla—Cetacea—Superfamily Odontoceti (toothed whales, dolphins, and porpoises) Family delphinidae Killer whale (Orcinus orca) n/a -/-; N unknown Uncommon. False killer whale (Pseudorca crassidens) n/a -/-; N 442 Uncommon. Pygmy killer whale (Feresa attenuata) n/a -/-; N unknown Rare. Short-finned pilot whale (Globicephala macrorhynchus) n/a -/-; N 21,515 Uncommon. Long-finned pilot whale (Globicephala melas) n/a -/-; N 5,636 Uncommon. Harbor porpoise (Phocoena phocoena) n/a -/-; N 79,833 Uncommon. Bottlenose dolphin (Tursiops truncatus) n/a -/-; N 77,532 Uncommon. Striped dolphin (Stenella coeruleoala) n/a -/-; N 54,807 Uncommon. Risso's dolphin (Grampus griseus) n/a -/-; N 18,250 Uncommon. Common dolphin 4 (Delphinus delphis) n/a -; N 173,486 Uncommon. Atlantic white-sided dolphin (Lagenorhynchus obliquidens) n/a -; N 48,819 Uncommon. Atlantic spotted dolphin (Stenella frontalis) n/a -; N 44,715 Uncommon. Pantropical spotted dolphin (Stenella attenuate) n/a -; N 3,333 Uncommon. White beaked dolphin (Lagenorhynchus albirostris) n/a -; N 2,003 Uncommon. Rough-toothed dolphin (Steno bredanensis) n/a -; N 271 Rare. Order Cetartiodactyla—Cetacea—Superfamily Odontoceti (toothed whales, dolphins, and porpoises) Family: Ziphiidae Cuvier's beaked whale (Ziphius cavirostris) n/a -/-; N 6,532 Uncommon. Blainville's beaked whale 6 (Mesoplodon densirostris) n/a -; N 7,092 Uncommon. True's beaked whale 6 (Mesoplodon mirus) n/a -/-; N 7,092 Rare. Gervais beaked whale 6 (Mesoplodon europaeus) n/a -; N 7,092 Uncommon. Sowerby's beaked whale 6 (Mesoplodon bidens) n/a -; N 7,092 Uncommon. Northern bottlenose whale (Hyperoodon ampullatus) n/a -; N unknown Uncommon. Order Carnivora—Superfamily Pinnipedia Family Phocidae (earless seals) Hooded seal (Cystophora cristata) n/a -; N 592,100 Rare. Harp seal (Pagophilus groenlandicus) n/a -; N 7,100,000 Rare. Ringed seal (Pusa hispida) 7 n/a -; N unknown Rare. 1 Endangered Species Act (ESA) status: Endangered (E), Threatened (T)/MMPA status: Depleted (D). A dash (-) indicates that the species is not listed under the ESA or designated as depleted under the MMPA. Under the MMPA, a strategic stock is one for which the level of direct human-caused mortality exceeds PBR or which is determined to be declining and likely to be listed under the ESA within the foreseeable future. Any species or stock listed under the ESA is automatically designated under the MMPA as depleted and as a strategic stock. 2 Abundance estimates are from the NMFS 2017 draft Atlantic SAR (Hayes et al., 2017) unless otherwise noted. We note that marine mammals in the survey area would not belong to NMFS stocks, as the survey area is outside the geographic boundaries for stock assessments, thus stock abundance estimates are provided for comparison purposes only. 3 NMFS defines a stock of humpback whales only on the basis of the Gulf of Maine feeding population; however, multiple feeding populations originate from the Distinct Population Segment (DPS) that is expected to occur in the proposed survey area (the West Indies DPS). As West Indies DPS whales from multiple feeding populations may be encountered in the proposed survey area, the total abundance of the West Indies DPS best reflects the abundance of the population that may encountered by the proposed survey. The West Indies DPS abundance estimate shown here reflects the latest estimate as described in the NMFS Status Review of the Humpback Whale under the Endangered Species Act (Bettridge et al., 2015). 4 Abundance for these species is from the 2007 TNASS, which provided full coverage of the Atlantic Canadian coast (Lawson and Gosselin, 2009). Abundance estimates from TNASS were corrected for perception and availability bias, when possible. In general, where the TNASS survey effort provided superior coverage of a stock's range (as compared with NOAA shipboard survey effort), we elect to use the resulting abundance estimate over the current NMFS abundance estimate (derived from survey effort with inferior coverage of the stock range). 5 Abundance estimate represents pygmy and dwarf sperm whales combined. 6 Abundance estimate represents all species of Mesoplodon in the Atlantic. 7 NMFS does not have a defined stock of ringed seals in the Atlantic Ocean.

    Four marine mammal species that are listed under the Endangered Species Act (ESA) may be present in the survey area and are included in the take request: The fin whale, sei whale, blue whale and sperm whale. Though marine mammal species other than those described in Table 2 are known to occur in the North Atlantic Ocean, the temporal and/or spatial occurrence of several of these species is such that take of these species is not expected to occur, and they are therefore not discussed further beyond the explanation provided here. Four cetacean species, although present in the wider North Atlantic Ocean, likely would not be found near the proposed project area because their ranges generally do not extend as far north: Clymene dolphin, Fraser's dolphin, spinner dolphin, and melon-headed whale. Another cetacean species, the North Atlantic right whale, occurs in nearshore waters off the U.S. coast, and its range does not extend as far offshore as the proposed project area. Another three cetacean species occur in arctic waters, and their ranges generally do not extend as far south as the proposed project area: The bowhead whale, narwhal, and beluga. Two additional cetacean species, the Atlantic humpback dolphin (which occurs in coastal waters of western Africa) and the long-beaked common dolphin (which occurs in coastal waters of South America and western Africa) do not occur in deep offshore waters. Several pinniped species also are known to occur in North Atlantic waters, but are not expected to occur in deep offshore waters of the proposed project area, including the gray seal, harbor seal, and bearded seal.

    A detailed description of the species likely to be affected by SIO's survey, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice of the proposed IHA (83 FR 18644; April 27, 2018); since that time, we are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not repeated here. Please refer to that Federal Register notice for these descriptions. Please also refer to NMFS' website (www.fisheries.noaa.gov/species-directory) for generalized species accounts.

    Information concerning marine mammal hearing, including marine mammal functional hearing groups, was provided in the Federal Register notice of the proposed IHA (83 FR 18644; April 27, 2018), therefore that information is not repeated here; please refer to that Federal Register notice for this information. For further information about marine mammal functional hearing groups and associated frequency ranges, please see NMFS (2016) for a review of available information. Thirty-three marine mammal species (thirty cetacean and three pinniped (all phocid) species) have the reasonable potential to co-occur with the proposed survey activities (Table 2). Of the cetacean species that may be present, six are classified as low-frequency cetaceans (i.e., all mysticete species), twenty-two are classified as mid-frequency cetaceans (i.e., all delphinid species, beaked whales, and sperm whale), and three are classified as a high-frequency cetaceans (i.e., harbor porpoise, pygmy and dwarf sperm whales).

    Potential Effects of Specified Activities on Marine Mammals and Their Habitat

    The effects of underwater noise from SIO's survey activities have the potential to result in behavioral harassment of marine mammals in the vicinity of the survey area. The Federal Register notice of the proposed IHA (83 FR 18644; April 27, 2018) included a discussion of the effects of anthropogenic noise on marine mammals and their habitat, therefore that information is not repeated here; please refer to that Federal Register notice for that information. No instances of hearing threshold shifts, injury, serious injury, or mortality are expected as a result of the planned activities.

    Estimated Take

    This section provides an estimate of the number of incidental takes authorized through this IHA, which will inform both NMFS' consideration of “small numbers” and the negligible impact determination.

    Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

    Authorized takes would primarily be by Level B harassment, as use of the seismic airguns have the potential to result in disruption of behavioral patterns for individual marine mammals. There is also some potential for auditory injury (Level A harassment) to result, primarily for high frequency cetaceans. Auditory injury is unlikely to occur for low- and mid-frequency cetaceans given very small modeled zones of injury for those species. The mitigation and monitoring measures are expected to minimize the severity of such taking to the extent practicable. As described previously, no mortality is anticipated or authorized for this activity. Below we describe how the take is estimated.

    Described in the most basic way, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and (4) and the number of days of activities. Below, we describe these components in more detail and present the exposure estimate and associated numbers of take authorized.

    Acoustic Thresholds

    Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).

    Level B Harassment for non-explosive sources—Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source (e.g., frequency, predictability, duty cycle), the environment (e.g., bathymetry), and the receiving animals (hearing, motivation, experience, demography, behavioral context) and can be difficult to predict (Southall et al., 2007, Ellison et al. 2011). Based on the best available science and the practical need to use a threshold based on a factor that is both predictable and measurable for most activities, NMFS uses a generalized acoustic threshold based on received level to estimate the onset of behavioral harassment. NMFS predicts that marine mammals are likely to be behaviorally harassed in a manner we consider to fall under Level B harassment when exposed to underwater anthropogenic noise above received levels of 120 dB re 1 μPa (rms) for continuous (e.g. vibratory pile-driving, drilling) and above 160 dB re 1 μPa (rms) for non-explosive impulsive (e.g., seismic airguns) or intermittent (e.g., scientific sonar) sources. SIO's proposed activity includes the use of impulsive seismic sources. Therefore, the 160 dB re 1 μPa (rms) criteria is applicable for analysis of level B harassment.

    Level A harassment for non-explosive sources— NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (NMFS, 2016) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). As described above, SIO's proposed activity includes the use of intermittent and impulsive seismic sources. These thresholds are provided in Table 3.

    These thresholds are provided in the table below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2016 Technical Guidance, which may be accessed at: http://www.nmfs.noaa.gov/pr/acoustics/guidelines.htm.

    Table 3—Thresholds Identifying the Onset of Permanent Threshold Shift in Marine Mammals Hearing group PTS onset thresholds Impulsive * Non-impulsive Low-Frequency (LF) Cetaceans L pk,flat: 219 dB L E,LF,24h: 183 dB L E,LF,24h: 199 dB. Mid-Frequency (MF) Cetaceans L pk,flat: 230 dB L E,MF,24h: 185 dB L E,MF,24h: 198 dB. High-Frequency (HF) Cetaceans L pk,flat: 202 dB L E,HF,24h: 155 dB L E,HF,24h: 173 dB. Phocid Pinnipeds (PW) (Underwater) L pk,flat: 218 dB L E,PW,24h: 185 dB L E,PW,24h: 201 dB. Otariid Pinnipeds (OW) (Underwater) L pk,flat: 232 dB L E,OW,24h: 203 dB L E,OW,24h: 219 dB. Note:* Dual metric acoustic thresholds for impulsive sounds: Use whichever results in the largest isopleth for calculating PTS onset. If a non-impulsive sound has the potential of exceeding the peak sound pressure level thresholds associated with impulsive sounds, these thresholds should also be considered. Note: Peak sound pressure (Lpk) has a reference value of 1 μPa, and cumulative sound exposure level (LE) has a reference value of 1μPa2s. In this Table, thresholds are abbreviated to reflect American National Standards Institute standards (ANSI 2013). However, peak sound pressure is defined by ANSI as incorporating frequency weighting, which is not the intent for this Technical Guidance. Hence, the subscript “flat” is being included to indicate peak sound pressure should be flat weighted or unweighted within the generalized hearing range. The subscript associated with cumulative sound exposure level thresholds indicates the designated marine mammal auditory weighting function (LF, MF, and HF cetaceans, and PW and OW pinnipeds) and that the recommended accumulation period is 24 hours. The cumulative sound exposure level thresholds could be exceeded in a multitude of ways (i.e., varying exposure levels and durations, duty cycle). When possible, it is valuable for action proponents to indicate the conditions under which these acoustic thresholds will be exceeded. Ensonified Area

    Here, we describe operational and environmental parameters of the activity that will feed into estimating the area ensonified above the acoustic thresholds.

    The survey would entail the use of a 2-airgun array with a total discharge of 90 in3 at a tow depth of 2-4 m. The distances to the predicted isopleths corresponding to the threshold for Level B harassment (160 dB re 1 μPa) were calculated for both array configurations based on results of modeling performed by LDEO. Received sound levels were predicted by LDEO's model (Diebold et al. 2010) as a function of distance from the airgun array. The LDEO modeling approach uses ray tracing for the direct wave traveling from the array to the receiver and its associated source ghost (reflection at the air-water interface in the vicinity of the array), in a constant-velocity half-space (infinite homogeneous ocean layer unbounded by a seafloor). In addition, propagation measurements of pulses from a 36-airgun array at a tow depth of 6 m have been reported in deep water (~1,600 m), intermediate water depth on the slope (~600-1100 m), and shallow water (~50 m) in the Gulf of Mexico in 2007-2008 (Tolstoy et al. 2009; Diebold et al. 2010). The estimated distances to Level B harassment isopleths for the two configurations of the Atlantis airgun array are shown in Table 4.

    Table 4—Predicted Radial Distances From R/V Atlantis 90 in3 Seismic Source to Isopleth Corresponding to Level B Harassment Threshold Array configuration Predicted
  • distance to threshold (160 dB re 1 μPa)
  • 2 m airgun separation 578 m 8 m airgun separation 539 m

    For modeling of radial distances to predicted isopleths corresponding to harassment thresholds in deep water (>1,000 m), LDEO used the deep-water radii for various Sound Exposure Levels obtained from LDEO model results down to a maximum water depth of 2,000 m (see Figures 2 and 3 in the IHA application). LDEO's modeling methodology is described in greater detail in the IHA application (LGL, 2018) and we refer to the reader to that document rather than repeating it here.

    Predicted distances to Level A harassment isopleths, which vary based on marine mammal functional hearing groups (Table 3), were calculated based on modeling performed by LDEO using the Nucleus software program and the NMFS User Spreadsheet, described below. The updated acoustic thresholds for impulsive sounds (such as airguns) contained in the Technical Guidance (NMFS, 2016) were presented as dual metric acoustic thresholds using both cumulative sound exposure level (SELcum) and peak sound pressure level metrics. As dual metrics, NMFS considers onset of PTS (Level A harassment) to have occurred when either one of the two metrics is exceeded (i.e., metric resulting in the largest isopleth). The SELcum metric considers both level and duration of exposure, as well as auditory weighting functions by marine mammal hearing group. In recognition of the fact that the requirement to calculate Level A harassment ensonified areas could be more technically challenging to predict due to the duration component and the use of weighting functions in the new SELcum thresholds, NMFS developed an optional User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to facilitate the estimation of take numbers.

    The values for SELcum and peak SPL for the Atlantis airgun array were derived from calculating the modified farfield signature (Table 5). The farfield signature is often used as a theoretical representation of the source level. To compute the farfield signature, the source level is estimated at a large distance below the array (e.g., 9 km), and this level is back projected mathematically to a notional distance of 1 m from the array's geometrical center. However, when the source is an array of multiple airguns separated in space, the source level from the theoretical farfield signature is not necessarily the best measurement of the source level that is physically achieved at the source (Tolstoy et al. 2009). Near the source (at short ranges, distances <1 km), the pulses of sound pressure from each individual airgun in the source array do not stack constructively, as they do for the theoretical farfield signature. The pulses from the different airguns spread out in time such that the source levels observed or modeled are the result of the summation of pulses from a few airguns, not the full array (Tolstoy et al. 2009). At larger distances, away from the source array center, sound pressure of all the airguns in the array stack coherently, but not within one time sample, resulting in smaller source levels (a few dB) than the source level derived from the farfield signature. Because the farfield signature does not take into account the array effect near the source and is calculated as a point source, the modified farfield signature is a more appropriate measure of the sound source level for distributed sound sources, such as airgun arrays. Though the array effect is not expected to be as pronounced in the case of a 2-airgun array as it would be with a larger airgun array, the modified farfield method is considered more appropriate than use of the theoretical farfield signature.

    Table 5—Modeled Source Levels (dB) for R/V Atlantis 90 in3 Airgun Array Functional hearing group 8-kt survey
  • with
  • 8-m airgun
  • separation:
  • Peak SPLflat
  • 8-kt survey
  • with
  • 8-m airgun
  • separation:
  • SELcum
  • 5-kt survey
  • with
  • 2-m airgun
  • separation:
  • Peak SPLflat
  • 5-kt survey
  • with
  • 2-m airgun
  • separation:
  • SELcum
  • Low frequency cetaceans (L pk,flat: 219 dB; L E,LF,24h: 183 dB) 228.8 207 232.8 206.7 Mid frequency cetaceans (L pk,flat: 230 dB; L E,MF,24h: 185 dB) N/A 206.7 229.8 206.9 High frequency cetaceans (L pk,flat: 202 dB; L E,HF,24h: 155 dB) 233 207.6 232.9 207.2 Phocid Pinnipeds (Underwater) (L pk,flat: 218 dB; L E,HF,24h: 185 dB) 230 206.7 232.8 206.9 Otariid Pinnipeds (Underwater) (L pk,flat: 232 dB; L E,HF,24h: 203 dB) N/A 203 225.6 207.4

    In order to more realistically incorporate the Technical Guidance's weighting functions over the seismic array's full acoustic band, unweighted spectrum data for the Atlantis's airgun array (modeled in 1 Hz bands) was used to make adjustments (dB) to the unweighted spectrum levels, by frequency, according to the weighting functions for each relevant marine mammal hearing group. These adjusted/weighted spectrum levels were then converted to pressures (μPa) in order to integrate them over the entire broadband spectrum, resulting in broadband weighted source levels by hearing group that could be directly incorporated within the User Spreadsheet (i.e., to override the Spreadsheet's more simple weighting factor adjustment). Using the User Spreadsheet's “safe distance” methodology for mobile sources (described by Sivle et al., 2014) with the hearing group-specific weighted source levels, and inputs assuming spherical spreading propagation, a source velocity of 2.57 m/second (for the 2 m airgun separation survey) and 4.12 m/second (for the 8 m airgun separation survey), and a shot interval of 9.72 seconds (for the 2 m airgun separation survey) and 12.15 seconds (for the 8 m airgun separation survey) (LGL, 2018), potential radial distances to auditory injury zones were calculated for SELcum thresholds, for both array configurations. Inputs to the User Spreadsheet are shown in Table 5. Outputs from the User Spreadsheet in the form of estimated distances to Level A harassment isopleths are shown in Table 6. As described above, the larger distance of the dual criteria (SELcumor Peak SPLflat) is used for estimating takes by Level A harassment. The weighting functions used are shown in Table 3 of the IHA application.

    Table 6—Modeled Radial Distances (m) From R/V Atlantis 90 in3 Airgun Array to Isopleths Corresponding to Level A Harassment Thresholds Functional hearing group
  • (Level A harassment thresholds)
  • 8-kt survey
  • with
  • 8-m airgun
  • separation:
  • Peak SPLflat
  • 8-kt survey
  • with
  • 8-m airgun
  • separation:
  • SELcum
  • 5-kt survey
  • with
  • 2-m airgun
  • separation:
  • Peak SPLflat
  • 5-kt survey
  • with
  • 2-m airgun
  • separation:
  • SELcum
  • Low frequency cetaceans (L pk,flat: 219 dB; L E, LF,24h: 183 dB) 3.08 2.4 4.89 6.5 Mid frequency cetaceans (L pk,flat: 230 dB; L E, MF,24h: 185 dB) 0 0 0.98 0 High frequency cetaceans (L pk,flat: 202 dB; L E,HF,24h: 155 dB) 1 35.53 0 1 35.13 0 Phocid Pinnipeds (Underwater) (L pk,flat: 218 dB; L E,HF,24h: 185 dB) 4.02 0 5.51 0.1 Otariid Pinnipeds (Underwater) (L pk,flat: 232 dB; L E,HF,24h: 203 dB) 0 0 0.48 0 1 Distances to isopleths corresponding to Level A harassment threshold for HF cetaceans (peak SPL) have been revised from those shown in the proposed IHA based on use of radial distances (vs radii) to estimate Level A isopleths for high frequency cetaceans.

    We note that radial distances to isopleths corresponding to the Level A harassment threshold for high frequency cetaceans shown in Table 6, for the peak SPL metric, are slightly different than the distances that were presented in the proposed IHA. The proposed IHA presented the radii (versus radial distances) to the Level A isopleth for high frequency cetaceans, for the peak SPL metric, as shown in Table 6 of the IHA application (the distances to radii are 34.62 m for the 2-m airgun separation survey and 34.84 m for the 8-m airgun separation survey). However, as radial distances to the Level A isopleth for high frequency cetaceans, for the peak SPL metric, are slightly larger than the radii, we determined that, to be conservative, the radial distances (as shown in Table 6) should be used to calculate ensonified areas and to estimate take.

    Note that because of some of the assumptions included in the methods used, isopleths produced may be overestimates to some degree, which will ultimately result in some degree of overestimate of Level A take. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available, and NMFS continues to develop ways to quantitatively refine these tools and will qualitatively address the output where appropriate. For mobile sources, such as the proposed seismic survey, the User Spreadsheet predicts the closest distance at which a stationary animal would not incur PTS if the sound source traveled by the animal in a straight line at a constant speed.

    Marine Mammal Occurrence

    In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations. The best available scientific information was considered in conducting marine mammal exposure estimates (the basis for estimating take). For all cetacean species, densities calculated by Mannocci et al. (2017) were used. These represent the most comprehensive and recent density data available for cetacean species in the survey area. Mannocci et al. (2017) modeled marine mammal densities using available line transect survey data and habitat-based covariates and extrapolated model predictions to unsurveyed regions, including the proposed survey area. The authors considered line transect surveys that used two or more protected species observers and met the assumptions of the distance sampling methodology as presented by Buckland et al. (2001), and included data from shipboard and aerial surveys conducted from 1992 to 2014 by multiple U.S. organizations (details provided in Roberts et al. (2016)). The data underlying the model predictions for the proposed survey area originated from shipboard survey data presented in Waring et al. (2008). To increase the success of model transferability to new regions, the authors considered biological covariates expected to be related directly to cetacean densities (Wenger & Olden, 2012), namely biomass and production of epipelagic micronekton and zooplankton predicted with the Spatial Ecosystem and Population DYnamics Model (SEAPODYM) (Lehodey et al. 2010). Zooplankton and epipelagic micronekton (i.e., squid, crustaceans, and fish) constitute potential prey for many of the cetaceans considered, in particular dolphins and mysticetes (Pauly et al. 1998), and all these covariates correlate with cetacean distributions (e.g., Ferguson et al. 2006; Doniol-Valcroze et al. 2007; Lambert et al. 2014). There is some uncertainty related to the estimated density data and the assumptions used in their calculations, as with all density data estimates. However, the approach used is based on the best available data.

    Take Calculation and Estimation

    Here we describe how the information provided above is brought together to produce a quantitative take estimate. In order to estimate the number of marine mammals predicted to be exposed to sound levels that would result in Level B harassment or Level A harassment, radial distances to predicted isopleths corresponding to the Level A harassment and Level B harassment thresholds are calculated, as described above (Table 7). Those distances are then used to calculate the area(s) around the airgun array predicted to be ensonified to sound levels that exceed the Level A and Level B harassment thresholds. The areas estimated to be ensonified in a single day of the survey are then calculated, based on the areas predicted to be ensonified around the array and the estimated trackline distance traveled per day (Table 8). This number is then multiplied by the number of survey days (i.e., 7.5 days for the 5-kt survey with 2-m airgun separation and 17.5 days for the 8-kt survey with 8-m airgun separation). The product is then multiplied by 1.25 to account for an additional 25 percent contingency for potential additional seismic operations due to airgun testing, mechanical failure, etc. This results in an estimate of the total areas (km2) expected to be ensonified to the Level A harassment and Level B harassment thresholds. For purposes of Level B take calculations, areas estimated to be ensonified to Level A harassment thresholds are subtracted from total areas estimated to be ensonified to Level B harassment thresholds in order to avoid double counting the animals taken (i.e., if an animal is taken by Level A harassment, it is not also counted as taken by Level B harassment). Areas estimated to be ensonified over the duration of the survey are shown in Table 9. The marine mammals predicted to occur within these respective areas, based on estimated densities, are assumed to be incidentally taken. Estimated takes for all marine mammal species are shown in Table 10.

    Table 7—Distances (m) to Isopleths Corresponding to Level A and Level B Harassment Thresholds Survey Level B
  • harassment threshold
  • All marine mammals Level A harassment threshold 1 Low frequency cetaceans Mid frequency cetaceans High
  • frequency
  • cetaceans
  • Otariid pinnipeds Phocid pinnipeds
    5-kt survey with 2-m airgun separation 539 6.5 0.98 2 35.13 5.51 0.48 8-kt survey with 8-m airgun separation 578 3.08 0 2 35.53 4.02 0 1 Level A ensonified areas are estimated based on the greater of the distances calculated to Level A isopleths using dual criteria (SELcum and peak SPL). 2 Distances to isopleths corresponding to Level A harassment threshold for HF cetaceans have been revised from those shown in the proposed IHA based on use of radial distances (vs radii) to estimate Level A isopleths for high frequency cetaceans, as described above.
    Table 8—Areas (km 2) Estimated To Be Ensonified to Level A and Level B Harassment Thresholds per Day Survey Level B
  • harassment
  • threshold
  • All marine
  • mammals
  • Level A harassment threshold 1 Low frequency
  • cetaceans
  • Mid frequency
  • cetaceans
  • High
  • frequency
  • cetaceans
  • Otariid
  • pinnipeds
  • Phocid
  • pinnipeds
  • 5-kt survey with 2-m airgun separation 240.68 2.90 0.44 2 15.63 2.45 0.21 8-kt survey with 8-m airgun separation 412.10 2.19 0 2 25.28 2.86 0 1 Level A ensonified areas are estimated based on the greater of the distances calculated to Level A isopleths using dual criteria (SELcum and peak SPL). 2  Ensonified areas have been revised from those shown in the proposed IHA based on use of radial distances (vs radii) to estimate Level A isopleths for high frequency cetaceans, as described above. Note: Estimated areas shown for single day do not include additional 25 percent contingency.
    Table 9—Areas (km 2) Estimated To Be Ensonified to Level A and Level B Harassment Thresholds Over Duration of Survey Survey Level B
  • harassment
  • threshold
  • All marine
  • mammals
  • Level A harassment threshold 1 Low frequency
  • cetaceans
  • Mid frequency
  • cetaceans
  • High
  • frequency
  • cetaceans
  • Otariid
  • pinnipeds
  • Phocid
  • pinnipeds
  • 5-kt survey with 2-m airgun separation 2256.33 27.10 4.09 2146.57 22.97 2.0 8-kt survey with 8-m airgun separation 9014.56 47.84 0 2552.93 62.50 0 1 Level A ensonified areas are estimated based on the greater of the distances calculated to Level A isopleths using dual criteria (SELcum and peak PL). 2 Ensonified areas have been revised from those shown in the proposed IHA based on use of radial distances (vs radii) to estimate Level A isopleths for high frequency cetaceans, as described above. Note: Estimated areas shown include additional 25 percent contingency.
    Table 10—Numbers of Potential Incidental Take of Marine Mammals Authorized Species Density
  • (#/1,000 km 2)
  • Estimated
  • Level A takes
  • Authorized
  • Level A takes
  • Estimated
  • Level B takes
  • Authorized
  • Level B takes
  • Total takes
  • authorized
  • Total
  • instances of
  • takes as a
  • percentage of
  • SAR
  • abundance 1
  • Humpback whale 2 10 1 0 112 113 113 * 0.9 Minke whale 4 0 0 45 45 45 * 0.2 Bryde's whale 0.1 0 0 1 1 1 unknown Sei whale 2 10 1 0 112 113 113 31.4 Fin whale 8 1 0 89 90 90 * 2.6 Blue whale 0 0 0 0 1 1 0.2 Sperm whale 40 0 0 451 451 451 19.7 Cuvier's beaked whale 3 60 0 0 135 135 135 2.0 Northern bottlenose whale 4 0.8 0 0 9 9 9 unknown True's beaked whale 3 60 0 0 135 135 135 1.9 Gervais beaked whale 3 60 0 0 135 135 135 1.9 Sowerby's beaked whale 3 60 0 0 135 135 135 1.9 Blainville's beaked whale 3 60 0 0 135 135 135 1.9 Rough-toothed dolphin 3 0 0 34 34 34 12.5 Bottlenose dolphin 4 60 0 0 676 676 676 0.9 Pantropical spotted dolphin 10 0 0 113 113 113 3.4 Atlantic spotted dolphin 40 0 0 451 451 451 1.0 Striped dolphin 80 0 0 902 902 902 1.6 Atlantic white-sided dolphin 4 60 0 0 676 676 676 1.4 White-beaked dolphin 1 0 0 11 11 11 0.6 Common dolphin 800 3 0 9014 9017 9017 * 5.2 Risso's dolphin 4 20 0 0 225 225 225 1.2 Pygmy killer whale 5 1.5 0 0 17 17 17 unknown False killer whale 2 0 0 23 23 23 5.2 Killer whale  5 6 0.2 0 0 2 5 5 unknown Long-finned/short-finned Pilot whale  7 200 1 0 2253 2254 2254 8.3 Pygmy/dwarf sperm whale 0.6 0 0 7 7 7 0.2 Harbor porpoise 8 60 42 42 634 634 676 0.8 Ringed seal 5 0 0 0 0 1 1 unknown Hooded seal 0 0 0 0 1 1 <0.1 Harp seal 0 0 0 0 1 1 <0.1 1  While we have in most cases provided comparisons of the instances of takes as a percentage of SAR abundance as the best available information regarding population abundance, we note that these are likely underestimates of the relevant North Atlantic populations, as the proposed survey area is outside the U.S. EEZ. * Instances of takes are shown as a percentage of abundance as described by TNASS or NMFS Status Review, as described above. 2 Level A takes of these species were estimated based on NMFS' take calculation methodology, but NMFS has determined Level A take of these species is not likely to occur, as described in more detail in the text below. To avoid undercounting the takes estimated to occur, the number of takes by Level A harassment that had been estimated for these species, but that NMFS has determined are unlikely to occur as described below, are therefore assumed to be Level B harassment takes. Thus the number of Level A harassment takes that had been calculated for these species has been added to the number of Level B takes authorized for the species. 3 Density value represents the density for all beaked whale species combined. Requested take and take authorized are based on the proportion of all beaked whales expected to be taken (thus 677 total estimated beaked whale takes were calculated based on the density of all beaked whales combined, and this number has been divided by 5 (for the 5 species of beaked whales expected to be taken) for a total of 135 takes per species of beaked whale. 4 Number of take authorized has been revised slightly from that shown in proposed IHA due to math error. 5 The population abundance for the species is unknown. 6 Authorized take number for killer whales has been increased from the calculated take to mean group size for the species. Source for mean group size is Waring et al. (2008). 7 Values for density, take number, and percentage of population authorized are for short-finned and long-finned pilot whales combined. 8 Number of Level A and Level B takes authorized is slightly different than shown in proposed IHA due to use of radial distance (vs radii) to level A isopleth as described above.

