Federal Register Vol. 83, No.152,

Federal Register Volume 83, Issue 152 (August 7, 2018)

Page Range38657-38949
FR Document

83_FR_152
Current View
Page and SubjectPDF
83 FR 38939 - Reimposing Certain Sanctions With Respect to IranPDF
83 FR 38726 - Sunshine Act MeetingsPDF
83 FR 38760 - Extension of Public Comment Period Concerning Proposed Modification of Action Pursuant to Section 301: China's Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and InnovationPDF
83 FR 38759 - Sunshine Act MeetingsPDF
83 FR 38692 - Deletion of Item From Sunshine Act MeetingPDF
83 FR 38727 - Sunshine Act Meeting NoticePDF
83 FR 38691 - Problem Formulations for the Risk Evaluations To Be Conducted for the First Ten Chemical Substances Under the Toxic Substances Control Act, and Application of Systematic Review in TSCA Risk Evaluations; Extension of Comment PeriodPDF
83 FR 38720 - Proposed Flood Hazard DeterminationsPDF
83 FR 38686 - Notice of Availability of Government-Owned Inventions; Available for LicensingPDF
83 FR 38763 - Notice of OFAC Sanctions ActionsPDF
83 FR 38738 - New Postal ProductsPDF
83 FR 38694 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
83 FR 38697 - Medicare and Medicaid Programs: National Dialysis Accreditation Commission (NDAC) for Approval of its End Stage Renal Disease (ESRD) Facility Accreditation ProgramPDF
83 FR 38761 - FAA Approval of Noise Compatibility Program 14 CFR Part 150; Jackson Hole Airport, Jackson, WYPDF
83 FR 38759 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of VermontPDF
83 FR 38719 - Merchant Mariner Medical Advisory CommitteePDF
83 FR 38759 - Presidential Declaration Amendment of a Major Disaster for the State of TexasPDF
83 FR 38677 - Submission for OMB Review; Comment RequestPDF
83 FR 38686 - Withdrawal of the Notice of Intent To Prepare an Environmental Impact Statement (EIS) for the City of Abilene, TX, Cedar Ridge Reservoir Water Supply ProjectPDF
83 FR 38686 - Availability of the Final Environmental Impact Statement for the Northern Integrated Supply Project, Larimer and Weld Counties, ColoradoPDF
83 FR 38700 - Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-April Through June 2018PDF
83 FR 38663 - Schedule for Rating Disabilities: Skin; CorrectionPDF
83 FR 38724 - Notice of Application for a Recordable Disclaimer of Interest for Lands Underlying the Egegik River, Becharof Lake, and Ruth Lake and Outlet, AlaskaPDF
83 FR 38722 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Desert Land Entry ApplicationPDF
83 FR 38701 - Declaration Under the Public Readiness and Emergency Preparedness Act for Zika Virus VaccinesPDF
83 FR 38724 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Onshore Geophysical ExplorationPDF
83 FR 38722 - Notice of Realty Action: Non-Competitive Direct Sale of the Reversionary Interest in a Recreation and Public Purposes Act (R&PP) Patent, in Clark County, Nevada (N-94498)PDF
83 FR 38664 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna FisheriesPDF
83 FR 38678 - Notice of Funds Availability (NOFA) for the Conservation Reserve Program (CRP) Forest Inventory Analysis PilotPDF
83 FR 38760 - Advisory Committee for the Study of Eastern Europe and the Independent States of the Former Soviet Union (Title VIII) Public Meeting NoticePDF
83 FR 38682 - Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity To Request Administrative ReviewPDF
83 FR 38660 - Drawbridge Operation Regulation; Lake Washington Ship Canal, Seattle, WAPDF
83 FR 38660 - Drawbridge Operation Regulation; Atlantic Intracoastal Waterway (AIWW), Wrightsville Beach, NC and Northeast Cape Fear River, Wilmington, NCPDF
83 FR 38692 - Agency Information Collection Activities: Proposed Collection Renewal; Comment Request (OMB No. 3064-0151)PDF
83 FR 38661 - Safety Zone; USA Triathlon Age Group National Championships; Lake Erie, Cleveland, OHPDF
83 FR 38669 - Reducing Regulation and Public Burden, and Controlling CostPDF
83 FR 38764 - Notice of OFAC Sanctions ActionsPDF
83 FR 38711 - Government-Owned Inventions; Availability for LicensingPDF
83 FR 38712 - Scientific Advisory Committee on Alternative Toxicological Methods; Announcement of Meeting; Request for CommentsPDF
83 FR 38707 - Government-Owned Inventions; Availability for LicensingPDF
83 FR 38710 - Government-Owned Inventions; Availability for LicensingPDF
83 FR 38717 - Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2016-2017; Availability of ReportPDF
83 FR 38707 - Prospective Grant of Exclusive Patent License: Treatment of Type I Diabetes and its ComorbiditiesPDF
83 FR 38716 - Government-Owned Inventions; Availability for LicensingPDF
83 FR 38670 - Special Local Regulation; Battle of the Bridges, Intracoastal Waterway, Venice, FLPDF
83 FR 38693 - Notice to All Interested Parties of Intent To Terminate ReceivershipPDF
83 FR 38693 - Notice of Termination of ReceivershipsPDF
83 FR 38728 - Southern Nuclear Operating Company, Inc., Vogtle Electric Generating Plant, Units 3 and 4, Ventilation System ChangesPDF
83 FR 38729 - Radiation Safety Surveys at Medical InstitutionsPDF
83 FR 38730 - Standard Format and Content of Physical Security Plans, Training and Qualifications Plans and Safeguards Contingency Plans for Nuclear Power PlantsPDF
83 FR 38687 - Goose River Hydro, Inc.; Notice of Application Accepted for Filing and Soliciting Motions To Intervene and ProtestsPDF
83 FR 38690 - Notice of Request Under Blanket Authorization; Florida Gas Transmission, LLCPDF
83 FR 38762 - Petition for Exemption; Summary of Petition ReceivedPDF
83 FR 38763 - Petition for Exemption; Summary of Petition ReceivedPDF
83 FR 38738 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Amendments No. 1 and 2 To Advance Notice Concerning Enhanced and New Tools for Recovery ScenariosPDF
83 FR 38750 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Partial Amendments No. 1, 2, and 3 to Advance Notice Concerning Updates to and Formalization of OCC's Recovery and Orderly Wind-Down PlanPDF
83 FR 38689 - NextEra Desert Center Blythe, LLC v. California Independent System Operator Corporation: Notice of FilingPDF
83 FR 38696 - Privacy Act of 1974; Matching ProgramPDF
83 FR 38690 - Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization; Minco Wind IV, LLCPDF
83 FR 38691 - Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization; Minco Wind V, LLCPDF
83 FR 38688 - Combined Notice of Filings #1PDF
83 FR 38681 - Agency Information Collection Activities: Proposed Collection: Comment Request-Summer Food Site Locations for State AgenciesPDF
83 FR 38682 - Boundary Establishment for Ontonagon National Wild and Scenic River, Ottawa National Forest; Gogebic, Houghton, Iron, and Ontonagon Counties, MichiganPDF
83 FR 38727 - Notice of Information CollectionPDF
83 FR 38699 - Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Draft Guidance for Industry; AvailabilityPDF
83 FR 38684 - Notice of Availability of Draft Programmatic Environmental Assessments for Field Operations at Thirteen National Marine Sanctuaries and Two Marine National MonumentsPDF
83 FR 38738 - Product Change-Priority Mail Negotiated Service AgreementPDF
83 FR 38731 - Digital Instrumentation and Controls-Interim Staff Guidance-06, “Licensing Process”PDF
83 FR 38685 - Pacific Fishery Management Council; Public MeetingPDF
83 FR 38765 - Change in Burden of ProofPDF
83 FR 38666 - Future Format of the National Drug Code; Public Hearing; Request for CommentsPDF
83 FR 38765 - Proposed Collection; Comment Request for Regulation ProjectPDF
83 FR 38764 - Proposed Collection; Comment Request for Regulation ProjectPDF
83 FR 38753 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To Amend Commentary .01 to NYSE Arca Rule 8.600-E Relating to Certain Generic Listing Standards for Managed Fund SharesPDF
83 FR 38757 - Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Pilot Period for the Exchange's Retail Price Improvement ProgramPDF
83 FR 38748 - Order Granting Applications by Nasdaq BX, Inc., Nasdaq GEMX, LLC, Nasdaq ISE, LLC, Nasdaq MRX, LLC, and Nasdaq PHLX LLC for Exemption Pursuant to Section 36(a) of the Exchange Act From the Rule Filing Requirements of Section 19(b) of the Exchange Act With Respect to Certain CAT Rules Incorporated by ReferencePDF
83 FR 38748 - Self-Regulatory Organization; Cboe BYX Exchange, Inc.; Order Granting an Extension to Limited Exemption From Rule 612(c) of Regulation NMS in Connection With the Exchange's Retail Price Improvement ProgramPDF
83 FR 38694 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
83 FR 38713 - National Institute of Mental Health; Notice of MeetingPDF
83 FR 38715 - National Institute of Mental Health; Notice of WorkshopPDF
83 FR 38714 - Office of the Director, National Institutes of Health; Notice of MeetingPDF
83 FR 38714 - National Institute of General Medical Sciences; Notice of MeetingPDF
83 FR 38718 - National Institute of Diabetes and Digestive and Kidney Diseases Notice of MeetingsPDF
83 FR 38709 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingsPDF
83 FR 38716 - National Institute on Aging; Notice of Closed MeetingPDF
83 FR 38707 - National Institute on Aging; Notice of Closed MeetingPDF
83 FR 38709 - National Institute on Aging; Notice of Closed MeetingPDF
83 FR 38709 - National Institute of Aging; Notice of MeetingPDF
83 FR 38710 - National Cancer Institute; Notice of Closed MeetingsPDF
83 FR 38725 - Notice of Intent To Prepare an Environmental Impact Statement for the Willow Master Development Plan Oil and Gas Prospect, AlaskaPDF
83 FR 38672 - National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the Eureka Mills Superfund SitePDF
83 FR 38676 - National Flood Insurance Program (NFIP): Conforming Changes To Reflect the Biggert-Waters Flood Insurance Reform Act of 2012 (BW-12) and the Homeowners Flood Insurance Affordability Act of 2014 (HFIAA), and Additional Clarifications for Plain Language; CorrectionPDF
83 FR 38657 - Airworthiness Directives; Honda Aircraft Company LLC AirplanesPDF
83 FR 38768 - Regulation of NMS Stock Alternative Trading SystemsPDF
83 FR 38732 - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving Proposed No Significant Hazards Considerations and Containing Sensitive Unclassified Non-Safeguards Information and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards InformationPDF

Issue

83 152 Tuesday, August 7, 2018 Contents Agriculture Agriculture Department See

Commodity Credit Corporation

See

Food and Nutrition Service

See

Forest Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 38677-38678 2018-16849 2018-16864
Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 38694-38696 2018-16797 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Medicare and Medicaid Programs: National Dialysis Accreditation Commission for Approval of Its End Stage Renal Disease Facility Accreditation Program, 38697-38699 2018-16871 Privacy Act; Matching Programs, 38696-38697 2018-16821 Coast Guard Coast Guard RULES Drawbridge Operations: Atlantic Intracoastal Waterway, Wrightsville Beach, NC and Northeast Cape Fear River, Wilmington, NC, 38660 2018-16847 Lake Washington Ship Canal, Seattle, WA, 38660-38661 2018-16848 Safety Zones: USA Triathlon Age Group National Championships; Lake Erie, Cleveland, OH, 38661-38663 2018-16844 PROPOSED RULES Special Local Regulations: Battle of the Bridges, Intracoastal Waterway, Venice, FL, 38670-38672 2018-16834 NOTICES Meetings: Merchant Mariner Medical Advisory Committee, 38719-38720 2018-16867 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Commodity Credit Commodity Credit Corporation NOTICES Funding Availability: Conservation Reserve Program Forest Inventory Analysis Pilot, 38678-38680 2018-16852 Defense Department Defense Department See

Engineers Corps

See

Navy Department

Energy Department Energy Department See

Federal Energy Regulatory Commission

Engineers Engineers Corps NOTICES Environmental Impact Statements; Availability, etc.: City of Abilene, TX, Cedar Ridge Reservoir Water Supply Project, 38686 2018-16862 Northern Integrated Supply Project, Larimer and Weld Counties, CO, 38686 2018-16861 Environmental Protection Environmental Protection Agency PROPOSED RULES National Oil and Hazardous Substances Pollution Contingency Plan Priorities List: Deletion of Eureka Mills Superfund Site, 38672-38675 2018-16772 NOTICES Problem Formulations for Risk Evaluations; Applications of Systematic Reviews: First Ten Chemical Substances under Toxic Substances Control Act; TSCA Risk Evaluations, 38691-38692 2018-16879 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Honda Aircraft Company LLC Airplanes, 38657-38660 2018-15978 NOTICES Noise Compatibility Program: Jackson Hole Airport Jackson, WY, 38761-38762 2018-16870 Petitions for Exemptions; Summaries, 38762-38763 2018-16825 2018-16826 Federal Communications Federal Communications Commission NOTICES Meetings; Sunshine Act, 38692 2018-16896 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 38692-38693 2018-16846 Receiverships; Terminations, 38693-38694 2018-16832 2018-16833 Federal Emergency Federal Emergency Management Agency PROPOSED RULES National Flood Insurance Program; Correction, 38676 2018-16718 NOTICES Proposed Flood Hazard Determination, 38720-38722 2018-16876 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Goose River Hydro, Inc., 38687-38688 2018-16828 Combined Filings, 38688-38689 2018-16817 Filings: NextEra Desert Center Blythe, LLC v. California Independent System Operator Corp., 38689-38690 2018-16822 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Minco Wind IV, LLC, 38690-38691 2018-16819 Minco Wind V, LLC, 38691 2018-16818 Requests under Blanket Authorizations: Florida Gas Transmission, LLC, 38690 2018-16827 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 38694 2018-16872 Food and Drug Food and Drug Administration PROPOSED RULES Hearings: Future Format of the National Drug Code, 38666-38669 2018-16807 NOTICES Guidance: Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment, 38699-38700 2018-16813 Food and Nutrition Food and Nutrition Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Summer Food Site Locations for State Agencies, 38681-38682 2018-16816 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 38763-38764 2018-16842 2018-16874 Forest Forest Service NOTICES Boundary Establishment for Ontonagon National Wild and Scenic River, Ottawa National Forest; Gogebic, Houghton, Iron, and Ontonagon Counties, MI, 38682 2018-16815 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

National Institutes of Health

NOTICES Declarations: Zika Virus Vaccines, 38701-38707 2018-16856 Medicare Program: Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances—April through June 2018, 38700-38701 2018-16860
Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

Interior Interior Department See

Land Management Bureau

Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 38764-38765 2018-16804 2018-16806 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Opportunity to Request Administrative Review, 38682-38684 2018-16850 Land Land Management Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Desert Land Entry Application, 38722 2018-16857 Onshore Geophysical Exploration, 38724 2018-16855 Applications for Recordable Disclaimers of Interest: Lands underlying Egegik River, Becharof Lake, and Ruth Lake and Outlet, AK, 38724-38725 2018-16858 Environmental Impact Statements; Availability, etc.: Willow Master Development Plan Oil and Gas Prospect, Alaska, 38725-38726 2018-16783 Realty Actions: Non-Competitive Direct Sale of Reversionary Interest in Recreation and Public Purposes Act Patent, in Clark County, NV (N-94498), 38722-38724 2018-16854 Mississippi Mississippi River Commission NOTICES Meetings; Sunshine Act, 38726-38727 2018-16943 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 38727 2018-16814 National Institute National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing, 38707, 38710-38712, 38716-38717 2018-16835 2018-16838 2018-16839 2018-16841 Meetings: National Cancer Institute, 38710 2018-16784 National Institute of Allergy and Infectious Diseases, 38709-38710 2018-16789 National Institute of Diabetes and Digestive and Kidney Diseases, 38718-38719 2018-16790 National Institute of General Medical Sciences, 38714-38715 2018-16791 National Institute of Mental Health, 38713-38716 2018-16793 2018-16794 National Institute on Aging, 38707, 38709, 38716 2018-16786 2018-16787 2018-16788 National Institutes on Aging, 38709 2018-16785 Office of the Director, 38714 2018-16792 Scientific Advisory Committee on Alternative Toxicological Methods, 38712-38713 2018-16840 Prospective Grants of Exclusive Patent Licenses: Treatment of Type I Diabetes and its Comorbidities, 38707-38708 2018-16836 Reports; Availabilities: Interagency Coordinating Committee on Validation of Alternative Methods Biennial Progress Report: 2016-2017, 38717-38718 2018-16837 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: Atlantic Bluefin Tuna Fisheries, 38664-38665 2018-16853 NOTICES Environmental Assessments; Availability, etc.: Field Operations at Thirteen National Marine Sanctuaries and Two Marine National Monuments, 38684-38685 2018-16812 Meetings: Pacific Fishery Management Council, 38685-38686 2018-16809 Navy Navy Department NOTICES Government-Owned Inventions; Licensing Availabilities, 38686-38687 2018-16875 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Applications and Amendments Involving Proposed No Significant Hazards Considerations, etc., 38732-38738 2018-14915 Digital Instrumentation and Controls-Interim Staff Guidance-06, Licensing Process, 38731-38732 2018-16810 Exemptions and Combined Licenses; Amendments: Southern Nuclear Operating Co., Inc.; Vogtle Electric Generating Plant, Units 3 and 4: Ventilation System Changes, 38728-38729 2018-16831 Guidance: Radiation Safety Surveys at Medical Institutions; Withdrawal, 38729-38730 2018-16830 Standard Format and Content of Physical Security Plans, Training and Qualifications Plans and Safeguards Contingency Plans for Nuclear Power Plants, 38730-38731 2018-16829 Meetings; Sunshine Act, 38727-38728 2018-16894 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 38738 2018-16873 Postal Service Postal Service NOTICES Product Changes: Priority Mail Negotiated Service Agreement, 38738 2018-16811 Presidential Documents Presidential Documents EXECUTIVE ORDERS Iran; Reimposing Certain Sanctions (EO 13846), 38937-38949 2018-17068 Securities Securities and Exchange Commission RULES Regulation of NMS Stock Alternative Trading Systems, 38768-38936 2018-15896 NOTICES Applications: Nasdaq BX, Inc., Nasdaq GEMX, LLC, Nasdaq ISE, LLC, Nasdaq MRX, LLC, and Nasdaq PHLX, LLC, 38748-38750 2018-16799 Meetings; Sunshine Act, 38759 2018-16903 Self-Regulatory Organizations; Proposed Rule Changes: Cboe BYX Exchange, Inc., 38748, 38757-38759 2018-16798 2018-16802 NYSE Arca, Inc., 38753-38757 2018-16803 Options Clearing Corp., 38738-38748, 38750-38752 2018-16823 2018-16824 Small Business Small Business Administration NOTICES Disaster Declarations: Texas, 38759 2018-16866 Vermont, 38759-38760 2018-16868 State Department State Department PROPOSED RULES Reducing Regulation and Public Burden, and Controlling Cost, 38669-38670 2018-16843 NOTICES Meetings: Advisory Committee for Study of Eastern Europe and Independent States of Former Soviet Union, 38760 2018-16851 Trade Representative Trade Representative, Office of United States NOTICES Proposed Modifications of Actions Pursuant to Section 301: China's Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation; Extension of Comment Period, 38760-38761 2018-16919 Transportation Department Transportation Department See

Federal Aviation Administration

Treasury Treasury Department See

Foreign Assets Control Office

See

Internal Revenue Service

Veteran Affairs Veterans Affairs Department RULES Schedule for Rating Disabilities: Skin; Correction, 38663 2018-16859 NOTICES Changes in Burdens of Proof, 38765 2018-16808 Separate Parts In This Issue Part II Securities and Exchange Commission, 38768-38936 2018-15896 Part III Presidential Documents, 38937-38949 2018-17068 Reader Aids

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

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83 152 Tuesday, August 7, 2018 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0688; Product Identifier 2018-CE-026-AD; Amendment 39-19338; AD 2018-15-06] RIN 2120-AA64 Airworthiness Directives; Honda Aircraft Company LLC Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; request for comments.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain Honda Aircraft Company LLC Model HA-420 airplanes. This AD requires incorporating new and revised airworthiness limitations into the airplane's maintenance program. This AD was prompted by a report that several maintenance tasks were omitted from the airworthiness limitations section of the Honda Aircraft Company, Inc. Model HA-420 Airworthiness Limitation and Inspection Manual (ALIM). We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD is effective August 13, 2018.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of August 13, 2018.

We must receive comments on this AD by September 21, 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 Honda Aircraft Company LLC, 6430 Ballinger Road, Greensboro, North Carolina 27410; telephone (336) 662-0246; internet: http://www.hondajet.com. You may view this service information at the FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0688.

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-2018-0688; 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:

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

SUPPLEMENTARY INFORMATION:

Discussion

Honda Aircraft Company LLC has informed us that several required maintenance tasks driven by system safety assessment requirements were inadvertently omitted from or listed incorrectly in the airworthiness limitations section of the Honda Aircraft Company, Inc. Model HA-420 ALIM with a revision level prior to Revision C1 and dated earlier than May 1, 2018. Additional airworthiness limitations, additional maintenance tasks for various systems, and reduced compliance times for existing maintenance tasks are necessary to maintain all airplanes in a condition for safe operation.

In addition, we determined that some airplanes may have exceeded the new maintenance intervals once the ALIM was revised, including but not limited to:

1. Latent failure mode of the Wing Anti-Ice Crossflow Valve (WAIXV): This condition would prevent the opening of the WAIXV when commanded and could result in loss of control of the airplane if one bleed air source becomes unavailable while operating in icing conditions. An existing ice protection system check would identify this condition; however, the system check was not located in the airworthiness limitations section of the ALIM. The revised ALIM relocates the system check to the airworthiness limitations section and reduces the system check intervals from 600 hours time-in-service (TIS) to 300 hours TIS.

2. Latent failures in the brake and emergency accumulators: The hydraulic power system check for identifying and correcting potential latent failures in the brake and emergency accumulators contained incorrect procedures and was not located in the airworthiness limitations section of the ALIM. Honda corrected these procedures and superseded the current procedures (−801) with the new procedures (−802). The revised ALIM lists the correct procedures for the hydraulic power system check and relocates this check to the airworthiness limitations section.

These conditions, if not addressed, could result in failures in various airplane systems, including but not limited to the hydraulic and ice protection systems, which could result in loss of control of the airplane.

Related Service Information Under 1 CFR Part 51

We reviewed Honda Aircraft Company HA-420 Airworthiness Limitation and Inspection Manual “Airworthiness Limitations—Inspection/Check” (Airworthiness Limitations section 05-60-00), dated May 1, 2018. The service information contains airworthiness limitations, additional maintenance tasks for various systems, and reduced compliance times for existing maintenance tasks, including but not limited to the hydraulic and ice protection systems. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

FAA's Determination

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

AD Requirements

This AD requires revising the airworthiness limitations section of the maintenance program by replacing Airworthiness Limitations section 05-60-00 with an issue date earlier than May 1, 2018, with the revised Airworthiness Limitations section 05-60-00, dated May 1, 2018. Incorporating these airworthiness limitations makes them mandatory (reference 14 CFR 43.16 and 14 CFR 91.403(c)). For airplanes that have exceeded the new maintenance intervals, compliance with replacement times or inspection intervals is required before further flight once the limitations are incorporated. Operators have the compliance time period of the AD to plan for any immediate maintenance action required by the new limitations. This includes, but is not limited to the following:

• The 600-hour TIS ice protection system check, AMM Task Reference 30-10-01-700-801, previously located in the Scheduled Inspections section 05-20-00, has been relocated to the Airworthiness Limitations section 05-60-00, and reduced to a 300-hour TIS interval. Airplanes that have exceeded 300 hours TIS since the ice protection system check was last performed must have the ice protection system check within the compliance time specified in paragraph (f) of the AD. This AD allows a credit for airplanes that had the system check at the previous 600-hour TIS interval but have not exceeded 300 hours TIS since the last check and the WAIXV passed the functionality check contained in the procedure.

• The 600-hour TIS hydraulic power system check, AMM Task Reference 29-00-01-700-801, previously located in the Scheduled Inspections section 05-20-00, has been relocated to the Airworthiness Limitations section 05-60-00, and revised to AMM Task Reference 29-00-01-700-802. Airplanes that had the system check per the previous incorrect version of the maintenance task (29-00-01-700-801) at 600 hours TIS must have the inspection done before further flight after incorporating the airworthiness limitations.

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 adoption of this rule because exceeding certain maintenance intervals and/or limitations could cause failures in various airplane systems, including but not limited to the hydraulic and ice protection systems, which could result in loss of control. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reasons 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-2018-0688 and Product Identifier 2018-CE-026-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 96 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
  • Incorporate the revised Airworthiness Limitations section 05-60-00 into the ALIM 1 work-hour × $85 per hour = $85 Not applicable $85 $8,160
    Authority for This Rulemaking

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

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

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

    Regulatory Findings

    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): 2018-15-06 Honda Aircraft Company LLC: Amendment 39-19338; Docket No. FAA-2018-0688; Product Identifier 2018-CE-026-AD. (a) Effective Date

    This AD is effective August 13, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Honda Aircraft Company LLC Model HA-420 airplanes with a serial number in the range of 42000011 through 42000112, certificated in any category.

    (d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 05, Time Limits.

    (e) Unsafe Condition

    This AD was prompted by a report that several required maintenance tasks were omitted from “Airworthiness Limitations—Inspection/Check” (Airworthiness Limitations section 05-60-00), of the Honda Aircraft Company HA-420 Airworthiness Limitation and Inspection Manual (ALIM), with a revision level prior to C1 and dated earlier than May 1, 2018. We are issuing this AD to prevent failures in various airplane systems, including but not limited to the hydraulic and ice protection systems, which could result in loss of control of the airplane.

    (f) Compliance

    Comply with the action of this AD within 30 days after August 13, 2018 (the effective date of this AD) or within 15 hours time-in-service (TIS) after August 13, 2018 (the effective date of this AD), whichever occurs first, unless already done. The airworthiness limitations section revision required in paragraph (g) of this AD contains new and reduced inspection intervals. Once you comply with paragraph (g) of this AD, if the hours TIS of your airplane exceed the threshold of any new limitation, you are required to comply with the replacement times or inspection intervals before further flight. This includes, but is not limited to, the following revised inspections:

    (1) The 600-hour TIS interval ice protection system check, AMM Task Reference 30-10-01-700-801, previously located in the Scheduled Inspections section 05-20-00, has been relocated to the Airworthiness Limitations section 05-60-00, and reduced to a 300-hour TIS interval.

    (2) The 600-hour TIS interval hydraulic power system check (AMM Task Reference 29-00-01-700-801), previously located in the Scheduled Inspections section 05-20-00, has been relocated to the Airworthiness Limitations section 05-60-00 and revised to AMM Task Reference 29-00-01-700-802.

    (g) Airworthiness Limitations Revision

    Revise the airworthiness limitations section of the maintenance program by replacing Airworthiness Limitations section 05-60-00 with an issue date earlier than May 1, 2018, with Airworthiness Limitations section 05-60-00, “Airworthiness Limitation—Inspection/Check,” dated May 1, 2018. Incorporating these airworthiness limitations makes them mandatory (reference 14 CFR 43.16 and 14 CFR 91.403(c)).

    Note 1 to paragraph (g) of this AD:

    Airworthiness Limitations section 05-60-00 is contained in the Honda Aircraft Company, Inc. Model HA-420 ALIM.

    (h) No Alternative Actions or Intervals

    After revising the airworthiness limitations section as required by paragraph (g) of this AD, no alternative replacement times or inspection intervals may be approved unless the actions and/or intervals are approved as an alternative method of compliance in accordance with the procedures specified in paragraph (k)(1) of this AD.

    (i) Credit for Previous Actions

    Actions accomplished before the effective date of this AD in accordance with the 600-hour TIS ice protection system check, AMM Task Reference 30-10-01-700-801 located in the Scheduled Inspections section 05-20-00, is considered acceptable for compliance with the 300-hour TIS interval ice protection system check, AMM Task Reference 30-10-01-700-801 located in the Airworthiness Limitations section 05-60-00, dated May 1, 2018, if:

    (1) The wing anti-ice crossflow valve (WAIXV) passed the functionality check contained in the procedure; and

    (2) The airplane has not exceeded 300 hours TIS since the ice protection check was last performed.

    (j) Special Flight Permit

    Special flight permits are prohibited.

    (k) Alternative Methods of Compliance (AMOCs)

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

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

    (l) Related Information

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

    (m) 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) Honda Aircraft Company, Inc. Model HA-420 Airworthiness Limitation and Inspection Manual “Airworthiness Limitations—Inspection/Check,” (Airworthiness Limitations section (05-60-00)), dated May 1, 2018.

    (ii) Reserved.

    (3) For Honda Aircraft Company LLC service information identified in this AD, contact Honda Aircraft Company LLC, 6430 Ballinger Road, Greensboro, North Carolina 27410; telephone (336) 662-0246; internet: http://www.hondajet.com.

    (4) You may view this service information at the FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

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

    Issued in Kansas City, Missouri, on July 19, 2018. Pat Mullen, Aircraft Certification Service, Acting Deputy Director, Policy and Innovation Division, AIR-601.
    [FR Doc. 2018-15978 Filed 8-6-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0745] Drawbridge Operation Regulation; Atlantic Intracoastal Waterway (AIWW), Wrightsville Beach, NC and Northeast Cape Fear River, Wilmington, NC AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedules that govern the S.R. 74 (Wrightsville Beach) Bridge across the Atlantic Intracoastal Waterway (AIWW), mile 283.1, at Wrightsville Beach, NC, and the Isabel S. Holmes Bridge across the Northeast Cape Fear River, mile 1.0, at Wilmington, NC. The deviation is necessary to accommodate the free movement of pedestrians and vehicles during the 2018 PPD IRONMAN North Carolina “Beach2Battleship” Triathlon. This deviation allow these bridges to remain in their closed-to-navigation position.

    DATES:

    The deviation is effective from 6:30 a.m. to 3 p.m. on October 13, 2018.

    ADDRESSES:

    The docket for this deviation, [USCG-2018-0745], is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLMENTARY INFORMATION:

    The event director, PPD Ironman North Carolina, with approval from the North Carolina Department of Transportation, who owns and operates the S.R. 74 (Wrightsville Beach) and the Isabel S. Holmes Bridges has requested a temporary deviation from the current operating regulations to accommodate the free movement of pedestrians and vehicles during the 2018 PPD IRONMAN North Carolina “Beach2Battleship” Triathlon. The bridges are double bascule bridges and have vertical clearances in the closed position of 20 feet and 40 feet, respectively, above mean high water.

    The current operating schedule is set out in 33 CFR 117.821(a)(4) and 33 CFR 117.829(a), respectively. Under this temporary deviation, the S.R. 74 (Wrightsville Beach) Bridge will be maintained in the closed-to-navigation position from 6:30 a.m. to 10 a.m. on October 13, 2018, and the Isabel S. Holmes Bridge will be maintained in the closed-to-navigation position from 7:30 a.m. to 3 p.m. on October 13, 2018. The Atlantic Intracoastal Waterway is used by a variety of vessels including, small commercial fishing vessels and recreational vessels. The Northeast Cape Fear River is used by a variety of vessels including, small commercial fishing vessels, recreational vessels, and tug and barge traffic. The Coast Guard has carefully considered the nature and volume of vessel traffic on the waterway in publishing this temporary deviation.

    Vessels able to pass through these bridges in their closed positions may do so at anytime. These bridges will be able to open for emergencies and there are no immediate alternative routes for vessels unable to pass through the bridges in their closed positions. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedules for these bridges so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

    Dated: August 2, 2018. Hal R. Pitts, Bridge Program Manager, Fifth Coast Guard District.
    [FR Doc. 2018-16847 Filed 8-6-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0702] Drawbridge Operation Regulation; Lake Washington Ship Canal, Seattle, WA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Montlake Bridge across the Lake Washington Ship Canal, mile 5.2, at Seattle, WA. The deviation is necessary to accommodate vehicular traffic attending football games at Husky Stadium at the University of Washington. This deviation allows the bridge to remain in the closed-to-navigation position.

    DATES:

    This deviation is effective from 11:30 a.m. on September 8, 2018 through 11 p.m. on November 17, 2018.

    ADDRESSES:

    The docket for this deviation, USCG-2018-0702 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    Washington Department of Transportation (bridge owner), has requested a temporary deviation from the operating schedule for the Montlake Bridge across the Lake Washington Ship Canal, at mile 5.2, at Seattle, WA. The deviation is necessary to manage heavy vehicular traffic expected for University of Washington football games. While all dates have been released, exact game times for five of the six events scheduled for Husky Stadium have not yet been determined by the National Collegiate Athletic Association. The times for TBA (Time to Be Announced) closures on September 22, 2018, September 29, 2018, October 20, 2018, November 3, 2018 and November 17, 2018 will be announced in the Local Notice to Mariners as they become available. The Montlake Bridge in the closed-to-navigation position provides 30 feet of vertical clearance throughout the navigation channel, and 46 feet of vertical clearance throughout the center 60 feet of the bridge; vertical clearance references to the Mean Water Level of Lake Washington.

    The normal operating schedule for the Montlake Bridge operates in accordance with 33 CFR 117.1051(e). The deviation period and span operation is described in the table below:

    Time/date start Time/date end Action 11:30 a.m. to 2 p.m. Sep 8, 2018 5 p.m. to 7:30 p.m. Sep 8, 2018 span in the closed-to-navigation position. TBA Sep 22, 2018 TBA Sep 22, 2018 span in the closed-to-navigation position. TBA Sep 29, 2018 TBA Sep 29, 2018 span in the closed-to-navigation position. TBA Oct 20, 2018 TBA Oct 20, 2018 span in the closed-to-navigation position. TBA Nov 3, 2018 TBA Nov 3, 2018 span in the closed-to-navigation position. TBA Nov 17, 2018 TBA Nov 17, 2018 span in the closed-to-navigation position.

    Waterway usage on the Lake Washington Ship Canal ranges from commercial tug and barge to small pleasure craft. Vessels able to pass through the bridge in the closed-to-navigation position may do so at anytime. The bridge will be able to open for emergency vessels in route to a call when an hour notice is given to the bridge operator. The Lake Washington Ship Canal has no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

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

    Dated: July 31, 2018. Steven M. Fischer, Bridge Administrator, Thirteenth Coast Guard District.
    [FR Doc. 2018-16848 Filed 8-6-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2018-0427] RIN 1625-AA00 Safety Zone; USA Triathlon Age Group National Championships; Lake Erie, Cleveland, OH AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone for certain waters of Lake Erie during the USA Triathlon Age Group National Championships. This safety zone is intended to restrict vessels from a portion of Lake Erie off of Edgewater Park during the USA Triathlon Age Group National Championships. This temporary safety zone is necessary to protect participants and spectators during the event from the hazards associated with a large scale swimming event. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Buffalo.

    DATES:

    This rule is effective from 9:45 a.m. August 10, 2018 until 12:15 p.m. August 12, 2018.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0427 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email LT Ryan Junod, Chief of Waterways Management, U.S. Coast Guard Marine Safety Unit Cleveland; telephone 216-937-0124, email [email protected]

    SUPPLEMENTARY INFORMATION:

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

    On June 26, 2018 the Coast Guard published a Notice of Proposed Rulemaking (NPRM) titled USA Triathlon Age Group National Championships; Lake Erie, Cleveland, OH (83 FR 29721). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this swim event. During the comment period that ended July 26, 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 because doing so would be impracticable and contrary to the public interest. Delaying the effective date would be contrary to the rule's objectives of ensuring safety of life on the navigable waters and protection of persons and vessels near the event.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Buffalo (COTP) has determined that a large-scale swim event on a navigable waterway will pose a significant risk to participants and the boating public. This rule is necessary to protect participants and spectators during the USA Triathlon Age Group National Championships.

    IV. Discussion of Comments, Changes, and The Rule

    As noted above, we received no comments on our NPRM published June 26, 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 10:00 a.m. to 1:30 p.m. on August 10, 2018, from 5:00 a.m. to 5:30 p.m. on August 11, 2018, and from 5:00 a.m. to 12:00 p.m. on August 12, 2018. The safety zone will cover all navigable waters of Lake Erie, off of Edgewater Park, Cleveland OH, inside an area starting on shore at position 41°29′16″ N, 081°44′49″ W then Northwest to 41°29′34″ N, 081°45′02″ W then Northeast to 41°29′43″ N, 081°44′31″ W then Southeast back to shore at position 41°29′28″ N, 081°44′22″ (NAD 83). The duration of the zone is intended to enhance the safety of vessels and swimmers on these navigable waters before, during, and after the scheduled events over the course of the three days.

    No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

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

    This regulatory action determination is based on the characteristics of the safety zone. The safety zone created by this rule will be relatively small and is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. In addition, the safety zone is located off a beach where there are normally swimmers. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order13132.

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishment of a safety zone. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and 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.T09-0427 to read as follows:
    § 165.T09-0427 Safety Zone; USA Triathlon Age Group National Championships; Lake Erie, Cleveland, OH.

    (a) Location. The safety zone will encompass all waters of Lake Erie, off of Edgewater Park, Cleveland OH, inside an area starting on shore at position 41°29′16″ N, 081°44′49″ W then Northwest to 41°29′34″ N, 081°45′02″ W then Northeast to 41°29′43″ N, 081°44′31″ W, and Southeast back to shore at position 41°29′28″ N, 081°44′22″ (NAD 83).

    (b) Enforcement period. This rule will be enforced from 9:45 a.m. until 1:45 p.m. on August 10, 2018, from 5:00 a.m. until 5:45 p.m. on August 11, 2018, and from 5:00 a.m. until 12:15 p.m. on August 12, 2018.

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

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

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

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

    Dated: August 2, 2018. Joseph S. Dufresne, Captain, U.S. Coast Guard, Captain of the Port Buffalo.
    [FR Doc. 2018-16844 Filed 8-6-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 4 RIN 2900-AP27 Schedule for Rating Disabilities: Skin; Correction AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Final rule; correction.

    SUMMARY:

    The Department of Veterans Affairs (VA) published a final rule amending its Schedule for Rating Disabilities regulations pertaining to the skin body system in the Federal Register on Friday, July 13, 2018. VA has since determined that certain language added to the final rule was unintended and could be construed to prevent appropriate disability compensation ratings from being assigned to veterans. Therefore, VA is issuing this technical correction to ensure that skin disabilities are rated correctly.

    DATES:

    This correction is effective August 13, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Stephanie Li, Chief, Regulations Staff (211D), Compensation Service, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-9700. (This is not a toll-free telephone number.)

    SUPPLEMENTARY INFORMATION:

    On Friday, July 13, 2018, VA published in the Federal Register (83 FR 32592) a final rule amending its Schedule for Rating Disabilities regulations pertaining to the skin body system.

    In § 4.118, under the General Rating Formula for the Skin for DCs 7806, 7809, 7813-7816, 7820-7822, AND 7824, the 30 percent criteria published in the final rule, contains a phrase “Characteristic lesions involving more than” without a corresponding explanation for the additional phrase “more than.”

    VA notes that the inclusion of the phrase “more than” in the final rule was clearly a technical error. This document corrects this technical error by removing the phrase “more than” from the 30 percent rating criteria under the General Rating Formula for the Skin. This error does not affect any benefits which were previously paid as the final rule for skin will not become effective until August 13, 2018.

    In FR Doc. 18-14957, appearing on page 32598 in the Federal Register of July 13, 2018, correct the following:

    § 4.118 [Corrected]
    1. On page 32598, in the table, under the heading General Rating Formula For The Skin for DCs 7806, 7809, 7813-7816, 7820-7822, AND 7824, revise the 30 percent disability rating criteria to read as follows: *         *         *         *         *         *         * At least one of the following 30 Characteristic lesions involving 20 to 40 percent of the entire body or 20 to 40 percent of exposed areas affected; or Systemic therapy including, but not limited to, corticosteroids, phototherapy, retinoids, biologics, photochemotherapy, PUVA, or other immunosuppressive drugs required for a total duration of 6 weeks or more, but not constantly, over the past 12-month period *         *         *         *         *         *         * Approved: August 2, 2018. Jeffrey M. Martin, Impact Analyst, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.
    [FR Doc. 2018-16859 Filed 8-6-18; 8:45 am] BILLING CODE 8320-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket No. 150121066-5717-02] RIN 0648-XG391 Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries AGENCY:

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

    ACTION:

    Temporary rule; inseason quota transfer.

    SUMMARY:

    NMFS is transferring 30 metric tons (mt) of Atlantic bluefin tuna (BFT) quota from the Reserve category to the Harpoon category. With this transfer, the adjusted Harpoon category quota for the 2018 fishing season is 68.6 mt. The 2018 Harpoon category fishery is open until November 15, 2018, or until the Harpoon category quota is reached, whichever comes first. The action is based on consideration of the regulatory determination criteria regarding inseason adjustments, and applies to Atlantic tunas Harpoon category (commercial) permitted vessels.

    DATES:

    Effective August 2, 2018, through November 15, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Sarah McLaughlin or Brad McHale, 978-281-9260.

    SUPPLEMENTARY INFORMATION:

    Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq.) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq.) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) and as implemented by the United States among the various domestic fishing categories, per the allocations established in the 2006 Consolidated Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (71 FR 58058, October 2, 2006) and amendments, and in accordance with implementing regulations. NMFS is required under ATCA and the Magnuson-Stevens Act to provide U.S. fishing vessels with a reasonable opportunity to harvest the ICCAT-recommended quota.

    The current baseline quotas for the Harpoon and Reserve categories are 38.6 mt and 24.8 mt, respectively. See § 635.27(a). To date for 2018, NMFS has published two actions that have adjusted the available 2018 Reserve category quota, which currently is 108.5 mt (83 FR 9232, March 5, 2018, and 83 FR 17110, April 18, 2018). The 2018 Harpoon category fishery opened June 1 and is open through November 15, 2018, or until the Harpoon category quota is reached, whichever comes first.

    Although NMFS has published a proposed rule (83 FR 31517, July 6, 2018) to increase the baseline U.S. bluefin tuna quota from 1,058.79 mt to 1,247.86 mt and subquotas for 2018 (including an expected increase in the Harpoon category quota from 38.6 mt to 46 mt, consistent with the annual bluefin tuna quota calculation process established in § 635.27(a)), NMFS does not anticipate that the final rule will be effective until September 2018.

    Quota Transfer

    Under § 635.27(a)(9), NMFS has the authority to transfer quota among fishing categories or subcategories, after considering regulatory determination criteria provided under § 635.27(a)(8). NMFS has considered the relevant determination criteria and their applicability to the Harpoon category fishery. These considerations include, but are not limited to, the following:

    Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(8)(i)), biological samples collected from BFT landed by Harpoon category fishermen and provided by BFT dealers continue to provide valuable data for ongoing scientific studies of BFT age and growth, migration, and reproductive status. Additional opportunity to land BFT in the Harpoon category would support the continued collection of a broad range of data for these studies and for stock monitoring purposes.

    NMFS also considered the catches of the Harpoon category quota to date and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(8)(ii) and (ix)). As of August 1, 2018, the Harpoon category has landed 26.2 mt. Commercial-size BFT are currently readily available to vessels fishing under the Harpoon category quota. Without a quota transfer at this time, Harpoon category participants would have to stop BFT fishing activities with very short notice, while commercial-sized BFT remain available in the areas Harpoon category permitted vessels operate. Transferring 30 mt of BFT quota from the Reserve category would result in a total of 68.6 mt being available for the Harpoon category for the 2018 Harpoon category fishing season.

    Regarding the projected ability of the vessels fishing under the particular category quota (here, the Harpoon category) to harvest the additional amount of BFT before the end of the fishing year (§ 635.27(a)(8)(iii)), NMFS considered Harpoon category landings over the last several years. Landings are highly variable and depend on access to commercial-sized BFT and fishing conditions, among other factors. NMFS anticipates that the Harpoon category could harvest the transferred 30 mt prior to the end of the Harpoon category season, subject to weather conditions and BFT availability. NMFS may transfer unused Harpoon category quota to other quota categories, as appropriate. NMFS also anticipates that some underharvest of the 2017 adjusted U.S. BFT quota will be carried forward to 2018 and placed in the Reserve category, in accordance with the regulations. Thus, this quota transfer would allow fishermen to take advantage of the availability of fish on the fishing grounds, consider the expected increases in available 2018 quota later in the year, and provide a reasonable opportunity to harvest the full U.S. BFT quota.

    NMFS also considered the estimated amounts by which quotas for other gear categories of the fishery might be exceeded (§ 635.27(a)(8)(iv)) and the ability to account for all 2018 landings and dead discards. In the last several years, total U.S. BFT landings have been below the available U.S. quota such that the United States has carried forward the maximum amount of underharvest allowed by ICCAT from one year to the next. NMFS will need to account for 2018 landings and dead discards within the adjusted U.S. quota, consistent with ICCAT recommendations, and anticipates having sufficient quota to do that.

    This transfer would be consistent with the current quotas, which were established and analyzed in the 2015 BFT quota final rule (80 FR 52198, August 28, 2015), and with objectives of the 2006 Consolidated HMS FMP and amendments (§ 635.27(a)(8)(v) and (vi)). Another principal consideration is the objective of providing opportunities to harvest the full annual U.S. BFT quota without exceeding it based on the goals of the 2006 Consolidated HMS FMP and amendments, including to achieve optimum yield on a continuing basis and to optimize the ability of all permit categories to harvest their full BFT quota allocations (related to § 635.27(a)(8)(x)).

    Based on the considerations above, NMFS is transferring 30 mt of the available 108.5 mt of Reserve category quota to the Harpoon category. Therefore, NMFS adjusts the Harpoon category quota to 68.6 mt for the 2018 Harpoon category fishing season (i.e., through November 15, 2018, or until the Harpoon category quota is reached, whichever comes first), and adjusts the Reserve category quota to 78.5 mt.

    Monitoring and Reporting

    NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Harpoon category vessel owners are required to report their own catch of all BFT retained or discarded dead, within 24 hours of the landing(s) or end of each trip, by accessing hmspermits.noaa.gov, using the HMS Catch Reporting app, or calling (888) 872-8862 (Monday through Friday from 8 a.m. until 4:30 p.m.). Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional action (i.e., quota and/or daily retention limit adjustment, or closure) is necessary to ensure available quota is not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the Federal Register. In addition, fishermen may call the Atlantic Tunas Information Line at (978) 281-9260, or access hmspermits.noaa.gov, for updates on quota monitoring and inseason adjustments.

    Classification

    The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:

    The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Affording prior notice and opportunity for public comment to implement the quota transfer for the remainder of 2018 is also contrary to the public interest as such a delay would likely result in closure of the Harpoon fishery when the baseline quota is met and the need to re-open the fishery, with attendant administrative costs and costs to the fishery. The delay would preclude the fishery from harvesting BFT that are available on the fishing grounds and that might otherwise become unavailable during a delay. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For these reasons, there also is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.

    This action is being taken under § 635.27(a)(9), and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 971 et seq. and 1801 et seq.

    Dated: August 2, 2018. Margo B. Schulze-Haugen, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-16853 Filed 8-2-18; 4:15 pm] BILLING CODE 3510-22-P
    83 152 Tuesday, August 7, 2018 Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 [Docket No. FDA-2018-N-2610] Future Format of the National Drug Code; Public Hearing; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of public hearing; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is announcing a public hearing and an opportunity for public comment on the future format of the National Drug Code (NDC). FDA is seeking input from a variety of stakeholders through comments and responses to FDA questions included in this notice and associated web content to be published ahead of the hearing. The questions are intended to allow FDA to obtain stakeholders' perspectives on the impact of any future changes made to the length and format of the NDC.

    DATES:

    The public hearing will be held on November 5, 2018, from 8:30 a.m. to 5 p.m. The hearing may be extended or end early depending on the level of public participation. Persons seeking to attend or present at the public hearing must register by October 15, 2018. Electronic or written comments will be accepted after the public hearing until January 5, 2019.

    ADDRESSES:

    The public hearing will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503 Section B and C), Silver Spring, MD 20993-0002. Entrance for the public hearing participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2018-N-2610 for “Future Format of the National Drug Code; Public Hearing; Request for Comments.” Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    FOR FURTHER INFORMATION CONTACT:

    Leyla Rahjou-Esfandiary, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2262, Silver Spring, MD 20993, 301-796-3185, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    The NDC is an FDA standard for uniquely identifying drugs in the United States. Currently, NDCs assigned by FDA contain 10 digits. As described in § 207.33(b) (21 CFR 207.33(b)), NDCs consist of three segments: the labeler code, the product code, and the package code. At some point in the next 10 to 15 years, NDC formatting will need to be updated to accommodate longer NDCs because new labelers are continually entering the U.S. market. In 2016, when FDA published the “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, Final Rule” FDA stated that when it runs out of 5-digit labeler codes, it will begin assigning 6-digit labeler codes. (81 FR 60170, August 31, 2016). As a result, FDA will add two new 11-digit NDC formats to accommodate the longer labeler codes. However, FDA acknowledged that some stakeholders expressed an interest in FDA moving to a single, standard format for NDCs and announced that it would initiate a public discussion of future formatting options (81 FR 60170 at 60187). Because of the widespread use and dependency on NDCs in prescribing, dispensing, reimbursement, safety, clinical management, supply chain management, and pharmaceutical manufacturing and labeling systems, the Agency is holding a public hearing and requesting comments from stakeholders on the impact of the transition to 6-digit labeler codes.

    Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) requires each registered drug establishment to provide FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by the establishment for commercial distribution. Drug products are identified and reported using the NDC.

    The NDC for each listed drug in the United States is a unique 10-digit, 3-segment number. The 3 segments of NDC include the labeler code, product code, and package code. A labeler code is a unique 4-, 5-, or (in the future) 6-digit number assigned by FDA that identifies the manufacturer, repacker, relabeler, or private label distributor of the drug. The second segment, the product code, identifies a specific strength, dosage form, and formulation of a drug manufactured, repackaged, relabeled, or distributed by the labeler. The third segment, the package code, identifies package sizes and types. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging. Both the product and package codes are proposed by persons submitting drug listing information. FDA will assign a proposed NDC if it has not been used previously, is not currently in use, and has not been reserved for future assignment to a different product. The NDC for a given drug is currently in one of the following configurations (with each number representing the number of digits in that segment): 4-4-2, 5-3-2, or 5-4-1.

    According to current regulations, labeler codes may consist of 4, 5, or 6 digits (§ 207.33(b)(1)). Currently, 5-digit labeler codes are being assigned by FDA. A 5-digit labeler code format provides FDA with 90,000 labeler codes that could be assigned to drug manufacturers and private label distributors ranging from 10,000 to 99,999. Based on current assignment rates, FDA anticipates that it will run out of 5-digit labeler codes in approximately 15 years. FDA will begin assigning 6-digit labeler codes at some point in the future due to exhaustion of 5-digit labeler codes. Moving up to 6-digit labeler codes will expand NDCs to 11 digits and, per regulation, allows for two additional NDC configurations: 6-3-2 and 6-4-1, for a total of five possible NDC configurations (including the three 10-digit NDC configurations).

    The Health Insurance Portability and Accountability Act (HIPAA) (Pub. L. 104-191) contains provisions calling for the administrative simplification “of the national standards for electronic health care transactions and code sets, unique health identifiers, and security” 1 and specifically references the NDC. In its implementation of these rules, in August 2000, the Department of Health and Human Services (HHS) published a final rule on standards for electronic transactions that established NDC numbers as the standard medical data code set for reporting drugs and biologics in all standard transactions under HIPAA (65 FR 50312). If a HIPAA-covered transaction includes a drug, the NDC is required to be a part of the medical code data set (see 45 CFR subpart J 162.1002(a)(3)). However, in the preamble to the HIPAA regulations, HHS stated that it was adopting a uniform 11-digit format to conform with customary practice used in computer systems (65 FR 50312 at 50329). The HIPAA standard 11-digit NDC format is standardized such that the labeler code is always 5 digits, the product code is always 4 digits, and the package code always 2 digits. To convert a 10-digit NDC to an 11-digit HIPAA standard NDC, a leading zero is added to the appropriate segment to create the 11-digit configuration as defined above.

    1 See http://www.hhs.gov/ocr/privacy/hipaa/administrative/index.html (last accessed July 3, 2017).

    When FDA moves to a 6-digit labeler code, although these new 11-digit native NDC 2 configurations will have the same number of digits as required by the HIPAA standards, they will not be in the same format.3 Additionally, some of the systems that utilize HIPAA standard 11-digit NDCs 4 do not use hyphens to separate the segments which, as illustrated below, will result in some 11-digit native NDCs being indistinguishable from HIPAA standard 11-digit NDCs. Therefore, to ensure unhyphenated NDCs are distinguishable, FDA anticipates that the HIPAA standards, and other code sets that currently require 10-digit native NDCs to be converted to 11-digit NDCs, will likely be updated in some manner.

    2 NDCs in the format and with the digits assigned by FDA are referred to as native NDCs.

    3 An 11-digit native NDC will have an extra labeler code digit but will be short a digit in either the product code or package code.

    4 NDCs that contain additional digits necessary to comply with HIPAA standards are referred to as Converted NDCs.

    Table 1—NDC Conversion Example Native NDC format Converted NDC format 10-digit
  • hyphenated
  • 11-digit
  • converted
  • (hyphenated)
  • 11-digit
  • converted
  • (unhyphenated)
  • Native 10-digit (5-3-2) 10010-001-01 10010-0001-01 10010000101 Native 11-digit (6-3-2) 100100-001-01 10010000101
    II. Purpose and Scope of the Hearing

    The purpose of this public hearing is to obtain and discuss stakeholder feedback on the future format of NDCs. FDA is seeking information on the following topics:

    1. The impact of transitioning from a 5-digit labeler code to a 6-digit labeler code, including the business, economic, information technology, and medical/clinical practice impacts, and its impact on the safety and security of drug products.

    2. Issues associated with the current lack of NDC uniformity in the marketplace.

    3. What should FDA consider as it explores any further changes or expansion to the format or length of the NDC?

    4. How to best transition to a new format for the NDC.

    To facilitate stakeholder feedback, some options for discussion and questions will be posted in the docket and on FDA's website at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm at least 30 days prior to the hearing. These options and questions are not meant to be exhaustive. We encourage interested stakeholders to address these and/or other issues related to the formatting of NDCs. FDA encourages stakeholders to provide the rationale and basis for their comments, including any available data and information, and any underlying assumptions. For example, to provide context associated with a stakeholders response, FDA also is interested in the following information within the submission or testimony.

    1. How would you describe your business or area of focus (e.g., payor, hospital, health care practitioner, benefit manager or administrator, pharmacy, manufacturer, repackager, wholesale distributor, third-party logistics provider, drug compendia, standard setting organization, government entity)?

    2. How do you or your members use the NDC?

    3. What challenges does your organization or your members face with the current NDC and how do you overcome these challenges?

    4. What changes, if any, would you or your members need to make to your systems to accommodate the 6-digit labeler code or other larger NDC formats?

    III. Registration Registration and Requests for Oral Presentations

    The FDA Conference Center at the White Oak location is a Federal facility with security procedures and limited seating. Attendance is free and early registration is recommended. Individuals who wish to attend must register on or before October 15, 2018, at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm and provide complete contact information, including name, title, affiliation, email, and phone number. Those without internet access may register by contacting Leyla Rahjou-Esfandiary at 301-796-3185. FDA may allow onsite registration if space is available. If registration reaches maximum capacity, FDA will post a notice closing registration at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm.

    This hearing will include public comment sessions. Individuals who wish to present during a public comment session at the public hearing must register as noted at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm and identify the topics or questions (see section II) they wish to address in their presentation and the stakeholder group they best associate with, if any, to help FDA organize the presentations. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation.

    FDA will do its best to accommodate requests to present during the public comment session and will determine the amount of time allotted for each oral presentation and the approximate time that each oral presentation is scheduled to begin. FDA will notify registered presenters of their scheduled times and make available an agenda and background material at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm on or before October 22, 2018. Once FDA notifies registered presenters of their scheduled times, presenters should submit an electronic copy of their presentation to [email protected] on or before October 29, 2018.

    If you need special accommodations because of a disability, please send an email to [email protected] at least 7 days before the hearing.

    Streaming Webcast of the Public Hearing

    A link to the live webcast of this public hearing will be available at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm on the day of public hearing. A video record of the public hearing will be available at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm following the hearing.

    IV. Notice of Public Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The hearing will be conducted by a presiding officer, who will be accompanied by FDA senior management from the Office of the Commissioner and the relevant centers/offices.

    Under § 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation. At their discretion, the presiding officer(s) may permit questions to be submitted from the audience for response by FDA or other persons attending the hearing (§ 15.30(e)). Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b) (see Transcripts). To the extent that the conditions for the hearing, as described in this notice, conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30(h).

    Transcripts

    Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulation.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's website at https://www.fda.gov.

    Dated: July 31, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-16807 Filed 8-6-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF STATE 22 CFR Chapter I 48 CFR Chapter 6 [Public Notice: 10489] Reducing Regulation and Public Burden, and Controlling Cost AGENCY:

    Department of State.

    ACTION:

    Request for comments.

    SUMMARY:

    As part of its continuing implementation of Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs,” issued by the President on January 30, 2017, the Department of State (the Department) is seeking comments and information from interested parties to assist the Department in identifying existing regulations, paperwork requirements and other regulatory obligations that can be modified or repealed, consistent with law, to achieve meaningful burden reduction while continuing to achieve the Department's statutory obligations.

    DATES:

    Written comments and related material must be received on or before September 6, 2018.

    ADDRESSES:

    You may submit comments by email to the following address: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Alice Kottmyer, Attorney-Adviser, 202-647-2318; or Janet Freer, Director of the Office of Directives Management. Both can be reached at [email protected]

    SUPPLEMENTARY INFORMATION:

    On January 30, 2017, President Trump issued Executive Order 13771, Reducing Regulation and Controlling Regulatory Costs. Under that Executive Order, for every one new regulation issued, at least two prior regulations must be identified for elimination, and the cost of planned regulations must be prudently managed and controlled through a budgeting process. On February 24, 2017, the President issued Executive Order 13777, Enforcing the Regulatory Reform Agenda. That Executive Order directs agencies to take specific steps to identify and alleviate unnecessary regulatory burdens placed on the American people. We are seeking comments on Department regulations, guidance documents, and collections of information that you believe should be removed or modified to alleviate unnecessary burdens. The Department is also requesting economic data to support any proposed changes.

    The Regulatory Reform Task Force

    Executive Order 13777 directs agencies to designate a Regulatory Reform Officer (RRO) and to establish a Regulatory Reform Task Force (RRTF). The Deputy Secretary of State is the RRO. Other RRTF members include senior officials in the Department's primary regulatory bureaus (Bureaus of Consular Affairs, Educational and Cultural Affairs, Political-Military Affairs, and Administration), as well as other Department officials with expertise in legal requirements, planning and budget.

    One of the duties of the RRTF is to evaluate existing regulations and make recommendations to the Secretary regarding their repeal, replacement, or modification. Executive Order 13777 further directs that the RRTF attempt to identify regulations that:

    • Eliminate jobs, or inhibit job creation;

    • Are outdated, unnecessary, or ineffective;

    • Impose costs that exceed benefits;

    • Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;

    • Are inconsistent with the requirements of section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note), or the guidance issued pursuant to that provision, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard of reproducibility; or

    • Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.

    Section 3(e) of the Executive Order calls on the RRTF to “seek input and other assistance, as permitted by law, from entities significantly affected by Federal regulations, including State, local, and tribal governments, small businesses, consumers, nongovernmental organizations, and trade associations” on regulations that meet some or all of the criteria above. The Department sought input in 2017 (see 82 FR 32493), and again solicits your comments.

    Location of Department Regulations

    Existing Department of State regulations can be found in the Code of Federal Regulations (CFR) in two places:

    • 22 CFR Chapter I (parts 1 through 199), which contains rules governing Department operations); and

    • 48 CFR Chapters VI (part 600), which contains the Department's Acquisition Rules.

    In addition, guidance regarding Department grants can be found at 2 CFR chapter VI.

    You may view the most up-to-date versions of these authorities in the electronic CFR, located at www.ecfr.gov.

    Location of Department Guidance

    Department guidance that relates to the missions of the rulemaking bureaus (identified above) can be found in a number of locations on the state.gov public website. The Department is interested in comments regarding any of the guidance located on its public site. For your convenience, the following sites cover specific missions:

    • For Consular Affairs, including passports and visas, please visit https://travel.state.gov.

    • For Educational and Cultural Affairs, including the Exchange Visitor Program, please visit https://exchanges.state.gov/.

    • For Defense Trade issues, please visit: https://www.pmddtc.state.gov/.

    You are invited to provide comment on any guidance published by the Department that you feel should be considered for modification or elimination, in accordance with E.O. 13777.

    Location of the Department's Unified Agenda Submission

    The Department's most current submission to the Unified Agenda of Regulatory and Deregulatory Actions is located at https://www.reginfo.gov/public/do/eAgendaMain. Select “Department of State” from the dropdown menu. The Agenda consists of regulatory and de-regulatory actions either in progress or contemplated by the Department. The rules are identified by Regulatory Information Numbers (RINs), which for the Department all begin with “1400-”. When commenting on a rule in the Agenda, please identify it by its RIN.

    Location of Approved Collections of Information

    You can find the Department's approved collections of information at https://www.reginfo.gov/public/do/PRAMain. Please choose “Current Inventory” and pick “Department of State” from the dropdown menu. All approved collections of information have a Control Number issued by the Office of Management and Budget (OMB). Department Control Numbers all begin with “1405-”. When commenting on an information collection, please identify it by the OMB Control Number.