    For some marine mammal species, we authorize a different number of incidental takes than the number of incidental takes requested by SIO (see Table 8 in the IHA application for requested take numbers). For instance, SIO requested 1 take of a North Atlantic right whale and 3 takes of bowhead whales; however, we have determined the likelihood of the survey encountering these species is so low as to be discountable, therefore we do not authorize takes of these species. Also, SIO requested Level A takes of humpback whales, sei whales, fin whales, common dolphins, and pilot whales; however, due to very small zones corresponding to Level A harassment for low-frequency and mid-frequency cetaceans (Table 6) we have determined the likelihood of Level A take occurring for species from these functional hearing groups is so low as to be discountable, therefore we do not authorize Level A take of these species. Note that the Level A takes that were calculated for these species (humpback whales, sei whales, fin whales, common dolphins, and pilot whales) have been included in the number of Level B takes. Finally, SIO requested 2,254 takes of short-finned pilot whales and 2,254 takes of long-finned pilot whales (total 4,508 pilot whale takes requested); however, as Mannocci et al. (2017) presents one single density estimate for all pilot whales (the pilot whale “guild”), a total of 2,254 takes of pilot whales were calculated as potentially taken by the proposed survey. Thus SIO's request take number is actually double the number of take that was calculated. We do not think doubling the take estimate is warranted, thus we authorize a total of 2,254 takes of pilot whales (short-finned and long-finned pilot whales combined). We note that numbers of take authorized for bottlenose dolphin, Atlantic white-sided dolphin, and Risso's dolphin have changed slightly (each has been reduced by one take) from the numbers of take presented in the proposed IHA due to a math error. We note also that the number of instances of authorized Level A take of harbor porpoise has increased by one, and the number of instances of authorized Level B take of harbor porpoise has decreased by one, versus the numbers of take presented in the proposed IHA, due to the slight change in the estimate of the Level A ensonified area for high frequency cetaceans as described above; the total number of harbor porpoise takes has not changed from the total presented in the proposed IHA.

    Species with Take Estimates Less than Mean Group Size: Using the approach described above to estimate take, the take estimate for killer whales was less than the average group size estimated for the species (Waring et al., 2008). Information on the social structure and life history of the species indicates it is common for the species to be encountered in groups. The results of take calculations support the likelihood that SIO's survey may encounter and incidentally take the species, and we believe it is likely that the species may be encountered in groups; therefore it is reasonable to conservatively assume that one group of the species will be taken during the proposed survey. We therefore authorize the take of the average (mean) group size for the species to account for the possibility that SIO's survey encounters a group of killer whales.

    Species with No Available Density Data: No density data were available for the blue whale; however, blue whales have been observed in the survey area (Waring et al., 2008), thus we determined there is a possibility that the proposed survey may encounter one blue whale and that one blue whale may be taken by Level B harassment by the proposed survey; we therefore authorize one take of blue whale as requested by SIO. No density data were available for ringed seal, hooded seal or harp seal; however based on the ranges of these species we have determined it is possible they may be encountered and taken by Level B harassment by the proposed survey, therefore we authorize one take of each species as requested by SIO.

    It should be noted that the take numbers shown in Table 10 are believed to be conservative for several reasons. First, in the calculations of estimated take, 25 percent has been added in the form of operational survey days (equivalent to adding 25 percent to the proposed line km to be surveyed) to account for the possibility of additional seismic operations associated with airgun testing, and repeat coverage of any areas where initial data quality is sub-standard.

    Mitigation

    In order to issue an IHA under Section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).

    In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:

    (1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned) the likelihood of effective implementation (probability implemented as planned); and

    (2) The practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations, and, in the case of a military readiness activity, personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.

    SIO has reviewed mitigation measures employed during seismic research surveys authorized by NMFS under previous incidental harassment authorizations, as well as recommended best practices in Richardson et al. (1995), Pierson et al. (1998), Weir and Dolman (2007), Nowacek et al. (2013), Wright (2014), and Wright and Cosentino (2015), and has incorporated a suite of mitigation measures into their project description based on the above sources.

    To reduce the potential for disturbance from acoustic stimuli associated with the activities, SIO has proposed to implement the following mitigation measures for marine mammals:

    (1) Vessel-based visual mitigation monitoring;

    (2) Establishment of a marine mammal exclusion zone (EZ);

    (3) Shutdown procedures;

    (4) Ramp-up procedures; and

    (5) Vessel strike avoidance measures.

    In addition to the measures proposed by SIO, NMFS has incorporated the following mitigation measure: Establishment of a marine mammal buffer zone.

    PSO observations will take place during all daytime airgun operations and nighttime start-ups (if applicable) of the airguns. If airguns are operating throughout the night, observations will begin 30 minutes prior to sunrise. If airguns are operating after sunset, observations will continue until 30 minutes following sunset. Following a shutdown for any reason, observations will occur for at least 30 minutes prior to the planned start of airgun operations. Observations will also occur for 30 minutes after airgun operations cease for any reason. Observations will also be made during daytime periods when the Atlantis is underway without seismic operations, such as during transits, to allow for comparison of sighting rates and behavior with and without airgun operations and between acquisition periods. Airgun operations will be suspended when marine mammals are observed within, or about to enter, the designated EZ (as described below).

    During seismic operations, three visual PSOs will be based aboard the Atlantis. PSOs will be appointed by SIO with NMFS approval. During the majority of seismic operations, two PSOs will monitor for marine mammals around the seismic vessel. A minimum of one PSO must be on duty at all times when the array is active. PSO(s) will be on duty in shifts of duration no longer than 4 hours. Other crew will also be instructed to assist in detecting marine mammals and in implementing mitigation requirements (if practical). Before the start of the seismic survey, the crew will be given additional instruction in detecting marine mammals and implementing mitigation requirements.

    The Atlantis is a suitable platform from which PSOs will watch for marine mammals. Standard equipment for marine mammal observers will be 7 × 50 reticule binoculars and optical range finders. At night, night-vision equipment will be available. The observers will be in communication with ship's officers on the bridge and scientists in the vessel's operations laboratory, so they can advise promptly of the need for avoidance maneuvers or seismic source shutdown.

    The PSOs must have no tasks other than to conduct observational effort, record observational data, and communicate with and instruct relevant vessel crew with regard to the presence of marine mammals and mitigation requirements. PSO resumes will be provided to NMFS for approval. At least one PSO must have a minimum of 90 days at-sea experience working as PSOs during a seismic survey. One “experienced” visual PSO will be designated as the lead for the entire protected species observation team. The lead will serve as primary point of contact for the vessel operator. The PSOs must have successfully completed relevant training, including completion of all required coursework and passing a written and/or oral examination developed for the training program, and must have successfully attained a bachelor's degree from an accredited college or university with a major in one of the natural sciences and a minimum of 30 semester hours or equivalent in the biological sciences and at least one undergraduate course in math or statistics. The educational requirements may be waived if the PSO has acquired the relevant skills through alternate training, including (1) secondary education and/or experience comparable to PSO duties; (2) previous work experience conducting academic, commercial, or government-sponsored marine mammal surveys; or (3) previous work experience as a PSO; the PSO should demonstrate good standing and consistently good performance of PSO duties.

    Exclusion Zone and Buffer Zone

    An EZ is a defined area within which occurrence of a marine mammal triggers mitigation action intended to reduce the potential for certain outcomes, e.g., auditory injury, disruption of critical behaviors. The PSOs will establish a minimum EZ with a 100 m radius for the airgun array. The 100 m EZ will be based on radial distance from any element of the airgun array (rather than being based on the center of the array or around the vessel itself). With certain exceptions (described below), if a marine mammal appears within, enters, or appears on a course to enter this zone, the acoustic source will be shut down (see Shutdown Procedures below).

    The 100 m radial distance of the standard EZ is precautionary in the sense that it would be expected to contain sound exceeding injury criteria for all marine mammal hearing groups (Table 6) while also providing a consistent, reasonably observable zone within which PSOs would typically be able to conduct effective observational effort. In this case, the 100 m radial distance would also be expected to contain sound that would exceed the Level A harassment threshold based on sound exposure level (SELcum) criteria for all marine mammal hearing groups (Table 6). In the 2011 Programmatic Environmental Impact Statement for marine scientific research funded by the National Science Foundation or the U.S. Geological Survey (NSF-USGS 2011), Alternative B (the Preferred Alternative) conservatively applied a 100 m EZ for all low-energy acoustic sources in water depths >100 m, with low-energy acoustic sources defined as any towed acoustic source with a single or a pair of clustered airguns with individual volumes of ≤250 in3. Thus the 100 m EZ for this survey is consistent with the PEIS.

    Our intent in prescribing a standard EZ distance is to (1) encompass zones within which auditory injury could occur on the basis of instantaneous exposure; (2) provide additional protection from the potential for more severe behavioral reactions (e.g., panic, antipredator response) for marine mammals at relatively close range to the acoustic source; (3) provide consistency for PSOs, who need to monitor and implement the EZ; and (4) define a distance within which detection probabilities are reasonably high for most species under typical conditions.

    PSOs will also establish and monitor a 200 m buffer zone. During use of the acoustic source, occurrence of marine mammals within the buffer zone (but outside the EZ) will be communicated to the operator to prepare for potential shutdown of the acoustic source. The buffer zone is discussed further under Ramp Up Procedures below.

    Shutdown Procedures

    If a marine mammal is detected outside the EZ but is likely to enter the EZ, the airguns will be shut down before the animal is within the EZ. Likewise, if a marine mammal is already within the EZ when first detected, the airguns will be shut down immediately.

    Following a shutdown, airgun activity will not resume until the marine mammal has cleared the 100 m EZ. The animal will be considered to have cleared the 100 m EZ if the following conditions have been met:

    • It is visually observed to have departed the 100 m EZ; or

    • it has not been seen within the 100 m EZ for 15 min in the case of small odontocetes and pinnipeds; or

    • it has not been seen within the 100 m EZ for 30 min in the case of mysticetes and large odontocetes, including sperm, pygmy and dwarf sperm, and beaked whales.

    This shutdown requirement will be in place for all marine mammals, with the exception of small delphinoids under certain circumstances. As defined here, the small delphinoid group is intended to encompass those members of the Family Delphinidae most likely to voluntarily approach the source vessel for purposes of interacting with the vessel and/or airgun array (e.g., bow riding). This exception to the shutdown requirement will apply solely to specific genera of small dolphins—Tursiops, Steno, Stenella, Lagenorhynchus and Delphinus—and will only apply if the animals were traveling, including approaching the vessel. If, for example, an animal or group of animals is stationary for some reason (e.g., feeding) and the source vessel approaches the animals, the shutdown requirement applies. An animal with sufficient incentive to remain in an area rather than avoid an otherwise aversive stimulus could either incur auditory injury or disruption of important behavior. If there is uncertainty regarding identification (i.e., whether the observed animal(s) belongs to the group described above) or whether the animals are traveling, the shutdown will be implemented.

    We include this small delphinoid exception because shutdown requirements for small delphinoids under all circumstances represent practicability concerns without likely commensurate benefits for the animals in question. Small delphinoids are generally the most commonly observed marine mammals in the specific geographic region and would typically be the only marine mammals likely to intentionally approach the vessel. As described below, auditory injury is extremely unlikely to occur for mid-frequency cetaceans (e.g., delphinids), as this group is relatively insensitive to sound produced at the predominant frequencies in an airgun pulse while also having a relatively high threshold for the onset of auditory injury (i.e., permanent threshold shift). Please see the Federal Register notice of proposed IHA (83 FR 18644; April 27, 2018) for further discussion of sound metrics and thresholds and marine mammal hearing.

    A large body of anecdotal evidence indicates that small delphinoids commonly approach vessels and/or towed arrays during active sound production for purposes of bow riding, with no apparent effect observed in those delphinoids (e.g., Barkaszi et al., 2012). The potential for increased shutdowns resulting from such a measure would require the Atlantis to revisit the missed track line to reacquire data, resulting in an overall increase in the total sound energy input to the marine environment and an increase in the total duration over which the survey is active in a given area. Although other mid-frequency hearing specialists (e.g., large delphinoids) are no more likely to incur auditory injury than are small delphinoids, they are much less likely to approach vessels. Therefore, retaining a shutdown requirement for large delphinoids would not have similar impacts in terms of either practicability for the applicant or corollary increase in sound energy output and time on the water. We do anticipate some benefit for a shutdown requirement for large delphinoids in that it simplifies somewhat the total range of decision-making for PSOs and may preclude any potential for physiological effects other than to the auditory system as well as some more severe behavioral reactions for any such animals in close proximity to the source vessel.

    Shutdown of the acoustic source will also be required upon observation of any of the following:

    • A large whale (i.e., sperm whale or any baleen whale) with a calf observed at any distance;

    • an aggregation of six or more large whales of any species (i.e., sperm whale or any baleen whale) that does not appear to be traveling (e.g., feeding, socializing, etc.) observed at any distance; or

    • a species for which authorization has not been granted, or, a species for which authorization has been granted but the authorized number of takes are met, observed approaching or within the Level A or B harassment zone.

    Ramp-up Procedures

    Ramp-up of an acoustic source is intended to provide a gradual increase in sound levels following a shutdown, enabling animals to move away from the source if the signal is sufficiently aversive prior to its reaching full intensity. Ramp-up will be required after the array is shut down for any reason. Ramp-up will begin with the activation of one 45 in3 airgun, with the second 45 in3 airgun activated after 5 minutes.

    At least two PSOs will be required to monitor during ramp-up. During ramp up, the PSOs will monitor the EZ, and if marine mammals were observed within the EZ or buffer zone, a shutdown will be implemented as though the full array were operational. If airguns have been shut down due to PSO detection of a marine mammal within or approaching the 100 m EZ, ramp-up will not be initiated until all marine mammals have cleared the EZ, during the day or night. Criteria for clearing the EZ will be as described above.

    Thirty minutes of pre-clearance observation are required prior to ramp-up for any shutdown of longer than 30 minutes (i.e., if the array were shut down during transit from one line to another). This 30 minute pre-clearance period may occur during any vessel activity (i.e., transit). If a marine mammal were observed within or approaching the 100 m EZ during this pre-clearance period, ramp-up will not be initiated until all marine mammals cleared the EZ. Criteria for clearing the EZ will be as described above. If the airgun array has been shut down for reasons other than mitigation (e.g., mechanical difficulty) for a period of less than 30 minutes, it may be activated again without ramp-up if PSOs have maintained constant visual observation and no detections of any marine mammal have occurred within the EZ or buffer zone. Ramp-up will be planned to occur during periods of good visibility when possible. However, ramp-up is allowed at night and during poor visibility if the 100 m EZ and 200 m buffer zone have been monitored by visual PSOs for 30 minutes prior to ramp-up.

    The operator is required to notify a designated PSO of the planned start of ramp-up as agreed-upon with the lead PSO; the notification time should not be less than 60 minutes prior to the planned ramp-up. A designated PSO must be notified again immediately prior to initiating ramp-up procedures and the operator must receive confirmation from the PSO to proceed. The operator must provide information to PSOs documenting that appropriate procedures were followed. Following deactivation of the array for reasons other than mitigation, the operator is required to communicate the near-term operational plan to the lead PSO with justification for any planned nighttime ramp-up.

    Vessel Strike Avoidance Measures

    Vessel strike avoidance measures are intended to minimize the potential for collisions with marine mammals. These requirements do not apply in any case where compliance creates an imminent and serious threat to a person or vessel or to the extent that a vessel is restricted in its ability to maneuver and, because of the restriction, cannot comply.

    The measures include the following: Vessel operator and crew will maintain a vigilant watch for all marine mammals and slow down or stop the vessel or alter course to avoid striking any marine mammal. A visual observer aboard the vessel will monitor a vessel strike avoidance zone around the vessel according to the parameters stated below. Visual observers monitoring the vessel strike avoidance zone will be either third-party observers or crew members, but crew members responsible for these duties will be provided sufficient training to distinguish marine mammals from other phenomena. Vessel strike avoidance measures will be followed during surveys and while in transit.

    The vessel will maintain a minimum separation distance of 100 m from large whales (i.e., baleen whales and sperm whales). If a large whale is within 100 m of the vessel the vessel will reduce speed and shift the engine to neutral, and will not engage the engines until the whale has moved outside of the vessel's path and the minimum separation distance has been established. If the vessel is stationary, the vessel will not engage engines until the whale(s) has moved out of the vessel's path and beyond 100 m. The vessel will maintain a minimum separation distance of 50 m from all other marine mammals (with the exception of delphinids of the genera Tursiops, Steno, Stenella, Lagenorhynchus and Delphinus that approach the vessel, as described above). If an animal is encountered during transit, the vessel will attempt to remain parallel to the animal's course, avoiding excessive speed or abrupt changes in course. Vessel speeds will be reduced to 10 knots or less when mother/calf pairs or large assemblages of cetaceans (what constitutes “large” will vary depending on species) are observed within 500 m of the vessel. Mariners may use professional judgment as to when such circumstances warranting additional caution are present.

    Based on our evaluation of the applicant's proposed measures, NMFS has determined that the mitigation measures provide the means effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Monitoring and Reporting

    In order to issue an IHA for an activity, Section 101(a)(5)(D) of the MMPA states that NMFS must set forth, requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.

    Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:

    • Occurrence of marine mammal species or stocks in the area in which take is anticipated (e.g., presence, abundance, distribution, density);

    • Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (e.g., source characterization, propagation, ambient noise); (2) affected species (e.g., life history, dive patterns); (3) co-occurrence of marine mammal species with the action; or (4) biological or behavioral context of exposure (e.g., age, calving or feeding areas);

    • Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;

    • How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;

    • Effects on marine mammal habitat (e.g., marine mammal prey species, acoustic habitat, or other important physical components of marine mammal habitat); and

    • Mitigation and monitoring effectiveness.

    SIO submitted a marine mammal monitoring and reporting plan in their IHA application. Monitoring that is designed specifically to facilitate mitigation measures, such as monitoring of the EZ to inform potential shutdowns of the airgun array, are described above and are not repeated here.

    SIO's monitoring and reporting plan includes the following measures:

    Vessel-Based Visual Monitoring

    As described above, PSO observations will take place during daytime airgun operations and nighttime start-ups (if applicable) of the airguns. During seismic operations, three visual PSOs will be based aboard the Atlantis. PSOs will be appointed by SIO with NMFS approval. During the majority of seismic operations, one PSO will monitor for marine mammals around the seismic vessel. PSOs will be on duty in shifts of duration no longer than 4 hours. Other crew will also be instructed to assist in detecting marine mammals and in implementing mitigation requirements (if practical). During daytime, PSOs will scan the area around the vessel systematically with reticle binoculars (e.g., 7×50 Fujinon) and with the naked eye. At night, PSOs will be equipped with night-vision equipment.

    PSOs will record data to estimate the numbers of marine mammals exposed to various received sound levels and to document apparent disturbance reactions or lack thereof. Data will be used to estimate numbers of animals potentially `taken' by harassment (as defined in the MMPA). They will also provide information needed to order a shutdown of the airguns when a marine mammal is within or near the EZ. When a sighting is made, the following information about the sighting will be recorded:

    (1) Species, group size, age/size/sex categories (if determinable), behavior when first sighted and after initial sighting, heading (if consistent), bearing and distance from seismic vessel, sighting cue, apparent reaction to the airguns or vessel (e.g., none, avoidance, approach, paralleling, etc.), and behavioral pace; and

    (2) Time, location, heading, speed, activity of the vessel, sea state, visibility, and sun glare.

    All observations and shutdowns will be recorded in a standardized format. Data will be entered into an electronic database. The accuracy of the data entry will be verified by computerized data validity checks as the data are entered and by subsequent manual checking of the database. These procedures will allow initial summaries of data to be prepared during and shortly after the field program and will facilitate transfer of the data to statistical, graphical, and other programs for further processing and archiving. The time, location, heading, speed, activity of the vessel, sea state, visibility, and sun glare will also be recorded at the start and end of each observation watch, and during a watch whenever there is a change in one or more of the variables.

    Results from the vessel-based observations will provide:

    (1) The basis for real-time mitigation (e.g., airgun shutdown);

    (2) Information needed to estimate the number of marine mammals potentially taken by harassment, which must be reported to NMFS;

    (3) Data on the occurrence, distribution, and activities of marine mammals in the area where the seismic study is conducted;

    (4) Information to compare the distance and distribution of marine mammals relative to the source vessel at times with and without seismic activity; and

    (5) Data on the behavior and movement patterns of marine mammals seen at times with and without seismic activity.

    Reporting

    A report will be submitted to NMFS within 90 days after the end of the survey. The report will describe the operations that were conducted and sightings of marine mammals near the operations. The report will provide full documentation of methods, results, and interpretation pertaining to all monitoring and will summarize the dates and locations of seismic operations, and all marine mammal sightings (dates, times, locations, activities, associated seismic survey activities). The report will also include estimates of the number and nature of exposures that occurred above the harassment threshold based on PSO observations, including an estimate of those on the trackline but not detected.

    Negligible Impact Analysis and Determination

    NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through harassment, NMFS considers other factors, such as the likely nature of any responses (e.g., intensity, duration), the context of any responses (e.g., critical reproductive time or location, migration), as well as effects on habitat, and the likely effectiveness of the mitigation. We also assess the number, intensity, and context of estimated takes by evaluating this information relative to population status. Consistent with the 1989 preamble for NMFS's implementing regulations (54 FR 40338; September 29, 1989), the impacts from other past and ongoing anthropogenic activities are incorporated into this analysis via their impacts on the environmental baseline (e.g., as reflected in the regulatory status of the species, population size and growth rate where known, ongoing sources of human-caused mortality, or ambient noise levels).

    To avoid repetition, our analysis applies to all the species listed in Table 2, given that NMFS expects the anticipated effects of the planned seismic survey to be similar in nature. Where there are meaningful differences between species or stocks, or groups of species, in anticipated individual responses to activities, impact of expected take on the population due to differences in population status, or impacts on habitat, NMFS has identified species-specific factors to inform the analysis.

    NMFS does not anticipate that serious injury or mortality will occur as a result of SIO's planned seismic survey, even in the absence of mitigation. Thus the authorization does not authorize any mortality. As discussed in the Potential Effects section, non-auditory physical effects, stranding, and vessel strike are not expected to occur.

    We authorize a limited number of instances of Level A harassment (Table 10) for one species. However, we believe that any PTS incurred in marine mammals as a result of the planned activity would be in the form of only a small degree of PTS and not total deafness that would not be likely to affect the fitness of any individuals, because of the constant movement of both the Atlantis and of the marine mammals in the project area, as well as the fact that the vessel is not expected to remain in any one area in which individual marine mammals would be expected to concentrate for an extended period of time (i.e., since the duration of exposure to loud sounds will be relatively short). Also, as described above, we expect that marine mammals would be likely to move away from a sound source that represents an aversive stimulus, especially at levels that would be expected to result in PTS, given sufficient notice of the Atlantis's approach due to the vessel's relatively low speed when conducting seismic surveys. We expect that the majority of takes would be in the form of short-term Level B behavioral harassment in the form of temporary avoidance of the area or decreased foraging (if such activity were occurring), reactions that are considered to be of low severity and with no lasting biological consequences (e.g., Southall et al., 2007).

    Potential impacts to marine mammal habitat were discussed previously in this document (see Potential Effects of the Specified Activity on Marine Mammals and their Habitat). Marine mammal habitat may be impacted by elevated sound levels, but these impacts would be temporary. Feeding behavior is not likely to be significantly impacted, as marine mammals appear to be less likely to exhibit behavioral reactions or avoidance responses while engaged in feeding activities (Richardson et al., 1995). Prey species are mobile and are broadly distributed throughout the project area; therefore, marine mammals that may be temporarily displaced during survey activities are expected to be able to resume foraging once they have moved away from areas with disturbing levels of underwater noise. Because of the temporary nature of the disturbance, the availability of similar habitat and resources in the surrounding area, and the lack of important or unique marine mammal habitat, the impacts to marine mammals and the food sources that they utilize are not expected to cause significant or long-term consequences for individual marine mammals or their populations. In addition, there are no feeding, mating or calving areas known to be biologically important to marine mammals within the proposed project area.

    As described above, though marine mammals in the survey area would not be assigned to NMFS stocks, for purposes of the small numbers analysis we rely on stock numbers from the U.S. Atlantic SARs as the best available information on the abundance estimates for the species of marine mammals that could be taken. The activity is expected to impact a very small percentage of all marine mammal populations that would be affected by SIO's planned survey (less than 32 percent each for all marine mammal stocks, when compared with stocks from the U.S. Atlantic as described above). Additionally, the acoustic “footprint” of the proposed survey would be very small relative to the ranges of all marine mammals that would potentially be affected. Sound levels would increase in the marine environment in a relatively small area surrounding the vessel compared to the range of the marine mammals within the proposed survey area. The seismic array would be active 24 hours per day throughout the duration of the proposed survey. However, the very brief overall duration of the proposed survey (25 days) would further limit potential impacts that may occur as a result of the proposed activity.

    The mitigation measures are expected to reduce the number and/or severity of takes by allowing for detection of marine mammals in the vicinity of the vessel by visual and acoustic observers, and by minimizing the severity of any potential exposures via shutdowns of the airgun array. Based on previous monitoring reports for substantially similar activities that have been previously authorized by NMFS, we expect that the mitigation measures will be effective in preventing at least some extent of potential PTS in marine mammals that may otherwise occur in the absence of mitigation measures.

    Of the marine mammal species under our jurisdiction that are likely to occur in the project area, the following species are listed as endangered under the ESA: fin, sei, blue, and sperm whales. There are currently insufficient data to determine population trends for these species (Hayes et al., 2017); however, we are authorizing very small numbers of takes for these species (Table 10), relative to their population sizes (again, when compared to U.S. Atlantic stocks, for purposes of comparison only), therefore we do not expect population-level impacts to any of these species. The other marine mammal species that may be taken by harassment during SIO's seismic survey are not listed as threatened or endangered under the ESA. There is no designated critical habitat for any ESA-listed marine mammals within the project area; of the non-listed marine mammals for which we authorize take, none are considered “depleted” or “strategic” by NMFS under the MMPA.

    NMFS concludes that exposures to marine mammal species due to SIO's seismic survey would result in only short-term (temporary and short in duration) effects to individuals exposed, or some small degree of PTS to a very small number of individuals of four species. Marine mammals may temporarily avoid the immediate area, but are not expected to permanently abandon the area. Major shifts in habitat use, distribution, or foraging success are not expected. NMFS does not anticipate the take estimates to impact annual rates of recruitment or survival.

    In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:

    • No mortality is anticipated or authorized;

    • The anticipated impacts of the proposed activity on marine mammals would primarily be temporary behavioral changes due to avoidance of the area around the survey vessel. The relatively short duration of the proposed survey (25 days) would further limit the potential impacts of any temporary behavioral changes that would occur;

    • The number of instances of PTS that may occur are expected to be very small in number (Table 10). Instances of PTS that are incurred in marine mammals would be of a low level, due to constant movement of the vessel and of the marine mammals in the area, and the nature of the survey design (not concentrated in areas of high marine mammal concentration);

    • The availability of alternate areas of similar habitat value for marine mammals to temporarily vacate the survey area during the proposed survey to avoid exposure to sounds from the activity;

    • The proposed project area does not contain areas of significance for feeding, mating or calving;

    • The potential adverse effects on fish or invertebrate species that serve as prey species for marine mammals from the proposed survey would be temporary and spatially limited; and

    • The mitigation measures, including visual and acoustic monitoring and shutdowns, are expected to minimize potential impacts to marine mammals.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the monitoring and mitigation measures, NMFS finds that the total marine mammal take from the specified activity will have a negligible impact on all affected marine mammal species or stocks.

    Small Numbers

    As noted above, only small numbers of incidental take may be authorized under Section 101(a)(5)(D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.

    Due to the location of SIO's survey, some of the marine mammals potentially taken by the proposed survey would not be expected to originate from the U.S. Atlantic stocks as defined by NMFS (Hayes et al., 2017). Population abundance data for marine mammal species in the survey area is not available. Therefore, in most cases the U.S. Atlantic SARs represent the best available information on marine mammal abundance in the Northwest Atlantic Ocean. For certain species (i.e., fin whale, minke whale and common dolphin) the 2007 Canadian Trans-North Atlantic Sighting Survey (TNASS), which provided full coverage of the Atlantic Canadian coast (Lawson and Gosselin, 2009) represents the best available information on abundance, as noted previously. Abundance estimates from TNASS were corrected for perception and availability bias, when possible. In general, where the TNASS survey effort provided more extensive coverage of a stock's range (as compared with NOAA shipboard survey effort), we elected to use the resulting abundance estimate over the current NMFS abundance estimate (derived from survey effort with more limited coverage of the stock range). For the humpback whale, NMFS defines a stock of humpback whales in the Atlantic only on the basis of the Gulf of Maine feeding population; however, multiple feeding populations originate from the DPS of humpback whales that is expected to occur in the proposed survey area (the West Indies DPS). As West Indies DPS whales from multiple feeding populations may be encountered in the proposed survey area, the total abundance of the West Indies DPS best reflects the abundance of the population that may encountered by the proposed survey. The West Indies DPS abundance estimate used here reflects the latest estimate as described in the NMFS Status Review of the Humpback Whale under the Endangered Species Act (Bettridge et al., 2015). Therefore, we use abundance data from the SARs in most cases, as well as from the TNASS and NMFS Status Review, for purposes of the small numbers analysis.

    The numbers of takes that we authorize are less than 10 percent of the population abundance for the majority of species and stocks, and 20 percent for sperm whales and 31 percent for fin whales, when compared to abundance estimates from U.S. Atlantic SARs and TNASS and NMFS Status Review (Table 10). We again note that while some animals from U.S. stocks may occur in the proposed survey area, the proposed survey area is outside the geographic boundaries of the U.S. Atlantic SARs, thus populations of marine mammals in the proposed survey area would not be limited to the U.S. stocks and those populations may in fact be larger than the U.S. stock abundance estimates. In addition, it should be noted that take numbers represent instances of take, not individuals taken. Given the relatively small survey grids (Figure 1 in the IHA application), it is reasonable to expect that some individuals may be exposed more than one time, which would mean that the number of individuals taken is somewhat smaller than the total instances of take indicated in Table 10.