    Public Comments

    Please make your comments as specific as possible, and include any supporting data or other information, such as cost information, that you may have. Please note that all comments are publically available, so do not include any information in your comments that you would not want released to the public. We accept anonymous comments. The Department will not edit your comments to remove personal information; however, in our discretion, we might not post on regulations.gov any comments that contain personal information. If your submission cannot be made using www.regulations.gov, please submit using the email address listed in the ADDRESSES section, or contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

    The Executive Orders are at the following sites:

    • Executive Order 13771 is located at: http://bit.ly/2kx0TlY • Executive Order 13777 is located at: http://bit.ly/2lTZPIQ

    Although the Department will not respond to individual comments, we value your comments and will give careful consideration to them.

    Janet M. Freer, Director, Office of Directive Management, Department of State.
    [FR Doc. 2018-16843 Filed 8-6-18; 8:45 am] BILLING CODE 4710-05-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2018-0608] RIN 1625-AA08 Special Local Regulation; Battle of the Bridges, Intracoastal Waterway, Venice, FL AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to establish a temporary special local regulation for certain waters of the Intracoastal Waterway. This action is necessary to provide for the safety of life on these navigable waters in Venice, FL, during the Battle of the Bridges on September 15, 2018. This proposed rulemaking would prohibit persons and vessels from being in the race area unless authorized by the Captain of the Port St. Petersburg (COTP) or a designated representative. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before August 22, 2018.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2018-0608 using the Federal eRulemaking 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 proposed rulemaking, call or email Marine Science Technician First Class Michael Shackleford, U.S. Coast Guard; telephone 813-228-2191, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

    On November 7, 2017, the Sarasota Scullers Youth Rowing Program notified the Coast Guard that it will be conducting the Battle of the Bridges sculler race from 7 a.m. to 7:30 p.m. on September 15, 2018. The race will take place in portions of the Intracoastal Waterway in Venice, FL. The Captain of the Port St. Petersburg (COTP) has determined that potential hazards associated with the race to be a safety concern for anyone within area where the race is taking place.

    The Coast Guard is requesting that interested parties provide comments within a shortened comment period of 15 days instead of a standard 30 days for this notice of proposed rulemaking. The Coast Guard believes a shortened comment period is necessary and reasonable because the special local regulation is necessary to ensure the safety of vessels and the navigable waters within, or near the race area during the scheduled event. Any delay in making this final rule effective by allowing comments for more than 15 days would not be in the best interest of public safety.

    The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1233.

    III. Discussion of Proposed Rule

    The COTP proposes to establish a temporary special local regulation from 7 a.m. to 7:30 p.m. on September 15, 2018. The regulation would cover a race which would take place on approximately 3.5 miles of the Intracoastal Waterway starting near the Shamrock Park & Nature Center and ending near the Tamiami Trail Bridge in Venice, FL. The duration of the regulation is intended to ensure the safety of vessels and these navigable waters during the scheduled 7 a.m. to 7:30 p.m. race. No vessel or person would be permitted to enter the regulated area without obtaining permission from the COTP or a designated representative. Persons or vessels receiving permission to enter the regulated area must comply with the instructions of the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.

    IV. Regulatory Analyses

    We developed this proposed 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 NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM 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-day of the special local regulation. This regulation would impact approximately 3.5 miles of the Intracoastal Waterway in Venice, FL for twelve and half hours on one day. The Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the regulation, and the rule would allow vessels to seek permission to enter the race area in emergency situations. Advance notice of the regulation will provide the local community with ample time to plan around the race event accordingly.

    B. Impact on Small Entities

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

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

    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

    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 proposed 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. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

    C. Collection of Information

    This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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 proposed 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

    F. Environment

    We have analyzed this proposed 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 made a preliminary determination 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 proposed rule involves special local regulation which temporarily limits access to the portions of the Intracoastal Waterway in Venice, FL to race participants only, except in emergency situations. Normally such actions are categorically excluded from further review under paragraph L[61] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    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.

    V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

    We encourage you to submit comments through the Federal eRulemaking 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.

    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 NPRM 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. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

    List of Subjects in 33 CFR Part 100

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

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

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

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

    2. Add § 100.35T07-0195 to read as follows:
    § 100.35T07-0195 Special Local Regulation; Battle of the Bridges, Intracoastal Waterway; Venice, FL.

    (a) Regulated Area. A regulated area is established to include a race area located on all waters of the Intracoastal Waterway south of a line made connecting the following points: 27°06′15″ N, 082°26′43″ W, to position 27°06′12″ N, 082°26′43″ W, and all waters of the Intracoastal Waterway north of a line made connecting the following points: 27°03′21″ N, 082°26′17″ W, to position 27°03′19″ N, 082°26′15″ W. All coordinates are North American Datum 1983.

    (b) Definitions. The term “designated representative” means Coast Guard Patrol Commanders, including Coast Guard coxswains, petty officers, and other officers operating Coast Guard vessels, and Federal, state, and local officers designated by or assisting the COTP St. Petersburg in the enforcement of the regulated areas.

    (c) Regulations.(1) All non-participant persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the race area unless authorized by the Captain of the Port (COTP) St. Petersburg or a designated representative.

    (2) Persons and vessels desiring to enter, transit through, anchor in, or remain within the race area may contact the COTP St. Petersburg by telephone at (727) 824-7506 or via VHF-FM radio Channel 16 to request authorization.

    (3) If authorization to enter, transit through, anchor in, or remain within the race area is granted, all persons and vessels receiving such authorization shall comply with the instructions of the COTP or a designated representative.

    (4) The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, or by on-scene designated representatives.

    (d) Enforcement Period. This rule will be enforced from 7 a.m. until 7:30 p.m. on September 15, 2018.

    Holly L. Najarian, Captain, U.S. Coast Guard, Captain of the Port Saint Petersburg.
    [FR Doc. 2018-16834 Filed 8-6-18; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [EPA-HQ-SFUND-2002-0001; FRL-9981-92-Region 8] National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the Eureka Mills Superfund Site AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule; notice of intent.

    SUMMARY:

    The Environmental Protection Agency (EPA) Region 8 is issuing a Notice of Intent to Delete the Eureka Mills Superfund Site (Site) located in Eureka, Utah, from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of Utah, through the Utah Department of Environmental Quality (UDEQ), have determined that all appropriate response actions under CERCLA, other than operation and maintenance and five-year reviews (FYR), have been completed. However, this deletion does not preclude future actions under Superfund.

    DATES:

    Comments must be received by September 6, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID no. EPA-HQ-SFUND-2002-0001 by one of the following methods:

    http://www.regulations.gov. Follow on-line 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.

    Email: [email protected].

    Mail: Armando Saenz, Remedial Project Manager, U.S. EPA, Region 8, Mail Code 8EPR-SR, 1595 Wynkoop Street, Denver, CO 80202-1129.

    Instructions: Direct your comments to Docket ID no. EPA-HQ-SFUND-2002-0001. The http://www.regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through http://www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in the hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at: Eureka City Hall, 255 W Main Street, Eureka, UT 84628; Phone: (435-433-6915); Hours: M-Fri: 8:30 a.m.—5:00 p.m.

    FOR FURTHER INFORMATION CONTACT:

    Armando Saenz, Remedial Project Manager, U.S. Environmental Protection Agency, Region 8, EPR-SR, Denver, CO 80202, (303) 312-6559, email: [email protected].

    SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. NPL Deletion Criteria III. Deletion Procedures IV. Basis for Intended Site Deletion I. Introduction

    EPA Region 8 announces its intent to delete the Eureka Mills Superfund Site from the NPL and requests public comment on this proposed action. The NPL constitutes Appendix B of 40 CFR part 300 which is the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to section 105 of CERCLA of 1980, as amended. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). As described in 40 CFR 300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible for Fund-financed remedial actions if future conditions warrant such actions.

    EPA will accept comments on the proposal to delete this Site for thirty (30) days after publication of this document in the Federal Register.

    Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the Eureka Mills Superfund Site and demonstrates how it meets the deletion criteria.

    II. NPL Deletion Criteria

    The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the State, whether any of the following criteria have been met:

    i. Responsible parties or other persons have implemented all appropriate response actions required;

    ii. All appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

    iii. The remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures in not appropriate.

    Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-year reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure. EPA conducts such five-year reviews even if a site is deleted from the NPL. EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

    III. Deletion Procedures

    The following procedures apply to deletion of the Site:

    (1) EPA consulted with the State before developing this Notice of Intent to Delete.

    (2) EPA has provided the State 30 working days for review of this notice prior to publication of it today.

    (3) In accordance with the criteria discussed above, EPA has determined that no further response is appropriate;

    (4) The State of Utah, through the UDEQ, has concurred with deletion of the Site from the NPL.

    (5) Concurrently with the publication of this Notice of Intent to Delete in the Federal Register, a notice is being published in the local Eureka Review Newsletter. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent to Delete the Site from the NPL.

    (6) The EPA placed copies of documents supporting the proposed deletion in the deletion docket and made these items available for public inspection and copying at the Site information repositories identified above.

    If comments are received within the 30-day public comment period on this document, EPA will evaluate and respond appropriately to the comments before making a final decision to delete. If necessary, EPA will prepare a Responsiveness Summary to address any significant public comments received. After the public comment period, if EPA determines it is still appropriate to delete the Site, the Regional Administrator will publish a final Notice of Deletion in the Federal Register. Public notices, public submissions and copies of the Responsiveness Summary, if prepared, will be made available to interested parties and in the Site information repositories listed above.

    Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.

    IV. Basis for Intended Site Deletion

    The following information provides EPA's rationale for deleting the Site from the NPL.

    Site Background and History

    The 450-acre Eureka Mills Superfund Site (UT0002240158) encompasses much of Eureka. The town is situated in a southwest trending valley on the west side of the East Tintic Mountains in Juab County about 80 miles southwest of Salt Lake City, Utah. The town was founded in 1870 upon the discovery of a high-grade mineralized outcrop containing silver, lead, gold, copper and arsenic. The area was extensively mined until 1958. Because of extensive mining activities, numerous mine waste piles were formed and spread throughout the town (including residential areas).

    Investigations of the impacts from historic mining activities in Eureka began in 2000. Based on the results of initial blood lead testing and soil sampling, EPA and the State initiated an extensive blood lead testing program for Eureka residents in the summer of 2000. In addition, EPA's Emergency Response Program initiated an extensive soil sampling program of residential properties and mine waste areas.

    During the 2001 and 2002 construction seasons, EPA's Emergency Response Program conducted an emergency removal action on 69 properties. The action consisted of removing and replacing up to 18 inches of soil high in lead content on each property. The properties were selected based on soil lead levels greater than 3000 ppm and/or a child living in the home with a blood lead level greater than 10 μg/dL. The Site was proposed for the NPL on June 14, 2001 (66 FR 32287) and finalized on September 5, 2002 (67 FR 56757).

    Remedial Investigation and Feasibility Study (RI/FS)

    The RI/FS began in 2000 and was completed in 2002. Samples confirmed that metals were present in mine waste piles, residential/non-residential soils and within the interiors of some residences/commercial buildings. Over 4,205 soil samples were collected from 505 residential/commercial properties. One hundred residential properties contained surface soil lead in concentrations greater than 3,000 ppm. An additional 350 residential properties showed surface soil lead concentrations at levels between 231 and 2,999 ppm. Samples were also collected from mine waste piles and areas with future development potential. Lead concentrations within the waste pile material ranged from 1,000 ppm to 47,806 ppm. Lead in areas with future development potential ranged from 325 ppm to 15,000 ppm.

    The Baseline Human Health Risk Assessment (BHHRA) was completed in 2002 and evaluated the current/future risks to human health associated with elevated concentrations of metals in soils and mine waste within the Site. Lead was found to be the primary soil contaminant of concern (COC) and other soil COCs (antimony, arsenic, mercury, silver and thallium) were found to be co-located with lead.

    Selected Remedy

    An interim ROD (September 2002) for Operable Unit (OU) 00 addressed the public health actions to reduce the immediate exposure of residents (particularly, children under the age of 7 years) to lead from soil/dust in the environment prior to the implementation of the final remedy for the soils and mine wastes. Five OUs were designated for the Site:

    00—Entire Site including the residential/commercial areas 01—May Day Shaft, Godiva Shaft and the Godiva Tunnel 02—Bullion Beck Mine/Mill and Gemini Mine Waste Piles 03—Central Eureka Mining Areas 04—Ecological Risk Assessment, Groundwater and Surface Water

    With the completion of the BHHRA and RI/FS in 2002, EPA issued the final Site remedy for the soils and mine waste areas found to pose an imminent/substantial endangerment to public health in the September 2002 ROD for OUs 00-03. Lead was found to be the primary soil COC and other soil COCs (antimony, arsenic, mercury, silver and thallium) were co-located with lead. The health based clean-up levels specified in the ROD were 231 ppm lead in soils for residential use and 735 ppm lead in soils for recreational use.

    The Remedial Action Objectives were:

    • Prevent exposure of children to lead in surface soil within current residential properties, vacant properties interspersed among residential properties, and commercial properties at the Site where soil is determined to be the source of lead and the ingestion of soil is predicted to result in a greater than 5% chance that an individual child or a group of similarly exposed children will have a blood lead level greater than 10 μg/dL.

    • Prevent exposure of adolescents/adults engaging in recreational activities to lead in surface soil within discrete mine waste piles and non-residential properties (areas currently used for recreation but could be proposed for future development) where ingestion of soil is predicted to result in a greater than 5% chance that an individual or a similarly exposed group will have a blood lead level greater than 11.1 μg/dL.

    • The final remedy included the following components:

    • Cleanup of 691 residential and commercial properties with lead in soil concentrations greater than the action level. The cleanup generally consisted of removal of 18 inches of soil, placement of a marker barrier at 18 inches to define contaminated soil below and construction of an 18-inch cap consisting of soil with a vegetative cover or rock materials;

    • Capping of 13 mine waste piles near Eureka that posed a human health risk with an 18-inch cap of vegetated soil or rock;

    • Construction of a disposal cell (open cell) for contaminated soils that may be excavated during future development activities;

    • Implementation of institutional controls in the form of (1) proprietary controls in the form of easements or environmental covenants and; (2) local governmental ordinances to control excavation activities that could disturb contaminated materials; and,

    • Conducting public health actions, including information programs, periodic blood lead testing of children, and a program for evaluating sources of indoor lead exposure.

    The 2002 ROD for OUs 00-03 did not address the groundwater, surface water and ecological pathways because of the urgency to address actual exposures to lead contaminated soils evident in blood lead tests Eureka children. EPA conducted an RI for the surface water/groundwater from 2007 to 2009. Analysis of surface water samples collected during the RI met the Utah State Criteria for agricultural and recreational use. No groundwater impacts were found from historical mining that presented a concern for human health. In addition, samples from drinking water wells showed consistently high-quality water with no metals exceeding Maximum Contaminant Levels (MCLs). An ecological risk assessment (conducted from 2009 to 2010) concluded that, while there was a small risk to certain avian species, addressing the associated contamination would result in the destruction of valuable habitat for other avian species/wildlife not at risk. A No Action ROD for OU O4 was issued in September 2011 for the groundwater, surface water and ecological pathways.

    In summary, the three RODs for the Site are as follows: (1) Early Interim Action ROD for Operable Unit 00 at the Eureka Mills Site (September 30, 2002); (2) ROD for Lead-Contaminated Soil, Operable Unit 00-03 at the Eureka Mills NPL Site (September 30, 2002); and (3) Eureka Mills OU 4 Groundwater, Surface Water and Ecological Risk ROD (September 21, 2011).

    Response Actions

    The remedial design (RD) was completed in May 2003 and the remedial action (RA) began in August 2003 and was completed in October 2010. Most of the RA activities were performed by EPA with the assistance from the United States Army Corps of Engineers (USACE) under an interagency agreement. The USACE oversaw all work performed by its contractors and provided monthly progress reports. The monthly progress reports documented the work completed, problems encountered and their resolution, upcoming work and invoices submitted for payment during the reporting period. Potentially responsible parties (mine owners/operators) performed portions of the RA and provided materials and resources for other RA tasks.

    Because the duration of the RA extended over an eight-year period with multiple parties performing the RA work, pre-final/final inspections were conducted throughout the remedial action as specific portions of the Site were completed. Each PRP prepared a RA report after its work which was then reviewed by EPA and UDEQ and approved by EPA. EPA prepared annual RA reports documenting the work completed during the year which were reviewed and concurred on by UDEQ.

    The OU 00 RA for residential cleanup began in August 2004, and was completed in September 2010. EPA and UDEQ conducted inspections of the residential cleanup on a continual basis during each construction season from 2004 through 2010. Punch list items identified during the residential inspections were minor and immediately addressed. The remedial activities of the residential cleanup were summarized in each annual RA report.

    The surface runoff control features were designed to conform to the Federal Emergency Management Agency's (FEMA) revised Flood Insurance Rate Map. The initial hydrologic studies for the mapping were jointly conducted by FEMA and EPA in 2003. Following the completion of the RA and the surveying of the constructed drainages, EPA (on behalf of Eureka) submitted a letter to FEMA requesting revisions to the 2004 Flood Insurance Rate Map. FEMA approved the revisions in a letter dated May 12, 2011.

    Construction completion for the Site was achieved with the signing of the Preliminary Close Out Report (PCOR) and RA Report on September 21, 2011.

    Operation and Maintenance

    The O&M Plan and O&M Manual for the Site were approved on July 31, 2009 as attachments to the amended State Superfund Contract (SSC). The O&M Plan outlines the responsibilities of UDEQ and the City of Eureka for the O&M of the remedy at the Site including the implementation of ICs and operation of the open cell. The remedy was determined to be Operational and Functional on July 18, 2011 by EPA and the State of Utah assumed responsibility for O&M pursuant to the O&M Plan.

    The O&M Manual defines the maintenance tasks—inspection schedule, operation of the open cell and any material specifications for erosion repairs, etc. The O&M Manual includes the “as-built” drawings of the Response Action Structures (RASs) and individual inspection sheets for each RAS. In addition, the O&M Manual includes the survey descriptions and drawings of the RASs attached to the environmental covenants filed on each affected parcel.

    The final remedy requires ICs because contaminated materials remain at the Site above levels that allow for unlimited use and unrestricted exposure. The ICs at the Site include environmental covenants and a local excavation ordinance.

    Environmental covenants (ECs) were filed for each land parcel wholly or partially within the footprint of each RAS. RASs include the capped mine waste piles, drainage control features (sedimentation ponds/constructed drainages) and access roads. Filed by the property owner (usually a PRP), the ECs limit the type of land uses on RASs. Uses that could compromise the integrity of the remedy are prohibited. The ECs prohibit any disturbance or alteration of the RASs without prior approval by EPA/UDEQ and require compliance with Eureka's excavation ordinance. Future property owners will have to comply with the requirements of the ECs given that the ECs run with the land.

    In October 2010, Eureka adopted a local ordinance that governs excavation activities in areas that have been remediated but not developed. Undeveloped areas were not remediated at the time of the RA because of thick vegetation (and limited exposure to contaminated soils). The 00-03 ROD determined that the most appropriate time to remediate undeveloped areas would be during development. The ordinance requires property owners to obtain a permit for certain excavation activities defined as “restricted activities.” All contaminated materials displaced during excavation must either be disposed at the open cell or be capped with 18 inches of clean topsoil/road base material or capped with a structure or paved surface (minimum 2-inch hard cover surface). UDEQ provides technical/financial support to Eureka for the administration and enforcement of the ordinance through a funding agreement.

    Five-Year Review

    Statutory Five-Year Reviews (FYR) of the Site are required because hazardous substances remain on-Site above levels which allow for unlimited use and unrestricted exposure. The last FYR Report was signed on July 17, 2018 and found that, because the remedial actions at all OUs are protective, the remedy implemented at the Site is protective of human health and the environment. There were no issues/recommendations. The next five-year review is scheduled to be completed by July 2023.

    Community Involvement

    Since the implementation of the final Site remedy, there has not been any significant public/congressional interest. There have been no expressions of health/environmental concerns with the remedy.

    Community involvement activities associated with the most recent FYR included a public notice published in the Eureka Review Newsletter on March 1, 2018 and stakeholder interviews to discuss the review and address concerns or issues with the Site. The interviews were conducted from March 1 through April 15, 2018 and included representatives from the Eureka City Council, Eureka City Officials and surrounding property owners.

    None of the interviewees expressed any health or environmental concerns with the remedy and felt the remedy remains protective. The City of Eureka expressed concerns about issues that are not remedy-related such as problems with sewer/water lines, roads, drainage areas and historic head frames. Property owners either approved of the necessity of a cleanup for a healthy community or disapproved of the rock appearance extensively used for cover of mine waste areas. The interviewees approved of EPA's proposal and State concurrence to delete the Site from the NPL by the end of the federal fiscal year 2018.

    Determination That the Site Meets the Criteria for Deletion

    This Site meets all the completion requirements as specified in the OSWER Directive 9320.2-22, Close Out Procedures for National Priorities List Sites. All remedial activities at the Site are consistent with agency policy and guidance. The only remaining CERCLA activities to be performed at the Site are O&M and five-year reviews. No further Superfund responses are needed to protect human health and the environment at the Site.

    The NCP (40 CFR 300.425(e)) states that a site may be deleted from the NPL when no further response action is appropriate. EPA, in consultation with the State of Utah, has determined that all required response actions have been implemented and no further response action is appropriate.

    List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals, Hazardous waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.

    Authority:

    33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626, 77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 193.

    Dated: July 30, 2018. Douglas H. Benevento, Regional Administrator, Region 8.
    [FR Doc. 2018-16772 Filed 8-6-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Parts 59, 61, and 62 [Docket ID FEMA-2018-0026] RIN 1660-AA95 National Flood Insurance Program (NFIP): Conforming Changes To Reflect the Biggert-Waters Flood Insurance Reform Act of 2012 (BW-12) and the Homeowners Flood Insurance Affordability Act of 2014 (HFIAA), and Additional Clarifications for Plain Language; Correction AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Proposed rule; correction.

    SUMMARY:

    On July 16, 2018, FEMA published a proposed rule which would revise the National Flood Insurance Program's regulations to codify certain provisions of the Biggert-Waters Flood Insurance Reform Act of 2012 and the Homeowner Flood Insurance Affordability Act of 2014 that FEMA has already implemented and to clarify certain existing NFIP rules relating to NFIP operations and the Standard Flood Insurance Policy. In the preamble to the proposed rule, an incorrect web address appeared. This correction fixes that address.

    DATES:

    This correction is effective August 7, 2018. The closing of the comment period for the proposed rule published July 16, 2018, at 83 FR 39256, remains September 14, 2018.

    ADDRESSES:

    For information on submitting comments, see the July 16, 2018, proposed rule at 83 FR 39256.

    SUPPLEMENTARY INFORMATION:

    In proposed rule document 2018-13292 appearing on pages 32956 through 33015 in the issue of Monday, July 16, 2018, make the following correction:

    1. On page 32957, in the third column, in the first full paragraph, correct the web address “www.nfipservice.com” to read “https://www.nfipdirect.fema.gov”.

    Brock Long, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2018-16718 Filed 8-6-18; 8:45 am] BILLING CODE 9111-52-P
    83 152 Tuesday, August 7, 2018 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request August 2, 2018.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. 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.

    Comments regarding this information collection received by September 6, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. 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. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    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.

    Animal and Plant Health Inspection Service

    Title: Foreign Quarantine Notices.

    OMB Control Number: 0579-0049.

    Summary of Collection: Under the Plant Protection Act (PPA) (Title IV, Pub. L. 106-224, 114 Stat. 438, 7 U.S.C. 7701-7772), the Secretary of Agriculture is authorized to prohibit or restrict the importation, entry, exportation, or movement in interstate commerce of plants and plant products to prevent the introduction of plant pests into the United States. Regulations governing the importation of fruits, vegetables, plants for planting, logs, lumber, unprocessed wood products, cotton, corn, rice, sugar cane, and coffee are contained in 7 CFR part 319 and part 352. Implementing the laws through regulations is necessary to prevent injurious plant and insect pests from entering the United States and creating serious physical and economic consequences for U.S. agriculture.

    The regulations and subsequent requirements are enforced by the Animal and Plant Health Inspection Service (APHIS) and require the collection of information verifying oversight and inspection of the growing, handling, packing, transporting, and importing of fruits, vegetables, plants for planting, logs, lumber, unprocessed wood products, cotton, corn, rice, sugar cane, and coffee into the United States. The information is collected from businesses, individuals, and foreign government officials, via forms, labels, certifications, and other formats. On a quarterly basis, APHIS will submit a report to the Office of Management and Budget that documents the burden imposed by import requirements for commodities covered by this information collection (fruits, vegetables, plants for planting, logs, lumber, unprocessed wood products, cotton, corn, rice, sugar cane, and coffee) that have been finalized within that quarterly period.

    Need and Use of the Information: APHIS will collect information such as operational workplans; cooperative service agreements; trust funds; production or processing site/facility registrations; foreign site certification of inspection and/or treatment; applications for permits; appeals of denial or revocation of permits; requests for additional mailing labels; compliance agreements; phytosanitary certificates; labeling; importer documents; agreements for post entry quarantine State screening notices; 30-day article notifications; requests for emergency transshipment or diversion; notices of arrival; emergency action notifications; and monitoring/recordkeeping from responsible entities. In addition, APHIS will collect required information from national plant protection organizations as part of the commodity import approval process. If this information is not collected, APHIS' ability to safeguard the United States from injurious plant and insect pests from entering the country would be severely compromised.

    Description of Respondents: Businesses, Individuals and Households, National and State Governments.

    Number of Respondents: 22,353.

    Frequency of Responses: Reporting, Recordkeeping, Third-Party Disclosure: On occasion.

    Total Burden Hours: 550,363.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-16864 Filed 8-6-18; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request August 2, 2018.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. 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.

    Comments regarding this information collection received by September 6, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street NW, Washington, DC 20502. 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. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    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.

    Agricultural Research Service

    Title: U.S. National Arboretum Use of the Grounds and Facilities as well as Commercial Photography and Cinematography.

    OMB Control Number: 0518-0024.

    Summary of Collection: The mission of the U.S. National Arboretum (USNA) is to conduct research, provide education, and conserve and display trees, shrubs, flowers, and other plans to enhance the environment. The USNA is a 446-acre public facility. The grounds of the USNA are available to the general public for purposes of education and passive recreation. The USNA has many spectacular feature and garden displays which are very popular to visitors and photographers. Section 890(b) of the Federal Agriculture Improvement and Reform Act of 1996, Public Law 104-107 (“FAIR ACT”) provided statutory authorities regarding the USNA. These authorities include the ability to charge fees for temporary use by individuals or groups of USNA facilities and grounds for any purpose consistent with the mission of USNA. Also, the authority was provided to charge fees for the use of the USNA for commercial photography and cinematography.

    Need and Use of the Information: USNA officials will collect the information using applications in the form of questionnaires. The collected information is used by USNA management to determine if a requestor's needs can be met and the request is consistent with the mission and goals of the USNA uses of the information. If the basic information is not collected, USNA officials will not be able to determine if a requestor's needs are met.

    Description of Respondents: Business or other for profit; Not-for-profit institutions; Individuals or households; State, Local or Tribal Government.

    Number of Respondents: 302.

    Frequency of Responses: Reporting: On occasion.

    Total burden Hours: 151.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-16849 Filed 8-6-18; 8:45 am] BILLING CODE 3410-03-P
    DEPARTMENT OF AGRICULTURE Commodity Credit Corporation Notice of Funds Availability (NOFA) for the Conservation Reserve Program (CRP) Forest Inventory Analysis Pilot AGENCY:

    Commodity Credit Corporation and Farm Service Agency, U.S. Department of Agriculture (USDA).

    ACTION:

    Notice.

    SUMMARY:

    The Farm Service Agency (FSA), on behalf of Commodity Credit Corporation (CCC), is republishing this announcement to extend the application deadline for the availability of competitive grants to conduct a forest inventory analysis, forest management, and economic outcomes modelling, for certain currently enrolled Conservation Reserve Program (CRP) land. The analysis is focused on lands enrolled in CRP for at least 8 years and located in areas with a substantial concentration of acres enrolled under the following conservation practices devoted to multiple bottomland hardwood tree species: General tree planting, hardwood tree planting, vegetative cover on previously established tree stands, riparian buffers, bottomland timber establishments, and farmable and aquaculture wetlands. Qualified applicants must be non-profit organizations dedicated to conservation, forestry, and wildlife habitats that have experience in conducting accurate forest inventory analysis through the use of advanced, cost-effective technology, as determined by FSA.

    DATES:

    Application Deadline: August 25, 2018.

    ADDRESSES:

    Applications must be submitted in the following method: Grants Portal: Go to www.grants.gov. Follow the online instructions for submitting grants.

    FOR FURTHER INFORMATION CONTACT:

    Richard Iovanna, telephone (202) 720-5291.

    SUPPLEMENTARY INFORMATION:

    Background

    When the NOFA was initially published on July 19, 2018, (83 FR 34098-34100), the application deadline was August 15, 2018. FSA is republishing the NOFA to extend the application deadline to August 25, 2018. No other changes have been made to the announcement.

    Section 743 of the Consolidated Appropriations Act, 2018 (Pub. L. 115-141) requires that the USDA enter into grant agreements for forest inventory analysis, and forest management, and economic outcomes modelling of certain CRP land. Under this authority, the CCC will make available not more than $1 million in grants to non-profit organizations. The CRP Forest Inventory Analysis Pilot will be administered under the general supervision of FSA on behalf of CCC, in accordance with the provisions of 2 CFR part 200.

    Description

    The CRP Forest Inventory Analysis Pilot is focused on lands enrolled in CRP for at least 8 years and located in areas with a substantial concentration of acres enrolled under certain conservation practices devoted to multiple bottomland hardwood tree species, including conservation practices for general tree planting, hardwood tree planting, vegetative cover on previously established tree stands, riparian buffers, bottomland timber establishments, and farmable and aquaculture wetlands. Qualified applicants must be non-profit organizations dedicated to conservation, forestry, and wildlife habitats that have experience in conducting accurate forest inventory analysis through the use of advanced, cost-effective technology.

    Comprehensive data analysis using advanced, cost-effective technology on land enrolled in CRP with certain bottomland hardwood practices is important for several reasons. Such data will provide the FSA CRP program manager with the information needed to more effectively manage enrollment. For example, the inventory may find that mortality of a selected species of tree is high in certain situations. As a result, the CRP program manager may adjust what tree species can be enrolled in CRP on a regional and site-specific basis. Economic modeling will provide information on the expected net returns to CRP enrollees, as well as an evaluation of taxpayer costs. In short, there is a need for data collection and analysis of bottomland hardwood conservation practices and economics.

    For more than 30 years under CRP, landowners have voluntarily enrolled tens of millions of farmland acres to conserve and improve soil, protect water quality, and provide wildlife habitat by establishing long-term cover, primarily grasses and trees. Landowners voluntarily enroll their lands for periods of between 10 and 15 years.

    CRP cost share funding is provided to landowners who install the prescribed conservation practices. These practices can be costly and require ample investment by the landowner and technical assistance provider to ensure that the practices are appropriate and properly installed. The adequacy of the conservation plan is paramount to achieving CRP enrollment goals, especially for bottomland hardwoods.

    Bottomland hardwoods are streamside forest trees—such as cottonwood, sycamore, oak, maple, ash, cypress, and tupelo—that typically grow on lands prone to flooding. Over the past 8 years, 46 States have enrolled land into CRP that is devoted to bottomland hardwood trees. Cumulative CRP bottomland hardwood tree enrollment, over the past 8 years, is just over 799,000 acres, with over 550,000 acres (69 percent) located in the States shown in Table 1.

    Table 1—Tree Enrollment in CRP by State Over the Past 8 Years; USDA May 31, 2018 State Total CRP tree acres Cumulative acres Acres of total percent Region Mississippi 204,870 204,870 26 Southern Forest. Arkansas 79,341 284,211 36 Southern Forest. Louisiana 75,087 359,298 45 Southern Forest. Alabama 58,035 417,333 52 Southeast Forest. Illinois 47,824 465,156 58 Midwest Forest. Georgia 35,212 500,369 63 Southeast Forest. North Carolina 26,942 527,310 66 Southeast Forest. Minnesota 24,346 551,674 69 Northern Forest.

    The CRP Forest Inventory Analysis Pilot is intended to provide information and analysis needed to better inform CRP decision making associated with the following bottomland hardwood conservation and stand maintenance practices:

    1. CP03—Tree Planting;

    2. CP03A—Hardwood Tree Planting;

    3. CP11—Vegetative Cover—Trees Already Established; 1

    1 The purpose of the CP11 practice is to maintain a stand of trees in a timber planting previously established on cropland as practice CP-3 or CP-3A to enhance environmental benefits. This CP11 practice was available only through a re-offer of expiring or expired CRP acres.

    4. CP22—Riparian Buffer;

    5. CP31—Bottomland Timber Establishment; and

    6. CP40—Farmable Wetland Program—Aquaculture Wetland.

    The inventory, analysis, and modeling must estimate, at a minimum, stand composition, stand density, basal area, and tree height using remotely sensed data (rather than data collected by visiting a site). The data will be used to generate statistically robust estimates of commercial value, economic returns, carbon sequestration, and wildlife and water quality impacts for each of the practices in at least one of the regions and states enumerated in Table 1. These estimates will identify species appropriate for bottomland CRP practices or sites, as well as forest management practices needed to maintain cover during the contract period. An accurate assessment of the model output will be conducted using ground plots.

    Definitions

    The 2018 Consolidated Appropriations Act uses the term “non-profit organizations.” Consistent with OMB Circular A-122, the term “non-profit organization” means any corporation, trust, association, cooperative, or other organization that:

    1. Is operated primarily for scientific, educational, service, charitable, or similar purposes in the public interest;

    2. Is not organized primarily for profit; and

    3. Uses its net proceeds to maintain, improve, or expand its operations.

    The term “non-profit organization” excludes:

    1. Colleges and universities, unless a 501(c)(3) has been established;

    2. Hospitals;

    3. State, local, and federally-recognized Indian tribal governments; and

    4. Those non-profit organizations that are excluded from coverage under paragraph 5 of Office of Management and Budget (OMB) Circular A-122.

    The term “economic outcomes modelling” as used in this NOFA, must include multiple dimensions, including, but not limited to, baseline return estimates to CRP participants (taking into account, among other items, commercial value), and returns under alternative scenarios that reflect management recommendations.

    Eligibility and Application Process

    Non-profit organizations dedicated to conservation, forestry, and wildlife habitats, that have experience in conducting forest inventory analysis through the use of remote sensing data and technology are eligible to apply. Applicants must submit an application by August 25, 2018, through www.grants.gov. To find the CRP Forest Inventory Analysis Pilot in www.grants.gov, search on funding opportunity number USDA-FSA-CRPFIA-2018. Applications must include, but are not limited to, an executive summary, work plan, and budget information using Application for Federal Assistance (SF-424) form. (See www.grants.gov for more details about the specific application requirements.)

    Non-profit organizations may submit a combined cross-organization proposal to include work that will be coordinated across more than one organization, especially if a joint proposal creates synergies or increased efficiencies. The application may include one or more forest regions.

    The result of a successful application will be a one-time grant agreement. Successful applicants will be required to sign the grant agreement with FSA, which will include reporting and recordkeeping requirements. It is possible that not all of the $1 million authorized by Congress for this pilot will be expended. All applications are subject to the approval of FSA, and FSA reserves the right to reject any and all applications.

    Application Selection Criteria

    FSA will evaluate applications using the evaluation criteria specified in this NOFA and on www.grants.gov to select the application(s) that best support the goals of CRP Forest Inventory Analysis Pilot. A proposal must include the following information; this information will be used by FSA in the awarding of grants:

    1. Amount of funding requested;

    2. Amount of funding from other parties (with sufficient documentation) that provide additional leverage, if any; for example, specifying the regions, states, practices and plots where the proposal goes beyond minimal requirements (such as by considering CP-36, long-leaf pine);

    3. Sampling approach to be used;

    4. Remotely sensed data to be used, including its sources and its spatial, temporal, and spectral resolution;

    5. Number and relevance of metrics to be estimated and the modeling approach to be used to estimate the metrics;

    6. The accuracy assessment, including sampling approach and location of ground plots following the U.S. Forest Service's Common Stand Examination protocols or those in the peer-reviewed literature; and

    7. Work plan and timeline for completion by September 30, 2020.

    Process for Evaluation and Application and Awards of Grants

    After applicants submit applications, FSA, on behalf of CCC, will screen each application to determine whether the applicant is eligible and whether the application is complete and sufficiently responsive to the requirements specified in this NOFA. Applicants may revise their applications and re-submit them prior to the published deadline if there is sufficient time to do so. FSA will appoint an inter-agency review panel to evaluate the applications. During the evaluation period, FSA may contact an applicant to seek clarification and modification of the proposal. The resulting CRP Forest Inventory Analysis Pilot grant agreements will be between the non-profit organization(s) and FSA.

    Any non-profit organization that receives a grant must commit to fully expend the awarded federal funds by September 30, 2020, with an opportunity for extension upon approval by FSA.

    Responsibilities of the Participants

    Successful applicants will be required to sign an agreement with FSA and provide detailed budget and schedule information. The agreement will require periodic achievement reports. The agreement will require the grantee to commit to do all of the following:

    1. Perform inventory, analysis, modelling and validating, including conducting site visits and plot sampling, on the CRP enrolled acreage; and

    2. Provide an accounting for the money received by the grantee.

    During the term of the grant, the grantee will be required to obtain prior approval for any changes to the scope, objectives, or funding allocation of the approved agreement. Failure to obtain prior approval of such changes may be considered a violation, and in such case the grantee may be required to return all grant funds, including any funds already expended, as determined appropriate by FSA. Grantees will be required to monitor funds and report on expenditures. The grantee must certify that the CCC funds will not be used to:

    1. Duplicate existing inventories, analysis, or economic modelling efforts; however, grant funds may be used to expand the prior inventories, analysis, or economic modelling efforts;

    2. Pay costs of preparing a CRP Forest Inventory Analysis Pilot grant application;

    3. Pay costs of the project incurred prior to the date of grant approval;

    4. Fund political activities or lobbying efforts;

    5. Pay any judgment or debt owed to the United States;

    6. Pay for the repair of privately owned vehicles;

    7. Pay for unrelated salaries, overhead, and expenses; or

    8. Pay for unrelated research.

    Failure of the grantee to execute a grant agreement in a timely fashion, as determined by FSA, will be construed to be a withdrawal from the CRP Forest Inventory Analysis Pilot. In this event, FSA will demand a refund of the grant funds as deemed appropriate by FSA.

    Distribution of Grant Funds and Reimbursement of Unused Funds

    FSA expects to transfer CCC funds to the selected non-profit organization applicants before September 30, 2018.

    Environmental Review

    The environmental impacts of this NOFA have been considered in a manner consistent with the provisions of the National Environmental Policy Act (NEPA, 42 U.S.C. 4321-4347), the regulations of the Council on Environmental Quality (40 CFR parts 1500 through 1508), and the FSA regulations for compliance with NEPA (7 CFR part 799).

    The purpose of the grants for the CRP Forest Inventory Analysis Pilot is to provide the CRP Program Manager with information to inform decision-making about the effectiveness of certain conservation practices on CRP land for bottomland hardwoods and are passive in nature and will not involve ground disturbance or tree removals or disturbance. The discretionary aspects of the CRP Forest Inventory Analysis Pilot include, but are not limited to, eligibility, how many grants to award, and how to evaluate submissions. As such, the Categorical Exclusions in 7 CFR 799.31 apply, specifically 7 CFR 799.31(b)(6)(vii) and (viii) (these two categorical exclusions include site characterization, environmental testing, and monitoring where no significant alteration of existing ambient conditions would occur; and, stand analysis for forest management planning, respectively). No “Extraordinary circumstances” (7 CFR 799.33) exist; as such, FSA has determined that this NOFA does not constitute a major Federal action that would significantly affect the quality of the human environment, individually or cumulatively. Therefore, beyond this Environmental Review in this NOFA, FSA will not prepare any additional environmental documentation for this action.

    Paperwork Reduction Act Requirements

    The CRP Forest Inventory Analysis Pilot is exempt from the requirements of the Paperwork Reduction Act (44 U.S.C. Chapter 35), as amended, as specified in subsection 1601(c)(2)(B) of the Agricultural Act of 2014 (the 2014 Farm Bill, 16 U.S.C. 3846(b)), which provides that CRP, as a Title II program, be promulgated and administered without regard to the Paperwork Reduction Act.

    Catalog of Federal Domestic Assistance

    The title and number of the Federal assistance in the Catalog of Federal Domestic Assistance to which this NOFA applies is 10.122, the Conservation Reserve Program (CRP) Forest Inventory Analysis Pilot.

    Robert Stephenson, Executive Vice President, Commodity Credit Corporation.
    [FR Doc. 2018-16852 Filed 8-6-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Proposed Collection: Comment Request—Summer Food Site Locations for State Agencies AGENCY:

    Food and Nutrition Service (FNS), USDA.

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a new information collection for the voluntary collection of summer meal site information from State agencies.

    DATES:

    Written comments must be received on or before October 9, 2018.

    ADDRESSES:

    Comments may be sent to: Community Meals Branch, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Room 1200, Alexandria, VA 22302. Comments may also be submitted via fax to the attention of Andrea Farmer at 703-305-6294 or via email to [email protected] Comments will also be accepted through the Federal eRulemaking Portal. Go to http://www.regulations.gov, and follow the online instructions for submitting comments electronically.

    All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of this information collection should be directed to Andrea Farmer at 703-305-2590.

    SUPPLEMENTARY INFORMATION:

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Title: Summer Food Site Locations for State Agencies.

    Form Number: FNS-905.

    OMB Number: 0584-XXXX.

    Expiration Date: XX/XX/20xx.

    Type of Request: This is a new data collection.

    Abstract:

    This data collection was originally part of OMB control number 0584-0474 National Hunger Clearinghouse Database Forms and now has been transferred to Child Nutrition in order to improve efficiency under form number FNS-905 and a new OMB control number (0584-XXXX) Summer Food Site Locations for State Agencies.

    The Form FNS-905: Summer Food Site Locations for State Agencies is the instrument used to voluntarily collect information from State agencies about approved summer meal sites for the Summer Food Service Program and the Seamless Summer Option of the National School Lunch Program. The form collects site name, location, and operating details, such as dates and times of the day that the sites are in operation, that provide summer meals to children 18 years and younger in low income communities during the summer. The Form FNS-905 may only be completed by State agencies as Summer Sites must be approved by the State agencies before being made public.

    The Form FNS-905 is part of requirements found in statute in Section 26 of the National School Lunch Act (NLSA), which mandates that the Food and Nutrition Service (FNS) enter into a contract with a nongovernmental organization to develop and maintain a national information clearinghouse of grassroots organizations working on hunger, food, nutrition, and other agricultural issues, including food recovery, food assistance and self-help activities to aid individuals to become self-reliant, and other activities that empower low-income individuals.

    The Form FNS-543, originally developed to satisfy this statutory requirement, collects information and resources to help build the capacity of emergency food providers to address the immediate needs of struggling families and individuals while promoting self-reliance and access to healthy food. The Form FNS-543a was submitted as an addendum to Form FNS-543. The Form FNS-543 collects information directly from organizations providing other types of assistance; however, the information collected through Form FNS-543a was collected and submitted by the State agencies. Because of this, FNS decided to develop a new form to replace Form FNS-543a. Form FNS-905 was developed for this purpose and may only be submitted by State agencies. The Form FNS-905 collects information about approved summer meal sites. The information from both of these forms populates the National Hunger Clearinghouse, which is a resource for the public to find information about the food safety net.

    FNS will also provide this information for individuals to find meals for children when school is out, and for groups that assist these low income individuals or communities to find meals for children in the summer. The information provides an innovative way to connect families to meals during the summer months, and assists communities in the development, coordination, and evaluation of strategic initiatives, partnership, and outreach activities.

    Affected Public: State, Local and Tribal Government: Respondent groups identified include State agencies administering the Summer Food Service Program.

    Estimated Number of Respondents: The total estimated number of respondents is 53. This includes: the 50 State agencies administering the Summer Food Service Program as well as the District of Columbia, Virgin Islands and Puerto Rico.

    Estimated Number of Responses per Respondent: Form FNS-905 is voluntary and State agencies are asked to complete the form at least once annually. However, State agencies may submit revisions weekly throughout the summer (approximately 17 weeks). On average, State agencies tend to submit 8 revisions in the course of a year.

    Estimated Total Annual Responses: 424.

    Estimated Time per Response: The estimated time of response is approximately 7.5 minutes (0.125 hours) for each response.

    Estimated Total Annual Burden on Respondents: 53 hours. See the table below for estimated total annual burden for the state agencies.

    Respondent Estimated
  • number
  • respondent
  • Responses annually per respondent Total annual responses
  • (col. bxc)
  • Estimated
  • avg. number
  • of hours per
  • response
  • Estimated total hours
  • (col. dxe)
  • Reporting Burden State agencies 53 8 424 0.125 53 Total Reporting Burden 53 424 53
    Dated: July 30, 2018. Brandon Lipps, Administrator, Food and Nutrition Service.
    [FR Doc. 2018-16816 Filed 8-6-18; 8:45 am] BILLING CODE 3410-30-P
    DEPARTMENT OF AGRICULTURE Forest Service Boundary Establishment for Ontonagon National Wild and Scenic River, Ottawa National Forest; Gogebic, Houghton, Iron, and Ontonagon Counties, Michigan AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of availability.

    SUMMARY:

    In accordance with Section 3(b) of the Wild and Scenic Rivers Act, the USDA Forest Service, Washington Office, transmitted the final boundary of the Ontonagon National Wild and Scenic River to Congress.

    FOR FURTHER INFORMATION CONTACT:

    Information may be obtained by contacting the Ottawa National Forest, E6248 US 2; Ironwood, MI; 49938; (906)-932-1330.

    SUPPLEMENTARY INFORMATION:

    The Ontonagon Wild and Scenic River boundary is available for review at the following offices: USDA Forest Service, Lands, Yates Building, 14th and Independence Avenues SW, Washington, DC 20024; Eastern Region, 626 East Wisconsin Ave., Milwaukee, WI, 53202; and, Ottawa National Forest, E6248 US 2, Ironwood, MI, 49938.

    The Michigan Scenic Rivers Act of 1991, Public Law 102-249, March 3, 1992, designated the Ontonagon River, Michigan, as a National Wild and Scenic River, to be administered by the Secretary of Agriculture. The USDA Forest Service transmitted the final boundary to Congress on March 2, 2017. As specified by law, the boundary became effective ninety days after Congress received the transmittal.

    Dated: July 19, 2018. Glenn P. Casamassa, Associate Deputy Chief, National Forest System.
    [FR Doc. 2018-16815 Filed 8-6-18; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF COMMERCE International Trade Administration Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity To Request Administrative Review AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    FOR FURTHER INFORMATION CONTACT:

    Brenda E. Brown, Office of AD/CVD Operations, Customs Liaison Unit, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-4735.

    Background

    Each year during the anniversary month of the publication of an antidumping or countervailing duty order, finding, or suspended investigation, an interested party, as defined in section 771(9) of the Tariff Act of 1930, as amended (the Act), may request, in accordance with 19 CFR 351.213, that the Department of Commerce (Commerce) conduct an administrative review of that antidumping or countervailing duty order, finding, or suspended investigation.

    All deadlines for the submission of comments or actions by Commerce discussed below refer to the number of calendar days from the applicable starting date.

    Respondent Selection

    In the event Commerce limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, Commerce intends to select respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports during the period of review. We intend to release the CBP data under Administrative Protective Order (APO) to all parties having an APO within five days of publication of the initiation notice and to make our decision regarding respondent selection within 21 days of publication of the initiation Federal Register notice. Therefore, we encourage all parties interested in commenting on respondent selection to submit their APO applications on the date of publication of the initiation notice, or as soon thereafter as possible. Commerce invites comments regarding the CBP data and respondent selection within five days of placement of the CBP data on the record of the review.

    In the event Commerce decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:

    In general, Commerce finds that determinations concerning whether particular companies should be “collapsed” (i.e., treated as a single entity for purposes of calculating antidumping duty rates) require a substantial amount of detailed information and analysis, which often require follow-up questions and analysis. Accordingly, Commerce will not conduct collapsing analyses at the respondent selection phase of a review and will not collapse companies at the respondent selection phase unless there has been a determination to collapse certain companies in a previous segment of this antidumping proceeding (i.e., investigation, administrative review, new shipper review or changed circumstances review). For any company subject to a review, if Commerce determined, or continued to treat, that company as collapsed with others, Commerce will assume that such companies continue to operate in the same manner and will collapse them for respondent selection purposes. Otherwise, Commerce will not collapse companies for purposes of respondent selection. Parties are requested to (a) identify which companies subject to review previously were collapsed, and (b) provide a citation to the proceeding in which they were collapsed. Further, if companies are requested to complete a Quantity and Value Questionnaire for purposes of respondent selection, in general each company must report volume and value data separately for itself. Parties should not include data for any other party, even if they believe they should be treated as a single entity with that other party. If a company was collapsed with another company or companies in the most recently completed segment of a proceeding where Commerce considered collapsing that entity, complete quantity and value data for that collapsed entity must be submitted.

    Deadline for Withdrawal of Request for Administrative Review

    Pursuant to 19 CFR 351.213(d)(1), a party that requests a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that Commerce may extend this time if it is reasonable to do so. Determinations by Commerce to extend the 90-day deadline will be made on a case-by-case basis.

    Opportunity to Request a Review: Not later than the last day of August 2018,1 interested parties may request administrative review of the following orders, findings, or suspended investigations, with anniversary dates in August for the following periods:

    1 Or the next business day, if the deadline falls on a weekend, federal holiday or any other day when Commerce is closed.

    Period of review Antidumping Duty Proceedings GERMANY: Seamless Line and Pressure Pipe A-428-820 8/1/17-7/31/18 GERMANY: Sodium Nitrite A-428-841 8/1/17-7/31/18 INDIA: Finished Carbon Steel Flanges A-533-871 2/8/17-7/31/18 ITALY: Finished Carbon Steel Flanges A-475-835 2/8/17-7/31/18 JAPAN: Brass Sheet & Strip A-588-704 8/1/17-7/31/18 JAPAN: Tin Mill Products A-588-854 8/1/17-7/31/18 MALAYSIA: Polyethylene Retail Carrier Bags A-557-813 8/1/17-7/31/18 MEXICO: Light-Walled Rectangular Pipe and Tube A-201-836 8/1/17-7/31/18 REPUBLIC OF KOREA: Dioctyl Terephthalate (Dotp) A-580-889 2/3/17-7/31/18 REPUBLIC OF KOREA: Large Power Transformers A-580-867 8/1/17-7/31/18 REPUBLIC OF KOREA: Light-Walled Rectangular Pipe and Tube A-580-859 8/1/17-7/31/18 ROMANIA: Carbon and Alloy Seamless Standard, Line, and Pressure Pipe A-428-805 (Under 41/2 Inches) 8/1/17-7/31/18 SOCIALIST REPUBLIC OF VIETMAN: Frozen Fish Fillets A-552-801 8/1/17-7/31/18 THAILAND: Polyethylene Retail Carrier Bags A-549-821 8/1/17-7/31/18 THE PEOPLE'S REPUBLIC OF CHINA: Floor-Standing, Metal-Top Ironing Tables and Parts Thereof A-570-888 8/1/17-7/31/18 THE PEOPLE'S REPUBLIC OF CHINA: Hydrofluorocarbon Blends A-570-028 8/1/17-7/31/18 THE PEOPLE'S REPUBLIC OF CHINA: Laminated Woven Sacks A-570-916 8/1/17-7/31/18 THE PEOPLE'S REPUBLIC OF CHINA: Light-Walled Rectangular Pipe and Tube A-570-914 8/1/17-7/31/18 THE PEOPLE'S REPUBLIC OF CHINA: Passenger Vehicle and Light Truck Tires A-570-016 8/1/17-7/31/18 THE PEOPLE'S REPUBLIC OF CHINA: Petroleum Wax Candles A-570-504 8/1/17-7/31/18 THE PEOPLE'S REPUBLIC OF CHINA: Polyethylene Retail Carrier Bags A-570-886 8/1/17-7/31/18 THE PEOPLE'S REPUBLIC OF CHINA: Sodium Nitrite A-570-925 8/1/17-7/31/18 THE PEOPLE'S REPUBLIC OF CHINA: Steel Nail A-570-909 8/1/17-7/31/18 THE PEOPLE'S REPUBLIC OF CHINA: Sulfanilic Acid A-570-815 8/1/17-7/31/18 THE PEOPLE'S REPUBLIC OF CHINA: Tetrahydrofurfuryl Alcohol A-570-887 8/1/17-7/31/18 THE PEOPLE'S REPUBLIC OF CHINA: Tow-Behind Lawn Groomers and Parts Thereof A-570-939 8/1/17-7/31/18 UKRAINE: Silicomanganese A-823-805 8/1/17-7/31/18 Countervailing Duty Proceedings INDIA: Finished Carbon Steel Flanges C-533-872 11/29/16-12/31/17 REPUBLIC OF KOREA: Stainless Steel Sheet and Strip in Coils C-580-835 1/1/17-12/31/17 THE PEOPLE'S REPUBLIC OF CHINA: Laminated Woven Sacks C-570-917 1/1/17-12/31/17 THE PEOPLE'S REPUBLIC OF CHINA: Light-Walled Rectangular Pipe and Tube C-570-915 1/1/17-12/31/17 THE PEOPLE'S REPUBLIC OF CHINA: Passenger Vehicle and Light Truck Tires C-570-017 1/1/17-12/31/17 THE PEOPLE'S REPUBLIC OF CHINA: Sodium Nitrite C-570-926 1/1/17-12/31/17 Suspension Agreements None

    In accordance with 19 CFR 351.213(b), an interested party as defined by section 771(9) of the Act may request in writing that the Secretary conduct an administrative review. For both antidumping and countervailing duty reviews, the interested party must specify the individual producers or exporters covered by an antidumping finding or an antidumping or countervailing duty order or suspension agreement for which it is requesting a review. In addition, a domestic interested party or an interested party described in section 771(9)(B) of the Act must state why it desires the Secretary to review those particular producers or exporters. If the interested party intends for the Secretary to review sales of merchandise by an exporter (or a producer if that producer also exports merchandise from other suppliers) which was produced in more than one country of origin and each country of origin is subject to a separate order, then the interested party must state specifically, on an order-by-order basis, which exporter(s) the request is intended to cover.

    Note that, for any party Commerce was unable to locate in prior segments, Commerce will not accept a request for an administrative review of that party absent new information as to the party's location. Moreover, if the interested party who files a request for review is unable to locate the producer or exporter for which it requested the review, the interested party must provide an explanation of the attempts it made to locate the producer or exporter at the same time it files its request for review, in order for the Secretary to determine if the interested party's attempts were reasonable, pursuant to 19 CFR 351.303(f)(3)(ii).

    As explained in Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003), and Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011), Commerce clarified its practice with respect to the collection of final antidumping duties on imports of merchandise where intermediate firms are involved. The public should be aware of this clarification in determining whether to request an administrative review of merchandise subject to antidumping findings and orders.2

    2See also the Enforcement and Compliance website at http://trade.gov/enforcement/.

    Commerce no longer considers the non-market economy (NME) entity as an exporter conditionally subject to an antidumping duty administrative reviews.3 Accordingly, the NME entity will not be under review unless Commerce specifically receives a request for, or self-initiates, a review of the NME entity.4 In administrative reviews of antidumping duty orders on merchandise from NME countries where a review of the NME entity has not been initiated, but where an individual exporter for which a review was initiated does not qualify for a separate rate, Commerce will issue a final decision indicating that the company in question is part of the NME entity. However, in that situation, because no review of the NME entity was conducted, the NME entity's entries were not subject to the review and the rate for the NME entity is not subject to change as a result of that review (although the rate for the individual exporter may change as a function of the finding that the exporter is part of the NME entity). Following initiation of an antidumping administrative review when there is no review requested of the NME entity, Commerce will instruct CBP to liquidate entries for all exporters not named in the initiation notice, including those that were suspended at the NME entity rate.

    3See 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).

    4 In accordance with 19 CFR 351.213(b)(1), parties should specify that they are requesting a review of entries from exporters comprising the entity, and to the extent possible, include the names of such exporters in their request.

    All requests must be filed electronically in Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS) on Enforcement and Compliance's ACCESS website at http://access.trade.gov. 5 Further, in accordance with 19 CFR 351.303(f)(l)(i), a copy of each request must be served on the petitioner and each exporter or producer specified in the request.

    5See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011).

    Commerce will publish in the Federal Register a notice of “Initiation of Administrative Review of Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation” for requests received by the last day of August 2018. If Commerce does not receive, by the last day of August 2018, a request for review of entries covered by an order, finding, or suspended investigation listed in this notice and for the period identified above, Commerce will instruct CBP to assess antidumping or countervailing duties on those entries at a rate equal to the cash deposit of estimated antidumping or countervailing duties required on those entries at the time of entry, or withdrawal from warehouse, for consumption and to continue to collect the cash deposit previously ordered.

    For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period of the order, if such a gap period is applicable to the period of review.

    This notice is not required by statute but is published as a service to the international trading community.

    Dated: August 1, 2018. James Maeder, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2018-16850 Filed 8-6-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Notice of Availability of Draft Programmatic Environmental Assessments for Field Operations at Thirteen National Marine Sanctuaries and Two Marine National Monuments AGENCY:

    Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).

    ACTION:

    Notice of availability.

    SUMMARY:

    The National Oceanic and Atmospheric Administration (NOAA) has prepared four draft programmatic environmental assessments for the proposed continuation of field operations for each region of sites managed by the Office of National Marine Sanctuaries. The field operations support resource protection, research and education objectives as mandated by the National Marine Sanctuaries Act and as described in site-specific management plans. In each PEA, NOAA analyzes the potential effects on the human environment of two alternatives to implement field operations in the subject region. NOAA is soliciting public comment on the four regional draft programmatic environmental assessments.

    DATES:

    Comments on these draft programmatic environmental assessments will be considered if received by September 21, 2018.

    ADDRESSES:

    You may submit comments on these documents, identified by NOAA-NOS-2018-XXXX, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NOS-2018-XXXX, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments. Mail: Helene Scalliet, Office of National Marine Sanctuaries, 1305 East West Highway, R/ORM6, Silver Spring, MD 20910.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NOAA. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NOAA will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    FOR FURTHER INFORMATION CONTACT:

    Helene Scalliet, Policy and Planning Division, Office of National Marine Sanctuaries at 240-533-0648 or via email at [email protected] Copies of the draft programmatic environmental assessments can be downloaded or viewed on the internet at www.regulations.gov (search for docket #NOAA-NOS-2018-XXXX). Copies can also be obtained by contacting the person identified under FOR FURTHER INFORMATION CONTACT.

    SUPPLEMENTARY INFORMATION: I. Background

    NOAA's Office of National Marine Sanctuaries (ONMS) serves as the trustee for a network of underwater parks encompassing more than 600,000 square miles of marine and Great Lakes waters. The network includes a system of 13 national marine sanctuaries and Papahānaumokuākea and Rose Atoll marine national monuments. The National Marine Sanctuaries Act (NMSA; 16 U.S.C. 1431 et seq.) is the statute governing the National Marine Sanctuary System. The NMSA authorizes the Secretary of Commerce to designate as national marine sanctuaries areas of the marine environment or Great Lakes with special national significance due to their conservation, recreational, ecological, historical, scientific, cultural, archeological, educational or aesthetic qualities. The primary objective of the NMSA is to protect sanctuary resources, which span diverse geographic and administrative boundaries. Accordingly, ONMS subscribes to a broad and comprehensive management approach to meet the NMSA's primary objective of resource protection. Comprehensive sanctuary and monument management, described in detail in each site's management plan, serves as a framework for addressing long-term protection of a wide range of living and non-living marine resources, while allowing multiple uses of the site to the extent that they are compatible with the primary goal of resource protection. These plans are site-specific documents used by all national marine sanctuaries and the monuments for which ONMS has management responsibilities. The NMSA requires that ONMS develop and periodically review the management plans for each national marine sanctuary (Sec. 304(a)(2)(A) and (e)). Since revision of a management plan often constitutes a Federal action, ONMS typically analyzes changes to the management plan under NEPA. In many cases, this analysis does not analyze in-depth consequences of routine field operations, such as vessel operations and ongoing research programs. The draft PEAs announced through this notice are designed to analyze these routine field operations not previously adequately analyzed under the National Environmental Policy Act during the management plan review process.

    Within the context of the ONMS management plans, field operations are an important component of implementing many of the actions necessary to support resource protection, research and education activities. The management plans also contain information relevant to these draft regional programmatic environmental assessments (PEAs) such as background about each sanctuary environment and its resources.

    II. NOAA's Proposed Action

    NOAA has prepared four draft PEAs for the proposed continuation of field operations described in management plans for each site managed by the Office of National Marine Sanctuaries. There is a draft PEA for each of the following regions: West Coast, Pacific Islands, Northeast/Great Lakes, and Southeast/Gulf of Mexico. The purpose of the underlying field operations analyzed in the draft PEAs is to support resource protection, research and education objectives as mandated by the National Marine Sanctuaries Act and as described in site-specific management plans. Field operations in ONMS-managed sites fall under 10 categories: vessel operations; vessel maintenance; aircraft operations; non-motorized craft operations; SCUBA or snorkel operations; onshore field work; deployment of autonomous underwater vehicles (AUVs)/remotely operated vehicles (ROVs)/gliders/drifters; deployment of remote sensing equipment; deployment of equipment on the seafloor; and other sampling activities. The four regional draft PEAs describe in detail the field operations taking place at each site in the next five years as well as their environmental impacts on the physical, biological, socioeconomic, maritime heritage and cultural environment.

    In these documents, NOAA analyzes the potential effects of two alternatives to implement the proposed action. NOAA also intends to use these four draft PEAs as the basis for compliance under the Marine Mammal Protection Act, Endangered Species Act, Magnuson-Stevens Act, National Historic Preservation Act, and Coastal Zone Management Act. NOAA intends to finalize any necessary compliance requirements for these statutes prior to finalizing this action.

    Authority:

    16 U.S.C. 1431 et seq.

    Thomas Culliton, Acting Director, Office of National Marine Sanctuaries.
    [FR Doc. 2018-16812 Filed 8-6-18; 8:45 am] BILLING CODE 3510-NK-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG386 Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of public meeting (webinar).

    SUMMARY:

    The Pacific Fishery Management Council's (Pacific Council) Ad Hoc Ecosystem Workgroup (EWG) will hold a meeting via webinar, which is open to the public.

    DATES:

    The webinar meeting will be held on Tuesday, August 21, 2018, from 1:30 p.m. to 3:30 p.m. (Pacific Daylight Time) or until business for the day has been completed.

    ADDRESSES:

    The meeting will be held via webinar. A public listening station is available at the Pacific Council office (address below). To attend the webinar (1) join by visiting this link http://www.gotomeeting.com/online/webinar/join-webinar, (2) enter the Webinar ID: 241-675-131, and (3) enter your name and email address (required). After logging in to the webinar, please (1) dial this TOLL number +1 (415) 655-0052 (not a toll-free number), (2) enter the attendee phone audio access code 563-806-284, and (3) then enter your audio phone pin (shown after joining the webinar). NOTE: We have disabled Mic/Speakers as an option and require all participants to use a telephone or cell phone to participate. Technical Information and system requirements: PC-based attendees are required to use Windows® 7, Vista, or XP; Mac®-based attendees are required to use Mac OS® X 10.5 or newer; Mobile attendees are required to use iPhone®, iPad®, AndroidTM phone or Android tablet (See https://www.gotomeeting.com/webinar/ipad-iphone-android-webinar-apps). You may send an email to Mr. Kris Kleinschmidt at [email protected] or contact him at (503) 820-2280, extension 411 for technical assistance.

    Council address: Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Kit Dahl, Pacific Council; telephone: (503) 820-2422.

    SUPPLEMENTARY INFORMATION:

    The EWG is holding this webinar to help other Council advisory bodies and the public prepare comments on two topics the Council will take up at its September 7-12, 2018 meeting. First, the Council will be deciding on future activities as part of the Climate and Communities Initiative pursuant to its Fishery Ecosystem Plan (FEP). Second, the Council will be scoping the first 5-year review of the FEP. The Council may consider initiating revisions to FEP and forming any new ad hoc committees necessary to revise the Plan. To help advisory bodies and the public make comments on these topics the EWG prepared two sets of discussion questions, available on the Council's website (https://www.pcouncil.org/):

    • Webinar Discussion Questions • Webinar Agenda

    Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt, (503) 820-2411, at least 10 business days prior to the meeting date.

    Dated: August 1, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-16809 Filed 8-6-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers Availability of the Final Environmental Impact Statement for the Northern Integrated Supply Project, Larimer and Weld Counties, Colorado AGENCY:

    Department of the Army, U.S. Army Corps of Engineers, DoD.

    ACTION:

    Notice; extension of public comment deadline.

    SUMMARY:

    The comment period for the Availability of the Final Environmental Impact Statement for the Northern Integrated Supply Project, Larimer and Weld Counties, Colorado published in the Federal Register on Friday, July 20, 2018, and required comments be postmarked on or before September 4, 2018. The Corps is extending the deadline for submitting public comments to October 4, 2018.

    FOR FURTHER INFORMATION CONTACT:

    John Urbanic, NISP EIS Project Manager, telephone 303-979-4120, fax at 303-979-0602, or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    None.

    Brenda S. Bowen, Army Federal Register Liaison Officer.
    [FR Doc. 2018-16861 Filed 8-6-18; 8:45 am] BILLING CODE 3720-58-P
    DEPARTMENT OF DEFENSE Department of the Army; Corps of Engineers Withdrawal of the Notice of Intent To Prepare an Environmental Impact Statement (EIS) for the City of Abilene, TX, Cedar Ridge Reservoir Water Supply Project AGENCY:

    Department of the Army, U.S. Army Corps of Engineers, DoD.

    ACTION:

    Notice.

    SUMMARY:

    The U.S. Army Corps of Engineers, Fort Worth District, Regulatory Division is notifying interested parties that it has withdrawn the Notice of Intent (NOI) to develop an EIS for the proposed Cedar Ridge Reservoir. The original NOI to Prepare an EIS was published in the Federal Register on Friday, April 13, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Questions regarding the withdrawal of this NOI should be addressed to Mr. Frederick Land, Regulatory Division (CESWF-DE-R), Fort Worth District, U.S. Army Corps of Engineers, P.O. Box 17300, Fort Worth, TX 76102-0300; (817) 886-1729; [email protected].

    SUPPLEMENTARY INFORMATION:

    On March 20, 2018, the Office of Management and Budget (OMB) and the Council on Environmental Quality (CEQ) issued an OMB/CEQ Memorandum for Heads of Federal Departments and Agencies titled “One Federal Decision Framework for the Environmental Review and Authorization Process for Major Infrastructure Projects under Executive Order [E.O.] 13807.” Additionally, twelve federal agencies, including Department of the Army, signed a Memorandum of Understanding (MOU) as an appendix to the OMB/CEQ Memorandum. The MOU is titled “Memorandum of Understanding Implementing One Federal Decision Under Executive Order 13807” and was effective on April 10, 2018. E.O. 13807 sets a goal for agencies of reducing the time for completing environmental reviews and authorization decisions to an agency average of not more than two years from publication of a NOI to prepare an EIS. The MOU set forth activities to be accomplished before the issuance of an NOI, including project prescoping, the development of a permitting timetable, and the development of project Purpose and Need. Because the Cedar Ridge Reservoir planning had not reached these milestones prior to publication of the NOI, the NOI is being withdrawn until such time that these milestones are complete.

    Brenda S. Bowen, Army Federal Register Liaison Officer.
    [FR Doc. 2018-16862 Filed 8-6-18; 8:45 am] BILLING CODE 3720-58-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. 10,012,457 (Navy Case No. 200367): TAKE-DOWN COMPACT PRECISION RIFLE//Patent No. 10,036,800 (Navy Case No. 103387): SYSTEMS AND METHODS FOR USING COHERENT NOISE FILTERING//and Patent No. 10,037,498 (Navy Case No. 100130): PROJECT MANAGEMENT SYSTEM AND METHOD.

    Authority:

    35 U.S.C. 207, 37 CFR part 404

    Dated: August 2, 2018. Emilee Kujat Baldini, Lieutenant Commander, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer.
    [FR Doc. 2018-16875 Filed 8-6-18; 8:45 am] BILLING CODE 3810-FF-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2804-035] Goose River Hydro, Inc.; Notice of Application Accepted for Filing and Soliciting Motions To Intervene and Protests

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.

    a. Type of Application: New Minor License.

    b. Project No.: 2804-035.

    c. Date filed: February 2, 2018.

    d. Applicant: Goose River Hydro, Inc.

    e. Name of Project: Goose River Hydroelectric Project.

    f. Location: On the Goose River, in Waldo County, Maine. 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: Nicholas Cabral, Goose River Hydro, Inc., 41 Sedgewood Drive, Kennebunk, ME 04043; (207) 604-4394; email—[email protected].

    i. FERC Contact: Julia Kolberg at (202) 502-8261; or email at [email protected].

    j. Deadline for filing motions to intervene and protests: 60 days from the issuance date of this notice.

    The Commission strongly encourages electronic filing. Please file motions to intervene and protests 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-2804-035.

    The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor 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.

    k. This application has been accepted, but is not ready for environmental analysis at this time.

    l. The project consists of the following existing facilities:

    Swan Lake Dam

    (1) A 14-foot-high, 250-foot-long rock masonry gravity dam impounding Swan Lake with a surface area of approximately 1,364 acres at an elevation of 201 feet above sea level; (2) a concrete inlet structure; (3) three 3.5-foot-high, 4-foot-wide manually operated butterfly gates that regulate flow through the inlet structure; (4) two culverts the convey flow under Route 141; and (5) appurtenant facilities.

    Mason's Dam

    (1) A 15-foot-high, 86-foot-long rock masonry dam impounding a reservoir with a storage capacity of approximately 1,621 acre-feet at an elevation of 188 feet above sea level; (2) a concrete inlet structure; (3) a manually operated butterfly gate regulating flow from the inlet structure to the penstock; (4) a 3-foot-diameter, 350-foot-long steel penstock; (5) a 266-square-foot concrete powerhouse containing two Kaplan turbines and generating units with a licensed capacity of 75 kW; (6) a 300-foot-long, 12-kilovolt (kV) transmission line and (7) appurtenant facilities.

    Kelley Dam

    (1) A 15-foot-high, 135-foot-long masonry gravity dam impounding a reservoir with a storage capacity of approximately 200 acre-feet at an elevation of approximately 159 feet above sea level; and (2) three 3-foot-high, 4-foot-wide manually operated butterfly gates.

    Mill Dam

    (1) A 6-foot-tall, 70-foot-wide masonry dam impounding a reservoir with a storage capacity of approximately 7 acre-feet at an elevation of approximately 128 feet above sea level; (2) a concrete inlet structure; (3) a trash sluice with wooden stop logs; (4) a powerhouse containing a Francis-type turbine and generator unit with a licensed capacity of 94 kW; and (5) an approximately 100-foot-long, 12-kV transmission line. The penstock used to deliver water to the powerhouse has been removed due to deterioration and subsequent leakage; thus, the powerhouse is not operating.

    CMP Dam

    (1) A 21-foot-high, 231-foot-long buttress dam impounding a reservoir with a storage capacity of approximately 72 acre-feet at an elevation of approximately 109 feet above sea level; (2) a manually operated low-level water release lift gate; (3) a manually operated lift gate regulating flow to the penstock; (4) a 5-foot-diameter, 1,200-foot-long steel penstock; (5) a 300-square-foot concrete and timber powerhouse with a Kaplan-type turbine and generator unit with a licensed capacity of 200 kW; and (6) an approximately 500-foot-long, 12-kV transmission line. The penstock used to deliver water to the powerhouse is currently out of service due to damage, deterioration, and subsequent leakage; thus, the powerhouse is not operating.

    m. 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.

    n. Anyone may submit a protest or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, 385.211, and 385.214. In determining the appropriate action to take, the Commission will consider all protests 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 protests or motions to intervene must be received on or before the specified deadline date for the particular application.

    All filings must (1) bear in all capital letters the title PROTEST or MOTION TO INTERVENE; (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. 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.

    Dated: July 30, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-16828 Filed 8-6-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC18-125-000.

    Applicants: RE Rosamond One LLC, RE Rosamond Two LLC, CS HoldCo 1 LLC.

    Description: Joint Application for Authorization Under Section 203 of the Federal Power Act of RE Rosamond One LLC, et. al.

    Filed Date: 7/26/18.

    Accession Number: 20180726-5215.

    Comments Due: 5 p.m. ET 8/16/18.

    Docket Numbers: EC18-126-000.

    Applicants: Minco Wind III, LLC, Minco IV & V Interconnection, LLC.

    Description: Joint Application for Authorization Under Section 203 of the Federal Power Act of Minco Wind III, LLC, et. al.

    Filed Date: 7/26/18.

    Accession Number: 20180726-5220.

    Comments Due: 5 p.m. ET 8/16/18.

    Docket Numbers: EC18-127-000.

    Applicants: RE McKenzie 1 LLC, RE McKenzie 2 LLC, RE McKenzie 3 LLC, RE McKenzie 4 LLC, RE McKenzie 5 LLC, RE McKenzie 6 LLC, CS HoldCo 1 LLC.

    Description: Joint Application for Authorization Under Section 203 of the Federal Power Act of McKenzie 1 LLC, et. al.

    Filed Date: 7/26/18.

    Accession Number: 20180726-5223.

    Comments Due: 5 p.m. ET 8/16/18.

    Docket Numbers: EC18-128-000.

    Applicants: Llano Estacado Wind, LLC, Mitsubishi Heavy Industries America, Inc.

    Description: Joint Application for Authorization Under Section 203 of the Federal Power Act of Llano Estacado Wind, LLC, et. al.

    Filed Date: 7/26/18.

    Accession Number: 20180726-5227.

    Comments Due: 5 p.m. ET 8/16/18.

    Docket Numbers: EC18-129-000.

    Applicants: Noble Great Plains Windpark, LLC.

    Description: Application for Authorization Under Section 203 of the Federal Power Act of Noble Great Plains Windpark, LLC.

    Filed Date: 7/26/18.

    Accession Number: 20180726-5229.

    Comments Due: 5 p.m. ET 8/16/18.

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG18-112-000.

    Applicants: Enel Green Power North America, Inc.

    Description: Self-Certification of EG or FC of Enel Green Power Hilltopper Wind LLC, a subsidiary of Enel Green Power North America, Inc.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5130.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: EG18-113-000.

    Applicants: Enel Green Power North America, Inc.

    Description: Self-Certification of EG Enel Green Power Rattlesnake Creek Wind Project, LLC a subsidiary of Enel Green Power North America, Inc.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5131.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: EG18-114-000.

    Applicants: Enel Green Power North America, Inc.

    Description: Self-Certification of EG of Enel Green Power Diamond Vista Wind Project, LLC, a subsidiary of Enel Green Power North America, Inc.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5132.

    Comments Due: 5 p.m. ET 8/17/18.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER18-1636-001.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Tariff Amendment: 2018-07-27_Deficiency response to Align PRA and Attachment Y Process to be effective 7/16/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5141.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2070-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-07-26_Address Change Clean- Up Filing to be effective 7/27/2018.

    Filed Date: 7/26/18.

    Accession Number: 20180726-5188.

    Comments Due: 5 p.m. ET 8/16/18.

    Docket Numbers: ER18-2071-000.

    Applicants: Niagara Mohawk Power Corporation, New York Independent System Operator, Inc.

    Description: Tariff Cancellation: Niagara Mohawk cancellation re: interconnection agreement Village of Ilion to be effective 9/26/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5002.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2072-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 1875R3 Kansas Electric Power Cooperative, Inc. NITSA and NOA to be effective 7/31/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5027.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2073-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-07-27_SA 3134 Entergy Texas-Liberty County Solar Project GIA (J483) to be effective 7/13/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5036.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2074-000.

    Applicants: AEP Texas Inc.

    Description: § 205(d) Rate Filing: AEPTX-Pedernales Electric Cooperative TSA Amend & Restated to be effective 6/1/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5038.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2075-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-07-27_SA 3135 Entergy Louisiana, LLC-Entergy Louisiana, LLC GIA (J484) to be effective 7/13/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5042.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2076-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-07-27_SA 3136 Entergy Texas, Inc.-Entergy Texas, Inc GIA (J472) to be effective 7/13/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5043.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2077-000.

    Applicants: Rock River I, LLC.

    Description: § 205(d) Rate Filing: Notice of Change in Status and Change in Category Seller Status to be effective 7/28/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5044.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2078-000.

    Applicants: ISO New England Inc., New England Power Pool Participants Committee.

    Description: § 205(d) Rate Filing: ISO-NE and NEPOOL; Revisions to the Rationing Limit to be effective 9/25/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5101.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2079-000.

    Applicants: Entergy Arkansas, Inc.

    Description: Tariff Cancellation: EAI-ESI Reimbursement Agreement to be effective 8/1/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5111.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2080-000.

    Applicants: Entergy Louisiana, LLC.

    Description: Tariff Cancellation: ELL-ESI Reimbursement Agreement to be effective 8/1/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5114.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2081-000.

    Applicants: Entergy Mississippi, Inc.

    Description: Tariff Cancellation: EMI-ESI Reimbursement Agreement to be effective 8/1/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5121.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2082-000.

    Applicants: Duke Energy Carolinas, LLC.

    Description: § 205(d) Rate Filing: DEC-NC BioGas, LLC ASOA (SA-496) to be effective 9/26/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5122.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2083-000.

    Applicants: Entergy New Orleans, Inc.

    Description: Tariff Cancellation: ENO-ESI Reimbursement Agreement to be effective 8/1/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5123.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2084-000.

    Applicants: Entergy Texas, Inc.

    Description: Tariff Cancellation: ETI-ESI Reimbursement Agreement to be effective 8/1/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5125.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2085-000.

    Applicants: Cambria CoGen Company.

    Description: Baseline eTariff Filing: Cambria CoGen Reactive Supply Service Tariff Filing to be effective 9/1/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5154.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2086-000.

    Applicants: 64KT 8me LLC.

    Description: § 205(d) Rate Filing: Certificate of Concurrence to Co-Tenancy and Shared Facilities Agreement to be effective 7/28/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5155.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2087-000.

    Applicants: ITC Midwest LLC.

    Description: § 205(d) Rate Filing: Filing of CIAC Agreement to be effective 7/30/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5156.

    Comments Due: 5 p.m. ET 8/17/18.

    Docket Numbers: ER18-2088-000.

    Applicants: 64KT 8me LLC.

    Description: § 205(d) Rate Filing: Certificate of Concurrence to LGIA Co-Tenancy Agreement to be effective 7/28/2018.

    Filed Date: 7/27/18.

    Accession Number: 20180727-5157.

    Comments Due: 5 p.m. ET 8/17/18.

    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: July 27, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-16817 Filed 8-6-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL15-47-003] NextEra Desert Center Blythe, LLC v. California Independent System Operator Corporation: Notice of Filing

    Take notice that on July 31, 2018, NextEra Desert Center Blythe, LLC on behalf of itself, Southern California Edison Company, and California Independent System Operator Corporation submitted an offer of settlement intended to resolve all issues in the above-captioned proceeding.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.

    The Commission encourages electronic submission of 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.

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern Time on August 21, 2018.

    Dated: July 31, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-16822 Filed 8-6-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP18-530-000] Notice of Request Under Blanket Authorization; Florida Gas Transmission, LLC

    Take notice that on July 19, 2018, Florida Gas Transmission, LLC (FGT), 1300 Main St., Houston, Texas 77002, filed in Docket No. CP18-530-000 a prior notice request pursuant to sections 157.205, 157.208, 157.210 and 157.211 of the Commission's regulations under the Natural Gas Act (NGA), requesting authorization to construct/modify, own, maintain and operate, certain natural gas mainline facilities and appurtenances in Santa Rosa County, Florida, and modify an existing delivery point, in Escambia County, Alabama for its South Alabama Project. FGT's South Alabama Project would provide up to 60,000 million British thermal units per day of firm transportation service to two shippers, all as more fully set forth in the application which is on file with the Commission and open to public inspection. FGT estimates the cost of the proposed project to be approximately $7,000,000. 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 Blair Lichtenwalter, Senior Director of Certificates, Florida Gas Transmission Company, LLC, 1300 Main St., Houston, Texas 77002, or call (713) 989-2605, or fax (713) 989-1205, or via eMail to [email protected]

    Any person or the Commission's staff may, within 60 days after issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and pursuant to section 157.205 of the regulations under the NGA (18 CFR 157.205), a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for filing a protest. If a protest is filed and not withdrawn within 30 days after the allowed time for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.

    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 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 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 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.

    Dated: July 27, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-16827 Filed 8-6-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-2066-000] Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization; Minco Wind IV, LLC

    This is a supplemental notice in the above-referenced proceeding of Minco Wind IV, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is August 16, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: July 27, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-16819 Filed 8-6-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-2067-000] Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization; Minco Wind V, LLC

    This is a supplemental notice in the above-referenced proceeding of Minco Wind V, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is August 16, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: July 27, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-16818 Filed 8-6-18; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2018-0210; FRL-9981-54] Problem Formulations for the Risk Evaluations To Be Conducted for the First Ten Chemical Substances Under the Toxic Substances Control Act, and Application of Systematic Review in TSCA Risk Evaluations; Extension of Comment Period AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice; extension of comment period.

    SUMMARY:

    EPA issued a notice in the Federal Register of June 11, 2018, opening a comment period on problem formulations for the risk evaluations to be conducted for the first ten chemical substances listed in Table 1, along with a document entitled Application of Systematic Review in TSCA Risk Evaluations. This document extends the close of the comment period on the problem formulations for an additional 21 days, from July 26, 2018 to August 16, 2018. This comment period is being extended in response to requests received by the Agency. The Agency is also taking comments on the document entitled Application of Systematic Review in TSCA Risk Evaluations in conjunction with this comment period and not through a separate comment period. The systematic review document includes a structured process of identifying, evaluating and integrating evidence for both the hazard and exposure assessments developed during the TSCA risk evaluation process. This document may be revised periodically. EPA welcomes public input on the document.

    DATES:

    Comments, identified by docket identification (ID) numbers identified in Table 1, must be received on or before August 16, 2018.

    ADDRESSES:

    Follow the detailed instructions provided under ADDRESSES in the Federal Register document of June 11, 2018 (83 FR 26998) (FRL-9978-40).

    FOR FURTHER INFORMATION CONTACT:

    For technical information on the Problem Formulation documents contact: Christina Motilall, Risk Assessment Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-1287; email address: [email protected]

    For technical information on Application of Systematic Review in TSCA Risk Evaluations contact: Iris Camacho, Risk Assessment Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-1229; email address: [email protected]

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

    SUPPLEMENTARY INFORMATION:

    This document extends the public comment period for certain chemicals established in the Federal Register document of June 11, 2018 (83 FR 26998) (FRL- 9978-40). In that document, a public comment period opened on EPA's problem formulation documents for the first 10 chemical substances undergoing risk evaluation under the Toxic Substances Control Act (TSCA) in Table 1 and the document entitled Application of Systematic Review in TSCA Risk Evaluations. EPA is hereby further extending the comment period for the problem formulation, and the document entitled Application of Systematic Review in TSCA Risk Evaluations, which was set to end on July 26, 2018, to August 16, 2018.

    Although the comment periods will end on August 16, 2018, EPA will try to consider any additional comments received after this date. However, given the need to peer review the draft risk evaluations, the peer reviewers may not receive public comments submitted late. There will be an additional comment period following the publication of each of the draft risk evaluations.

    Table 1—Chemicals With Extended Comment Periods Chemical name Docket ID No. Agency contact Asbestos EPA-HQ-OPPT-2016-0736 Robert Courtnage, [email protected], 202-566-1081. 1-Bromopropane EPA-HQ-OPPT-2016-0741 Ana Corado, [email protected], 202-564-0140. 1,4-Dioxane EPA-HQ-OPPT-2016-0723 Cindy Wheeler, [email protected], 202-566-0484. Carbon Tetrachloride EPA-HQ-OPPT-2016-0733 Stephanie Jarmul, [email protected], 202-564-6130. Cyclic Aliphatic Bromide Cluster (HBCD) EPA-HQ-OPPT-2016-0735 Sue Slotnick, [email protected], 202-566-1973. Methylene Chloride EPA-HQ-OPPT-2016-0742 Ana Corado, [email protected], 202-564-0140. N-Methylpyrrolidone (NMP) EPA-HQ-OPPT-2016-0743 Ana Corado, [email protected], 202-564-0140. Pigment Violet 29 (Anthra[2,1,9-def:6,5,10-d′e′f′] diisoquinoline-1,3,8,10(2H,9H)-tetrone) EPA-HQ-OPPT-2016-0725 Hannah Braun, [email protected], 202-564-5614. Tetrachloroethylene (also known as perchloroethylene) EPA-HQ-OPPT-2016-0732 Tyler Lloyd, [email protected], 202-564-4016. Trichloroethylene (TCE) EPA-HQ-OPPT-2016-0737 Toni Krasnic, [email protected], 202-564-0984.

    To submit comments, or access the docket, please follow the detailed instructions provided under ADDRESSES in the Federal Register document of June 11, 2018. If you have questions on individual chemicals, consult the person listed in Table 1.

    Authority:

    15 U.S.C. 2601 et seq.

    Dated: July 25, 2018. Jeffery T. Morris, Director, Office of Pollution Prevention and Toxics, Office of Chemical Safety and Pollution Prevention.
    [FR Doc. 2018-16879 Filed 8-6-18; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION Deletion of Item From Sunshine Act Meeting August 1, 2018.

    The following item has been deleted from the list of items scheduled for consideration at the Thursday, August 2, 2018, Open Meeting and previously listed in the Commission's Notice of July 26, 2018.

    7 OFFICE OF MANAGING DIRECTOR Title: Office of Managing Director Personnel Action #75. Summary: The Commission will consider a personnel action. Federal Communications Commission. Marlene Dortch, Secretary.
    [FR Doc. 2018-16896 Filed 8-3-18; 11:15 am] BILLING CODE 6712-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Agency Information Collection Activities: Proposed Collection Renewal; Comment Request (OMB No. 3064-0151) AGENCY:

    Federal Deposit Insurance Corporation (FDIC).

    ACTION:

    Notice and request for comment.

    SUMMARY:

    The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collection, as required by the Paperwork Reduction Act of 1995 (OMB No. 3064-0151).

    DATES:

    Comments must be submitted on or before October 9, 2018.

    ADDRESSES:

    Interested parties are invited to submit written comments to the FDIC by any of the following methods:

    Agency website: https://www.FDIC.gov/regulations/laws/federal.

    Email: [email protected] Include the name and number of the collection in the subject line of the message.

    Mail: Jennifer Jones (202-898-6768), Counsel, MB-3105, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429.

    Hand Delivery: Comments may be hand-delivered to the guard station at the rear of the 17th Street Building (located on F Street), on business days between 7:00 a.m. and 5:00 p.m.

    All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Jones, Counsel, 202-898-6768, [email protected], MB-3105, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429.

    SUPPLEMENTARY INFORMATION:

    Proposal to renew the following currently approved collection of information:

    1. Title: Notice Regarding Assessment Credits.

    OMB Number: 3064-0151.

    Form Number: None.

    Affected Public: FDIC-Insured Institutions.

    Burden Estimate:

    Summary of Annual Burden Type of
  • burden
  • Obligation to respond Estimated
  • number of
  • respondents
  • Estimated
  • frequency
  • of
  • responses
  • Estimated
  • time per
  • response
  • Frequency
  • of
  • response
  • Total
  • annual
  • estimated
  • burden
  • (hours)
  • Notice Regarding Assessment Credits Reporting Required to Obtain or Retain Benefits 2 1 2 On occasion 4 Total Hourly Burden 4
    General Description of Collection

    Section 7(e)(3) of the Federal Deposit Insurance Act (12 U.S.C. 1817(e)(3)) (FDI Act), as amended by the Federal Deposit Insurance Reform Act of 2005, requires that the FDIC provide by regulation an initial, one-time assessment credit to each “eligible” insured depository institution (or its successor) based on the assessment base of the institution as of December 31, 1996, as compared to the combined aggregate assessment base of all eligible institutions as of that date, taking into account such other factors as the FDIC Board of Directors determines to be appropriate. The one-time credits must, with certain exceptions, be applied by the FDIC to the maximum extent allowed by law to the assessments imposed on such institution that become due for assessment periods beginning after the effective date of the one-time credit regulations until such time as the credit is exhausted. For assessments that become due for assessment periods beginning in fiscal years 2008, 2009, and 2010, the FDI Act provides that credits may not be applied to more than 90 percent of an institution's assessment.

    FDIC-insured institutions must notify the FDIC if their one-time assessment credit is transferred, e.g., through a sale of the credits or through a merger, so that the FDIC can accurately track such transfers, apply available credits appropriately against institutions' deposit insurance assessments, and determine an institution's 1996 assessment base if the transaction involved both the base and the credit amount. The need for credit transfer information will expire when the credit pool has been exhausted.

    There is no change in the method or substance of the collection and the burden remains unchanged from the previous Paperwork Reduction Act submission.

    Request for Comment

    Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

    Dated at Washington, DC, on August 2, 2018. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2018-16846 Filed 8-6-18; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of Intent To Terminate Receivership

    Notice is hereby given that the Federal Deposit Insurance Corporation (FDIC or Receiver) as Receiver for the institution listed below intends to terminate its receivership for said institution.

    Notice of Intent To Terminate Receivership Fund Receivership name City State Date of
  • appointment
  • of receiver
  • 10407 Decatur First Bank Decatur GA 10/21/2011

    The liquidation of the assets for the receivership has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing, identify the receivership to which the comment pertains, and sent within thirty days of the date of this notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated at Washington, DC, on August 2, 2018. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2018-16833 Filed 8-6-18; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination of Receiverships

    The Federal Deposit Insurance Corporation (FDIC or Receiver), as Receiver for each of the following insured depository institutions, was charged with the duty of winding up the affairs of the former institutions and liquidating all related assets. The Receiver has fulfilled its obligations and made all dividend distributions required by law.

    Notice of Termination of Receiverships Fund Receivership name City State Termination date 10035 Alliance Bank Culver City CA 8/1/2018 10225 BC National Banks Butler MO 8/1/2018 10285 Sonoma Valley Bank Sonoma CA 8/1/2018 10460 Excel Bank Sedalia MO 8/1/2018 10482 1st Commerce Bank North Las Vegas NV 8/1/2018

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary, including but not limited to releases, discharges, satisfactions, endorsements, assignments, and deeds. Effective on the termination dates listed above, the Receiverships have been terminated, the Receiver has been discharged, and the Receiverships have ceased to exist as legal entities.

    Dated at Washington, DC, on August 2, 2018. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2018-16832 Filed 8-6-18; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than September 4, 2018.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. First Mid-Illinois Bancshares, Inc., Mattoon, Illinois; to acquire 100 percent of SCB Bancorp, Inc., and thereby indirectly acquire Soy Capital Bank and Trust Company, both of Decatur, Illinois.

    B. Federal Reserve Bank of Minneapolis (Mark A. Rauzi, Vice President), 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:

    1. Park Financial Group, Inc., Minneapolis, Minnesota; to acquire 48.46 percent of Mesaba Bancshares, Inc., Grand Rapids, Minnesota; and thereby indirectly acquire The Lake Bank, Two Harbors, Minnesota, and American Bank of the North, Nashwauk, Minnesota. In addition, Park Financial Group, Inc., has acquired an option to purchase the remaining 51.54 percent of the voting shares of Mesaba Bancshares, Inc., Grand Rapids, Minnesota.

    Board of Governors of the Federal Reserve System, August 2, 2018. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2018-16872 Filed 8-6-18; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-18-17BAN] Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request entitled Strengthening United States Response to Resistant Gonorrhea (SURRG) to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on November 15, 2017 to obtain comments from the public and affected agencies. CDC received one non-substantive comment on this 60 day public notice. This notice serves to allow an additional 30 days for public and affected agency comments.

    CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

    (a) 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;

    (b) Evaluate the accuracy of the agencies 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;

    (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; and

    (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

    Proposed Project

    Strengthening U.S. Response to Resistant Gonorrhea (SURRG)—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    The purposes of Strengthening U.S. Response to Resistant Gonorrhea (SURRG) are to: (1) Improve national capacity to detect, monitor, and respond to emerging antibiotic-resistant gonorrhea, (2) understand trends in, and factors contributing to antibiotic-resistant gonorrhea, and (3) build a robust evidence base for public health action. This information collection is important because: (1) Effective treatment of gonorrhea is critical to gonorrhea control and prevention; (2) untreated or inadequately treated gonorrhea can cause serious reproductive health complications, such as infertility; (3) Neisseria gonorrhoeae (the bacterium that causes gonorrhea) has consistently demonstrated the ability to develop resistance to the antibiotics used for treatment and may be developing resistance to the last remaining treatment option recommended by the CDC; and (4) antibiotic-resistant gonorrhea is extremely difficult to detect without enhanced surveillance and public health activities, such as SURRG, because healthcare providers rarely perform or have access to resistance testing for individual patients.

    SURRG will support rapid detection of resistant gonorrhea and get actionable information into the hands of healthcare providers (to support appropriate treatment of individual patients) and local health departments (to support rapid public health response to slow the spread of resistant infections).

    Jurisdictions participating in SURRG applied, as part of a competitive process, and will participate voluntarily. As an overview of SURRG, healthcare providers at participating clinics (sexually transmitted disease [STD] clinics affiliated with a single public health department or other participating non-STD clinic sites) will collect specimens for N. gonorrhoeae culture testing from men and women seeking care for possible gonorrhea. Specimens that demonstrate N. gonorrhoeae (called “isolates”) will undergo antibiotic resistance testing within several days at the local public health laboratory. Laboratory results demonstrating resistance will be rapidly communicated by the laboratory to the healthcare provider and designated health department staff member, who will initiate a field investigation. Researchers will interview the patient (from whom the resistant specimen was collected) about risk factors and recent contacts, and will re-test to ensure cure. The health department will interview recent contacts and test them for gonorrhea. The participating health departments will collect and transmit to CDC, demographic and clinical data about persons tested for and diagnosed with gonorrhea in the participating clinics, results of local antibiotic resistance testing, and information about field investigations. None of the data transmitted to CDC will contain any personally identifiable information. CDC will use the data to monitor resistance, understand risk factors for resistance, and identify new approaches to prevent the spread of resistance. CDC will receive transmitted data through its Secure Access Management Services (SAMS). SAMS is an approved federal information technology system that provides authorized and validated users secure and encrypted access to CDC file transfer applications. The encrypted data will be stored in a secure CDC server with strictly controlled and restricted access rights. Isolates will be shipped each month to one of four Antibiotic Resistance Regional Laboratory Network (ARLN) laboratories for confirmatory antibiotic susceptibility testing and molecular characterization.

    Under the SURRG protocol, the local SURRG data managers from each of the funded jurisdictions will abstract STD clinic data for patients tested for gonorrhea, receive data from non-STD clinic healthcare sites about persons tested for gonorrhea, receive resistance testing laboratory results from local public health laboratories, abstract data about field investigations, and will merge the data. Every two months, the local SURRG data manager will clean the data, remove personally identifiable information, and transmit the data to CDC. We estimate these data processes will take 16 hours every two months. Annually, the local SURRG data manager will send a final cumulative data file. Seven data transmissions/responses will occur.

    Every two months, data managers at each of the participating non-STD clinic health centers will abstract and clean data and securely transmit the data to the local SURRG data manager. We estimate that it will take 3 hours each time data managers at each non-STD SURRG location abstract, clean, and transmit SURRG data.

    Microbiologists at public health laboratories from each of the nine SURRG funded jurisdictions will conduct antibiotic resistance testing on all N. gonorrhoeae isolates from all STD clinic sites and non-STD clinic sites participating in SURRG. Each test takes approximately 10 minutes of staff time, and testing of control strains will also be conducted approximately twice per week at each laboratory. On average, each jurisdiction will conduct approximately 600 resistance tests per year for patient care, plus 100 control strains per year for quality assurance. Thus, each grantee will perform approximately 700 tests per year. Every two months, a laboratory data manager will abstract test results and securely send the data file to the local SURRG data manager. We estimate that laboratory data managers will spend approximately 1 hour each time they abstract, clean, and transmit project data.

    Health department staff will interview any person diagnosed with antibiotic-resistant gonorrhea or having a case of gonorrhea of public health significance index case, a diagnosed person's social and sexual contacts, and the sexual contacts of the index case's sexual contacts.

    On average, each jurisdiction will identify four drug-resistant isolates each month. These isolates will spur field investigations, which will result in six additional interviews each month. We estimate 120 interviews will occur annually at each site (annual 1,080 interviews for the nine sites). Each interview will take 30 minutes.

    The total estimated annual burden hours are 2,976. Respondents receive federal funds to participate in this project. There are no additional costs to respondents other than their time.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Local SURRG data manager Facility, Laboratory and field Elements 9 7 16 Data manager at non-STD clinic health centers Non-STD clinic Elements 18 6 3 Public Health Laboratory Microbiologist Laboratory Testing 9 700 10/60 Public Health Laboratory Data Manager Laboratory Elements 9 6 1 Gonorrhea Patients, Social and Sexual Contacts Field Investigation Elements 1,080 1 30/60
    Jeffrey M. Zirger, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2018-16797 Filed 8-6-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Matching Program AGENCY:

    Centers for Medicare & Medicaid Services, Department of Health and Human Services.

    ACTION:

    Notice of a new matching program.

    SUMMARY:

    In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a re-established matching program between CMS and the Social Security Administration (SSA), “Determining Enrollment or Eligibility for Insurance Affordability Programs Under the Patient Protection and Affordable Care Act (ACA).” The matching program provides CMS with SSA data to use in determining individuals' eligibility to enroll in a qualified health plan through an exchange established under the ACA and for insurance affordability programs and certificates of exemption, and to make eligibility redeterminations and renewals, including appeal determinations.

    DATES:

    The deadline for comments on this notice is September 6, 2018. The re-established matching program will commence not sooner than 30 days after publication of this notice, provided no comments are received that warrant a change to this notice. The matching program will be conducted for an initial term of 18 months (from approximately September 2018 to March 2020) and within 3 months of expiration may be renewed for one additional year if the parties make no change to the matching program and certify that the program has been conducted in compliance with the matching agreement.

    ADDRESSES:

    Interested parties may submit written comments on this notice, by mail or email, to the CMS Privacy Officer, Division of Security, Privacy Policy & Governance, Information Security & Privacy Group, Office of Information Technology, Centers for Medicare & Medicaid Services, Location: N1-14-56, 7500 Security Blvd., Baltimore, MD 21244-1850, [email protected].

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about the matching program, you may contact Jack Lavelle, Senior Advisor, Marketplace Eligibility and Enrollment Group, Centers for Consumer Information and Insurance Oversight, CMS, at (410) 786-0639, or by email at [email protected], or by mail at 7501 Wisconsin Ave., Bethesda, MD 20814.

    SUPPLEMENTARY INFORMATION:

    The Privacy Act of 1974, as amended (5 U.S.C. 552a) provides certain protections for individuals applying for and receiving Federal benefits. The law governs the use of computer matching by Federal agencies when records in a system of records (meaning, federal agency records about individuals retrieved by name or other personal identifier) are matched with records of other federal or non-federal agencies. The Privacy Act requires agencies involved in a matching program to:

    1. Enter into a written agreement, which must be prepared in accordance with the Privacy Act, approved by the Data Integrity Board of each source and recipient Federal agency, provided to Congress and the Office of Management and Budget (OMB), and made available to the public, as required by 5 United States Code (U.S.C.) 552a(o), (u)(3)(A), and (u)(4).

    2. Notify the individuals whose information will be used in the matching program that the information they provide is subject to verification through matching, as required by 5 U.S.C. 552a(o)(1)(D).

    3. Verify match findings before suspending, terminating, reducing, or making a final denial of an individual's benefits or payments or taking other adverse action against the individual, as required by 5 U.S.C. 552a(p).

    4. Report the matching program to Congress and the OMB, in advance and annually, as required by 5 U.S.C. 552a(o)(2)(A)(i), (r), and (u)(3)(D).

    5. Publish advance notice of the matching program in the Federal Register as required by 5 U.S.C. 552a(e)(12).

    This matching program meets these requirements.

    Dated: August 1, 2018. Walter Stone, CMS Privacy Act Officer, Division of Security Privacy Policy and Governance, Information Security and Privacy Group, Office of Information Technology, Centers for Medicare & Medicaid Services. PARTICIPATING AGENCIES

    Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is the recipient agency, and the Social Security Administration (SSA) is the source agency.

    AUTHORITY FOR CONDUCTING THE MATCHING PROGRAM:

    The matching program is authorized under 42 U.S.C. 18001.

    PURPOSE(S):

    The purpose of the matching program is to provide CMS with SSA data that CMS needs to determine individuals' eligibility to enroll in a qualified health plan through an exchange established under the ACA and for insurance affordability programs and certificates of exemption, and to make eligibility redetermination and renewal decisions, including appeal determinations. The program enables CMS to compare its data to SSA data to confirm an applicant's or other relevant individual's identity, citizenship, status as deceased or imprisoned, and Title II disability benefit quarters of coverage (QC) and monthly and annual income. The data is used by CMS to authenticate identity, determine eligibility, and determine the amount of an advance payment of the premium tax credit (APTC) or cost sharing reduction (CSR).

    CATEGORIES OF INDIVIDUALS:

    The categories of individuals whose information is involved in the matching program are consumers who apply for any of the following eligibility determinations, and other relevant individuals (e.g., an applicant's household members) who have eligibility to enroll in a qualified health plan through an exchange established under the ACA, eligibility for insurance affordability programs and certificates of exemption, and subsequent eligibility redeterminations and renewals, including appeal determinations.

    CATEGORIES OF RECORDS:

    The categories of records used in the matching program are identity, citizenship, birth, death, disability coverage and income, and imprisonment status records. The data elements are as follows:

    1. For each applicant and for relevant individuals, CMS will submit a request file to SSA that contains the following mandatory specified data elements in a fixed record format: Last name, first name, date of birth, social security number (SSN), and citizenship indicator.

    2. For each applicant, SSA will provide CMS with a response file in a fixed record format. Depending on CMS' request, SSA's response may include the following data elements: Last name, first name, date of birth, death indicator, disability indicator, prisoner information, Title II (annual and monthly) income information, and confirmation of attestations of citizenship status and SSN. SSA may also provide QC data when CMS requests it.

    3. For relevant individuals, CMS will request a limited amount of SSA information. Based on CMS' request, SSA will verify a relevant individual's SSN with a death indicator and may provide a relevant individual's QC data or Title II (annual and monthly) income information. CMS will not request citizenship or immigration status data for a relevant individual.

    4. For renewals and redeterminations, CMS will request and SSA will verify SSN with a death indicator, disclose Title II income information, and provide the disability indicator.

    5. For self-reported redeterminations, CMS will provide SSA with the following: Updated or new information reported by the enrollee or enrolled individual, last name, first name, date of birth, and SSN. Depending on CMS' request, SSA's response will include each of the following data elements that are relevant and responsive to CMS' request: Last name, first name, date of birth, death indicator, disability indicator, prisoner information, Title II (annual and monthly) income information, and confirmation of new attestations of citizenship status, verification of SSN, and QC data.

    6. For individuals seeking an exemption, CMS will provide last name, first name, date of birth, citizenship indicator, and SSN to SSA. SSA will provide CMS with a response including: Last name, first name, date of birth, confirmation of attestations of citizenship status, verification of SSN, death indicator, disability indicator, prisoner information, and Title II (annual and monthly) income information.

    SYSTEM(S) OF RECORDS:

    The records used in this matching program are disclosed from the following systems of records, as authorized by routine uses published in the System of Records Notices (SORNs) cited below:

    CMS System of Records:

    ☐ The CMS SOR that supports this matching program is the “CMS Health Insurance Exchanges System (HIX)”, CMS System No. 09-70-0560, last published in full at 78 FR 63211 (October 23, 2013), as amended at 83 FR 6591 (February 14, 2018).

    SSA Systems of Records:

    ☐ Master Files of SSN Holders and SSN Applications, 60-0058, 75 FR 82121 (Dec. 29, 2010), as amended at 78 FR 40542 (July 5, 2013), and 79 FR 8780 (Feb. 13, 2014);

    ☐ Prisoner Update Processing System (PUPS), 60-0269, 64 FR 11076 (Mar. 8, 1999), as amended at 72 FR 69723 (Dec. 10, 2007) and 78 FR 40542 (July 5, 2013);

    ☐ Master Beneficiary Record, 60-0090, 71 FR 1826 (Jan. 1, 2006), as amended at 72 FR 69723 (Dec. 10, 2007) and 78 FR 40542 (July 5, 2013); and

    ☐ Earnings Recording and Self-Employment Income System, 60-0059, 71 FR 1819 (Jan. 11, 2006), as amended at 78 FR 40542 (July 5, 2013).

    [FR Doc. 2018-16821 Filed 8-6-18; 8:45 am] BILLING CODE 4120-03-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3366-PN] Medicare and Medicaid Programs: National Dialysis Accreditation Commission (NDAC) for Approval of its End Stage Renal Disease (ESRD) Facility Accreditation Program AGENCY:

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

    ACTION:

    Notice with request for comment.

    SUMMARY:

    This proposed notice acknowledges the receipt of an application from the National Dialysis Accreditation Commission (NDAC) for recognition as a national accrediting organization (AO) for End Stage Renal Disease (ESRD) Facilities 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 September 6, 2018.

    ADDRESSES:

    In commenting, refer to file code CMS-3366-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-3366-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-3366-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:

    Tara Lemons, (410) 786-3030, 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 from an end-stage renal disease (ESRD) facility provided the facility meets the requirements established by the Secretary of the Department of Health and Human Services (Secretary). Section 1881(b) of the Social Security Act (the Act) establishes distinct requirements for facilities seeking designation as an ESRD facility under Medicare. Regulations concerning provider agreements and supplier approval are at 42 CFR part 489 and those pertaining to activities relating to the survey, certification, and enforcement procedures of suppliers which include ESRD facilities are at 42 CFR part 488. The regulations at 42 CFR part 494 subparts A through D implement section 1881(b) of the Act, which specify the conditions that an ESRD facility must meet in order to participate in the Medicare program and the conditions for Medicare payment for ESRD facilities.

    Generally, to enter into a Medicare agreement, an ESRD facility must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 494 subparts A through D of our Medicare regulations. Thereafter, the ESRD facility is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements.

    Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by a Centers for Medicare & Medicaid Services (CMS) approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we may deem those provider entities as having met the requirements. Section 1865(a)(1) of the Act had historically prohibited dialysis facilities from participating in Medicare via a CMS-approved accreditation program; however, section 50403 of the Bipartisan Budget Act of 2018 amended section 1865(a) of the Act to include renal dialysis facilities as provider entities allowed to participate in Medicare through a CMS-approved accreditation program. Accreditation by an AO is voluntary and is not required for Medicare participation.

    If an AO is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program may be deemed to meet the Medicare conditions. An AO applying for approval of its accreditation program under part 488, subpart A, must provide CMS with reasonable assurance that the AO requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of AOs are set forth at § 488.5.

    II. Provisions of the Proposed Notice A. 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 an AO's requirements consider, among other factors, the applying AO'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 National Dialysis Accreditation Commission's (NDAC) request for CMS-approval of its ESRD facility accreditation program. This notice also solicits public comment on whether NDAC's requirements meet or exceed the Medicare conditions for coverage (CfCs) for ESRD facilities.

    This is the first application from a national accreditation body seeking approval of an accreditation program for ESRD facilities.

    B. Evaluation of Deeming Authority Request

    NDAC submitted all the necessary materials to enable us to make a determination concerning its request for CMS-approval of its ESRD facility accreditation program. This application was determined to be complete on June 8, 2018. Under section 1865(a)(2) of the Act and our regulations at § 488.5, our review and evaluation of NDAC will be conducted in accordance with, but not necessarily limited to, the following factors:

    • The equivalency of NDAC's standards for ESRD facilities as compared with Medicare's CfCs for ESRD facilities.

    • NDAC's survey process to determine the following:

    ++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.

    ++ The comparability of NDAC's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.

    ++ NDAC's processes and procedures for monitoring an ESRD facility found out of compliance with NDAC's program requirements. These monitoring procedures are used only when NDAC identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the State survey agency monitors corrections as specified at § 488.9(c)(1).

    ++ NDAC's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.

    ++ NDAC's capacity to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process.

    ++ The adequacy of NDAC's staff and other resources, and its financial viability.

    ++ NDAC's capacity to adequately fund required surveys.

    ++ NDAC's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.

    ++ NDAC's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as CMS may require (including corrective action plans).

    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 Public 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.

    Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the Federal Register announcing the result of our evaluation.

    Dated: July 27, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services.
    [FR Doc. 2018-16871 Filed 8-6-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2382] Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.” This guidance addresses the clinical endpoints acceptable to demonstrate effectiveness of drugs for medication-assisted treatment of opioid use disorder. FDA is also requesting comments on when the use of placebo or active controls is most appropriate in clinical trials for such drugs.

    DATES:

    Submit either electronic or written comments on the draft guidance by October 9, 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-2382 for “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Silvana Borges, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3200, Silver Spring, MD 20993-0002, 301-796-0963.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.” This guidance addresses the clinical endpoints acceptable to demonstrate effectiveness of drugs for medication-assisted treatment of opioid use disorder. FDA is also requesting comments on when the use of placebo or active controls is most appropriate in clinical trials for such drugs.

    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 endpoints for demonstrating effectiveness of drugs for medication-assisted treatment of opioid use disorder. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: August 1, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-16813 Filed 8-6-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES [OMHA-1801-N] Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances—April Through June 2018 AGENCY:

    Office of Medicare Hearings and Appeals (OMHA), HHS.

    ACTION:

    Notice.

    SUMMARY:

    This quarterly notice announces the reorganization and revision of the OMHA Case Processing Manual (OCPM) and lists the OCPM manual instructions that were published from April through June 2018. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations, and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.

    FOR FURTHER INFORMATION CONTACT:

    Amanda Axeen, by telephone at (571) 777-2705, or by email at [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    The Office of Medicare Hearings and Appeals (OMHA), a staff division within the Office of the Secretary within the U.S. Department of Health and Human Services (HHS), administers the nationwide Administrative Law Judge hearing program for Medicare claim, organization and coverage determination, and entitlement appeals under sections 1869, 1155, 1876(c)(5)(B), 1852(g)(5), and 1860D-4(h) of the Social Security Act (the Act). OMHA ensures that Medicare beneficiaries and the providers and suppliers that furnish items or services to Medicare beneficiaries, as well as Medicare Advantage Organizations (MAOs), Medicaid State Agencies, and applicable plans, have a fair and impartial forum to address disagreements with Medicare coverage and payment determinations made by Medicare contractors, MAOs, or Part D Plan Sponsors (PDPSs), and determinations related to Medicare eligibility and entitlement, Part B late enrollment penalty, and income-related monthly adjustment amounts (IRMAA) made by the Social Security Administration (SSA).

    The Medicare claim, organization and coverage determination appeals processes consist of four levels of administrative review, and a fifth level of review with the Federal district courts after administrative remedies under HHS regulations have been exhausted. The first two levels of review are administered by the Centers for Medicare & Medicaid Services (CMS) and conducted by Medicare contractors for claim appeals, by MAOs and an independent review entity for Part C organization determination appeals, or by PDPSs and an independent review entity for Part D coverage determination appeals. The third level of review is administered by OMHA and conducted by Administrative Law Judges and attorney adjudicators. The fourth level of review is administered by the HHS Departmental Appeals Board (DAB) and conducted by the Medicare Appeals Council (Council). In addition, OMHA and the DAB administer the second and third levels of appeal, respectively, for Medicare eligibility, entitlement, Part B late enrollment penalty, and IRMAA reconsiderations made by SSA; a fourth level of review with the Federal district courts is available after administrative remedies within SSA and HHS have been exhausted.

    Sections 1869, 1155, 1876(c)(5)(B), 1852(g)(5), and 1860D-4(h) of the Act are implemented through the regulations at 42 CFR part 405 subparts I and J; part 417, subpart Q; part 422, subpart M; part 423, subparts M and U; and part 478, subpart B. As noted above, OMHA administers the nationwide Administrative Law Judge hearing program in accordance with these statutes and applicable regulations. To ensure nationwide consistency in that effort, OMHA established a manual, the OMHA Case Processing Manual (OCPM). Through the OCPM, the OMHA Chief Administrative Law Judge establishes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations and OMHA directives. The OCPM provides direction for processing appeals at the OMHA level of adjudication for Medicare Part A and B claims; Part C organization determinations; Part D coverage determinations; and SSA eligibility and entitlement, Part B late enrollment penalty, and IRMAA determinations.

    Section 1871(c) of the Act requires that the Secretary publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register.

    II. Format for the Quarterly Issuance Notices

    This quarterly notice provides the specific updates to the OCPM that have occurred in the three-month period of April through June 2018. A hyperlink to the available chapters on the OMHA website is provided below. The OMHA website contains the most current, up-to-date chapters and revisions to chapters, and will be available earlier than we publish our quarterly notice. We believe the OMHA website provides more timely access to the current OCPM chapters for those involved in the Medicare claim, organization and coverage determination and entitlement appeals processes. We also believe the website offers the public a more convenient tool for real time access to current OCPM provisions. In addition, OMHA has a listserv to which the public can subscribe to receive notification of certain updates to the OMHA website, including when new or revised OCPM chapters are posted. If accessing the OMHA website proves to be difficult, the contact person listed above can provide the information.

    This notice lists the OCPM chapters and subjects published during the quarter covered by the notice so the reader may determine whether any are of particular interest. We expect this notice to be used in concert with future published notices. The OCPM can be accessed at https://www.hhs.gov/about/agencies/omha/the-appeals-process/case-processing-manual/index.html.

    III. How To Use the Notice

    This notice lists the OCPM chapters and subjects published during the quarter covered by the notice so the reader may determine whether any are of particular interest. We expect this notice to be used in concert with future published notices. The OCPM can be accessed at https://www.hhs.gov/about/agencies/omha/the-appeals-process/case-processing-manual/index.html.

    IV. Reorganization and Revision of the OCPM

    OMHA is in the process of restructuring, reorganizing, and reformatting the OCPM to make it more user friendly. As part of this ongoing process, we are drafting new OCPM chapters and revising existing OCPM chapters to conform to the new format. Previously, the OCPM contained separate divisions for each Medicare part, and most chapters were repeated in each division. New and revised chapters provide information pertaining to all appeals arising under all Medicare parts. Plain language is used where possible and guidance is provided in a user-friendly, question-and-answer format. The manual is also being revised to reflect regulatory changes made by the final rule that was published in the January 17, 2017 Federal Register and became effective on March 20, 2017 (82 FR 4974). New and revised chapters can be accessed at https://www.hhs.gov/about/agencies/omha/the-appeals-process/case-processing-manual/index.html. Unless inconsistent with a statute, regulation, or other controlling authority, provisions of chapters that were published before May 10, 2018, remain in effect until revised, and can be accessed at: https://www.hhs.gov/about/agencies/omha/the-appeals-process/case-processing-manual/2017/index.html.

    IV. OCPM Releases for April Through June 2018

    The OCPM is used by OMHA adjudicators and staff to administer the OMHA program. It offers day-to-day operating instructions, policies, and procedures based on statutes and regulations, and OMHA directives.

    The following is a list and description of new OCPM provisions and the subject matter. For future quarterly notices, we will list only the specific updates to the list of manual provisions that have occurred in the covered 3-month period. This information is available on our website at https://www.hhs.gov/about/agencies/omha/the-appeals-process/case-processing-manual/index.html.

    OCPM Chapter 1: Manual Overview, Definition, and Governance

    Chapter 1, Manual Overview, Definition, Governance. This chapter describes the OCPM's purpose and organization. It also describes how to navigate the OCPM, and when and how to cite an OCPM provision as an authority in an action issued by an OMHA adjudicator.

    OMHA receives a variety of appeals, as discussed in section I above. This chapter describes when a specific OCPM provision may be read to apply to all or certain types of appeals, and describes OCPM conventions for citing to statutory, regulatory, and other applicable authorities. In addition, this chapter describes the process for updating an OCPM chapter, as well as how to determine when a revision was issued or became effective, and how to access prior versions of a chapter.

    OCPM Chapter 19: Closing the Case

    Chapter 19, Closing the Case. Timely notice of the disposition and closing of a case, in compliance with applicable laws and policy, is important to ensure that effectuation of a decision, or other necessary actions, can be undertaken by the parties to the appeal, CMS, CMS contractors, plans, SSA, or the Council. Receipt of the disposition package also governs the timing for parties to file an appeal, and for the Council to initiate a review of a case on its own motion. In addition, the timely transfer of the administrative record helps ensure effectuation can occur, SSA, CMS, or CMS contractors can refer cases for review by the Council, and the record can be transitioned to storage. This revised chapter describes the necessary steps to timely and accurately close appeals pending at OMHA.

    OCPM Chapter 20: Post-Adjudication Actions

    Chapter 20, Post-Adjudication Actions. This new chapter describes the various potential actions that may occur after an OMHA adjudicator issues a decision, dismissal, or remand, and the procedures for responding to such actions. These actions include requests to correct a clerical error, reopen a decision, vacate a dismissal, or review a remand issued by an OMHA adjudicator. OMHA adjudicators take action to grant or deny such a request, and in some instances may initiate an action on their own motion.

    In addition, parties may seek Council review of decisions and dismissals. CMS and its contractors, or SSA, may also refer decisions and dismissals to the Council for possible own motion review. The chapter also describes actions the Council may take on an appealed or referred case, including remanding the case to OMHA.

    Dated: July 23, 2018. Amanda M. Axeen, Acting Chief Advisor, Office of Medicare Hearings and Appeals.
    [FR Doc. 2018-16860 Filed 8-6-18; 8:45 am] BILLING CODE 4150-46-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Declaration Under the Public Readiness and Emergency Preparedness Act for Zika Virus Vaccines AGENCY:

    Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The Secretary is amending a Declaration pursuant to the Public Health Service Act to provide liability immunity protection for activities related to Zika virus vaccines consistent with the terms of the Declaration.

    DATES:

    The declaration is effective as of August 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; Telephone: 202-205-2882.

    SUPPLEMENTARY INFORMATION:

    The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the administration or use of medical countermeasures (Covered Countermeasures), except for claims that meet the PREP Act's definition of willful misconduct. The Secretary may, through publication in the Federal Register, amend any portion of a Declaration. Using this authority, effective August 1, 2016 (82 FR 10365 (February 10, 2017)), Acting Secretary Norris Cochran issued a Declaration to provide liability immunity to Covered Persons for activities related to the Covered Countermeasures, Zika virus vaccines as listed in Section VI of the Declaration, consistent with the terms of the Declaration. The Secretary is amending the August 1, 2016 Declaration to extend the effective time period of the declaration through December 31, 2022 and to clarify and add to the list of covered countermeasures to include all Zika virus vaccine types and technologies.

    The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2. It amended the Public Health Service (PHS) Act, adding Section 319F-3, which addresses liability immunity, and Section 319F-4, which creates a compensation program. These sections are codified in the U.S. Code as 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

    The Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, was enacted on March 13, 2013. Among other things, PAHPRA added sections 564A and 564B to the Federal Food, Drug & Cosmetic (FD&C) Act to provide new authorities for the emergency use of approved products in emergencies and products held for emergency use. PAHPRA accordingly amended the definitions of “Covered Countermeasures” and “qualified pandemic and epidemic products” in Section 319F-3 of the Public Health Service Act (PREP Act provisions), so that products made available under these new FD&C Act authorities could be covered under PREP Act Declarations. PAHPRA also extended the definition of qualified pandemic and epidemic products that may be covered under a PREP Act Declaration to include products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic or epidemic or against adverse events from these products. Zika virus is a mosquito-borne flavivirus that usually causes mild symptoms but has been determined to cause microcephaly and other severe brain abnormalities in fetuses and infants born to women infected with Zika virus before birth. Zika virus has also been associated with other adverse pregnancy outcomes, including miscarriage, stillbirth, and congenital Zika syndrome, and is linked to Guillain-Barre Syndrome. Beginning in 2015, Brazil experienced the largest outbreak of disease caused by Zika infection since its discovery in Uganda in 1947. On February 1, 2016, the World Health Organization (WHO) determined that microcephaly cases and other neurologic disorders reported in Brazil constituted a Public Health Emergency of International Concern (PHEIC) in accordance with the International Health Regulations (IHR). Since 2015, Zika virus has been detected in nations throughout the world. In the United States, traveler-associated cases have been identified in all the states, and local transmission of Zika virus is occurring in Puerto Rico; American Samoa; areas of Miami, Florida; and Texas. On August 12, 2016, former Secretary Sylvia M. Burwell determined that a public health emergency of national significance existed within the Commonwealth of Puerto Rico relating to pregnant women and children born to pregnant women with Zika. Former Secretary Burwell renewed that determination on November 4, 2016; Acting Secretary Norris Cochran renewed that determination on January 31, 2017; and former Secretary Thomas E. Price renewed that declaration on April 28, 2017. The Secretary's public health emergency declaration expired on July 26, 2017. On November 18, 2016, the WHO Director-General declared the end of the PHEIC based on recommendations of the WHO Emergency Committee that Zika virus and associated consequences no longer represent a PHEIC as defined under the IHR, but remain a significant enduring public health challenge requiring intense action that should be escalated into a sustained program of work with dedicated resources to address the long-term nature of the disease and its associated consequences. In 2018, cases continue to be reported throughout the U.S. states and territories of laboratory-confirmed Zika virus disease in individuals returning from travel to affected areas, or presumed local mosquito-borne transmission, or other modes of transmission.1

    1 CDC Zika case reporting; https://www.cdc.gov/zika/reporting/2018-case-counts.html, accessed 23July2018, 1630.

    Unless otherwise noted, all statutory citations below are to the U.S. Code.

    Section I, Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency

    Before issuing a Declaration under the PREP Act, the Secretary is required to determine that a disease or other health condition or threat to health constitutes a public health emergency or that there is a credible risk that the disease, condition, or threat may constitute such an emergency. This determination is separate and apart from a Declaration issued by the Secretary under Section 319 of the PHS Act that a disease or disorder presents a public health emergency or that a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, or other Declarations or determinations made under other authorities of the Secretary. Accordingly, in Section I, the Secretary determines that there is a credible risk that the spread of Zika virus and the resulting disease may constitute a public health emergency.

    Section II, Factors Considered

    In deciding whether and under what circumstances to issue a Declaration with respect to a Covered Countermeasure, the Secretary must consider the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the countermeasure. In Section II, the Secretary states that he has considered these factors.