    No known current regional population estimates are available for five marine mammal species that could be incidentally taken as a result of the planned survey: the Bryde's whale, killer whale, pygmy killer whale, Northern bottlenose whale, and ringed seal. NMFS has reviewed the geographic distributions of these species in determining whether the numbers of takes authorized are likely to represent small numbers. Bryde's whales are distributed worldwide in tropical and sub-tropical waters (Kato and Perrin, 2009). Killer whales are broadly distributed in the Atlantic from the Arctic ice edge to the West Indies (Waring et al., 2015). The pygmy killer whale is distributed worldwide in tropical to sub-tropical waters (Jefferson et al. 1994). Northern bottlenose whales are distributed in the North Atlantic from Nova Scotia to about 70° N in the Davis Strait, along the east coast of Greenland to 77° N and from England, Norway, Iceland and the Faroe Islands to the south coast of Svalbard (Waring et al., 2015). The harp seal occurs throughout much of the North Atlantic and Arctic Oceans (Lavigne and Kovacs 1988). Based on the broad spatial distributions of these species relative to the areas where the proposed survey would occur, NMFS concludes that the authorized take of these species represent small numbers relative to the affected species' overall population sizes, though we are unable to quantify the authorized take numbers as a percentage of population.

    Based on the analysis contained herein of the specified activity (including the mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.

    Unmitigable Adverse Impact Analysis and Determination

    There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

    Endangered Species Act (ESA)

    Section 7(a)(2) of the ESA of 1973 (16 U.S.C. 1531 et seq.) requires that each Federal agency insure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of IHAs, NMFS consults internally, in this case with the ESA Interagency Cooperation Division, whenever we propose to authorize take for endangered or threatened species.

    The NMFS Permits and Conservation Division is authorizing the incidental take of 4 species of marine mammals which are listed under the ESA: The sei whale, fin whale, blue whale and sperm whale. Under Section 7 of the ESA, we requested initiation of Section 7 consultation with the NMFS OPR Interagency Cooperation Division for the issuance of this IHA. In June, 2018, the NMFS OPR Interagency Cooperation Division issued a Biological Opinion with an incidental take statement, which concluded that the issuance of the IHA was not likely to jeopardize the continued existence of the sei whale, fin whale, blue whale and sperm whale. The Biological Opinion also concluded that the issuance of the IHA would not destroy or adversely modify designated critical habitat for these species.

    Authorization

    NMFS has issued an IHA to SIO for the potential harassment of small numbers of 35 marine mammal species incidental to a low-energy marine geophysical survey in the northwest Atlantic Ocean, provided the previously mentioned mitigation, monitoring and reporting requirements are incorporated.

    Dated: June 12, 2018. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-12907 Filed 6-14-18; 8:45 am] BILLING CODE 3510-22-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Proposed Additions and Deletions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Proposed additions to and deletions from the Procurement List.

    SUMMARY:

    The Committee is proposing to add products and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and a service previously furnished by such agencies.

    DATES:

    Comments must be received on or before: July 15, 2018.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    For further information or to submit comments contact: Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

    Additions

    If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products and service listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.

    The following products and service are proposed for addition to the Procurement List for production by the nonprofit agencies listed:

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USMC, Women's, Short Sleeve, White, 8R 8410-00-NIB-0043—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 8L 8410-00-NIB-0044—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 10S 8410-00-NIB-0045—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 10R 8410-00-NIB-0046—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 10L 8410-00-NIB-0047—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 12S 8410-00-NIB-0048—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 12R 8410-00-NIB-0049—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 12L 8410-00-NIB-0050—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 14S 8410-00-NIB-0051—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 14R 8410-00-NIB-0052—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 14L 8410-00-NIB-0053—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 16S 8410-00-NIB-0054—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 16R 8410-00-NIB-0055—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 16L 8410-00-NIB-0056—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, 18R 8410-00-NIB-0057—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, USMC, Women's, Short Sleeve, White, XOR 8410-00-NIB-0058—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 32 x 12 8410-00-NIB-0059—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 32 x 13 8410-00-NIB-0060—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 34 x 12 8410-00-NIB-0061—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 34 x 13 8410-00-NIB-0062—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 34 x 14 8410-00-NIB-0063—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 34 x 15 8410-00-NIB-0064—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 36 x 13 8410-00-NIB-0065—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 36 x 14 8410-00-NIB-0066—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 36 x 15 8410-00-NIB-0067—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 38 x 13 8410-00-NIB-0068—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 38 x 14 8410-00-NIB-0069—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 38B x 15N 8410-00-NIB-0070—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 38 x 16 8410-00-NIB-0071—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 40 x 14 8410-00-NIB-0072—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 40 x 15 8410-00-NIB-0073—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 40 x 16 8410-00-NIB-0074—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 42 x 15 8410-00-NIB-0075—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 42 x 16 8410-00-NIB-0076—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 44 x 14 8410-00-NIB-0077—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 44 x 15 8410-00-NIB-0078—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 44 x 16 8410-00-NIB-0079—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 46 x 14 8410-00-NIB-0080—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 46 x 15 8410-00-NIB-0081—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 46 x 16 8410-00-NIB-0082—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 46 x 17 8410-00-NIB-0083—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 48 x 14 8410-00-NIB-0084—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 48 x 15 8410-00-NIB-0085—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 48 x 16 8410-00-NIB-0086—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 48 x 17 8410-00-NIB-0087—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 50 x 14 8410-00-NIB-0088—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 50 x 15 8410-00-NIB-0089—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 50 x 16 8410-00-NIB-0090—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 50B x 17N 8410-00-NIB-0091—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 50 x 18 8410-00-NIB-0092—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 52 x 14 8410-00-NIB-0093—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 52 x 15 8410-00-NIB-0094—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 52 x 16 8410-00-NIB-0095—Kit, Pre-Cut Fabric, Pinpoint Dress Shirt, Navy, Women's, Short Sleeve, White, 52 x 17 Mandatory for: 100% of the requirements of Federal Prison Industries Mandatory Source(s) of Supply: Winston-Salem Industries for the Blind, Inc., Winston-Salem, NC Contracting Activity: Federal Prison System Distribution: C-List Service Service Type: Recycling Service Mandatory for: U.S. Army, Walter Reed Army Institute of Research, Safety & Environment Department, Forest Glen Annex, Buildings 500, 501, 503, 508, 509, 511 & the Temporary Phasing Facilities, 503 Robert Grant Avenue, Silver Spring, MD Mandatory Source of Supply: MVLE, Inc., Springfield, VA Contracting Activity: Dept. of the Army, W4PZ USA MED RSCH ACQUIS ACT Deletions

    The following products and service are proposed for deletion from the Procurement List:

    Products NSN(s)—Product Name(s): 7520-01-496-5479—Planner, Hanging Kit, EA 7520-01-584-0877—Planner, Hanging Kits, 20 Kits Mandatory Source of Supply: Chicago Lighthouse Industries, Chicago, IL Contracting Activity: General Services Administration, Philadelphia, PA NSN(s)—Product Name(s): 7530-01-600-7616—Monthly Desk Planner, Dated 2018, Wire Bound, Non-refillable, Black Cover 7530-01-600-7593—Weekly Desk Planner, Dated 2018, Wire Bound, Non-refillable, Black Cover 7530-01-600-7583—Daily Desk Planner, Dated 2018, Wire bound, Non-refillable, Black Cover 7530-01-600-7605—Weekly Planner Book, Dated 2018, 5″ x 8″, Black 7510-01-600-7568—Monthly Wall Calendar, Dated 2018, Jan-Dec, 81/2″ x 11″ 7510-01-600-7629—Wall Calendar, Dated 2018, Wire Bound w/Hanger, 12″ x 17″ 7510-01-600-7563—Wall Calendar, Dated 2018, Wire Bound w/hanger, 151/2″ x 22″ Mandatory Source of Supply: Chicago Lighthouse Industries, Chicago, IL Contracting Activity: General Services Administration, New York, NY Service Service Type: Microfiche/Microfilm Reproduction Service Mandatory for: Great Plains Area: Department of Housing and Urban Development (HUD), Chicago, IL Mandatory Source of Supply: Lester and Rosalie ANIXTER CENTER, Chicago, IL Contracting Activity: Dept. of Housing and Urban Development Amy Jensen, Director, Business Operations.
    [FR Doc. 2018-12903 Filed 6-14-18; 8:45 am] BILLING CODE 6353-01-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Addition and Deletions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Addition to and Deletions from the Procurement List.

    SUMMARY:

    This action adds a service to the Procurement List that will be provided by a nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products from the Procurement List previously furnished by such agencies.

    DATES:

    Date added to and deleted from the Procurement List: July 15, 2018.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    Addition

    On 5/11/2018 (83 FR 92), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed addition to the Procurement List.

    After consideration of the material presented to it concerning capability of a qualified nonprofit agency to provide the service and impact of the addition on the current or most recent contractor, the Committee has determined that the service listed below is suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

    Regulatory Flexibility Act Certification

    I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

    1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organization that will provide the service to the Government.

    2. The action will result in authorizing a small entity to provide the service to the Government.

    3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the service proposed for addition to the Procurement List.

    End of Certification

    Accordingly, the following service is added to the Procurement List:

    Service Service Type: Warehouse and Distribution Service. Mandatory for: National Institutes of Health, Information Resource Center, 6001 Executive Boulevard, Rockville, MD. Mandatory Source of Supply: The ARC of the District of Columbia, Inc., Washington, DC. Contracting Activity: National Institutes of Health. Deletions

    On 5/11/2018 (83 FR 92), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.

    After consideration of the relevant matter presented, the Committee has determined that the products listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

    Regulatory Flexibility Act Certification

    I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

    1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

    2. The action may result in authorizing small entities to furnish the products to the Government.

    3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products deleted from the Procurement List.

    End of Certification

    Accordingly, the following products are deleted from the Procurement List:

    Products NSN(s)—Product Name(s): MR 568—Scrubber, 3-pk. Mandatory Source(s) of Supply: Beacon Lighthouse, Inc., Wichita Falls, TX. Contracting Activity: Defense Commissary Agency. NSN(s)—Product Name(s): 7920-01-621-9146—Towel, Cleaning, Non-woven Microfiber, Disposable, 16″ × 16″. Mandatory Source of Supply: Bestwork Industries for the Blind, Inc., Cherry Hill, NJ. Contracting Activity: General Services Administration, Fort Worth, TX. Amy Jensen, Director, Business Operations.
    [FR Doc. 2018-12904 Filed 6-14-18; 8:45 am] BILLING CODE 6353-01-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No. CFPB-2018-0018] Agency Information Collection Activities: Comment Request; Correction AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice and request for comment.

    SUMMARY:

    The Bureau of Consumer Financial Protection published a notice in the Federal Register on May 14, 2018 concerning a request for comments on the proposed revision of a currently approved collection of an Office of Management and Budget (OMB) control number. The information collection title in the notice was incorrect.

    FOR FURTHER INFORMATION CONTACT:

    The Bureau of Consumer Financial Protection, (Attention: PRA Office), 1700 G Street NW, Washington, DC 20552, (202) 435-9575, or email: [email protected] If you require this document in an alternative electronic format, please contact [email protected]

    Correction

    In the Federal Register of May 14, 2018 in FR Doc. 2018-10221 on page 22254, in the third column, and on page 22255, in the first column, correct “Compliant” to read: “Complaint.”

    Dated: June 12, 2018. Darrin A. King, Paperwork Reduction Act Officer, Bureau of Consumer Financial Protection.
    [FR Doc. 2018-12908 Filed 6-14-18; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF DEFENSE Office of the Secretary Defense Intelligence Agency National Intelligence University Board of Visitors; Notice of Federal Advisory Committee Meeting AGENCY:

    National Intelligence University, Defense Intelligence Agency, Department of Defense.

    ACTION:

    Notice of closed meeting.

    SUMMARY:

    The Department of Defense is publishing this notice to announce that the following Federal Advisory Committee meeting of the National Intelligence University Board of Visitors has been scheduled. The meeting is closed to the public.

    DATES:

    Tuesday, June 19, 2018 (7:30 a.m. to 5:15 p.m.) and Wednesday, June 20, 2018 (7:30 a.m. to 1:00 p.m.).

    ADDRESSES:

    Defense Intelligence Agency 7400 Pentagon, ATTN: NIU, Washington, DC 20301-7400.

    FOR FURTHER INFORMATION CONTACT:

    Dr. J. Scott Cameron, President, Defense Intelligence Agency National Intelligence University, Washington, DC 20340-5100, Phone: (301) 243-2118.

    SUPPLEMENTARY INFORMATION:

    Due to circumstances beyond the control of the Department of Defense (DoD) and the Designated Federal Officer, the National Intelligence University Board of Visitors was unable to provide public notification required by 41 CFR 102-3.150(a) concerning the meeting on June 19, 2018 through June 20, 2018, of the National Intelligence University Board of Visitors. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

    Purpose: The National Intelligence University Board of Visitors will discuss several current critical intelligence issues and advise the Director, Defense Intelligence Agency, as to the successful accomplishment of the mission assigned to the National Intelligence University.

    Agenda: The following topics are listed on the National Intelligence University Board of Visitors meeting agenda: Welcome and opening remarks by the President and Board Chair; Accreditation Update; Follow-up on presentations made at June 2017 meeting; Legislative Update, Board Business and Executive Sessions; Working Lunch with Intelligence Community Senior Leaders.

    The entire meeting is devoted to the discussion of classified information as defined in 5 U.S.C. 552b(c)(1) and therefore will be closed. Pursuant to 41 CFR 102-3.105(j) and 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written statements to the National Intelligence University Board of Visitors about its mission and functions. Written statements may be submitted at any time or in response to the stated agenda of a planned meeting of the National Intelligence University Board of Visitors. All written statements shall be submitted to the Designated Federal Officer for the National Intelligence University Board of Visitors, and this individual will ensure that the written statements are provided to the membership for their consideration. Contact information for the Designated Federal Officer can be obtained from the GSA's FACA Database—http://www.facadatabase.gov/.

    Dated: June 11, 2018. Shelly E. Finke, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-12901 Filed 6-14-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Charter Renewal of Department of Defense Federal Advisory Committees AGENCY:

    Office of the Secretary, Department of Defense.

    ACTION:

    Renewal of Federal Advisory Committee.

    SUMMARY:

    The Department of Defense (DoD) is publishing this notice to announce that it is renewing the charter for the Chief of Engineers Environmental Advisory Board (“the Board”).

    FOR FURTHER INFORMATION CONTACT:

    Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.

    SUPPLEMENTARY INFORMATION:

    The Board's charter is being renewed in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(d). The Board's charter and contact information for the Board's Designated Federal Officer (DFO) can be found at http://www.facadatabase.gov/.

    The Board provides the Secretary of Defense and the Deputy Secretary of Defense, through the Secretary of the Army, the Assistant Secretary of the Army (Civil Works), and the Chief of Engineers, independent advice and recommendations on matters related to the two distinct component programs of the United States Corps of Engineers—the Military Program, which supports Army war fighters, and the Civil Works Program, which manages many of the water resources of the Nation.

    The Board is composed of no more than 10 members who are eminent authorities in the fields of natural (e.g., biology, ecology), social (e.g., anthropology, community planning), and related sciences. All members of the Board are appointed to provide advice on behalf of the Government on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Except for reimbursement of official Board-related travel and per diem, Board members serve without compensation.

    The public or interested organizations may submit written statements to the Board membership about the Board's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Board. All written statements shall be submitted to the DFO for the Board, and this individual will ensure that the written statements are provided to the membership for their consideration.

    Dated: June 11, 2018. Shelly E. Finke, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-12857 Filed 6-14-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Navy Notice of Availability of Government-Owned Inventions; Available for Licensing AGENCY:

    Department of the Navy, DoD.

    ACTION:

    Notice.

    SUMMARY:

    The Department of the Navy (DoN) announces the availability of the inventions listed below, assigned to the United States Government, as represented by the Secretary of the Navy, for domestic and foreign licensing by the Department of the Navy.

    ADDRESSES:

    Requests for copies of the patents cited should be directed to Naval Surface Warfare Center, Crane Div, Code OOL, Bldg 2, 300 Highway 361, Crane, IN 47522-5001.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Christopher Monsey, Naval Surface Warfare Center, Crane Div, Code OOL, Bldg 2, 300 Highway 361, Crane, IN 47522-5001, Email [email protected], 812-854-2777.

    SUPPLEMENTARY INFORMATION:

    The following patents are available for licensing: Patent No. 9,958,544 (Navy Case No. 200113): VESSEL-TOWED MULTIPLE SENSOR SYSTEMS AND RELATED METHODS//and Patent No. 9,959,430 (Navy Case No. 103079): COUNTERFEIT MICROELECTRONICS DETECTION BASED ON CAPACITIVE AND INDUCTIVE SIGNATURES.

    Authority:

    35 U.S.C. 207, 37 CFR part 404.

    Dated: June 7, 2018. E.K. Baldini, Lieutenant Commander, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer.
    [FR Doc. 2018-12834 Filed 6-14-18; 8:45 am] BILLING CODE 3810-FF-P
    DEPARTMENT OF DEFENSE Department of the Navy [Docket ID: USN-2018-HQ-0004] Submission for OMB Review; Comment Request AGENCY:

    Department of the Navy, DoD.

    ACTION:

    30-Day information collection notice.

    SUMMARY:

    The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

    DATES:

    Consideration will be given to all comments received by July 16, 2018.

    ADDRESSES:

    Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at [email protected] Please identify the proposed information collection by DoD Desk Officer, Docket ID number, and title of the information collection.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493, or [email protected]

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: CATCH Program; DD-XXXX; OMB Control Number 0703-XXXX.

    Type of Request: New collection.

    Number of Respondents: 300.

    Responses per Respondent: 1.

    Annual Responses: 300.

    Average Burden per Response: 30 minutes.

    Annual Burden Hours: 150.

    Needs and Uses: The information collection requirement is necessary to assist with the identification of serial sexual assault offenders within the military services.

    Affected Public: Individuals or Households.

    Frequency: On occasion.

    Respondent's Obligation: Voluntary.

    OMB Desk Officer: Ms. Jasmeet Seehra.

    You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

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

    Instructions: All submissions received must include the agency name, Docket ID 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.

    DOD Clearance Officer: Mr. Frederick Licari.

    Requests for copies of the information collection proposal should be sent to Mr. Licari at [email protected]

    Dated: June 11, 2018. Shelly E. Finke, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-12850 Filed 6-14-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP18-492-000] Pine Prairie Energy Center, LLC; Notice of Application

    Take notice that on May 25, 2018, Pine Prairie Energy Center, LLC (Pine Prairie), 333 Clay Street, Suite 1500, Houston, Texas 77002, filed in Docket No. CP18-492-000, an application under section 7(c) of the Natural Gas Act seeking authorization to amend its certificate of public convenience and necessity issued in Docket No. CP11-1-000 to reallocate the previously certificated aggregate capacities of each of Cavern Nos. 1 through 7 at its Pine Prairie Energy Center natural gas storage facility located in Evangeline Parrish, Louisiana. Pine Prairie proposes to increase the certificated base gas capacity of each cavern with a corresponding decrease in the certificated working gas capacity in each cavern. The proposed capacity reallocation would not result in any change to the previously certificated total storage capacity of any individual cavern or to the aggregate certificated capacity of the Pine Prairie natural gas storage facility, all as more fully set forth in the application which is on file with the Commission and open to public inspection. This filing may be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC at [email protected] or call toll-free, (886) 208-3676 or TYY, (202) 502-8659.

    Any questions regarding this Application should be directed William E. Rice, King & Spaulding LLP, 1700 Pennsylvania Avenue NW, Suite 200, Washington, DC 20006, 202-626-9602 (phone), 202-626-3737 (fax), [email protected]; or Eileen Wilson Kisluk, Pine Prairie Energy Center, LLC, 333 Clay Street, Suite 1500, Houston, Texas 77002, 713-993-5203 (phone), 713-652-3701 (fax), [email protected]

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 7 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenter's will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenter's will not be required to serve copies of filed documents on all other parties. However, the non-party commentary, will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's website under the “e-Filing” link.

    Comment Date: 5:00 p.m. Eastern Time on June 29, 2018.

    Dated: June 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-12876 Filed 6-14-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2883-009] Notice of Application Tendered for Filing With the Commission and Soliciting Additional Study Requests and Establishing Procedural Schedule for Relicensing and a Deadline for Submission of Final Amendments: Aquenergy Systems, LLC

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.

    a. Type of Application: New Major License.

    b. Project No.: 2883-009.

    c. Date Filed: May 30, 2018.

    d. Applicant: Aquenergy Systems, LLC.

    e. Name of Project: Fries Hydroelectric Project.

    f. Location: On the New River in the Town of Fries, Grayson County, Virginia. No federal lands are occupied by the project works or located within the project boundary.

    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).

    h. Applicant Contact: Mr. Kevin Webb, Hydro Licensing Manager, Enel Green Power North America, Inc., 100 Brickstone Square, Suite 300, Andover, MA 01810; (978) 935-6039.

    i. FERC Contact: Nicholas Ettema, (202) 502-6565 or [email protected]

    j. Cooperating agencies: Federal, state, local, and tribal agencies with jurisdiction and/or special expertise with respect to environmental issues that wish to cooperate in the preparation of the environmental document should follow the instructions for filing such requests described in item l below. Cooperating agencies should note the Commission's policy that agencies that cooperate in the preparation of the environmental document cannot also intervene. See, 94 FERC ¶ 61,076 (2001).

    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.

    l. Deadline for filing additional study requests and requests for cooperating agency status: July 29, 2018.

    The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket number P-2883-009.

    m. This application is not ready for environmental analysis at this time.

    n. The existing Fries Hydroelectric Project (Fries Project) consists of: (1) A 41-foot-high, 610-foot-long rock masonry dam with a 500-foot-long spillway; (2) an 88-acre impoundment at the normal pool elevation (spillway crest elevation) of 2,188.27 feet National Geodetic Vertical Datum of 1929; (3) an approximately 750-foot-long, 110-foot-wide intake canal with four 15.5-foot-high, 6.5-foot-wide headgates; (4) a canal spillway consisting of 10 stoplog bays totaling 47 feet in length; (5) two 12.5-foot-high, 5.0-foot-wide canal gates; (6) a steel powerhouse that contains a single vertical Kaplan turbine with a capacity of 2.1 megawatts (MW) that discharges into a 180-foot-long, 75-foot-wide, 12-foot-deep tailrace; (7) a masonry powerhouse that contains one vertical and two horizontal Francis turbines with a total capacity of 3.0 MW that discharges into a 180-foot-long, 120-foot-wide, 12-foot-deep tailrace; (8) a 500-foot-long, 450-foot-wide bypassed reach that extends from the toe of the dam to the confluence with the tailraces; (9) a 567-foot-long, 13.2-kilovolt (kV) transmission line that runs from the steel powerhouse to the interconnection point with the grid; (10) a 130-foot-long transmission line that connects the masonry powerhouse to a 5,000 kilovolt-amp step-up transformer and an additional 323-foot-long, 13.2-kV transmission line leading from the transformer to the interconnection point; (11) and appurtenant facilities.

    The Fries Project is operated in a run-of-river mode. For the period 2003 through 2016, the average annual generation at the Fries Project was 26,150 megawatt-hours.

    o. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support. A copy is also available for inspection and reproduction at the address in item h above.

    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    p. Procedural schedule and final amendments: The application will be processed according to the following preliminary schedule. Revisions to the schedule will be made as appropriate.

    Issue Deficiency Letter (if necessary) August 2018 Request Additional Information August 2018 Issue Acceptance Letter October 2018 Issue Scoping Document 1 for comments November 2018 Request Additional Information (if necessary) January 2019 Issue Scoping Document 2 February 2019 Issue notice of ready for environmental analysis February 2019 Commission issues EA August 2019 Comments on EA September 2019

    q. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.

    Dated: June 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-12880 Filed 6-14-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2503-167] Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests: Duke Energy Carolinas, LLC

    Take notice that the following hydroelectric application has been filed with the Federal Energy Regulatory Commission and is available for public inspection:

    a. Type of Application: Non-project use of project lands and water.

    b. Project No.: 2503-167.

    c. Date Filed: February 1, 2018 and supplemented June 4, 2018.

    d. Applicant: Duke Energy Carolinas, LLC (licensee).

    e. Name of Project: Keowee-Toxaway Hydroelectric Project.

    f. Location: Lake Keowee in Oconee County, South Carolina.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.

    h. Applicant Contact: Kelvin Reagan, Manager, Lake Services South, Duke Energy Carolinas, LLC, 526 South Church Street, ECQ12, Charlotte, North Carolina 28202; phone (704) 382-9386.

    i. FERC Contact: Ms. Joy Kurtz at 202-502-6760, or [email protected]

    j. Deadline for filing comments, motions to intervene, and protests is 30 days from the issuance of this notice by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, and comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket number P-2503-167.

    k. Description of Request: The licensee requests Commission approval to grant the City of Walhalla permission to use project lands and water within the project boundary to construct and operate a raw water intake on Lake Keowee in order to meet demands for public drinking water. Construction activities within the project boundary would include installation of an intake line outfitted with a dual tee screen system and air burst line, installation of a floating dock extending over the intake line, placement of rip rap along the stream bank and intake line, and installation of a stormwater outfall. The through-slot velocity at the intake screen will not exceed 0.5 feet per second. The raw water line would leave the project boundary and lead to a water treatment plant, which is not yet constructed. Once constructed, the facility would withdrawal up to 6.75 million gallons per day (mgd) from Lake Keowee.

    l. Locations of the Application: A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE, Room 2A, Washington, DC 20426, or by calling 202-502-8371. This filing may also be viewed on the Commission's website at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, call 866-208-3676 or email [email protected], for TTY, call 202-502-8659. A copy is also available for inspection and reproduction at the address in item (h) above.

    m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.

    n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

    o. Filing and Service of Responsive Documents: Any filing must (1) bear in all capital letters the title “COMMENTS”; “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). All comments, motions to intervene, or protests should relate to the non-project use application. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. If an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: June 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-12878 Filed 6-14-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP18-493-000] Notice of Request Under Blanket Authorization: Saltville Gas Storage Company, LLC

    Take notice that on May 31, 2018, Saltville Gas Storage Company, L.L.C. (Saltville), 5400 Westheimer Court, Houston, Texas 77056-5310, filed in Docket No. CP18-493-000 a prior notice request pursuant to sections 157.205, 157.208, 157.213 and 157.216 of the Commission's regulations under the Natural Gas Act notifying the Commission of Saltville's intent to drill two new injection and withdrawal (I/W) wells, to replace two previously abandon I/W wells and one existing I/W well, to maintain the deliverability of the Early Grove depleted reservoir facility, as well as to abandon one existing monitoring well at its Early Grove natural gas storage facility in Scott and Washington Counties, Virginia, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or TTY, contact (202) 502-8659.

    Any questions concerning this application may be directed to Lisa A. Connolly, Director, Rates & Certificates, Saltville Gas Storage Company. L.L.C., P.O. Box 1642, Houston, Texas 77251-1642 at (713) 627-4102 or at [email protected]

    Specifically, Saltville proposes to: (i) Drill new horizontal/high angle I/W wells; (ii) install connecting piping and other appurtenances facilities; (iii) plug and abandon one existing I/W well, EH-96, and one existing monitoring well, EH-95; and (iv) abandon by removal related connecting piping and appurtenance facilities. Saltville states that, the project will have no impact on the certificate parameters of the facility, including total inventory, reservoir pressure, reservoir and buffer boundaries, or certificated capacity, and there will be no abandonment or reduction in service to any customer of Saltville as a result of the project. The project cost will be approximately $20 million.

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenter will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    Dated: June 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-12879 Filed 6-14-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC18-98-000.

    Applicants: Grays Harbor Energy LLC, Hardee Power Partners Limited, Invenergy Cannon Falls LLC, Invenergy Nelson LLC, Lackawanna Energy Center LLC, Spindle Hill Energy LLC.

    Description: Application for Authorization Under Section 203 of the Federal Power Act and Request for Waivers and Expedited Action of Grays Harbor Energy LLC, et al.

    Filed Date: 6/7/18.

    Accession Number: 20180607-5150.

    Comments Due: 5 p.m. ET 6/28/18.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER18-1078-001.

    Applicants: Southwest Power Pool, Inc.

    Description: Tariff Amendment: Deficiency Response—Revisions to Require PMUs at New Interconnections to be effective 5/13/2018.

    Filed Date: 6/7/18.

    Accession Number: 20180607-5127.

    Comments Due: 5 p.m. ET 6/28/18.

    Docket Numbers: ER18-1762-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Notice of Cancellation of ISA SA No. 3525; Queue No. V3-015 to be effective 6/26/2018.

    Filed Date: 6/7/18.

    Accession Number: 20180607-5131.

    Comments Due: 5 p.m. ET 6/28/18.

    Docket Numbers: ER18-1763-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Original WMPA, SA No. 5100; Queue No. AC1-212 to be effective 5/9/2018.

    Filed Date: 6/8/18.

    Accession Number: 20180608-5119.

    Comments Due: 5 p.m. ET 6/29/18.

    Docket Numbers: ER18-1764-000.

    Applicants: Public Service Company of Colorado.

    Description: § 205(d) Rate Filing: PSCo-TSGT-UP-PkwySS-CO-Agmt F174-479-0.0.0 to be effective 6/9/2018.

    Filed Date: 6/8/18.

    Accession Number: 20180608-5120.

    Comments Due: 5 p.m. ET 6/29/18.

    Take notice that the Commission received the following electric securities filings:

    Docket Numbers: ES18-39-000.

    Applicants: Consumers Energy Company.

    Description: Application of Consumers Energy Company for Authority to Issue Securities.

    Filed Date: 6/8/18.

    Accession Number: 20180608-5083.

    Comments Due: 5 p.m. ET 6/29/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: June 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-12875 Filed 6-14-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator and Foreign Utility Company Status Midway Wind, LLC EG18-49-000 Victoria City Power LLC EG18-50-000 Victoria Port Power LLC EG18-51-000 Meadow Lake Wind Farm VI LLC EG18-53-000 Prairie Queen Wind Farm LLC EG18-54-000 Turtle Creek Wind Farm LLC EG18-55-000 Kestrel Acquisition LLC EG18-56-000 Imperial Valley Solar 2, LLC EG18-57-000 Delta Solar Power I, LLC EG18-58-000 Delta Solar Power II, LLC EG18-59-000 Walleye Energy, LLC EG18-60-000 Pinal Central Energy Center, LLC EG18-61-000 Trishe Wind Ohio, LLC EG18-62-000 NRG Cottonwood Tenant LLC EG18-63-000 SP Sandhills Solar, LLC EG18-64-000 SP Butler Solar, LLC EG18-65-000 SP Pawpaw Solar, LLC EG18-66-000 SP Decatur Parkway Solar, LLC EG18-67-000 Camilla Solar Energy LLC EG18-68-000 NC 102 Project LLC EG18-69-000 64KT 8ME LLC EG18-70-000 I Squared Capital FC18-3-000 I Squared Capital FC18-4-000 DATES:

    June 8, 2018.

    Take notice that during the month of May 2018, the status of the above-captioned entities as Exempt Wholesale Generators or Foreign Utility Companies became effective by operation of the Commission's regulations. 18 CFR 366.7(a) (2017).

    Dated: June 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-12877 Filed 6-14-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14876-000] Western Minnesota Municipal Power Authority; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications

    On April 19, 2018, Western Minnesota Municipal Power Authority filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Gregory County Pumped Storage Project to be located on Lake Francis Case on the Missouri River, near the township of Lucas, in Gregory, Charles Mix, and Brule Counties, South Dakota. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.

    The proposed project would consist of the following: (1) A new 1,200-acre earthen embankment levee (upper reservoir) having a total storage capacity of 50,000 acre-feet with an operating elevation level of between 2,045 feet mean sea level (msl) and 2,087 feet msl; (2) a new 550-foot-long by 120-foot-wide by 100-foot-high reinforced concrete powerhouse containing eight new 150-megawatt (MW) turbine units for a total plant rating of 1,200 MW; (3) thirty new 15-foot-wide by 20-foot-deep reinforced concrete trashracks with an open bar spacing of 3.75 inches; (4) two new 6,000-foot-long, 32-foot-diameter reinforced concrete penstocks; (5) two new 120-foot-high, 40-foot-diameter reinforced concrete surge tanks connected to each penstock; (6) the existing 102,000-acre Lake Francis Case (lower reservoir) with a storage capacity of 5,494,000 acre-feet at normal maximum operation elevation of 1,355 feet msl; (7) a new 6,000-foot-long, horse-shoe configured tailrace tunnel that daylights to a 350-foot-long tailrace channel (upstream of the trashrack) from the powerhouse to Lake Francis Case; (8) a new 200-foot by 360-foot substation on top of the powerhouse containing four step-up transformers; (9) a new 21-mile-long, 345-kilovolt (kV) transmission line extending from the project substation to the existing Lake Platte substation (the point of interconnection); and (10) appurtenant facilities. The estimated annual generation of the Gregory County Pumped Storage Project would be 3,500 gigawatt-hours.

    Applicant Contact: Mr. Raymond J. Wahle, Missouri River Energy Services, 3724 W. Avera Drive, P.O. Box 88920, Sioux Falls, SD 57109; phone: (605) 330-6963.

    FERC Contact: Tyrone Williams; phone: (202) 502-6331.

    Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.

    The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket number P-14876-000.

    More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-14876) in the docket number field to access the document. For assistance, contact FERC Online Support.

    Dated: June 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-12881 Filed 6-14-18; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OW-2011-0465; FRL-9979-51-OW] Proposed Information Collection Request; Comment Request; Water Quality Standards Regulation (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency is planning to submit an information collection request (ICR), “Water Quality Standards Regulation (Renewal)” (EPA ICR No. 0988.13, OMB Control No. 2040-0049) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This ICR renews the Water Quality Standards Regulation ICR (most recently approved in 2016) and consolidates the burden and costs associated with activities previously reported in ICRs for two recent rules affecting the WQS program: The Water Quality Standards Regulatory Revisions (approved in 2015), and the Revised Interpretation of Clean Water Act Tribal Provision (approved in 2016). An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Comments must be submitted on or before August 14, 2018.

    ADDRESSES:

    Submit your comments, referencing Docket ID No. EPA-HQ-OW-2011-0465, online using www.regulations.gov (our preferred method), by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

    The EPA's policy is that all comments received will be included in the public docket without change including any personal information provided unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Tanyan Bailey, Office of Water, Office of Science and Technology, Standards and Health Protection Division, (4305T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-564-3133; fax number: 202-566-0409; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents which explain in detail the information that the EPA would be collecting are available in the public docket for this Information Collection Request (ICR) (Docket ID No. EPA-HQ-OW-2011-0465). The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave., NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about the EPA's public docket, visit http://www.epa.gov/dockets.

    Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act (PRA), the EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and, (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The EPA will consider the comments received and amend the proposed ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, the EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

    Abstract: Water quality standards (WQS) under the Clean Water Act (hereafter referred to as “the Act”) are provisions of state,1 tribal,2 or federal law which consist of designated uses for waters of the United States, water quality criteria to protect those uses, and antidegradation requirements. WQS are established to protect public health or welfare, protect and enhance the quality of water, and serve the purposes of the Clean Water Act. Such standards serve the dual purposes of establishing the water quality goals for water bodies and serving as the regulatory basis for the establishment of water quality-based treatment controls and strategies beyond technology-based levels of treatment required by sections 301(b) and 306 of the Act. The WQS Regulation establishes the framework for states and authorized tribes to adopt standards, and for the EPA to review and approve or disapprove them. For the purposes of this ICR, the WQS Regulation consists of 40 CFR part 131 (Water Quality Standards), and portions of part 132 (Water Quality Guidance for the Great Lakes System) that are related to WQS.3 This ICR is for information collections needed to implement the WQS Regulation and required to obtain or retain benefits (e.g., relaxed regulatory requirements) under the WQS Regulation.

    1 “States” in the EPA's WQS Regulation and in this document includes the 50 states, the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Virgin Islands, American Samoa, and the Commonwealth of the Northern Mariana Islands.

    2 “Tribes” in this document refers to federally recognized tribes and “authorized tribes” refers to those federally recognized Indian tribes with authority to administer a CWA WQS program.

    3 These portions include 40 CFR 132.3, appendices A, B, C, D, E, and Procedures 1 and 2 of appendix F.

    This ICR renews the WQS Regulation ICR, OMB control no. 2040-0049, expiration date 6/30/2019, and consolidates the burden and costs associated with activities previously reported in two related ICRs, which upon OMB approval will be discontinued as separate ICRs:

    The WQS Regulatory Revisions ICR, OMB control no. 2040-0286, expiration date 12/31/2018; and,

    The Revised Interpretation of Clean Water Act Tribal Provision ICR, OMB control no. 2040-0289, expiration date 7/31/2019.

    This ICR renewal and consolidation describes the estimated burden for states, authorized tribes and certain Great Lakes dischargers associated with the information collections related to: Implementation of the requirements of 40 CFR part 131 (Water Quality Standards); implementation of the WQS portions of the 40 CFR part 132 (Water Quality Guidance for the Great Lakes System); tribal applications to be treated in a similar manner as a state (TAS); and, tribal requests for dispute resolution under CWA section 518(e). This ICR also covers periodic requests for voluntary WQS information from, or voluntary participation in workgroups by, state and tribes to ensure efficient and effective administration of the WQS program and further cooperative federalism.

    Form Numbers: None.

    Respondents/affected entities: Potential respondents to this ICR include: The 50 states, the District of Columbia, five territories, authorized tribes with EPA-approved Water Quality Standards (44 tribes as of May 2018), and a total of 18 additional tribal respondents over the three-year duration of the ICR (based on six additional tribal respondents expected to apply per year for TAS to administer the WQS program). In addition, an estimated total of 258 dischargers located in the Great Lakes watershed over the three-year duration of this ICR (based on an estimated 86 dischargers per year) could apply for certain forms of regulatory relief. The total number of potential respondents is thus 376. This corresponds to 2,693 responses per year (see draft Supporting Statement in the docket for this ICR).

    Respondent's obligation to respond: Some collections in this ICR are mandatory; some are required to obtain or retain benefits (e.g., relaxed regulatory requirements) pursuant to the WQS Regulation; and, some are voluntary.

    Estimated number of respondents: 2,693.

    Frequency of response: Variable depending on type of information collected (once every three years; annually; on occasion or as necessary; or, only once).

    Total estimated burden: From 376,097 to 514,987 hours per year. Burden is defined at 5 CFR 1320.03(b).

    Total estimated cost: From $17,103,064 to $23,173,945 of labor costs per year, and $263,520 of operations and maintenance costs per year. There are no annualized capital costs.

    Changes in Estimates: There is a decrease of 226,040 hours in the total upper estimates of respondent burden compared with the combined burden of the three ICRs currently approved by OMB and consolidated in this ICR. This decrease reflects adjustments made to the EPA's burden estimates based on experience gained since the previous ICRs were approved.

    Dated: June 6, 2018. Deborah G. Nagle, Acting Director, Office of Science and Technology.
    [FR Doc. 2018-13027 Filed 6-14-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-OW-2018-0270; FRL-9979-53-OW] Announcement of the Per- and Polyfluoroalkyl Substances (PFAS) New England Community Engagement AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of an event.

    SUMMARY:

    The Environmental Protection Agency (EPA) will kick off the Per- and Polyfluoroalkyl Substances (PFAS) community engagements with a two-day event in Exeter, New Hampshire. The goal of the event is to allow the EPA to hear directly from New England communities to understand ways the Agency can best support the work that is being done at the state, local, and tribal level. For more information on the event, visit the EPA's PFAS website: https://www.epa.gov/pfas/pfas-community-engagement. During the recent PFAS National Leadership Summit, the EPA announced plans to visit communities to hear directly from those impacted by PFAS. This engagement is the next step in the EPA's commitment to address challenges with PFAS. The EPA anticipates that the community engagements will provide valuable insight for the agency's efforts moving forward. For more information, go to the SUPPLEMENTARY INFORMATION section of this notice.

    DATES:

    The event will be held on June 25-26, 2018. On June 25, a listening session will be held at 4:30 p.m. to 10:00 p.m., eastern time. A working session will be held on June 26 from 8:00 a.m. to 3:00 p.m., eastern time.

    ADDRESSES:

    The two-day event will be held at the Exeter High School, 1 Blue Hawk Drive, Exeter, New Hampshire 03833. If you are unable to attend the New England Community Engagement, you will be able to submit comments at http://www.regulations.gov: Enter Docket ID No. EPA-OW-2018-0270. Citizens are encouraged to send written statements to the public docket. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Doug Gutro, EPA New England Headquarters (Mail Code ORAO1-1), 5 Post Office Square, Suite 100, Boston, MA 02109-3912; telephone number: 617-918-1021; fax number: 617-918-0021; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Details about Participating in the Event: The public is invited to speak during the June 25 listening session. Those interested in speaking can sign up for a 3-minute speaking slot on EPA's website at https://www.epa.gov/pfas/pfas-community-engagement. Please check this website for event materials as they become available, including a full agenda, leading up to the event.

    The PFAS National Leadership Summit: On May 22-23, 2018, the EPA hosted the PFAS National Leadership Summit. During the summit, participants worked together to share information on ongoing efforts to characterize risks from PFAS, develop monitoring and treatment/cleanup techniques, identify specific near-term actions (beyond those already underway) that are needed to address challenges currently facing states and local communities, and develop risk communication strategies that will help communities to address public concerns regarding PFAS.

    The EPA wants to ensure the public that their input is valuable and meaningful. Using information from the National Leadership Summit, public docket, and community engagements, the EPA plans to develop a PFAS Management Plan for release later this year. A summary of the New England Community Engagement will be made available to the public following the event on the EPA's PFAS Community Engagement website at: https://www.epa.gov/pfas/pfas-community-engagement.

    Dated: June 11, 2018. Eric Burneson, Acting Director, Office of Ground Water and Drinking Water.
    [FR Doc. 2018-12911 Filed 6-14-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-9039-8] Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General Information (202) 564-7156 or https://www2.epa.gov/nepa/.

    Weekly receipt of Environmental Impact Statements Filed 06/04/2018 Through 06/08/2018 Pursuant to 40 CFR 1506.9. Notice

    Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

    EIS No. 20180129, Final, FTA, CA, Geary Corridor Bus Rapid Transit Project, Under 23 U.S.C. 139(n)(2), FTA has issued a single document that consists of a final environmental impact statement and record of decision. Therefore, the 30-day wait/review period under NEPA does not apply to this action. Contact: Alex Smith 415-734-9472 EIS No. 20180130, Draft, USFS, MT, Gold Butterfly, Comment Period Ends: 07/30/2018, Contact: Tami Sabol 406-777-7410 EIS No. 20180131, Draft, FTA, OR, Southwest Corridor Light Rail Project Draft Environmental Impact Statement, Comment Period Ends: 07/30/2018, Contact: Mark Assam 206-220-7954 EIS No. 20180132, Final, NY, State Governor's Office of Storm Recovery, NY, Coastal and Social Resiliency Initiatives for Tottenville Shoreline, Review Period Ends: 07/16/2018, Contact: Daniel Greene 212-480-2321 Amended Notice

    Revision to the Federal Register Notice published 05/04/2018, extend comment period from 06/18/2018 to 06/29/2018.

    EIS No. 20180078, Draft, TxDOT, TX, Oakhill Parkway, Contact: Carlos Swonke 512-416-2734 Adoption

    EPA has adopted EIS 20180075, Pure Water San Diego Program, North City Project, Final, BR, CA. EPA was a cooperating agency on this project; therefore, recirculation is not necessary under Section 1506.3(c) of the CEQ NEPA regulations. Contact: Danusha Chandy 202-566-2165.

    Dated: June 12, 2018. Robert Tomiak, Director, Office of Federal Activities.
    [FR Doc. 2018-12861 Filed 6-14-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2011-0928; FRL-9979-47-OAR] Proposed Information Collection Request; Comment Request; Fuel Use Requirements for Great Lake Steamships (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency is planning to submit an information collection request (ICR), “Fuel Use Requirements for Great Lakes Steamships” (EPA ICR No. 2458.03, OMB Control No. 2060-0679) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through August 31, 2018. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Comments must be submitted on or before August 14, 2018.

    ADDRESSES:

    Submit your comments, referencing Docket ID No. EPA-HQ-OAR-2011-0928, online using www.regulations.gov (our preferred method), or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Alan Stout, Office of Transportation and Air Quality, Environmental Protection Agency, 2565 Plymouth Road, Ann Arbor, MI 48105; 734-214-4805; [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents explaining in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

    Abstract: The U.S. Environmental Protection Agency (EPA) adopted requirements for marine vessels operating in and around U.S. territorial waters to use reduced-sulfur diesel fuel. This requirement does not apply for steamships, but it would apply for steamships that are converted to run on diesel engines. A regulatory provision allows vessel owners to qualify for a waiver from the fuel-use requirements for a defined period for such converted vessels.

    One condition of the exemption from the fuel standard is that engines meet current emission standards. EPA uses the data to oversee compliance with regulatory requirements, including communicating with affected companies and answering questions from the public or other industry participants regarding the waiver in question. Since the IMO Tier III NOX standards apply for Category 3 engines installed on U.S. vessels, we don't expect anyone to use the steamship exemption.

    Form Numbers: None.

    Respondents/affected entities: 0.

    Respondent's obligation to respond: Required to obtain a benefit (40 CFR 1043.95).

    Estimated number of respondents: 0.

    Frequency of response: One time for a new notification.

    Total estimated burden: 0 hours (per year). Burden is defined at 5 CFR 1320.03(b).

    Total estimated cost: $0.

    Changes in Estimates: The burden estimate decreases from the current estimate of 14 hours per year in the total estimated respondent burden currently approved by OMB. Since the IMO Tier III NOX standards apply for Category 3 engines installed on U.S. vessels, we don't expect anyone to use the steamship exemption.

    Dated: June 4, 2018. William J. Charmley, Director, Assessment and Standards Division.
    [FR Doc. 2018-12912 Filed 6-14-18; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [MB Docket No. 18-139; FCC 18-56] Family Voice Communications, LLC, Application for Renewal of License of FM Radio Station KLSX(FM), Rozet, WY AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice.

    SUMMARY:

    This document commences a hearing to determine whether the application filed by Family Voice Communications, LLC to renew its license for radio station KLSX(FM), Rozet, Wyoming, should be granted. The application has been designated for hearing based on the station's extended periods of silence since its first day of claimed operation on November 8, 2010.

    DATES:

    Persons desiring to participate as parties in the hearing shall file a petition for leave to intervene not later than July 16, 2018.

    ADDRESSES:

    File documents with the Office of the Secretary, Federal Communications Commission, 445 12th Street SW, Washington, DC 20554, with a copy mailed to each party to the proceeding. Each document that is filed in this proceeding must display on the front page the docket number of this hearing, “MB Docket No. 18-139.”

    FOR FURTHER INFORMATION CONTACT:

    Albert Shuldiner, Media Bureau, (202) 418-2700.

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Hearing Designation Order (Order), MB Docket No. 18-139, FCC 18-56, adopted May 4, 2018, and released May 7, 2018. The full text of the Order is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street SW, Washington, DC 20554. The full text is also available online at http://apps.fcc.gov/ecfs/.

    Summary of the Hearing Designation Order

    1. The Order commences a hearing proceeding before the Commission to determine whether the application filed by Family Voice Communications, LLC (FVC) to renew the license for radio station KLSX(FM), Rozet, Wyoming (KLSX Renewal Application) should be granted pursuant to section 309(k)(1) of the Communications Act of 1934 (Act), 47 U.S.C. 309(k)(1). The KLSX Renewal Application is designated for hearing based on the station's record of extended periods of silence during and following its license term.

    2. A broadcast licensee's authorization to use radio spectrum in the public interest carries with it the obligation that the station serve its community, providing programming responsive to local needs and interests. Broadcast licensees also are required to operate in compliance with the Act and the Commission's rules (Rules). These requirements include the obligation to transmit potentially lifesaving national level Emergency Alert System (EAS) messages in times of emergency and to engage in periodic tests to ensure that their stations are equipped to do so.

    3. The basic duty of broadcast licensees to serve their communities is reflected in the license renewal provisions of the Act. In 1996, Congress revised the Commission's license renewal process and the renewal standards for broadcast stations by adopting section 309(k) of the Act, 47 U.S.C. 309(k). Section 309(k)(1) of the Act, 47 U.S.C. 309(k)(1), provides that the Commission shall grant a license renewal application if it finds, with respect to the applying station, that during the preceding license term: (a) The station has served the public interest, convenience, and necessity; (b) there have been no serious violations by the licensee of the Act or the Rules; and (c) there have been no other violations by the licensee of the Act or the Rules which, taken together, would constitute a pattern of abuse. Section 309(k)(2) of the Act, 47 U.S.C. 309(k)(2), provides that if a station fails to meet the foregoing standard, the Commission may deny the renewal application pursuant to Section 309(k)(3), 47 U.S.C. 309(k)(3), or grant the application on appropriate terms and conditions, including a short-term renewal. Section 309(k)(3) of the Act, 47 U.S.C. 309(k)(3), provides that if the Commission determines, after notice and opportunity for hearing, that the licensee has failed to meet the standard of section 309(k)(1), 47 U.S.C. 309(k)(1), and that no mitigating factors justify the imposition of lesser sanctions, the Commission shall issue an order denying the license renewal application for the station.

    4. KLSX(FM) (Station) was licensed as a commercial Class C3 FM station serving Rozet, Wyoming on November 8, 2010. However, the Station went silent after only one day of claimed operation. Filings submitted by FVC allege the following operational history by the Station since November 8, 2010: (a) Silent for 1037 days and operational for 23 days during the remaining license term from November 9, 2010 to October 1, 2013; and (b) silent for 1306 days and operating for 373 days from October 2, 2013 to the date of release of the Order on May 7, 2018.

    10. Section 309(k)(3) of the Act, 47 U.S.C. 309(k)(3), requires “notice and opportunity for a hearing as provided in subsection (e).” Section 309(e), 47 U.S.C. 309(e), requires a “full hearing in which the applicant and all other parties in interest shall be permitted to participate.” The Commission and courts have held that the hearing need not be a trial-type evidentiary hearing meeting the standards of sections 554 and 556 of the Administrative Procedure Act, 5 U.S.C. 554, 556. The Commission has repeatedly observed that trial-type hearings impose significant burdens and delays, both on applicants and the agency. We have found no substantial issues of material fact or any credibility issues regarding these renewal applications. We thus believe cases such as this one can be appropriately resolved with a “paper” hearing.

    11. We have identified no substantial and material questions of fact with respect to the KLSX Renewal Application, which presents only a narrow range of issues for Commission consideration. Thus, many Subpart B rules are facially irrelevant to this proceeding. In these circumstances, we find that the use of summary procedures would expedite the resolution of this hearing while affording FVC the full hearing required by section 309, 47 U.S.C. 309, and not placing unnecessary burdens on the licensee. Accordingly, we find that the following rules are either inapplicable to or would serve no useful purpose in this proceeding: 47 CFR 1.221(c)-(h); 1.241-1.253; 1.255-1.279; 1.282(a) and (b)(2); 1.297-1.340; and 1.352-1.364.

    12. Anyone seeking status as a party in interest in this proceeding must file a petition to intervene in accordance with 47 CFR 1.223(a). Anyone else seeking to participate in the hearing as a party may file a petition for leave to intervene in accordance with 47 CFR 1.223(b). Any filing in this docket must be served in accordance with 47 CFR 1.211 on all other parties, including each person or entity that has filed a petition to intervene or petition for leave to intervene, pending a ruling on each such petition.

    13. FVC shall have the right to seek reconsideration of any interlocutory action in this proceeding. Accordingly, we waive the 47 CFR 1.106(a) restriction limiting the filing of a petition for reconsideration by FVC of this hearing designation order.

    14. FVC shall file in this docket, within 30 days of publication of notice of the Order in the Federal Register, complete copies of the following records for the Station (as such records exist as of the release date of the Order): (a) All station logs for the relevant license term; (b) all quarterly issues and programs lists for the relevant license term; and (c) to the extent not included in the station logs, all EAS participant records for the relevant license term. FVC may not destroy or remove any of such records prior to such filing, or redact or modify any information in such records as they exist as of the release date of the Order. In the event that, on or after the release date of the Order, FVC creates or modifies any documents that it so provides, each such document should be prominently marked with the date that it was created or revised (identifying the revision(s)) and FVC should include in the sponsoring affidavit or declaration an explanation of who created or revised the document and when he or she did so. We otherwise will conduct the hearing without discovery, although the Commission or its staff may make inquiries or conduct investigations pursuant to Part 73 of the Rules and any reports filed in this docket as a result of such inquiries or investigations will become part of the record in this hearing.

    15. We will take official notice of all publicly-available Commission records for the Station as part of the record in this docket. FVC has the burden of proceeding with evidence and the burden of proof in this hearing. Within 60 days of publication of notice of the Order in the Federal Register, FVC will file a written direct case on the designated issues, no longer than 25 pages, and supported by an affidavit or unsworn declaration pursuant to 47 CFR 1.16. Within 30 days of FVC's filing, any other person granted party status may file a responsive submission, no longer than 25 pages and supported by an affidavit or unsworn declaration. Within 10 days of the deadline for filing such responses, FVC may file a rebuttal submission addressing all responses, no longer than 10 pages and supported by an affidavit or unsworn declaration.

    16. Accordingly, it is ordered, pursuant to sections 309(e) and (k)(3) and 312(g) of the Communications Act of 1934, as amended, 47 U.S.C. 309(e), 309(k)(3) and 312(g), the captioned application for renewal of license for Station KLSX(FM) is designated for a hearing upon the following issues: (a) To determine whether, during the preceding license term, (i) the station has served the public interest, convenience, and necessity, (ii) there have been any serious violations by the licensee of the Communications Act of 1934, as amended, or the rules and regulations of the Commission, and (iii) there have been any other violations of the Communications Act of 1934, as amended, or the rules and regulations of the Commission which, taken together, would constitute a pattern of abuse; (b) In light of the evidence adduced pursuant to issue (a) above, whether the captioned application for renewal of the license for Station KLSX(FM) should be granted on such terms and conditions as are appropriate, including renewal for a term less than the maximum otherwise permitted, or denied due to failure to satisfy the requirements of section 309(k)(1) of the Communications Act of 1934, as amended, 47 U.S.C. 309(k)(1).

    17. It is further ordered, pursuant to section 309(e) of the Communications Act of 1934, as amended, 47 U.S.C. 309(e), and section 1.254 of the Commission's rules, 47 CFR 1.254, that the burden of proceeding with the introduction of evidence and the burden of proof with respect to the issues specified in Paragraph 18 of the Order shall be on the applicant, Family Voice Communications, LLC.

    18. It is further ordered that Family Voice Communications, LLC is made a party to this proceeding.

    19. It is further ordered that, to avail itself of the opportunity to be heard and the right to present evidence at a hearing in these proceedings, Family Voice Communications, LLC shall file complete and correct copies of the documents described in Paragraph 16 of the Order, on or before the date specified. If Family Voice Communications, LLC fails to file such documents for KLSX(FM) within the time specified, or a petition to accept, for good cause shown, such filing beyond the expiration of such period, its captioned license renewal application for the station shall be dismissed with prejudice for failure to prosecute and the license of the station shall be terminated.

    20. It is further ordered that Family Voice Communications, LLC shall, pursuant to section 311(a)(2) of the Communications Act of 1934, as amended, 47 U.S.C. 311(a)(2), and 47 CFR 73.3594, give notice of the hearing within the time and in the manner prescribed therein, and thereafter submit the statement described in 47 CFR 73.3594(g).

    21. It is further ordered that a copy of this Order shall be sent by Certified Mail, Return Receipt Requested, and by regular first-class mail to Family Voice Communications, LLC, 9004 South 8th Drive, Phoenix, AZ 85041, with a copy to its counsel of record, Lee J. Peltzman, Esq., Shainis & Peltzman Chartered, 1850 M Street NW, Suite 240, Washington, DC 20036.

    22. It is further ordered that the Secretary of the Commission shall cause to have this Order or a summary thereof published in the Federal Register.

    Federal Communications Commission. Katura Jackson, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2018-12835 Filed 6-14-18; 8:45 am] BILLING CODE 6712-01-P
    GENERAL SERVICES ADMINISTRATION [Notice-QP-2018-03; Docket No. 2018-0002; Sequence No. 12] Request for Information From Platform Providers of Commercial e-Commerce Portals AGENCY:

    Office of Enterprise Strategy Management, General Services Administration (GSA).

    ACTION:

    Request for information.

    SUMMARY:

    The General Services Administration (GSA) is soliciting information from the providers of commercial e-Commerce Portals in order to complete Phase II of the requirements enacted in Section 846 of the National Defense Authorization Act (NDAA) for Fiscal Year 2018, Procurement through Commercial e-Commerce Portals. Note: A separate RFI is posted for suppliers who sell products through commercial e-commerce portal. Throughout the design of this program, GSA and the Office of Management and Budget (OMB) have emphasized open and ongoing engagement. The questions in this RFI are intended to continue the dialogue and to allow GSA and OMB both to draft the Phase II report (due to Congress in March 2019) and to move towards phased implementation later in 2019.

    DATES:

    Interested parties may submit written comments to www.regulations.gov by July 20, 2018. GSA is also hosting its second modified town-hall style public meeting. This meeting is in furtherance of Phase II on June 21, 2018, at 8:30 a.m. Eastern Standard Time. Further Information for the public meeting may be found on the Commercial Platform Interact group page on https://interact.gsa.gov/group/commercial-platform-initiative and in the Federal Register notice (83 FR 25004) published on May 31, 2018.

    ADDRESSES:

    Submit comments identified by “Request for information from Platform Providers of Commercial e-Commerce Portals”, by any of the following methods:

    Regulations.gov: http://www.regulations.gov.

    Submit comments by searching for “Request for information from Platform Providers of Commercial e-Commerce Portals”. Select the link “Comment Now” and follow the instructions provided at the “You are commenting on” screen. Please include your name, company name (if any), and “Request for information from Platform Providers of Commercial e-Commerce Portals”, on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, 2nd Floor, ATTN: Ms. Mandell, Washington, DC 20405-0001.

    Instructions: Please submit comments only and cite “Request for information from Platform Providers of Commercial e-Commerce Portals” in all correspondence related to this case. All comments received will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided.

    FOR FURTHER INFORMATION CONTACT:

    Jasmine Schaaphok at [email protected], or 571-330-3941, for clarification of content and submission of comment. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 202-501-4755. Please cite “Request for information from Platform Providers of Commercial e-Commerce Portals”.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The General Services Administration's (GSA) mission is to deliver value and savings in real estate, acquisition, technology, and other mission-support services across Government. For decades, GSA has provided access to commercial products through a number of channels including GSA Advantage!, GSA eBuy, GSA Global Supply, and the Federal Supply Schedules.

    GSA has long been focused on improving the acquisition of commercial items. Throughout its history, GSA has sought to leverage the best available technology to help agencies shorten the time to delivery, reduce administrative cost, make compliance easier, be a strategic thought leader and supplier of choice across the Federal Government, and be a good partner to industry. Today, the best available technology includes commercial e-commerce portals.

    The National Defense Authorization Act (NDAA) for Fiscal Year 2018, Section 846 Procurement Through Commercial e-Commerce Portals, directs the Administrator of the GSA to establish a program to procure commercial products through commercial e-commerce portals. Section 846 language can be found at the following link—https://interact.gsa.gov/group/commercial-platform-initiative. Section 846 paragraph (c) instructs the “Director of the Office of Management and Budget, in consultation with the GSA Administrator and the heads of other relevant departments and agencies,” to carry out three implementation phases. OMB and GSA completed Phase I, an initial implementation plan, in March of 2018.

    The plan, found at https://interact.gsa.gov/document/gsa-and-omb-phase-i-deliverable-attached, discusses government and industry stakeholder goals and concerns, the different types of portal provider models currently prevalent in the commercial market, and areas where legislative change or clarification are required to enable flexibility in the full and effective use of commercial e-commerce portals in accordance with the goals of section 846. The plan also outlines deliverables anticipated to be completed in FYs 18, 19, and 20.