    Section III, Recommended Activities

    The Secretary must recommend the activities for which the PREP Act's liability immunity is in effect. These activities may include, under conditions as the Secretary may specify, the manufacture, testing, development, distribution, administration, or use of one or more Covered Countermeasures (Recommended Activities). In Section III, the Secretary recommends activities for which the immunity is in effect.

    Section IV, Liability Immunity

    The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, “[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.” In Section IV, the Secretary states that liability protections are in effect with respect to the Recommended Activities.

    Section V, Covered Persons

    The PREP Act's liability immunity applies to “Covered Persons” with respect to administration or use of a Covered Countermeasure. The term “Covered Persons” has a specific meaning and is defined in the PREP Act to include manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States. The PREP Act further defines the terms “manufacturer,” “distributor,” “program planner,” and “qualified person” as described below.

    A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.

    A distributor means a person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to: Manufacturers; repackers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.

    A program planner means a state or local government, including an Indian tribe; a person employed by the state or local government; or other person who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a Covered Countermeasure, including a person who establishes requirements, provides policy guidance, or supplies technical or scientific advice or assistance or provides a facility to administer or use a Covered Countermeasure in accordance with the Secretary's Declaration. Under this definition, a private sector employer or community group or other “person” can be a program planner when it carries out the described activities.

    A qualified person means a licensed health professional or other individual authorized to prescribe, administer, or dispense Covered Countermeasures under the law of the state in which the Covered Countermeasure was prescribed, administered, or dispensed; or a person within a category of persons identified as qualified in the Secretary's Declaration. Under this definition, the Secretary can describe in the Declaration other qualified persons, such as volunteers, who are Covered Persons. Section V describes other qualified persons covered by this Declaration.

    The PREP Act also defines the word “person” as used in the Act: A person includes an individual, partnership, corporation, association, entity, or public or private corporation, including a federal, state, or local government agency or department.

    Section V describes Covered Persons under the Declaration, including Qualified Persons.

    Section VI, Covered Countermeasures

    As noted above, Section III describes the Secretary's Recommended Activities for which liability immunity is in effect. This section identifies the Covered Countermeasures for which the Secretary has recommended such activities. The PREP Act states that a “Covered Countermeasure” must be: A “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act.

    A qualified pandemic or epidemic product means a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that is: (i) Manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause; (ii) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device; (iii) or a product or technology intended to enhance the use or effect of such a drug, biological product, or device.

    A security countermeasure is a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that: (i)(a) The Secretary determines to be a priority to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat by the Secretary of Homeland Security, or (b) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; and (ii) is determined by the Secretary of Health and Human Services to be a necessary countermeasure to protect public health.

    To be a Covered Countermeasure, qualified pandemic or epidemic products or security countermeasures also must be approved or cleared under the FD&C Act; licensed under the PHS Act; or authorized for emergency use under Sections 564, 564A, or 564B of the FD&C Act.

    A qualified pandemic or epidemic product also may be a Covered Countermeasure when it is subject to an exemption (that is, it is permitted to be used under an Investigational Drug Application or an Investigational Device Exemption) under the FD&C Act and is the object of research for possible use for diagnosis, mitigation, prevention, treatment, or cure, or to limit harm of a pandemic or epidemic or serious or life-threatening condition caused by such a drug or device.

    A security countermeasure also may be a Covered Countermeasure if it may reasonably be determined to qualify for approval or licensing within 10 years after the Department's determination that procurement of the countermeasure is appropriate.

    Section VI lists Zika virus vaccines that are Covered Countermeasures. The Secretary is amending the list of vaccines by: Deleting “whole particle” from the first category of vaccines listed to clarify that the category includes all inactivated virus vaccines; adding “and/or polysaccharide and/or conjugate” to the sixth category of vaccines listed to include these types of peptide vaccine; and adding a new ninth category, “recombinant vaccines” to include any Zika virus vaccines using this type of technology.

    Section VI also refers to the statutory definitions of Covered Countermeasures to make clear that these statutory definitions limit the scope of Covered Countermeasures. Specifically, the Declaration notes that Covered Countermeasures must be “qualified pandemic or epidemic products,” or “security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

    Section VII, Limitations on Distribution

    The Secretary may specify that liability immunity is in effect only to Covered Countermeasures obtained through a particular means of distribution. The Declaration states that liability immunity is afforded to Covered Persons for Recommended Activities related to: (a) Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements; or (b) Activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a Declaration of an emergency.

    Section VII defines the terms “Authority Having Jurisdiction” and “Declaration of an emergency.” We have specified in the definition that Authorities having jurisdiction include federal, state, local, and tribal authorities and institutions or organizations acting on behalf of those governmental entities.

    For governmental program planners only, liability immunity is afforded only to the extent they obtain Covered Countermeasures through voluntary means, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles. This last limitation on distribution is intended to deter program planners that are government entities from seizing privately held stockpiles of Covered Countermeasures. It does not apply to any other Covered Persons, including other program planners who are not government entities.

    Section VIII, Category of Disease, Health Condition, or Threat

    The Secretary must identify, for each Covered Countermeasure, the categories of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the countermeasure. In Section VIII, the Secretary states that the disease threat for which he recommends administration or use of the Covered Countermeasures is Zika virus.

    Section IX, Administration of Covered Countermeasures

    The PREP Act does not explicitly define the term “administration” but does assign the Secretary the responsibility to provide relevant conditions in the Declaration. In Section IX, the Secretary defines “Administration of a Covered Countermeasure:”

    Administration of a Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution, and dispensing of the countermeasures to recipients; management and operation of countermeasure programs; or management and operation of locations for purpose of distributing and dispensing countermeasures.

    The definition of “administration” extends only to physical provision of a countermeasure to a recipient, such as vaccination or handing drugs to patients, and to activities related to management and operation of programs and locations for providing countermeasures to recipients, such as decisions and actions involving security and queuing, but only insofar as those activities directly relate to the countermeasure activities. Claims for which Covered Persons are provided immunity under the Act are losses caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a Covered Countermeasure consistent with the terms of a Declaration issued under the Act. Under the definition, these liability claims are precluded if they allege an injury caused by physical provision of a countermeasure to a recipient, or if the claims are directly due to conditions of delivery, distribution, dispensing, or management and operation of countermeasure programs at distribution and dispensing sites.

    Thus, it is the Secretary's interpretation that, when a Declaration is in effect, the Act precludes, for example, liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct. Likewise, the Act precludes a liability claim relating to the management and operation of a countermeasure distribution program or site, such as a slip-and-fall injury or vehicle collision by a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location that alleges, for example, lax security or chaotic crowd control. However, a liability claim alleging an injury occurring at the site that was not directly related to the countermeasure activities is not covered, such as a slip and fall with no direct connection to the countermeasure's administration or use. In each case, whether immunity is applicable will depend on the particular facts and circumstances.

    Section X, Population

    The Secretary must identify, for each Covered Countermeasure specified in a Declaration, the population or populations of individuals for which liability immunity is in effect with respect to administration or use of the countermeasure. This section explains which individuals should use the countermeasure or to whom the countermeasure should be administered—in short, those who should be vaccinated or take a drug or other countermeasure. Section X provides that the population includes “any individual who uses or who is administered a Covered Countermeasure in accordance with the Declaration.”

    In addition, the PREP Act specifies that liability immunity is afforded: (1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; and (2) to program planners and qualified persons when the countermeasure is either used by or administered to this population or the program planner or qualified person reasonably could have believed the recipient was in this population. Section X includes these statutory conditions in the Declaration for clarity.

    Section XI, Geographic Area

    The Secretary must identify, for each Covered Countermeasure specified in the Declaration, the geographic area or areas for which liability immunity is in effect with respect to administration or use of the countermeasure, including, as appropriate, whether the Declaration applies only to individuals physically present in the area or, in addition, applies to individuals who have a described connection to the area. Section XI provides that liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation. This could include claims related to administration or use in countries outside the U.S. It is possible that claims may arise in regard to administration or use of the Covered Countermeasures outside the U.S. that may be resolved under U.S. law.

    In addition, the PREP Act specifies that liability immunity is afforded: (1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to individuals in the geographic areas; and (2) to program planners and qualified persons when the countermeasure is either used or administered in the geographic areas or the program planner or qualified person reasonably could have believed the countermeasure was used or administered in the areas. Section XI includes these statutory conditions in the Declaration for clarity.

    Section XII, Effective Time Period

    The Secretary must identify, for each Covered Countermeasure, the period or periods during which liability immunity is in effect, designated by dates, milestones, or other description of events, including factors specified in the PREP Act. Section XII extends the effective period for different means of distribution of Covered Countermeasures through December 31, 2022.

    Section XIII, Additional Time Period of Coverage

    The Secretary must specify a date after the ending date of the effective time period of the Declaration that is reasonable for manufacturers to arrange for disposition of the Covered Countermeasure, including return of the product to the manufacturer, and for other Covered Persons to take appropriate actions to limit administration or use of the Covered Countermeasure. In addition, the PREP Act specifies that for Covered Countermeasures that are subject to a Declaration at the time they are obtained for the Strategic National Stockpile (SNS) under 42 U.S.C. 247d-6b(a), the effective period of the Declaration extends through the time the countermeasure is used or administered pursuant to a distribution or release from the stockpile. Liability immunity under the provisions of the PREP Act and the conditions of the Declaration continues during these additional time periods. Thus, liability immunity is afforded during the “Effective Time Period,” described under XII of the Declaration, plus the “Additional Time Period” described under Section XIII of the Declaration.

    Section XIII provides for 12 months as the additional time period of coverage after expiration of the Declaration. Section XIII also explains the extended coverage that applies to any products obtained for the SNS during the effective period of the Declaration.

    Section XIV, Countermeasures Injury Compensation Program

    Section 319F-4 of the PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to eligible individuals who sustain a serious physical injury or die as a direct result of the administration or use of a Covered Countermeasure. Compensation under the CICP for an injury directly caused by a Covered Countermeasure is based on the requirements set forth in this Declaration, the administrative rules for the Program, and the statute. To show direct causation between a Covered Countermeasure and a serious physical injury, the statute requires “compelling, reliable, valid, medical and scientific evidence.” The administrative rules for the Program further explain the necessary requirements for eligibility under the CICP. Please note that, by statute, requirements for compensation under the CICP may not align with the requirements for liability immunity provided under the PREP Act. Section XIV, “Countermeasures Injury Compensation Program” explains the types of injury and standard of evidence needed to be considered for compensation under the CICP.

    Further, the administrative rules for the CICP specify if countermeasures are administered or used outside the United States, only otherwise eligible individuals at American embassies, military installations abroad (such as military bases, ships, and camps) or at North Atlantic Treaty Organization (NATO) installations (subject to the NATO Status of Forces Agreement) where American servicemen and servicewomen are stationed may be considered for CICP benefits. Other individuals outside the United States may not be eligible for CICP benefits.

    Section XV, Amendments

    The Secretary may amend any portion of this Declaration through publication in the Federal Register.

    Declaration

    Declaration for Public Readiness and Emergency Preparedness Act Coverage for Zika Virus Vaccines.

    I. Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency 42 U.S.C. 247d-6d(b)(1)

    I have determined that there is a credible risk that the spread of Zika virus and the resulting disease or conditions may in the future constitute a public health emergency.

    II. Factors Considered 42 U.S.C. 247d-6d(b)(6)

    I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures.

    III. Recommended Activities 42 U.S.C. 247d-6d(b)(1)

    I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.

    IV. Liability Immunity 42 U.S.C. 247d-6d(a), 247d-6d(b)(1)

    Liability immunity as prescribed in the PREP Act and conditions stated in this Declaration is in effect for the Recommended Activities described in Section III.

    V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)

    Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States.

    In addition, I have determined that the following additional persons are qualified persons: (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency; (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act; (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

    VI. Covered Countermeasures 42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)

    Covered Countermeasures are the following Zika virus vaccines, all components and constituent materials of these vaccines, and all devices and their constituent components used in the administration of these vaccines:

    (1) Inactivated virus vaccines

    (2) Live-attenuated vaccines

    (3) mRNA vaccines

    (4) DNA vaccines

    (5) Subunit vaccines

    (6) Peptide and/or polysaccharide and/or conjugate vaccines

    (7) Virus-like particles vaccines

    (8) Nanoparticle vaccines

    (9) Recombinant vaccines

    Covered Countermeasures must be “qualified pandemic or epidemic products,” or “security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

    VII. Limitations on Distribution 42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)

    I have determined that liability immunity is afforded to Covered Persons only for Recommended Activities involving Covered Countermeasures that are related to:

    (a) Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements; or,

    (b) Activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of an emergency.

    i. The Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority.

    ii. A Declaration of Emergency means any Declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of a federal Declaration in support of an Emergency Use Authorization under Section 564 of the FD&C Act unless such Declaration specifies otherwise;

    I have also determined that for governmental program planners only, liability immunity is afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles.

    VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A)

    The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is Zika virus.

    IX. Administration of Covered Countermeasures 42 U.S.C. 247d-6d(a)(2)(B)

    Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures.

    X. Population 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)

    The populations of individuals include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration.

    Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population.

    XI. Geographic Area 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)

    Liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation.

    Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered in any designated geographic area; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area.

    XII. Effective Time Period 42 U.S.C. 247d-6d(b)(2)(B)

    Liability immunity for Covered Countermeasures through means of distribution, as identified in Section VII(a) of this Declaration, other than in accordance with the public health and medical response of the Authority Having Jurisdiction and extends through December 31, 2022.

    Liability immunity for Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction begins with a Declaration and lasts through (1) the final day the emergency Declaration is in effect, or (2) December 31, 2022, whichever occurs first.

    XIII. Additional Time Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B) and (C)

    I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures.

    Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS.

    XIV. Countermeasures Injury Compensation Program 42 U.S.C 247d-6e

    The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services. Information about the CICP is available at the toll-free number 1-855-266-2427 or http://www.hrsa.gov/cicp/.

    XV. Amendments 42 U.S.C. 247d-6d(b)(4)

    Amendments to this Declaration will be published in the Federal Register.

    Authority:

    42 U.S.C. 247d-6d.

    Dated: August 1, 2018. Alex M. Azar II Secretary, Department of Health and Human Services.
    [FR Doc. 2018-16856 Filed 8-6-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Aging Initial Review Group; Clinical Aging Review Committee NIA-C.

    Date: September 27-28, 2018.

    Time: 3:00 p.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814.

    Contact Person: Alicja L. Markowska, Ph.D., DSC, National Institute on Aging, National Institutes of Health, Gateway Building 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301-496-9666, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: August 1, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-16787 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

    FOR FURTHER INFORMATION CONTACT:

    Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information.

    SUPPLEMENTARY INFORMATION:

    This notice is in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve commercialization of results of federally-funded research and development.

    Technology description follows.

    Neuroendocrine Tumor Evans Blue Containing Radiotherapeutics

    The invention pertains to a radiotherapeutic against neuroendocrine tumors that express somatostatin receptor. Radionuclide therapies directed against tumors that express somatostatin receptors (SSTRs) have proven effective for the treatment of advanced, low- to intermediate-grade neuroendocrine tumors. The subject radiotherapeutic covered by the subject patent estate includes a somatostatin (SST) peptide derivative like octreotate (TATE), conjugated to an Evans Blue (EB) analog, and further chelated via DOTA to therapeutic radionuclide177Lu, a beta emitter. The EB analog reversibly binds to circulating serum albumin and improves the pharmacokinetics of SST peptide derivatives and reduce peptide-receptor radionuclide therapy toxicity. EB analog conjugated to octreotate (EB-DOTATATE) has been shown by the inventors to provide reversible albumin binding in vivo and extended half-life in circulation. When EB-TATE is slowly released into the tumor microenvironment, tumor uptake and internalization into SSTR positive tumors resulted in delivery of radioactive particles and tumor cell killing. EB-TATE displayed significantly more favorable pharmacokinetics than TATE alone by achieving higher tumor to non-tumor penetration as evidenced by positron emission tomography.

    Potential Commercial Applications:

    • Cancer therapeutics • Higher stability/Lower toxicity

    Development Stage:

    • Early stage

    Inventors: Xiaoyuan Chen and Orit Jacobson Weiss (both of NIBIB).

    Intellectual Property: HHS Reference No. E-150-2016-1; International Patent Application PCT/US2017/031696.

    Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; [email protected].

    Dated: July 20, 2018. Michael Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development.
    [FR Doc. 2018-16839 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Treatment of Type I Diabetes and its Comorbidities AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent License to Inversago Pharma, Inc., located in Montreal, Quebec, Canada, 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 NHLBI Office of Technology Transfer and Development August 22, 2018 will be considered.

    ADDRESSES:

    Requests for copies of the patent applications, inquiries, and comments relating to the contemplated exclusive patent license should be directed to: Michael Shmilovich, Esq., Senior Licensing and Patent Manager, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479, phone number 301-435-5019, or [email protected]

    SUPPLEMENTARY INFORMATION:

    The following and all continuing U.S. and foreign patents/patent applications thereof are the intellectual properties to be licensed under the prospective agreement to Inversago Pharma, Inc.:

    HHS Reference No. Patent No. or application No. Filing date Title E-282-2012-0-US-01 61/725,949 November 13, 2012 Cannabinoid Receptor Mediating Compounds. E-282-2012-0-PCT-02 PCT/US2013/069686 November 12, 2013 Cannabinoid Receptor Mediating Compounds. E-282-2012-0-US-03 9,765,031 November 12, 2013 Cannabinoid Receptor Mediating Compounds. E-282-2012-0-CA-04 2889697 April 27, 2015 Cannabinoid Receptor Mediating Compounds. E-282-2012-0-EP-05 13802153.0 June 01, 2015 Cannabinoid Receptor Mediating Compounds. E-282-2012-0-IN-06 3733/DELNP/2015 May 1, 2015 Cannabinoid Receptor Mediating Compounds. E-282-2012-0-JP-07 2015-542015 May 11, 2015 Cannabinoid Receptor Mediating Compounds. E-282-2012-0-CN-08 201380069389.9 July 3, 2015 Cannabinoid Receptor Mediating Compounds. E-282-2012-0-US-09 15/674,365 August 10, 2017 Cannabinoid Receptor Mediating Compounds. E-282-2012-0-US-10 15/674,333 August 10, 2017 Cannabinoid Receptor Mediating Compounds. E-140-2014-0-US-01 61/991,333 May 9, 2014 Cannabinoid Receptor Mediating Compounds. E-282-2012-1-US-01 62/171,179 June 4, 2015 Cannabinoid Receptor Mediating Compounds. E-282-2012-1-PCT-02 PCT/US2016/035291 June 1, 2016 Cannabinoid Receptor Mediating Compounds. E-282-2012-1-EP-05 16728547.7 June 1, 2016 Cannabinoid Receptor Mediating Compounds. E-282-2012-1-US-08 15/579,123 December 1, 2017 Cannabinoid Receptor Mediating Compounds. E-140-2014-0-PCT-02 PCT/US2015/029946 May 8, 2015 Cannabinoid Receptor Mediating Compounds. E-140-2014-0-AU-03 2015255765 November 7, 2016 Cannabinoid Receptor Mediating Compounds. E-140-2014-0-CA-04 2948349 May 8, 2015 Cannabinoid Receptor Mediating Compounds. E-140-2014-0-EP-06 15728668.3 May 8, 2015 Cannabinoid Receptor Mediating Compounds. E-140-2014-0-CN-05 201580028788.X May 8, 2015 Cannabinoid Receptor Mediating Compounds. E-140-2014-0-IN-07 201637038171 November 8, 2016 Cannabinoid Receptor Mediating Compounds. E-140-2014-0-JP-08 2017-511558 May 8, 2015 Cannabinoid Receptor Mediating Compounds. E-140-2014-0-US-09 15/309,728 November 8, 2016 Cannabinoid Receptor Mediating Compounds. E-140-2014-0-HK-10 17105705.6 June 9, 2017 Cannabinoid Receptor Mediating Compounds

    The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive patent license territory will be granted worldwide and in a field of use not broader than human therapeutics for type I diabetes and its comorbidities diabetic nephropathy, chronic kidney disease, diabetic retinopathy, and peripheral and autonomic neuropathy.

    The invention covered by the patents and patent applications pertaining to HHS Ref. No. E-282-2012-0 pertain to cannabinoid receptor 1 (CN1R) inverse agonists. CN1R activation plays a key role in appetitive behavior and metabolism. Of importance as a therapeutic target here is that the receptor is expressed in both peripheral tissue as well as the central nervous system. The invention is a class of pyrazole compounds that act as CN1 receptor inverse agonists and have been shown effective at reducing obesity and its associated metabolic consequences while having no experimentally discernable neuropsychotropic side effects that are considered adverse such as the earlier antagonists rimonabant. These CN1R receptor compounds were developed with the goals of limiting their brain penetrance without losing their metabolic efficacy due to CN1 inverse agonism, and having a primary metabolite directly targeting enzymes involved in inflammatory and fibrotic processes associated with metabolic disorders. The patent rights cover both compositions of matter and methods of use.

    The inventions covered by HHS Ref. E-140-2014-0 also pertain to pyrazole CN1R receptor inverse agonists. In addition, some of these compounds also have a direct inhibitory effect on inducible nitric oxide synthase (iNOS), whereas another group of the compounds directly activates AMP kinase. There is evidence that the metabolic effects of endocannabinoids are mediated by CN1 receptors in peripheral tissues. These dual-target compounds may be useful for treating metabolic disease and related conditions such as obesity and diabetes and their complications, including liver or kidney fibrosis, without the dangerous the side effects.

    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent license will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the NHLBI 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 license.

    Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: July 25, 2018. Michael A. Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development.
    [FR Doc. 2018-16836 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Aging; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, NIA.

    The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

    The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL INSTITUTE ON AGING, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Board of Scientific Counselors, NIA.

    Date: October 9, 2018.

    Time: October 9, 2018, 8:00 a.m. to 8:20 a.m.

    Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators.

    Place: National Institutes on Aging, Biomedical Research Center, 3rd Floor Conference Room 03C227, 251 Bayview Boulevard, Baltimore, MD.

    Time: October 9, 2018, 8:20 a.m. to 10:50 a.m.

    Agenda: Committee discussion, individual presentations, laboratory overview.

    Place: National Institutes on Aging, Biomedical Research Center, 3rd Floor Conference Room 03C227, 251 Bayview Boulevard, Baltimore, MD.

    Time: October 9, 2018, 10:50 a.m. to 11:05 a.m.

    Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators.

    Place: National Institutes on Aging, Biomedical Research Center, 3rd Floor Conference Room 03C227, 251 Bayview Boulevard, Baltimore, MD.

    Time: October 9, 2018, 11:05 a.m. to 11:30 a.m.

    Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators.

    Place: National Institutes on Aging, Biomedical Research Center, 3rd Floor Conference Room 03C227, 251 Bayview Boulevard, Baltimore, MD.

    Time: October 9, 2018, 11:30 a.m. to 2:30 p.m.

    Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators.

    Place: National Institutes on Aging, Biomedical Research Center, 3rd Floor Conference Room 03C227, 251 Bayview Boulevard, Baltimore, MD.

    Time: October 9, 2018, 2:30 p.m. to 5:10 p.m.

    Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators.

    Place: National Institutes on Aging, Biomedical Research Center, 3rd Floor Conference Room 03C227, 251 Bayview Boulevard, Baltimore, MD.

    Time: October 9, 2018, 5:10 p.m. to 6:10 p.m.

    Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators.

    Place: National Institutes on Aging, Biomedical Research Center, 3rd Floor Conference Room 03C227, 251 Bayview Boulevard, Baltimore, MD.

    Contact Person: Luigi Ferrucci, Ph.D., MD, Scientific Director, National Institute on Aging, 251 Bayview Boulevard, Suite 100, Room 4C225, Baltimore, MD 21224, 410-558-8110, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: August 1, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-16785 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Aging Special Emphasis Panel; Metformin and Aging.

    Date: September 12, 2018.

    Time: 2:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, Suite 2W-200, 7201 Wisconsin Avenue, Bethesda, MD 20892.

    Contact Person: Anita H. Undale, Ph.D., MD, Scientific Review Branch, National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892, 240-747-7825, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: August 1, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-16786 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement Applications (U44).

    Date: August 22, 2018.

    Time: 9:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: Priti Mehrotra, Ph.D., Chief, Immunology Review Branch, Scientific Review Program, Division of Extramural Activities, Room #3G40 National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892-7616, 240-669-5066, [email protected].

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Clinical Trial Planning Grant (R34) and Implementation Cooperative Agreement (U01).

    Date: August 28, 2018.

    Time: 10:00 a.m. to 12:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: Louis A. Rosenthal, Ph.D., Scientific Review Officer Scientific Review Program, Division of Extramural Activities, Rm. 3G42B, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9834, Bethesda, MD 20892-9834, (240) 669-5070, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)
    Dated: August 1, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-16789 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; 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 grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Clinical and Translational Exploratory/Developmental Studies.

    Date: September 14, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Westin Arlington Gateway, 801 North Glebe Road, Arlington, VA 22203.

    Contact Person: Robert S. Coyne, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W236, Bethesda, MD 20892-9750, 240-276-7684, [email protected].

    Name of Committee: National Cancer Institute Special Emphasis Panel; SEP-7: NCI Clinical and Translational R21 and Omnibus R03.

    Date: September 27, 2018.

    Time: 7:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852.

    Contact Person: Saejeong J. Kim, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W640, Bethesda, MD 20892-9750, 240-276-5179, [email protected].

    Name of Committee: National Cancer Institute Initial Review Group, Subcommittee J—Career Development.

    Date: October 11-12, 2018.

    Time: 5:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda Marriott Suites, 6711 Democracy Boulevard Bethesda, MD 20817.

    Contact Person: Tushar Deb, Ph.D., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W624, Bethesda, MD 20892-9750, 240-276-6132, [email protected].

    Name of Committee: National Cancer Institute Special Emphasis Panel; Innovative Molecular and Cellular Analysis Technologies (IMAT).

    Date: October 19, 2018.

    Time: 8:30 a.m. to 5:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 2E908, Rockville, MD 20850.

    Contact Person: Yasuko Furumoto, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W634, Bethesda, MD 20892-9750, 240-276-5287, [email protected].

    Name of Committee: National Cancer Institute Special Emphasis Panel; R25 Review.

    Date: October 24, 2018.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W110, Rockville, MD 20850 (Telephone Conference Call).

    Contact Person: Robert E. Bird, Ph.D., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W110, Bethesda, MD 20892-9750, 240-276-6344, [email protected].

    Name of Committee: National Cancer Institute Special Emphasis Panel; Innovative Molecular Analysis Technologies (IMAT).

    Date: November 1, 2018.

    Time: 11:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W634, Rockville, MD 20850 (Telephone Conference Call).

    Contact Person: Yasuko Furumoto, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W634, Bethesda, MD 20892-9750, 240-276-5287, [email protected].

    Name of Committee: National Cancer Institute Special Emphasis Panel; UH2/UH3 Review.

    Date: November 7, 2018.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W110, Rockville, MD 20850 (Telephone Conference Call).

    Contact Person: Robert E. Bird, Ph.D., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W110, Bethesda, MD 20892-9750, 240-276-6344, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS)
    Dated: August 1, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-16784 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

    FOR FURTHER INFORMATION CONTACT:

    Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information.

    SUPPLEMENTARY INFORMATION:

    This notice is in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve commercialization of results of federally-funded research and development.

    Technology description follows.

    Albumin Binding Prostate Cancer Treating Compositions

    The invention pertains to a therapeutic agent that includes a chemically conjugated residue derived from (((R-)-1-carboxy-2-mercaptoethyl)carbamoyl)-L-glutamic acid that is further bound to an Evans blue analog (EB). The EB analog reversibly binds to circulating serum albumin to provide a radiopharmaceutical that retains affinity and specificity to prostate specific membrane antigen (PSMA; in this case PSMA-617). PSMA is a surface molecule shown to be specifically expressed by prostate tumor cells. PSMA expression levels correlate with disease stage and with hormone refractory cancers. Although most PSMA expression appears to be restricted to the prostate cancer, low levels of expression can also be detected in the brain, kidneys, salivary glands, and small intestine. The antigen is also shown to be expressed by neovascular tumor vessels of multiple other cancers. Inclusion of the Evans blue analog promotes high internalization and retention rates of the conjugated target ligand, and therefore, higher accumulation in PSMA positive tumors. Labeling EB-PSMA-617 derivatives with the therapeutic beta emitters, e.g., 90Y, 86Y, and 177Lu gives rise to improved tumor response and survival rates.

    Potential Commercial Applications:

    • Cancer therapeutics • Higher stability/Lower toxicity

    Development Stage:

    • Early stage

    Inventors: Xiaoyuan Chen and Orit Jacobson Weiss (both of NIBIB).

    Intellectual Property: HHS Reference No. E-054-2018/0; U.S. Provisional Patent Applications 62/633,648 filed February 22, 2018.

    Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; [email protected].

    Dated: July 20, 2018. Michael Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development.
    [FR Doc. 2018-16838 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

    FOR FURTHER INFORMATION CONTACT:

    Barry Buchbinder, Ph.D., 240-627-3678; barry.[email protected] Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.

    SUPPLEMENTARY INFORMATION:

    Technology description follows.

    Self-Assembling Insect Ferritin Nanoparticles for Display of Co-assembled Trimeric Antigens Description of Technology

    Antigens on the surface of virus particles are displayed in a regular, repetitive pattern which facilitates B cell activation. Presenting trimeric antigens on engineered particles that mimic the geometric patterns observed for native viral proteins can lead to an improved host antibody response.

    Self-assembling globular ferritin nanoparticles have previously been used to display multiple copies of a co-assembled trimeric antigen to the immune system. However, prior ferritin nanoparticle technologies only permit a random co-assembly of diverse trimeric antigens, and therefore cannot guarantee the pattern and ratio of diverse trimeric antigens on a single ferritin nanoparticle.

    Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases are developing novel recombinant ferritin nanoparticles that are based on insect ferritin proteins, and that have been engineered to display two different trimeric antigens in a defined ratio and geometric pattern. This system has been tested with antigens derived from HIV-1 envelope (Env) and influenza hemagglutinin (HA). Interestingly, when guinea pigs are immunized with ferritin nanoparticles displaying two different trimeric antigens, induced B cells could simultaneously recognize both trimeric antigens, thus leading to an immune response with improved neutralization breadth.

    This technology can be used as a platform for multimerized display of trimeric antigens such as viral type I fusion glycoproteins, and may be applied to many high-priority vaccine targets, such as HIV-1, influenza, respiratory syncytial virus, parainfluenza viruses, and coronaviruses.

    Potential Commercial Applications:

    • Platform for multimerized immunogen presentation and vaccine design.

    • Vaccines for pathogens that use genetic diversity to escape the immune response.

    Competitive Advantages:

    • Particles have equal fractions of two different antigens in a specific configuration on the nanoparticle surface (unlike regular ferritin used previously)

    • Designed particles have a geometry that allows for attachment of trimeric antigens (unlike the native insect ferritin).

    Development Stage:

    In vivo testing (rodents).

    Inventors: Peter Kwong (NIAID), Ivelin Georgiev (NIAID), Michael Gordon Joyce (NIAID), Masaru Kanekiyo (NIAID), Aliaksandr Druz (NIAID), Ulrich Baxa (NIAID), Joseph Van Galen (NIAID), Rita Chen (NIAID), Cheng Cheng (NIAID), John Mascola (NIAID), Yaroslav Tsybovsky (Leidos Biomedical Research, Inc), Yongping Yang (NIAID), Paul Thomas (NIAID), Barney Graham (NIAID).

    Publications: Georgiev, Ivelin S., et al., ACS Infectious Diseases (2018) 4 (5), 788-796.

    Intellectual Property: HHS Reference Number E-270-2015: U.S. Patent Application No. 62/355,212 filed 06/27/2016; PCT Application No. PCT/US2017/039595 filed 06/27/2017 (pending).

    Related Intellectual Property: HHS Reference Number E-531-2013, E-293-2011, E-060-2015.

    Licensing Contact: Barry Buchbinder, Ph.D., 240-627-3678; [email protected].

    Dated: July 20, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.
    [FR Doc. 2018-16841 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Scientific Advisory Committee on Alternative Toxicological Methods; Announcement of Meeting; Request for Comments AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the next meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM, a federally chartered, external advisory group composed of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organization, will review and provide advice on programmatic activities. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activites of NICEATM. The meeting is open to the public and registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/32822.

    DATES:

    Meeting: September 5-6, 2018; Begins at 9:00 a.m. (EDT) each day and continues until adjournment.

    Written Public Comment Submissions: Deadline is August 29, 2018.

    Oral Comments: Deadline is August 29, 2018.

    Registration for Meeting: Deadline September 6, 2018.

    Registration to view the meeting via the webcast is required.

    ADDRESSES:

    Meeting Location: Rodbell Auditorium, Rall Building, National Institute of Environmental Health Sciences (NIEHS), 111 T.W. Alexander Drive, Research Triangle Park, NC 27709.

    Meeting web page: The preliminary agenda, registration, and other meeting materials are at https://ntp.niehs.nih.gov/go/32822.

    Webcast: The meeting will be webcast; the URL will be provided to those who register for viewing.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Mary Wolfe, Designated Federal Official for the SACATM, Office of Liaison, Policy and Review, Division of NTP, NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709. Phone: 984-287-3209, Fax: 301-451-5759, Email: [email protected] Hand Deliver/Courier address: 530 Davis Drive, Room K2130, Morrisville, NC 27560.

    SUPPLEMENTARY INFORMATION:

    Meeting and Registration: The meeting is open to the public with time scheduled for oral public comments; attendance at the meeting is limited only by the space available.

    SACATM will provide input to ICCVAM, NICEATM, and NIEHS on programmatic activities and issues. Preliminary agenda includes the US Strategic Roadmap including challenges to and opportunities for implementing non-animal approaches to evaluate chemicals and medical products and the importance of international harmonization through the Organisation for Economic Co-operation and Development activites. Please see the preliminary agenda for information about the specific presentations. The preliminary agenda, roster of SACATM members, background materials, public comments, and any additional information, when available, will be posted on the SACATM meeting website (https://ntp.niehs.nih.gov/go/32822) or may be requested in hardcopy from the Designated Federal Official for SACATM. Following the meeting, summary minutes will be prepared and made available on the BSC meeting website.

    The public may attend the meeting in person or view the webcast. Registration is required to view the webcast; the URL for the webcast will be provided in the email confirming registration. Individuals who plan to provide oral comments (see below) are encouraged to register online at the SACATM meeting website (https://ntp.niehs.nih.gov/go/32822) by August 29, 2018, to facilitate planning for the meeting. Individuals are encouraged to access the website to stay abreast of the most current information regarding the meeting. Visitor and security information for those attending in-person is available at niehs.nih.gov/about/visiting/index.cfm. Individuals with disabilities who need accommodation to participate in this event should contact Ms. Robbin Guy at phone: (984) 287-3136 or email: [email protected] TTY users should contact the Federal TTY Relay Service at 800-877-8339. Requests should be made at least five business days in advance of the event.

    Written Public Comments: Written and oral public comment are invited for the agenda topics. Guidelines for public comments are available at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.

    The deadline for submission of written comments is August 29, 2018. Written public comments should be submitted through the meeting website. Persons submitting written comments should include name, affiliation, mailing address, phone, email, and sponsoring organization (if any). Written comments received in response to this notice will be posted on the NTP website, and the submitter will be identified by name, affiliation, and sponsoring organization (if any).

    Oral Public Comment Registration: The preliminary agenda allows for several public comment periods with each allowing for up to 4 commenters for up to 5 minutes per speaker. Oral comments may be presented in person at NIEHS or by teleconference line. Registration for oral comments is on or before August 29, 2018, at https://ntp.niehs.nih.gov/go/32822. Registration is on a first-come, first-served basis, and registrants will be assigned a number in their confirmation email. Each organization is allowed one time slot per comment period. After the maximum number of speakers per comment period is exceeded, individuals registered to provide oral comment will be placed on a wait list and notified should an opening become available. Commenters will be notified after August 29, 2018, about the actual time allotted per speaker, and the teleconference number will be sent to those registered to give oral comments by teleconference line.

    If possible, oral public commenters should send a copy of their slides and/or statement or talking points to Robbin Guy by email: [email protected] by August 29, 2018.

    Meeting Materials: The preliminary meeting agenda is available on the meeting web page https://ntp.niehs.nih.gov/go/32822 and will be updated one week before the meeting. Individuals are encouraged to access the meeting web page to stay abreast of the most current information regarding the meeting.

    Background Information on ICCVAM, NICEATM, and SACATM: ICCVAM is an interagency committee composed of representatives from 16 federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological and safety-testing methods that more accurately assess the safety and hazards of chemicals and products and that reduce, refine (decrease or eliminate pain and distress), or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) established ICCVAM as a permanent interagency committee of the NIEHS under NICEATM.

    NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts independent validation studies to assess the usefulness and limitations of new, revised, and alternative test methods and strategies. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods and strategies applicable to the needs of U.S. federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative test methods and strategies for validation studies and technical evaluations. Additional information about ICCVAM and NICEATM can be found at http://ntp.niehs.nih.gov/go/iccvam and http://ntp.niehs.nih.gov/go/niceatm.

    SACATM was established in response to the ICCVAM Authorization Act [Section 285l-3(d)] and is composed of scientists from the public and private sectors. SACATM advises ICCVAM, NICEATM, and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. SACATM provides advice on priorities and activities related to the development, validation, scientific review, regulatory acceptance, implementation, and national and international harmonization of new, revised, and alternative toxicological test methods.

    Additional information about SACATM, including the charter, roster, and records of past meetings, can be found at http://ntp.niehs.nih.gov/go/167.

    Dated: July 24, 2018. Brian R. Berridge, Associate Director, National Toxicology Program.
    [FR Doc. 2018-16840 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Interagency Autism Coordinating Committee.

    The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

    Name of Committee: Interagency Autism Coordinating Committee (IACC).

    Type of Meeting: Open Meeting.

    Date: Wednesday, October 17, 2018.

    Time: 9:00 a.m. to 5:00 p.m. *Eastern Time* Approximate end time.

    Agenda: To discuss business, updates, and issues related to ASD research and services activities.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Conference Room C and D, Rockville, MD 20852.

    Webcast Live: https://videocast.nih.gov.

    Conference Call Access: Dial: 800-369-3190.

    Access Code: 1724926.

    Cost: The meeting is free and open to the public.

    Registration: A registration web link will be posted on the IACC website (www.iacc.hhs.gov) prior to the meeting. Pre-registration is recommended to expedite check-in. Seating in the meeting room is limited to room capacity and on a first come, first served basis. Onsite registration will also be available.

    Deadlines: Notification of interest to present oral comments: Friday, October 5, 2018 by 5:00 p.m. ET

    Submission of written/electronic statement for oral comments: Tuesday, October 9, 2018 by 5:00 p.m. ET

    Submission of written comments: Tuesday, October 9, 2018 by 5:00 p.m. ET

    For IACC Public Comment guidelines please see: https://iacc.hhs.gov/meetings/public-comments/guidelines/

    Access: White Flint Metro Station (Red Line) in combination with a brief walk.

    Contact Person: Ms. Angelice Mitrakas, Office of Autism Research Coordination, National Institute of Mental Health, NIH, 6001 Executive Boulevard, Room 6182A, Bethesda, MD 20892-9669, Phone: 301-435-9269, Email: [email protected].

    Public Comments: Any member of the public interested in presenting oral comments to the IACC must notify the Contact Person listed on this notice by 5:00 p.m. ET on Friday, October 5, 2018 with their request to present oral comments at the meeting, and a written/electronic copy of the oral presentation/statement must be submitted by 5:00 p.m. ET on Tuesday, October 9, 2018. A limited number of slots for oral comment are available, and in order to ensure that as many different individuals are able to present throughout the year as possible, any given individual only will be permitted to present oral comments once per calendar year (2018). Only one representative of an organization will be allowed to present oral comments in any given meeting; other representatives of the same group may provide written comments. If the oral comment session is full, individuals who could not be accommodated are welcome to provide written comments instead. Comments to be read or presented in the meeting will be assigned a 3-5 minute time slot depending on the number of comments, but a longer version may be submitted in writing for the record. Commenters going beyond their allotted time in the meeting may be asked to conclude immediately in order to allow other comments and presentations to proceed on schedule.

    Any interested person may submit written public comments to the IACC prior to the meeting by emailing the comments to [email protected] or by submitting comments at the web link: https://iacc.hhs.gov/meetings/public-comments/submit/index.jsp by 5:00 p.m. ET on Tuesday, October 9, 2018. The comments should include the name, address, telephone number, and when applicable, the business or professional affiliation of the interested person. National Institute on Mental Health (NIMH) anticipates written public comments received by 5:00 p.m. ET on Tuesday, October 9, 2018 will be presented to the IACC prior to the meeting for the IACC's consideration. Any written comments received after the 5:00 p.m. ET, October 9, 2018 deadline through October 15, 2018 will be provided to the IACC either before or after the meeting, depending on the volume of comments received and the time required to process them in accordance with privacy regulations and other applicable Federal policies. All written public comments and oral public comment statements received by the deadlines for both oral and written public comments will be provided to the IACC for their consideration and will become part of the public record. Attachments of copyrighted publications are not permitted, but web links or citations for any copyrighted works cited may be provided.

    In the 2016-2017 IACC Strategic Plan, the IACC listed the “Spirit of Collaboration” as one of its core values, stating that, “We will treat others with respect, listen with open minds to the diverse views of people on the autism spectrum and their families, thoughtfully consider community input, and foster discussions where participants can comfortably where participants can comfortably offer opposing opinions.” In keeping with this core value, the IACC and the NIMH Office of Autism Research Coordination ask that members of the public who provide public comments or participate in meetings of the IACC also seek to treat others with respect and consideration in their communications and actions, even when discussing issues of genuine concern or disagreement.

    Remote Access: The meeting will be open to the public through a conference call phone number and webcast live on the internet. Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard. If you experience any technical problems with the webcast or conference call, please send an e- mail to [email protected] or call 240-668-0302.

    Individuals wishing to participate in person or by using these electronic services and who need special assistance, such as captioning of the conference call or other reasonable accommodations, should submit a request to the Contact Person listed on this notice at least five days prior to the meeting.

    Security: Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. Also, as a part of security procedures, attendees should be prepared to present a photo ID at the meeting registration desk during the check-in process. Pre-registration is recommended. Seating will be limited to the room capacity and seats will be on a first come, first served basis, with expedited check-in for those who are pre-registered.

    Meeting schedule subject to change. Information about the IACC is available on the website: http://www.iacc.hhs.gov.

    Dated: August 1, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-16794 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the meeting of the Council of Councils.

    The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (http://videocast.nih.gov).

    A portion of the meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4), and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Council of Councils.

    Open: September 7, 2018.

    Time: 8:15 a.m. to 12:15 p.m.

    Agenda: Call to Order and Introductions; Announcements and Updates; Environmental influences on Child Health Outcomes (ECHO), Program Genetics and Epigenetics Research to be Supported by Future ECHO Genetics Core; All of Us Research Program Update; NIH Update; Common Fund Program—Stimulating Peripheral Activity to Address Conditions.

    Place: National Institutes of Health, 9000 Rockville Pike, Building 60/Cloisters, Lecture Hall/Chapel, Bethesda, MD 20892.

    Closed: September 7, 2018.

    Time: 12:25 p.m. to 1:25 p.m.

    Agenda: Review of Grant Applications.

    Place: National Institutes of Health, 9000 Rockville Pike, Building 60/Cloisters, Lecture Hall/Chapel, Bethesda, MD 20892.

    Open: September 7, 2018.

    Time: 1:25 p.m. to 4:30 p.m.

    Agenda: Council Operating Procedures; Workshop Report on Contributions of Social and Behavioral Research in Addressing the Opioid Crisis; Retiring Council Members' Perspectives.

    Place: National Institutes of Health, 9000 Rockville Pike, Building 60/Cloisters, Lecture Hall/Chapel, Bethesda, MD 20892.

    Contact Person: Franziska Grieder, D.V.M., Ph.D., Executive Secretary, Council of Councils Director, Office of Research Infrastructure Programs, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH, 6701 Democracy Boulevard, Room 948, Bethesda, MD 20892, [email protected], 301-435-0744.

    Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

    In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.

    Information is also available on the Council of Council's home page at http://dpcpsi.nih.gov/council/ where an agenda will be posted before the meeting date.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS)
    Dated: August 1, 2018. David D. Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-16792 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory General Medical Sciences Council.

    The meeting will be open to the public as indicated below, with a short public comment period at the end. Attendance is limited by the space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The open session will also be videocast and can be accessed from the NIH Videocasting and Podcasting website (http://videocast.nih.gov).

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Advisory General Medical Sciences Council.

    Date: September 13-14, 2018.

    Time: September 13, 2018, 9:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health Natcher Building, Conference Rooms E1 & E2, 45 Center Drive, Bethesda, MD 20892.

    Time: September 14, 2018, 8:30 a.m. to 12:00 p.m.

    Agenda: For the discussion of program policies and issues; opening remarks; report of the Director, NIGMS; and other business of the Council.

    Place: National Institutes of Health Natcher Building, Conference Rooms E1 & E2, 45 Center Drive, Bethesda, MD 20892.

    Contact Person: Ann A. Hagan, Ph.D., Associate Director for Extramural Activities, NIGMS, NIH, DHHS, 45 Center Drive, Room 2AN24B, MSC 6200, Bethesda, MD 20892-6200, (301) 594-4499, [email protected].

    Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

    In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.

    Information is also available on the Institute's/Center's home page: http://www.nigms.nih.gov/About/Council, where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS)
    Dated: August 1, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-16791 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Workshop

    Notice is hereby given of a workshop convened by the Interagency Autism Coordinating Committee (IACC).

    The purpose of the 2018 IACC Workshop, Addressing the Health Needs of People with Autism Spectrum Disorder (ASD), is to convene a working group of the IACC that will focus on health needs and outcomes among individuals with ASD. The working group will use this workshop to discuss health epidemiology, patient-provider interactions, and co-occurring health conditions that affect individuals with ASD. The workshop will be open to the public, will include time for public comments, and will be accessible by live webcast and conference call.

    Name of Committee: Interagency Autism Coordinating Committee (IACC).

    Type of meeting: 2018 IACC Workshop on Addressing the Health Needs of People with Autism Spectrum Disorder (ASD).

    Date: Thursday, September 27, 2018.

    Time: 8:30 a.m. to 5:00 p.m. Eastern Time (ET).

    Agenda: The workshop will focus discussion on the health and wellness of individuals with ASD, including health epidemiology, patient-provider interaction, and the state of the science on commonly co-occurring health conditions affecting individuals on the autism spectrum.

    Place: National Institute of Mental Health (NIMH), 6001 Executive Boulevard, Neuroscience Center (NSC), Conference Rooms C, D, and E, Rockville, MD 20852.

    Conference Call: 800-369-1744.

    Access Code: 6697418.

    Webcast Live: http://videocast.nih.gov/.

    Cost: The meeting is free and open to the public.

    Registration: Pre-registration is recommended to expedite check-in. Seating in the meeting room is limited to room capacity and on a first come, first serve basis. To register, please visit www.iacc.hhs.gov.

    Deadlines: Notification of intent to present oral comments: Friday, September 14, 2018 by 5:00 p.m. ET.

    Submission of written/electronic statement for oral comments: Wednesday, September 19, 2018 by 5:00 p.m. ET.

    Final deadline for submission of written comments: Wednesday, September 19, 2018 by 5:00 p.m. ET. For IACC public comment guidelines, please see: https://iacc.hhs.gov/meetings/public-comments/guidelines/.

    Access: White Flint Metro Station (Red Line).

    Contact Person: Ms. Angelice Mitrakas, Office of Autism Research Coordination, National Institute of Mental Health, National Institutes of Health, 6001 Executive Boulevard, Room 6182A, Bethesda, MD 20892-9669, Phone: 301-435-9269, Email: [email protected].

    The IACC invites oral and written public-related comments relevant to the topic of the workshop. Individuals interested in presenting oral comments must notify the Contact Person listed on this notice by 5:00 p.m. ET on Friday, September 14, 2018 with their request to present oral comments at the meeting, and a written/electronic copy of the oral presentation/statement must be submitted by 5:00 p.m. ET on Wednesday, September 19, 2018. A limited number of slots for oral comment are available and will be assigned on a first come, first serve basis. Only one representative of an organization will be allowed to present oral comments at this meeting; other representatives of the same group may provide written comments. If the oral comment session is full, individuals who could not be accommodated are welcome to provide written comments instead. Comments to be read or presented in the meeting will be assigned a 3-minute time slot, but a longer version may be submitted in writing for the record. Commenters going beyond their allotted time in the meeting may be asked to conclude immediately to allow other comments and presentations to proceed on schedule.

    Any interested person may submit written public comments to the IACC prior to the meeting by emailing the comments to [email protected], or by submitting comments at the web link: https://iacc.hhs.gov/meetings/public-comments/submit/index.jsp by 5:00 p.m. ET on Wednesday, September 19, 2018. The comments should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. NIMH anticipates written public comments received by 5:00 p.m. ET on Wednesday, September 19, 2018 will be presented to the working group prior to the workshop. Any written comments received after the 5:00 p.m. ET, Wednesday, September 19, 2018 deadline through Tuesday, September 25, 2018 will be provided to the working group either before or after the meeting, depending on the volume of comments received and the time required to process them in accordance with privacy regulations and other applicable Federal policies. All written public comments and oral public comment statements received by the deadlines for both oral and written public comments will be provided to the IACC for their consideration and will become part of the public record. Attachments of copyrighted publications are not permitted, but web links or citations for any copyrighted works cited may be provided.

    In the 2009 IACC Strategic Plan, the IACC listed the “Spirit of Collaboration” as one of its core values, stating that, “We will treat others with respect, listen to diverse views with open minds, discuss submitted public comments, and foster discussions where participants can comfortably offer opposing opinions.” In keeping with this core value, the IACC and the NIMH Office of Autism Research Coordination (OARC) ask that members of the public who provide public comments or participate in meetings of the IACC also seek to treat others with respect and consideration in their communications and actions, even when discussing issues of genuine concern or disagreement.

    Remote Access: The meeting will be open to the public through a conference call phone number and webcast live on the internet. Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard. If you experience any technical problems with the webcast or conference call, please send an e- mail to [email protected] Individuals wishing to participate in person or by using these electronic services and who need special assistance, such as captioning of the conference call or other reasonable accommodations, should submit a request to the Contact Person listed on this notice at least 5 days prior to the meeting.

    Special Accommodations: Individuals who participate in person or by using these electronic services and who need special assistance, such as captioning of the conference call or other reasonable accommodations, should submit a request to the Contact Person listed on this notice at least 5 days prior to the meeting.

    Security: Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. Also, as a part of security procedures, attendees should be prepared to present a photo ID at the meeting registration desk during the check-in process. Pre-registration is recommended. Seating will be limited to the room capacity and seats will be on a first come, first serve basis, with expedited check-in for those who are pre-registered.

    Meeting schedule subject to change. Information about the IACC is available on the website: http://www.iacc.hhs.gov.

    Dated: August 1, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-16793 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Aging Initial Review Group, Biological Aging Review Committee NIA-B.

    Date: September 27-28, 2018.

    Time: 2:00 p.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814 (Telephone Conference Call).

    Contact Person: Bita Nakhai, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Bldg., 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301-402-7701, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: August 1, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-16788 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

    FOR FURTHER INFORMATION CONTACT:

    Vince Contreras, Ph.D., 240-669-2823; [email protected] Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.

    SUPPLEMENTARY INFORMATION:

    Technology description follows.

    Substitutions-Modified Prefusion RSV F Proteins and Their Use

    Description of Technology: The respiratory syncytial virus (RSV) fusion (F) glycoprotein is the primary target of neutralizing antibodies. The F glycoprotein exists in at least two conformations, a meta-stable prefusion state, and an extremely stable postfusion state. Both states share several epitopes targeted by neutralizing antibodies, but it has been demonstrated that the prefusion conformation of F contains at least one epitope not present in the postfusion conformation. Natural infection results in neutralizing antibodies that are primarily directed against the prefusion conformation of F, not its postfusion conformation. The instability of the prefusion form of F has hindered both its characterization and its use as a vaccine antigen.

    Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases have overcome technical obstacles to produce a homogeneous, soluble RSV F glycoprotein vaccine which is stabilized in the prefusion conformation and has improved stability and immunogenicity compared to the native protein. Additionally, several modifications were introduced to remove the requirement for furin during production, resulting in an increase in expression levels of the immunogen. Stability of the immunogen was increased 20-fold as compared to DS-CAV1 (a prefusion-stabilized RSV F glycoprotein vaccine candidate that is currently being assessed in clinical trials) upon incubation at 60 °C. In mice, these immunogens elicited neutralization titers that were 2 to 5-fold higher than DS-CAV1.

    This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration.

    Potential Commercial Applications:

    Vaccine: RSV vaccine for human use.

    Probe: B cell-sorting probe to isolate potent neutralizing monoclonal antibodies.

    Diagnostics: To assess the titer of prefusion-specific antibodies in sera.

    Competitive Advantages:

    • Increased stability compared to the current leading RSV vaccine candidate (DS-Cav1).

    • Elicits increased neutralization titers in mice.

    Development Stage:

    In vivo testing (mice).

    Inventors: Peter D. Kwong (NIAID), M. Gordon Joyce (NIAID), Baoshan Zhang (NIAID), Man Chen (NIAID), Barney S. Graham (NIAID), John R. Mascola (NIAID), Aliaksandr A. Druz (NIAID), Wing-Pui Kong (NIAID), Ivelin Georgiev (NIAID), Yaroslav Tsybovsky (Leidos Biomedical Research), Paul V. Thomas (NIAID), Marie L. Pancera (NIAID), Mallika Sastry (NIAID), Cinque Soto (NIAID), Guillaume B.E. Stewart-Jones (NIAID), Yongping Yang (NIAID), Li Ou (NIAID), Ulrich Baxa (NCI), Emily Rundlet (NIAID), Joseph Van Galen (NIAID).

    Publications: Joyce, M. Gordon, et al., Nature structural & molecular biology, 23.9 (2016): 811; PMID: 27478931.

    Intellectual Property: HHS Reference Number E-064-2016: U.S. Patent Application No. 62/314,946 filed 03/29/2016; PCT Application Number PCT/US2017/024714 filed 03/29/2017 (pending).

    Related Intellectual Property: HHS Reference Number E-081-2013.

    Licensing Contact: Vince Contreras, Ph.D., 240-669-2823; [email protected]

    Dated: July 20, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.
    [FR Doc. 2018-16835 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2016-2017; Availability of Report AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Biennial Progress Report: 2016-2017. This report, prepared in accordance with requirements of the ICCVAM Authorization Act of 2000, describes activities and accomplishments from January 2016 through December 2017.

    ADDRESSES:

    The report is available at http://ntp.niehs.nih.gov/iccvamreport/2017/index.html.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Warren Casey, Director, NICEATM; email: [email protected]; telephone: (984) 287-3118.

    SUPPLEMENTARY INFORMATION:

    Background: The ICCVAM Authorization Act of 2000 established ICCVAM as a permanent interagency committee of the National Institute of Environmental Health Sciences (NIEHS) under NICEATM. ICCVAM's mission is to facilitate development, validation, and regulatory acceptance of new and revised regulatory test methods that reduce, refine, or replace the use of animals in testing while maintaining and promoting scientific quality and the protection of human health, animal health, and the environment.

    A provision of the ICCVAM Authorization Act states that ICCVAM shall prepare “reports to be made available to the public on its progress under this Act.” The eighth ICCVAM biennial progress report describing ICCVAM activities and accomplishments from January 2016 through December 2017 is now available.

    Summary of Report Contents: Key ICCVAM, ICCVAM agency, and NICEATM accomplishments summarized in the report include:

    • Development of a strategic roadmap for incorporating new approaches into safety testing of chemicals and medical products in the United States.

    • Publication of two guidance documents by the U.S. Environmental Protection Agency (EPA) in 2016. One included a policy statement to waive all acute dermal lethality studies for pesticide formulations. The other described a transparent, stepwise process for evaluating and implementing alternative methods for six-pack studies, which test for acute systemic toxicity by the oral, dermal, and inhalation routes; skin and eye irritation; and skin sensitization.

    • Publication of notices permitting removal of back-titration hamsters for potency testing of vaccines containing Leptospira pomona and Leptospira grippotyphosa by the U.S. Department of Agriculture, further reducing the number of hamsters required for leptospirosis vaccine potency testing.

    • Publication by the U.S. Food and Drug Administration of the Predictive Toxicology Roadmap for integrating predictive toxicology methods into safety and risk assessments.

    • Development by NICEATM and EPA scientists of a defined approach that combines data from 11 high-throughput screening assays with a computational model to identify chemicals with the potential to interact with the androgen receptor pathway.

    • Development by NICEATM and ICCVAM scientists of a defined approach that uses non-animal approaches to predict murine local lymph node assay outcomes and human skin sensitization hazard and potency.

    • Submission of a proposal to develop a performance-based test guideline for defined approaches to skin sensitization testing and assessment to the Organisation for Economic Co-operation and Development (OECD) by partners in the International Cooperation on Alternative Test Methods in 2016. The proposal was approved as part of the OECD workplan in 2017.

    • Launch of the Integrated Chemical Environment, a publicly accessible online resource developed to provide high-quality curated data and computational workflows to facilitate chemical safety assessment, by NICEATM.

    Availability of Report: The report is available at http://ntp.niehs.nih.gov/iccvamreport/2017/index.html. Links to this report and all past ICCVAM annual and biennial reports are available at http://ntp.niehs.nih.gov/go/iccvam-bien.

    Background Information on ICCVAM and NICEATM: ICCVAM is an interagency committee composed of representatives from 16 federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods and integrated testing strategies with regulatory applicability. ICCVAM also promotes the scientific validation and regulatory acceptance of testing methods that more accurately assess the safety and hazards of chemicals and products and replace, reduce, or refine (enhance animal well-being and lessen or avoid pain and distress) animal use.

    The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) establishes ICCVAM as a permanent interagency committee of NIEHS and provides the authority for ICCVAM involvement in activities relevant to the development of alternative test methods. Additional information about ICCVAM can be found at http://ntp.niehs.nih.gov/go/iccvam.

    NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts and publishes analyses and evaluations of data from new, revised, and alternative testing approaches. NICEATM and ICCVAM work collaboratively to evaluate new and improved testing approaches applicable to the needs of U.S. federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative testing approaches for validation studies and technical evaluations. Additional information about NICEATM can be found at http://ntp.niehs.nih.gov/go/niceatm.

    Dated: July 24, 2018. Brian R. Berridge, Associate Director, National Toxicology Program.
    [FR Doc. 2018-16837 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases Notice of Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of meetings of the National Diabetes and Digestive and Kidney Diseases Advisory Council.

    The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Diabetes and Digestive and Kidney Diseases Advisory Council.

    Date: September 7, 2018.

    Open: 8:30 a.m. to 12:00 p.m.

    Agenda: To present the Director's Report and other scientific presentations.

    Place: National Institutes of Health, Building 31, C Wing, 6th Floor, Conference Room 10, 31 Center Drive, Bethesda, MD 20892.

    Closed: 1:00 p.m. to 4:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Building 31, C Wing, 6th Floor, Conference Room 10, 31 Center Drive, Bethesda, MD 20892.

    Contact Person: Karl F. Malik, Ph.D., Acting Director, Division of Extramural Activities, National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd., Room 7329, MSC 5452, Bethesda, MD 20892, (301) 594-4757, [email protected].

    Name of Committee: National Diabetes and Digestive and Kidney Diseases Advisory Council; Kidney, Urologic and Hematologic Diseases Subcommittee.

    Date: September 7, 2018.

    Open: 1:00 p.m. to 2:45 p.m.

    Agenda: To review the Division's scientific and planning activities.

    Place: National Institutes of Health, Building 31, C Wing, 6th Floor, Conference Room 7, 31 Center Drive, Bethesda, MD 20892.

    Closed: 2:45 p.m. to 3:15 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Building 31, C Wing, 6th Floor, Conference Room 7, 31 Center Drive, Bethesda, MD 20892.

    Contact Person: Karl F. Malik, Ph.D., Acting Director, Division Of Extramural Activities, National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd., Room 7329, MSC 5452, Bethesda, MD 20892, (301) 594-4757, [email protected].

    Name of Committee: National Diabetes and Digestive and Kidney Diseases Advisory Council; Diabetes, Endocrinology, and Metabolic Diseases Subcommittee.

    Date: September 7, 2018.

    Open: 1:00 p.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Building 31, C Wing, 6th Floor, Conference Room 10, 31 Center Drive, Bethesda, MD 20892.

    Closed: 2:00 p.m. to 3:15 p.m.

    Agenda: To review the Division's scientific and planning activities.

    Place: National Institutes of Health, Building 31, C Wing, 6th Floor, Conference Room 10, 31 Center Drive, Bethesda, MD 20892.

    Contact Person: Karl F. Malik, Ph.D., Acting Director, Division Of Extramural Activities, National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd., Room 7329, MSC 5452, Bethesda, MD 20892, (301) 594-4757, [email protected].

    Name of Committee: National Diabetes and Digestive and Kidney Diseases Advisory Council; Digestive Diseases and Nutrition Subcommittee.

    Date: September 7, 2018.

    Open: 1:00 p.m. to 2:00 p.m.

    Agenda: To review the Division's scientific and planning activities.

    Place: National Institutes of Health, Building 31, C Wing, 6th Floor, Conference Room 6, 31 Center Drive, Bethesda, MD 20892.

    Closed: 2:15 p.m. to 3:15 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Building 31, C Wing, 6th Floor, Conference Room 6, 31 Center Drive, Bethesda, MD 20892.

    Contact Person: Karl F. Malik, Ph.D., Acting Director, Division of Extramural Activities, National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd., Room 7329, MSC 5452, Bethesda, MD 20892, (301) 594-4757, [email protected].

    Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

    In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.

    Information is also available on the Institute's/Center's home page: www.niddk.nih.gov/fund/divisions/DEA/Council/coundesc.htm., where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS)
    Dated: August 1, 2018. David D. Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-16790 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2018-0495] Merchant Mariner Medical Advisory Committee AGENCY:

    U.S. Coast Guard, Department of Homeland Security.

    ACTION:

    Notice of Federal Advisory Committee Meeting.

    SUMMARY:

    The Merchant Mariner Medical Advisory Committee and its Working Groups will meet to discuss matters relating to medical certification determinations for issuance of licenses, certificates of registry, and merchant mariners' documents, medical standards and guidelines for the physical qualifications of operators of commercial vessels, medical examiner education, and medical research. The meetings will be open to the public.

    DATES:

    Meetings: The Merchant Mariner Medical Advisory Committee and its Working Groups are scheduled to meet on Thursday, September 13, 2018, and on Friday, September 14, 2018, from 8:00 a.m. until 5:30 p.m. each day. These meetings may adjourn early if the Committee has completed its business.

    Comments and supporting documentation: To ensure your comments are received by Committee members before the meetings, submit your written comments no later than September 5, 2018.

    ADDRESSES:

    The meetings will be held at STAR Center, 2 West Dixie Highway, Dania Beach, FL 33004, https://www.star-center.com/.

    Pre-registration Information: Pre-registration is not required for access to this meeting by the public. All attendees will be required to provide a driver's license or government-issued identification card in order to gain admittance to the building.

    For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the Alternate Designated Federal Officer as soon as possible using the contact information provided in the FOR FURTHER INFORMATION CONTACT section of this notice.

    Instructions: You are free to submit comments at any time, including orally at the meetings, but if you want Committee members to review your comment before the meetings, please submit your comments no later than September 5, 2018. We are particularly interested in comments on the issues in the “Agenda” section below. You must include “Department of Homeland Security” and the docket number USCG-2018-0495. Written comments may also be submitted using the Federal eRulemaking Portal at http://www.regulations.gov. If you encounter technical difficulties with comments submission, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section below. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You may review the Privacy and Security Notice for the Federal Docket Management System at https://www.regulations.gov/privacyNotice.

    Docket Search: For access to the docket, to read documents or comments related to this notice, go to http://www.regulations.gov, type USCG-2018-0495 in the “Search” box, press Enter, and then click on the item you wish to view.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Davis Breyer, Alternate Designated Federal Officer of the Merchant Mariner Medical Advisory Committee, 2703 Martin Luther King Jr. Ave. SE, Stop 7509, Washington, DC 20593-7509, telephone 202-372-1445, fax 202-372-8382 or [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice of this meeting is pursuant with the Federal Advisory Committee Act, Title 5 United States Code Appendix.

    The Merchant Mariner Medical Advisory Committee Meeting is authorized by U.S. Code, Title 46, section 7115. The Committee advises the Secretary of the Department of Homeland Security on matters related to (a) medical certification determinations for issuance of licenses, certificates of registry, and merchant mariners' documents; (b) medical standards and guidelines for the physical qualifications of operators of commercial vessels; (c) medical examiner education; and (d) medical research.

    Agenda Day 1

    The agenda for the September 13, 2018, meeting is as follows:

    (1) The full Committee will meet briefly to discuss the Working Groups' business/task statements, which are listed under paragraph 2 and 3 (a)-(b) below.

    (2) General Discussion of Mariner Mental Health Issues with presentations by mariner service organizations and industry.

    (3) Working Groups will separately address the following task statements, which are available at https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/medmac.

    (a) Task statement 16-24 Recommendations on Appropriate Diets and Wellness for Mariners While Onboard Merchant Vessels; and

    (b) Task statement 17-26, Input to Support Regulatory Reform of Coast Guard Regulations-Executive Orders 13771 and 13783.

    (4) Public comment period.

    (5) Reports of Working Groups. At the end of the day, the Working Groups will report to the full Committee on what was accomplished in their meetings. The full Committee will not take action on these reports on this date. Any official action taken as a result of these Working Group meetings will be taken on day two of the meeting.

    (6) Adjournment of meeting.

    Day 2

    The agenda for the September 14, 2018, meeting is as follows:

    (1) Introduction.

    (2) Designated Federal Officer announcements.

    (3) Remarks from U.S. Coast Guard Leadership.

    (4) Roll call of Committee members and determination of a quorum.

    (5) Reports from the following Working Groups:

    (a) Task statement 16-24, requesting recommendations on appropriate diets and wellness for mariners while aboard merchant vessels; and

    (b) Task statement 17-26, Input to Support Regulatory Reform of Coast Guard Regulations-Executive Orders 13771 and 13783.

    (6) New Business:

    (a) Task Statement X-1, Communication Between External Stakeholders and the Mariner; and

    (b) Task Statement X-2, Mariner Health Issues.

    (7) Other items for discussion:

    (a) Report on the Mariner Credentialing Program;

    (b) Report on National Maritime Center activities; and

    (c) Drug and Alcohol Prevention and Investigations.

    (8) Public comment period.

    (9) Discussion of Working Group recommendations. The Committee will review the information presented on each issue, deliberate on any recommendations presented by the Working Groups, approve/formulate recommendations and close any completed tasks. Official action on these recommendations may be taken on this date.

    (10) Closing remarks/plans for next meeting.

    (11) Adjournment of meeting.

    A copy of all meeting documentation will be available at https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/medmac no later than September 5, 2018. Alternatively, you may contact Mr. Davis Breyer as noted in the FOR FURTHER INFORMATION CONTACT section above.

    A public comment period will be held during each Working Group and full Committee meeting concerning matters being discussed. Public comments will be limited to three minutes per speaker. Please note that the meeting may adjourn early if the work is completed.

    Dated: August 1, 2018. Jeffrey G. Lantz, Director of Commercial Regulations and Standards.
    [FR Doc. 2018-16867 Filed 8-6-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA-2018-0002; Internal Agency Docket No. FEMA-B-1842] Proposed Flood Hazard Determinations AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.

    DATES:

    Comments are to be submitted on or before November 5, 2018.

    ADDRESSES:

    The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location https://www.fema.gov/preliminaryfloodhazarddata and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.

    You may submit comments, identified by Docket No. FEMA-B-1842, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email) [email protected]a.dhs.gov.

    FOR FURTHER INFORMATION CONTACT:

    Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email) [email protected]; or visit the FEMA Map Information eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

    SUPPLEMENTARY INFORMATION:

    FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).

    These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.

    The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.

    Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.

    The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location https://www.fema.gov/preliminaryfloodhazarddata and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.

    (Catalog of Federal Domestic Assistance No. 97.022, “Flood Insurance.”) David I. Maurstad, Deputy Associate Administrator for Insurance and Mitigation, Department of Homeland Security, Federal Emergency Management Agency. Community Community map repository address Barnstable County, Massachusetts (All Jurisdictions) Project: 16-01-0273S Preliminary Date: April 18, 2018 Town of Bourne Bourne Town Hall, 24 Perry Avenue, Buzzards Bay, MA 02532. Bristol County, Massachusetts (All Jurisdictions) Project: 16-01-0273S Preliminary Date: April 18, 2018 City of Fall River City Hall, 1 Government Center, Fall River, MA 02722. City of New Bedford City Hall, 133 William Street, New Bedford, MA 02740. Town of Acushnet Parting Ways Building, 130 Main Street, 2nd Floor, Acushnet, MA 02743. Town of Dartmouth Town Hall, 400 Slocum Road, Dartmouth, MA 02747. Town of Fairhaven Town Hall, 40 Center Street, Fairhaven, MA 02719. Town of Freetown Freetown Town Hall, 3 North Main Street, Assonet, MA 02702. Town of Westport Town Hall, 816 Main Road, Westport, MA 02790. Norfolk County, Massachusetts (All Jurisdictions) Project: 16-01-0273S Preliminary Date: April 18, 2018 Town of Cohasset Town Hall, 41 Highland Avenue, Cohasset, MA 02025. Plymouth County, Massachusetts (All Jurisdictions) Project: 16-01-0273S Preliminary Date: April 18, 2018 Town of Abington Town Hall, 500 Gliniewicz Way, Abington, MA 02351. Town of Carver Town Hall, 108 Main Street, Carver, MA 02330. Town of Duxbury Town Hall, 878 Tremont Street, Duxbury, MA 02332. Town of Halifax Town Hall, 499 Plymouth Street, Halifax, MA 02338. Town of Hanover Town Hall, 550 Hanover Street, Hanover, MA 02339. Town of Hanson Town Hall, 542 Liberty Street, Hanson, MA 02341. Town of Hingham Town Hall, 210 Central Street, Hingham, MA 02043. Town of Kingston Town House, 26 Evergreen Street, Kingston, MA 02364. Town of Marion Town House, 2 Spring Street, Marion, MA 02738. Town of Marshfield Town Hall, 870 Moraine Street, Marshfield, MA 02050. Town of Mattapoisett Town Hall, 16 Main Street, Mattapoisett, MA 02739. Town of Middleborough Town Hall, 10 Nickerson Avenue, Middleborough, MA 02346. Town of Norwell Town Hall, 345 Main Street, Room 112, Norwell, MA 02061. Town of Pembroke Town Hall, 100 Center Street, Pembroke, MA 02359. Town of Plymouth Town Hall, 26 Court Street, Plymouth, MA 02360. Town of Plympton Town Hall, 5 Palmer Road, Plympton, MA 02367. Town of Rochester Town Hall, 1 Constitution Way, Rochester, MA 02770. Town of Rockland Town Hall, 242 Union Street, Rockland, MA 02370. Town of Scituate Town Hall, 600 Chief Justice Cushing Highway, Scituate, MA 02066. Town of Wareham Memorial Town Hall, 54 Marion Road, Wareham, MA 02571. Musselshell County, Montana and Incorporated Areas Project: 17-08-0803S Preliminary Date: March 22, 2018 City of Roundup City Office, 34 3rd Avenue West, Roundup, MT 59072. Unincorporated Areas of Musselshell County Musselshell County Emergency Operations Center, 704 1st Street East, Roundup, MT 59072. Petroleum County, Montana and Incorporated Areas Project: 17-08-0803S Preliminary Date: March 22, 2018 Unincorporated Areas of Petroleum County Petroleum County Courthouse, 302 East Main, Winnett, MT 59087. Rosebud County, Montana and Incorporated Areas Project: 17-08-0803S Preliminary Date: March 22, 2018 Unincorporated Areas of Rosebud County Rosebud County Commission, 1200 Main Street, Forsyth, MT 59327. Newport County, Rhode Island (All Jurisdictions) Project: 16-01-0273S Preliminary Date: April 18, 2018 Town of Little Compton Town Hall, 40 Commons, Little Compton, RI 02837. Town of Tiverton Town Hall, 343 Highland Road, Tiverton, RI 02878.
    [FR Doc. 2018-16876 Filed 8-6-18; 8:45 am] BILLING CODE 9110-12-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLWO3500000.L14400000.PN0000.18X; OMB Control Number 1004-0004] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Desert Land Entry Application AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of information collection; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) is proposing to renew an information collection.

    DATES:

    Interested persons are invited to submit comments on or before September 6, 2018.

    ADDRESSES:

    Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at [email protected]; or via facsimile to (202) 395-5806. Please provide a copy of your comments to the BLM at U.S. Department of the Interior, Bureau of Land Management, 1849 C Street NW, Room 2134LM, Washington, DC 20240, Attention: Jean Sonneman; or by email to [email protected] Please reference OMB Control Number 1004-0004 in the subject line of your comments.

    FOR FURTHER INFORMATION CONTACT:

    To request additional information about this ICR, contact Flora Bell by email at [email protected], or by telephone at 202-912-7347. You may also view the ICR at http://www.reginfo.gov/public/do/PRAMain.

    SUPPLEMENTARY INFORMATION:

    In accordance with the Paperwork Reduction Act of 1995, the BLM provides the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format. A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on April 5, 2018 (83 FR 14670), and the comment period ended on June 4, 2018. The BLM received one comment that did not pertain to the collection of information. The BLM did not revise the ICR in response.

    We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BLM; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BLM enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BLM minimize the burden of this collection on the respondents, including through the use of information technology.

    Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may 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.

    Abstract: The BLM uses the information to determine if an individual is eligible to make a desert land entry for agricultural purposes.

    Title of Collection: Desert Land Entry Application.

    OMB Control Number: 1004-0004.

    Form Number: 2520-1.

    Type of Review: Extension of a currently approved collection.

    Respondents/Affected Public: Individuals who wish to make a desert land entry for agricultural purposes.

    Total Estimated Number of Annual Respondents: 3.

    Total Estimated Number of Annual Responses: 3.

    Estimated Completion Time per Response: 2 hours.

    Total Estimated Number of Annual Burden Hours: 6 hours.

    Respondent's Obligation: Required to obtain or retain a benefit.

    Frequency of Collection: On occasion.

    Total Estimated Annual Nonhour Burden Cost: $45.

    An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq).

    Jean Sonneman, Bureau of Land Management, Information Collection Clearance Officer.
    [FR Doc. 2018-16857 Filed 8-6-18; 8:45 am] BILLING CODE 4310-84-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLNVS01000.L71220000. EU0000.LVTFF1604660; N-94498; 12-08807; MO# 4500109952; TAS: 14X5232] Notice of Realty Action: Non-Competitive Direct Sale of the Reversionary Interest in a Recreation and Public Purposes Act (R&PP) Patent, in Clark County, Nevada (N-94498) AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of Realty Action.

    SUMMARY:

    The Bureau of Land Management (BLM) intends to dispose of the reversionary interest held by the United States in a 140-acre parcel of public land in Las Vegas, Nevada, pursuant to Section 203 of the Federal Land Policy and Management Act of October 21, 1976 (FLPMA), as amended, for a non-competitive direct sale to the Black Mountain Golf and Country Club (BMGCC). The BLM has found this parcel suitable for disposal under the authority of Section 202 of FLPMA.

    DATES:

    Interested parties may submit written comments regarding the direct sale on or before September 21, 2018.

    ADDRESSES:

    Send written comments to the BLM Las Vegas Field Manager, 4701 North Torrey Pines Drive, Las Vegas, Nevada 89130.

    FOR FURTHER INFORMATION CONTACT:

    Supervisory Realty Specialist Manuela Johnson at the above address, by phone at 702-515-5224, or by email at [email protected] Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    The BMGCC is operated as a non-profit corporation. The land occupied by the BMGCC was patented on May 9, 1962, under the authority of the Recreation and Public Purposes (R&PP) Act of June 14, 1926. The purpose of the non-competitive direct sale is to dispose of the reversionary interest in the patented lands that prevents the BMGCC from using the land for other purposes.

    The parcel, which was identified as suitable for direct sale of the reversionary interest, is located on the northwest corner of Horizon Drive and Mona Lane in Henderson, Nevada, and is legally described as:

    Mount Diablo Meridian, Nevada T. 22 S., R. 63 E., Sec. 20, E1/2SW1/4, NW1/4SW1/4 and E1/2SW1/4SW1/4.

    The area described contains 140 acres.

    The 140-acre parcel of public land is difficult and uneconomic to manage, and meets the criteria for disposal set forth in 43 CFR 2710.0-3(a)(3). The parcel is within the boundaries of the City of Henderson and is surrounded by private lands. The parcel is not contiguous to any public land administered by the BLM. The location and absence of other contiguous public land makes the parcel impractical for the BLM to administer. Therefore, it is in the best interest of the public to dispose of this parcel of public land by direct sale procedures pursuant to 43 CFR 2711.3-3 to BMGCC.

    The sale is consistent with the BLM Las Vegas Resource Management Plan (RMP) and the Record of Decision (ROD) approved on October 5, 1998. This sale would be made pursuant to Section 202 of the FLPMA, as amended, and Section 203, which authorizes a sale of public lands when the Secretary determines that the proposed sale parcel, “because of its location or other characteristics is difficult and uneconomic to manage as part of the public lands, and is not suitable for management by another Federal department or agency.” The parcel is not needed for any Federal purposes; therefore, its disposal is in the public interest.

    The appraised fair market value of the parcel is $30,800,000. The appraisal report, dated February 1, 2017, is available for public review at the BLM Las Vegas Field Office.

    Upon conveyance of the reversionary interest, all other terms and conditions of Patent No. 1226785 will continue to apply.

    The reversionary interest will not be sold until at least October 9, 2018. The conveyance document issued will only transfer the reversionary interest retained by the United States in patent 1226785 and will contain the following terms, conditions, and reservations:

    1. A right-of-way thereon for ditches or canals constructed by the authority of the United States, Act of August 30, 1890 (43 U.S.C. 945);

    2. The terms and conditions of the United States Patent No. 1226785, including but not limited to, the reservation of all mineral deposits in the land so patented, and the right to prospect for, mine, and remove such deposits from the same under applicable law and regulations to be established by the Secretary of the Interior;

    3. Additional terms and conditions that the authorized officer deems appropriate.

    The purchaser, by accepting the release of the reversionary interest of the United States agrees to indemnify, defend, and hold the United States, its officers, agents, or employees harmless from any costs, damages, claims, causes of action, penalties, fines, liabilities, and judgements of any kind arising from the past, present, or future acts or omissions of the purchaser, its employees, agents, contractors, or lessees, or third-party arising out of or in connection with the purchaser's acceptance of the aforementioned release or purchaser's use and/or occupancy of the land involved resulting in: (1) Violations of Federal, State, and local laws and regulations that are now, or in the future become, applicable to real property; (2) judgments, claims, or demands of any kind assessed against the United States; (3) cost, expenses, or damages of any kind incurred by the United States; (4) releases or threatened releases of solid or hazardous waste(s) and/or hazardous substances(s), as defined by Federal or State environmental laws, off, on, into or under land, property, and other interests of the United States; (5) other activities by which solids or hazardous substances or wastes, as defined by Federal and State environmental laws are generated, released, stored, used, or otherwise disposed of on the land involved, and any cleanup, response, remedial action, or other actions related in any manner to said solid or hazardous substances or wastes; or (6) natural resource damages as defined by Federal and State law. Patentee shall stipulate that it will be solely responsible for compliance with all applicable Federal, State, and local environmental and regulatory provisions, throughout the life of the facility, including any closure and/or post closure requirements that may be imposed with respect to any physical plant and/or facility upon the land involved under any Federal, State, or local environmental laws or regulatory provisions. This covenant shall be construed as running with the land and may be enforced by the United States in a court of competent jurisdiction.

    No warranty of any kind, express or implied, is given by the United States in connection with the sale or release of the reversionary interest. The documentation for land use conformance, National Environmental Policy Act (NEPA) procedures, a map, and the appraisal report, are available for review at the BLM Las Vegas Office located at the address listed above. A Determination of NEPA Adequacy document—with the number DOI-BLM-NV-S010-2017-0091-DNA—was prepared in connection with this Notice of Realty Action.

    Interested parties may submit written comments on the direct sale of the reversionary interest for the 140-acres sale parcel. Before including your address, phone number, email address, or other personally identifying information in your comment, you should be aware that your entire comment—including your personally identifying information—may be made publicly available at any time. While you can ask the BLM in your comment to withhold your personally identifying information from public review, we cannot guarantee that we will be able to do so.

    Any adverse comments will be reviewed by the BLM Nevada State Director who may sustain, vacate, or modify this realty action. In the absence of any adverse comments, the decision will become effective on October 9, 2018.

    Authority:

    43 CFR 2711.1-2.

    Kerri-Anne Thorpe, Acting Assistant Field Manager, Las Vegas Field Office.
    [FR Doc. 2018-16854 Filed 8-6-18; 8:45 am] BILLING CODE 4310-HC-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLWO310000.L13100000.PP0000.18X; OMB Control Number 1004-0162] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Onshore Geophysical Exploration AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of information collection; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) is proposing to renew an information collection with revisions.

    DATES:

    Interested persons are invited to submit comments on or before September 6, 2018.

    ADDRESSES:

    Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at [email protected]; or via facsimile to (202) 395-5806. Please provide a copy of your comments to the BLM at U.S. Department of the Interior, Bureau of Land Management, 1849 C Street NW, Room 2134LM, Washington, DC 20240, Attention: Jean Sonneman; or by email to [email protected] Please reference OMB Control Number 1004-0162 in the subject line of your comments.

    FOR FURTHER INFORMATION CONTACT:

    To request additional information about this ICR, contact Jennifer Spencer by email at [email protected], or by telephone at 202-912-7146. You may also view the ICR at http://www.reginfo.gov/public/do/PRAMain.

    SUPPLEMENTARY INFORMATION:

    In accordance with the Paperwork Reduction Act of 1995, the BLM provides the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

    A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on March 2, 2018 (83 FR 9025). No comments were received.

    The BLM is again soliciting comments on the proposed ICR that is described below. The BLM is especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BLM; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BLM enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BLM minimize the burden of this collection on the respondents, including through the use of information technology.

    Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may 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.

    Abstract: This information collection pertains to onshore geophysical exploration on Federal lands. Federal land-management agencies are responsible for regulating geophysical exploration on the Federal surface estate. The BLM regulates exploration for oil and gas on lands it manages, and on occasion regulates such exploration on lands managed by other Federal land-management agencies. The U.S. Forest Service (FS) regulates exploration for various types of minerals, including oil and gas, on lands it manages. The BLM and the FS propose to revise the accuracy and usefulness of the forms they use for this collection of information.

    Title of Collection: Onshore Geophysical Exploration.

    OMB Control Number: 1004-0162.

    Form Numbers: BLM Form 3150-4/FS Form 2800-16 and BLM Form 3150-5/FS Form 2800-16a.

    Type of Review: Revision of a currently approved collection.

    Respondents/Affected Public: The respondents for this collection of information are business that seek to conduct geophysical exploration on Federal lands.

    Total Estimated Number of Annual Respondents: 23.

    Total Estimated Number of Annual Responses: 23.

    Estimated Completion Time per Response: Varies from 20 minutes to 1 hour, depending on activity.

    Total Estimated Number of Annual Burden Hours: 17.67.

    Respondent's Obligation: Required to obtain or retain a benefit.

    Frequency of Collection: On occasion.

    Total Estimated Annual Nonhour Burden Cost: $25.

    An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    Jean Sonneman, Bureau of Land Management, Information Collection Clearance Officer.
    [FR Doc. 2018-16855 Filed 8-6-18; 8:45 am] BILLING CODE 4310-84-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [14X.LLAK942000.L54200000.FR0000.LVDIL14L0540; AA094269] Notice of Application for a Recordable Disclaimer of Interest for Lands Underlying the Egegik River, Becharof Lake, and Ruth Lake and Outlet, Alaska AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The State of Alaska (State) has filed an application with the Bureau of Land Management (BLM) for a Recordable Disclaimer of Interest (RDI) from the United States in those lands underlying the Egegik River, Becharof Lake, and Ruth Lake and Outlet in southwest Alaska. The State asserts that the Egegik River, Becharof Lake, and Ruth Lake and Outlet, were navigable and unreserved at the time of Alaska Statehood in 1959.

    DATES:

    The BLM should receive all comments to this action on or before November 5, 2018.

    ADDRESSES:

    You may submit comments by mail or email on the State's application for an RDI or on the BLM Draft “Summary Report on Federal Interest in Lands Underlying the Egegik River, Becharof Lake, and Ruth Lake and Outlet in Alaska” (Draft Summary Report). To file comments by mail, send to: RDI Program Manager (AK-942), Division of Lands and Cadastral, BLM Alaska State Office, 222 West 7th Avenue, #13, Anchorage, Alaska 99513. To submit comments by email, send to [email protected]

    Copies of the State's application, supporting evidence, the Draft Summary Report, and comments, including names and street addresses of commenters, will be available for public review at the BLM Alaska Public Information Center (Public Room), 222 West 8th Avenue, Anchorage, Alaska, during regular business hours 8 a.m. to 4 p.m., Monday through Friday, except holidays.

    FOR FURTHER INFORMATION CONTACT:

    Angie Nichols, RDI Program Manager, 222 West 7th Avenue, #13, Anchorage, Alaska 99513; 907-271-3359; [email protected]; or visit the BLM RDI website at https://www.blm.gov/programs/lands-and-realty/regional-information/alaska/RDI/bristol-bay.

    People who use a telecommunications device for the deaf (TDD) may call the Federal Relay System (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or a question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    On Sept. 7, 2016, the State filed an application (AA-94269) for an RDI pursuant to Section 315 of the Federal Land Policy and Management Act of 1976 (FLPMA) and the regulations contained in 43 CFR subpart 1864 for the lands underlying the Egegik River, Becharof Lake, and Ruth Lake and Outlet. The State asserts that these waterbodies were navigable at the time of Alaska Statehood. As such, the State contends that ownership of the lands underlying this river system automatically passed from the United States to the State in 1959 at the time of Statehood under the Equal Footing Doctrine; the Submerged Lands Act of 1953; the Alaska Statehood Act; and other title navigability law. Section 315 of FLPMA authorizes the BLM to issue an RDI when it determines that a record interest of the United States in lands has terminated by law or is otherwise invalid, and a disclaimer will help remove a cloud on title to such lands.

    The State's application is for an RDI for all submerged lands underlying the portions described below of the Egegik River, Becharof Lake, and Ruth Lake and Outlet. Specifically, these are Becharof Lake: All submerged lands and bed up to and including the ordinary high water lines of Becharof Lake upstream from its outlet within section 5, township 25 south, range 46 west, Seward Meridian, Alaska; Egegik River: All submerged lands and bed of the Egegik River lying between the ordinary high water lines of the left and right banks of the Egegik River, beginning at the outlet of Becharof Lake, downstream to the limit of tidal influence; Unnamed outlet Ruth Lake: All submerged lands up to and including the ordinary high water lines of Unnamed outlet of Ruth Lake upstream from its outlet at Becharof Lake within section 5, township 30 south, range 42 west, Seward Meridian, Alaska, upstream to Ruth Lake; and Ruth Lake: All submerged lands and bed up to and including the ordinary high water lines of Ruth Lake upstream from its outlet within section 9, township 30 south, range 42 west, Seward Meridian, Alaska.

    The State listed the coverage area on the USGS 1:63,360 series topographic maps as follows: Naknek A-1 through A-3, Karluk C-6, D-6 and Ugashik C-1 and D-1, D-2, D-3. Over time, the precise location of the submerged lands described above may vary between townships due to the ambulatory nature of these water bodies.

    An RDI is a legal document through which the BLM disclaims the United States' interest in, or ownership of, specified lands, but the disclaimer does not grant, convey, transfer, or renounce any title or interest in the lands, nor does it release any tax, judgment, or lien. This Notice of Application is to inform the public of the pending application and the State's supporting evidence, as well as to provide the opportunity to comment or provide additional information to the BLM.

    The BLM will not make a final decision on the merits of the State's application before November 5, 2018. During this 90-day period, interested parties may comment on the State's application, AA-94269, and supporting evidence. Interested parties may also comment on the BLM's Draft Summary Report, which is available on the BLM's RDI website (see FOR FURTHER INFORMATION CONTACT above).

    Copies of the State's application, supporting evidence, the Draft Summary Report, and comments, including names and street addresses of commenters, will be available for public review at the BLM Alaska Public Information Center (Public Room), 222 West 8th Avenue, Anchorage, Alaska, during regular business hours 8 a.m. to 4 p.m., Monday through Friday, except holidays. Before including your address, phone number, email address, or other personally identifiable information in your comment, you should be aware that your entire comment—including your personally identifiable information—may be made publicly available at any time. While you can ask the BLM in your comment to withhold your personally identifiable information from public review, we cannot guarantee that we will be able to do so.

    If the BLM determines the State's evidence and any additional information the agency receives concerning the State's application is sufficient to reach a favorable determination, and neither the records nor a valid objection discloses a reason not to disclaim, the BLM may decide to approve the application for the RDI.

    Authority:

    43 CFR 1864.2.

    Erika L. Reed, Deputy State Director, Division of Lands and Cadastral, Alaska.
    [FR Doc. 2018-16858 Filed 8-6-18; 8:45 am] BILLING CODE 4310-JA-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [18X.LLAK930100.L51010000.000000.LVRWL18L1090] Notice of Intent To Prepare an Environmental Impact Statement for the Willow Master Development Plan Oil and Gas Prospect, Alaska AGENCY:

    Bureau of Land Management, Interior

    ACTION:

    Notice of Intent.

    SUMMARY:

    In accordance with the National Environmental Policy Act (NEPA) of 1969, as amended, and the Naval Petroleum Reserves Production Act of 1976, as amended, the Bureau of Land Management (BLM) Alaska State Office, Anchorage, Alaska, intends to prepare a Master Development Plan Environmental Impact Statement (MDP/EIS) for the Willow oil and gas prospect within the Bear Tooth Unit of the National Petroleum Reserve in Alaska (NPR-A).

    DATES:

    This Notice initiates the public scoping process for the Willow oil and gas prospect MDP/EIS. Comments on issues, impacts, and potential alternatives to be analyzed may be submitted in writing until September 6, 2018. The BLM will hold public scoping meetings in Anchorage, Fairbanks, Nuiqsut, and Utqiagvik. The dates, times, and locations of scoping meetings will be announced through local news media, newspapers, and the BLM Alaska website. Any Federal, state, local agency, or Tribe that is interested in serving as a cooperating agency for the development of the MDP/EIS is asked to submit such requests to the BLM by September 6, 2018.

    ADDRESSES:

    You may submit comments on issues related to the scope of the proposed Willow MDP/EIS by any of the following methods:

    Email: [email protected].

    Mail: Willow MDP/EIS Scoping Comments, Bureau of Land Management, 222 West 7th Avenue, Stop #13, Anchorage, AK 99513.

    Requests for information regarding the Willow MDP/EIS and cooperating agency requests may be mailed to: Attn: Willow MDP/EIS, 222 West 7th Avenue, Stop #13, Anchorage, Alaska 99517. You may also request to be added to the mailing list for the MDP/EIS.

    Documents and other information pertaining to the MDP/EIS are available on the BLM Alaska website at http://www.blm.gov/alaska.

    You may examine documents pertinent to this proposal at the BLM Alaska Public Room, Arctic District Office, 222 University Avenue, Fairbanks, Alaska 99709, and at the BLM Alaska Public Information Center, Alaska State Office, 222 West 7th Ave., Anchorage, Alaska 99513.

    FOR FURTHER INFORMATION CONTACT:

    Ferris Couture, BLM Alaska State Office, 907-271-1306. People who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, seven days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    ConocoPhillips Alaska, Inc. (ConocoPhillips) initiated discussions with the BLM regarding potential development of its recently announced Willow oil and gas prospect, which is located on Federal oil and gas leases ConocoPhillips holds within the Bear Tooth Unit of the NPR-A approximately 30 air miles west of the Native Village of Nuiqsut. The BLM manages approximately 23 million acres comprising the NPR-A, located on Alaska's North Slope.

    On May 10, 2018, ConocoPhillips submitted a letter requesting the development of the Willow prospect through a MDP/EIS. The letter, available on the BLM Alaska website, includes a description of the foreseeable infrastructure and activity associated with the proposed Willow prospect development and a map of the proposed area of development. Analyzing the entire proposed Willow development in a single MDP/EIS will allow the BLM to make determinations of National Environmental Policy Act (NEPA) adequacy when individual applications for permits to drill are submitted. This is expected to result in a quicker and more efficient process for the approval of applications for permits to drill.

    The MDP/EIS will analyze the environmental impacts and appropriate mitigation measures to reduce adverse effects to surface resources of the proposed Willow prospect which would involve the construction, operation, and maintenance of an oil and gas development project which may include: One central processing facility, an infrastructure pad, up to five drill pads with up to fifty wells on each pad, access and infield roads, an airstrip, pipelines, a gravel mine, and a temporary island to support module delivery via sealift barges.

    The MDP/EIS will be prepared in accordance with recently issued Executive Orders and Secretarial guidance on streamlining and improving the NEPA and other regulatory processes. At present, the BLM has identified the following preliminary issues for evaluation in the MDP/EIS, impacts to: Subsistence use and access; biological resources, including caribou, polar bears, spectacled and Stellar eiders, yellow billed loons, and fisheries; social and cultural resources; air quality and climate; and aquatic resources.

    The BLM will use NEPA public participation guidelines to assist the agency in satisfying the public involvement requirements under Section 106 of the National Historic Preservation Act (54 U.S.C. 306108), pursuant to 36 CFR 800.2(d)(3).

    The information about historic and cultural resources within the area potentially affected by the Willow development project will assist the BLM in identifying and evaluating impacts to cultural resources in the context of both NEPA and Section 106 of the National Historic Preservation Act.

    Before including your address, phone number, email address, or other personally identifiable information in your comment, you should be aware that your entire comment—including your personally identifiable information—may be made publicly available at any time. While you can ask the BLM in your comment to withhold your personally identifiable information from public review, we cannot guarantee that we will be able to do so.

    The BLM will consult with federally recognized Tribes on a government-to-government basis in accordance with Executive Order 13175 and other policies. Tribal concerns will be given appropriate consideration.

    Federal, state, local agencies, and Tribes that may be interested in or substantially affected by the proposal that the BLM is evaluating are invited to request participation in the development of the MDP/EIS as cooperating agencies. Appropriate cooperating agencies are those with jurisdiction by law and/or those that can offer special expertise in the development of the MDP/EIS.

    Authority:

    40 CFR 1501.7.

    Karen E. Mouritsen, Acting State Director, Alaska.
    [FR Doc. 2018-16783 Filed 8-6-18; 8:45 am] BILLING CODE 4310-JA-P
    MISSISSIPPI RIVER COMMISSION Sunshine Act Meetings TIME AND DATE:

    9:00 a.m., August 20, 2018.

    PLACE:

    On board MISSISSIPPI V at City Front, Caruthersville, Missouri.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    (1) Summary report by President of the Commission on national and regional issues affecting the U.S. Army Corps of Engineers and Commission programs and projects on the Mississippi River and its tributaries; (2) District Commander's overview of current project issues within the St. Louis and Memphis Districts; and (3) Presentations by local organizations and members of the public giving views or comments on any issue affecting the programs or projects of the Commission and the Corps of Engineers.

    TIME AND DATE:

    9:00 a.m., August 21, 2018.

    PLACE:

    On board MISSISSIPPI V at Beale Street Landing, Memphis, Tennessee.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    (1) Summary report by President of the Commission on national and regional issues affecting the U.S. Army Corps of Engineers and Commission programs and projects on the Mississippi River and its tributaries; (2) District Commander's overview of current project issues within the Memphis District; and (3) Presentations by local organizations and members of the public giving views or comments on any issue affecting the programs or projects of the Commission and the Corps of Engineers.

    TIME AND DATE:

    12:00 noon, August 22, 2018.

    PLACE:

    On board MISSISSIPPI V at City Front, Vicksburg, Mississippi.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    (1) Summary report by President of the Commission on national and regional issues affecting the U.S. Army Corps of Engineers and Commission programs and projects on the Mississippi River and its tributaries; (2) District Commander's overview of current project issues within the Vicksburg District; and (3) Presentations by local organizations and members of the public giving views or comments on any issue affecting the programs or projects of the Commission and the Corps of Engineers.

    TIME AND DATE:

    9:00 a.m., August 24, 2018.

    PLACE:

    On board MISSISSIPPI V at Morgan City Port Commission Dock, Morgan City, Louisiana.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    (1) Summary report by President of the Commission on national and regional issues affecting the U.S. Army Corps of Engineers and Commission programs and projects on the Mississippi River and its tributaries; (2) District Commander's overview of current project issues within the New Orleans District; and (3) Presentations by local organizations and members of the public giving views or comments on any issue affecting the programs or projects of the Commission and the Corps of Engineers.

    CONTACT PERSON FOR MORE INFORMATION:

    Mr. Charles A. Camillo, telephone 601-634-7023.

    Charles A. Camillo, Director, Mississippi River Commission.
    [FR Doc. 2018-16943 Filed 8-3-18; 4:15 pm] BILLING CODE 3720-58-P
    NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (18-058)] Notice of Information Collection AGENCY:

    National Aeronautics and Space Administration (NASA).

    ACTION:

    Notice of information collection.

    SUMMARY:

    The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections.

    DATES:

    All comments should be submitted within 60 calendar days from the date of this publication.

    ADDRESSES:

    All comments should be addressed to Gatrie Johnson, National Aeronautics and Space Administration, 300 E Streets SW, Washington, DC 20546-0001.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Gatrie Johnson, NASA Clearance Officer, NASA Headquarters, 300 E Street SW, JF0000, Washington, DC 20546 or email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    A federal grant is an award of financial assistance from a federal agency to a recipient to carry out a public purpose of support or stimulation authorized by a law of the United States. The NASA Procurement Office supports NASA research, science, and education communities through the award of research/education/and training grants in the science, technology, engineering, and math (STEM) fields. NASA has a continuing commitment to identify and address inequities associated with its grant review and awards processes. To support that commitment, NASA implemented a process to collect demographic data from grant applicants for the purpose of analyzing demographic differences associated with its award processes. Information collected includes the name, gender, race, ethnicity, disability status, citizenship status, education, and career data of the respondents.

    Submission of the information is voluntary and is not a precondition of award. However, if the information is not submitted, it will undermine the usefulness of information received from other respondents.

    II. Methods of Collection

    Electronic.

    III. Data

    Title: Research and Related Personal Data.

    OMB Number: 2700-0161.

    Type of Review: Existing information collection.

    Affected Public: Not-For-Profit Institutions.

    Estimated Number of Respondents: 5,000.

    Estimated Time per Response: 5 minutes.

    Estimated Total Annual Public Burden Hours: 416.7.

    Estimated Total Annual Government Cost: $37,500.

    IV. Request for Comments

    Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including automated collection techniques or the use of other forms of information technology.

    Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.

    Gatrie Johnson, NASA PRA Clearance Officer.
    [FR Doc. 2018-16814 Filed 8-6-18; 8:45 am] BILLING CODE 7510-13-P
    NUCLEAR REGULATORY COMMISSION [NRC-2018-0001] Sunshine Act Meeting Notice TIME AND DATE:

    Weeks of August 6, 13, 20, 27, September 3, 10, 2018.

    PLACE:

    Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.

    STATUS:

    Public and Closed.

    Week of August 6, 2018—Tentative

    There are no meetings scheduled for the week of August 6, 2018.

    Week of August 13, 2018—Tentative

    There are no meetings scheduled for the week of August 13, 2018.

    Week of August 20, 2018—Tentative

    There are no meetings scheduled for the week of August 20, 2018.

    Week of August 27, 2018—Tentative

    There are no meetings scheduled for the week of August 27, 2018.

    Week of September 3, 2018—Tentative

    There are no meetings scheduled for the week of September 3, 2018.

    Week of September 10, 2018—Tentative Monday, September 10, 2018 10:00 a.m. Briefing on NRC International Activities (Closed—Ex. 1 & 9)

    The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at [email protected]

    The NRC Commission Meeting Schedule can be found on the internet at: http://www.nrc.gov/public-involve/public-meetings/schedule.html.

    The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (e.g., braille, large print), please notify Kimberly Meyer-Chambers, NRC Disability Program Manager, at 301-287-0739, by videophone at 240-428-3217, or by email at [email protected] Determinations on requests for reasonable accommodation will be made on a case-by-case basis.

    Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or you may email [email protected] or [email protected]

    Dated: August 2, 2018. Glenn Ellmers, Policy Coordinator, Office of the Secretary.
    [FR Doc. 2018-16894 Filed 8-3-18; 11:15 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [Docket Nos. 52-025 and 52-026; NRC-2008-0252] Southern Nuclear Operating Company, Inc., Vogtle Electric Generating Plant, Units 3 and 4, Ventilation System Changes AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Exemption and combined license amendment; issuance.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is granting exemptions to allow a departure from elements of the certification information of Tier 1 of the generic AP1000 design control document (DCD) and issuing License Amendment Nos. 131 and 130 to Combined Licenses (COL), NPF-91 and NPF-92, respectively. The COLs were issued to Southern Nuclear Operating Company, and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, and the City of Dalton, Georgia (the licensee); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia.

    The granting of the exemptions allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemptions were determined in part by the acceptability of the amendments, the exemptions and amendments are being issued concurrently.

    The exemption revises the plant-specific Tier 1 information and corresponding changes to COL Appendix C, and the amendment changes the associated plant-specific DCD Tier 2 material incorporated into the VEGP Updated Final Safety Analysis Report (UFSAR), to modify an administrative program to manage unqualified inorganic zinc coatings in Service Level I areas of the VEGP Units 3 and 4 containment buildings.

    DATES:

    The exemptions and amendments were issued on July 10, 2018.

    ADDRESSES:

    Please refer to Docket ID NRC-2008-0252 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 http://www.regulations.gov and search for Docket ID NRC-2008-0252. Address questions about NRC dockets to Jennifer Borges; 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 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. The request for the amendments and exemptions was designated License Amendment Request (LAR) 17-039 and submitted by letter dated November 3, 2017, and supplemented by letter dated March 28, 2018 (ADAMS Accession No. ML17307A201 and ML18087A147, respectively).

    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:

    William (Billy) Gleaves, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-5848; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Introduction

    The NRC is granting an exemption from paragraph B of section III, “Scope and Contents,” of appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the Code of Federal Regulations (10 CFR) and issuing License Amendment Nos. 131 and 130 to COLs, NPF-91 and NPF-92, respectively, to the licensee. The exemption is required by paragraph A.4 of section VIII, “Processes for Changes and Departures,” appendix D, to 10 CFR part 52 to allow the licensee to depart from Tier 1 information. With the requested license amendment, the licensee proposed changes to plant-specific Tier 1 and associated COL Appendix C information, as well as plant-specific Tier 2 materials located in the plant-specific UFSAR, all of which are related to changes in an administrative program to manage unqualified coatings in Service Level I areas of the VEGP Units 3 and 4 containment buildings.

    Part of the justification for granting the exemption was provided by the review of the amendment. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemption and issued the amendment concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemptions met all applicable regulatory criteria set forth in 10 CFR 50.12, 10 CFR 52.7, and section VIII.A.4 of appendix D to 10 CFR part 52. The license amendments met all applicable regulatory criteria and were found to be acceptable as well. The combined safety evaluation is available in ADAMS under Accession No. ML18158A313.

    Identical exemption documents (except for referenced unit numbers and license numbers) were issued to the licensee for VEGP Units 3 and 4 (COLs NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML18158A307 and ML18158A308, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COLs NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML18158A309 and ML18158A311, respectively. A summary of the amendment documents is provided in Section III of this document.

    II. Exemption

    Reproduced below is the exemption document issued to VEGP Units 3 and Unit 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:

    1. In a letter dated November 3, 2017, as supplemented March 28, 2018, Southern Nuclear Operating Company (SNC) requested from the Commission an exemption to allow departures from Tier 1 information in the certified DCD incorporated by reference in 10 CFR part 52, appendix D, “Design Certification Rule for the AP1000 Design,” as part of license amendment request (LAR) 17-039, “Unqualified Service Level I Coatings Program.”

    For the reasons set forth in Section 3.2 of the NRC staff's Safety Evaluation, which can be found under ADAMS Accession No. ML18158A313, the Commission finds that:

    A. The exemption is authorized by law;

    B. the exemption presents no undue risk to public health and safety;

    C. the exemption is consistent with the common defense and security;

    D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;

    E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and

    F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.

    2. Accordingly, the licensee is granted an exemption from the certified DCD Tier 1 information, with corresponding changes to Appendix C of the Facility Combined License, as described in the licensee's request dated November 3, 2017, as supplemented by letter dated March 28, 2018. This exemption is related to, and necessary for the granting of License Amendment No. 131 (Unit 3) and 130 (Unit 4), which is being issued concurrently with this exemption.

    3. As explained in Section 5.0 of the NRC staff's Safety Evaluation (ADAMS Accession Number ML18158A313), this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.

    4. This exemption is effective as of the date of its issuance.

    III. License Amendment Request

    By letter dated November 3, 2017, as supplemented by letter dated March 28, 2018 (ADAMS Accession No. ML17307A201 and ML18087A147), the licensee requested that the NRC amend the COLs for VEGP, Units 3 and 4, COLs NPF-91 and NPF-92. The proposed amendment is described in Section I of this Federal Register notice.

    The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.

    A notice of consideration of issuance of amendment to facility operating license or COL, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the Federal Register on December 19, 2017 (82 FR 60223). No comments were received during the 30-day comment period.

    The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.

    IV. Conclusion

    Using the reasons set forth in the combined safety evaluation, the staff granted the exemptions and issued the amendments that the licensee requested by letter November 3, 2017, as supplemented by letter dated March 28, 2018 (ADAMS Accession No. ML17307A201 and ML18087A147, respectively).

    The exemptions and amendments were issued on July 10, 2018, as part of a combined package to the licensee (ADAMS Accession No. ML18158A305).

    Dated at Rockville, Maryland, this 2nd day of August 2018.

    For the Nuclear Regulatory Commission.

    Jennifer L. Dixon-Herrity, Chief, Licensing Branch 4, Division of Licensing, Siting and Environmental Analysis. Office of New Reactors.
    [FR Doc. 2018-16831 Filed 8-6-18; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2018-0162] Radiation Safety Surveys at Medical Institutions AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Regulatory guide; withdrawal.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is withdrawing Regulatory Guide (RG) 8.23, “Radiation Safety Surveys at Medical Institutions.” RG 8.23 is being withdrawn because the NRC amended its regulations to remove certain prescriptive requirements regarding the types and frequencies of surveys. Therefore, the prescriptive guidance in RG 8.23 is no longer needed.

    DATES:

    The withdrawal of RG 8.23 is applicable August 7, 2018.

    ADDRESSES:

    Please refer to Docket ID NRC-2018-0162 when contacting the NRC about the availability of information regarding this document. You may access 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-2018-0162. Address questions about NRC dockets to Jennifer Borges; telephone: 301-287-9127; email: [email protected] For technical questions, contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may access publicly available documents online in the NRC Library 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 basis for withdrawal is located at ADAMS Accession No. ML18122A278. RG 8.23 is available at ADAMS Accession No. ML003739603.

    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:

    Vered, Shaffer, telephone: 630-829-9862, email: [email protected], or Harriet Karagiannis, telephone: 301-415-2493, email: [email protected] Both are staff of the Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    SUPPLEMENTARY INFORMATION:

    Regulatory Guide 8.23 was published in January 1981 to provide guidance on the types and frequencies of surveys that are acceptable to the NRC staff for use in medical institutions to comply with part 20 of title 10 of the Code of Federal Regulations (10 CFR), “Standards for Protection Against Radiation.”

    The regulations in 10 CFR part 20 were revised after 1981 and became less prescriptive. As part of amending its regulations in 10 CFR part 20, several of the prescriptive survey requirements applicable to radiation protection programs were deleted. Therefore, the prescriptive guidance in RG 8.23 is no longer needed, and RG 8.23 is being withdrawn.

    The NRC is withdrawing RG 8.23 because it is no longer needed. Withdrawal of a RG means that the guide no longer provides useful information or has been superseded by other guidance, technological innovations, congressional actions, or other events. The withdrawal of RG 8.23 does not alter any prior or existing NRC licensing approval or the acceptability of licensee commitments to RG 8.23. Although RG 8.23 is withdrawn, current licensees may continue to use it, and withdrawal does not affect any existing licenses or agreements. However, RG 8.23 should not be used in future requests or applications for NRC licensing actions.

    Dated at Rockville, Maryland, this 1st day of August 2018.

    For the Nuclear Regulatory Commission.

    Thomas H. Boyce, Chief, Regulatory Guidance and Generic Issues Branch, Division of Engineering, Office of Nuclear Regulatory Research.
    [FR Doc. 2018-16830 Filed 8-6-18; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2018-0092] Standard Format and Content of Physical Security Plans, Training and Qualifications Plans and Safeguards Contingency Plans for Nuclear Power Plants AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Draft regulatory guide; extension of comment period.

    SUMMARY:

    On May 29, 2018, the U.S. Nuclear Regulatory Commission (NRC) solicited comments on draft regulatory guide (DG), DG-5048, “Standard Format and Content of Physical Security Plans, Training and Qualifications Plans and Safeguards Contingency Plans for Nuclear Power Plants.” The public comment period was originally scheduled to close on August 13, 2018. The NRC has decided to extend the public comment period by 30 days to allow more time for members of the public to develop and submit their comments.

    DATES:

    The due date of comments requested in the document published on May 29, 2018 (83 FR 24510), is extended. Comments should be filed no later than September 13, 2018. Comments received after this date will be considered, if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0092. Address questions about NRC dockets to Jennifer Borges; telephone: 301-287-9127; email: [email protected] For technical questions, contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Mail comments to: May Ma, Office of Administration, Mail Stop: TWFN-7A86, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Dennis Gordon, Office of Nuclear Security and Incident Response, telephone: 301-287-3633, email: [email protected] and Mekonen Bayssie, Office of Nuclear Regulatory Research; telephone: 301-415-1699, email: [email protected] Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2018-0092 when contacting the NRC about the availability of information regarding this action. You may obtain publically-available information related to this action, by any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0092.

    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] DG-5048 is available in ADAMS under Accession No. ML17124A490.

    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.

    B. Submitting Comments

    Please include Docket ID NRC-2018-0092 in your comment submission. The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at http://www.regulations.gov as well as enters the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

    II. Background

    On May 29, 2018 (83 FR 24510), the NRC solicited comments on DG-5048, “Standard Format and Content of Physical Security Plans, Training and Qualifications Plans and Safeguards Contingency Plans for Nuclear Power Plants” (ADAMS Accession No. ML17124A490). The NRC granted an initial extension of the public comment period to August 13, 2018, and the NRC held a public meeting on July 25, 2018. On July 26, 2018, the Nuclear Energy Institute (NEI) requested an additional 30 days extension to the public comment period to allow NEI and its members' sufficient time to perform a thorough review of the document, consistent with other work priorities (ADAMS Accesion No. ML18208A473). The NRC has decided to extend the public comment period on this document until September 13, 2018, to allow more time for industry and members of the public to submit their comments.

    Dated at Rockville, Maryland, this 1st day of August 2018.

    For the Nuclear Regulatory Commission.

    Thomas H. Boyce, Chief, Regulatory Guidance and Generic Issues Branch, Division of Engineering, Office of Nuclear Regulatory Research.
    [FR Doc. 2018-16829 Filed 8-6-18; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2018-0056] Digital Instrumentation and Controls-Interim Staff Guidance-06, “Licensing Process” AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Draft interim staff guidance; request for comment.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is soliciting public comment on its draft Interim Staff Guidance (ISG) Digital Instrumentation and Controls (DI&C)-ISG-06, “Licensing Process.” This ISG defines the licensing process used to support the review of license amendment requests (LARs) associated with safety-related DI&C equipment modifications in operating plants and in new plants once they become operational. This ISG provides guidance for activities performed before an LAR is submitted and for activities performed during the LAR review. The NRC staff uses the process described in this ISG to evaluate compliance with NRC regulations.

    DATES:

    Submit comments by September 6, 2018. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received before this date.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0056. 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.

    Mail comments to: May Ma, Office of Administration, Mail Stop: TWFN-7-A60M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Joseph Golla, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1002, email: Joe[email protected].

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2018-0056 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0056.

    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 draft ISG DI&C-ISG-06 “Licensing Process,” is available in ADAMS under Accession No. ML18123A118.

    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.

    B. Submitting Comments

    Please include Docket ID NRC-2018-0056 in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. Background

    This ISG provides guidance for the NRC staff's review of LARs supporting installation of digital I&C equipment in accordance with licensing processes defined in NRC office instruction LIC-101, “License Amendment Review Procedures.” This ISG identifies information the NRC staff should review for digital I&C equipment. This ISG provides guidance on when that information should be reviewed.

    This ISG is designed to be used with the NRC's topical report review and approval process defined in NRC Office of Nuclear Reactor Regulation office instruction LIC-500, “Topical Report Process.” Where a licensee references an NRC-approved topical report, the NRC staff should be able to, where appropriate, limit its review to assessing whether the application of the digital I&C modification falls within the envelope of the topical report approval. This ISG was developed based upon, and is designed to work in concert with, established guidance. As a result, this ISG references other guidance documents for review criteria.

    The NRC staff performs evaluations of proposed digital I&C equipment to ensure equipment will perform required functions. These evaluations use the guidance in the Standard Review Plan, Chapter 7, and other associated guidance. When a license amendment is required, licensees are obligated to provide a description of the licensing basis functions of digital I&C equipment and include a description of the equipment that implements the functions. Additionally, licensees identify those parts of the licensing basis being updated as a result of the proposed change.

    The NRC staff review processes include activities for evaluating documentation of plans and processes which are used to support system development activities and their outcomes.

    The Standard Review Plan, Appendix 7.0-A, and Branch Technical Position 7-14, guide the NRC staff in performing reviews of digital systems in support of safety evaluations. For reviews using the Alternate Process as defined in the ISG, the ISG provides additional guidance for performing early stage reviews of digital safety-related systems in support of safety evaluations. The NRC staff may review the system design and development process to support a determination that the design meets regulatory requirements and that in safety-related applications in nuclear power plants, the process is of sufficient high quality to produce systems and software suitable for use.

    Dated at Rockville, Maryland, this 1st day of August 2018.

    For the Nuclear Regulatory Commission.

    Eric J. Benner, Director, Division of Engineering, Office of Nuclear Reactor Regulation.
    [FR Doc. 2018-16810 Filed 8-6-18; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2018-0139] Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving Proposed No Significant Hazards Considerations and Containing Sensitive Unclassified Non-Safeguards Information and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    License amendment request; notice of opportunity to comment, request a hearing, and petition for leave to intervene; order imposing procedures.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) received and is considering approval of one amendment request. The amendment request is for Millstone Power Station, Unit No. 3. For each amendment request, the NRC proposes to determine that they involve no significant hazards consideration. Because each amendment request contains sensitive unclassified non-safeguards information (SUNSI), an order imposes procedures to obtain access to SUNSI for contention preparation.

    DATES:

    Comments must be filed by September 6, 2018. A request for a hearing must be filed by October 9, 2018. Any potential party as defined in § 2.4 of title 10 of the Code of Federal Regulations (10 CFR), who believes access to SUNSI is necessary to respond to this notice must request document access by August 17, 2018.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0139. 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.

    Mail comments to: May Ma, Office of Administration, Mail Stop: TWFN-7-A60M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Paula Blechman, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-2242; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2018-0139, facility name, unit number(s), plant docket number, application date, and subject when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0139.

    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.

    B. Submitting Comments

    Please include Docket ID NRC-2018-0139, facility name, unit number(s), plant docket number, application date, and subject in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. Background

    Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the NRC is publishing this notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.

    This notice includes notice of an amendment containing SUNSI.

    III. Notice of Consideration of Issuance of Amendments to Facility Operating Licenses and Combined Licenses, Proposed No Significant Hazards Consideration Determination, and Opportunity for a Hearing

    The Commission has made a proposed determination that the following amendment request involves no significant hazards consideration. Under the Commission's regulations in 10 CFR 50.92, this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated, or (2) create the possibility of a new or different kind of accident from any accident previously evaluated, or (3) involve a significant reduction in a margin of safety. The basis for this proposed determination for each amendment request is shown below.

    The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.

    Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period if circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example, in derating or shutdown of the facility. If the Commission takes action prior to the expiration of either the comment period or the notice period, it will publish a notice of issuance in the Federal Register. If the Commission makes a final no significant hazards consideration determination, any hearing will take place after issuance. The Commission expects that the need to take this action will occur very infrequently.

    A. Opportunity To Request a Hearing and Petition for Leave To Intervene

    Within 60 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's website at http://www.nrc.gov/reading-rm/doc-collections/cfr/. Alternatively, a copy of the regulations is available at the NRC's Public Document Room, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. If a petition is filed, the Commission or a presiding officer will rule on the petition and, if appropriate, a notice of a hearing will be issued.

    As required by 10 CFR 2.309(d) the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest.

    In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to the specific sources and documents on which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant or licensee on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.

    Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.

    Petitions must be filed no later than 60 days from the date of publication of this notice. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii). The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document.

    If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to establish when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of the amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.

    A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission no later than 60 days from the date of publication of this notice. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions set forth in this section, except that under 10 CFR 2.309(h)(2) a State, local governmental body, or Federally-recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. Alternatively, a State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).

    If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.

    B. Electronic Submissions (E-Filing)

    All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities that request to participate under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562; August 3, 2012). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC website at http://www.nrc.gov/site-help/e-submittals.html. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.

    To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at [email protected], or by telephone at 301-415-1677, to (1) request a digital identification (ID) certificate, which allows the participant (or its counsel or representative) to digitally sign submissions and access the E-Filing system for any proceeding in which it is participating; and (2) advise the Secretary that the participant will be submitting a petition or other adjudicatory document (even in instances in which the participant, or its counsel or representative, already holds an NRC-issued digital ID certificate). Based upon this information, the Secretary will establish an electronic docket for the hearing in this proceeding if the Secretary has not already established an electronic docket.

    Information about applying for a digital ID certificate is available on the NRC's public website at http://www.nrc.gov/site-help/e-submittals/getting-started.html. Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit adjudicatory documents. Submissions must be in Portable Document Format (PDF). Additional guidance on PDF submissions is available on the NRC's public website at http://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the time the document is submitted through the NRC's E-Filing system. To be timely, an electronic filing must be submitted to the E-Filing system no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of a transmission, the E-Filing system time-stamps the document and sends the submitter an email notice confirming receipt of the document. The E-Filing system also distributes an email notice that provides access to the document to the NRC's Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the document on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before adjudicatory documents are filed so that they can obtain access to the documents via the E-Filing system.

    A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public website at http://www.nrc.gov/site-help/e-submittals.html, by email to [email protected], or by a toll-free call at 1-866-672-7640. The NRC Electronic Filing Help Desk is available between 9 a.m. and 6 p.m., Eastern Time, Monday through Friday, excluding government holidays.

    Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing adjudicatory documents in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.

    Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at https://adams.nrc.gov/ehd, unless excluded pursuant to an order of the Commission or the presiding officer. If you do not have an NRC-issued digital ID certificate as described above, click cancel when the link requests certificates and you will be automatically directed to the NRC's electronic hearing dockets where you will be able to access any publicly available documents in a particular hearing docket. Participants are requested not to include personal privacy information, such as social security numbers, home addresses, or personal phone numbers in their filings, unless an NRC regulation or other law requires submission of such information. For example, in some instances, individuals provide home addresses in order to demonstrate proximity to a facility or site. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, participants are requested not to include copyrighted materials in their submission.

    Dominion Energy Nuclear Connecticut, Inc. (DENC), Docket No. 50-423, Millstone Power Station, Unit No. 3 (MPS3), New London County, Connecticut

    Date of amendment request: May 3, 2018. A publicly-available version is in ADAMS under Accession No. ML18128A049.

    Description of amendment request: This amendment request contains sensitive unclassified non-safeguards information (SUNSI). The amendment would revise the MPS3 Technical Specifications (TSs). DENC performed a criticality safety evaluation for fuel assembly storage in the MPS3 spent fuel pool (SFP) storage racks and new fuel storage racks to support the proposed TS changes using a new methodology. Specifically, the proposed amendment would revise the MPS3 TSs supporting changes to the operation and administration of the SFP to (1) modify storage requirements in TSs 1.40, 1.41, 3/4.9.13 and 3/4.9.14, including updates to surveillance requirements for storing fuel assemblies and TS Figures detailing storage patterns and minimum fuel burnup versus fuel enrichment; (2) eliminate the requirement for cell blockers in Region 1 fuel storage racks; (3) modify SFP soluble boron requirements in 3/4.9.1.2; and (4) modify the description of SFP criticality control in TS 5.6.1.1.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    The proposed change will not affect plant equipment or structure, including the SFP, NFSR [new fuel storage racks], or fuel handling equipment, including how the equipment is operated and maintained. There are no changes to the equipment for fuel handling or how fuel assemblies are handled, including how fuel assemblies are inserted into and removed from SFP and NFSR storage locations. There is no change to administrative means to verify correct fuel assembly storage in the SFP, or the required response to a fuel assembly misload or drop event. There are no changes to how RCCAs [rod cluster control assemblies] will be handled, including how RCCAs are inserted into or removed from a fuel assembly or other location such as a SFP storage location. Also, since the proposed change does not modify plant equipment or its operation and maintenance, including equipment used to maintain SFP soluble boron levels, the proposed change will not impact a boron dilution event or plant response to it.

    The criticality safety evaluation concluded that the NFSR limiting accident is the fully flooded condition with each storage location loaded with a maximum reactivity fuel assembly. The NFSR maintains [k-effective] keff ≤ 0.95 for this postulated scenario including uncertainties and biases. The NFSR also maintains keff ≤ 0.98 for the optimum moderation scenario including uncertainties and biases. Thus, the consequences of a previously evaluated NFSR related accident is not significantly increased. There is no change to the plant equipment or its operation and maintenance due to the proposed change. Thus, the probability of a flooding accident that could impact the NFSR is not significantly increased.

    Regarding the SFP, the Region 1 storage configuration will change. The Region 2 and 3 burnup curves will be updated and reduced in number. The process of choosing fuel assembly storage locations will not change, except that the Region 1 storage configuration and Region 2 and 3 burnup requirements will be updated, and fuel assemblies containing RCCAs may be stored in Region 2 without consideration of the burnup curve. The physical handling, insertion, removal, and storage of fuel assemblies in SFP racks will not change. The MPS3 program for choosing fuel assembly storage locations, for fuel handling, and for assuring that the fuel assemblies are placed into correct locations will remain in place. Thus, the probability of a fuel assembly misloading or a fuel assembly drop in the SFP will not significantly increase due to the proposed change.