    GSA is currently working on Phase II with the intent of delivering a proof of concept near the end of FY19. Phase II of the legislation requires (excerpt below):

    (2) PHASE II: MARKET ANALYSIS AND CONSULTATION.—Not later than one year after the date of the submission of the implementation plan and schedule required under paragraph (1), recommendations for any changes to, or exemptions from, laws necessary for effective implementation of this section, and information on the results of the following actions:

    (A) Market analysis and initial communications with potential commercial e-commerce portal providers on technical considerations of how the portals function (including the use of standard terms and conditions of the portals by the Government), the degree of customization that can occur without creating a Government-unique portal, the measures necessary to address the considerations for supplier and product screening specified in subsection (e), security of data, considerations pertaining to nontraditional Government contractors, and potential fees, if any, to be charged by the Administrator, the portal provider, or the suppliers for participation in the program established pursuant to subsection (a).

    (B) Consultation with affected departments and agencies about their unique procurement needs, such as supply chain risks for health care products, information technology, software, or any other category determined necessary by the Administrator.

    (C) An assessment of the products or product categories that are suitable for purchase on the commercial e-commerce portals.

    (D) An assessment of the precautions necessary to safeguard any information pertaining to the Federal Government, especially precautions necessary to protect against national security or cybersecurity threats.

    (E) A review of standard terms and conditions of commercial e-commerce portals in the context of Government requirements.

    (F) An assessment of the impact on existing programs, including schedules, set-asides for small business concerns, and other preference programs.

    II. Written Comments

    To assist in meeting the requirements associated with Phase II of the implementation, GSA and OMB are inviting portal providers to submit written comments. (A separate RFI has been issued for suppliers interested in selling through portals.) GSA is requesting those comments be submitted by July 20, 2018, which will allow the Government to take them into account as we are drafting our Phase II deliverable.

    To facilitate comment submission, GSA and OMB have developed a number of questions grouped around five focus areas—spending trends, data standards, user experience, cybersecurity, and terms and conditions. These five areas are central to the analysis required for Phase II, e.g. the terms and conditions questions will further the analysis required in paragraph (E). A sixth focus area is intended to give respondents an opportunity to provide feedback that, in addition to the five areas described above, will help to inform GSA about the general scope, shape, and types of products that should be considered for a proof of concept. In accordance with the Phase I implementation plan, the proof of concept is planned for launch in FY 2019.

    Each question is intended to provide respondents with a general framework for commenting. These questions are not intended to be all-inclusive; other comments and observations are encouraged.

    1. Spending Trends Questions

    a. Spend Data: Over the past few months, GSA has participated in demos provided by portal providers, many of whom have expressed a willingness to share data on Government spend conducted through their platforms, i.e. purchases using government-issued purchase cards. Government spend data can be identified by looking at the first four digits of the government-issued purchase card. These four digits are: 5565 and 5568 (Mastercard); and 4486, 4614, and 4716 (Visa).

    Would you be willing to share this spend data with GSA? Additionally, are you willing to share reports or dashboards demonstrating your analytics capabilities? (If yes, GSA will reach out separately to coordinate these requests.)

    For those portal providers willing to share such information, the following categories of aggregated Government spend data from civilian agency and DoD buyers, over the last 3 years, would be particularly useful:

    i. Spend by agency:

    1. Total spend broken out by agency 2. Number of transactions by agency 3. Average order size by agency 4. Seasonality of purchasing (i.e. only at the end of an FY or are they spread out evenly throughout the year?)

    ii. Spend by product category:

    1. Categories/subcategories comprising 80% of the annual spend through your portal 2. Dollar value, count of transactions, count of suppliers, proportion of small and large supplier (count and dollars) for each category/subcategory 3. Agencies comprising 80% of the dollar value for each category/subcategory

    iii. Spend outside the Contiguous US (OCONUS) vs spend within the Contiguous US (CONUS)

    iv. Spend by socioeconomic/small business designations.

    b. Additional considerations:

    i. What taxonomy or taxonomies are used to sort products into suitable categories and subcategories, e.g. product service codes (PSCs) or North American Industry Classification System (NAICS) code? Please identify if the classification system is proprietary.

    ii. What level and types of transactional data are made available to buyers?

    iii. What functionalities and/or capabilities are available to buyers to analyze transactional data? Do you offer your commercial buyers the opportunity to develop customized data analytics capabilities?

    iv. How do the pricing algorithms respond to sudden increases in demand?

    v. The Government seeks to increase small business participation through this initiative. How might your platform aid in increasing small business participation? What capabilities does your system have (or what would you need from GSA or other agencies) to track agency spending from the various socio-economic categories of small business (small disadvantaged business, women-owned small business, service-disabled veteran-owned small business, HUBZone small business) so that Government agencies can receive credit toward their agency socio-economic goals when they buy through your portal? Please explain.

    vi. The Government seeks to promote compliance with mandatory sources (e.g. AbilityOne Program, Federal Prison Industries). What capabilities does your system have to track agency spending from these sources and limit “leakage” where purchases are made from non-mandatory sources?

    vii. How are you shipping items to base locations/overseas? What are your labelling requirements/standards that you follow?

    2. Data Standards

    a. How do you use third party supplier data?

    b. What are your data protection/security practices for safeguarding both user and third-party supplier data?

    c. What are your standard terms and conditions with third-party suppliers and buyers regarding your use and their use of spend data?

    d. Is your platform capable of integrating information from the System for Award Management (www.sam.gov) to identify if a seller is a small business in accordance with FAR 19.303? If not, explain why. Would you be interested in testing capabilities with beta sam.gov?

    3. User Experience and Program Design

    a. GSA seeks to ensure that the government purchase card buyers have a simple and clear user experience when selecting products across multiple providers. How would you suggest we accomplish this? For example, how could GSA get to a single log-on across portals? Are there commercial analogs that achieve this purpose? If so, what, if any, drawbacks or obstacles do those models present?

    b. How are your supplier relationships structured? What fees are charged? What do the onboarding and offboarding processes look like?

    c. As a portal providers, do you have the capability to participate in a `punchout' type of ecommerce experience? Please explain.

    d. Implementation and operationalization of this program will entail the involvement of GSA, ordering agencies, portal providers, and third-party suppliers. GSA envisions its role primarily focusing on the following:

    i. Negotiating the contracts with the portal providers;

    ii. working with stakeholders to shape the scope of product offerings, based on suitability, potential challenges in managing supply chain risk, and other considerations;

    iii. working with agencies on effective use of protocols and safeguards to refine access to product offerings;

    iv. collecting, vetting and sharing data; and,

    v. developing guidance in consultation with OMB and training federal agencies in proper competitive procedures through the portal; and,

    vi. potentially validating the suppliers as responsible business partners.

    Do you agree with this description of roles and responsibilities for GSA in optimizing the user experience and the overall success of the program? Are there key items missing?

    e. The section 846 language stated both that all existing procurement laws applied and that GSA should strive to be consistent with commercial practice. To reconcile these objectives, in Phase I, GSA only proposed legislative changes necessary to reach program implementation, primarily around the nature of competition. For purposes of Phase II, what additional legislative changes GSA should consider proposing?

    4. Cyber-Security Questions

    GSA welcomes any insights that can be shared regarding how your platform addresses the following cybersecurity topics:

    a. Financial data theft/fraud b. Intellectual property theft/damage c. Distributed Denial of Service d. Man in the Middle Attacks e. Compliance with Information Security Standards f. Data storage g. Vulnerability assessments/monitoring h. Encryption i. Disaster Recovery j. Network monitoring 5. Standard Terms and Conditions a. General Roles and Responsibilities

    i. For products sold by third parties on your portal, what, if any, responsibilities do you assume with respect to a sale?

    ii. For what, if any, purposes do you consider the third party supplier selling on your portal to be your “subcontractor”?

    iii. What, if any, of the value-added portal services and functionalities (e.g., order tracking, payment processing) have been outsourced? Do you consider them subcontractors? If not, why not?

    iv. Other than the suppliers selling on the portal and those providing value-added portal services and functionalities, are there entities that are considered subcontractors of your business? If yes, what functions do these entities perform for your business?

    b. Order Tracking, Delivery and Issue Resolution

    i. Describe how orders and delivery are tracked.

    ii. Describe how issues are resolved (e.g., if the product doesn't arrive in a timely manner or needs to be returned). Identify who is responsible for resolving these issues when the sale involves a third party seller. Include information on customer/ordering official management throughout the process.

    c. Payment

    i. When a buyer makes a payment for a purchase on the portal, who processes the payment?

    ii. What are the payment procedures?

    iii. Are payments by Electronic Funds Transfer allowed?

    d. To Assist GSA in Determining the Applicability of the Service Contract Act to a Portal Contract Under the Section 846 Program, Please Advise of the Type of Work Your Employees Would Perform Under Such a Contract. e. Suitability of FAR Commercial Service Requirements

    i. Please address the extent you believe the following clauses/provisions are consistent with and/or are relevant to current, standard commercial practice for operating commercial e-commerce portals. If they are not consistent and/or relevant, please indicate what obstacles they would present if applied to the section 846 program. Conversely, if there are public policy reasons why any of these should be retained, please explain.

    1. 52.212-4(a), Inspection and acceptance 2. 52.212-4(b), Assignment of claims 3. 52.212-4(g), Invoice 4. 52.212-4(k), Taxes 5. 52.212-4(n), Title 6. 52.212-4(q), Other compliances 7. 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards 8. 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award 9. 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns 10. 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside 11. 52.222-3, Convict Labor 12. 52.222-17, Nondisplacement of Qualified Workers 13. 52.222-35, Equal Opportunity for Veterans 14. 52.222-37, Employment Reports on Veterans 15. 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving 16. 52.232-29, Terms for Financing of Purchases of Commercial Items 17. 52.232-30, Installment Payments for Commercial Items 18. 52.242-5, Payments to Small Business Subcontractors 19. 52.212-3(t), Public Disclosure of Greenhouse Gas Emissions and Reduction Goals 20. 52-212-4(f), Excusable Delays 21. 52.212-4(h), Patent Indemnity 22. 52.212-4(i)(4), Discount 23. 52.212-4(s), Order of precedence 24. 52.232-40, Providing Accelerated Payments to Small Business Subcontractors 25. 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items f. Additional Considerations:

    i. Are there different terms and conditions based on the country being served by a given commercial e-commerce portal?

    ii. If you are not registered on www.sam.gov would you be willing to register? Why or why not?

    iii. For your other commercial customers, do you offer ways to limit access to products on your platform for B2B customers who may not want access to your full catalog?

    g. Copies of standard terms and conditions:

    i. Please provide GSA with copies of your standard terms and conditions that apply to your suppliers?

    ii. Please provide GSA with copies of your standard terms and conditions that apply to users (i.e. buyers)?

    6. Proof of concept

    As explained in the Phase I implementation plan, GSA intends to proceed with a proof of concept in FY 2019. What is your recommended vision for a proof of concept that would be both manageable and meaningful, including types of products offered?

    Dated: June 11, 2018. Laura J. Stanton, Assistant Commissioner, Office of Enterprise Strategy Management, Federal Acquisition Service, General Services Administration.
    [FR Doc. 2018-12891 Filed 6-14-18; 8:45 am] BILLING CODE 6820-89-P
    GENERAL SERVICES ADMINISTRATION [Notice-Qp-2018-02; Docket No. 2018-0002; Sequence No. 11] Request for Information From Suppliers Selling on Commercial E-Commerce Portals AGENCY:

    Office of Enterprise Strategy Management, General Services Administration (GSA).

    ACTION:

    Request for information.

    SUMMARY:

    The General Services Administration (GSA) is soliciting information from the suppliers selling product through commercial e-Commerce Portals in order to complete Phase II of the requirements enacted in Section 846 of the National Defense Authorization Act (NDAA) for Fiscal Year 2018, Procurement through Commercial e-Commerce Portals. Note: A separate RFI is posted for those companies who are providers of commercial e-commerce platforms. Throughout the design of this program, GSA and the Office of Management and Budget (OMB) have emphasized open and ongoing engagement. The questions in the RFI are intended to continue the dialogue and to allow GSA and OMB both to draft the Phase II report (due to Congress in March 2019) and to move towards phased implementation later in 2019.

    DATES:

    Interested parties may submit written comments to www.regulations.gov by July 20, 2018. GSA is also hosting its second modified town-hall style public meeting. This meeting is in furtherance of Phase II on June 21, 2018, at 8:30 a.m., Eastern Standard Time (EST). Further Information for the public meeting may be found on the Commercial Platform Interact group page on https://interact.gsa.gov/group/commercial-platform-initiative and in the Federal Register (83 FR 25004), published on May 31, 2018.

    ADDRESSES:

    Submit comments identified by “Request for information from Suppliers Selling on Commercial e-Commerce Portals”, by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments by searching for “Request for information from Suppliers Selling on Commercial e-Commerce Portals”. Select the link “Comment Now” and follow the instructions provided at the “You are commenting on” screen. Please include your name, company name (if any), and “Request for information from Suppliers Selling on Commercial e-Commerce Portals”, on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, 2nd Floor, ATTN: Ms. Mandell, Washington, DC 20405-0001.

    Instructions: Please submit comments only and cite “Request for information from Suppliers Selling on Commercial e-Commerce Portals” in all correspondence related to this case. All comments received will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided.

    FOR FURTHER INFORMATION CONTACT:

    Jasmine Schaaphok at [email protected], or 571-330-3941, for clarification of content, public meeting information, and submission of comment. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 202-501-4755. Please cite “Request for information from Suppliers Selling on Commercial e-Commerce Portals.”

    SUPPLEMENTARY INFORMATION:

    I. Background

    The General Services Administration's (GSA) mission is to deliver value and savings in real estate, acquisition, technology, and other mission-support services across Government. For decades, GSA has provided access to commercial products through a number of channels including GSA Advantage!, GSA eBuy, GSA Global Supply, and the Federal Supply Schedules.

    GSA has long been focused on improving the acquisition of commercial items. Throughout its history, GSA has sought to leverage the best available technology to help agencies shorten the time to delivery, reduce administrative cost, make compliance easier, be a strategic thought leader and supplier of choice across the Federal Government, and be a good partner to industry. Today, the best available technology includes commercial e-commerce portals.

    The National Defense Authorization Act (NDAA) for Fiscal Year 2018, Section 846 “Procurement Through Commercial e-Commerce Portals”, directs the Administrator of the GSA to establish a program to procure commercial products through commercial e-commerce portals. Section 846 language can be found at the following link—https://interact.gsa.gov/group/commercial-platform-initiative. Section 846 paragraph (c) instructs the “Director of the Office of Management and Budget, in consultation with the GSA Administrator and the heads of other relevant departments and agencies,” to carry out three implementation Phases: 1. Implementation Plan; 2. Market Analysis and Consultation; and 3. Program Implementation Guidance. OMB and GSA completed Phase I, an initial implementation plan, in March of 2018. The plan, found at https://interact.gsa.gov/document/gsa-and-omb-phase-i-deliverable-attached, discusses government and industry stakeholder goals and concerns, the different types of portal provider models currently prevalent in the commercial market, and areas where legislative change or clarification are required to enable flexibility in the full and effective use of commercial e-commerce portals in accordance with the goals of section 846. The plan also outlines deliverables anticipated to be completed in FYs 18, 19, and 20.

    GSA is currently working on Phase II with the intent of delivering a proof of concept near the end of FY19. Phase II of the legislation requires (excerpt below):

    (2) PHASE II: MARKET ANALYSIS AND CONSULTATION.—Not later than one year after the date of the submission of the implementation plan and schedule required under paragraph (1), recommendations for any changes to, or exemptions from, laws necessary for effective implementation of this section, and information on the results of the following actions:

    (A) Market analysis and initial communications with potential commercial e-commerce portal providers on technical considerations of how the portals function (including the use of standard terms and conditions of the portals by the Government), the degree of customization that can occur without creating a Government-unique portal, the measures necessary to address the considerations for supplier and product screening specified in subsection (e), security of data, considerations pertaining to nontraditional Government contractors, and potential fees, if any, to be charged by the Administrator, the portal provider, or the suppliers for participation in the program established pursuant to subsection (a).

    (B) Consultation with affected departments and agencies about their unique procurement needs, such as supply chain risks for health care products, information technology, software, or any other category determined necessary by the Administrator.

    (C) An assessment of the products or product categories that are suitable for purchase on the commercial e-commerce portals.

    (D) An assessment of the precautions necessary to safeguard any information pertaining to the Federal Government, especially precautions necessary to protect against national security or cybersecurity threats.

    (E) A review of standard terms and conditions of commercial e-commerce portals in the context of Government requirements.

    (F) An assessment of the impact on existing programs, including schedules, set-asides for small business concerns, and other preference programs.

    II. Written Comments

    To assist GSA in meeting the requirements associated with Phase II of the implementation, GSA and OMB are inviting suppliers selling product through commercial e-commerce platforms to submit written comments. Comments should be submitted by July 20, 2018, which will enable the Government to take them into account as we are drafting our Phase II deliverable. (A separate RFI has been issued focused on e-commerce platform operators.)

    GSA and OMB have developed a number of questions grouped around three focus areas: Product categories, terms and conditions, and program design. These three areas are central to the analysis required in paragraphs (A), (C), and (E) above. This information will also be used to help inform GSA about the general scope, shape, and types of products that should be considered for a proof of concept. In accordance with the Phase I implementation plan, the proof of concept is planned for launch in FY 2019. Each question is intended to provide respondents with a general framework for commenting. These questions are not intended to be all-inclusive; other comments and observations are encouraged.

    1. Product Categories

    a. Identify which product types/categories/subcategories should be considered in scope for inclusion in the program. Describe the classification system used, if not product service codes or North American Industry Classification System (NAICS) codes. For each category/subcategory identified, include as many of the following as possible:

    i. Rationale for inclusion;

    ii. Assessment of supply chain risk, including the extent to which you believe counterfeit products are a significant problem,and mitigation strategies;

    iii. List existing e-commerce commercial portals on which you currently sell these products;

    iv. Level of visibility into country of origin, including compliance with the Buy American Act (BAA), other domestic sourcing restrictions, and existing trade agreements; including how these are verified; and

    v. If multiple categories/subcategories are identified, provide a suggested ranking.

    b. Identify which categories/subcategories should be excluded from the scope of this effort and the rationale.

    2. Terms and Conditions (Ts&Cs)

    a. General

    i. To the extent you sell products as a third party through a commercial e-commerce portal, what Ts&Cs do you have with them?

    ii. What terms are unacceptable? What terms are absolute must-haves?

    iii. Are there unique terms and conditions when looking at serving the Contiguous United States (CONUS) vs. Outside the Contiguous United States (OCONUS)? What are some that we might need to consider?

    iv. What should GSA be thinking about with respect to BAA and existing trade agreements (and implementing regulations)? How do you currently track/monitor country of origin for products, if at all?

    v. How is security of data addressed in your standard Ts&Cs?

    vi. If you currently sell through a portal, how are fees/fee structures addressed in the terms and conditions?

    b. Suitability of FAR Commercially Available Off-the-Shelf (COTS) Item Requirements: Please address the extent you believe the following clauses/provisions are consistent with and/or relevant to current, standard commercial practice when selling through a commercial e-commerce portal. If they are not consistent and/or relevant, please indicate what obstacles they would present if applied to the section 846 program. Conversely, if there are public policy reasons why any of these should be retained, please explain.

    1. 52.212-1(a), NAICS/business size 2. 52.212-1(b), Submission of offers 3. 52.212-1(c), Period for acceptance of offers 4. 52.212-1(d), Product samples 5. 52.212-1(e), Multiple offers 6. 52.212-1(f), Late submissions, modifications, revisions, etc. 7. 52.212-1(g), Contract award 8. 52.212-1(h), Multiple awards 9. 52.212-1(i), Availability of requirements documents 10. 52.212-1(j), Unique entity identifier 11. 52.212-3(p), Ownership or Control of Offeror 12. 52.212-3(r), Predecessor of Offeror 13. 52.212-4(f), Excusable delays 14. 52.212-4(l), Termination for Government's convenience 15. 52.212-4(o), Warranty 16. 52.212-4(q), Other compliance 17. 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards 18. 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award 19. 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns 20. 52.219-8, Utilization of Small Business Concerns 21. 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside 22. 52.222-3, Convict Labor 23. 52.232-40, Providing Accelerated Payments to Small Business Subcontractors 24. 52.212-1(l), Debriefing 25. 52.212-3(i), Certification Regarding Knowledge of Child Labor for Listed End Products 26. 52.212-3(t), Public Disclosure of Greenhouse Gas Emissions and Reduction Goals 27. 52.212-4(a), Inspection and acceptance 28. 52.212-4(b), Assignment of claims 29. 52.212-4(c), Changes 30. 52.212-4(d), Disputes 31. 52.212-4(g), Invoice 32. 52.212-4(i)(1), Items accepted 33. 52.212-4(i)(3), Electronic Funds Transfer 34. 52.212-4(i)(4), Discount 35. 52.212-4(j), Risk of loss 36. 52.212-4(k), Taxes 37. 52.212-4(s), Order of precedence 3. Program Design

    a. Competition is a core goal of the program. Towards that end, the user needs to be able to see/compare products across multiple portals and/or suppliers. What is the best way to get to a single sign-on across portals?

    b. If you are not registered in the System for Award Management, would you be willing to register. Why or why not?

    c. The section 846 language stated both that all existing procurement laws applied and that GSA should strive to be consistent with commercial practice. To reconcile these objectives, in Phase I, GSA only proposed legislative changes necessary to reach program implementation, primarily around the nature of competition. For purposes of Phase II, what additional legislative changes GSA should consider proposing?

    d. In GSA's view, the nature of buying through an e-commerce portal brings a significant new level of competition into the micro-purchase world. GSA proposed raising the micro-purchase threshold to $25,000. What benefits and disadvantages do you see in a higher threshold? Would you recommend a higher threshold and, if so, what should it be?

    e. In the first phase of implementation, should this program be limited to orders within the contiguous United States? If so, why? If not, why not and what issues should be considered?

    f. How do the pricing algorithms respond to sudden increases in demand?

    g. As a supplier, do you have the capability to participate in either a public or private (or curated) `punchout' type of experience? Please explain.

    h. Implementation and operationalization of this program will entail the involvement of GSA, ordering agencies, portal providers, and third-party suppliers. GSA envisions its role primarily focusing on the following:

    i. Negotiating the contracts with the portal providers;

    ii. working with stakeholders to shape the scope of product offerings, based on suitability, potential challenges in managing supply chain risk, and other considerations;

    iii. working with agencies on effective use of protocols and safeguards to refine access to product offerings;

    iv. collecting, vetting and sharing data; and,

    v. developing guidance in consultation with OMB and training federal agencies in proper competitive procedures through the porta; and,

    vi. potentially validating the suppliers as responsible business partners. Do you agree with this description of roles and responsibilities for GSA in optimizing the user experience and the overall success of the program? Are there key items missing?

    i. What opportunities do you see for your existing Government business (and potential future new business)? How can we best design a program to promote small business utilization and new entrants into the federal marketplace?

    j. Proof of concept: As explained in the Phase I implementation plan, GSA intends to proceed with a proof of concept in FY 2019. What is your recommended vision for a proof of concept that would be both manageable and meaningful, including types of products offered?

    Dated: June 12, 2018. Laura J. Stanton, Assistant Commissioner, Office of Enterprise Strategy Management, Federal Acquisition Service, General Services Administration.
    [FR Doc. 2018-12893 Filed 6-14-18; 8:45 am] BILLING CODE 6820-89-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC-2018-0007; Docket Number NIOSH-307] Final National Occupational Research Agenda for Agriculture, Forestry, and Fishing AGENCY:

    National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice of availability.

    SUMMARY:

    NIOSH announces the availability of the final National Occupational Research Agenda for Agriculture, Forestry, and Fishing.

    DATES:

    The final document was published on June 8, 2018.

    ADDRESSES:

    The document may be obtained at the following link: https://www.cdc.gov/niosh/nora/councils/agff/research.html.

    FOR FURTHER INFORMATION CONTACT:

    Emily Novicki, M.A., M.P.H, ([email protected]), National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Mailstop E-20, 1600 Clifton Road NE, Atlanta, GA 30329, phone (404) 498-2581 (not a toll free number).

    SUPPLEMENTARY INFORMATION:

    On January 17, 2018, NIOSH published a request for public review in the Federal Register [83 FR 2447] of the draft version of the National Occupational Research Agenda for Agriculture, Forestry, and Fishing. The comment received expressed support for the Agenda.

    Dated: June 11, 2018. Frank J. Hearl, Chief of Staff, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.
    [FR Doc. 2018-12821 Filed 6-14-18; 8:45 am] BILLING CODE 4163-19-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS-3360-PN] Medicare and Medicaid Programs: Application From the Community Health Accreditation Partner for Continued CMS Approval of Its Hospice Accreditation Program AGENCY:

    Centers for Medicare and Medicaid Services, HHS.

    ACTION:

    Proposed notice.

    SUMMARY:

    This proposed notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.

    DATES:

    To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on July 16, 2018.

    ADDRESSES:

    In commenting, please refer to file code CMS-3360-PN. 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-3360-PN, P.O. Box 8010, Baltimore, MD 21244-8010.

    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-3360-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

    FOR FURTHER INFORMATION CONTACT:

    Lillian Williams, (410) 786-8636, Monda Shaver, (410) 786-3410, or Marie Vasbinder, (410) 786-8665.

    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

    Under the Medicare program, eligible beneficiaries may receive covered services in a hospice provided certain requirements are met by the hospice. Sections 1861(dd) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as a hospice. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 418, specify the conditions that a hospice must meet in order to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for hospices.

    Generally, to enter into an agreement, a hospice must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 418. Thereafter, the hospice is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements.

    However, there is an alternative to surveys by state agencies. Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation.

    If an accrediting organization is recognized by the Secretary of the Department of Health and Human Services as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national accrediting organization applying for deeming authority under part 488, subpart A, must provide the Centers for Medicare & Medicaid Services (CMS) with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the reapproval of accrediting organizations are set forth at § 488.5. The regulations at § 488.5(e)(2)(i) require accrediting organizations to reapply for continued deeming authority every 6 years or sooner as we determine.

    The Community Health Accreditation Partner's (CHAP's) term of approval for its hospice accreditation program expires November 20, 2018.

    II. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and our regulations at § 488.5 require that our findings concerning review and approval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide CMS with the necessary data for validation.

    Section 1865(a)(3)(A) of the Act further requires that we publish within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application.

    The purpose of this proposed notice is to inform the public of CHAP's request for continued CMS approval of its hospice accreditation program. This notice also solicits public comment on whether CHAP's requirements meet or exceed the Medicare conditions for participation for hospices.

    III. Evaluation of Deeming Authority Request

    CHAP submitted all the necessary materials to enable us to make a determination concerning its request for continued approval of its hospice accreditation program. This application was determined to be complete on April 24, 2018. Under section 1865(a)(2) of the Act and our regulations at § 488.5 (Application and re-application procedures for national organizations), our review and evaluation of CHAP will be conducted in accordance with, but not necessarily limited to, the following factors:

    • The equivalency of CHAP's standards for hospices as compared with CMS' hospice conditions of participation.

    • CHAP's survey process to determine the following:

    ++ CHAP's composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.

    ++ CHAP's processes compared to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.

    ++ CHAP's processes and procedures for monitoring a hospice found out of compliance with CHAP's program requirements. These monitoring procedures are used only when CHAP identifies noncompliance. If noncompliance is identified through validation reviews, the State survey agency monitors corrections as specified at § 488.9(c).

    ++ CHAP's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.

    ++ CHAP's capacity to provide CMS with electronic data, and reports necessary for effective validation and assessment of the organization's survey process.

    ++ CHAP's staff adequacy and other resources, and its financial viability.

    ++ CHAP's capacity to adequately fund required surveys.

    ++ CHAP's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.

    ++ CHAP's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as we may require (including corrective action plans).

    Upon completion of our evaluation, including evaluation of comments received as a result of this proposed notice, we will publish a final notice in the Federal Register announcing the result of our evaluation.

    III. Collection of Information Requirements

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

    IV. 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.

    Dated: May 29, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services.
    [FR Doc. 2018-12840 Filed 6-14-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3363-N] Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee—August 22, 2018 AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Notice of meeting.

    SUMMARY:

    This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (“Committee”) will be held on Wednesday, August 22, 2018. This meeting will focus on the state of evidence on Chimeric Antigen Receptor (CAR) T-cell therapies that are approved by the Food and Drug Administration (FDA). We are seeking the MEDCAC's recommendations regarding collection of patient reported outcomes (PRO) in cancer clinical studies. The MEDCAC will specifically focus on appraisal of evidence-based PRO assessments to provide information that impacts patients, their providers, and caregivers after a CAR T-cell therapy intervention for the patient's cancer. This meeting is open to the public in accordance with the Federal Advisory Committee Act.

    DATES:

    Meeting Date: The public meeting will be held on Wednesday, August 22, 2018 from 7:30 a.m. until 4:30 p.m., Eastern Daylight Time (EDT).

    Deadline for Submission of Written Comments: Written comments must be received at the address specified in the ADDRESSES section of this notice by 5:00 p.m., EDT, Monday, July 16, 2018. Once submitted, all comments are final.

    Deadlines for Speaker Registration and Presentation Materials: The deadline to register to be a speaker and to submit PowerPoint presentation materials and writings that will be used in support of an oral presentation is 5:00 p.m., EDT on Monday, July 16, 2018. Speakers may register by phone or via email by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Presentation materials must be received at the address specified in the ADDRESSES section of this notice.

    Deadline for All Other Attendees Registration: Individuals may register online at http://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3 or by phone by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by 5:00 p.m. EDT, Wednesday, August 15, 2018.

    We will be broadcasting the meeting live via Webcast at http://www.cms.gov/live/.

    Deadline for Submitting a Request for Special Accommodations: Persons attending the meeting who are hearing or visually impaired, or have a condition that requires special assistance or accommodations, are asked to contact the Executive Secretary as specified in the FOR FURTHER INFORMATION CONTACT section of this notice no later than 5:00 p.m., EDT Friday, August 3, 2018.

    ADDRESSES:

    Meeting Location: The meeting will be held in the main auditorium of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244.

    Submission of Presentations and Comments: Presentation materials and written comments that will be presented at the meeting must be submitted via email to [email protected] or by regular mail to the contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice.

    FOR FURTHER INFORMATION CONTACT:

    Maria Ellis, Executive Secretary for MEDCAC, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Coverage and Analysis Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410-786-0309) or via email at [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    MEDCAC, formerly known as the Medicare Coverage Advisory Committee (MCAC), is advisory in nature, with all final coverage decisions resting with CMS. MEDCAC is used to supplement CMS' internal expertise. Accordingly, the advice rendered by the MEDCAC is most useful when it results from a process of full scientific inquiry and thoughtful discussion, in an open forum, with careful framing of recommendations and clear identification of the basis of those recommendations. MEDCAC members are valued for their background, education, and expertise in a wide variety of scientific, clinical, and other related fields. (For more information on MCAC, see the MEDCAC Charter (http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/Downloads/medcaccharter.pdf) and the CMS Guidance Document, Factors CMS Considers in Referring Topics to the MEDCAC (http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=10)).

    II. Meeting Topic and Format

    This notice announces the Wednesday, August 22, 2018, public meeting of the Committee. This meeting will focus on the state of evidence on CAR-T cell therapies that are approved by the FDA. We are seeking the MEDCAC's recommendations regarding collection of PRO in cancer clinical studies. The MEDCAC will specifically focus on appraisal of evidence-based PRO assessments to provide information that impacts patients, their providers, and caregivers after a CAR T-cell therapy intervention for the patient's cancer. Background information about this topic, including panel materials, is available at http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. We will no longer be providing paper copies of the handouts for the meeting. Electronic copies of all the meeting materials will be on the CMS website no later than 2 business days before the meeting. We encourage the participation of organizations with expertise in the appraisal of the state of evidence for patient reported outcomes, development of patient reported health outcome measures, and use of patient reported health outcome assessments in cancer clinical trials. This meeting is open to the public. The Committee will hear oral presentations from the public for approximately 45 minutes. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, we may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by July 23, 2018. Your comments should focus on issues specific to the list of topics that we have proposed to the Committee. The list of research topics to be discussed at the meeting will be available on the following website prior to the meeting: http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. We require that you declare at the meeting whether you have any financial involvement with manufacturers (or their competitors) of any items or services being discussed. Speakers presenting at the MEDCAC meeting should include a full disclosure slide as their second slide in their presentation for financial interests (for example, type of financial association—consultant, research support, advisory board, and an indication of level, such as minor association <$10,000 or major association >$10,000) as well as intellectual conflicts of interest (for example, involvement in a federal or nonfederal advisory committee that has discussed the issue) that may pertain in any way to the subject of this meeting. If you are representing an organization, we require that you also disclose conflict of interest information for that organization. If you do not have a PowerPoint presentation, you will need to present the full disclosure information requested previously at the beginning of your statement to the Committee.

    The Committee will deliberate openly on the topics under consideration. Interested persons may observe the deliberations, but the Committee will not hear further comments during this time except at the request of the chairperson. The Committee will also allow a 15-minute unscheduled open public session for any attendee to address issues specific to the topics under consideration. At the conclusion of the day, the members will vote and the Committee will make its recommendation(s) to CMS.

    III. Registration Instructions

    CMS' Coverage and Analysis Group is coordinating meeting registration. While there is no registration fee, individuals must register to attend. You may register online at http://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3 or by phone by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the deadline listed in the DATES section of this notice. Please provide your full name (as it appears on your state-issued driver's license), address, organization, telephone number(s), fax number, and email address. You will receive a registration confirmation with instructions for your arrival at the CMS complex or you will be notified that the seating capacity has been reached.

    IV. Security, Building, and Parking Guidelines

    This meeting will be held in a federal government building; therefore, federal security measures are applicable. The Real ID Act, enacted in 2005, establishes minimum standards for the issuance of state-issued driver's licenses and identification (ID) cards. It prohibits Federal agencies from accepting an official driver's license or ID card from a state unless the Department of Homeland Security determines that the state meets these standards. Beginning October 2015, photo IDs (such as a valid driver's license) issued by a state or territory not in compliance with the Real ID Act will not be accepted as identification to enter Federal buildings. Visitors from these states/territories will need to provide alternative proof of identification (such as a valid passport) to gain entrance into CMS buildings. The current list of states from which a Federal agency may accept driver's licenses for an official purpose is found at http://www.dhs.gov/real-id-enforcement-brief. We recommend that confirmed registrants arrive reasonably early, but no earlier than 45 minutes prior to the start of the meeting, to allow additional time to clear security. Security measures include the following:

    • Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel.

    • Inspection of vehicle's interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection.

    • Inspection, via metal detector or other applicable means, of all persons entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation.

    Note:

    Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes prior to the convening of the meeting.

    All visitors must be escorted in areas other than the lower and first floor levels in the Central Building.

    V. Collection of Information

    This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

    Authority:

    5 U.S.C. App. 2, section 10(a).

    Dated: June 4, 2018. Kate Goodrich, Director, Center for Clinical Standards and Quality, Chief Medical Officer, Centers for Medicare & Medicaid Services.
    [FR Doc. 2018-12831 Filed 6-14-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Councils on Developmental Disabilities—Annual Program Performance Report (PPR) (OMB Control Number—0985-0033) AGENCY:

    Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL), U.S. Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the State Councils on Developmental Disabilities—Annual Program Performance Report (PPR) [Proposed Extension with Changes of a Currently Approved Collection (ICR Rev)].

    DATES:

    Submit written comments on the collection of information by July 16, 2018.

    ADDRESSES:

    Submit written comments on the collection of information by:

    (a) Email to: [email protected], Attn: OMB Desk Officer for ACL;

    (b) fax to 202.395.5806, Attn: OMB Desk Officer for ACL; or

    (c) by mail to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW, Rm. 10235, Washington, DC 20503, Attn: OMB Desk Officer for ACL.

    FOR FURTHER INFORMATION CONTACT:

    Sara Newell-Perez at (202) 795-7413 or [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, ACL has submitted the following proposed collection of information to OMB for review and clearance. The proposed data collection represents a revision of a currently approved information collection (ICR-Rev). This collection is necessary for the proper performance and function of the agency. On an annual basis, Councils are required to submit a Program Performance Report (PPR) to describe the extent to which annual progress is being achieved on the 5-year State plan goals. The PPR will be used by (1) the Council as a planning document to track progress made in meeting state plan goals; (2) the citizenry of the State as a mechanism for monitoring progress and activities on the plans of the Council; and (3) the Department as a stewardship tool for ensuring compliance with the Developmental Disabilities Assistance and Bill of Rights Act of 2000 and for monitoring and providing technical assistance (e.g., during site visits), and support for management decision making.

    Comments in Response to the 60-Day Federal Register Notice

    A notice was published in the Federal Register on October 4, 2017 (Vol. 82, Number 191; pp. 46246-46247). Two comments were received. The first was a comment about ACL and policies around deinstitutionalization. The second comment requested that Councils have more transparency and make their PPRs available to the public via their websites. ACL appreciates and understands these comments. Although ACL recognizes that these comments might provide useful information for the program, it is not required to meet the statutory requirements for this program. No change is proposed.

    The proposed template may be found on the ACL website at https://www.acl.gov/about-acl/public-input.

    Estimated Program Burden

    ACL estimates the burden of this collection of information as follows: The total estimated hour burden per respondent for the proposed DD Council PPR will increase from the 138 hours estimated in 2015 to 172 burden hours per response. The number of hours is multiplied by 56 State Council programs, resulting in a total estimated hour aggregate burden of 9,632.

    Respondent/data
  • collection activity
  • Number of
  • respondents
  • Responses
  • per
  • respondent
  • Hours per
  • response
  • Annual
  • burden hours
  • State Councils on
  • Developmental Disabilities/Program Performance Report
  • 56 1 172 9632
    Total 56 1 172 9632
    Dated: June 7, 2018. Lance Robertson, Administrator and Assistant Secretary for Aging.
    [FR Doc. 2018-12826 Filed 6-14-18; 8:45 am] BILLING CODE 4154-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Notice of Intent To Award a Single-Source Supplement ACTION:

    Intent To Award a Single-Source Supplement for the Amputee Coalition of America, Inc. for the National Limb Loss Resource Center Cooperative Agreement.

    The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the Amputee Coalition of America, Inc. for the National Limb Loss Resource Center (NLLRC). The purpose of this project is to expand on current grant activities, such as increasing activities and programs that promote health, wellness, and the adoption of healthy behaviors with the objective of preventing and/or reducing chronic conditions associated with limb loss and increase partnerships and collaborations with ACL programs that will benefit all people living with limb loss or limb differences. The administrative supplement for FY 2018 will be in the amount of $669,905, bringing the total award for FY 2018 to $3,697,142.

    The additional funding will not be used to begin new projects. The funding will be used to enhance and expand existing programs that can serve an increased number of veterans and people living with limb loss and limb differences by providing increased technical assistance activities; promoting health and wellness programs; promoting the adoption of healthy behaviors with the objective of preventing and/or reducing chronic conditions associated with limb loss; increasing partnerships and collaborations with ACL programs that will benefit all people living with limb loss or limb differences; enhancing and expanding the evaluation activities currently under way; and enhancing website capacities for improved information dissemination.

    Program Name: National Limb Loss Resource Center.

    Recipient: The Amputee Coalition of America, Inc.

    Period of Performance: The supplement award will be issued for the third year of the three-year project period of April 1, 2016, through March 29, 2019.

    Total Award Amount: $669,905 in FY 2018.

    Award Type: Cooperative Agreement Supplement.

    Statutory Authority: This program is authorized under Section 317 of the Public Health Service Act (42 U.S.C. 247(b-4)); Consolidated and Further Continuing Appropriations Act, 2015, Public Law 113-235 (Dec. 16, 2014).

    Basis for Award: The Amputee Coalition of America, Inc. is currently funded to carry out the objectives of this program, entitled The National Limb Loss Resource Center for the period of April 1, 2016, through March 29, 2019. Since the program transferred from CDC to ACL in late 2015, the grantee has accomplished a great deal. The supplement will enable the grantee to carry their work even further, serving more people living with limb loss and/or limb differences and providing even more comprehensive training and technical assistance in the development of LTSS supportive services. The additional funding will not be used to begin new projects or activities. The NLLRC will enhance and expand currently funded activities such as conducting national outreach for the development and dissemination of patient education materials, programs, and services; providing technical support and assistance to community based limb loss support groups; and raising awareness about the limb loss and limb differences communities.

    Establishing an entirely new grant project at this time would be potentially disruptive to the current work already well under way. More importantly, the people living with limb loss and limb differences currently being served by this program could be negatively impacted by a service disruption, thus posing the risk of not being able to find the right resources that could negatively impact on health and wellbeing. If this supplement were not provided, the project would be less able to address the significant unmet needs of additional limb loss survivors. Similarly, the project would be unable to expand its current technical assistance and training efforts in NLLRC concepts and approaches, let alone reach beyond traditional providers of services to this population to train more “mainstream” providers of disability services.

    For More Information Contact: For further information or comments regarding this program supplement, contact Elizabeth Leef, U.S. Department of Health and Human Services, Administration for Community Living, Administration on Disabilities, Independent Living Administration: telephone (202) 475-2486; email [email protected].

    Dated: June 6, 2018. Lance Robertson, Administrator and Assistant Secretary for Aging.
    [FR Doc. 2018-12978 Filed 6-14-18; 8:45 am] BILLING CODE 4154-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1788] Intravascular Catheters, Wires, and Delivery Systems With Lubricious Coatings—Labeling Considerations; Draft Guidance for Industry and Food and Drug Administration Staff; 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 the draft guidance entitled “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations.” This draft guidance addresses labeling considerations for devices containing lubricious coatings that are used in the vasculature. The purpose of this draft guidance is to provide recommendations for information to be included in device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for class III and class II devices, to enhance the consistency of information across these product areas as well as to promote the safe use of these devices in clinical settings. This draft guidance is not final nor is it in effect at this time.

    DATES:

    Submit either electronic or written comments on the draft guidance by August 14, 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-1788 for “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    An electronic copy of the draft guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Leigh Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 301-796-5613.

    SUPPLEMENTARY INFORMATION:

    I. Background

    Hydrophilic- and/or hydrophobic-coated devices have been used for more than 20 years in minimally invasive diagnostic and therapeutic cerebrovascular, cardiovascular, and peripheral vascular procedures. Although these devices may offer patient benefits, evidence indicates that the coating may separate from intravascular devices in some circumstances. FDA has received and analyzed information concerning serious adverse events associated with hydrophilic and/or hydrophobic coatings separating (e.g., peeling, flaking, shedding, delaminating, or sloughing off) from intravascular medical devices.

    FDA has not concluded that any specific manufacturer or brand of these devices is associated with higher risks than others. The cause of coating separation is multifactorial, and can be associated with factors including device design, manufacturing, and use. Current FDA analysis suggests that use-related issues may be mitigated through proper device selection, preparation, and other labeling considerations that are addressed within this draft guidance.

    This draft guidance addresses labeling considerations for devices containing lubricious coatings used in the vasculature. The purpose of this draft guidance is to provide recommendations for information to be included in device labeling, as submitted in PMAs or 510(k)s for class III and class II devices, to enhance the consistency of coating information across these product areas as well as to promote the safe use of these devices in clinical settings.

    II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 16016 to identify the guidance you are requesting.

    IV. 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 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E have been approved under OMB control number 0910-0231; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485.

    Dated: June 8, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-12824 Filed 6-14-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1775] Coronary, Peripheral, and Neurovascular Guidewires—Performance Tests and Recommended Labeling; Draft Guidance for Industry and Food and Drug Administration Staff; 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 the draft guidance entitled “Coronary, Peripheral, and Neurovascular Guidewires—Performance Tests and Recommended Labeling.” This draft guidance provides recommendations for the information and testing that should be included in premarket submissions for guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft guidance is not final nor is it in effect at this time.

    DATES:

    Submit either electronic or written comments on the draft guidance by August 14, 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-1775 for “Coronary, Peripheral, and Neurovascular Guidewires—Performance Tests and Recommended Labeling.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance entitled “Coronary, Peripheral, and Neurovascular Guidewires—Performance Tests and Recommended Labeling” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Jismi Johnson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002, 301-796-6424.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry and FDA staff entitled “Coronary, Peripheral, and Neurovascular Guidewires—Performance Tests and Recommended Labeling.” This draft guidance updates and clarifies performance testing and labeling recommendations to support a premarket notification (510(k) submission) for guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft guidance is intended to assist industry in designing and executing appropriate performance testing to support a premarket notification and provides recommendations for content and labeling to include in the submission. When final, this guidance will replace “Coronary and Cerebrovascular Guidewire Guidance” (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080789.pdf) dated January 1995.

    II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Coronary, Peripheral and Neurovascular Guidewires—Performance Tests and Recommended Labeling.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft guidance is also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Coronary, Peripheral, and Neurovascular Guidewires—Performance Tests and Recommended Labeling” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 16007 to identify the guidance you are requesting.

    IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations and guidance. 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 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485; and the collections of information in the guidance document “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” have been approved under OMB control number 0910-0756.

    Dated: June 8, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-12825 Filed 6-14-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1861] Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry #246 entitled “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program.” This draft guidance document, when finalized, will help animal food facilities comply with the requirements for the supply-chain program under our regulation “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.”

    DATES:

    Submit either electronic or written comments on the draft guidance by December 12, 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-1861 for “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program.” 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 Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Jenny Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public (human and animal) health by helping to ensure the safety and security of the food supply. FSMA enables FDA to focus more on preventing animal food safety problems rather than relying primarily on reacting to problems after they occur.

    Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d). We have established regulations to implement the hazard analysis and risk-based preventive controls requirements within part 507 (21 CFR part 507).

    We are announcing the availability of a draft guidance for industry #246 entitled “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program.” This draft guidance for industry is intended to explain how to comply with the requirements for the supply-chain program of the hazard analysis and risk-based preventive controls for food for animals under part 507. In the Federal Register of January 23, 2018 (83 FR 3163), we announced the availability of a related multichapter draft guidance for industry, #245 entitled “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.” In the Federal Register of February 5, 2018 (83 FR 5106), we announced a correction to the docket number for that draft guidance.

    II. Significance of Guidance

    This level 1 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 how to comply with the supply-chain program requirements for the regulation “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 507 have been approved under OMB control number 0910-0789.

    IV. Electronic Access

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

    Dated: June 8, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-12894 Filed 6-14-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Musculoskeletal and Oral Sciences, Imaging, Surgery and Informatics.

    Date: July 10-11, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Anshumali Chaudhari, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4124, MSC 7802, Bethesda, MD 20892, (301) 435-1210, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Platforms to Evaluate Adverse Biological Consequences of Cell Genome Editing.

    Date: July 10, 2018.

    Time: 11:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Methode Bacanamwo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2200, Bethesda, MD 20892, 301-827-7088, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Neuropharmacology.

    Date:.July 11, 2018.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Peter B. Guthrie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4142, MSC 7850, Bethesda, MD 20892, (301) 435-1239, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: June 11, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-12836 Filed 6-14-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Neurodevelopment and Psychiatric Disorders.

    Date: June 27-28, 2018.

    Time: 8:00 a.m. to 8:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Samuel C. Edwards, Ph.D., Chief, Brain Disorders and Clinical Neuroscience, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435-1246, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Infectious Diseases and Microbiology AREA Review.

    Date: July 13, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Edgewater Hotel, 2411 Alaskan Way, Pier 67, Seattle, WA 98121.

    Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3202, MSC 7808, Bethesda, MD 20892, 301-996-5819, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Psychopathology, Aging, and Cognition.

    Date: July 13, 2018.

    Time: 1:30 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6705 Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call).

    Contact Person: Maribeth Champoux, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3170, MSC 7848, Bethesda, MD 20892, 301-594-3163, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Drug Resistance, Drug Discovery and Clinical and Field Research.

    Date: July 16-17, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Tera Bounds, DVM, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 20892, 301-435-2306, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Topics in Bacterial Pathogenesis.

    Date: July 16, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Zoe Fisherman's Wharf, 425 North Point, San Francisco, CA 94133.

    Contact Person: Richard G. Kostriken, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3192, MSC 7808, Bethesda, MD 20892, 240-519-7808, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Gastrointestinal and Pancreatic Physiopathology.

    Date: July 16, 2018.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Martha Garcia, Ph.D., Scientific Reviewer Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2186, MSC 7818, Bethesda, MD 20892, 301-435-1243, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Healthcare Delivery and Methodologies.

    Date: July 16, 2018.

    Time: 2:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Karin F. Helmers, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3166, MSC 7770, Bethesda, MD 20892, 301-254-9975, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: June 8, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-12839 Filed 6-14-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent Commercialization License: Streptococcus Pneumonia PSAA Peptide for Treatment of Sepsis and Infection AGENCY:

    National Institutes of Health, Centers for Disease Control and Prevention, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, on behalf of the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to The University of Liverpool, located in Liverpool, UK, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.

    DATES:

    Only written comments and/or applications for a license which are received by the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases on or before July 2, 2018 will be considered.

    ADDRESSES:

    Requests for copies of the patent applications, inquiries, and comments relating to the contemplated exclusive patent commercialization license should be directed to: Karen Surabian, Licensing and Patenting Manager, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Suite 6D, MSC9804, Rockville, MD 20852-9804, phone number 301-496-2644, or [email protected]

    SUPPLEMENTARY INFORMATION:

    The following represents the intellectual property to be licensed under the prospective agreement: United States Provisional Patent Application Number 61/085,208, filed 07/31/2008, entitled “Methods of Enhancing Opsonophagocytosis in Response to a Pathogen” (HHS Reference No. E-329-2013/0-US-01); PCT Patent Application Number PCT/US2009/052384, filed 07/31/2009, entitled “Methods of Enhancing Opsonophagocytosis in Response to a Pathogen” (HHS Reference No. E-329-2013/0-PCT-02); China Patent Number 200980137625.X, issued 11/26/2014, entitled “Methods of Enhancing Opsonophagocytosis in Response to a Pathogen” (HHS Reference No. E-329-2013/0-CN-03); European Patent Number 2323684, issued 05/21/2014, entitled “Use of a Pneumococcal P4 Peptide for Enhancing Opsonophagocytosis in Response to a Pathogen” (HHS Reference No. E-329-2013/0-EP-04), and validated in Germany, Spain, France, the United Kingdom, and Ireland; Hong Kong Patent Number 1160391, issued 07/31/2015, entitled “Methods of Enhancing Opsonophagocytosis in Response to a Pathogen” (HHS Reference No. E-329-2013/0-HK-05); United States Patent Number 8,431,134, issued 04/30/2013, entitled “Use of a Pneumococcal P4 Peptide for Enhancing Opsonophagocytosis in Response to a Pathogen” (HHS Reference No. E-329-2013/0-US-06); United States Patent Number 9,101,582, issued 08/11/2015, entitled “Use of a Pneumococcal P4 Peptide for Enhancing Opsonophagocytosis in Response to a Pathogen” (HHS Reference No. E-329-2013/0-US-07); United States Provisional Patent Application Number 60/682,495, filed 05/19/2005, entitled “Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof” (HHS Reference No. E-338-2013/0-US-01); PCT Patent Application Number PCT/US2005/027290, filed 07/29/2005, entitled “Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof” (HHS Reference No. E-338-2013/0-PCT-02); Australia Patent Number 2005332058, issued 03/15/2012, entitled “Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof” (HHS Reference No. E-338-2013/0-AU-03); European Patent Number 1931700, issued 07/17/2003, entitled “Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof” (HHS Reference No. E-338-2013/0-EP-04), and validated in: Germany, Spain, France, the United Kingdom, and Ireland; Hong Kong Patent Number 1115144, issued 02/14/2014, entitled “Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof” (HHS Reference No. E-338-2013/0-HK-05); United States Patent Number 7,919,104, issued 04/05/2011, entitled “Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof” (HHS Reference No. E-338-2013/0-US-06); Canada Patent Application Number 2,631,556, filed 09/15/2014, entitled “Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof” (HHS Reference No. E-338-2013/0-CA-07); Australia Patent Number 2012201107, issued 06/06/2013, entitled “Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof” (HHS Reference No. E-338-2013/0-AU-08); Hong Kong Patent Number HK1163113, issued 06/05/2015, entitled “Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof” (HHS Reference No. E-338-2013/0-HK-09); European Patent Number 2371843, issued 09/17/2014, entitled “Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof” (HHS Reference No. E-338-2013/0-EP-10), and validated in: Germany, France, and the United Kingdom.

    All rights in these inventions have been assigned to the Government of the United States of America.

    The prospective exclusive patent commercialization license territory may be worldwide and the field of use may be limited to: “Development, manufacture, and sale of a P4 peptide therapeutic for the treatment of infection and sepsis.”

    These inventions, developed within the National Center for Immunization and Respiratory Diseases (NCIRD), at the Centers for Disease Control and Prevention (CDC), describe methods to bolster the human body's own mechanisms to fight infection by enhancing an innate immune response, opsonophagocytosis. The specific 24 amino acid peptide sequence (P4) acts as a polymorphonuclear cell activator. P4 can be administered in vivo along with disease-specific antibodies to enhance systemic bacterial clearance, thus leading to prolonged survival. This technology enhances the body's response to a variety of bacterial infections, including S. pneumoniae and S. aureus.

    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent commercialization license will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the National Institute of Allergy and Infectious Diseases receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

    Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent commercialization license. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information, and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: June 11, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.
    [FR Doc. 2018-12838 Filed 6-14-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the joint meeting of the National Cancer Advisory Board and NCI Board of Scientific Advisors, June 26, 2018, 8:30 a.m. to June 27, 2018, 12:00 p.m., National Cancer Institute Shady Grove, 9609 Medical Center Drive, Conference Room TE 406/408, Rockville, MD 20850 which was published in the Federal Register on June 05, 2018, 83 FR 26069.

    This meeting notice is being amended to update the meeting locations for the National Cancer Advisory Board Ad Hoc Subcommittee meetings. The National Cancer Advisory Board Ad Hoc Subcommittee Population Science, Epidemiology and Disparities meeting on June 25, 2018, 5:30 p.m. to 7:30 p.m., will be held at the Gaithersburg Marriott Washingtonian Center in Salons A and B. The National Cancer Advisory Board Ad Hoc Subcommittee on Global Cancer Research meeting on June 25, 2018, 7:30 p.m. to 9:00 p.m., will be held at the Gaithersburg Marriott Washingtonian Center in Salon C.

    Dated: June 11, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-12837 Filed 6-14-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.

    Project: Survey of State Underage Drinking Prevention Policies and Practices—(OMB No. 0930-0316)—Revision

    The Sober Truth on Preventing Underage Drinking Act (the “STOP Act”) (Pub. L. 109-422, reauthorized in 2016 by Pub. L. 114-255) states that the “Secretary [of Health and Human Services] shall . . . annually issue a report on each state's performance in enacting, enforcing, and creating laws, regulations, and programs to prevent or reduce underage drinking.” The Secretary has delegated responsibility for this report to SAMHSA. Therefore, SAMHSA has developed a Survey of State Underage Drinking Prevention Policies and Practices (the “State Survey”) to provide input for the state-by-state report on prevention and enforcement activities related to underage drinking component of the Annual Report to Congress on the Prevention and Reduction of Underage Drinking (“Report to Congress”).

    The STOP Act also requires the Secretary to develop “a set of measures to be used in preparing the report on best practices” and to consider categories including but not limited to the following:

    Category #1: Sixteen specific underage drinking laws/regulations enacted at the state level (e.g., laws prohibiting sales to minors; laws related to minors in possession of alcohol). Note that ten additional policies have been added to the Report to Congress pursuant to Congressional appropriations language or the Secretary's authority granted by the STOP Act;

    Category #2: Enforcement and educational programs to promote compliance with these laws/regulations;

    Category #3: Programs targeted to youths, parents, and caregivers to deter underage drinking and the number of individuals served by these programs;

    Category #4: The amount that each state invests, per youth capita, on the prevention of underage drinking broken into five categories: (a) Compliance check programs in retail outlets; (b) Checkpoints and saturation patrols that include the goal of reducing and deterring underage drinking; (c) Community-based, school-based, and higher-education-based programs to prevent underage drinking; (d) Underage drinking prevention programs that target youth within the juvenile justice and child welfare systems; and (e) Any other state efforts or programs that target underage drinking.

    Congress' purpose in mandating the collection of data on state policies and programs through the State Survey is to provide policymakers and the public with otherwise unavailable but much needed information regarding state underage drinking prevention policies and programs. SAMHSA and other Federal agencies that have underage drinking prevention as part of their mandate use the results of the State Survey to inform federal programmatic priorities, as do other stakeholders, including community organizations. The information gathered by the State Survey has established a resource for state agencies and the general public for assessing policies and programs in their own state and for becoming familiar with the programs, policies, and funding priorities of other states.

    Because of the broad scope of data required by the STOP Act, SAMHSA relies on existing data sources where possible to minimize the survey burden on the states. SAMHSA uses data on state underage drinking policies from the National Institute of Alcohol Abuse and Alcoholism's Alcohol Policy Information System (APIS), an authoritative compendium of state alcohol-related laws. The APIS data is augmented by SAMHSA with original legal research on state laws and policies addressing underage drinking to include all of the STOP Act's requested laws and regulations (Category #1 of the four categories included in the STOP Act, as described above, page 2).

    The STOP Act mandates that the State Survey assess “best practices” and emphasize the importance of building collaborations with federally recognized tribal governments (“tribal governments”). It also emphasizes the importance at the federal level of promoting interagency collaboration and to that end established the Interagency Coordinating Committee on the Prevention of Underage Drinking (ICCPUD). SAMHSA has determined that to fulfill the Congressional intent, it is critical that the State Survey gather information from the states regarding the best practices standards that they apply to their underage drinking programs, collaborations between states and tribal governments, and the development of state-level interagency collaborations similar to ICCPUD.

    SAMHSA has determined that data on Categories #2, #3, and #4 mandated in the STOP Act (as listed on page 2) (enforcement and educational programs; programs targeting youth, parents, and caregivers; and state expenditures) as well as states' best practices standards, collaborations with tribal governments, and state-level interagency collaborations are not available from secondary sources and therefore must be collected from the states themselves. The State Survey is therefore necessary to fulfill the Congressional mandate found in the STOP Act. Furthermore, the uniform collection of these data from the states over the last seven years has created a valuable longitudinal dataset, and the State Survey's renewal is vital to maintaining this resource.

    The State Survey is a single document that is divided into four sections, as follows:

    (1) Enforcement programs to promote compliance with underage drinking laws and regulations (as described in Category #2 above, page 2);

    (2) Programs and media campaigns targeted to youth, parents, and caregivers to deter underage drinking (as described in Category #3 above, page 2);

    (3) State interagency collaboration to implement prevention programs and media campaigns, state best-practice standards, and collaborations with tribal governments (as described above, page 4);

    (4) The amount that each state invests on the prevention of underage drinking in the categories specified in the STOP Act (see description of Category #4, above, page 2) and descriptions of any dedicated fees, taxes, or fines used to raise these funds.

    The number of questions in each section is as follows:

    Section 1: 38 questions Section 2A: 15 questions Section 2B: 12 questions Section 2C: 10 questions Section 2D: 10 questions Total: 85 questions

    Note that the number of questions in Section 2A is an estimate. This section asks states to identify up to 10 programs that are specific to underage drinking prevention. For each program identified there are three follow-up questions. Based on the average number of programs per state reported in the Survey's seven year history, it is anticipated that states will report an average of five programs for a total of 15 questions.

    It is anticipated that most respondents will actually respond to only a subset of this total. The Survey is designed with “skip logic,” which means that many questions will only be directed to a subset of respondents who report the existence of particular programs or activities.

    This latest version of the Survey has been revised as follows:

    1. Part 2, Section A: Programs

    a. A question about underage drinking prevention programs has been eliminated. Previously, states were asked to define each program by whether it was aimed at the “general population” or a “specific countable population (e.g., at-risk high school students).” This question was not misinterpreted by some respondents, leading to inconsistent data. It was not uncommon for states to provide specific population numbers for a program they had previously defined as being aimed at the general population. For this reason, it is being eliminated.

    b. Questions about the specific number of different populations (youth, parents, and caregivers) served by each prevention program have been reformatted as follows:

    i. Definitions of each population category have been deleted from the introduction to Part 2, Section A and have been incorporated into the subsequent questions about each program, making it easier for respondents to answer these questions without referring back to the introduction.

    ii. For the sake of efficiency, three separate questions about type of population served by each program have been collapsed into one question.

    c. References to “media campaigns” have been added to the introduction of this section to encourage respondents to include these among the prevention programs listed in their responses. As noted in the following description to changes in Part 2, Section B, the survey is being amended to evaluate awareness of, and participation in the national media campaign mandated by the STOP Act.