    Several postulated accidents for the SFP were reviewed for the proposed change which included postulated fuel assembly misload and drop scenarios. The criticality safety evaluation for the SFP concluded that the limiting accident, which bounds the other scenarios, is a multiple misload of fuel assemblies into each Region 2 fuel storage location. The criticality safety evaluation concluded that a SFP soluble boron concentration of 2600 ppm [part per million] will maintain keff ≤ 0.95, including uncertainties and biases, for this postulated scenario. The minimum TS soluble boron concentration will be increased from 800 ppm to 2600 ppm. MPS3 has maintained SFP soluble boron concentration greater than 2600 ppm for many years, so the proposed change will not affect the routine maintaining of the boron concentration.

    There are no changes to plant equipment, including its operation and maintenance, as a result of the proposed change, including equipment associated with maintaining SFP soluble boron concentration or possible flow paths that could contribute to a boron dilution event. Thus, no new avenues for a boron dilution event will be created. There is no change regarding how the plant maintains boron concentration or responds to a boron dilution event. The criticality safety evaluation for the postulated boron dilution event shows the SFP maintains keff ≤ 0.95 at 600 ppm soluble boron. Thus, there is no significant increase in the probability or consequences of a boron dilution accident.

    The MPS3 SFP is currently licensed to store 1860 fuel assemblies which include a Region 2 rack that has not been placed in the SFP (TS 5.6.3).

    Thus, the SFP seismic/structural loading requirements for the proposed change are bounded by the existing TS. The criticality safety evaluation shows that keff will be maintained ≤ 0.95 during a postulated seismic event. Thus, there is no increase in the consequences of a seismic event.

    In each of the above scenarios the proposed change does not significantly increase the probability of an accident previously evaluated, and maintains required keff margin. Therefore, it is concluded that the probability or consequences of a previously evaluated accident do not significantly increase.

    2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    There is no change to any plant equipment, including how equipment is operated and maintained. There will be no changes to equipment used to handle fuel assemblies (or any heavy load) over the NFSR or the SFP.

    There is no change regarding how the fuel assemblies are stored, inserted into, and removed from fuel storage locations. There is no change to how RCCAs will be inserted into or removed from a fuel assembly or other location, or otherwise how RCCAs are handled. Thus, there are no new accidents created over and above the existing postulated accidents of a fuel misload or a fuel assembly drop in the SFP or a flooding event in the NFSR area.

    Also, since there is no change to the plant equipment or how equipment is operated and maintained, the probability of a new type of accident that could impact the SFP or NFSR is not significantly increased.

    The criticality safety evaluation for the first time at MPS3 specifically analyzes a boron dilution event. However, the overall accident analyzed is the potential for a SFP criticality, and the boron dilution event is another potential initiator of the postulated SFP criticality accident. Also, the possibility of a SFP boron dilution event has always existed at MPS3 and the proposed change does not newly create or change the possibility of such an event occurring.

    The criticality safety evaluation for the first time at MPS3 specifically analyzes a multiple fuel misload event. As with the postulated boron dilution event, the possibility of a multiple fuel assembly misload has always existed at MPS3 and the proposed change does not newly create or change the possibility of such an event occurring. Also, this postulated event was analyzed for the MPS2 spent fuel pool criticality LAR [license amendment request] which the NRC approved in June 2016 [Reference 3 of the application dated May 3, 2018].

    Since the proposed change will not change fuel/RCCA handling equipment or how fuel assemblies and RCCAs are handled and stored, nor will it change any other plant equipment, there is no mechanism for creating a new or different kind of accident not previously evaluated. Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed change involve a significant reduction in the margin of safety?

    Response: No.

    The proposed change does not involve a significant reduction in a margin of safety.

    The licensing requirement for the SFP is that keff remain ≤ 0.95 under normal and postulated accident conditions with credit for soluble boron. The criticality safety evaluation concluded that this requirement is met for the bounding postulated accident of a multiple misload of fuel assemblies into each Region 2 fuel storage location. The analyses apply to all of the fuel assemblies currently stored in the MPS3 SFP and to future anticipated fuel designs.

    In addition, the criticality safety evaluation concludes that the SFP will maintain keff < 1.0 with 0 ppm soluble boron in the SFP under normal conditions with the maximum allowed reactivity fuel assembly stored in each fuel storage location.

    The criticality safety evaluation also allows the following storage configurations. In each case the storage configuration does not increase reactivity assuring that keff margin is maintained:

    • Storing non-fuel components in any spent fuel rack storage location where fuel assemblies are allowed

    • Storing non-fuel components in the guide tubes of any fuel assembly.

    The criticality safety evaluation evaluated non-standard fuel stored in the MPS3 to determine where they can be stored in the SFP. This information is used to maintain keff margin when storing non standard fuel assemblies.

    The licensing requirement for the NFSR is that keff remain ≤ 0.95 for the fully flooded scenario, and ≤ 0.98 for the optimum moderation scenario.

    The criticality safety evaluation concludes that these requirements are met assuming each fuel storage location is loaded with a maximum reactivity fuel assembly (5.0 wt% U-235 enrichment with no burnable poisons).

    Therefore, all the margins of safety are maintained, and the proposed change does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: Lillian M. Cuoco, Senior Counsel, Dominion Energy, Inc., 120 Tredegar Street, RS-2, Richmond, Virginia 23219.

    NRC Branch Chief: James G. Danna.

    Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information for Contention Preparation Dominion Energy Nuclear Connecticut, Inc., Docket No. 50-423, Millstone Power Station, Unit No. 3, New London County, Connecticut

    A. This Order contains instructions regarding how potential parties to this proceeding may request access to documents containing Sensitive Unclassified Non-Safeguards Information (SUNSI).

    B. Within 10 days after publication of this notice of hearing and opportunity to petition for leave to intervene, any potential party who believes access to SUNSI is necessary to respond to this notice may request access to SUNSI. A “potential party” is any person who intends to participate as a party by demonstrating standing and filing an admissible contention under 10 CFR 2.309. Requests for access to SUNSI submitted later than 10 days after publication of this notice will not be considered absent a showing of good cause for the late filing, addressing why the request could not have been filed earlier.

    C. The requester shall submit a letter requesting permission to access SUNSI to the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, and provide a copy to the Associate General Counsel for Hearings, Enforcement and Administration, Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The expedited delivery or courier mail address for both offices is: U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Rockville, Maryland 20852. The email address for the Office of the Secretary and the Office of the General Counsel are [email protected] and [email protected], respectively.1 The request must include the following information:

    1 While a request for hearing or petition to intervene in this proceeding must comply with the filing requirements of the NRC's “E-Filing Rule,” the initial request to access SUNSI under these procedures should be submitted as described in this paragraph.

    (1) A description of the licensing action with a citation to this Federal Register notice;

    (2) The name and address of the potential party and a description of the potential party's particularized interest that could be harmed by the action identified in C.(1); and

    (3) The identity of the individual or entity requesting access to SUNSI and the requester's basis for the need for the information in order to meaningfully participate in this adjudicatory proceeding. In particular, the request must explain why publicly available versions of the information requested would not be sufficient to provide the basis and specificity for a proffered contention.

    D. Based on an evaluation of the information submitted under paragraph C.(3) the NRC staff will determine within 10 days of receipt of the request whether:

    (1) There is a reasonable basis to believe the petitioner is likely to establish standing to participate in this NRC proceeding; and

    (2) The requestor has established a legitimate need for access to SUNSI.

    E. If the NRC staff determines that the requestor satisfies both D.(1) and D.(2) above, the NRC staff will notify the requestor in writing that access to SUNSI has been granted. The written notification will contain instructions on how the requestor may obtain copies of the requested documents, and any other conditions that may apply to access to those documents. These conditions may include, but are not limited to, the signing of a Non-Disclosure Agreement or Affidavit, or Protective Order 2 setting forth terms and conditions to prevent the unauthorized or inadvertent disclosure of SUNSI by each individual who will be granted access to SUNSI.

    2 Any motion for Protective Order or draft Non-Disclosure Affidavit or Agreement for SUNSI must be filed with the presiding officer or the Chief Administrative Judge if the presiding officer has not yet been designated, within 30 days of the deadline for the receipt of the written access request.

    F. Filing of Contentions. Any contentions in these proceedings that are based upon the information received as a result of the request made for SUNSI must be filed by the requestor no later than 25 days after receipt of (or access to) that information. However, if more than 25 days remain between the petitioner's receipt of (or access to) the information and the deadline for filing all other contentions (as established in the notice of hearing or opportunity for hearing), the petitioner may file its SUNSI contentions by that later deadline.

    G. Review of Denials of Access.

    (1) If the request for access to SUNSI is denied by the NRC staff after a determination on standing and requisite need, the NRC staff shall immediately notify the requestor in writing, briefly stating the reason or reasons for the denial.

    (2) The requester may challenge the NRC staff's adverse determination by filing a challenge within 5 days of receipt of that determination with: (a) The presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if he or she is unavailable, another administrative judge, or an Administrative Law Judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) if another officer has been designated to rule on information access issues, with that officer.

    (3) Further appeals of decisions under this paragraph must be made pursuant to 10 CFR 2.311.

    H. Review of Grants of Access. A party other than the requester may challenge an NRC staff determination granting access to SUNSI whose release would harm that party's interest independent of the proceeding. Such a challenge must be filed within 5 days of the notification by the NRC staff of its grant of access and must be filed with: (a) The presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if he or she is unavailable, another administrative judge, or an Administrative Law Judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) if another officer has been designated to rule on information access issues, with that officer.

    If challenges to the NRC staff determinations are filed, these procedures give way to the normal process for litigating disputes concerning access to information. The availability of interlocutory review by the Commission of orders ruling on such NRC staff determinations (whether granting or denying access) is governed by 10 CFR 2.311.3

    3 Requesters should note that the filing requirements of the NRC's E-Filing Rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562; August 3, 2012) apply to appeals of NRC staff determinations (because they must be served on a presiding officer or the Commission, as applicable), but not to the initial SUNSI request submitted to the NRC staff under these procedures.

    I. The Commission expects that the NRC staff and presiding officers (and any other reviewing officers) will consider and resolve requests for access to SUNSI, and motions for protective orders, in a timely fashion in order to minimize any unnecessary delays in identifying those petitioners who have standing and who have propounded contentions meeting the specificity and basis requirements in 10 CFR part 2. The attachment to this Order summarizes the general target schedule for processing and resolving requests under these procedures.

    It is so ordered.

    Dated at Rockville, Maryland, this 6th of July 2018.

    For the Nuclear Regulatory Commission.

    Russell E. Chazell, Acting, Secretary of the Commission.
    Attachment 1—General Target Schedule for Processing and Resolving Requests for Access to Sensitive Unclassified Non-Safeguards Information in This Proceeding Day Event/activity 0 Publication of Federal Register notice of hearing and opportunity to petition for leave to intervene, including order with instructions for access requests. 10 Deadline for submitting requests for access to Sensitive Unclassified Non-Safeguards Information (SUNSI) with information: Supporting the standing of a potential party identified by name and address; describing the need for the information in order for the potential party to participate meaningfully in an adjudicatory proceeding. 60 Deadline for submitting petition for intervention containing: (i) Demonstration of standing; and (ii) all contentions whose formulation does not require access to SUNSI (+25 Answers to petition for intervention; +7 petitioner/requestor reply). 20 U.S. Nuclear Regulatory Commission (NRC) staff informs the requester of the staff's determination whether the request for access provides a reasonable basis to believe standing can be established and shows need for SUNSI. (NRC staff also informs any party to the proceeding whose interest independent of the proceeding would be harmed by the release of the information). If NRC staff makes the finding of need for SUNSI and likelihood of standing, NRC staff begins document processing (preparation of redactions or review of redacted documents). 25 If NRC staff finds no “need” or no likelihood of standing, the deadline for petitioner/requester to file a motion seeking a ruling to reverse the NRC staff's denial of access; NRC staff files copy of access determination with the presiding officer (or Chief Administrative Judge or other designated officer, as appropriate). If NRC staff finds “need” for SUNSI, the deadline for any party to the proceeding whose interest independent of the proceeding would be harmed by the release of the information to file a motion seeking a ruling to reverse the NRC staff's grant of access. 30 Deadline for NRC staff reply to motions to reverse NRC staff determination(s). 40 (Receipt +30) If NRC staff finds standing and need for SUNSI, deadline for NRC staff to complete information processing and file motion for Protective Order and draft Non-Disclosure Affidavit. Deadline for applicant/licensee to file Non-Disclosure Agreement for SUNSI. A If access granted: Issuance of presiding officer or other designated officer decision on motion for protective order for access to sensitive information (including schedule for providing access and submission of contentions) or decision reversing a final adverse determination by the NRC staff. A + 3 Deadline for filing executed Non-Disclosure Affidavits. Access provided to SUNSI consistent with decision issuing the protective order. A + 28 Deadline for submission of contentions whose development depends upon access to SUNSI. However, if more than 25 days remain between the petitioner's receipt of (or access to) the information and the deadline for filing all other contentions (as established in the notice of opportunity to request a hearing and petition for leave to intervene), the petitioner may file its SUNSI contentions by that later deadline. A + 53 (Contention receipt +25) Answers to contentions whose development depends upon access to SUNSI. A + 60 (Answer receipt +7) Petitioner/Intervenor reply to answers. >A + 60 Decision on contention admission.
    [FR Doc. 2018-14915 Filed 8-6-18; 8:45 am] BILLING CODE 7590-01-P
    POSTAL REGULATORY COMMISSION [Docket Nos. CP2018-280; MC2018-202 and CP2018-281] 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: August 9, 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. 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).: CP2018-280; 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: August 1, 2018; Filing Authority: 39 CFR 3015.5; Public Representative: Christopher C. Mohr; Comments Due: August 9, 2018.

    2. Docket No(s).: MC2018-202 and CP2018-281; Filing Title: USPS Request to Add Priority Mail Contract 458 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: August 1, 2018; Filing Authority: 39 U.S.C. 3642, 39 CFR 3020.30 et seq., and 39 CFR 3015.5; Public Representative: Christopher C. Mohr; Comments Due: August 9, 2018.

    This notice will be published in the Federal Register.

    Stacy L. Ruble, Secretary.
    [FR Doc. 2018-16873 Filed 8-6-18; 8:45 am] BILLING CODE 7710-FW-P
    POSTAL SERVICE Product Change—Priority Mail Negotiated Service Agreement AGENCY:

    Postal ServiceTM.

    ACTION:

    Notice.

    SUMMARY:

    The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

    DATES:

    Date of required notice: August 7, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Reed, 202-268-3179.

    SUPPLEMENTARY INFORMATION:

    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on August 1, 2018, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail Contract 458 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2018-202, CP2018-281.

    Elizabeth Reed, Attorney, Corporate and Postal Business Law.
    [FR Doc. 2018-16811 Filed 8-6-18; 8:45 am] BILLING CODE 7710-12-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-83761; File No. SR-OCC-2017-809] Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Amendments No. 1 and 2 To Advance Notice Concerning Enhanced and New Tools for Recovery Scenarios August 1, 2018.

    Pursuant to Section 806(e)(1) of Title VIII of the Dodd-Frank Wall Street Reform and Consumer Protection Act, entitled Payment, Clearing and Settlement Supervision Act of 2010 (“Clearing Supervision Act”) 1 and Rule 19b-4(n)(1)(i) of the Securities Exchange Act of 1934 (“Act”),2 The Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”) an advance notice concerning updates to and formalization of OCC's Recovery and Orderly Wind-Down Plan (“Advance Notice”). The Advance Notice was published for public comment in the Federal Register on January 23, 2018.3 On January 23, 2018, the Commission requested OCC provide it with additional information regarding the Advance Notice.4 OCC responded to this request for information, and the information was received on July 13, 2018.5 On July 11, 2018, OCC filed Amendment No. 1 to the Advance Notice, and subsequently filed Amendment No. 2 to the advance notice to supersede and replace Amendment No. 1 in its entirety, due to technical defects in Amendment No. 1. Therefore, the Initial Filing, as modified by Amendment No. 2, reflects the changes being proposed.

    1 12 U.S.C. 5465(e)(1).

    2 17 CFR 240.19b-4(n)(1)(i).

    3See Securities Exchange Act Release No. 82513 (January 17, 2018), 83 FR 3244 (January 23, 2018) (SR-OCC-2017-809) (hereinafter referred to as the “Initial Filing”).

    4See Memorandum from Office of Clearance and Settlement, Division of Trading and Markets, dated January 23, 2018, available at https://www.sec.gov/comments/sr-occ-2017-809/occ2017809-2948229-161855.pdf.

    5See Memorandum from Office of Clearance and Settlement, Division of Trading and Markets, dated July 17, 2018, available at https://www.sec.gov/comments/sr-occ-2017-809/occ2017809-4062512-169148.pdf.

    Pursuant to Section 806(e)(1) of the Clearing Supervision Act 6 and Rule 19b-4(n)(1)(i) of the Act,7 the Commission is hereby publishing notice of these Amendments No. 1 and 2 as described in Items I, II and III below, which Items have been prepared by OCC. The Commission is publishing this notice to solicit comments on the Advance Notice, as amended by Amendments No. 1 and 2, from interested persons.

    6 12 U.S.C. 5465(e)(1).

    7 17 CFR 240.19b-4(n)(1)(i).

    I. Clearing Agency's Statement of the Terms of Substance of the Advance Notice

    This Amendment No. 2 to the advance notice is filed in connection with a proposed change to make certain revisions to OCC's Rules and By-Laws to enhance OCC's existing tools to address the risks of liquidity shortfalls and credit losses and to establish new tools by which OCC could re-establish a matched book following a default. Each of the tools proposed herein is contemplated to be deployed by OCC in an extreme stress event that has placed OCC into a recovery or orderly wind-down scenario.

    The proposed changes to OCC's By-Laws and Rules were submitted as Exhibits 5A and 5B of the filing, respectively, and proposed changes to OCC's Default Management Policy were submitted as confidential Exhibit 5C of the filing.8 OCC also has attached as Exhibits 4A and 4B the proposed amendments to the rule text in Exhibits 5A and 5B of the Initial Filing, respectively. Material proposed to be added to the proposed rule text in the Initial Filing is marked by double underlining and material proposed to be deleted is marked by double strikethrough text.

    8 OCC has filed a proposed rule change with the Commission in connection with the proposed change. See SR-OCC-2017-020.

    The proposed change is described in detail in Item II below. All terms with initial capitalization not defined herein have the same meaning as set forth in OCC's By-Laws and Rules.9

    9 OCC's By-Laws and Rules can be found on OCC's public website: http://optionsclearing.com/about/publications/bylaws.jsp.

    II. Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Advance Notice

    In its filing with the Commission, OCC included statements concerning the purpose of and basis for the advance notice and discussed any comments it received on the advance notice. The text of these statements may be examined at the places specified in Item IV below. OCC has prepared summaries, set forth in sections A and B below, of the most significant aspects of these statements.

    (A) Clearing Agency's Statement on Comments on the Advance Notice Received From Members, Participants or Others

    Written comments were not and are not intended to be solicited with respect to the advance notice and none have been received. OCC will notify the Commission of any written comments received by OCC.

    (B) Advance Notices Filed Pursuant to Section 806(e) of the Payment, Clearing, and Settlement Supervision Act Purpose of the Proposed Change Background

    The purpose of this advance notice is to make certain revisions to OCC's Rules and By-Laws Laws that are designed to enhance OCC's existing tools to address the risks of liquidity shortfalls and credit losses and to establish tools by which OCC could re-establish a matched book following a default. Each of the tools proposed herein is contemplated to be deployed by OCC in an extreme stress event that has placed OCC into a recovery or orderly wind-down scenario. Each of the proposed revisions also is designed to further OCC's compliance, in whole or in part, with the provisions of the Commission's rules identified immediately below.

    On September 28, 2016, the Commission adopted amendments to Rule 17Ad-22 10 and added new Rules 17Ad-22(e)(3)(ii), (e)(4)(viii), (e)(4)(ix), (e)(7)(ix), (e)(13), (e)(23)(i) and (e)(23)(ii) 11 pursuant to Section 17A of the Securities Exchange Act of 1934 12 and the Payment, Clearing, and Settlement Supervision Act of 2010 (“Payment, Clearing and Settlement Supervision Act”).13 In relevant part, these new rules collectively require a covered clearing agency (“CCA”), as defined by Rule 17Ad-22(a)(5),14 to establish, implement, maintain and enforce written policies and procedures reasonably designed to: (1) Maintain a risk management framework including plans for recovery and orderly wind-down necessitated by credit losses, liquidity shortfalls, general business risk losses or any other losses, (2) effectively identify, measure, monitor and manage its credit exposures to participants and those arising from its payment, clearing and settlement processes, including by addressing the allocation of credit losses a CCA might face if its collateral and other resources are insufficient to fully cover its credit exposures, (3) effectively identify, measure, monitor and manage credit exposures, including by describing the process to replenish any financial resource that a CCA may use following a default event or other event in which use of such resource is contemplated, (4) effectively identify, measure, monitor and manage liquidity risks that arises or is borne by the CCA by, at a minimum, describing the process for replenishing any liquid resource that a CCA may employ during a stress event, (5) ensure it has the authority and operational capacity to take timely action to contain losses and liquidity demands and continue to meet its obligations, (6) publicly disclose relevant rules and material procedures, including key aspects of its default rules and procedures, and (7) provide sufficient information to enable participants to identify and evaluate the risks, fees, and other material costs they incur by participating in the CCA. The relevant portions of each of these new requirements is restated below:

    10 17 CFR 240.17Ad-22.

    11 17 CFR 240.17Ad-22(e)(3)(ii), (e)(4)(viii), (e)(4)(ix), (e)(7)(ix), (e)(13), (e)(23)(i) and (e)(23)(ii).

    12 15 U.S.C. 78q-1.

    13 12 U.S.C. 5461 et. seq.

    14 17 CFR 240.17Ad-22(a)(5).

    • Rule 17Ad-22(e)(3)(ii) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [m]aintain a sound risk management framework for comprehensively managing legal, credit, liquidity, operational, general business, investment, custody, and other risks that arise in or are borne by the [CCA], which . . . [i]ncludes plans for the recovery and orderly wind-down of the [CCA] necessitated by credit losses, liquidity shortfalls, losses from general business risk, or any other losses.” 15

    15 17 CFR 240.17Ad-22(e)(3)(ii).

    • Rule 17Ad-22(e)(4)(viii) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [e]ffectively identify, measure, monitor, and manage its credit exposures to participants and those arising from its payment, clearing, and settlement processes, including by . . . [a]ddressing allocation of credit losses the [CCA] may face if its collateral and other resources are insufficient to fully cover its credit exposures, including the repayment of any funds the [CCA] may borrow from liquidity providers.” 16

    16 17 CFR 240.17Ad-22(e)(v)(viii).

    • Rule 17Ad-22(e)(4)(ix) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [e]ffectively identify, measure, monitor, and manage its credit exposures to participants and those arising from its payment, clearing, and settlement processes, including by . . . [d]escribing the [CCA's] process to replenish any financial resources it may use following a default or other event in which use of such resources is contemplated.” 17

    17 17 CFR 240.17Ad-22(e)(4)(ix).

    • Rule 17Ad-22(e)(7)(ix) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [e]ffectively measure, monitor, and manage the liquidity risk that arises in or is borne by the [CCA], including measuring, monitoring, and managing its settlement and funding flows on an ongoing and timely basis, and its use of intraday liquidity by, at a minimum, doing the following . . . [d]escribing the [CCA's] process to replenish any liquid resources that the clearing agency may employ during a stress event.” 18

    18 17 CFR 240.17Ad-22(e)(7)(ix).

    • Rule 17Ad-22(e)(13) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [e]nsure the covered clearing agency has the authority and operational capacity to take timely action to contain losses and liquidity demands and continue to meet its obligations . . .” 19

    19 17 CFR 240.17Ad-22(e)(13).

    • Rule 17Ad-22(e)(23)(i) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [p]ublicly disclos[e] all relevant rules and material procedures, including key aspects of its default rules and procedures.” 20

    20 17 CFR 240.17Ad-22(e)(23)(i).

    • Rule 17Ad-22(e)(23)(ii) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [p]rovid[e] sufficient information to enable participants to identify and evaluate the risks, fees, and other material costs they incur by participating in the covered clearing agency.” 21

    21 17 CFR 240.17Ad-22(e)(23)(ii).

    OCC meets the definition of a CCA and is therefore subject to the requirements of the CCA rules, including new Rules 17Ad-22(e)(3)(ii), (e)(4)(viii), (e)(4)(ix), (e)(7)(ix), (e)(13), (e)(23)(i) and (e)(23)(ii).22

    22 17 CFR 240.17Ad-22(e)(3)(ii), (e)(4)(viii), (e)(4)(ix) and (e)(7)(ix).

    Proposed Changes Summary of Proposed Changes

    In order to enhance OCC's existing tools to address the risks of liquidity shortfalls and credit losses and to establish new tools by which OCC could re-establish a matched book following a default, OCC is proposing to make the following revisions to its Rules and By-Laws:

    (1) Revise the existing assessment powers in Section 6 of Article VIII of OCC's By-Laws, specifically to:

    (a) Establish a rolling “cooling-off period” that would be triggered by the payment of a proportionate charge against the Clearing Fund (“triggering proportionate charge”), during which period the aggregate liability of a Clearing Member to replenish the Clearing Fund (inclusive of assessments) would be 200% of the Clearing Member's required contribution as of the time immediately preceding the triggering proportionate charge;

    (b) Clarify that a Clearing Member that chooses to terminate its membership status during a cooling-off period will not be liable for replenishment of the Clearing Fund immediately following the expiration of such cooling-off period, provided that the withdrawing Clearing Member satisfies enumerated criteria, including providing notice of such termination by no later than the end of the cooling-off period and by closing-out and/or transferring of all its open positions with OCC by no later than the last day of the cooling-off period; and

    (c) Delineate between the obligation of a Clearing Member to replenish its contributions to the Clearing Fund and its obligations to meet additional “assessments” that may be levied following a proportionate charge to the Clearing Fund.

    (2) Adopt a new Rule 1011 23 that would provide OCC with discretionary authority to call for voluntary payments from non-defaulting Clearing Members in a circumstance where one or more Clearing Members has already defaulted and OCC has determined that it may not have sufficient resources to satisfy its obligations and liabilities resulting from such default.24 Rule 1011 also would establish that OCC would prioritize compensation of Clearing Members that made voluntary payments from any amounts recovered from the defaulted Clearing Members.

    23 OCC is amending the Initial Filing to renumber proposed Rule 1009 to proposed Rule 1011 and updated related cross references in Rule 1111 to reflect this renumbering. OCC is also amending the Default Management Policy as submitted in the Initial Filing to update similar cross references.

    24 Under the Initial Filing, OCC's authority to conduct Partial Tear-Ups, as well as call for voluntary payments or to conduct Voluntary Tear-Ups, would be conditioned in part on OCC having determined that, notwithstanding the availability of any remaining resources, OCC may not have sufficient resources to satisfy its obligations and liabilities resulting from such default. Under the Initial Filing, the proposed text of Rules 1009(a), 1111(a) and 1111(b) incorrectly transcribed this condition to require that OCC determine that, notwithstanding the availability of any remaining resources, OCC does not have sufficient resources to satisfy its obligations and liabilities resulting from such default (emphasis added). In each such instance, OCC is amending the proposed text of Rules 1009(a) (which is being renumbered as Rule 1011(a)), 1111(a) and 1111(b) in Exhibit 5B of the Initial Filing to delete the word “does” and insert in its place the word “may.” 

    (3) Adopt a new Rule 1111 that would provide authority to:

    (a) Allow OCC to call for voluntary tear-ups (“Voluntary Tear-Up,” as defined below) of non-defaulting Clearing Member and/or customer positions at any time following the suspension or default of a Clearing Member, with the scope of any such Voluntary Tear-Ups being determined by the Risk Committee of OCC's Board (“Risk Committee”);

    (b) Allow OCC's Board to vote to tear-up the “Remaining Open Positions” (defined below) of a defaulted Clearing Member, as well as any “Related Open Positions” (defined below) in a circumstance where OCC has attempted one or more auctions of such defaulted Clearing Member's remaining open positions and OCC has determined that it may not have sufficient resources to satisfy its obligations and liabilities resulting from such default with the scope of any such tear-up (“Partial Tear-Up”) being determined by the Risk Committee; and

    (c) Allow OCC's Board to vote to re-allocate losses, costs and fees imposed upon holders of positions extinguished in a Partial Tear-Up through a special charge levied against remaining non-defaulting Clearing Members.

    (4) Revise the descriptions and authorizations in Article VIII of OCC's By-Laws concerning the use of the Clearing Fund to reflect the discretion of OCC to use remaining Clearing Fund contributions to re-allocate losses imposed on non-defaulting Clearing Members and customers from a Voluntary Tear-Up or a mandatory tear-up (“Partial Tear-Up,” as defined below).

    Discussion of Proposed Changes

    Each of the proposed revisions to OCC's Rules and By-Laws is described in more detail in the following sub-sections:

    1. Proposed Changes to OCC's Assessment Powers a. Current Assessment Powers

    OCC's current assessment powers are described in Section 6 of Article VIII of OCC's By-Laws. Section 6 establishes a general requirement for each Clearing Member to promptly make good any deficiency in its required contribution to the Clearing Fund whenever an amount is paid out of its Clearing Fund contribution (whether by proportionate charge or otherwise).25 In this regard, a Clearing Member's obligation to replenish the Clearing Fund is not currently subject to any pre-determined limit. Notwithstanding the foregoing, a Clearing Member can limit the amount of its liability for replenishing the Clearing Fund (at an additional 100% of the amount of its then-required Clearing Fund contribution) by winding-down its clearing activities and terminating its status as a Clearing Member. Any Clearing Member seeking to so limit its liability for replenishing the Clearing Fund must: (i) Notify OCC in writing not later than the fifth business day after the proportionate charge that it is terminating its status as a Clearing Member, (ii) not initiate any opening purchase or opening writing transaction, and, if the Clearing Member is a Market Loan Clearing Member or a Hedge Clearing Member, not initiate any Stock Loan transaction, through any of its accounts, and (iii) close out or transfer all of its open positions as promptly as practicable after giving notice to OCC. Thus, withdrawal from clearing membership is the only means by which a Clearing Member currently can limit its liability for replenishing the Clearing Fund.

    25 Under Article VIII, Section 6 of OCC's By-Laws, OCC currently has authority to assess proportionate charges against Clearing Members' contributions to the Clearing Fund in certain enumerated situations. For example, Section 6 generally provides that if the conditions regarding a Clearing Member default specified in subparagraphs (a)(i) through (vi) of Article VIII, Section 5 of OCC's By-Laws are satisfied, OCC will make good resulting losses or expenses that are suffered by OCC by applying the defaulting Clearing Member's Clearing Fund contribution after first applying other funds available to OCC in the accounts of the Clearing Member. If the sum of the obligations, however, exceeds the total Clearing Fund contribution and other funds of the defaulting Clearing Member available to OCC, then OCC will charge the amount of the remaining deficiency on a proportionate basis against all non-defaulting Clearing Members' required contributions to the Clearing Fund at the time. Section 5(b) of Article VIII of OCC's By-Laws similarly provides for proportionate charges against Clearing Members' contributions to the Clearing Fund when certain conditions are met that involve a failure by a bank or a securities or commodities clearing organization to perform obligations to OCC when they are due.

    b. Proposed Changes to Assessment Powers

    OCC proposes to revise Section 6 of Article VIII of OCC's By-Laws to make three primary modifications regarding its existing authority to assess proportionate charges against Clearing Members' contributions to the Clearing Fund. First, the proposal introduces an automatic minimum fifteen calendar day “cooling-off” period that begins when a proportionate charge is assessed by OCC against Clearing Members' Clearing Fund contributions. While the cooling-off period will continue for a minimum of fifteen consecutive calendar days, if one or more of the events described in clauses (i) through (iv) of Article VIII, Section 5(a) of OCC's By-Laws occur(s) during that fifteen calendar day period and result in one or more proportionate charges against the Clearing Fund, the cooling-off period shall be extended through either (i) the fifteenth calendar day from the date of the most recent proportionate charge resulting from the subsequent event, or (ii) the twentieth day from the date of the proportionate charge that initiated the cooling-off period, whichever is sooner.

    During a cooling-off period, each Clearing Member would have its aggregate liability to replenish the Clearing Fund capped at 200% of the Clearing Member's then-required contribution to the Clearing Fund. Once the cooling-off period ends each remaining Clearing Member would be required to replenish the Clearing Fund in the amount necessary to meet its then-required contribution. Once the cooling-off period ends, any remaining losses or expenses suffered by OCC as a result of any event described in clauses (i) through (iv) of Article VIII, Section 5(a) of OCC's By-Laws that occurred during such cooling-off period could not be charged against the amounts Clearing Members have contributed to replenish the Clearing Fund upon the expiration of the cooling-off period.26

    26 After a cooling-off period has ended, the occurrence of any event described in clauses (i) through (iv) of Article VIII, Section 5(a) of OCC's By-Laws that results in a proportionate charge against the Clearing Fund would trigger a new cooling off period, and thusly, a cap of 200% of each Clearing Member's then-required contribution would again apply.

    Second, in connection with the cooling-off period, the proposal would extend the time frame within which a Clearing Member may provide a termination notice to OCC to avoid liability for replenishment of the Clearing Fund after the cooling-off period and would modify the obligations of such a terminating Clearing Member for closing-out and transferring its remaining open positions. Specifically, to effectively terminate its status as a Clearing Member and not be liable for replenishing the Clearing Fund after the cooling-off period, a Clearing Member would be required to: (i) Notify OCC in writing of its intent to terminate not later than the last day of the cooling-off period, (ii) not initiate any opening purchase or opening writing transaction, and, if the Clearing Member is a Market Loan Clearing Member or a Hedge Clearing Member, not initiate any Stock Loan transaction, through any of its accounts, and (iii) close-out or transfer all of its open positions by no later than the last day of the cooling-off period. If a Clearing Member fails to satisfy all of these conditions by the end of a given cooling-off period, it would not have completed all of the requirements necessary to terminate its status as a Clearing Member under Article VIII, Section 6 of OCC's By-Laws and therefore it would remain subject to the obligation to replenish the Clearing Fund after the end of the cooling-off period.

    Third, the proposal would clarify the distinction between “replenishment” of the Clearing Fund and a Clearing Member's obligation to answer “assessments.” In this context, the term “replenish” (and its variations) shall to refer to a Clearing Member's standing duty, following any proportionate charge against the Clearing Fund, to return its Clearing Fund contribution to the amount required from such Clearing Member for the month in question.27 The term “assessment” (and its variations) shall refer to the amount, during any cooling-off period, that a Clearing Member would be required to contribute to the Clearing Fund in excess of the amount of the Clearing Member's pre-funded required Clearing Fund contribution.

    27 This assumes that the proportionate charge resulted in the Clearing Member's actual Clearing Fund contribution dropping below the amount of its required contribution (i.e., that the Clearing Member did not have excess above its required contribution that was sufficient to cover the amount of the proportionate charge allocated to such Clearing Member).

    Proposed Addition of Ability To Request Voluntary Payments

    OCC proposes to add new Rule 1011, which will provide a framework by which OCC could receive voluntary payments in a circumstance where a Clearing Member has defaulted and OCC has determined that, notwithstanding the availability of any remaining resources under OCC Rules 707, 1001, 1104 through 1107, 2210 and 2211,28 OCC may not have sufficient resources to satisfy its obligations and liabilities resulting from such default. Under new Rule 1011, OCC will initiate a call for voluntary payments by issuing a “Voluntary Payment Notice” inviting all non-defaulting Clearing Members to make payments to the Clearing Fund in addition to any amounts they are otherwise required to contribute pursuant to Rule 1001. The Voluntary Payment Notice would specify the terms applicable to any voluntary payment, including but not limited to, that any voluntary payment may not be withdrawn once made, that no Clearing Member shall be obligated to make a voluntary payment and that OCC shall retain full discretion to accept or reject any voluntary payment. Rule 1011 specifies that if OCC subsequently recovers from the defaulted Clearing Member or the estate(s) of the defaulted Clearing Member(s), OCC would seek to compensate first from such recovery all non-defaulting Clearing Members that made voluntary payments (and if the amount recovered from the defaulted Clearing Member(s) is less than the aggregate amount of voluntary payments, non-defaulting Clearing Members that made voluntary payments each would receive a percentage of the recovery that corresponds to that Clearing Member's percentage of the total amount of voluntary payments received).

    28 Rule 707 addresses the treatment of funds in a Clearing Member's X-M accounts. Rule 1001 addresses the size of OCC's Clearing Fund and the amount of a Clearing Member's contribution. Rules 1104 through 1107 concern the treatment of the portfolio of a defaulted Clearing Member. Rules 2210 and 2211 concern the treatment of Stock Loan positions of a defaulted Clearing Member.

    Proposed Addition of Ability To Conduct Voluntary Tear-Ups

    OCC proposes to add new Rule 1111, which, in relevant part, will establish a framework by which non-defaulting Clearing Members and non-defaulting customers of Clearing Members could be given an opportunity to voluntarily extinguish (i.e., voluntarily tear-up) their open positions at OCC in a circumstance where a Clearing Member has defaulted and OCC has determined that, notwithstanding the availability of any remaining resources under OCC Rules 707, 1001, 1104 through 1107, 2210 and 2211, OCC may not have sufficient resources to satisfy its obligations and liabilities resulting from such default.

    While Risk Committee approval is not needed to commence a voluntary tear-up, the Risk Committee would be responsible for determining the appropriate scope of each voluntary tear-up. To ensure OCC retains sufficient flexibility to effectively deploy this tool in an extreme stress event, proposed Rule 1111(c) is drafted to provide the Risk Committee with discretion to determine the appropriate scope of each voluntary tear-up.29 New Rule 1111(c) also would impose standards designed to circumscribe the Risk Committee's discretion, requiring that any determination regarding the scope of a voluntary tear-up shall (i) be based on then-existing facts and circumstances, (ii) be in furtherance of the integrity of OCC and the stability of the financial system, and (iii) take into consideration the legitimate interests of Clearing Members and market participants.

    29 Notwithstanding the discretion that would be afforded by the text of proposed Rule 1111(c), OCC anticipates that the scope of voluntary tear-ups likely would be dictated by the cleared contracts remaining in the portfolio(s) of the defaulted Clearing Member(s).

    Once the Risk Committee has determined the scope of the Voluntary Tear-Up, OCC will initiate the call for voluntary tear-ups by issuing a “Voluntary Tear-Up Notice.” The Voluntary Tear-Up Notice shall inform all non-defaulting Clearing Members of the opportunity to participate in a Voluntary Tear-Up.30 The Voluntary Tear-Up Notice would specify the terms applicable to any voluntary tear-up, including but not limited to, that no Clearing Member or customers of a Clearing Member shall be obligated to participate in a voluntary tear-up and that OCC shall retain full discretion to accept or reject any voluntary tear-up.

    30 Since OCC does not know the identities of Clearing Members' customers, OCC would depend on each Clearing Member to notify its customers with positions in scope of the Voluntary Tear-Up of the opportunity to participate in such tear-up.

    OCC is not proposing a tear-up process that would require the imposition of “gains haircutting” (i.e., the reduction of unpaid gains) on a portion of OCC's cleared contracts.31 Instead, OCC has determined that its tear-up process—for both Voluntary Tear-Ups as well as Partial Tear-Ups—should be initiated on a date sufficiently in advance of the exhaustion of OCC's financial resources such that OCC would be expected to have adequate remaining resources to cover the amount it must pay to extinguish the positions of Clearing Members and customers without haircutting gains.32

    31 In general, forced gains haircutting is a tool that can be more easily applied to products whose gains are settled at least daily, like futures through an exchange of variation margin, and by central counterparties with comparatively large daily settlement flows. Listed options, which constitute the vast majority of the contracts cleared by OCC, do not have daily settlement flows and any attempt to reduce the “unrealized gains” of a listed options contract would require the reduction of the option premium that is embedded within the required margin (such a process would effectively require haircutting the listed option's initial margin).

    32 OCC anticipates that it would determine the date on which to initiate Partial Tear-Ups by monitoring its remaining financial resources against the potential exposure of the remaining unauctioned positions from the portfolio(s) of the defaulted Clearing Member(s).

    In OCC's proposed tear-up process, the holders of torn-up positions would be assigned a Tear-Up Price and OCC would draw on its remaining financial resources in order to extinguish the torn-up positions at the assigned Tear-Up Price without forcing a reduction in the amount of unpaid value of such positions. OCC is amending the Initial Filing to clarify that while OCC does not intend, in the first instance, for its tear-up process to serve as a means of loss allocation, circumstances may arise such that, despite best efforts, OCC has inadequate remaining financial resources to extinguish torn-up positions at their assigned Tear-Up Price without forcing a reduction in the amount of unpaid value of such positions (e.g., despite best efforts, market movements not accounted for by monitoring, additional Clearing Member defaults occur immediately preceding a tear-up). In such circumstances, despite best efforts, OCC would use its partial tear-up process as a means of loss allocation.33

    33 This change does not impact the statutory basis for the advance notice filing.

    The proposed changes would provide OCC with two separate and non-exclusive means of equitably re-allocating the losses, costs or expenses imposed upon the holders of torn-up positions as a result of the tear-up(s). First, the proposed changes to Article VIII would provide OCC discretion to use remaining Clearing Fund contributions to re-allocate losses imposed on non-defaulting Clearing Members and customers from such tear-up(s). Second, Rule 1111(a) would provide that if OCC subsequently recovers from the defaulted Clearing Member or the estate(s) of the defaulted Clearing Member(s) and the amount of such recovery exceeds the amount OCC received in voluntary payments, then non-defaulting Clearing Members and non-defaulting customers that voluntarily tore-up open positions and incurred losses from such tear-ups would be repaid from the amount of the recovery in excess of the amount OCC received in voluntary payments.34 If the amount recovered is less than the aggregate amount of Voluntary Tear-Up, each non-defaulting Clearing Member and non-defaulting customer that incurred losses from voluntarily torn-up positions would be repaid in an amount proportionate to the percentage of its total amount of losses, costs and fees imposed on Clearing Members or customers as a result of the Voluntary Tear-Ups.

    34 In order to effect re-allocation of the losses, costs or expenses imposed upon the holders of torn-up positions, OCC expects that after it has completed its tear-up process and re-established a matched book, holders of both voluntarily torn-up and mandatorily torn-up positions would be provided with a limited opportunity to re-establish positions in the contracts that were voluntarily or mandatorily extinguished. After the expiration of such period, OCC would seek to collect the information on the losses, costs or expenses that had been imposed on the holders of torn-up positions. Based on the information collected, OCC would determine whether it can reasonably determine the losses, costs and expenses sufficiently to re-allocate such amounts.

    With respect to Voluntary Tear-Ups, new Rule 1111(h) would clarify that no action or omission by OCC pursuant to and in accordance with Rule 1111 shall constitute a default by OCC.

    Proposed Addition of Ability To Conduct Partial Tear-Ups

    OCC proposes to add new Rule 1111, which, in relevant part, will provide the Board with discretion to extinguish the remaining open positions of any defaulted Clearing Member or customer of such defaulted Clearing Member(s) (such positions, “Remaining Open Positions”), as well as any related open positions as necessary to mitigate further disruptions to the markets affected by the Remaining Open Positions (such positions, “Related Open Positions”), in a circumstance where a Clearing Member has defaulted and OCC has determined that, notwithstanding the availability of any remaining resources under OCC Rules 707, 1001, 1104 through 1107, 2210 and 2211, OCC may not have sufficient resources to satisfy its obligations and liabilities resulting from such default (such tear-ups hereinafter collectively referred to as “Partial Tear-Ups”). Like the determination for Voluntary Tear-Ups, the Risk Committee shall determine the appropriate scope of each Partial Tear-Up and such determination shall (i) be based on then-existing facts and circumstances, (ii) be in furtherance of the integrity of OCC and the stability of the financial system, and (iii) take into consideration the legitimate interests of Clearing Members and market participants. Once the Risk Committee has determined the scope of the Partial Tear-Up, OCC will initiate the Partial Tear-Up process by issuing a “Partial Tear-Up Notice.” The Partial Tear-Up Notice shall (i) identify the Remaining Open Positions and Related Open Positions designated for tear-up, (ii) identify the open positions of non-defaulting Clearing Members and non-defaulting customers that will be subject to Partial Tear-Up (such positions, “Tear-Up Positions”), (iii) specify the termination price (“Partial Tear-Up Price”) for each position to be torn-up, and (iv) list the date and time as of which the Partial Tear-Up will occur.35 With regard to the date and time of a Partial Tear-Up, Rule 1111(d) specifies that the Risk Committee shall set the date and time. With regard to the Partial Tear-Up Price, OCC anticipates that it is likely to use the last established end-of-day settlement price, in accordance with its existing practices concerning pricing and valuation. However, given that it is not possible to know in advance the precise circumstances that would cause OCC to conduct a tear-up, Rule 1111(f) has been drafted to allow OCC to exercise reasonable discretion, if necessary, in establishing the Partial Tear-Up Price by some means other than its existing practices concerning pricing and valuation.36 Specifically, Rule 1111(f) would require that OCC, in exercising any such discretion, would act in good faith and in a commercially reasonable manner to adopt methods of valuation expected to produce reasonably accurate substitutes for the values that would have been obtained from the relevant market if it were operating normally, including but not limited to the use of pricing models that use the market price of the underlying interest or the market prices of its components. Rule 1111(f) further specifies that OCC may consider the same information set forth in subpart (c) of Section 27, Article VI of OCC's By-Laws.37

    35 Since OCC does not know the identities of Clearing Members' customers, OCC would depend on each Clearing Member to notify its customers with positions in scope of the Partial Tear-Up of the possibility of tear-up.

    36 For example, OCC has observed certain rare circumstances in which a closing price for an underlying security of an option may be stale or unavailable. A stale or unavailable closing price could be the result of a halt on trading in the underlying security, or a corporate action resulting in a cash-out or conversion of the underlying security (but that has not yet been finalized), or the result of an ADR whose underlying security is being impacted by certain provisions under foreign laws. OCC would consider the presence of these factors on its end-of-day prices in determining whether use of the discretion that would be afforded under proposed Rule 1111(f) might be warranted.

    37 In relevant part, subpart (c) reads as follows: “In determining a close-out amount, the Corporation may consider any information that it deems relevant, including, but not limited to, any of the following: (1) Prices for underlying interests in recent transactions, as reported by the market or markets for such interests; (2) quotations from leading dealers in the underlying interest, setting forth the price (which may be a dealing price or an indicative price) that the quoting dealer would charge or pay for a specified quantity of the underlying interest; (3) relevant historical and current market data for the relevant market, provided by reputable outside sources or generated internally; and (4) values derived from theoretical pricing models using available prices for the underlying interest or a related interest and other relevant data. Amounts stated in a currency other than U.S. Dollars shall be converted to U.S. Dollars at the current rate of exchange, as determined by the Corporation. A position having a positive close-out value shall be an `asset position' and a position having a negative close-out value shall be a `liability position.' ”

    The scope of any Partial Tear-Up will be determined in accordance with Rule 1111(e).38 With respect to the extinguishment of Remaining Open Positions, OCC will designate Tear-Up Positions in identical Cleared Contracts and Cleared Securities on the opposite side of the market and in an aggregate amount equal to that of the Remaining Open Positions. OCC will only designate Tear-Up Positions in the accounts of non-defaulting Clearing Members (inclusive of such Clearing Members' customer accounts) with an open position in the applicable Cleared Contract or Cleared Security.39 Tear-Up Positions shall be designated and applied by OCC on a pro rata basis across all the identical positions in Cleared Contracts and Cleared Securities on the opposite side of the market in the accounts of non-defaulted Clearing Members and their customers.40

    38 OCC is amending the Initial Filing to reflect that after further evaluation of its proposed recovery tools and the proposed tear-up process, OCC does not believe there would be a need to assign or transfer any hedging transactions established with relation to tear-up positions. OCC is therefore amending the Initial Filing to remove text in proposed Rule 1111(e) concerning proposed authority for OCC to offer to assign or transfer any hedging transactions related to Remaining Open Positions with related Tear-Up Positions. This change does not impact the statutory basis for the advance notice filing.

    39 Since, as stated in the Initial Filing, the objective of Partial Tear-Ups is to extinguish the Remaining Open Positions cleared by the defaulted Clearing Member(s) or customer of such defaulted Clearing Member(s) (emphasis added), OCC does not believe there would be a need to designate Tear-Up Positions to the non-defaulted customers of a defaulted Clearing Member. OCC is therefore amending the Initial Filing to remove references to non-defaulted customers of defaulted Clearing Members.

    40 OCC is amending the Initial Filing to clarify that a non-defaulted Clearing Member would be required to allocate the assigned Tear-Up Positions on a pro rata basis across those customers that have open positions in such Cleared Contract or Cleared Security in such account, and for any listed option positions being extinguished, allocation across customer accounts should occur in accordance with such Clearing Member's procedures for allocating exercises and assignments. This change does not impact the statutory basis for the advance notice filing.

    Rule 1111(e)(iii) provides that every Partial Tear-Up position is automatically terminated upon and with effect from the Partial Tear-Up Time, without the need for any further step by any party to such Cleared Contract or Cleared Security, and that upon termination, either OCC or the relevant Clearing Member (as the case may be) shall be obligated to pay the other the applicable Partial Tear-Up Price. Rule 1111(e)(iii) further provides that the corresponding open position shall be deemed terminated at the Partial Tear-Up Price.41

    41 OCC is amending the Initial Filing and the proposed text of Rule 1111(e)(iii) to clarify that if, in the circumstances discussed in fn. 26 (above), OCC, in its discretion, determines that its remaining resources are inadequate to pay the applicable Partial Tear-Up Price for each position being extinguished in the Partial Tear-Up, OCC shall be obligated to pay each relevant Clearing Member a pro rata amount of the applicable Partial Tear-Up Price based on OCC's remaining resources, and the relevant Clearing Member shall have an unsecured claim against the Corporation for the value of the difference between the pro rata amount received and the Partial Tear-Up Price. With regard to amounts recovered from a suspended or defaulted Clearing Member (or from the estate of a suspended or defaulted Clearing Member) Rules 1011(b) and 111(a)(ii) would continue to apply. This change does not impact the statutory basis for the advance notice filing.

    Rule 1111(g) provides that to the extent losses imposed upon non-defaulting Clearing Members and non-defaulting customers resulting from a Partial Tear-Up can reasonably be determined, the Board may elect to re-allocate such losses among all non-defaulting Clearing Members through a special charge to all non-defaulting Clearing Members in an amount corresponding to each such non-defaulting Clearing Member's proportionate share of the variable amount of the Clearing Fund at the time such Partial Tear-Up is conducted.42

    42 For the avoidance of doubt, the special charge would be distinct and separate from a Clearing Member's obligation to satisfy Clearing Fund assessments, and therefore, would not be subject to the aforementioned assessment cap in the amount of 200% of a Clearing Member's then-required contribution to the Clearing Fund.

    With respect to Partial Tear-Ups, new Rule 1111(h) would clarify that no action or omission by OCC pursuant to and in accordance with Rule 1111 shall constitute a default by OCC.

    Expected Effect on and Management of Risk

    OCC believes that the proposed changes would reduce the nature and level of risk presented to OCC in three primary ways: (i) By providing greater certainty regarding what financial resources will be available to OCC after a proportionate charge is assessed; (ii) by providing additional tools by which to allocate credit losses in excess of OCC's available financial resources; and (iii) by enhancing OCC's ability to re-establish a matched book. First, OCC believes the imposition of a 200% cap on OCC's assessment powers during any cooling-off period provides Clearing Members with greater certainty regarding their maximum liability with respect to the Clearing Fund during extreme stress events, which in turn, facilitates Clearing Members' management of their own risks, and to the extent applicable, regulatory capital considerations. Further, OCC believes that extending the window for Clearing Member withdrawal following a proportionate charge to be equivalent with the cooling-off period would afford a Clearing Member a more reasonable period in which to evaluate whether the withdrawal from clearing membership would be necessary to cap its liability for proportionate charges at 200% of its then-required Clearing Fund contributions. With this change, OCC believes the increased predictability would help it to more reliably understand the amount of Clearing Fund contributions that will likely be available to it after a proportionate charge is assessed. Second, the introduction of rules to allow for voluntary payments, Voluntary Tear-Ups and Partial Tear-Ups would provide OCC with three distinct tools that could be used to allocate any credit losses OCC may face in excess of collateral and other resources available to OCC. Finally, in the event that OCC believes its obligations and liabilities arising from remaining positions in the portfolio of a defaulted Clearing Member may exceed its remaining available financial resources, the proposed changes ultimately would enable OCC to extinguish those positions, thereby re-establishing a matched book.

    The risks of a Partial Tear-Up are extremely remote; nonetheless, OCC believes that the express authority to conduct a Partial Tear-Up may be viewed as increasing Clearing Members' and customers' exposure to an extreme stress scenario. As explained above, the proposed Partial Tear-Up authority is consistent with regulatory requirements, as well as with the expectations of CCPs of various international organizations. OCC further believes that its proposed Partial Tear-Up authority strikes an appropriate balance between seeking to protect the interests of Clearing Members and customers and the need to have appropriate tools to stabilize a systemically important financial market utility and minimize the risk of disruption to the broader financial system. To address the potential impact of a Partial Tear-Up on Clearing Members and customers, OCC has proposed two tools that would enable it to equitably re-allocate the losses, costs and fees imposed upon holders of torn-up positions.

    Consistency With the Clearing Supervision Act

    The stated purpose of the Clearing Supervision Act is to mitigate systemic risk in the financial system and promote financial stability by, among other things, promoting uniform risk management standards for systemically important financial market utilities and strengthening the liquidity of systemically important financial market utilities.43 Section 805(a)(2) of the Clearing Supervision Act 44 also authorizes the Commission to prescribe risk management standards for the payment, clearing and settlement activities of designated clearing entities, like OCC, for which the Commission is the supervisory agency. Section 805(b) of the Clearing Supervision Act 45 states that the objectives and principles for risk management standards prescribed under Section 805(a) shall be to:

    43 12 U.S.C. 5461(b).

    44 12 U.S.C. 5464(a)(2).

    45 12 U.S.C. 5464(b).

    • Promote robust risk management;

    • promote safety and soundness;

    • reduce systemic risks; and

    • support the stability of the broader financial system.

    The Commission has adopted risk management standards under Section 805(a)(2) of the Clearing Supervision Act and the Act in furtherance of these objectives and principles, including those standards adopted pursuant to the Commission rules cited below.46 For the reasons set forth below, OCC believes that the proposed change is consistent with the risk management standards promulgated under Section 805(a) of the Clearing Supervision Act.47

    46 17 CFR 240.17Ad-22. See Securities Exchange Act Release Nos. 68080 (October 22, 2012), 77 FR 66220 (November 2, 2012) (S7-08-11) (“Clearing Agency Standards”); 78961 (September 28, 2016), 81 FR 70786 (October 13, 2016) (S7-03-14) (“Standards for Covered Clearing Agencies”). The Standards for Covered Clearing Agencies became effective on December 12, 2016. OCC is a “covered clearing agency” as defined in Rule 17Ad-22(a)(5) and therefore is subject to section (e) of Rule 17Ad-22.

    47 12 U.S.C. 5464(b)(1) and (4).

    Recovery and Orderly Wind-Down

    In relevant part, Rule 17Ad-22(e)(3)(ii) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . plan[ ] for the recovery and orderly wind-down of the [CCA] necessitated by credit losses, liquidity shortfalls, losses from general business risk, or any other losses.” 48 As stated above, each of the proposed changes is designed to provide OCC with tools to address the risks OCC might confront in a recovery and orderly wind-down scenario.49 Consistent with the requirements of Rule 17Ad-22(e)(3)(ii), the proposed tools would enable OCC to better address the risks of liquidity shortfalls and credit losses resulting from a Clearing Member default or certain other loss events and, if necessary, to ultimately re-establish a matched book in a recovery or orderly wind-down scenario.50 In this context, the proposed changes serve as a critical component of OCC's recovery and orderly wind-down plan. As a result, in OCC's view, the proposed changes are consistent with the requirements of Rule 17Ad-22(e)(3)(ii) as to the recovery and orderly wind-down plan.51

    48 17 CFR 240.17Ad-22(e)(3)(ii).

    49 Indeed, the OCC's separately filed recovery and orderly wind-down plan identifies OCC's assessment powers, ability to call for voluntary payments, ability to call for Voluntary Tear-Ups and ability to impose Partial Tear-Ups among its “Recovery Tools.” OCC has filed a proposed rule change with the Commission in connection with this proposal. See Securities Exchange Act Release No. 82352 (December 19, 2017), 82 FR 61072 (December 26, 2017) (SR-OCC-2017-021). On March 22, 2018, the U.S. Securities and Exchange Commission (“Commission”) instituted proceedings to determine whether to approve or disapprove the proposed rule change. See Securities Exchange Act Release No. 82927 (March 22, 2018), 83 FR 13176 (March 27, 2018) (SR-OCC-2017-021).

    50 17 CFR 240.17Ad-22(e)(3)(ii).

    51 17 CFR 240.17Ad-22(e)(3)(ii).

    Allocation of Credit Losses Above Available Resources

    In relevant part, Rule 17Ad-22(e)(4)(viii) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [ a]ddress[ ] allocation of credit losses the [CCA] may face if its collateral and other resources are insufficient to fully cover its credit exposures . . .” 52 The proposed changes would provide OCC with three distinct tools that could be used to allocate any credit losses OCC may face in excess of collateral and other resources available to OCC. First, new Rule 1011 would provide a framework by which OCC could receive voluntary payments in a circumstance where a Clearing Member has defaulted and OCC has determined that, notwithstanding the availability of any remaining resources under OCC Rules 707, 1001, 1104 through 1107, 2210 and 2211,53 OCC may not have sufficient resources to satisfy its obligations and liabilities resulting from such default. Second, new Rule 1111 would establish a framework by which non-defaulting Clearing Members and non-defaulting customers of Clearing Members could be given an opportunity to participate in Voluntarily Tear-Ups in a circumstance where a Clearing Member has defaulted and OCC has determined that, notwithstanding the availability of any remaining resources under OCC Rules 707, 1001, 1104 through 1107, 2210 and 2211, OCC may not have sufficient resources to satisfy its obligations and liabilities resulting from such default. Finally, new Rule 1111 also would provide the Board with discretion to mandatorily tear-up Remaining Open Positions and Related Open Positions, in a circumstance where a Clearing Member has defaulted and OCC has determined that, notwithstanding the availability of any remaining resources under OCC Rules 707, 1001, 1104 through 1107, 2210 and 2211, OCC may not have sufficient resources to satisfy its obligations and liabilities resulting from such default.54 In OCC's view, each of these tools could be deployed by OCC, if necessary, to allocate credit losses in excess of the collateral and other resources available to OCC, in accordance with Rule 17Ad-22(e)(4)(viii).55

    52 17 CFR 240.17Ad-22(e)(v)(viii).

    53 Rule 707 addresses the treatment of funds in a Clearing Member's X-M accounts. Rule 1001 addresses the size of OCC's Clearing Fund and the amount of a Clearing Member's contribution. Rules 1104 through 1107 concern the treatment of the portfolio of a defaulted Clearing Member. Rules 2210 and 2211 concern the treatment of Stock Loan positions of a defaulted Clearing Member.

    54 Rule 1111(g), which would provide the Board authority to equitably re-allocate losses, costs and fees directly imposed as a result of a Partial Tear-Up among all non-defaulting Clearing Members through a special charge, would serve as a discretionary tool to redistribute the credit losses allocated through Partial Tear-Up.

    55 17 CFR 240.17Ad-22(e)(v)(viii).

    Replenishment of Financial Resources Following a Default

    In relevant part, Rule 17Ad-22(e)(4)(ix) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [d]escrib[e] the [CCA's] process to replenish any financial resources it may use following a default or other event in which use of such resources is contemplated.” 56 OCC's Clearing Members have a standing obligation to replenish the Clearing Fund following any proportionate charge. The proposed changes would establish a rolling cooling-off period, triggered by the payment of a proportionate charge against the Clearing Fund, during which period the aggregate liability of a Clearing Member to replenish the Clearing Fund (inclusive of assessments) would be 200% of the Clearing Member's required contribution as of the time immediately preceding the triggering proportionate charge. Compared to the current requirement under which a Clearing Member may cap its liability to proportionate charges at an additional 100% of its then-required contribution, a Clearing Member would instead be permitted to cap its liability for proportionate charges at an additional 200% of its then-required Clearing Fund contribution.

    56 17 CFR 240.17Ad-22(e)(4)(ix).

    OCC believes that the proposed approach improves predictability for OCC and for Clearing Members regarding the size of Clearing Fund contributions that are likely to be subject to assessments for proportionate charges. Additionally, replacing the five business day withdrawal period with the withdrawal period commensurate with the cooling-off period (which, as proposed would be a minimum of fifteen calendar days) would give Clearing Members a more reasonable period in which to meet the wind-down and termination requirements necessary to cap their liability. OCC believes that this would afford them greater certainty regarding their maximum liability with respect to the Clearing Fund during extreme stress events, which in turn, facilitates Clearing Members' management of their own risk management, and to the extent applicable, regulatory capital considerations. And OCC believes this increased predictability would also be beneficial to OCC by helping it to more reliably understand the amount of Clearing Fund contributions that will likely be available to it after a proportionate charge is assessed.57

    57 Under the existing approach, it is less certain from OCC's standpoint regarding whether Clearing Members would reasonably be able to cap their liability to proportionate charges within five business days.

    OCC believes that the relative certainty provided by the proposed cooling-off period and 200% cap on assessments ultimately could reduce the risks of successive or “cascading” defaults, in which the financial demands on remaining non-defaulting Clearing Members to continually replenish OCC's Clearing Fund (and similar guaranty funds at other CCPs to which such Clearing Members might belong) have the effect of further weakening such Clearing Members to the point of default. In this regard, the proposed changes are designed to provide OCC, Clearing Members and other stakeholders with sufficient time to manage the ongoing default(s) without further aggravating the extreme stresses facing market participants.

    OCC recognizes that the proposed changes would limit the maximum amount of Clearing Fund resources that could be available to OCC in an extreme stress scenario, which introduces the possibility, however remote, that the proposed 200% cap ultimately could be reached. If during any cooling-off period the amount of aggregate proportionate charges against the Clearing Fund approaches the 200% cap, the amount remaining in the Clearing Fund may no longer be sufficient to comply with the applicable minimum regulatory financial resources requirements in the CCAs. In any such event, OCC's existing authority under Rule 603 would permit OCC to call on participants for additional initial margin, which could ensure that OCC's minimum financial resources remain in excess of applicable CCA requirements.58 OCC recognizes that the imposition of increased margin requirements could have an immediate pro-cyclical impact on participants (and consequential impacts on the broader financial system) that is potentially greater than the impact of replenishing the Clearing Fund. These risks would be limited to a specific extreme stress event and could be mitigated by certain factors. First, OCC, in coordination with its regulators, would carefully evaluate any potential increase in the context of then-existing facts and circumstances. Second, during the cooling-off period, Clearing Members and their customers will have the opportunity to reduce or rebalance their respective portfolios in order to mitigate their exposures to stress losses and initial margin increases. Finally, since initial margin is not designed to be subject to mutualized loss, the risk of loss faced by Clearing Members for amounts posted as additional margin would be substantially less than for replenishments of the Clearing Fund.

    58 Rule 603 provides that “[t]he Risk Committee may, from time to time, increase the amount of margin which may be required in respect of a cleared contract, open short position or exercised contract if, in its discretion, it determines that such increase is advisable for the protection of [OCC], the Clearing Members or the general public.”

    Given the products cleared by OCC and the composition of its clearing membership, OCC has determined that a minimum 15-calendar day cooling-off period, rolling up to a maximum of 20 calendar days, is likely to be a sufficient amount of time for OCC to manage the ongoing default(s) and take necessary steps in furtherance of stabilizing the clearing system. Further, through conversations with Clearing Members, OCC believes that the proposed cooling-off period is likely to be a sufficient amount for Clearing Members (and their customers) to orderly reduce or rebalance their positions, in an attempt to mitigate stress losses and exposure to potential initial margin increases as they navigate the stress event. Through conversations with Clearing Members, OCC also believes that the proposed cooling-off period is likely to be a sufficient amount for certain Clearing Members to orderly close-out their positions and transfer customer positions as they withdraw from clearing membership. OCC believes the proposed cooling-off period, coupled with the other proposed changes to OCC's assessment powers, is likely to provide Clearing Members with an adequate measure of stability and predictability as to the potential use of Clearing Fund resources, which OCC believes removes the existing incentive for Clearing Members to withdraw following a proportionate charge.59

    59 OCC initially considered a fixed 15-calendar day cooling-off period; however, OCC concluded that a fixed 15-calendar day cooling-off period may increase the risks of successive or cascading Clearing Member defaults and may perversely incentivize Clearing Members to seek to withdraw from clearing membership. Through conversations with Clearing Members, OCC believes that these potentially disruptive consequences are mitigated by the proposed rolling cooling-off period.

    In light of the foregoing, OCC believes that the proposed changes would enhance and strengthen its process to replenish the Clearing Fund following a default or other event in which use of the Clearing Fund is contemplated, in accordance with Rule 17Ad-22(e)(4)(ix).60

    60 17 CFR 240.17Ad-22(e)(4)(ix).

    Replenishment of Liquid Resources

    In relevant part, Rule 17Ad-22(e)(7)(ix) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [d]escrib[e] the [CCA's] process to replenish any liquid resources that the clearing agency may employ during a stress event.” 61 Since the use any part of the cash portion of OCC's Clearing Fund would constitute a depletion of one of OCC's liquid resources, OCC's assessment power, discussed above, is the primary means of replenishing the Clearing Fund cash that OCC used to address the stress event. For the same reasons stated above, OCC believes that the proposed changes enhance and strengthen its process to replenish the Clearing Fund, as necessary, following a default or other stress event in which the Clearing Fund is used, and therefore, OCC views the proposed changes as consistent with Rule 17Ad-22(e)(7)(ix).62

    61 17 CFR 240.17Ad-22(e)(7)(ix).

    62 17 CFR 240.17Ad-22(e)(7)(ix).

    Timely Action To Contain Losses

    In relevant part, Rule 17Ad-22(e)(13) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [e]nsure the [CCA] has the authority and operational capacity to take timely action to contain losses and liquidity demands and continue to meet its obligations . . .” 63 The proposed changes would provide OCC with the authority to call for Voluntary Tear-Ups and OCC's Board with the discretion to impose Partial Tear-Ups, which would provide OCC with authority necessary to extinguish certain losses (and attendant liquidity demands) thereby potentially enabling OCC to continue to meet its remaining obligations to participants. As designed, Voluntary Tear-Ups and Partial Tear-Ups would be initiated on a date sufficiently in advance of the exhaustion of OCC's financial resources such that OCC is expected to have adequate resources remaining to cover the amount it must pay to extinguish the positions of Clearing Members and customers without haircutting gains. Accordingly, OCC believes that its authority and capacity to conduct a Partial Tear-Up should be timely, relative to the adequacy of OCC's remaining financial resources. Finally, OCC believes it has the operational and systems capacity sufficient to support the proposed changes, and OCC's policies and procedures will be updated accordingly to reflect the existence of these new tools. As a result, OCC believes that the proposed changes conform to the relevant requirements in Rule 17Ad-22(e)(13).64

    63 17 CFR 240.17Ad-22(e)(13).

    64 17 CFR 240.17Ad-22(e)(13).

    Public Disclosure of Key Aspects of Default Rules

    In relevant part, Rule 17Ad-22(e)(23)(i) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [p]ublicly disclos[e] all relevant rules and material procedures, including key aspects of its default rules and procedures.” 65 As stated above, each of the tools discussed herein are contemplated to be deployed by OCC if an extreme stress event has placed OCC into a recovery or orderly wind-down scenario, and therefore, the tools discussed herein constitute key aspects of OCC's default rules. By incorporating the proposed changes into OCC's Rules and By-Laws, as further supplemented by the discussion in OCC's public rule filing, OCC believes that proposed changes would conform to the relevant requirements in Rule 17Ad-22(e)(23)(i).66

    65 17 CFR 240.17Ad-22(e)(23)(i).

    66 17 CFR 240.17Ad-22(e)(13).

    Sufficient Information Regarding the Risks, Fees and Costs of Clearing

    In relevant part, Rule 17Ad-22(e)(23)(ii) requires that each CCA “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [p]rovid[e] sufficient information to enable participants to identify and evaluate the risks, fees, and other material costs they incur by participating in the covered clearing agency.” 67 The proposed changes would clearly explain to Clearing Members and market participants that an extreme stress scenario could result in the use—and theoretically the exhaustion—of OCC's financial resources, inclusive of OCC's proposed assessment powers. Proposed changes to Section 6, Article VIII of OCC's By-Laws would explain Clearing Members' replenishment obligation and liability for assessments. The proposed changes also would clearly explain, through proposed Rules 1011 and 1111, that as OCC nears the exhaustion of its assessment powers, Clearing Members may be asked for voluntary payments and, if necessary, Clearing Members and customers may be asked to participate in a Voluntary Tear-Up and/or subject to a Partial Tear-Up. Proposed Rules 1011(b) and 1111(a)(ii) also would make clear that Clearing Members that made voluntary payments and Clearing Members and customers whose tendered positions were extinguished in the Voluntary Tear-Up would be prioritized in the distribution of any recovery from the defaulted Clearing Member(s). Proposed changes to Article VIII would clarify that the Clearing Fund contributions remaining after OCC has conducted a Voluntary Tear-Up or Partial Tear-Up could be used to compensate the non-defaulting Clearing Members and non-defaulting customers for the losses, costs or fees imposed upon them as a result of such Voluntary Tear-Up or Partial Tear-Up. Proposed Rule 1111(g) would make clear that, following a Partial Tear-Up, OCC's Board may seek to equitably re-allocate losses, costs and fees directly imposed as a result of a Partial Tear-Up among all non-defaulting Clearing Members through a special charge. By incorporating the proposed changes into OCC's Rules and By-Laws, as further supplemented by the discussion in OCC's public rule filing, OCC believes that is has provided sufficient information to enable participants to identify and evaluate the risks, fees, and other material costs they could incur by participating OCC, consistent with the requirements in Rule 17Ad-22(e)(23)(ii).68

    67 17 CFR 240.17Ad-22(e)(23)(ii).

    68 17 CFR 240.17Ad-22(e)(23)(ii).

    III. Date of Effectiveness of the Advance Notice and Timing for Commission Action

    The proposed change may be implemented if the Commission does not object to the proposed change within 60 days of the later of (i) the date the proposed change was filed with the Commission or (ii) the date any additional information requested by the Commission is received. OCC shall not implement the proposed change if the Commission has any objection to the proposed change.

    The Commission may extend the period for review by an additional 60 days if the proposed change raises novel or complex issues, subject to the Commission providing the clearing agency with prompt written notice of the extension. A proposed change may be implemented in less than 60 days from the date the advance notice is filed, or the date further information requested by the Commission is received, if the Commission notifies the clearing agency in writing that it does not object to the proposed change and authorizes the clearing agency to implement the proposed change on an earlier date, subject to any conditions imposed by the Commission.

    OCC shall post notice on its website of proposed changes that are implemented. The proposal shall not take effect until all regulatory actions required with respect to the proposal are completed.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the advance notice is consistent with the Clearing Supervision Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected]. Please include File Number SR-OCC-2017-809 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.

    All submissions should refer to File Number SR-OCC-2017-809. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the advance notice that are filed with the Commission, and all written communications relating to the advance notice between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549 on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of OCC and on OCC's website at https://www.theocc.com/about/publications/bylaws.jsp.

    All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal or identifying information from comment submissions. You should submit only information that you wish to make available publicly.

    All submissions should refer to File Number SR-OCC-2017-809 and should be submitted on or before August 22, 2018.

    By the Commission.

    Brent J. Fields, Secretary.
    [FR Doc. 2018-16824 Filed 8-6-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-83756; File No. SR-BYX-2012-019] Self-Regulatory Organization; Cboe BYX Exchange, Inc.; Order Granting an Extension to Limited Exemption From Rule 612(c) of Regulation NMS in Connection With the Exchange's Retail Price Improvement Program August 1, 2018.

    On November 27, 2012, the Securities and Exchange Commission (“Commission”) issued an order pursuant to its authority under Rule 612(c) of Regulation NMS (“Sub-Penny Rule) 1 that granted the BATS BYX-Exchange, Inc. (nka “Cboe BYX” or the “Exchange”) a limited exemption from the Sub-Penny Rule in connection with the operation of the Exchange's Retail Price Improvement (“RPI”) Program (the “Program”). The limited exemption was granted concurrently with the Commission's approval of the Exchange's proposal to adopt the Program for a one-year pilot term.2 The exemption was granted coterminous with the effectiveness of the pilot Program and has been extended five times; 3 both the pilot Program and exemption are scheduled to expire on July 31, 2018.

    1 17 CFR 242.612(c).

    2See Securities Exchange Act Release No. 68303 (November 27, 2012), 77 FR 71652 (December 3, 2012) (“RPI Approval Order”) (SR-BXY-2012-019).

    3See Securities Exchange Act Release Nos. 71249 (January 7, 2014), 79 FR 2229 (January 13, 2012) (SR-BYX-2014-001) (Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Extend the Pilot Period for the RPI); 71250 (January 7, 2014), 79 FR 2234 (January 13, 2012) (Order Granting an Extension to Limited Exemption From Rule 612(c) of Regulation NMS in Connection With the Exchange's Retail Price Improvement Program); 74111 (January 22, 2015), 80 FR 4598 (January 28, 2015) (SR-BYX-2015-05) (Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Extend the Pilot Period for the RPI); and 74115 (January 22, 2015), 80 FR 4324 (January 27, 2015) (Order Granting an Extension to Limited Exemption From Rule 612(c) of Regulation NMS in Connection With the Exchange's Retail Price Improvement Program); 76965 (January 22, 2016), 81 FR 4682 (January 27, 2016) (SR-BYX-2016-01) (Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Extend the Pilot Period for the RPI); 76953 (January 21, 2016), 81 FR 4728 (January 27, 2016) (Order Granting an Extension to Limited Exemption From Rule 612(c) of Regulation NMS in Connection With the Exchange's Retail Price Improvement Program); 78180 (June 28, 2016), 81 FR 43306 (July 1, 2016) (SR-BYX-2016-15) (Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Extend the Pilot Period for the RPI); 78178 (July 5, 2016), 81 FR 43689 (July 5, 2016) (Order Granting an Extension to Limited Exemption From Rule 612(c) of Regulation NMS in Connection With the Exchange's Retail Price Improvement Program); 81368 (August 10, 2017), 82 FR 38960 (August 16, 2017) (SR-BatsBYX-2017-18) (Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Extend the Pilot Period for the RPI); 81364 (August 8, 2018), 82 FR 38733 (August 15, 2017) (Order Granting an Extension to Limited Exemption From Rule 612(c) of Regulation NMS in Connection With the Exchange's Retail Price Improvement Program).

    The Exchange now seeks to extend the exemption until December 31, 2018.4 The Exchange's request was made in conjunction with an immediately effective filing that extends the operation of the Program until December 31, 2018.5 In its request to extend the exemption, the Exchange notes that the Program was implemented gradually over time. Accordingly, the Exchange has asked for additional time to allow itself and the Commission to analyze data concerning the Program, which the Exchange committed to provide to the Commission, as well as to allow additional opportunities for greater participation in the Program.6 For this reason and the reasons stated in the Order originally granting the limited exemption, the Commission finds that extending the exemption, pursuant to its authority under Rule 612(c) of Regulation NMS, is appropriate in the public interest and consistent with the protection of investors.

    4See letter from Anders Franzon, Senior Vice President and Associate General Counsel, Cboe BYX, to Brent J. Fields, Secretary, Commission, dated July 30, 2018.

    5See SR-CboeBYX-2018-015.

    6See RPI Approval Order, supra note 2, at 77 FR at 71657.

    THEREFORE, IT IS HEREBY ORDERED, that, pursuant to Rule 612(c) of Regulation NMS, the Exchange is granted a limited exemption from Rule 612(c) of Regulation NMS that allows it to accept and rank orders priced equal to or greater than $1.00 per share in increments of $0.001, in connection with the operation of its RPI Program.

    The limited and temporary exemption extended by this Order is subject to modification or revocation if at any time the Commission determines that such action is necessary or appropriate in furtherance of the purposes of the Securities Exchange Act of 1934. Responsibility for compliance with any applicable provisions of the federal securities laws must rest with the persons relying on the exemptions that are the subject of this Order.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.7

    7 17 CFR 200.30-3(a)(83).

    Brent J. Fields, Secretary.
    [FR Doc. 2018-16798 Filed 8-6-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-83757] Order Granting Applications by Nasdaq BX, Inc., Nasdaq GEMX, LLC, Nasdaq ISE, LLC, Nasdaq MRX, LLC, and Nasdaq PHLX LLC for Exemption Pursuant to Section 36(a) of the Exchange Act From the Rule Filing Requirements of Section 19(b) of the Exchange Act With Respect to Certain CAT Rules Incorporated by Reference August 1, 2018.

    Nasdaq BX, Inc. (“BX”), Nasdaq GEMX, LLC (“GEMX”), Nasdaq ISE, LLC (“ISE”), Nasdaq MRX, LLC (“MRX”), and Nasdaq PHLX LLC (“Phlx”) (each the “Exchange” and collectively, the “Exchanges”) have filed with the Securities and Exchange Commission (the “Commission”) an application for an exemption from the rule filing requirements of Section 19(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) 1 with respect to certain rules of The Nasdaq Stock Market LLC (the “Nasdaq Market”) that the Exchanges seek to incorporate by reference. Section 36(a)(1) of the Exchange Act,2 subject to certain limitations, authorizes the Commission to conditionally or unconditionally exempt any person, security, or transaction, or any class thereof, from any provision of the Exchange Act or rule thereunder, if necessary or appropriate in the public interest and consistent with the protection of investors.

    1 15 U.S.C. 78s(b).

    2 15 U.S.C. 78mm(a)(1).

    The Nasdaq Market and the Exchanges are Participants in the National Market System Plan Governing the Consolidated Audit Trail (“CAT NMS Plan” or “Plan”).3 Each Participant in the CAT NMS Plan is required to enforce compliance by its members with the provisions of the Plan by adopting a Compliance Rule applicable to its members.4 In 2017, pursuant to the CAT NMS Plan, the Nasdaq Market and the Exchanges each adopted a Compliance Rule.5 On April 10, 2018, the Exchanges filed proposed rule changes with the Commission to delete each Exchange's Compliance Rule from the rulebook and instead incorporate by reference, in each respective Exchange's rulebook, the Nasdaq Market's Compliance Rule (“Nasdaq Market Compliance Rule”).6

    3See Securities Exchange Act Release No. 79318 (November 15, 2016), 81 FR 84696 (November 23, 2016) (“CAT NMS Plan Approval Order”). All capitalized terms not otherwise defined herein have the meaning ascribed to them in the CAT NMS Plan or CAT NMS Plan Approval Order.

    4Id. at 84945, 84950.

    5See Securities Exchange Act Release No. 80256, 82 FR 14526 (March 21, 2017) (order approving the Compliance Rules for the Nasdaq Market and the Exchanges). On January 29, 2018, the Nasdaq Market filed a proposed rule change with the Commission to relocate the Nasdaq Market Compliance Rule to a new section General 7 in its rulebook. See Securities Exchange Act Release No. 82604 (January 30, 2018), 83 FR 5154 (February 5, 2018) (SR-NASDAQ-2018-007).

    6See Securities Exchange Act Release Nos. 83077 (April 20, 2018), 83 FR 18358 (April 26, 2018) (SR-Phlx-2018-30); 83081 (April 20, 2018), 83 FR 18371 (April 26, 2018) (SR-BX-2018-015); 83079 (April 20, 2018), 83 FR 18362 (April 26, 2018) (SR-ISE-2018-35); 83083 (April 20, 2018), 83 FR 18384 (April 26, 2018) (SR-GEMX-2018-13); and 83085 (April 20, 2018), 83 FR 18364 (April 26, 2018) (SR-MRX-2018-12). Although the proposed rule changes were filed pursuant to Section 19(b)(3)(A)(iii) of the Exchange Act, and thereby became effective upon filing with the Commission, the Exchanges stipulated in their filings that the incorporation by reference would not be operative until such time as the Commission grants this exemptive request.

    The Exchanges request, pursuant to Rule 0-12 under the Exchange Act,7 that the Commission grant the Exchanges an exemption from the rule filing requirements of Section 19(b) of the Exchange Act for changes to each Exchange's rules that are effected solely by virtue of a change to the Nasdaq Market Compliance Rule. Specifically, the Exchanges request that they be permitted to incorporate by reference changes made to the Nasdaq Market Compliance Rule that would be incorporated by reference in the Exchanges' rulebooks, without the need for each Exchange to file separately the same proposed rule changes pursuant to Section 19(b) of the Exchange Act.8 By virtue of incorporating the Nasdaq Market Compliance Rule by reference, members of each Exchange will be required to comply with the Nasdaq Market Compliance Rule as though it is fully set forth within each of the Exchanges' rulebooks.9

    7 17 CFR 240.0-12.

    8See Letter from Angela S. Dunn, Principal Associate General Counsel, Nasdaq Inc., to Brent J. Fields, Secretary, Commission, dated April 10, 2018, at 2-3.

    9Id. at 2.

    The Exchanges do not intend to incorporate by reference any trading rules. Instead, they represent that the Nasdaq Market Compliance Rule is regulatory in nature. Further, the Exchanges represent that they will, as a condition of this exemption, provide written notice to their members whenever the Nasdaq Market proposes a change to the Nasdaq Market Compliance Rule.10 Such notice will alert the members of each Exchange to the proposed rule change and give them an opportunity to comment on the proposal. The Exchanges state that they will also inform members in writing when the Commission approves any such proposed rule change.11

    10 The Exchanges also state that they will provide such notice on their websites in the same section they use to post their own proposed rule change pursuant to Rule 19b-4(l) of the Exchange Act. In addition, the Exchanges state that their website will include a link to the Nasdaq Market website where the proposed rule change would be located. Id.

    11Id.

    The Exchanges believe this exemption is appropriate because it will result in the Exchanges' rules pertaining to CAT NMS Plan compliance to remain consistent at all times, thus ensuring consistent regulation of joint members of the Nasdaq Market and Exchanges with respect to the incorporated rules.12

    12Id.

    The Commission has issued exemptions similar to the Exchanges' request.13 In granting one such exemption in 2010, the Commission repeated a prior, 2004 Commission statement that it would consider similar future exemption requests from other self-regulatory organizations (“SROs”), provided that:

    13See, e.g., Securities Exchange Act Release Nos. 80338 (March 29, 2017), 82 FR 16464 (April 4, 2017) (order granting exemptive request from MIAX PEARL, LLC relating to rules of Miami International Securities Exchange, LLC incorporated by reference); 72650 (July 22, 2014), 79 FR 44075 (July 29, 2014) (order granting exemptive requests from NASDAQ OMX BX, Inc. and the NASDAQ Stock Market LLC relating to rules of NASDAQ OMX PHLX LLC incorporated by reference); 67256 (June 26, 2012), 77 FR 39277, 39286 (July 2, 2012) (order approving SR-BX-2012-030 and granting exemptive request relating to rules incorporated by reference by the BX Options rules); 61534 (February 18, 2010), 75 FR 8760 (February 25, 2010) (order granting BATS Exchange, Inc.'s exemptive request relating to rules incorporated by reference by the BATS Exchange Options Market rules) (“BATS Options Market Order”); and 57478 (March 12, 2008), 73 FR 14521, 14539-40 (March 18, 2008) (order approving SR-NASDAQ-2007-004 and SR-NASDAQ-2007-080, and granting exemptive request relating to rules incorporated by reference by The NASDAQ Options Market).

    • An SRO wishing to incorporate rules of another SRO by reference has submitted a written request for an order exempting it from the requirement in Section 19(b) of the Exchange Act to file proposed rule changes relating to the rules incorporated by reference, has identified the applicable originating SRO(s), together with the rules it wants to incorporate by reference, and otherwise has complied with the procedural requirements set forth in the Commission's release governing procedures for requesting exemptive orders pursuant to Rule 0-12 under the Exchange Act; 14

    14See 17 CFR 240.0-12 and Securities Exchange Act Release No. 39624 (February 5, 1998), 63 FR 8101 (February 18, 1998) (“Commission Procedures for Filing Applications for Orders for Exemptive Relief Pursuant to Section 36 of the Exchange Act; Final Rule”).

    • The incorporating SRO has requested incorporation of categories of rules (rather than individual rules within a category) that are not trading rules (e.g., the SRO has requested incorporation of rules such as margin, suitability, or arbitration); and

    • The incorporating SRO has reasonable procedures in place to provide written notice to its members each time a change is proposed to the incorporated rules of another SRO.15

    15See BATS Options Market Order, supra note 13 (citing Securities Exchange Act Release No. 49260 (February 17, 2004), 69 FR 8500 (February 24, 2004) (order granting exemptive request relating to rules incorporated by reference by several SROs) (“2004 Order”)).

    The Commission believes that the Exchanges have satisfied each of these conditions. Further, the Commission also believes that granting the Exchanges an exemption from the rule filing requirements under Section 19(b) of the Exchange Act will promote efficient use of the Commission's and the Exchanges' resources by avoiding duplicative rule filings based on simultaneous changes to identical rule text sought by more than one SRO.16 The Commission therefore finds it appropriate in the public interest and consistent with the protection of investors to exempt the Exchanges from the rule filing requirements under Section 19(b) of the Exchange Act with respect to the above-described rules they incorporate by reference. This exemption is conditioned upon the Exchanges promptly providing written notice to their members whenever the Nasdaq Market changes a rule that the Exchanges have incorporated by reference.

    16See BATS Options Market Order, supra note 13, 75 FR at 8761; see also 2004 Order, supra note 15, 69 FR at 8502.

    Accordingly, it is ordered, pursuant to Section 36 of the Exchange Act,17 that the Exchanges are exempt from the rule filing requirements of Section 19(b) of the Exchange Act solely with respect to changes to the rules identified in its request that incorporate by reference certain Nasdaq Market rules that are the result of changes to such Nasdaq Market rules, provided that the Exchanges promptly provide written notice to their members whenever the Nasdaq Market proposes to change a rule that the Exchanges have incorporated by reference.

    17 15 U.S.C. 78mm.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.18

    18 17 CFR 200.30-3(a)(76).

    Brent J. Fields, Secretary.
    [FR Doc. 2018-16799 Filed 8-6-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-83762; File No. SR-OCC-2017-810] Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Partial Amendments No. 1, 2, and 3 to Advance Notice Concerning Updates to and Formalization of OCC's Recovery and Orderly Wind-Down Plan August 1, 2018. I. Introduction

    Pursuant to Section 806(e)(1) of Title VIII of the Dodd-Frank Wall Street Reform and Consumer Protection Act, entitled Payment, Clearing, and Settlement Supervision Act of 2010 (“Clearing Supervision Act”) 1 and Rule 19b-4(n)(1)(i) 2 under the Securities Exchange Act of 1934 (“Act”),3 The Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”) an advance notice pursuant to which OCC would formalize and update its Recovery and Orderly Wind-Down Plan (“RWD Plan” or “Plan”), consistent with the applicable requirement in Rule 17Ad-22(e)(3)(ii) 4 (“Advance Notice”). The Advance Notice was published for public comment in the Federal Register on January 23, 2018.5 On January 23, 2018, the Commission requested OCC provide it with additional information regarding the Advance Notice.6 OCC responded to this request for information, and the information was received on July 13, 2018.7 On July 11 and 12, 2018, OCC filed Partial Amendment No. 1 and Partial Amendment No. 2 to the Initial Filing. On July 12, 2018, OCC also filed a partial amendment (“Partial Amendment No. 3”) to the Initial Filing. This Partial Amendment No. 3 is intended to supersede and replace Amendments No. 1 and 2 in their entirety.8 Therefore, the Initial Filing together with Partial Amendment No. 3 reflects the changes being proposed.

    1 12 U.S.C. 5465(e)(1).

    2 17 CFR 240.19b-4(n)(1)(i).

    3 15 U.S.C. 78a et seq.

    4 17 CFR 240.17Ad-22(e)(3)(ii).

    5See Securities Exchange Act Release No. 82514 (January 17, 2018), 83 FR 3224 (January 23, 2018) (SR-OCC-2017-810) (hereinafter referred to as the “Initial Filing”). Initial Filing, 83 FR 3224.

    6See Memorandum from Office of Clearance and Settlement, Division of Trading and Markets, dated January 23, 2018, available at https://www.sec.gov/comments/sr-occ-2017-810/occ2017810-2948228-161854.pdf.

    7See Memorandum from Office of Clearance and Settlement, Division of Trading and Markets, dated July 17, 2018, available at https://www.sec.gov/comments/sr-occ-2017-810/occ2017810-4062513-169149.pdf.

    8 This Partial Amendment No. 3 is substantially the same as Partial Amendments No. 1 and 2 but would correct certain technical errors in the previous amendments (e.g., update a cross-reference to OCC filing SR-OCC-2017-809, as now amended by Amendment No. 2, and correct a pagination error in Exhibits 4 and 5). Substantive changes to the Initial Filing, as reflected in Partial Amendment No. 3, are described in Item II below.

    The Advance Notice, as amended by Partial Amendment No. 3 is described in Item II below, which Item has been prepared by OCC. The Commission is publishing this notice to solicit comments on the Advance Notice, as amended by Partial Amendments No. 1, 2 and 3, from interested persons.

    II. Clearing Agency's Statement of the Terms of Substance of Partial Amendment No. 3 to the Advance Notice

    This Partial Amendment No. 3 would make the following three amendments to the Initial Filing: (1) Removal of sections of the RWD Plan concerning OCC's proposed authority to require cash settlement of certain physically delivered options and single stock futures; (2) updating the list of OCC's Critical Support Functions; 9 and (3) making three changes to Chapter 5 of the RWD Plan in order to conform to a change contemporaneously proposed in Amendment No. 2 to OCC advance notice filing SR-OCC-2017-809 concerning enhanced and new tools for recovery scenarios.10

    9 The amendment to the list of Critical Support Functions would be made to the confidential and redacted portions of the RWD Plan.

    10See Amendment No. 2 to SR-OCC-2017-809. The three amendments to Chapter 5 also would be made to the confidential and redacted portions of the RWD Plan.

    With regard to the removal of sections of the RWD Plan concerning OCC's proposed authority to require cash settlement of certain physically delivered options and single stock futures, OCC proposes to amend the following text on pages 16-17 and 55 of the Initial Filing (new text is underlined and proposed deletions are marked in strikethrough text).

    EN07AU18.002

    OCC also proposes to amend the following text on pages 22-23 and 61-62 of the Initial Filing (including associated footnotes).

    EN07AU18.003

    OCC plans to resubmit the proposed cash settlement tool previously filed in SR-OCC-2017-018 and SR-OCC-2017-807 on a separate timeline from the rest of its enhanced and new tools for recovery scenarios and would submit a subsequent filing to the Commission to amend the RWD Plan at that time.

    In addition, OCC proposes to make the following amendments on pages 32 and 71 of the Initial Filing.

    EN07AU18.024

    With regard to updating the list of OCC's Critical Support Functions, the amendment would revise OCC's RWD Plan to consistently identify one of OCC's internal functions as a Critical Support Function.

    Finally, OCC proposes to make two changes to Chapter 5 of the RWD Plan, which would align an exhibit, a related list and a related paragraph with the certain changes OCC is contemporaneously proposing in Amendment No. 2 to OCC advance notice filing SR-OCC-2017-809 concerning enhanced and new tools for recovery scenarios.11 Specifically, OCC would change the aforementioned exhibit, list and paragraph in Chapter 5 to recognize that while OCC does not intend, in the first instance for its tear-up process to serve as a means of loss allocation, circumstances may arise such that, despite best efforts, OCC has inadequate remaining financial resources to extinguish torn-up positions at their assigned Tear-Up Price without forcing a reduction in the amount of unpaid value of such positions (e.g., despite best efforts, market movements not accounted for by monitoring, additional Clearing Member defaults occur immediately preceding a tear-up). In such circumstances, despite best efforts, OCC would use its partial tear-up process as a means of loss allocation.

    11See Amendment No. 2 to SR-OCC-2017-809.

    OCC has included an updated Exhibit 5 containing its RWD Plan as well as an Exhibit 4 showing the changes proposed in this Partial Amendment No. 3 to the proposed rule text in the Initial Filing, with the proposed changes in the Initial Filing marked in underlined and strikethrough text. Exhibits 4 and 5 have been redacted and filed separately with the Commission and confidential treatment for Exhibits 4 and 5 is requested pursuant to 17 CFR 240.24b-2.

    The Partial Amendments No. 1, 2 and 3 would not change the purpose of or basis for the proposed changes. All other representations in the Initial Filing remain as stated therein and no other changes are being made.

    III. Date of Effectiveness of the Advance Notice and Timing for Commission Action

    The proposed change may be implemented if the Commission does not object to the proposed change within 60 days of the later of (i) the date the proposed change was filed with the Commission or (ii) the date any additional information requested by the Commission is received. OCC shall not implement the proposed change if the Commission has any objection to the proposed change.

    The Commission may extend the period for review by an additional 60 days if the proposed change raises novel or complex issues, subject to the Commission providing the clearing agency with prompt written notice of the extension. A proposed change may be implemented in less than 60 days from the date the advance notice is filed, or the date further information requested by the Commission is received, if the Commission notifies the clearing agency in writing that it does not object to the proposed change and authorizes the clearing agency to implement the proposed change on an earlier date, subject to any conditions imposed by the Commission.

    OCC shall post notice on its website of proposed changes that are implemented. The proposal shall not take effect until all regulatory actions required with respect to the proposal are completed.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the advance notice is consistent with the Clearing Supervision Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commissions internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected]. Please include File Number SR-OCC-2017-810 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Brent Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

    All submissions should refer to File Number SR-OCC-2017-810. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the advance notice that are filed with the Commission, and all written communications relating to the advance notice between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be available for inspection and copying at the principal office of OCC and on OCC's website at http://www.theocc.com/about/publications/bylaws.jsp.

    All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal or identifying information from comment submissions. You should submit only information that you wish to make available publicly.

    All submissions should refer to File Number SR-OCC-2017-810 and should be submitted on or before August 22, 2018.

    By the Commission.

    Brent J. Fields, Secretary.
    [FR Doc. 2018-16823 Filed 8-6-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-83759; File No. SR-NYSEArca-2018-54] Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To Amend Commentary .01 to NYSE Arca Rule 8.600-E Relating to Certain Generic Listing Standards for Managed Fund Shares August 1, 2018.

    Pursuant to Section 19(b)(1) 1 of the Securities Exchange Act of 1934 (“Act”) 2 and Rule 19b-4 thereunder,3 notice is hereby given that, on July 18, 2018, NYSE Arca, Inc. (“Exchange” or “NYSE Arca”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the self-regulatory organization. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 15 U.S.C. 78a.

    3 17 CFR 240.19b-4.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange proposes to amend Commentary .01 to NYSE Arca Rule 8.600-E relating to certain generic listing standards for Managed Fund Shares. The proposed change is available on the Exchange's website at www.nyse.com, at the principal office of the Exchange, and at the Commission's Public Reference Room.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and the Statutory Basis for, the Proposed Rule Change 1. Purpose

    Commentary .01 to NYSE Arca Rule 8.600-E sets forth generic listing standards for listing and trading of Managed Fund Shares on the Exchange.4 The Exchange proposes to amend certain provisions in Commentary .01, as described below.5

    4 A Managed Fund Share is a security that represents an interest in an investment company registered under the Investment Company Act of 1940 (15 U.S.C. 80a-1) (the “1940 Act”) organized as an open-end investment company or similar entity that invests in a portfolio of securities selected by its investment adviser consistent with its investment objectives and policies. In contrast, an open-end investment company that issues Investment Company Units, listed and traded on the Exchange under NYSE Arca Rule 5.2-E(j)(3), seeks to provide investment results that correspond generally to the price and yield performance of a specific foreign or domestic stock index, fixed income securities index or combination thereof.

    5 The Commission approved the generic listing standards in Commentary .01 to NYSE Arca Rule 8.600-E in Securities Exchange Act Release No. 78397 (July 22, 2016), 81 FR 49320 (July 27, 2016) (SR-NYSEArca-2015-110) (Order Granting Approval of Proposed Rule Change, as Modified by Amendment No. 7 Thereto, Amending NYSE Arca Equities Rule 8.600 to Adopt Generic Listing Standards for Managed Fund Shares) (“Approval Order”).

    Proposed Amendments to Commentary .01(a) to Rule 8.600-E

    Commentary .01(a) to NYSE Arca Rule 8.600-E sets forth generic standards applicable to equity securities included in the portfolio of a series of Managed Fund Shares.6 Commentary .01(a)(2) (“Non-U.S. Component Stocks”) sets forth criteria to be met initially and on a continuing basis by component stocks of the equity portion of a portfolio that are Non-U.S. Component Stocks.7

    6 For purposes of Commentary .01(a) to Rule 8.600-E, equity securities include the following: U.S. Component Stocks (as described in Rule 5.2-E(j)(3)); Non-U.S. Component Stocks (as described in Rule 5.2-E(j)(3)); Derivative Securities Products (i.e., Investment Company Units and securities described in Section 2 of Rule 8-E); and Index-Linked Securities that qualify for Exchange listing and trading under Rule 5.2-E(j)(6).

    7 NYSE Arca Rule 5.2-E(j)(3) provides that the term “Non-US Component Stock” shall mean an equity security that is not registered under Sections 12(b) or 12(g) of the Securities Exchange Act of 1934 and that is issued by an entity that (a) is not organized, domiciled or incorporated in the United States, and (b) is an operating company (including Real Estate Investment Trusts (REITS) and income trusts, but excluding investment trusts, unit trusts, mutual funds, and derivatives).

    Commentary .01(a)(2)(A) provides that Non-U.S. Component Stocks each shall have a minimum market value of at least $100 million. Commentary .01(a)(2)(B) provides that Non-U.S. Component Stocks each shall have a minimum global monthly trading volume of 250,000 shares, or minimum global notional volume traded per month of $25,000,000, averaged over the last six months.

    The Exchange proposes to amend Commentary .01(a)(2)(A) to provide that Non-U.S. Component Stocks that in the aggregate account for at least 90% of the weight of the Non-U.S. Component Stocks of the equity portion of a portfolio each shall have a minimum market value of at least $100 million. In addition, the Exchange proposes to amend Commentary .01(a)(2)(B) to provide that Non-U.S. Component Stocks that in the aggregate account for at least 70% of the weight of the Non-U.S. Component Stocks of the equity portion of a portfolio each shall have a minimum global monthly trading volume of 250,000 shares, or minimum global notional volume traded per month of $25,000,000, averaged over the last six months.

    The proposed amendments are comparable to the current numerical requirements in Commentary .01(a)(B)(1) and Commentary .01(a)(B)(2) to NYSE Arca Rule 5.2-E(j)(3) applicable to component stocks in an index or portfolio underlying Investment Company Units. The Exchange notes that, in originally approving the generic listing criteria in Commentary .01(a)(B) to NYSE Arca Rule 5.2-E(j)(3) applicable to indexes that include only non-U.S. Component Stocks or both U.S. and Non-U.S. Component Stocks in an index or portfolio underlying a series of Investment Company Units, the Commission stated that “[t]hese requirements are designed, among other things, to require that components of an index or portfolio underlying an ETF are adequately capitalized and sufficiently liquid, and that no one stock dominates the index.” 8

    8See Securities Exchange Act Release No. 55621 (April 12, 2007), 72 FR 19571 (April 18, 2007) (SR-NYSEArca-2006-86) (Notice of Filing of Proposed Rule Change and Amendments No. 1, 2, 3, and 4 Thereto and Order Granting Accelerated Approval of the Proposed Rule Change as Modified by Amendments No. 2 and 4 Thereto Adopting Generic Listing Standards for Exchange-Traded Funds Based on International or Global Indexes or Indexes Described in Exchange Rules Previously Approved by the Commission as Underlying Benchmarks for Derivative Securities). See also Securities Exchange Act Release Nos. 54739 (November 9, 2006), 71 FR 61811 [sic] (October 19 [sic], 2006) (SR-Amex-2006-78) (Order Granting Accelerated Approval to Proposed Rule Change and Amendment No. 1 Thereto and Notice of Filing and Order Granting Accelerated Approval to Amendment No. 2 Thereto Relating to Generic Listing Standards for Series of Portfolio Depositary Receipts and Index Fund Shares Based on International or Global Indexes); 55113 (January 17, 2007), 72 FR 3179 (January 24, 2007) (SR-NYSE-2006-101) (Notice of Filing and Order Granting Accelerated Approval of a Proposed Rule Change as Modified by Amendments No. 1 and 2 Thereto Adopting Generic Listing Standards for Exchange-Traded Funds Based on International or Global Indexes or Indexes Previously Approved by the Commission as Underlying Benchmarks for Derivative Securities).

    Like the requirements applicable to an index or portfolio underlying Investment Company Units noted above, the proposed amendments to Commentary .01(a)(2)(A) and (B) would subject a substantial portion of a fund's holdings in Non-U.S. Component Stocks to specified minimum liquidity and market value requirements. Such holdings also will continue to be subject to the weighting and diversification requirements of Commentary .01(a)(2)(C) and (D), which prevent any stock or small group of stocks from dominating a fund's portfolio.9 The proposed amendments to Commentary .01(a)(2) to Rule 8.600-E would provide additional flexibility to series of Managed Fund Shares investing in Non-U.S. Component Stocks while continuing to apply substantial minimum criteria relating to liquidity, market capitalization and diversification.

    9 Commentary .01(a)(2)(C) provides that the most heavily weighted Non-U.S. Component stock shall not exceed 25% of the equity weight of the portfolio, and, to the extent applicable, the five most heavily weighted Non-U.S. Component Stocks shall not exceed 60% of the equity weight of the portfolio.

    Commentary .01(a)(2)(D) provides that, where the equity portion of the portfolio includes Non-U.S. Component Stocks, the equity portion of the portfolio shall include a minimum of 20 component stocks; provided, however, that there shall be no minimum number of component stocks if (i) one or more series of Derivative Securities Products or Index-Linked Securities constitute, at least in part, components underlying a series of Managed Fund Shares, or (ii) one or more series of Derivative Securities Products or Index-Linked Securities account for 100% of the equity weight of the portfolio of a series of Managed Fund Shares.

    Proposed Amendment to Commentary .01(b)(5) to Rule 8.600-E

    Commentary .01(b) to NYSE Arca Rule 8.600-E sets forth generic standards applicable to fixed income securities included in the portfolio of a series of Managed Fund Shares.10 Commentary .01(b)(5) provides that non-agency, non- GSE and privately-issued mortgage-related and other asset-backed securities (“ABS”) components of a portfolio shall not account, in the aggregate, for more than 20% of the weight of the fixed income portion of the portfolio. The Exchange proposes to amend Commentary .01(b)(5) by deleting the words “fixed income portion” to provide that such 20% limitation would apply to the entire portfolio rather than to only the fixed income portion of the portfolio. Thus, Commentary .01(b)(5) would provide that non-agency, non-GSE and privately-issued mortgage-related and other ABS components of a portfolio shall not account, in the aggregate, for more than 20% of the weight of the portfolio.

    10 Commentary .01(b) provides that fixed income securities are debt securities that are notes, bonds, debentures or evidence of indebtedness that include, but are not limited to, U.S. Department of Treasury securities (“Treasury Securities”), government-sponsored entity securities (“GSE Securities”), municipal securities, trust preferred securities, supranational debt and debt of a foreign country or a subdivision thereof, investment grade and high yield corporate debt, bank loans, mortgage and asset backed securities, and commercial paper.

    This Exchange believes this amendment is appropriate because a fund's investment in non-agency, non-GSE and privately-issued mortgage-related and other ABS may provide a fund with benefits associated with increased diversification, as such investments may be less correlated to interest rates than many other fixed income securities. In addition, a fund's investment in non-agency, non-GSE and privately-issued mortgage-related and other ABS will be subject to a fund's liquidity procedures as adopted by a fund's board of directors. The Exchange notes that the Commission has previously approved the listing of actively managed exchange-traded funds that can invest 20% of their total assets in non-U.S. Government, non-agency, non-GSE and other privately issued asset-backed and mortgage-backed securities (“MBS”).11 In addition, the Commission has previously approved listing and trading of shares of an issue of Managed Fund Shares where such fund's investments in non-U.S. Government, non-agency, non-GSE and other privately issued ABS will, in the aggregate, not exceed more than 20% of the total assets of the fund, rather than the weight of the fixed income portion of the fund's portfolio.12 Therefore, the Exchange believes it is appropriate to apply the 20% limitation to a fund's investment in non-agency, non-GSE and privately-issued mortgage-related and other asset-backed securities components of a portfolio in Commentary .01(b)(5) to a fund's total assets.

    11See, e.g., Securities Exchange Act Release Nos. 80946 (June 15, 2017) 82 FR 28126 (June 20, 2017) (SR-NASDAQ-2017-039) (permitting the Guggenheim Limited Duration ETF to invest up to 20% of its total assets in privately-issued, non-agency and non-GSE ABS and MBS); 76412 (November 10, 2015), 80 FR 71880 (November 17, 2015) (SR-NYSEArca-2015-111) (permitting the RiverFront Strategic Income Fund to invest up to 20% of its assets in privately-issued, non-agency and non-GSE ABS and MBS); 74814 (April 27, 2015), 80 FR 24986 (May 1, 2015) (SR-NYSEArca-2014-017 [sic]) (permitting the Guggenheim Enhanced Short Duration ETF to invest up to 20% of its assets in privately-issued, non-agency and non-GSE ABS and MBS); 74109 (January 21, 2015), 80 FR 4327 (January 27, 2015) (SR-NYSEArca-2014-134) (permitting the IQ Wilshire Alternative Strategies ETF to invest up to 20% of its total assets in MSB [sic] and other ABS, without any limit on the type of such MBS and ABS).

    12See Securities Exchange Act Release No. 83319 (May 24, 2018) (SR-NYSEArca-2018-15) (Order Approving a Proposed Rule Change, as Modified by Amendment No. 1 Thereto, to Continue Listing and Trading Shares of the PGIM Ultra Short Bond ETF Under NYSE Arca Rule 8.600-E).

    Proposed Amendment to Commentary .01(a)(3) to Rule 8.600-E

    The Exchange further proposes to add new Commentary .01(a)(3) to NYSE Arca Rule 8.600-E to provide that the portfolio of a series of Managed Fund Shares may include non-exchange-traded open-end management investment company securities, which securities shall be excluded from the equity portion of the portfolio for purposes of meeting the criteria in Commentary .01(a)(1).

    A fund's investment in such securities, which are registered under the 1940 Act, may be utilized, for example, to obtain income on short-term cash balances while awaiting attractive investment opportunities, to provide liquidity in preparation for anticipated redemptions or for defensive purposes.13 Such investments may include mutual funds that invest principally in securities and financial instruments that help the Fund meet its investment objective and/or to equitize cash in the short term.14 Because such securities must satisfy applicable 1940 Act diversification requirements, and have a net asset value based on the value of securities and financial instruments the investment company holds, it is both unnecessary and inappropriate to apply to such investment company securities the criteria in Commentary .01(a)(1).

    13 For purposes of Commentary .01(a)(3), non-exchange-traded open-end management investment company securities do not include money market funds, which are cash equivalents under Commentary .01(c) to Rule 8.600-E and for which there is no limitation in the percentage of the portfolio invested in such securities.

    14 The Commission has previously approved proposed rule changes under Section 19(b) of the Act for series of Managed Fund Shares that may invest in non-exchange traded investment company securities to the extent permitted by Section 12(d)(1) of the 1940 Act and the rules thereunder. See, e.g., Securities Exchange Act Release No. 78414 (July 26, 2016), 81 FR 50576 (August 1, 2016) (SR-NYSEArca-2016-79) (order approving listing and trading of shares of the Virtus Japan Alpha ETF under NYSE Arca Rule 8.600-E).

    The Exchange notes that Commentary .01(a)(1)(A) through (D) to Rule 8.600-E exclude certain “Derivative Securities Products” that are exchange-traded investment company securities, including Investment Company Units (as described in NYSE Arca Rule 5.2-E(j)(3)), Portfolio Depositary Receipts (as described in NYSE Arca Rule 8.100-E)) and Managed Fund Shares (as described in NYSE Arca Rule 8.600-E)).15 In its 2008 Approval Order approving amendments to Commentary .01(a) to Rule 5.2(j)(3) to exclude Derivative Securities Products from certain provisions of Commentary .01(a) (which exclusions are similar to those in Commentary .01(a)(1) to Rule 8.600-E), the Commission stated that “based on the trading characteristics of Derivative Securities Products, it may be difficult for component Derivative Securities Products to satisfy certain quantitative index criteria, such as the minimum market value and trading volume limitations.” The Exchange notes that it would be difficult or impossible to apply to mutual fund shares certain of the generic quantitative criteria (e.g., market capitalization, trading volume, or portfolio criteria) in Commentary .01 (A) through (D) applicable to U.S. Component Stocks. For example, the requirements for U.S. Component Stocks in Commentary .01(a)(1)(B) that there be minimum monthly trading volume of 250,000 shares, or minimum notional volume traded per month of $25,000,000, averaged over the last six months are tailored to exchange-traded securities (i.e., U.S. Component Stocks) and not to mutual fund shares, which do not trade in the secondary market and for which no such volume information is reported. In addition, Commentary .01(a)(1)(A) relating to minimum market value of portfolio component stocks, Commentary .01(a)(1)(C) relating to weighting of portfolio component stocks, and Commentary .01(a)(1)(D) relating to minimum number of portfolio components are not appropriately applied to open-end management investment company securities; open-end investment companies hold multiple individual securities as disclosed publicly in accordance with the 1940 Act.

    15 The Commission initially approved the Exchange's proposed rule change to exclude “Derivative Securities Products” (i.e., Investment Company Units and securities described in Section 2 of Rule 8) and “Index-Linked Securities (as described in Rule 5.2-E(j)(6)) from Commentary .01(a)(A) (1) through (4) to Rule 5.2-E(j)(3) in Securities Exchange Act Release No. 57751 (May 1, 2008), 73 FR 25818 (May 7, 2008) (SR-NYSEArca-2008-29) (Order Granting Approval of a Proposed Rule Change, as Modified by Amendment No. 1 Thereto, to Amend the Eligibility Criteria for Components of an Index Underlying Investment Company Units)(“2008 Approval Order”). See also Securities Exchange Act Release No. 57561 (March 26, 2008), 73 FR 17390 (April 1, 2008) (Notice of Filing of Proposed Rule Change and Amendment No. 1 Thereto to Amend the Eligibility Criteria for Components of an Index Underlying Investment Company Units). The Commission subsequently approved generic criteria applicable to listing and trading of Managed Fund Shares, including exclusions for Derivative Securities Products and Index-Linked Securities in Commentary .01(a)(1)(A) through (D), in Securities Exchange Act Release No. 78397 (July 22, 2016), 81 FR 49320 (July 27, 2016) (Order Granting Approval of Proposed Rule Change, as Modified by Amendment No. 7 Thereto, Amending NYSE Arca Rule 8.600-E To Adopt Generic Listing Standards for Managed Fund Shares). See also Amendment No. 7 to SR-NYSEArca-2015-110, available at https://www.sec.gov/comments/sr-nysearca-2015-110/nysearca2015110-9.pdf.

    The Exchange notes that the Commission has previously approved listing and trading of an issue of Managed Fund Shares that may invest in equity securities that are non-exchange-traded securities of other open-end investment company securities notwithstanding that the fund would not meet the requirements of Commentary .01(a)(1)(A) through (E) to Rule 8.600-E with respect to such fund's investments in such securities.16

    16See note 12, supra.

    The Exchange, therefore, believes it is appropriate to exclude non-exchange-traded open-end management investment company securities from the equity portion of the portfolio for purposes of meeting the criteria in Commentary .01(a)(1).

    The Exchange believes the proposed amendments would provide issuers of Managed Fund Shares with additional investment choices for fund portfolios for issues permitted to list and trade on the Exchange pursuant to the Rule 19b-4(e), which would enhance competition among market participants, to the benefit of investors and the marketplace.

    2. Statutory Basis

    The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,17 in general, and furthers the objectives of Sections [sic] 6(b)(5) of the Act,18 in particular, because it is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to, and perfect the mechanisms of, a free and open market and a national market system and, in general, to protect investors and the public interest and because it is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers

    17 15 U.S.C. 78f(b).

    18 15 U.S.C. 78f(b)(5).

    The Exchange has in place surveillance procedures that are adequate to properly monitor trading in series of Managed Fund Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws. The Exchange notes that the Exchange or Financial Industry Regulatory Authority (“FINRA”), on behalf of the Exchange, or both, would communicate as needed regarding trading in Managed Fund Shares with other markets and other entities that are members of the Intermarket Surveillance Group, and the Exchange or FINRA, on behalf of the Exchange, or both, could obtain trading information regarding trading in Managed Fund Shares from such markets and other entities. In addition, the Exchange could obtain information regarding trading in Managed Fund Shares from markets and other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement.

    With respect to the proposed amendment to Commentary .01(a)(2), the proposed amendments are comparable to the current numerical requirements in Commentary .01(a)(B)(1) and Commentary .01(a)(B)(2) to NYSE Arca Rule 5.2-E(j)(3) applicable to component stocks in an index or portfolio underlying Investment Company Units. The Exchange notes that, in originally approving the generic listing criteria in Commentary .01(a)(B) to NYSE Arca Rule 5.2-E(j)(3) applicable to indexes that include only non-U.S. Component Stocks or both U.S. and Non-U.S. Component Stocks in an index or portfolio underlying a series of Investment Company Units, the Commission stated that “[t]hese requirements are designed, among other things, to require that components of an index or portfolio underlying an ETF are adequately capitalized and sufficiently liquid, and that no one stock dominates the index.” 19

    19See note 8, supra.

    Like the requirements applicable to an index or portfolio underlying Investment Company Units noted above, the proposed amendments to Commentary .01(a)(2)(A) and (B) would subject a substantial portion of a fund's holdings in Non-U.S. Component Stocks to specified minimum liquidity and market value requirements. Such holdings also will continue to be subject to the weighting and diversification requirements of Commentary .01(a)(2)(C) and (D), which prevent any stock or small group of stocks from dominating a fund's portfolio. The proposed amendments to Commentary .01(a)(2) to Rule 8.600-E would provide additional flexibility to series of Managed Fund Shares investing in Non-U.S. Component Stocks while continuing to apply substantial minimum criteria relating to liquidity, market capitalization and diversification.

    With respect to the proposed amendment to Commentary .01(b)(5), the Exchange believes this amendment is appropriate because a fund's investment in non-agency, non-GSE and privately-issued mortgage-related and other ABS may provide a fund with benefits associated with increased diversification, as such investments may be less correlated to interest rates than many other fixed income securities. In addition, a fund's investment in non-agency, non-GSE and privately-issued mortgage-related and other ABS will be subject to a fund's liquidity procedures as adopted by a fund's board of directors.

    The Exchange notes that the Commission has previously approved the listing of actively managed exchange-traded funds that can invest 20% of their total assets in non-U.S. Government, non-agency, non-GSE and other privately issued asset-backed and MBS. In addition, the Commission has previously approved listing and trading of shares of an issue of Managed Fund Shares where such fund's investments in non-U.S. Government, non-agency, non-GSE and other privately issued ABS will, in the aggregate, not exceed more than 20% of the total assets of the fund, rather than the weight of the fixed income portion of the fund's portfolio.20 Therefore, the Exchange believes it is appropriate to apply the 20% limitation to a fund's investment in non-agency, non-GSE and privately-issued mortgage-related and other asset-backed securities components of a portfolio in Commentary .01(b)(5) to a fund's total assets.

    20See note 11 [sic], supra.

    The Exchange further proposes to add new Commentary .01(a)(3) to NYSE Arca Rule 8.600-E to provide that the equity portion of a portfolio may include non-exchange-traded open-end management investment company securities, which securities shall be excluded from the equity portion of the portfolio for purposes of meeting the criteria in Commentary .01(a)(1). A fund's investment in such securities may be utilized, for example, to obtain income on short-term cash balances while awaiting attractive investment opportunities, to provide liquidity in preparation for anticipated redemptions or for defensive purposes. Such investments may include mutual funds that invest principally in securities and financial instruments that help the Fund meet its investment objective and/or to equitize cash in the short term. Because such securities must satisfy applicable 1940 Act diversification requirements, and have a net asset value based on the value of securities and financial instruments the investment company holds, it is both unnecessary and inappropriate to apply to such investment company securities the criteria in Commentary .01(a)(1). For the same reasons, such investment company securities are appropriately excluded from the equity portion of the portfolio for purposes of meeting the criteria in Commentary .01(a)(1).

    The Exchange notes that Commentary .01(a)(1)(A) through (D) to Rule 8.600-E exclude certain “Derivative Securities Products” that are exchange-traded investment company securities, including Investment Company Units (as described in NYSE Arca Rule 5.2-E(j)(3)), Portfolio Depositary Receipts (as described in NYSE Arca Rule 8.100-E)) and Managed Fund Shares (as described in NYSE Arca Rule 8.600-E)). In its 2008 Approval Order approving amendments to Commentary .01(a) to Rule 5.2(j)(3) to exclude Derivative Securities Products from certain provisions of Commentary .01(a) (which exclusions are similar to those in Commentary .01(a)(1) to Rule 8.600-E), the Commission stated that “based on the trading characteristics of Derivative Securities Products, it may be difficult for component Derivative Securities Products to satisfy certain quantitative index criteria, such as the minimum market value and trading volume limitations.” The Exchange notes that it would be difficult or impossible to apply to mutual fund shares certain of the generic quantitative criteria (e.g., market capitalization, trading volume, or portfolio criteria) in Commentary .01 (A) through (D) applicable to U.S. Component Stocks. For example, the requirements for U.S. Component Stocks in Commentary .01(a)(1)(B) that there be minimum monthly trading volume of 250,000 shares, or minimum notional volume traded per month of $25,000,000, averaged over the last six months are tailored to exchange-traded securities (i.e., U.S. Component Stocks) and not to mutual fund shares, which do not trade in the secondary market and for which no such volume information is reported. In addition, Commentary .01(a)(1)(A) relating to minimum market value of portfolio component stocks, Commentary .01(a)(1)(C) relating to weighting of portfolio component stocks, and Commentary .01(a)(1)(D) relating to minimum number of portfolio components are not appropriately applied to open-end management investment company securities; open-end investment companies hold multiple individual securities as disclosed publicly in accordance with the 1940 Act.

    The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of additional types of Managed Fund Shares that will enhance competition among market participants, to the benefit of investors and the marketplace.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,21 the Exchange believes that the proposed rule change would not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change would permit Exchange listing and trading under Rule 19b-4(e) of additional types of Managed Fund Shares, which would enhance competition among market participants, to the benefit of investors and the marketplace.

    21 15 U.S.C. 78f(b)(8).

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the proposed rule change.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    Within 45 days of the date of publication of this notice in the Federal Register or within such longer period up to 90 days (i) as the Commission may designate if it finds such longer period to be appropriate and publishes its reasons for so finding or (ii) as to which the self-regulatory organization consents, the Commission will:

    (A) By order approve or disapprove the proposed rule change, or

    (B) institute proceedings to determine whether the proposed rule change should be disapproved.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected] Please include File Number SR-NYSEArca-2018-54 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

    All submissions should refer to File Number SR-NYSEArca-2018-54. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549 on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-NYSEArca-2018-54 and should be submitted on or before August 28, 2018.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.22

    22 17 CFR 200.30-3(a)(12).

    Robert W. Errett, Deputy Secretary.
    [FR Doc. 2018-16803 Filed 8-6-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-83758; File No. SR-CboeBYX-2018-015] Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Pilot Period for the Exchange's Retail Price Improvement Program August 1, 2018.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),1 and Rule 19b-4 thereunder,2 notice is hereby given that on July 30, 2018, Cboe BYX Exchange, Inc. (the “Exchange” or “BYX”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Exchange has designated this proposal as a “non-controversial” proposed rule change pursuant to Section 19(b)(3)(A) of the Act 3 and Rule 19b-4(f)(6)(iii) thereunder,4 which renders it effective upon filing with the Commission. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3 15 U.S.C. 78s(b)(3)(A).

    4 17 CFR 240.19b-4(f)(6)(iii).

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange filed a proposal to extend the pilot period for the Exchange's Retail Price Improvement Program, which is currently scheduled to expire on July 31, 2018, until the earlier of approval of the filing to make the Program permanent or December 31, 2018.

    The text of the proposed rule change is available at the Exchange's website at www.markets.cboe.com, at the principal office of the Exchange, and at the Commission's Public Reference Room.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The purpose of the proposed rule change is to extend the pilot period for the Exchange's Retail Price Improvement Program (the “Program”), which is set to expire on July 31, 2018, until the earlier of approval of the filing to make the Program permanent or December 31, 2018.5

    5 The Exchange has filed to make the pilot program permanent. See Cboe-BYX-2018-014 (pending publication).

    Background

    In November 2012, the Commission approved the Program on a pilot basis.6 The Program is designed to attract retail order flow to the Exchange, and allows such order flow to receive potential price improvement. The Program is currently limited to trades occurring at prices equal to or greater than $1.00 per share. Under the Program, all Exchange Users 7 are permitted to provide potential price improvement for Retail Orders 8 in the form of non-displayed interest that is better than the national best bid that is a Protected Quotation (“Protected NBB”) or the national best offer that is a Protected Quotation (“Protected NBO”, and together with the Protected NBB, the “Protected NBBO”).9

    6See Securities Exchange Act Release No. 68303 (November 27, 2012), 77 FR 71652 (December 3, 2012) (“RPI Approval Order”) (SR-BYX-2012-019).

    7 A “User” is defined in BYX Rule 1.5(cc) as any member or sponsored participant of the Exchange who is authorized to obtain access to the System.

    8 A “Retail Order” is defined in Rule 11.24(a)(2) as an agency order that originates from a natural person and is submitted to the Exchange by a RMO, provided that no change is made to the terms of the order with respect to price or side of market and the order does not originate from a trading algorithm or any computerized methodology. See Rule 11.24(a)(2).

    9 The term Protected Quotation is defined in BYX Rule 1.5(t) and has the same meaning as is set forth in Regulation NMS Rule 600(b)(58). The terms Protected NBB and Protected NBO are defined in BYX Rule 1.5(s). The Protected NBB is the best-priced protected bid and the Protected NBO is the best-priced protected offer. Generally, the Protected NBB and Protected NBO and the national best bid (“NBB”) and national best offer (“NBO”, together with the NBB, the “NBBO”) will be the same. However, a market center is not required to route to the NBB or NBO if that market center is subject to an exception under Regulation NMS Rule 611(b)(1) or if such NBB or NBO is otherwise not available for an automatic execution. In such case, the Protected NBB or Protected NBO would be the best-priced protected bid or offer to which a market center must route interest pursuant to Regulation NMS Rule 611.