    2. Part 2. Section B: Collaborations and Best Practices

    a. New questions about the national media campaign to reduce underage drinking aimed at adults (as mandated by the STOP Act) have been added. The questions are intended to:

    i. Evaluate awareness of and participation in the national media campaign, “Talk. They Hear You.” (TTHY), including questions about the commitment of state resources and funding to this effort. The STOP Act requires evaluation of the national media campaign, which is largely conducted by other survey instruments. However, adding a question on the campaign here is an efficient way to gather state-level data for the analysis.

    ii. Determine whether the states participate in other media campaigns intended to reduce underage drinking.

    iii. Expand the scope of the Survey to include social marketing or counter-advertising efforts in the effort to reduce underage drinking. Currently, the Survey includes a question about whether states have programs to measure or reduce youth exposure to alcohol advertising and marketing. This question will remain, but the new questions will capture proactive efforts to counter this advertising and marketing.

    No additional time burden should be placed on the respondents, as the added questions are balanced by the deletion of others, with a small net reduction in the total number of questions. All questions continue to ask only for readily available data.

    To ensure that the State Survey obtains the necessary data while minimizing the burden on the states, SAMHSA has conducted a lengthy and comprehensive planning process. It sought advice from key stakeholders (as mandated by the STOP Act) including hosting multiple stakeholders meetings, conducting two field tests with state officials likely to be responsible for completing the State Survey, and investigating and testing various State Survey formats, online delivery systems, and data collection methodologies.

    Based on these investigations, SAMHSA collects the required data using an online survey data collection platform (SurveyMonkey). Links to the four sections of the survey are distributed to states via email. The State Survey is sent to each state governor's office and the Office of the Mayor of the District of Columbia. Based on the experience from the last seven years of administering the State Survey, it is anticipated that the state governors will designate staff from state agencies that have access to the requested data (typically state Alcohol Beverage Control [ABC] agencies and state Substance Abuse Program agencies). SAMHSA provides both telephone and electronic technical support to state agency staff and emphasizes that the states are only expected to provide data that is readily available and are not required to provide data that has not already been collected. The burden estimate below takes into account these assumptions.

    The estimated annual response burden to collect this information is as follows:

    Instrument Number of
  • respondents
  • Responses/
  • respondent
  • Burden/
  • response
  • (hrs)
  • Annual
  • burden
  • (hrs)
  • State Questionnaire 51 1 17.7 902.7

    Written comments and recommendations concerning the proposed information collection should be sent by July 16, 2018 to the SAMHSA Desk Officer at the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). To ensure timely receipt of comments, and to avoid potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, commenters are encouraged to submit their comments to OMB via email to: [email protected]. Although commenters are encouraged to send their comments via email, commenters may also fax their comments to: 202-395-7285. Commenters may also mail them to: Office of Management and Budget, Office of Information and Regulatory Affairs, New Executive Office Building, Room 10102, Washington, DC 20503.

    Summer King, Statistician.
    [FR Doc. 2018-12865 Filed 6-14-18; 8:45 am] BILLING CODE 4162-20-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.

    Project: “Talk. They Hear You.” Campaign Evaluation: National Survey—NEW

    SAMHSA's Center for Substance Abuse Prevention (CSAP) is requesting approval from the Office of Management and Budget (OMB) for a new data collection, “Talk. They Hear You.” Campaign Evaluation: National Survey. This collection includes two instruments:

    1. Screener 2. Survey Tool

    The national survey is part of a larger effort to evaluate the impact of the “Talk. They Hear You.” campaign. These evaluations will help determine the extent to which the campaign has been successful in educating parents and caregivers nationwide about effective methods for reducing underage drinking (UAD). The campaign is designed to educate and empower parents and caregivers to talk with children about alcohol. To prevent initiation of underage drinking, the campaign targets parents and caregivers of children aged 9-15, with the specific aims of:

    1. Increasing parent or caregiver awareness of and receptivity to campaign messages (knowledge);

    2. Increasing parent or caregiver awareness of underage drinking prevalence (knowledge);

    3. Increasing parent or caregiver disapproval of underage drinking (attitudes);

    4. Increasing parent or caregiver knowledge, skills, and confidence in how to talk to their children about, and prevent, UAD (attitudes); and

    5. Increasing parent or caregiver actions to prevent underage drinking by talking to their children about UAD (behaviors).

    The national survey will target parents in the base year in 2018, and then annually in the 4 option years following that, making this a repeat cross-sectional research study. The survey will be based on the survey originally approved for use in the 2016 impact evaluation, which was designed to quantify parent and caregiver awareness of the campaign and retention of campaign messages, and to determine whether parents and caregivers have used the campaign materials in talking to their children. SAMHSA will seek to conduct this research nationwide through online surveys. The survey will be accessible via an access link that will be disseminated to respondents via email. Respondents will be recruited to participate in this online survey from a Qualtrics© panel (which hosts more than 6 million active panelists), as was done for the survey pilot conducted in 2016. Researchers will conduct a quota-based sampling approach to maximize the representativeness of the sample and will be oversampling the Hispanic population. This will allow us to achieve a representative sample of parents of middle-school-aged children in the United States across notable socioeconomic and demographic variables of interest to the study. This approach will also allow us to oversample minority populations, such as Hispanics, as necessary in order to achieve the diversity needed to yield a comprehensive set of opinions, experiences, and feedback of the “Talk. They Hear You.” campaign materials and products.

    Table 1—Estimated Burden for Respondents Category of respondent Number of
  • respondents
  • Responses per
  • respondent
  • Total number
  • of responses
  • Hours per
  • response
  • (hours)
  • Total hour
  • burden
  • Individuals (Screened) 5,555 1 5,555 .05 277.75 Individuals (Complete survey) 5,000 1 5,000 .17 850 Totals 5,555 10,555 1,127.75

    Written comments and recommendations concerning the proposed information collection should be sent by July 16, 2018 to the SAMHSA Desk Officer at the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). To ensure timely receipt of comments, and to avoid potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, commenters are encouraged to submit their comments to OMB via email to: [email protected]. Although commenters are encouraged to send their comments via email, commenters may also fax their comments to: 202-395-7285. Commenters may also mail them to: Office of Management and Budget, Office of Information and Regulatory Affairs, New Executive Office Building, Room 10102, Washington, DC 20503.

    Summer King, Statistician.
    [FR Doc. 2018-12864 Filed 6-14-18; 8:45 am] BILLING CODE 4162-20-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment; Notice of Meeting

    Pursuant to Public Law 92-463, notice is hereby given that the Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC) will meet on August 1, 2018, 9:00 a.m.-5:00 p.m. (EDT).

    The meeting is open and will include consideration of minutes from the SAMHSA CSAT NAC meeting of February 14, 2018, the Director's Report, a budget update, discussion on substance use disorder spending estimates, discussions with SAMHSA leadership, and discussions on the opioid epidemic.

    The meeting will be held at SAMHSA, 5600 Fishers Lane, 5E49, Rockville, MD 20857. Attendance by the public will be limited to space available and will be limited to the open sessions of the meeting. Interested persons may present data, information, or views, orally or in writing, on issues pending before the Council. Written submissions should be forwarded to the contact person on or before July 13, 2018. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations are encouraged to notify the contact person on or before July 13, 2018. Five minutes will be allotted for each presentation.

    The open meeting session may be accessed via telephone. To attend on site, obtain the call-in number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities. Please register on-line at http://nac.samhsa.gov/Registration/meetingsRegistration.aspx, or communicate with the CSAT National Advisory Council Designated Federal Officer; Tracy Goss (see contact information below).

    Meeting information and a roster of Council members may be obtained by accessing the SAMHSA Committee website at http://www.samhsa.gov/about-us/advisory-councils/csat-national-advisory-council or by contacting the CSAT National Advisory Council Designated Federal Officer; Tracy Goss (see contact information below).

    Council Name: SAMHSA's Center for Substance Abuse Treatment National Advisory Council.

    Date/Time/Type: August 1, 2018, 9:00 a.m.-5:00 p.m. EDT, Open.

    Place: SAMHSA, 5600 Fishers Lane, Rockville, Maryland 20857.

    Contact: Tracy Goss, Designated Federal Officer, CSAT National Advisory Council, 5600 Fishers Lane, Rockville, Maryland 20857 (mail), Telephone: (240) 276-0759, Fax: (240) 276-2252, Email: [email protected]

    Carlos Castillo, Committee Management Officer, SAMHSA.
    [FR Doc. 2018-12897 Filed 6-14-18; 8:45 am] BILLING CODE 4162-20-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA-2018-0003; OMB No. 1660-0138] Agency Information Collection Activities: Submission for OMB Review; Comment Request; Direct Housing Program Forms AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use.

    DATES:

    Comments must be submitted on or before July 16, 2018.

    ADDRESSES:

    Submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the Desk Officer for the Department of Homeland Security, Federal Emergency Management Agency, and sent via electronic mail to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection should be made to Director, Information Management Division, 500 C Street SW, Washington, DC 20472, email address [email protected] or Elizabeth McDowell, Supervisory Program Specialist, FEMA, Recovery Directorate, at (540) 686-3630.

    SUPPLEMENTARY INFORMATION:

    This proposed information collection previously published in the Federal Register on March 27, 2018 at 83 FR 13140 with a 60-day public comment period. We received one comment that was unrelated to the information collection. The purpose of this notice is to notify the public that FEMA will submit the information collection abstracted below to the Office of Management and Budget for review and clearance.

    Collection of Information

    Title: Direct Housing Program Forms.

    Type of Information Collection: Revision of a currently approved information collection.

    OMB Number: 1660-0138.

    Form Titles and Numbers: FEMA Form 009-0-129, Ready for Occupancy Status; FEMA Form 009-0-131, Sales Calculation Worksheet; FEMA Form 009-0-134, Disaster Assistance Recertification Worksheet; FEMA Form 009-0-135, Temporary Housing Agreement; FEMA Form 009-0-137, Unit Pad Requirements—Information Checklist.

    Abstract: The Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5174) authorizes the President to provide temporary housing units to include manufactured housing units, recreational vehicles and other readily fabricated dwellings to eligible applicants who require temporary housing as a result of a major disaster. The information collected is necessary to determine the feasibility of a potential site for placement of a Transportable Temporary Housing Unit (TTHU), to ensure the TTHU is ready for applicant occupancy, and to confirm applicant understanding of the requirements of occupancy of the TTHUs.

    Affected Public: Individuals or households, Business or other for-profits.

    Estimated Number of Respondents: 25,000.

    Estimated Number of Responses: 25,000.

    Estimated Total Annual Burden Hours: 7,917.

    Estimated Total Annual Respondent Cost: $320,453.28.

    Estimated Respondents' Operation and Maintenance Costs: $0.

    Estimated Respondents' Capital and Start-Up Costs: $0.

    Estimated Total Annual Cost to the Federal Government: $2,997,510.

    Comments

    Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Dated: June 11, 2018. Rachel Frier, Records Management Branch Chief, Office of the Chief Administrative Officer, Mission Support, Federal Emergency Management Agency, Department of Homeland Security.
    [FR Doc. 2018-12888 Filed 6-14-18; 8:45 am] BILLING CODE 9111-23-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA-2018-0022; OMB No. 1660-0059] Agency Information Collection Activities: Proposed Collection; Comment Request; National Flood Insurance Program Call Center and Agent Referral Enrollment Form AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on an extension, without change, of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning National Flood Insurance Program Call Center and Agent Referral Enrollment Form.

    DATES:

    Comments must be submitted on or before August 14, 2018.

    ADDRESSES:

    To avoid duplicate submissions to the docket, please use only one of the following means to submit comments:

    (1) Online. Submit comments at www.regulations.gov under Docket ID FEMA-2018-0022. Follow the instructions for submitting comments.

    (2) Mail. Submit written comments to Docket Manager, Office of Chief Counsel, DHS/FEMA, 500 C Street SW, 8NE, Washington, DC 20472-3100.

    All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to read the Privacy Act notice that is available via the link in the footer of www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Susan Bernstein, FloodSmart Program Manager, FEMA, Federal Insurance and Mitigation Administration at (202) 701-3595. You may contact the Information Management Division for copies of the proposed collection of information at email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under Flood Disaster Protection Act of 1973, Section 2(a)(6), 42 U.S.C. 4002(a)(6), Congress finds it is in the public interest for persons already living in flood prone areas to have an opportunity to purchase flood insurance and access to more adequate limits of coverage to be indemnified for their losses in the event of future flood disasters. To this end, FEMA established and carries out a National Flood Insurance Program (NFIP), which enables interested persons to purchase insurance against loss resulting from physical damage to or loss of real or personal property arising from any flood occurring in the United States. 42 U.S.C. 4011. In carrying out the NFIP, FEMA operates a call center in conjunction with the FloodSmart website (www.FloodSmart.gov). Together these methods of marketing and outreach provide the mechanism for current and potential policyholders to learn more about floods and flood insurance, contact an agent, or assess their risk. The information collected from callers/visitors is used to fulfill requests for published materials, email alerts, policy rates, and agent contact information.

    Additionally, FEMA and the NFIP offer Agents.FloodSmart.gov as a resource for agents. Upon website registration, agents can enroll in the Agent Referral Program to receive free leads through the consumer site or the call center as outlined above. This information collection seeks approval to continue collecting name, address and telephone number information from: (1) Business and residential property owners and renters who voluntarily call to request flood insurance information and possibly an insurance agent referral and, (2) insurance agents interested in enrolling in the agent referral service.

    Collection of Information

    Title: National Flood Insurance Program Call Center and Agent Referral Enrollment Form.

    Type of Information Collection: Extension, without change, of a currently approved information collection.

    OMB Number: 1660-0059.

    FEMA Forms: FEMA Form 517-0-1, National Flood Insurance Program Agent Site Registration; FEMA Form 512-0-1, National Flood Insurance Program Agent Referral Questionnaire.

    Abstract: Consumer names, addresses, and telephone numbers collected through the Call Center or FloodSmart website will be used exclusively for providing information on flood insurance and/or facilitate the purchase of a flood insurance policy through referrals or direct transfers to insurance agents in the agent referral service. Agent names, addresses, telephone numbers, and business information is retained for dissemination to interested consumers who would like to talk to an agent about purchasing a flood insurance policy as part of the agent referral program.

    Affected Public: Individuals or households; businesses or other for-profit.

    Estimated Number of Respondents: 59,194.

    Estimated Number of Responses: 59,194.

    Estimated Total Annual Burden Hours: 2,819 hours.

    Estimated Total Annual Respondent Cost: The estimated annual cost to respondents for the hour burden is $103,335.52.

    Estimated Respondents' Operation and Maintenance Costs: There are no annual costs to respondents' operations and maintenance costs for technical services.

    Estimated Respondents' Capital and Start-Up Costs: There are no annual start-up or capital costs.

    Estimated Total Annual Cost to the Federal Government: The cost to the Federal Government is $406,941.

    Comments

    Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Dated: June 11, 2018. Rachel Frier, Records Management Branch Chief, Office of the Chief Administrative Officer, Mission Support, Federal Emergency Management Agency, Department of Homeland Security.
    [FR Doc. 2018-12890 Filed 6-14-18; 8:45 am] BILLING CODE 9111-52-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R1-ES-2018-N017]; [FXES11140100000-189-FF01E00000] Request for Renewal of the Incidental Take Permit and Short-Term Habitat Conservation Plan for Operation and Maintenance of Existing and Limited Future Facilities Associated With the Kauai Island Utility Cooperative on Kauai, Hawaii AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    The Kauai Island Utility Cooperative (KIUC, or applicant) has submitted an application to the U.S. Fish and Wildlife Service (Service) for renewal of their incidental take permit (permit) under the Endangered Species Act of 1973, as amended. The permit is associated with KIUC's Short-Term Habitat Conservation Plan (Short-Term HCP) that addresses incidental take of three listed bird species caused by the operation and maintenance of KIUC's existing and anticipated electrical utility facilities on Kauai, Hawaii. The applicant is requesting renewal of the permit for an indefinite period until the Service renders a decision on a Long-Term HCP and permit application currently under development by KIUC. We are making the permit renewal application available for public review and comment.

    DATES:

    All comments from interested parties must be received on or before July 16, 2018.

    ADDRESSES:

    To request further information or submit written comments, please use one of the following methods:

    U.S. Mail: Field Supervisor, U.S. Fish and Wildlife Service, Pacific Islands Fish and Wildlife Office, 300 Ala Moana Boulevard, Room 3-122, Honolulu, Hawaii 96850. Include “KIUC Short-Term HCP” in the subject line of your request or comment.

    Email: [email protected] Include “KIUC Short-Term HCP” in the subject line of the message.

    Fax: 808-792-9580, Attn: Field Supervisor. Include “KIUC Short-Term HCP” in the subject line of the message.

    Internet: You may obtain copies of this notice on the internet at https://www.fws.gov/pacificislands/, or from the Service's Pacific Islands Fish and Wildlife Office in Honolulu, Hawaii (see FOR FURTHER INFORMATION CONTACT section).

    We request that you send comments by only one of the methods described above. See the Public Availability of Comments section below for more information.

    FOR FURTHER INFORMATION CONTACT:

    Leila Nagatani, U.S. Fish and Wildlife Service (see ADDRESSES above), telephone (808) 792-9400. Hearing or speech impaired individuals may call the Federal Relay Service at 800-877-8339 for TTY assistance.

    SUPPLEMENTARY INFORMATION:

    The Kauai Island Utility Cooperative (KIUC, or applicant) has submitted an application to the U.S. Fish and Wildlife Service (Service) for renewal of their incidental take permit (permit) under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.). The permit is associated with KIUC's Short-Term Habitat Conservation Plan (Short-Term HCP) that addresses incidental take of three listed species caused by the operation and maintenance of KIUC's existing and anticipated electrical utility facilities on Kauai, Hawaii. The applicant is requesting renewal of the permit to authorize incidental take of the federally endangered Hawaiian petrel, the federally endangered band-rumped storm-petrel, and the federally threatened Newell's (Townsends) shearwater (collectively referred to as “Covered Species”) for an indefinite period until the Service renders a decision on a Long-Term HCP and permit application currently under development by KIUC. We are making the permit renewal application available for public review and comment.

    Background

    Section 9 of the ESA prohibits “take” of fish and wildlife species listed as endangered under section 4 (16 U.S.C. 1538 and 16 U.S.C. 1533). The ESA implementing regulations extend, under certain circumstances, the prohibition of take to threatened species (50 CFR 17.31). Under section 3 of the ESA, the term “take” means to “harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in any such conduct” (16 U.S.C. 1532(19)). The term “harm” is defined by regulation as “an act which actually kills or injures wildlife. Such act may include significant habitat modification or degradation where it actually kills or injures wildlife by significantly impairing essential behavioral patterns, including breeding, feeding, or sheltering” (50 CFR 17.3). The term “harass” is defined in the regulations as “an intentional or negligent act or omission which creates the likelihood of injury to wildlife by annoying it to such an extent as to significantly disrupt normal behavioral patterns which include, but are not limited to, breeding, feeding, or sheltering” (50 CFR 17.3).

    Under section 10(a) of the ESA, the Service may issue permits to authorize incidental take of listed fish and wildlife species. “Incidental take” is defined by the ESA as take that is incidental to, and not the purpose of, carrying out an otherwise lawful activity. Section 10(a)(1)(B) of the ESA contains provisions for issuing incidental take permits to non-Federal entities for the take of endangered and threatened species, provided the following criteria are met:

    • The taking will be incidental;

    • The applicant will, to the maximum extent practicable, minimize and mitigate the impact of such taking;

    • The applicant will develop a proposed HCP and ensure that adequate funding for the plan will be provided;

    • The taking will not appreciably reduce the likelihood of the survival and recovery of the species in the wild; and

    • The applicant will carry out any other measures that the Service may require as being necessary or appropriate for the purposes of the HCP.

    Regulations governing permits for endangered and threatened species are at 50 CFR 17.22 and 17.32.

    A permittee may submit an application for renewal of their permit if they certify that all information in the original application remains current and correct, unless previously changed or corrected. If such information is no longer current or correct, they must provide corrected information; see 50 CFR 13.22(a). The Service shall issue a renewal of a permit if the issuance criteria set forth in 50 CFR 13.21(b) are met and the applicant for renewal is not disqualified. The Service may deny renewal of a permit to an applicant who fails to meet the issuance criteria set forth in § 13.21 or the parts or sections specifically governing the activity for which renewal is requested (discussed above); see 50 CFR 13.22(d). Under certain conditions, an entity holding a valid, renewable permit may continue the activities authorized by the expired permit until the Service acts on the application for renewal; see 50 CFR 13.22(c).

    Covered Species

    The federally endangered Hawaiian petrel (Pterodroma sandwichensis), the federally endangered Hawaii population (distinct population segment (DPS)) of the band-rumped storm petrel (Oceanodroma castro), and the federally threatened Newell's Townsend's shearwater (Puffinus auricularis newelli) or Newell's shearwater (as a subspecies of the Townsend's shearwater), are seabirds that breed on Kauai and feed in the open ocean. Each of these species spends a large part of the year at sea. Adults generally return to their colonial nesting grounds in the interior mountains of Kauai beginning in March and April, and depart beginning in September. Juvenile seabirds travel from the nesting colony to the sea in the fall. Both adults and juveniles are known to collide with tall buildings, towers, power lines, and other structures while flying at night between their nesting colonies and at-sea foraging areas. These birds, and particularly juveniles, are also attracted to bright lights. Disoriented birds are commonly observed circling repeatedly around exterior light sources until they fall to the ground or collide with structures.

    KIUC Short-Term HCP

    KIUC is a not-for-profit, tax-exempt cooperative association owned by its ratepayer/customers and governed by a publicly-elected Board of Directors. It generates and distributes electricity to the entire island of Kauai, Hawaii. KIUC's existing facilities include over 1,400 miles of electrical transmission and distribution lines, two fossil fuel-fired generating stations, two hydroelectric stations, two 12-megawatt solar energy parks, 14 substations, and approximately 3,500 streetlights. KIUC developed a Short-Term HCP that addresses incidental take of the three Covered Species caused by the operation and maintenance of KIUC's existing and anticipated facilities over a period of up to 5 years from 2011 to 2016.

    In 2011, the KIUC Short-Term HCP was approved by the Service, and KIUC received a permit for incidental take of the Covered Species. The Short-Term HCP covers activities within all areas on Kauai where KIUC's facilities (e.g., generating stations, power lines, utility poles, lights) are located. These activities include the continuing operation, maintenance, and repair of all existing facilities, and the construction, operation, maintenance, and repair of certain new facilities, during the term of the permit. The Short-Term HCP describes the impacts of take incidental to those activities on the Covered Species, and provides certain measures to minimize and mitigate the impacts of such take on each of the Covered Species.

    The Covered Species are subject to injury or mortality as a result of colliding with KIUC-owned power lines and utility infrastructure, and injury or mortality as a result of attraction to nighttime lighting from KIUC-owned and operated streetlights and facilities. The Short-Term HCP permit authorized an annual take amount of 162 Newell's shearwaters, 2 Hawaiian petrels, and 2 band-rumped storm petrels over a 5-year period, as a result of attraction to, or collision with, KIUC facilities. In total, the permit authorized a combined take amount of 830 sub-adults or adults of the Covered Species.

    Current estimates of the Newell's shearwater population on Kauai, where 90 percent of the total population nests, range from 16,400 to 33,400, based on at-sea population estimates from 1998 through 2011 (Joyce 2013). Analyses of radar data (a proxy for the breeding population) suggest that the Newell's shearwater population on Kauai declined 94 percent between 1993 and 2013 (an average annual rate of 13 percent) (Raine et al. 2017a).

    The Hawaiian petrel population nests on several of the southeastern Hawaiian Islands, including Hawaii, Kauai, Lanai, and Maui, and the total population is estimated at 19,000 individuals (Spear et al. 1995). While the majority of the breeding population nests on Maui within Haleakalā National Park (over 2,500 nests; HAVO 2015), all extant populations of Hawaiian petrels across the Hawaiian Islands are biologically valuable toward ensuring the survival and recovery of the species. The Kauai population of Hawaiian petrels decreased by 78 percent (an average of 6 percent per year) between 1993 and 2013, according to trends in radar data over the 20 year period (Raine et al. 2017a).

    The band-rumped storm-petrel occurs in Japan, Hawaii, Galapagos Islands, and subtropical areas of the Atlantic. The Hawaii DPS of the band-rumped storm-petrel is found on the islands of Hawaii, Maui, Kauai, and Lehua. The band-rumped storm-petrel is known to nest in remote areas on vegetated to sparsely vegetated cliff faces or steeply sloping areas on Kauai and Lehua Islet (VanderWerf et al. 2007; Raine et al. 2017b). It has also been known to occur in sparsely vegetated areas, high-elevation lava fields on Hawaii Island (Banko et al. 1991; Banko 2015 in litt.), and possibly Haleakalā Crater on Maui, where several birds were heard calling (Wood et al. 2002). An estimate of the number of band-rumped storm-petrels within the Hawaiian Islands is not available at this time.

    Seabird colony monitoring data reflect significant threats from feral pig, cat, barn owl, and rat predation, as well as habitat degradation from invasive plants. Combined with the take caused by power line collisions and light attraction, the above threats have resulted in the dramatic decline of several breeding colonies on Kauai, including Kalaheo and Kaluahonu, to the point of near extirpation (Raine et al. 2017a).

    The 2011 Short-Term HCP established a comprehensive monitoring and research program designed to further evaluate the impact of the power line system on seabird populations and to provide key biological data to more adequately inform a longer term HCP and take authorization. To this end, KIUC provides funding to the Kauai Endangered Seabird Recovery Project (KESRP), a project of the University of Hawaii's Pacific Cooperative Studies Unit, to monitor seabird colonies and develop approaches to assess seabird-power line collisions. Due to the remote location of many power lines on Kauai and the nocturnal behavior of seabirds, in 2012, KESRP developed an acoustic song-meter monitoring system to detect seabird collisions. This acoustic system became the foundation for KIUC's Underline Monitoring Program (UMP) and has been accepted and is funded by KIUC.

    During the course of implementation of the KIUC Short-Term HCP, KESRP observed a total of 43 seabird power line collisions using night vision equipment. Of the 43 seabird power line collisions observed, four of these collision events definitively resulted in an immediate grounded bird within the observer's field of view. Additionally, about 25 deceased Newell's shearwaters have been opportunistically found from 2011 through 2015, associated with KIUC power lines or lights. The acoustic system, which is able to monitor the power lines for seabird collisions more extensively than human observers can, has detected a minimum in excess of 1,000 seabird collision events annually in 2014, 2015, and 2016 (KIUC Short-Term HCP 2014, 2015, and 2016 UMP Reports). Despite the above strike monitoring data, the applicant has only requested take authorization at the original permit level of 166 listed seabirds per year in its permit renewal application. KIUC's request for extension without an amendment means its actual take would likely continue to exceed the authorized level should the permit be renewed.

    Since 2012, KESRP, in collaboration with KIUC, has identified all high and medium risk power line spans that pose a threat to the Covered Species. These high and medium risk lines are continually monitored every year, and those data are used to plan and test for effective minimization measures, including reconfiguring lines or installing bird diverters. While the acoustic system has been successful in detecting seabird power line collisions, only a subset of the power line system can be monitored and therefore collisions outside of the monitored areas must be estimated. Moreover, while a minimum of over 1,000 seabird collision events have been detected in 2016, the fate of the birds that collided with these lines is unknown. Based on KESRP field observations, it is certain that some portion of these collisions results in immediate grounding or mortality, and that some additional proportion results in harm or injury, or potential mortality sometime after the collision event. Previous scientific studies based on waterfowl and their interactions with power lines have estimated that this subsequent mortality after the collision event could range from 20 percent to 74 percent of total detected collisions (Bevanger 1995; Bevanger 1999; Beaulaurier 1981; and Shaw et al. 2010).

    The Short-Term HCP has been successful in guiding measures that KIUC has implemented to partially mitigate the impacts of the taking of the Covered Species caused by its existing facilities, increasing knowledge related to the impact of KIUC's power line system on seabird populations, providing key biological data concerning the Covered Species, and improving our understanding of the effectiveness of conservation measures to more adequately inform a longer term habitat conservation plan and take authorization.

    Since 2011, under the Short-Term HCP, KIUC spent approximately $7.7 million to implement seabird colony management (i.e., predator control and seabird monitoring) and the retrieval and rehabilitation of seabirds on Kauai. KIUC has undergrounded or reconfigured 25 percent of their identified high collision-risk power lines since 2011 and installed bird deterrent devices to minimize impacts from high collision-risk power lines. Although KIUC's current mitigation and minimization programs are meaningful, these efforts are likely not commensurate with the actual level of take occurring.

    The Short-Term HCP permit expiration date was in May 2016. On April 12, 2016, one month before permit expiration, we received an application for renewal of that permit pending preparation of a Long-Term HCP.

    Request for Information

    We specifically request information from the public on whether the application meets the statutory and regulatory requirements and criteria for renewal of a permit. We are also soliciting information regarding the adequacy of a potentially renewed Short-Term HCP and permit to minimize, mitigate, and monitor the impacts of the taking of the Covered Species caused by KIUC's covered activities, and to provide for adaptive management for an indefinite period until the Service renders a decision on a Long-Term HCP and permit application currently under development by KIUC, as evaluated against our permit issuance criteria found in section 10(a) of the ESA, 16 U.S.C. 1539(a), and 50 CFR 13.21, 17.22, and 17.32.

    Public Availability of Comments

    You may submit your comments and materials by one of the methods listed above in the ADDRESSES section. Before including your address, phone number, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—might be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Comments and materials we receive will be available for public inspection by appointment, during normal business hours, at the Service's Pacific Islands Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT section).

    Authority

    We provide this notice in accordance with the requirements of section 10 of the ESA (16 U.S.C. 1531 et seq.).

    Theresa E. Rabot, Deputy Regional Director, Pacific Region, U.S. Fish and Wildlife Service.
    [FR Doc. 2018-12889 Filed 6-14-18; 8:45 am] BILLING CODE 4333-15-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 701-TA-581 (Final)] Citric Acid and Certain Citrate Salts From Thailand; Termination of Investigation AGENCY:

    United States International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    On June 5, 2018, the Department of Commerce published notice in the Federal Register of a negative final determination of subsidies in connection with the subject investigation concerning citric acid and certain citrate salts from Thailand (83 FR 26004). Accordingly, the countervailing duty investigation concerning citric acid and certain citrate salts from Thailand (Investigation No. 701-TA-581 (Final)) is terminated.

    DATES:

    June 5, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Amelia Shister (202-205-2047), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (https://www.usitc.gov).

    Authority:

    This investigation is being terminated under authority of title VII of the Tariff Act of 1930 and pursuant to section 207.40(a) of the Commission's Rules of Practice and Procedure (19 CFR 207.40(a)). This notice is published pursuant to section 201.10 of the Commission's rules (19 CFR 201.10).

    By order of the Commission.

    Issued: June 12, 2018. Lisa Barton, Secretary to the Commission.
    [FR Doc. 2018-12905 Filed 6-14-18; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION [USITC SE-18-028] Government in the Sunshine Act Meeting Notice AGENCY HOLDING THE MEETING:

    United States International Trade Commission.

    TIME AND DATE:

    June 22, 2018 at 11:00 a.m.

    PLACE:

    Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    1. Agendas for future meetings: None.

    2. Minutes.

    3. Ratification List.

    4. Vote on Inv. Nos. 701-TA-588 and 731-TA-1392-1393 (Final) (Polytetrafluoroethylene (“PTFE”) Resin from China and India). The Commission is currently scheduled to complete and file its determinations and views of the Commission by July 6, 2018.

    5. Outstanding action jackets: None.

    In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.

    By order of the Commission.

    Issued: June 12, 2018. William Bishop, Supervisory Hearings and Information Officer.
    [FR Doc. 2018-12973 Filed 6-13-18; 11:15 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration ACTION:

    Notice of registration.

    SUMMARY:

    Registrants listed below have applied for and been granted registration by-the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances.

    SUPPLEMENTARY INFORMATION:

    The companies listed below applied to be registered as importers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted and no requests for hearing were submitted for these notices.

    Company FR citation Published Sharp Clinical Services, Inc 83 FR 13521 March 29, 2018. Fisher Clinical Services, Inc 83 FR 13519 March 29, 2018. Wildlife Laboratories Inc 83 FR 14505 April 4, 2018. Catalent Pharma Solutions, LLC 83 FR 14504 April 4, 2018. Lipomed 83 FR 15627 April 11, 2018. Almac Clinical Services Incorp (ACSI) 83 FR 15634 April 11, 2018. Clinical Supplies Management Holdings, Inc 83 FR 16901 April 17, 2018.

    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrants to import the applicable basic classes of schedule I or II controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each company's background and history.

    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule I or II controlled substances to the above listed companies.

    Dated: June 6, 2018. John J. Martin, Assistant Administrator.
    [FR Doc. 2018-12884 Filed 6-14-18; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    On June 6, 2018, the Department of Justice filed a Complaint and concurrently lodged a proposed Consent Decree to resolve claims by the United States and the State of West Virginia against Defendant Felman Production, LLC for violations of the Clean Air Act, specifically the National Emission Standards for Hazardous Air Pollutants for Ferroalloys Production as codified at 40 CFR part 63, subpart XXX, effective May 20, 1999, as amended on March 22, 2001, as well as West Virginia's State Implementation Plan and Defendant's Title V Permit. The Complaint alleges that Defendant failed to comply with opacity standards, performance testing and monitoring requirements, and good air pollution control practices at its silicomanganese facility in Letart, West Virginia. The proposed Consent Decree addresses the alleged violations by requiring Defendant to install pollution-control measures, conduct additional monitoring for pollution, and pay a $200,000 civil penalty, equal shares of which are allocated between the United States and the State of West Virginia.

    The publication of this notice opens a period for public comment on the Consent Decree. Comments should be addressed to the Acting Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States v. Felman Production, LLC, Civil Action No. 3:18-cv-01003 (S.D. W. Va.), DOJ number 90-5-2-1-10991. All comments must be submitted no later than 30 days after the publication date of this notice. Comments may be submitted either by email or by mail:

    To submit comments: Send them to: By email [email protected]. By mail Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044-7611.

    During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department website: https://www.justice.gov/enrd/consent-decrees. We will provide a paper copy of the Consent Decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, US DOJ—ENRD, P.O. Box 7611, Washington, DC 20044-7611.

    Please enclose a check or money order for $21.00 (25 cents per page reproduction cost) payable to the United States Treasury. For a paper copy without the exhibits and signature pages, the cost is $18.50.

    Robert Brook, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division.
    [FR Doc. 2018-12862 Filed 6-14-18; 8:45 am] BILLING CODE 4410-15-P
    OFFICE OF MANAGEMENT AND BUDGET Cumulative Report of Rescissions Proposals Pursuant to the Congressional Budget and Impoundment Control Act of 1974 AGENCY:

    Executive Office of the President, Office of Management and Budget.

    ACTION:

    Notice of monthly cumulative report pursuant to the Congressional Budget and Impoundment Control Act of 1974.

    SUMMARY:

    Pursuant to the Congressional Budget and Impoundment Control Act of 1974, OMB is issuing a cumulative report from the Director detailing the status of rescission proposals that were previously transmitted to the Congress on May 8, 2018, and amended by the supplementary message transmitted on June 5, 2018.

    DATES:

    Release Date: June 8, 2018.

    ADDRESSES:

    The cumulative report is available on-line on the OMB website at: https://www.whitehouse.gov/omb/budget-rescissions-deferrals/.

    FOR FURTHER INFORMATION CONTACT:

    Jessica Andreasen, 6001 New Executive Office Building, Washington, DC 20503, Email address: [email protected], telephone number: (202) 395-3645. Because of delays in the receipt of regular mail related to security screening, respondents are encouraged to use electronic communications.

    John Mulvaney, Director.
    [FR Doc. 2018-12909 Filed 6-14-18; 8:45 am] BILLING CODE 3110-01-P
    NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Institute of Museum and Library Services Submission for OMB Review, Comment Request, Proposed Collection: IMLS Inspire! Grants for Small Museums (IGSM) Notice of Funding Opportunity AGENCY:

    Institute of Museum and Library Services, National Foundation on the Arts and the Humanities.

    ACTION:

    Submission for OMB review, comment request.

    SUMMARY:

    The Institute of Museum and Library Services announces the following information collection has been submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. This notice proposes the clearance of the instructions for the IMLS Inspire! Grants for Small Museums (IGSM) Notice of Funding Opportunity. A copy of the proposed information collection request can be obtained by contacting the individual listed below in the ADDRESSES section of this notice.

    DATES:

    Comments must be submitted to the office listed in the CONTACT section below on or before July 16, 2018.

    ADDRESSES:

    Comments should be sent to Office of Information and Regulatory Affairs, Attn.: OMB Desk Officer for Education, Office of Management and Budget, Room 10235, Washington, DC 20503, (202) 395-7316.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Sandra Webb, Director of Grant Policy and Management, Institute of Museum and Library Services, 955 L'Enfant Plaza North SW, Suite 4000, Washington, DC 20024-2135. Dr. Webb can be reached by Telephone: 202-653-4718 Fax: 202-653-4608, or by email at [email protected], or by teletype (TTY/TDD) for persons with hearing difficulty at 202-653-4614.

    SUPPLEMENTARY INFORMATION:

    The Institute of Museum and Library Services is the primary source of federal support for the nation's libraries and museums. We advance, support, and empower America's museums, libraries, and related organizations through grant making, research, and policy development. Our vision is a nation where museums and libraries work together to transform the lives of individuals and communities. To learn more, visit www.imls.gov.

    OMB is particularly interested in comments that help the agency to:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (e.g., permitting electronic submission of responses).

    Current Actions: The goal of IMLS Inspire! Grants for Small Museums (IGSM) is to support projects that strengthen the ability of small museums to serve their community. This new initiative will specifically support small museums by funding relevant activities that are clearly linked to an individual institution's organizational priorities and broader community needs. IMLS Inspire! Grants for Small Museums is being offered as a special initiative with funding from the Museums for America Program. This action is to create the forms and instructions for the Notice of Funding Opportunity for the next three years.

    Agency: Institute of Museum and Library Services.

    Title: 2019-2021 IMLS Inspire! Grants for Small Museums Notice of Funding Opportunity.

    OMB Number: 3137-TBD.

    Frequency: Once per year.

    Affected Public: Museum organization applicants.

    Number of Respondents: 125.

    Estimated Average Burden per Response: 35 hours.

    Estimated Total Annual Burden: 4,375 hours.

    Total Annualized capital/startup costs: n/a.

    Total Annual costs: $99,356.

    Dated: June 12, 2018. Kim Miller, Grants Management Specialist, Office of Grants Policy and Management.
    [FR Doc. 2018-12866 Filed 6-14-18; 8:45 am] BILLING CODE 7036-01-P
    NATIONAL TRANSPORTATION SAFETY BOARD Investigative Hearing

    Two recent Amtrak (National Railroad Passenger Corporation) accidents have motivated this investigative hearing: First, an Amtrak overspeed derailment in a 30 mph curve that occurred in DuPont, Washington, and, second, an Amtrak head-on collision with a standing freight train in Cayce, South Carolina.

    The first accident occurred on December 18, 2017, at 7:33 a.m., Pacific standard time, and involved southbound Amtrak passenger train 501, consisting of a leading and trailing locomotive, a power car, 10 passenger railcars, and a luggage car. Train 501 was traveling at 78 mph when it derailed from a highway overpass near DuPont, Washington. The train was on its first regular passenger service trip on a single main track (Lakewood subdivision) at milepost (MP) 19.86. The lead locomotive, the power car, and two passenger railcars derailed onto Interstate 5. Fourteen highway vehicles came into contact with the derailed equipment. At the time of the accident, 77 passengers, 5 Amtrak employees, and a Talgo Incorporated technician were on the train.1 Of these individuals, 3 passengers were killed and 62 passengers and crewmembers were injured. Eight individuals in highway vehicles were also injured. The damage is estimated to be more than $40 million. At the time of the accident, the temperature was 48 °F, the wind was from the south at 9 mph, and the visibility was 10 miles in light rain.

    1 Talgo Incorporated, which was the original manufacturer of the passenger railcars, has the service and maintenance contract.

    The second accident occurred on February 4, 2018, about 2:27 a.m. eastern standard time, and involved southbound Amtrak train 91, operating on a track warrant. Train 91 was diverted from the main track through a hand-thrown switch into a siding and collided head-on with stationary CSX Transportation (CSX) local freight train F777 03.2 The accident occurred on the CSX Columbia subdivision in Cayce, South Carolina. The engineer and conductor of the Amtrak train died in the collision, and at least 92 passengers and crewmembers on the Amtrak train were transported to medical facilities. The engineer of the stopped CSX train had exited the lead locomotive before the Amtrak train entered the siding, ran to safety, and was not injured. The conductor of the CSX lead locomotive saw the Amtrak train approaching in the siding and ran to the back of locomotive.

    2Track warrant is a method of authorizing movements or protecting employees or on-track equipment in signaled or nonsignaled territory on controlled track within specified signals. These movements are under the jurisdiction of the train dispatcher.

    The investigative hearing will discuss the following issue areas:

    • Amtrak Operations on Host Railroads.

    • Addressing Safety in Preparation for the Point Defiance Bypass.

    • Managing Safety on Passenger Railroads.

    • International Approach to Passenger Train Operations on Shared Use and Safety Management Principles From Other Industries.

    Parties to hearing are the Federal Railroad Administration (FRA); Amtrak; CSX; Sound Transit; Brotherhood of Locomotive Engineers and Trainmen; Brotherhood of Railroad Signalmen; International Association of Sheet Metal, Air, Rail and Transportation Workers; Washington State Utilities and Transportation Commission; and the Washington State Department of Transportation.

    Order of Proceedings 1. Opening Statement by the Chairman of the Board of Inquiry 2. Introduction of the Board of Inquiry and Technical Panel 3. Introduction of the Parties to the Hearing 4. Introduction of Exhibits by Hearing Officer 5. Overview of the incident and the investigation by Investigator-In-Charge 6. Calling of Witnesses by Hearing Officer 7. Closing Statement by the Chairman of the Board of Inquiry

    The investigative hearing will be held in the NTSB Board Room and Conference Center, located at 429 L'Enfant Plaza SW, Washington, DC on Tuesday, July 10, 2018, and Wednesday, July 11, 2018, beginning at 8:30 a.m. Media planning to cover the investigative hearing are asked to contact the NTSB's chief of media relations, Chris O'Neil at 202-314-6133 or [email protected]

    The investigative hearing will be transmitted live via the NTSB's website at http://www.capitolconnection.net/capcon/ntsb/ntsb.htm. A link for webcast will be available shortly before the start of the hearing. An archival video of the hearing will be available via the website for 30 days after the hearing.

    Individuals requiring reasonable accommodation and/or wheelchair access directions should contact Ms. Rochelle McCallister at (202) 314-6305 or by email at [email protected]

    NTSB Investigative Hearing Officer: Mr. Robert “Joe” Gordon—[email protected].

    Candi R. Bing, Federal Register Liaison Officer.
    [FR Doc. 2018-12846 Filed 6-14-18; 8:45 am] BILLING CODE 7533-01-P
    NUCLEAR REGULATORY COMMISSION [Docket No. 70-1151; NRC-2015-0039] Westinghouse Electric Company, LLC; Columbia Fuel Fabrication Facility AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Environmental assessment and finding of no significant impact; issuance.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is considering the renewal of Special Nuclear Materials (SNM) License No. SNM-1107 to allow Westinghouse Electric Company, LLC (WEC) to continue to operate its Columbia Fuel Fabrication Facility (CFFF) for an additional 40 years. The NRC has prepared a final environmental assessment (EA) and finding of no significant impact (FONSI) for this licensing action.

    DATES:

    The final EA referenced in this document was made available on June 8, 2018.

    ADDRESSES:

    Please refer to Docket ID NRC-2015-0039 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0039. Address questions about NRC dockets to Jennifer Borges; telephone: 301-287-9127; email: [email protected]. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]. The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in this document.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    FOR FURTHER INFORMATION CONTACT:

    Jessie Muir Quintero, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7476, email: [email protected].

    SUPPLEMENTARY INFORMATION: I. Introduction

    The NRC is considering renewing License SNM-1107 to allow WEC to continue to operate its CFFF for an additional 40 years. The license renewal period of 40 years would begin once the NRC approves the renewal. As required by part 51 of title 10 of the Code of Federal Regulations (10 CFR), “Environmental Protection Regulation for Domestic Licensing and Related Regulatory Functions,” the NRC prepared an EA (ADAMS Accession No. ML18120A318). Based on the results of the final EA, described as follows, the NRC has determined not to prepare an environmental impact statement (EIS) for the license renewal, and is issuing a FONSI.

    II. Environmental Assessment Description of the Proposed Action

    WEC submitted a license renewal application in 2014 (ADAMS Accession No. ML14352A111), which was updated in March 2018 (ADAMS Accession No. ML18087A400) to operate CFFF for an additional 40 years. The 40-year timeframe would begin upon NRC's approval of the license renewal application.

    Need for the Proposed Action

    The proposed action would allow CFFF to continue to be a source of nuclear fuel for commercial nuclear power plants.

    Environmental Impacts of the Proposed Action

    The NRC assessed the potential environmental impacts from the renewal of License SNM-1107 for an additional 40 years and determined there would be noticeable but not significant impacts to the quality of the human environment. WEC is not proposing any new construction or land disturbance activities. Although there is existing ground-water contamination on site, it has not migrated offsite or into the deeper aquifers and there is currently no pathway for human exposure. WEC's environmental monitoring program will continue to provide information on existing ground-water contamination and help identify future unintended releases to the environment. If needed, WEC will implement corrective actions to address contamination in the surface water and ground water. NRC expects that WEC will continue to meet all local, State, and Federal requirements, including its National Pollutant Discharge Elimination System permit and its obligations with the South Carolina Department of Health and Environmental Control (SCDHEC) under its voluntary cleanup contract related to ground-water contamination.

    Environmental Impacts of the Alternatives to the Proposed Action

    As an alternative to the proposed action, the NRC staff considered denial of the proposed action (i.e., the “no-action” alternative). The no-action alternative would mean that the NRC would not approve the license renewal. The CFFF would continue to operate under its current license until it expires on September 30, 2027. The NRC staff previously evaluated the environmental impacts of WEC continuing to operate the CFFF until September 2027 when it approved WEC's license renewal in 2007. The NRC staff concluded in the 2007 EA that the continued operation of the CFFF site would not result in a significant impact to the environment (ADAMS Accession No. ML070510647).

    The impacts of the no-action alternative would be similar to those of the Proposed Action except the impacts of the no-action alternative would occur only until 2027, when the current license expires, and decommissioning including any site remediation would occur sooner.

    Agencies and Persons Consulted

    On March 27, 2017, the NRC staff sent a copy of the draft EA to the SCDHEC for their review and comment (ADAMS Accession No. ML18088A415). The SCDHEC responded on April 27, 2018, with no additional comments on the draft EA (ADAMS Accession No. ML18117A130).

    The NRC consulted with the U.S. Fish and Wildlife Service (FWS) on listed protected species at the CFFF. The FWS concurred with the NRC's determination that the proposed activity may affect but is not likely to adversely affect the six federally listed species (ADAMS Accession No. ML15161A543). In August 2017, the NRC submitted a Biological Evaluation to the National Marine Fisheries Service (NMFS) with the determination that the license renewal may affect but is not likely to adversely affect the shortnose sturgeon (ADAMS Accession No. ML17227A378). On April 12, 2018, the NMFS concurred with the NRC's determination (ADAMS Accession No. ML18103A020).

    III. Finding of No Significant Impact

    Based on its review of the proposed action, and in accordance with the requirements in 10 CFR part 51, the NRC staff has determined that renewing License No. SNM-1107 for an additional 40 years would not significantly affect the environment. The NRC will require, by license condition, that WEC take corrective action if ground-water contamination exceeds State or Federal levels. The NRC staff has determined that pursuant to section 10 CFR 51.31, preparation of an EIS is not required for the proposed action and, pursuant to section 10 CFR 51.32, a FONSI is appropriate.

    On the basis of the final EA, the NRC concludes that the proposed action will not have a significant effect on the quality of the human environment. Accordingly, the NRC has determined not to prepare an EIS for the proposed action.

    Dated at Rockville, Maryland, this 11th day of June 2018.

    For the Nuclear Regulatory Commission.

    Craig G. Erlanger, Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, Office of Nuclear Material Safety and Safeguards.
    [FR Doc. 2018-12841 Filed 6-14-18; 8:45 am] BILLING CODE 7590-01-P
    POSTAL REGULATORY COMMISSION [Docket Nos. CP2016-138; MC2018-162 and CP2018-233; MC2018-163 and CP2018-234; MC2018-164 and CP2018-235; MC2018-165 and CP2018-236; CP2018-237; MC2018-166 and CP2018-238] New Postal Products AGENCY:

    Postal Regulatory Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

    DATES:

    Comments are due: June 18, 2018 and June 19, 2018.

    ADDRESSES:

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

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    The June 18, 2018 comment due date applies to Docket Nos. CP2016-138; MC2018-162 and CP2018-233; MC2018-163 and CP2018-234; MC2018-164 and CP2018-235; MC2018-165 and CP2018-236.

    The June 19, 2018 comment due date applies to Docket Nos. CP2018-237; MC2018-166 and CP2018-238.

    Table of Contents I. Introduction II. Docketed Proceeding(s) I. Introduction

    The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.

    Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.

    The public portions of the Postal Service's request(s) can be accessed via the Commission's website (http://www.prc.gov). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3007.40.

    The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.

    II. Docketed Proceeding(s)

    1. Docket No(s).: CP2016-138; Filing Title: USPS Notice of Amendment to Priority Mail Contract 203, Filed Under Seal; Filing Acceptance Date: June 8, 2018; Filing Authority: 39 CFR 3015.5; Public Representative: Christopher C. Mohr; Comments Due: June 18, 2018.

    2. Docket No(s).: MC2018-162 and CP2018-233; Filing Title: USPS Request to Add Priority Mail Contract 439 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: June 8, 2018; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Christopher C. Mohr; Comments Due: June 18, 2018.

    3. Docket No(s).: MC2018-163 and CP2018-234; Filing Title: USPS Request to Add Priority Mail Contract 440 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: June 8, 2018; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Kenneth R. Moeller; Comments Due: June 18, 2018.

    4. Docket No(s).: MC2018-164 and CP2018-235; Filing Title: USPS Request to Add Priority Mail Contract 441 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: June 18, 2018; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Kenneth R. Moeller; Comments Due: June 18, 2018.

    5. Docket No(s).: MC2018-165 and CP2018-236; Filing Title: USPS Request to Add Priority Mail Express & Priority Mail Contract 66 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: June 8, 2018; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Gregory Stanton; Comments Due: June 18, 2018.

    6. Docket No(s).: CP2018-237; Filing Title: Notice of United States Postal Service of Filing a Functionally Equivalent Global Expedited Package Services 7 Negotiated Service Agreement and Application for Non-Public Treatment of Materials Filed Under Seal; Filing Acceptance Date: June 8, 2018; Filing Authority: 39 CFR 3015.5; Public Representative: Gregory Stanton; Comments Due: June 19, 2018.

    7. Docket No(s).: MC2018-166 and CP2018-238; Filing Title: USPS Request to Add Priority Mail Contract 442 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: June 8, 2018; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Lawrence Fenster; Comments Due: June 19, 2018.

    This notice will be published in the Federal Register.

    Stacy L. Ruble, Secretary.
    [FR Doc. 2018-12828 Filed 6-14-18; 8:45 am] BILLING CODE 7710-FW-P
    POSTAL REGULATORY COMMISSION [Docket No. CP2018-232; Order No. 4640] Inbound Parcel Post (at UPU Rates) AGENCY:

    Postal Regulatory Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commission is noticing a recently filed Postal Service notice of intention to change prices not of general applicability to be effective July 1, 2018. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

    DATES:

    Comments are due: June 18, 2018.

    ADDRESSES:

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

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Introduction II. Contents of Filing III. Commission Action IV. Ordering Paragraphs I. Introduction

    On June 8, 2018, the Postal Service filed notice announcing its intention to change prices not of general applicability for Inbound Parcel Post (at Universal Postal Union (UPU) Rates) effective July 1, 2018.1

    1 Notice of the United States Postal Service of Filing Changes in Rates Not of General Applicability for Inbound Parcel Post (at UPU Rates), and Application for Non-Public Treatment, June 8, 2018, at 1-2 (Notice).

    II. Contents of Filing

    To accompany its Notice, the Postal Service filed: A redacted copy of the UPU International Bureau (IB) Circular that contains the new prices; a copy of the certification required under 39 CFR 3015.5(c)(2); redacted Postal Service data used to justify any bonus payments; and redacted copies of Governors' Decisions 14-04 and 11-6. Id. at 2-3; see id. Attachments 2-6. The Postal Service also filed redacted financial workpapers. Notice at 4.

    Additionally, the Postal Service filed unredacted copies of Governors' Decisions 14-04 and 11-6, an unredacted copy of the new prices, and related financial information under seal. See Notice at 4. The Postal Service filed an application for non-public treatment of materials filed under seal. Id. Attachment 1.

    The Postal Service states that it has provided supporting documentation as required by Order Nos. 2102 and 2310.2 In addition, the Postal Service states that it provided citations and copies of relevant UPU IB Circulars and updates to inflation-linked adjustments as required by Order No. 3716.3

    2 Notice at 4-5. See Docket No. CP2014-52, Order Accepting Price Changes for Inbound Air Parcel Post (at UPU Rates), June 26, 2014, at 6 (Order No. 2102); Docket No. CP2015-24, Order Accepting Changes in Rates for Inbound Parcel Post (at UPU Rates), December 29, 2014, at 4 (Order No. 2310).

    3 Notice at 5-6. See Docket Nos. MC2017-58 and CP2017-86, Order Acknowledging Changes in Rates for Inbound Parcel Post (at UPU Rates), December 30, 2016, at 5 (Order No. 3716).

    III. Commission Action

    The Commission establishes Docket No. CP2018-232 for consideration of matters raised by the Notice.

    The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, and 39 CFR part 3015. Comments are due no later than June 18, 2018. The public portions of the filing can be accessed via the Commission's website (http://www.prc.gov).

    The Commission appoints Katalin K. Clendenin to serve as Public Representative in this docket.

    IV. Ordering Paragraphs

    It is ordered:

    1. The Commission establishes Docket No. CP2018-232 for consideration of the matters raised by the Postal Service's Notice.

    2. Pursuant to 39 U.S.C. 505, Katalin K. Clendenin is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).

    3. Comments are due no later than June 18, 2018.

    4. The Secretary shall arrange for publication of this order in the Federal Register.

    By the Commission.

    Stacy L. Ruble, Secretary.
    [FR Doc. 2018-12844 Filed 6-14-18; 8:45 am] BILLING CODE 7710-FW-P
    SECURITIES AND EXCHANGE COMMISSION [Investment Company Act Release No. 33120; 812-14880] Aptus Capital Advisors, LLC and ETF Series Solutions June 12, 2018. AGENCY:

    Securities and Exchange Commission (“Commission”).

    ACTION:

    Notice.

    Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under section 12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and 12(d)(1)(B) of the Act. The requested order would permit (a) actively-managed series of certain open-end management investment companies (“Funds”) to issue shares redeemable in large aggregations only (“Creation Units”); (b) secondary market transactions in Fund shares to occur at negotiated market prices rather than at net asset value (“NAV”); (c) certain Funds to pay redemption proceeds, under certain circumstances, more than seven days after the tender of shares for redemption; (d) certain affiliated persons of a Fund to deposit securities into, and receive securities from, the Fund in connection with the purchase and redemption of Creation Units; (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the Funds (“Funds of Funds”) to acquire shares of the Funds; and (f) certain Funds (“Feeder Funds”) to create and redeem Creation Units in-kind in a master-feeder structure.

    Applicants: Aptus Capital Advisors, LLC (the “Initial Adviser”), an Alabama limited liability company registered as an investment adviser under the Investment Advisers Act of 1940, and ETF Series Solutions (the “Trust”), a Delaware statutory trust registered under the Act as an open-end management investment company with multiple series.

    Filing Dates: The application was filed on February 26, 2018.

    Hearing or Notification of Hearing: An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on July 9, 2018, and should be accompanied by proof of service on applicants, in the form of an affidavit, or for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.

    ADDRESSES:

    Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090; Applicants: Aptus Capital Advisors, LLC, 407 Johnson Ave., Fairhope, Alabama 36532 and ETF Series Solutions, 615 East Michigan Street, 4th Floor, Milwaukee, Wisconsin 53202.

    FOR FURTHER INFORMATION CONTACT:

    Jill Ehrlich, Senior Counsel, at (202) 551-6819, or Andrea Ottomanelli Magovern, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).

    SUPPLEMENTARY INFORMATION:

    The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or for an applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling (202) 551-8090.

    Summary of the Application

    1. Applicants request an order that would allow Funds to operate as actively-managed exchange traded funds (“ETFs”).1 Fund shares will be purchased and redeemed at their NAV in Creation Units only. All orders to purchase Creation Units and all redemption requests will be placed by or through an “Authorized Participant” which will have signed a participant agreement with the Distributor. Shares will be listed and traded individually on a national securities exchange, where share prices will be based on the current bid/offer market. Certain Funds may operate as Feeder Funds in a master-feeder structure. Any order granting the requested relief would be subject to the terms and conditions stated in the application.

    1 Applicants request that the order apply to the new series of the Trust as well as to additional series of the Trust and any other open-end management investment company or series thereof that currently exist or that may be created in the future (each, included in the term “Fund”), each of which will operate as an actively-managed ETF. Any Fund will (a) be advised by the Initial Adviser or an entity controlling, controlled by, or under common control with the Initial Adviser (each such entity and any successor thereto is included in the term “Adviser”) and (b) comply with the terms and conditions of the application. For purposes of the requested order, the term “successor” is limited to an entity that results from a reorganization into another jurisdiction or a change in the type of business organization.

    2. Each Fund will consist of a portfolio of securities and other assets and investment positions (“Portfolio Instruments”). Each Fund will disclose on its website the identities and quantities of the Portfolio Instruments that will form the basis for the Fund's calculation of NAV at the end of the day.

    3. Shares will be purchased and redeemed in Creation Units only and generally on an in-kind basis. Except where the purchase or redemption will include cash under the limited circumstances specified in the application, purchasers will be required to purchase Creation Units by depositing specified instruments (“Deposit Instruments”), and shareholders redeeming their shares will receive specified instruments (“Redemption Instruments”). The Deposit Instruments and the Redemption Instruments will each correspond pro rata to the positions in the Fund's portfolio (including cash positions) except as specified in the application.

    4. Because shares will not be individually redeemable, applicants request an exemption from section 5(a)(1) and section 2(a)(32) of the Act that would permit the Funds to register as open-end management investment companies and issue shares that are redeemable in Creation Units only.

    5. Applicants also request an exemption from section 22(d) of the Act and rule 22c-1 under the Act as secondary market trading in shares will take place at negotiated prices, not at a current offering price described in a Fund's prospectus, and not at a price based on NAV. Applicants state that (a) secondary market trading in shares does not involve a Fund as a party and will not result in dilution of an investment in shares, and (b) to the extent different prices exist during a given trading day, or from day to day, such variances occur as a result of third-party market forces, such as supply and demand. Therefore, applicants assert that secondary market transactions in shares will not lead to discrimination or preferential treatment among purchasers. Finally, applicants represent that share market prices will be disciplined by arbitrage opportunities, which should prevent shares from trading at a material discount or premium from NAV.

    6. With respect to Funds that hold non-U.S. Portfolio Instruments and that effect creations and redemptions of Creation Units in kind, applicants request relief from the requirement imposed by section 22(e) in order to allow such Funds to pay redemption proceeds within fifteen calendar days following the tender of Creation Units for redemption. Applicants assert that the requested relief would not be inconsistent with the spirit and intent of section 22(e) to prevent unreasonable, undisclosed or unforeseen delays in the actual payment of redemption proceeds.

    7. Applicants request an exemption to permit Funds of Funds to acquire Fund shares beyond the limits of section 12(d)(1)(A) of the Act; and the Funds, and any principal underwriter for the Funds, and/or any broker or dealer registered under the Exchange Act, to sell shares to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act. The application's terms and conditions are designed to, among other things, help prevent any potential (i) undue influence over a Fund through control or voting power, or in connection with certain services, transactions, and underwritings, (ii) excessive layering of fees, and (iii) overly complex fund structures, which are the concerns underlying the limits in sections 12(d)(1)(A) and (B) of the Act.

    8. Applicants request an exemption from sections 17(a)(1) and 17(a)(2) of the Act to permit persons that are affiliated persons, or second-tier affiliates, of the Funds, solely by virtue of certain ownership interests, to effectuate purchases and redemptions in-kind. The deposit procedures for