    The Program was approved by the Commission on a pilot basis running one year from the date of implementation.10 The Commission approved the Program on November 27, 2012.11 The Exchange implemented the Program on January 11, 2013, and has extended the pilot period five times.12 The pilot period for the Program is set to expire on July 31, 2018. This filing seeks to extend the pilot until the earlier of approval of the filing to make the Program permanent or December 31, 2018.

    10See RPI Approval Order, supra note 6 at 71652.

    11Id.

    12See Securities Exchange Act Release Nos. 71249 (January 7, 2014), 79 FR 2229 (January 13, 2014) (SR-BYX-2014-001); 74111 (January 22, 2015), 80 FR 4598 (January 28, 2015) (SR-BYX-2015-05); 76965 (January 22, 2016), 81 FR 4682 (January 27, 2016) (SR-BYX-2016-01); 78180 (June 28, 2016), 81 FR 43306 (July 1, 2016) (SR-BYX-2016-15); 81368 (August 10, 2017), 82 FR 38960 (August 16, 2017) (SR-BYX-2017-18).

    Proposal To Extend the Operation of the Program

    The Exchange established the Program in an attempt to attract retail order flow to the Exchange by potentially providing price improvement to such order flow. The Exchange believes that the Program promotes competition for retail order flow by allowing Exchange members to submit Retail Price Improvement Orders (“RPI Orders”) 13 to interact with Retail Orders. Such competition has the ability to promote efficiency by facilitating the price discovery process and generating additional investor interest in trading securities, thereby promoting capital formation. The Exchange believes that extending the pilot is appropriate because it will allow the Exchange and the Commission additional time to gather and analyze data regarding the Program that the Exchange has committed to provide.14 As such, the Exchange believes that it is appropriate to extend the current operation of the Program.15 Through this filing, the Exchange seeks to extend the current pilot period of the Program until the earlier of approval of the filing to make the Program permanent or December 31, 2018.

    13 A “Retail Price Improvement Order” is defined in Rule 11.24(a)(3) as an order that consists of non-displayed interest on the Exchange that is priced better than the Protected NBB or Protected NBO by at least $0.001 and that is identified as such. See Rule 11.24(a)(3).

    14See RPI Approval Order, supra note 6 at 71655.

    15 Concurrently with this filing, the Exchange has submitted a request for an extension of the exemption under Regulation NMS Rule 612 previously granted by the Commission that permits it to accept and rank the RPI orders in sub-penny increments. See Letter from Anders Franzon, SVP, Deputy General Counsel, Cboe BYX Exchange, Inc. to Brent J. Fields, Secretary, Securities and Exchange Commission dated July 30, 2018.

    2. Statutory Basis

    The Exchange believes that its proposal is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6(b) of the Act.16 In particular, the Exchange believes the proposed change furthers the objectives of Section 6(b)(5) of the Act,17 in that it is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, and to remove impediments to and perfect the mechanism of a free and open market and a national market system. The Exchange believes that extending the pilot period for the Program is consistent with these principles because the Program is reasonably designed to attract retail order flow to the exchange environment, while helping to ensure that retail investors benefit from the better price that liquidity providers are willing to give their orders. Additionally, as previously stated, the competition promoted by the Program may facilitate the price discovery process and potentially generate additional investor interest in trading securities. The extension of the pilot period will allow the Commission and the Exchange to continue to monitor the Program for its potential effects on public price discovery, and on the broader market structure.

    16 15 U.S.C. 78f(b).

    17 15 U.S.C. 78f(b)(5).

    B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change extends an established pilot program, thus allowing the Program to enhance competition for retail order flow and contribute to the public price discovery process.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any written comments from Members or other interested parties.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    Because the foregoing proposed rule change does not: (A) Significantly affect the protection of investors or the public interest; (B) impose any significant burden on competition; and (C) by its terms, become operative for 30 days from the date on which it was filed or such shorter time as the Commission may designate it has become effective pursuant to Section 19(b)(3)(A) of the Act 18 and paragraph (f)(6) of Rule 19b-4 thereunder, provided that the self-regulatory organization has given the Commission written notice of its intent to file the proposed rule change at least five business days prior to the date of filing of the proposed rule change or such shorter time as designated by the Commission,19 the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 20 and Rule 19b-4(f)(6) thereunder.21

    18 15 U.S.C. 78s(b)(3)(A).

    19 The Exchange has fulfilled this requirement.

    20 15 U.S.C. 78s(b)(3)(A).

    21 17 CFR 240.19b-4(f)(6).

    The Exchange has requested that the Commission waive the 30-day operative delay period after which a proposed rule change under Rule 19b-4(f)(6) becomes operative so that the proposal may become operative immediately upon filing. The Commission believes that waiver of the 30-day operative delay is consistent with the protection of investors and the public interest because such waiver will allow the Exchange to extend the Program uninterrupted and will ensure that the Program continues while the Exchange and Commission continue to analyze data. Accordingly, the Commission hereby grants the Exchange's request and designates the proposal operative upon filing.22

    22 For purposes only of waiving the operative delay, the Commission has considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).

    At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B) 23 of the Act to determine whether the proposed rule change should be approved or disapproved.

    23 15 U.S.C. 78s(b)(2)(B).

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposal is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected]. Please include File No. SR-CboeBYX-2018-015 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

    All submissions should refer to File No. SR-CboeBYX-2018-015. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filing will also be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File No. SR-CboeBYX-2018-015 and should be submitted on or before August 28, 2018.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.24

    24 17 CFR 200.30-3(a)(12).

    Robert W. Errett, Deputy Secretary.
    [FR Doc. 2018-16802 Filed 8-6-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION Sunshine Act Meetings TIME AND DATE:

    2:00 p.m. on Thursday, August 9, 2018.

    PLACE:

    Closed Commission Hearing Room 10800.

    STATUS:

    This meeting will be closed to the public.

    MATTERS TO BE CONSIDERED:

    Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.

    The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.

    Commissioner Stein, as duty officer, voted to consider the items listed for the closed meeting in closed session.

    The subject matters of the closed meeting will be:

    Institution and settlement of injunctive actions;

    Institution and settlement of administrative proceedings;

    Resolution of litigation claims; and

    Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in the scheduling of meeting items.

    CONTACT PERSON FOR MORE INFORMATION:

    For further information and to ascertain what, if any, matters have been added, deleted or postponed; please contact Brent J. Fields from the Office of the Secretary at (202) 551-5400.

    Dated: August 2, 2018. Brent J. Fields, Secretary.
    [FR Doc. 2018-16903 Filed 8-3-18; 11:15 am] BILLING CODE 8011-01-P
    SMALL BUSINESS ADMINISTRATION [Disaster Declaration #15584 and #15585; Texas Disaster Number TX-00500] Presidential Declaration Amendment of a Major Disaster for the State of Texas AGENCY:

    U.S. Small Business Administration.

    ACTION:

    Amendment 2.

    SUMMARY:

    This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-4377-DR), dated 07/06/2018.

    Incident: Severe Storms and Flooding.

    Incident Period: 06/19/2018 through 07/13/2018.

    DATES:

    Issued on 07/31/2018.

    Physical Loan Application Deadline Date: 09/04/2018.

    Economic Injury (EIDL) Loan Application Deadline Date: 04/08/2019.

    ADDRESSES:

    Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.

    FOR FURTHER INFORMATION CONTACT:

    A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.

    SUPPLEMENTARY INFORMATION:

    The notice of the President's major disaster declaration for the State of Texas, dated 07/06/2018, is hereby amended to include the following areas as adversely affected by the disaster:

    Primary Counties (Physical Damage and Economic Injury Loans): Jim Wells Contiguous Counties (Economic Injury Loans Only): Texas: Duval, Kleberg, Live Oak, Nueces, San Patricio

    All other information in the original declaration remains unchanged.

    (Catalog of Federal Domestic Assistance Number 59008) James Rivera, Associate Administrator for Disaster Assistance.
    [FR Doc. 2018-16866 Filed 8-6-18; 8:45 am] BILLING CODE 8025-01-P
    SMALL BUSINESS ADMINISTRATION [Disaster Declaration #15618 and #15619; Vermont Disaster Number VT-00035] Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Vermont AGENCY:

    U.S. Small Business Administration.

    ACTION:

    Notice.

    SUMMARY:

    This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of VERMONT (FEMA-4380-DR), dated 07/30/2018.

    Incident: Severe Storm and Flooding.

    Incident Period: 05/04/2018 through 05/05/2018.

    DATES:

    Issued on 07/30/2018.

    Physical Loan Application Deadline Date: 09/28/2018.

    Economic Injury (EIDL) Loan Application Deadline Date: 04/30/2019.

    ADDRESSES:

    Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.

    FOR FURTHER INFORMATION CONTACT:

    A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given that as a result of the President's major disaster declaration on 07/30/2018, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.

    The following areas have been determined to be adversely affected by the disaster:

    Primary Counties: Chittenden, Grand Isle, Lamoille, Orange, Orleans

    The Interest Rates are:

    Percent For Physical Damage: Non-Profit Organizations with Credit Available Elsewhere 2.500 Non-Profit Organizations without Credit Available Elsewhere 2.500 For Economic Injury: Non-Profit Organizations without Credit Available Elsewhere 2.500

    The number assigned to this disaster for physical damage is 156186 and for economic injury is 156190.

    (Catalog of Federal Domestic Assistance Number 59008) James Rivera, Associate Administrator for Disaster Assistance.
    [FR Doc. 2018-16868 Filed 8-6-18; 8:45 am] BILLING CODE 8025-01-P
    DEPARTMENT OF STATE [Public Notice: 10487] Advisory Committee for the Study of Eastern Europe and the Independent States of the Former Soviet Union (Title VIII) Public Meeting Notice

    The Advisory Committee for the Study of Eastern Europe and the Independent States of the Former Soviet Union (Advisory Committee) will convene on Wednesday, September 5, 2018, from 1:30 p.m. until approximately 3:30 p.m. The meeting will take place at the U.S. Department of State, Harry S Truman Building, 2201 C Street NW, Washington, DC, in room 1406.

    The Advisory Committee will recommend grant recipients for the 2018 funding opportunity for the Program for the Study of Eastern Europe and the Independent States of the Former Soviet Union, in accordance with the Research and Training for Eastern Europe and the Independent States of the Former Soviet Union Act of 1983, Public Law 98-164, as amended. The agenda will include opening statements by the chairperson and members of the committee. The committee will provide an overview and discussion of grant proposals from “national organizations with an interest and expertise in conducting research and training concerning the countries of Eastern Europe and the Independent States of the Former Soviet Union,” based on the guidelines set forth in the June request for proposals published on Grants.gov and SAMS Domestic (mygrants.service-now.com). Following committee deliberation, interested members of the public may make oral statements concerning the Title VIII program.

    This meeting will be open to the public; however, attendance is limited to available seating. Entry into the Harry S Truman building is controlled and must be arranged in advance of the meeting. Those planning to attend should notify the Title VIII Program Officer at the U.S. Department of State at [email protected], subject: Public Meeting RSVP, no later than close of business, Tuesday, September 4, 2018.

    For pre-clearance into the Harry S Truman building, the Title VIII Program Officer will request identifying data pursuant to Public Law 99-399 (Omnibus Diplomatic Security and Antiterrorism Act of 1986), as amended; Public Law 107-56 (USA PATRIOT Act); and Executive Order 13356. This information is being collected pursuant to 22 U.S.C. 2651a and 22 U.S.C. 4802 for the purpose of screening and pre-clearing participants to enter the host venue at the U.S. Department of State, in line with standard security procedures for events of this size. The Department of State will use this information consistent with the routine uses set forth in the System of Records Notices for Security Records (State-36). Provision of this information is voluntary, but failure to provide accurate information may impede your ability to register for the event. Please see the Security Records System of Records Notice (State-36) at https://www.state.gov/documents/organization/242611.pdf for additional information.

    All attendees must use the 2201 C Street entrance and must arrive no later than 12:30 p.m. to pass through security before entering the building. The Program Officer cannot admit visitors who arrive without prior notification or without photo identification.

    Catherine L. Kuchta-Helbling Executive Director, Advisory Committee for Study of Eastern Europe, and the Independent States of the Former Soviet Union.
    [FR Doc. 2018-16851 Filed 8-6-18; 8:45 am] BILLING CODE 4710-32-P
    OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE [Docket No. USTR-2018-0026] Extension of Public Comment Period Concerning Proposed Modification of Action Pursuant to Section 301: China's Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation AGENCY:

    Office of the United States Trade Representative.

    ACTION:

    Extension of public comment period.

    SUMMARY:

    In a notice published on July 17, 2018 (83 FR 33608), the U.S. Trade Representative (Trade Representative) proposed a modification of the action taken in this investigation in the form of an additional 10 percent ad valorem duty on products of China with an annual trade value of approximately $200 billion. The July 17th notice sought public comment and provided notice of a public hearing regarding this proposed modification of the action in the investigation. On August 1, 2018, the Trade Representative announced that the President had directed the Trade Representative to consider raising the level of the additional duty in the proposed supplemental action from 10 percent to 25 percent. In light of this possible increase in the rate of additional duty, the Trade Representative is extending certain comment periods set out in the July 17th notice.

    DATES:

    To be assured of consideration, you must submit comments and responses in accordance with the following schedule:

    August 13, 2018: The due date for filing requests to appear and a summary of expected testimony at the public hearing and for filing pre-hearing submissions is extended from July 27 to August 13, 2018.

    September 6, 2018: The due date for submission of written comments is extended from August 17 to September 6, 2018.

    August 20-23, 2018: The scheduled start date of the Section 301 hearing (August 20) has not changed. The Section 301 Committee may extend the length of the hearing depending on the number of additional interested persons who request to appear. The Section 301 Committee will convene the public hearing in the main hearing room of the U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436 beginning at 9:30 a.m. on August 20, 2018.

    September 6, 2018: The due date for submission of post-hearing rebuttal comments is extended from August 30 to September 6, 2018.

    ADDRESSES:

    USTR strongly prefers electronic submissions made through the Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments in sections E and F of the July 17th notice. The docket number—USTR-2018-0026—has not changed.

    FOR FURTHER INFORMATION CONTACT:

    For questions about the ongoing investigation or proposed action, contact Arthur Tsao, Assistant General Counsel, or Justin Hoffmann, Director of Industrial Goods, at (202) 395-5725. For questions on customs classification of products, contact [email protected]

    SUPPLEMENTARY INFORMATION:

    A. Background

    In the July 17th notice, the Trade Representative proposed modifying the action in this investigation by maintaining the original $34 billion action and the proposed $16 billion action, and by taking a further, supplemental action. In particular, the Trade Representative proposed a supplemental action of an additional 10 percent ad valorem duty on products of China covered in a list of 6,031 tariff subheadings in the Annex to the July 17th notice.

    On August 1, 2018, the Trade Representative announced that the President directed the Trade Representative to consider increasing the proposed level of the additional duty from 10 percent to 25 percent. This additional 25 percent duty would be applied to the proposed list of products in the Annex to the July 17th notice. The possible increase in the proposed rate of the additional duty is intended to provide the Administration with additional options to obtain the elimination of the acts, policies, and practices covered in the investigation.

    B. Request for Public Comments and Hearing Participation

    Subject to the modified due dates set out above, the procedures for submission of public comments and requests to participate in the public hearing set out in sections E and F of the July 17th notice continue to apply. Interested persons are invited to include comments in their written submissions and oral testimony on the possible imposition of a 25 percent additional duty. In the event an interested person already has provided written comments and wishes to provide further comments in light of the possible increase in the rate of additional duty, the submitter may file a supplemental comment.

    Robert E. Lighthizer, United States Trade Representative.
    [FR Doc. 2018-16919 Filed 8-3-18; 11:15 am] BILLING CODE 3290-F8-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration FAA Approval of Noise Compatibility Program 14 CFR Part 150; Jackson Hole Airport, Jackson, WY AGENCY:

    Federal Aviation Administration, DOT.

    ACTION:

    Notice.

    SUMMARY:

    The Federal Aviation Administration (FAA) announces its findings (Record of Approval) on the noise compatibility program submitted by the Jackson Hole Airport under the provisions of the Aviation Safety and Noise Abatement Act, (hereinafter referred to as “the Act”) and 14 CFR part 150 (Part 150). On March 23, 2018, the FAA determined that the noise exposure maps submitted by the Jackson Hole Airport under Part 150 were in compliance with applicable requirements. On August 1, 2018 the FAA approved the Jackson Hole Airport Noise Compatibility Program. Five of the 15 measures recommended in the noise compatibility plan was approved and ten measures were disapproved for the purposes of Part 150. Three of the approved recommendations were approved as a continuation of a measure approved in a prior ROA, one was approved as voluntary, and one was approved for the purposes of Part 150. The attachment to this ROA provides a summary of all of the recommendations in the three NCPs (1985, 2004 and 2018) for JAC along with FAA's decision and the status of each.

    DATES:

    Effective Date: The effective date of the FAA's approval of the Jackson Hole Airport Noise Compatibility Program is August 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Kandice Krull, Federal Aviation Administration, Denver Airports District Office, 26805 E 68th Ave., Suite 224, Denver, CO 80249, telephone 303-342-1261. Documents reflecting this FAA action may be reviewed at this same location.

    SUPPLEMENTARY INFORMATION:

    This notice announces that the FAA has given its overall approval to the noise compatibility program for the Jackson Hole Airport, effective August 1, 2018.

    Under section 47504 of the Act, an airport operator who has previously submitted a noise exposure map may submit to the FAA a noise compatibility program which sets forth the measures taken or proposed by the airport operator for the reduction of existing non-compatible land uses and prevention of additional non-compatible land uses within the area covered by the noise exposure maps. The Act requires such programs to be developed in consultation with interested and affected parties including local communities, government agencies, airport users, and FAA personnel.

    Each airport noise compatibility program developed in accordance with the Part 150 regulations is a local program, not a Federal program. The FAA does not substitute its judgment for that of the airport proprietor with respect to which measures should be recommended for action. The FAA's approval or disapproval of Part 150 program recommendations is measured according to the standards expressed in Part 150 and the Act and is limited to the following determinations:

    a. The noise compatibility program was developed in accordance with the provisions and procedures of Part 150;

    b. Program measures are reasonably consistent with achieving the goals of reducing existing non-compatible land uses around the airport and preventing the introduction of additional non-compatible land uses;

    c. Program measures would not create an undue burden on interstate or foreign commerce, unjustly discriminate against types or classes of aeronautical uses, violate the terms of airport grant agreements, or intrude into areas preempted by the Federal Government; and

    d. Program measures relating to the use of flight procedures can be implemented within the period covered by the program without derogating safety, adversely affecting the efficient use and management of the navigable airspace and air traffic control systems, or adversely affecting other powers and responsibilities of the Administrator prescribed by law.

    Specific limitations with respect to FAA's approval of an airport noise compatibility program are delineated in Part 150, section 150.5. Approval is not a determination concerning the acceptability of land uses under Federal, state, or local law. Approval does not by itself constitute an FAA implementing action. A request for Federal action or approval to implement specific noise compatibility measures may be required, and an FAA decision on the request may require an environmental review of the proposed action. Approval does not constitute a commitment by the FAA to financially assist in the implementation of the program nor a determination that all measures covered by the program are eligible for grant-in-aid funding from the FAA. Where federal funding is sought, requests for project grants must be submitted to the FAA Denver Airports District Office in Denver, CO. The Jackson Hole Airport submitted to the FAA on March 21, 2018 the noise exposure maps, descriptions, and other documentation produced during the noise compatibility planning study for the Jackson Hole Airport conducted in 2013-2018. The Jackson Hole Airport noise exposure maps were determined by FAA to be in compliance with applicable requirements on March 23, 2018. Notice of this determination was published in the Federal Register on April 5, 2018 (FR Volume 83, No. 66, pages 14713-14714).

    Comments received during the noise compatibility planning public process were addressed in the final noise compatibility program submitted to FAA. No comments were received during the 60-day public comment period for the Jackson Hole Airport Noise Compatibility Program that ended May 22, 2018.

    The Jackson Hole Airport study contains a proposed noise compatibility program comprised of actions designed for phased implementation by airport management and adjacent jurisdictions. It was requested that the FAA evaluate and approve this material as a noise compatibility program as described in section 47504 of the Act. The FAA began its review of the program on March 23, 2018, and was required by a provision of the Act to approve or disapprove the program within 180 days (other than the use of new or modified flight procedures for noise control). Failure to approve or disapprove such program within the 180-day period shall be deemed to be an approval of such program.

    The submitted program contained six (6) noise abatement recommendations, two (2) land use management recommendations and seven (7) program management recommendations for FAA action. The FAA completed its review and determined that the procedural and substantive requirements of the Act and Part 150 have been satisfied. The overall program therefore, was approved by the FAA on August 1, 2018.

    Approval was granted for five of the 15 measures and ten measures were disapproved for the purposes of Part 150. Three of the approved recommendations were approved as a continuation of a measure approved in a prior ROA, one was approved as voluntary, and one was approved for the purposes of Part 150. The attachment to this ROA provides a summary of all of the recommendations in the three NCPs for JAC along with FAA's decision and the status of each.

    These determinations are set forth in detail in a Record of Approval signed by the Airports Division Manager, Northwest Mountain Region on August 1, 2018. The Record of Approval, as well as other evaluation materials and the documents comprising the submittal are available for review at the FAA office listed above and at the Jackson Hole Airport, 1250 E Airport Road, Jackson, WY 83001. The Record of Approval also will be available on-line at http://www.faa.gov/airports/environmental/airport_noise/part_150/states/.

    Issued in Renton, Washington on August 1, 2018. Randall S. Fiertz, Manager, Airports Division, Northwest Mountain Region.
    [FR Doc. 2018-16870 Filed 8-6-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration [Summary Notice No. PE-2018-63] Petition for Exemption; Summary of Petition Received AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of petition for exemption received.

    SUMMARY:

    This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

    DATES:

    Comments on this petition must identify the petition docket number involved and must be received on or before August 27, 2018.

    ADDRESSES:

    Send comments identified by docket number FAA-2018-0725 using any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your comments electronically.

    Mail: Send comments to Docket Operations, M-30; U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

    Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: Fax comments to Docket Operations at 202-493-2251.

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

    Docket: Background documents or comments received may be read at http://www.regulations.gov at any time. Follow the online instructions for accessing the docket or go to the Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Mark Forseth, AIR-673, Federal Aviation Administration, 2200 S 216th St., WA 98198-6547, email [email protected], phone (206) 231-3179; or Alphonso Pendergrass, ARM-200, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591, email [email protected], phone (202) 267-4713.

    This notice is published pursuant to 14 CFR 11.85.

    Issued in Renton, Washington, on July 31, 2018. Suzanne Masterson, Acting Manager, Transport Standards Branch. Petition for Exemption

    Docket No.: FAA-2018-0725.

    Petitioner: Gulfstream Aerospace Corporation.

    Section of 14 CFR Affected: § 25.1309(b) and Special Conditions No. 25-662-SC.

    Description of Relief Sought: Provide relief to allow for the installation of seat airbag systems equipped with lithium batteries on Gulfstream Model GVII-G500/G600 airplanes.

    [FR Doc. 2018-16826 Filed 8-6-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration [Summary Notice No. PE-2018-64] Petition for Exemption; Summary of Petition Received AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of petition for exemption received.

    SUMMARY:

    This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

    DATES:

    Comments on this petition must identify the petition docket number involved and must be received on or before August 27, 2018.

    ADDRESSES:

    Send comments identified by docket number FAA-2018-0267 using any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your comments electronically.

    Mail: Send comments to Docket Operations, M-30; U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

    Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: Fax comments to Docket Operations at 202-493-2251.

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

    Docket: Background documents or comments received may be read at http://www.regulations.gov at any time. Follow the online instructions for accessing the docket or go to the Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Mark Forseth, AIR-673, Federal Aviation Administration, 2200 S. 216th St., WA 98198-6547, email [email protected], phone (206) 231-3179; or Alphonso Pendergrass, ARM-200, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591, email [email protected], phone (202) 267-4713.

    This notice is published pursuant to 14 CFR 11.85.

    Issued in Renton, Washington, on July 31, 2018. Suzanne Masterson, Acting Manager, Transport Standards Branch. Petition for Exemption

    Docket No.: FAA-2018-0267.

    Petitioner: The Boeing Company.

    Section of 14 CFR Affected: § 25.795(b)(1).

    Description of Relief Sought:

    Provide relief from the requirements of flightdeck smoke protection for Boeing Model 737-7, 737-8, and 737-8200 airplanes.

    [FR Doc. 2018-16825 Filed 8-6-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF THE TREASURY Office of Foreign Assets Control Notice of OFAC Sanctions Actions AGENCY:

    Office of Foreign Assets Control, Treasury.

    ACTION:

    Notice.

    SUMMARY:

    The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

    DATES:

    See SUPPLEMENTARY INFORMATION section.

    FOR FURTHER INFORMATION CONTACT:

    OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel. 202-622-4855; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.

    SUPPLEMENTARY INFORMATION:

    Electronic Availability

    The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (www.treasury.gov/ofac).

    Notice of OFAC Action(s)

    On August 1, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authority listed below.

    Individuals

    1. SOYLU, Suleyman; DOB 21 Nov 1969; POB Istanbul, Turkey; nationality Turkey; Gender Male (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(C)(1) of Executive Order 13818 of December 20, 2017, “Blocking the Property of Persons Involved in Serious Human Rights Abuse or Corruption” (E.O. 13818) for being or having been a leader or official of Turkey's Ministry of Interior, an entity that has engaged in, or whose members have engaged in, serious human rights abuse relating to the leader's or official's tenure.

    2. GUL, Abdulhamit; DOB 12 Mar 1977; POB Nizip, Gaziantep, Turkey; nationality Turkey; Gender Male (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(C)(1) of E.O. 13818 for being or having been a leader or official of Turkey's Ministry of Justice, an entity that has engaged in, or whose members have engaged in, serious human rights abuse relating to the leader's or official's tenure.

    Dated: August 1, 2018. Andrea Gacki, Acting Director, Office of Foreign Assets Control.
    [FR Doc. 2018-16874 Filed 8-6-18; 8:45 am] BILLING CODE 4810-AL-P
    DEPARTMENT OF THE TREASURY Office of Foreign Assets Control Notice of OFAC Sanctions Actions AGENCY:

    Office of Foreign Assets Control, Treasury.

    ACTION:

    Notice.

    SUMMARY:

    The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of two persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

    DATES:

    See SUPPLEMENTARY INFORMATION section.

    FOR FURTHER INFORMATION CONTACT:

    OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel. 202-622-4855; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.

    SUPPLEMENTARY INFORMATION: Electronic Availability

    The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (www.treasury.gov/ofac).

    Notice of OFAC Action(s)

    On July 31, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authority listed below.

    Individuals

    1. JABBAR, Abdul (a.k.a. JABAR, Abdul), 124 Yasir Ghaffar Town, Okara, Punjab, Pakistan; DOB 03 Feb 1977; nationality Pakistan; Gender Male (individual) [SDGT].

    Designated pursuant to section 1(c) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism” (E.O. 13224) for acting for or on behalf of LASHKAR-E TAYYIBA, an entity determined to be subject to E.O. 13224.

    2. HASSAN, Hameed ul (a.k.a. HASAN, Hameed ul; a.k.a. HASSAN, Hameedul), House number 4, Lane 4, Village flag 2, Dhalwan, Pasrur Tehsil, Sialkot District, Punjab Province, Pakistan; DOB 02 Jan 1980; alt. DOB 02 Nov 1980; POB Sialkot, Pakistan; nationality Pakistan; Gender Male (individual) [SDGT].

    Designated pursuant to section 1(c) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism” (E.O. 13224) for acting for or on behalf of LASHKAR-E TAYYIBA, an entity determined to be subject to E.O. 13224.

    Dated: July 31, 2018. Andrea M. Gacki, Acting Director, Office of Foreign Assets Control.
    [FR Doc. 2018-16842 Filed 8-6-18; 8:45 am] BILLING CODE 4810-AL-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service Proposed Collection; Comment Request for Regulation Project AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning certain gambling winnings.

    DATES:

    Written comments should be received on or before October 9, 2018 to be assured of consideration.

    ADDRESSES:

    Direct all written comments to Laurie Brimmer, Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW, Washington, DC 20224.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the form should be directed to Kerry Dennis, at (202) 317-5751 or Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet, at [email protected]

    SUPPLEMENTARY INFORMATION:

    Title: Certain Gambling Winnings.

    OMB Number: 1545-0238.

    Form Number: W2-G.

    Abstract: Internal Revenue Code sections 6041, 3402(q), and 3406 require payers of certain gambling winnings to withhold tax and to report the winnings to the IRS. IRS uses the information to verify compliance with the reporting rules and to verify that the winnings are properly reported on the recipient's tax return.

    Current Actions: There are changes to the previously approved burden of this existing collection.

    Type of Review: Revision of a currently approved collection.

    Affected Public: Businesses or other for-profit organizations, state or local governments, and non-profit institutions.

    Estimated Number of Respondents: 15,349,567.

    Estimated Time per Respondent: 24 minutes.

    Estimated Total Annual Burden Hours: 6,293,323.

    The following paragraph applies to all of the collections of information covered by this notice.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

    Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.

    Approved: August 1, 2018. Laurie Brimmer, Senior Tax Analyst.
    [FR Doc. 2018-16804 Filed 8-6-18; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service Proposed Collection; Comment Request for Regulation Project AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning long-term care and accelerated death benefits.

    DATES:

    Written comments should be received on or before October 9, 2018 to be assured of consideration.

    ADDRESSES:

    Direct all written comments to Laurie Brimmer, Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW, Washington, DC 20224.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the form should be directed to Kerry Dennis, at (202) 317-5751 or Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW, Washington DC 20224, or through the internet, at [email protected].

    SUPPLEMENTARY INFORMATION:

    Title: Long-Term Care and Accelerated Death Benefits.

    OMB Number: 1545-1519.

    Form Number: 1099-LTC.

    Abstract: File Form 1099-LTC, Long-Term Care and Accelerated Death Benefits, if you pay any long-term care benefits.

    Current Actions: There are changes to the previously approved burden of this existing collection.

    Type of Review: Revision of a currently approved collection.

    Affected Public: Businesses or other for-profit organizations, individuals or households, not-for-profit institutions, and state, local or tribal governments.

    Estimated Number of Respondents: 377,467.

    Estimated Time per Respondent: 13 minutes.

    Estimated Total Annual Burden Hours: 86,818.

    The following paragraph applies to all of the collections of information covered by this notice.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

    Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.

    Approved: August 1, 2018. Laurie Brimmer, Senior Tax Analyst.
    [FR Doc. 2018-16806 Filed 8-6-18; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF VETERANS AFFAIRS Change in Burden of Proof AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Notice with request for comments.

    SUMMARY:

    This notice announces that the burden of proof for disciplinary and major adverse actions imposed against certain employees of the Department of Veterans Affairs has been changed from preponderance of evidence to substantial evidence.

    DATES:

    Comments must be received on or before September 6, 2018. The proposed effective date of these amendments is 30 days after publication of this notice.

    ADDRESSES:

    Written comments may be directed to: Elizabeth A. Hill, Team Lead, Employee Relations & Performance Management Service, Office of Human Resources Management, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420. Comments may also be faxed to (202) 495-5200.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth A. Hill, Team Lead, (706) 504-3988, or by email to [email protected]

    SUPPLEMENTARY INFORMATION:

    Section 203 of the Department of Veterans Affairs Health Care Personnel Act of 1991 (Pub. L. 102-40), dated May 7, 1991, revised the disciplinary grievance and appeal procedures for employees appointed under 38 United States Code (U.S.C.) 7401(1). 38 U.S.C. 7461(e) requires that whenever the Secretary proposes to prescribe regulations under 38 U.S.C., Part V, Chapter 74, Subchapter V, “the Secretary shall publish the proposed regulations in the Federal Register for notice-and-comment not less than 30 days before the day on which they take effect.”

    Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Jacquelyn Hayes-Byrd, Acting Chief of Staff, Department of Veterans Affairs, approved this document on July 30, 2018, for publication.

    Dated: July 30, 2018. Luvenia Potts, Program Specialist, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.
    [FR Doc. 2018-16808 Filed 8-6-18; 8:45 am] BILLING CODE 8320-01-P
    83 152 Tuesday, August 7, 2018 Rules and Regulations Part II Securities and Exchange Commission 17 CFR Parts 232, 240, 242, et al. Regulation of NMS Stock Alternative Trading Systems; Final Rule SECURITIES AND EXCHANGE COMMISSION 17 CFR Parts 232, 240, 242, and 249 [Release No. 34-83663; File No. S7-23-15] RIN 3235-AL66 Regulation of NMS Stock Alternative Trading Systems AGENCY:

    Securities and Exchange Commission.

    ACTION:

    Final rule.

    SUMMARY:

    The Securities and Exchange Commission is adopting amendments to regulatory requirements in Regulation ATS under the Securities Exchange Act of 1934 (“Exchange Act”) applicable to alternative trading systems (“ATSs”) that trade National Market System (“NMS”) stocks (hereinafter referred to as “NMS Stock ATSs”), including so called “dark pools.” First, we are adopting new Form ATS-N, which will require NMS Stock ATSs to disclose information about their manner of operations, the broker-dealer that operates the ATS (“broker-dealer operator”), and the ATS-related activities of the broker-dealer operator and its affiliates. Second, as amended, the regulations will require public posting of certain Form ATS-N filings on the Commission's website, which will be accomplished through the Commission's Electronic Data Gathering, Analysis, and Retrieval system (“EDGAR”) and require each NMS Stock ATS that has a website to post on its website a direct URL hyperlink to the Commission's website. Third, the amendments that we are adopting today provide a process for the Commission to review Form ATS-N filings and, after notice and opportunity for hearing, declare an NMS Stock ATS's Form ATS-N ineffective. Fourth, the regulations, as amended, will require all ATSs subject to the regulations to place in writing its safeguards and procedures to protect subscribers' confidential trading information. We are also adopting conforming amendments.

    DATES:

    Effective Date: October 9, 2018.

    Compliance Dates: The applicable compliance dates are discussed in the section of the release titled “VIII. Effective Date and Compliance Date.”

    FOR FURTHER INFORMATION CONTACT:

    Tyler Raimo, Senior Special Counsel, at (202) 551-6227; Matthew Cursio, Special Counsel, at (202) 551-5748; Marsha Dixon, Special Counsel, at (202) 551-5782; Jennifer Dodd, Special Counsel, at (202) 551-5653; David Garcia, Special Counsel, at (202) 551-5681; or Megan Mitchell, Special Counsel, at (202) 551-4887; Office of Market Supervision, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-7010.

    SUPPLEMENTARY INFORMATION:

    We are adopting: (1) Amendments to 17 CFR 242.300 through 242.303 (“Regulation ATS”) to add new 17 CFR 242.304 (“Rule 304”) under the Exchange Act to provide new conditions for NMS Stock ATSs seeking to rely on the exemption from the definition of “exchange” provided by 17 CFR 240.3a1-1(a) (“Rule 3a1-1(a)”) of the Exchange Act; (2) new Form ATS-N 1 under the Exchange Act, which NMS Stock ATSs will file to comply with the new conditions provided under Rule 304; and (3) related amendments to 17 CFR 242.300; 17 CFR 242.301, 17 CFR 242.303, and 17 CFR 240.3a1-1 under the Exchange Act (respectively, “Rule 300,” “Rule 301,” and “Rule 303” of Regulation ATS, and “Rule 3a1-1”). We are also adopting amendments to 17 CFR 242.301(b)(10) and 17 CFR 242.303 (“Rules 301(b)(10) and 303 of Regulation ATS”) under the Exchange Act to require all ATSs to make and keep written safeguards and written procedures to protect subscribers' confidential trading information.

    1 17 CFR 249.640.

    Table of Contents I. Introduction II. Background A. Role of ATSs in the Current Equity Market Structure 1. Significant Source of Liquidity for NMS Stocks 2. Operational Complexity; Conflict of Interests B. Exemption for Alternative Trading Systems C. Conditions to the ATS Exemption; Confidential Notice Regime D. Concerns Regarding the Lack of Operational Transparency III. Heightened Regulatory Requirements for NMS Stock ATSs A. Exchange Act Rule 3a1-1(a) Exemption: New Conditions for NMS Stock ATSs 1. Comments on the Rule 304 Requirements; Effectiveness a. Comments on Form ATS-N Requirement b. Comments on Effects on ATSs Relative to National Securities Exchanges c. Comments on Effectiveness Requirement 2. Comments on Extending Rule 304 to Non-NMS Stock ATSs B. Amendments to Existing Regulation ATS Rules for NMS Stock ATSs 1. Rule 300(k): Definition of NMS Stock ATS 2. Rule 301(a): Exemption From Compliance With Regulation ATS 3. Rule 301(a)(5): Exemptions From Certain Requirements of Regulation ATS Pursuant to Application to the Commission 4. Rule 301(b)(2): Form ATS Reporting Requirements No Longer Apply to NMS Stock ATSs 5. Rule 301(b)(9): Form ATS-R Quarterly Reports 6. Rule 303: Recordkeeping Requirements for Form ATS-N 7. Comments Recommending Changes To Other Existing Regulation ATS Rules IV. Form ATS-N Filing Process; Effectiveness Review A. Initial Form ATS-N 1. Rule 304(a)(1)(i): Filing and Effectiveness Requirement 2. Rule 304(a)(1)(ii): Commission Review Period 3. Rule 304(a)(1)(iii): Effectiveness; Ineffectiveness Determination a. Comments on the Standard of Review To Accept Filings on Form ATS-N b. Comments on the Review for Declarations of Ineffectiveness c. Effectiveness, Ineffectiveness Process d. Effectiveness; Ineffectiveness Determinations Under Rule 301(a)(1)(iii) 4. Rule 304(a)(1)(iv): Transition for Legacy NMS Stock ATSs a. Rule 304(a)(1)(iv)(A): Initial Filing Requirements b. Rule 304(a)(1)(iv)(B): Commission Review Period; Ineffectiveness Determination c. Rule 304(a)(1)(iv)(C): Amendments to Initial Form ATS-N B. Rule 304(a)(2): Form ATS-N Amendments 1. Rule 304(a)(2)(i): Filing Requirements a. Material Changes (i) Comments on Advance Notice (ii) Comments on Materiality (iii) Order Display and Fair Access Amendments b. Updating Amendments c. Correcting Amendments 2. Rule 304(a)(2)(ii): Commission Review Period; Ineffectiveness Determination C. Rule 304(a)(3): Notice of Cessation D. Rule 304(a)(4): Suspension, Limitation, or Revocation of the Exemption From the Definition of Exchange E. Rule 304(b): Public Disclosure of Form ATS-N and Related Commission Orders 1. Rule 304(b)(1): Form ATS-N “Report” 2. Rule 304(b)(2): Making Public Form ATS-N Filings and Commission Orders a. Public Disclosure of Effective Initial Form ATS-N, As Amended b. Public Disclosure of Orders of an Ineffective Initial Form ATS-N c. Public Disclosure of Form ATS-N Amendments d. Public Disclosure of Ineffective Form ATS-N Amendment e. Public Disclosure of Notices of Cessation f. Public Disclosure of Each Order Suspending, Limiting, or Revoking the Rule 3a1-1(a)(2) Exemption 3. Rule 304(b)(3): Disclosure of Form ATS-N on the NMS Stock ATS's Website V. Form ATS-N Disclosures A. Form ATS-N Disclosure Requirements and Definitions 1. Rule 304(c): Disclosure Requirements 2. Terminology a. Definitions for Form ATS-N (i) Proposed Defined Terms (ii) New Defined Terms b. Comments on the Definition of “Subscriber” B. Cover Page and Part I of Form ATS-N: Identifying Information 1. Cover Page 2. Part I of Form ATS-N: Identifying Information a. Part I: Identifying Information b. Comments on Proposed Exhibit 1 c. ATS Governance Structure and Compliance Programs and Controls C. Part II of Form ATS-N: ATS-Related Activities of the Broker-Dealer Operator and Affiliates 1. Broker-Dealer Operator and its Affiliate Trading Activities on the NMS Stock ATS a. Proposed Requests and Response to Comments b. Adopted Part II, Item 1 and 2 of Form ATS-N; ATS-Related Trading Activities of the Broker-Dealer Operator and its Affiliates 2. Order Interaction with Broker-Dealer Operator; Affiliates 3. Arrangements with Trading Centers 4. Other Products and Services 5. Activities of Service Providers a. Shared Employees b. Third-Party Service Providers 6. Protection of Confidential Trading Information 7. Differences in Availability of Services, Functionalities, or Procedures 8. Other Recommendations From Commenters D. Part III Form ATS-N: Manner of ATS Operations 1. Types of ATS Subscribers 2. Eligibility for ATS Services 3. Exclusion From ATS Services 4. Hours of Operations 5. Means of Entry 6. Connectivity and Co-Location 7. Order Types and Attributes 8. Order Sizes 9. Conditional Order and Indications of Interest 10. Opening and Reopening 11. Trading Services, Facilities and Rules 12. Liquidity Providers 13. Segmentation; Notice 14. Counter-Party Selection 15. Display 16. Routing 17. Closing 18. Trading Outside of Regular Trading Hours 19. Fees 20. Suspension of Trading 21. Trade Reporting 22. Clearance and Settlement 23. Market Data 24. Order Display and Execution Access 25. Fair Access 26. Aggregate Platform-Wide Data; Trading Statistics a. Disseminated Aggregated Platform-Wide Data b. Other Standardized Statistical Disclosures VI. Amendments to Rule 301(b)(10) and Rule 303(a)(1) for Written Safeguards and Written Procedures To Protect Confidential Trading Information VII. EDGAR Filing Requirements; Structured Data VIII. Effective Date and Compliance Date IX. Paperwork Reduction Act A. Summary of Collection of Information 1. Requirements Relating to Rule 301(b)(10) and 303(a)(1) of Regulation ATS 2. Requirements Relating to Rules 301(b)(2)(viii) and 304 of Regulation ATS, Including Form ATS-N B. Proposed Use of Information 1. Amendments to Rule 301(b)(10) and 303(a)(1) of Regulation ATS 2. Rules 301(b)(2)(viii), 304 of Regulation ATS, Including Form ATS-N, and 301(b)(9) C. Respondents D. Total Initial and Annual Reporting and Recordkeeping Burdens 1. Rules 301(b)(10) and 303(a)(1)(v) of Regulation ATS a. Baseline Measurements b. Burdens 2. Rules 301(b)(2)(viii) and 304 of Regulation ATS, Including Form ATS-N a. Baseline Measurements b. Burdens (i) Analysis of Estimated Additional Burden for Form ATS-N (a) Part I (b) Part II (c) Part III (ii) Estimated Burden Above the Current Baseline for an Initial Form ATS-N, Form ATS-N Amendment, and Notice of Cessation on Form ATS-N (a) Initial Form ATS-N (b) Form ATS-N Amendments (c) Notice of Cessation on Form ATS-N (iii) ATSs That Trade Both NMS and Non-NMS Stocks (iv) Access to EDGAR (v) Recordkeeping Requirements E. Collection of Information Is Mandatory F. Confidentiality of Responses to Collection of Information G. Retention Period for Recordkeeping Requirements X. Economic Analysis A. Background B. Baseline 1. Current NMS Stock ATSs 2. Current Reporting Requirements for NMS Stock ATSs 3. Lack of Standardized Public Disclosure 4. NMS Stock ATS Treatment of Subscriber Confidential Trading Information 5. Competition a. Competition Between NMS Stock ATSs and Registered National Securities Exchanges b. Competition Among NMS Stock ATSs c. Competition Between Broker-Dealers That Operate NMS Stock ATSs and Broker-Dealers That Do Not Operate NMS Stock ATSs 6. Effect of NMS Stock ATSs on the Current Market for NMS Stock Execution Services a. Trading Costs b. Price Discovery c. Market Efficiency C. Economic Effects and Effects on Efficiency, Competition, and Capital Formation 1. Economic Effects of Enhanced Filing Requirements of Form ATS-N a. Benefits b. Costs 2. Economic Effects of Public Disclosure of Form ATS-N a. Benefits (i) Benefits of Public Disclosure of Standardized Information of Operations of NMS Stock ATSs (ii) Benefits of Public Disclosure of the ATS-Related Activities of the Broker-Dealer Operator and Its Affiliates (iii) Benefits of Public Disclosure of Aggregate Platform-Wide Order Flow and Execution Statistics (iv) Benefits of Filing Form ATS-N in a Structured Format b. Costs (i) Costs to NMS Stock ATSs (ii) Price Impact Costs (iii) Filing in Structured Format 3. Economic Effects of Written Safeguards and Written Procedures To Protect Subscribers' Confidential Trading Information a. Benefits b. Costs 4. Impact on Efficiency, Competition, and Capital Formation a. Competition (i) Entry of New and Continuation of Legacy NMS Stock ATSs (a) Enhance Filing Requirements of Form ATS-N (b) Implementation and Ongoing Compliance Costs (c) Public Disclosure of Form ATS-N (ii) Effects on Changes in Number of NMS Stock ATSs on Market Participant Trading Costs (iii) Innovation b. Efficiency c. Capital Formation D. Reasonable Alternatives 1. Require NMS Stock ATSs To Publicly Disclose Current Form ATS 2. Require Form ATS-N but Deem Information Confidential 3. Require NMS Stock ATSs To Publicly Disclose Form ATS-N but not Declare Form ATS-N Ineffective 4. Initiate Differing Levels of Public Disclosure Depending on NMS Stock ATS Characteristics 5. Require NMS Stock ATSs To Register as National Securities Exchanges and Become SROs 6. Discontinue Quarterly Volume Reports on Form ATS-R 7. Require NMS Stock ATSs To Operate as Limited Purpose Entities 8. Prohibit Broker-Dealer Operators and Affiliates From Trading on the NMS Stock ATS 9. Lower the Fair Access Threshold for NMS Stock ATSs 10. Requirements To Disclose Aggregate Platform-Wide Order Flow and Execution Statistics to All Subscribers 11. Specify Alternative Structured Formats for Form ATS-N 12. Specify Other Filings Methods for Form ATS-N XI. Regulatory Flexibility Act Certification I. Introduction

    NMS Stock ATSs, including trading centers commonly referred to as dark pools,2 have become an integral part of the national market system. Since the adoption of Regulation ATS in 1998,3 the number of these ATSs, and the volume of NMS stocks traded on them, has significantly increased. NMS Stock ATSs, which meet the definition of an exchange but are not required to register as national securities exchanges, compete with, and operate with complexity akin to, national securities exchanges. Many NMS Stock ATSs are operated by multi-service broker-dealers, whose business activities have become increasingly intertwined with those of the ATS, adding further complexity to their operations of NMS Stock ATSs and creating the potential for conflicts between the interests of the broker-dealer operator and the ATS's subscribers.

    2 The term “dark pool” is not used or defined in the Exchange Act or Commission rules. For purposes of this release, the term refers to NMS Stock ATSs that do not publicly display quotations in the consolidated quotation data. See Securities Exchange Act Release No. 76474 (Nov. 18, 2015), 80 FR 80998, 81008 n.123 (Dec. 28, 2015) (“Proposal”). Currently, NMS Stock ATSs operate predominantly as dark pools. See infra Section II.A.1.

    A “trading center” means a national securities exchange or national securities association that operates an SRO trading facility, an ATS, an exchange market maker, an OTC market maker, or any other broker or dealer that executes orders internally by trading as principal or crossing orders as agent. 17 CFR 242.600(b)(78). Some trading centers, such as OTC market makers, also offer dark liquidity, primarily in a principal capacity, and do not operate as ATSs. For purposes of this adopting release, these trading centers are not defined as dark pools because they are not ATSs.

    3 Securities Exchange Act Release No. 40760 (December 8, 1998), 63 FR 70844, 70863 (December 22, 1998) (Regulation of Exchanges and Alternative Trading Systems) (“Regulation ATS Adopting Release”).

    Despite their role in the equity markets, little information is widely available to market participants about NMS Stock ATSs, which restricts their ability to adequately assess these ATSs as potential routing destinations. On November 18, 2015, we proposed to amend Regulation ATS with the stated goals of enhancing operational transparency for NMS Stock ATSs to enable market participants to make more informed order routing decisions, and to facilitate better Commission oversight of these trading venues.4 To achieve these goals, we proposed to require NMS Stock ATSs to publicly report on new Form ATS-N information about how the ATS operates and activities of the broker-dealer operator and its affiliates that relate to the ATS; and provide a process for the Commission to determine whether an NMS Stock ATS qualifies for the exemption from the definition of “exchange,” in which the Commission would, by order, declare a Form ATS-N effective or, after notice and opportunity for hearing, ineffective.

    4See Proposal, supra note 2. Section 11A(a)(2) of the Exchange Act (15 U.S.C. 78k-1(a)(2)) enacted as part of the Securities Acts Amendments of 1975 (“1975 Amendments”) (Pub. L. 94-29, 89 Stat. 97 (1975)) directs the Commission, having due regard for the public interest, the protection of investors, and the maintenance of fair and orderly markets, to use its authority under the Exchange Act to facilitate the establishment of a national market system for securities in accordance with the Congressional findings and objectives set forth in Section 11A(a)(1) of the Exchange Act. See 15 U.S.C. 78k-1(a)(1). See also Regulation ATS Adopting Release, supra note 3, at 70858; Proposal, supra note 2, at 80999-81000.

    We received 32 comment letters on the Proposal from a variety of interested persons, including ATSs, a national securities exchange, broker-dealers, institutional investors, industry trade groups, the Commission's Investor Advocate, and the Attorney General of the State of New York.5 Commenters generally support the goals of the Proposal, although some commenters express concern about various specific elements, and recommend certain modifications or clarifications. We are adopting Form ATS-N and amendments to Regulation ATS and Exchange Act Rule 3a1-1(a) with modifications from the Proposal, as discussed below.6

    5 Comments received on the Proposal are available on the Commission's website, available at: https://www.sec.gov/comments/s7-23-15/s72315.shtml. See Appendix A for a citation key to comment letters cited in this release.

    6 If any of the provisions of these rules, or the application thereof to any person or circumstance, is held to be invalid, such invalidity shall not affect other provisions or application of such provisions to other persons or circumstances that can be given effect without the invalid provision or application.

    II. Background A. Role of ATSs in the Current Equity Market Structure 1. Significant Source of Liquidity for NMS Stocks

    At the time Regulation ATS was proposed, there were 8 registered national securities exchanges,7 and the Commission estimated that there were approximately 43 systems that would be eligible to operate as ATSs.8 As of March 31, 2018, there were 21 registered national securities exchanges and 87 ATSs with a Form ATS on file with the Commission. Of these, there were 12 national securities exchanges that trade NMS stocks and 41 ATSs that had noticed on Form ATS that they expect to trade NMS stocks.9 Approximately 502.8 billion shares ($25.4 trillion) were traded in NMS stocks during the first quarter of 2018.10 During this period, the 33 ATSs that reported transactions in NMS stocks 11 accounted for 57.3 billion shares (approximately $2.9 trillion in dollar volume), representing 11.4% of the combined total share trading volume (11.5% of the total dollar volume) in NMS stocks on all national securities exchanges, ATSs, and non-ATS OTC trading centers.12 By comparison, the number of active dark pools trading NMS stocks in 2002 was approximately 10,13 and in 2009, dark pools accounted for 7.9% of NMS share volume.14 Additionally, no individual ATS executed more than 20.1% of the total share volume on NMS Stock ATSs or more than 2.3% of total NMS stock share volume during the first quarter of 2018.15 Given this dispersal of trading volume in NMS stocks among an increasing number of trading centers, NMS Stock ATSs, with their approximately 11.4% market share, represent a significant source of liquidity in NMS stocks.

    7See Securities Exchange Act Release No. 39884 (April 21, 1998), 63 FR 23504, 23523 (April 29, 1998) (“Regulation ATS Proposing Release”) at 23543 n.341.

    8See id. at 23540 n.313 and accompanying text.

    9 Data compiled from Forms ATS submitted to the Commission as of March 31, 2018.

    NYSE National, Inc. (f.k.a. National Stock Exchange, Inc.) was not trading as of March 31, 2018 but filed a proposed rule change with the Commission for its proposed relaunch. See Securities Exchange Act Release No. 82819 (March 7, 2018) 83 FR 11098 (March 13, 2018) (NYSENAT-2018-02) (notice of proposed ruled change). The Commission has approved the proposed rule change. See Securities Exchange Act Release No. 83289 (May 17, 2018) 83 FR 23968 (May 23, 2018) (NYSENAT-2018-02) (order approving proposed ruled change).

    In contrast to dark pools, an ATS could be an Electronic Communication Network (“ECN”), which are ATSs that provide their best-priced orders for inclusion in the consolidated quotation data, whether voluntarily or as required by Rule 301(b)(3) of Regulation ATS. See Rule 600(b)(23) of Regulation NMS, 17 CFR 242.600(b)(23) (definition of “electronic communications network”); see also 2010 Equity Market Structure Release, supra note 13, at 3599. In general, ECNs offer trading services (such as displayed or non-displayed order types, maker-taker pricing, and data feeds) that are analogous to national securities exchanges. See id. Currently, however, based on Form ATS filings, there are no NMS Stock ATSs operating as ECNs.

    10See infra Table 1—“NMS Stock ATSs Ranked by Dollar Trading Volume—January 1, 2018 to March 30, 2018” (citing Trade and Quote (TAQ) Data).

    11 Data compiled from Forms ATS and Forms ATS-R filed with the Commission as of the end of, and for the first quarter of 2018.

    12See infra Table 1—“NMS Stock ATSs Ranked by Dollar Trading Volume—January 1, 2018 to March 30, 2018.” See id. (citing Trade and Quote (TAQ) Data).

    During the second quarter of 2015, there were 38 ATSs that reported transactions in NMS stocks, accounting for 59 billion shares traded in NMS stocks ($2.5 trillion), which represented approximately 15.0% of total share trading volume (15.4% of total dollar trading volume) on all national securities exchanges, ATSs, and non-ATS OTC trading venues combined. See Proposal, supra note 2, at 81008 n.121 and accompanying text.

    Competitors for listed-equity (NMS) trading services also include several hundred OTC market makers and broker-dealers.

    13See Regulation of Non-Public Trading Interest, Securities Exchange Act Release No. 60997 (November 13, 2009) 74 FR 61208, 61209 n.9 (November 23, 2009) (“Regulation of Non-Public Trading Interest”).

    In 2009, there were 32 active dark pools trading in NMS stocks. See Securities Exchange Act Release No. 61358 (January 14, 2010), 75 FR 3594 (January 21, 2010) (“2010 Equity Market Structure Release”)), at 3598 n.22 and accompanying text.

    14See id. at 3598.

    15 The NMS Stock ATS with the greatest volume executed approximately 20.1% of NMS Stock ATS share volume and 2.3% of the total consolidated NMS stock share trading volume.

    The market share percentages were calculated by Commission staff using aggregate trade data reported by ATSs to the FINRA equity trade reporting facilities and made available on FINRA's website and TAQ Data. See infra Table 1—“NMS Stock ATSs Ranked by Dollar Trading Volume—January 1, 2018 to March 30, 2018.”

    Pursuant to FINRA rules, each ATS is required to use a unique MPID in its reporting to FINRA, such that its volume reporting is distinguishable from other transaction volume reported by the broker-dealer operator of the ATS, including volume reported for other ATSs operated by the same broker-dealer. See FINRA Rules 6160, 6170, 6480, and 6720. FINRA aggregates on a weekly basis ATS data reported by ATSs to the FINRA equity trade reporting facilities. The data can be viewed on a security-by-security basis or by ATS. See FINRA Rules 6110 and 6610. See also Securities Exchange Act Release No. 76931 (January 19, 2016), 81 FR 4076 (January 25, 2016) (SR-FINRA-2016-002) (notice of filing and immediate effectiveness of a proposed rule change relating to ATS volume and trading information) (“FINRA ATS Reporting Notice”).

    2. Operational Complexity; Conflict of Interests

    NMS Stock ATSs have grown increasingly complex in terms of the services and functionalities that they offer subscribers, and they have used advances in technology to improve the speed, capacity, and efficiency of the trading functionalities that they offer to execute orders in NMS stocks.16 Additionally, NMS Stock ATSs today offer a wide range of order types, matching systems to bring together orders and counterparties in NMS stocks, order interaction protocols, or opportunities to customize trading parameters, such as parameters that allow subscribers to preference interaction of their order flow with that of certain other specific subscribers or types of subscribers.17 A variety of market participants use these ATSs to display or execute orders and trading interest in NMS stocks, including broker-dealers that route customer orders to ATSs for execution and potential price improvement, and asset managers that seek to execute large size orders without suffering adverse price impact.18

    16 ATSs that traded NMS stocks prior to the adoption of Regulation ATS did not offer the same services and functionalities that they do today. See Proposal, supra note 2, at 81009.

    17See id. at 81009-81010.

    18 Market participants may include many different types of persons seeking to transact in NMS stocks, including broker-dealers and institutional or retail investors. See id. at 81001 n.28 and accompanying text.

    The relationships between broker-dealer operators 19 and the ATSs they operate have also become more complex and intertwined since the adoption of Regulation ATS.20 The broker-dealer operator of an NMS Stock ATS controls all aspects of the operation of the ATS, including, among other things: the means of access to the ATS; who may trade on the ATS; how orders are matched and executed; and any differences in access to services among subscribers.21 The broker-dealer operator, or its affiliate, may also own, and control access to, the technology and systems that support the trading facilities of the NMS Stock ATS, or provide and control the personnel servicing the ATS's trading facilities.22 Additionally, the broker-dealer operator, or in some cases, its affiliates, determines the means by which orders are entered on the ATS, in many cases, through the use of a smart order router that is owned and operated by the broker-dealer operator or one of its affiliates.23 The broker-dealer operator, or in some cases, its affiliates, also controls the market data that the ATS uses to match, and execute orders and the transmission of, and access to, confidential order and execution information sent to and from the ATS.24 The operations of the NMS Stock ATS and the other operations of the broker-dealer operator are usually closely intertwined, and the broker-dealer operator may leverage its information technology, systems, personnel, and market data, and those of its affiliates, to operate the ATS.

    19See Proposal, supra note 2, at 81010, 81041-81043.

    20See id.

    21See id. at 81010.

    22See id. Some technology or functions of an ATS may be licensed from a third party. The broker-dealer operator of the ATS is nonetheless legally responsible for ensuring that all aspects of the ATS comply with applicable laws. See id. at 81041 n.362.

    23See id. at 81041.

    24See id. For example, the broker-dealer operator determines the source of market data that the NMS Stock ATS uses to calculate the NBBO and how the NBBO will be calculated.

    Furthermore, ATSs that trade NMS stocks are increasingly operated by multi-service broker-dealers that engage in significant brokerage and dealing activities in addition to operation of their ATS.25 These other business activities may include, among others, providing algorithmic trading software, agency sales desk support, and automated smart order routing services, often with, or through, their affiliates. As indicated by commenters, the fees charged to subscribers for their use of an NMS Stock ATS operated by a multi-service broker-dealer are generally bundled with other services offered by the broker-dealer operator to subscribers.26 Multi-service broker-dealers that also operate NMS Stock ATSs may use the ATS as a complement to the broker-dealer's other service lines. For instance, the broker-dealer operator of an NMS Stock ATS, or its affiliate, may also operate an OTC market making desk or principal trading desk,27 or may have other business units that actively trade NMS stocks on a principal or agency basis in the ATS or at other trading centers.28 Some of these broker-dealer operators that operate multiple NMS Stock ATSs may use their ATSs as an opportunity to execute orders “in house” before seeking contra-side interest at other execution venues. A multi-service broker-dealer may also execute orders in NMS stocks internally (and not within its ATS) by trading as principal against such orders or crossing orders as agent in a riskless principal capacity, before routing the orders to its NMS Stock ATS or another external trading center. Consequently, the non-ATS trading centers operated by the broker-dealer operator of an NMS Stock ATS, or its affiliates, may compete with the ATS for the execution of transactions in NMS stocks.

    25 Throughout the Proposal and this release, broker-dealer operators of NMS Stock ATSs that provide brokerage or dealing services in addition to operating an ATS are referred to as “multi-service broker-dealers.” See id. at 81001 n.30.

    26See infra Section V.D.19.

    27 These non-ATS, OTC activities in NMS stocks may include operating as an OTC market maker or block positioner or operating an internal broker-dealer system. See 2010 Equity Market Structure Release, supra note 13, at 3599-3600. Additionally, an affiliate of the broker-dealer operator of an NMS Stock ATS may also operate non-ATS trading centers.

    28See id. See also infra Section V.C (discussing comments on the proposed disclosure requirements of Form ATS-N).

    B. Exemption for Alternative Trading Systems

    Exchange Act Rule 3b-16(a) 29 provides a functional test to assess whether a trading platform meets the definition of exchange, and if so, triggers the requirement to register as a national securities exchange pursuant to Section 5 of the Exchange Act 30 and comply with the requirements applicable to exchanges. Under Rule 3b-16(a), “an organization, association, or group of persons shall be considered to constitute, maintain, or provide `a market place or facilities for bringing together purchasers and sellers of securities or for otherwise performing with respect to securities the functions commonly performed by a stock exchange,' if such organization, association, or group of persons: (1) Brings together the orders for securities of multiple buyers and sellers; and (2) uses established, non-discretionary methods (whether by providing a trading facility or by setting rules) under which such orders interact with each other, and the buyers and sellers entering such orders agree to the terms of a trade.” 31 Exchange Act Rule 3b-16(b) explicitly excluded certain systems that the Commission believed were not exchanges.32 Accordingly, a system is not included in the Commission's interpretation of “exchange” if: (1) The system fails to meet the two-part test in paragraph (a) of Rule 3b-16; (2) the system falls within one of the exclusions in paragraph (b) of Rule 3b-16; or (3) the Commission otherwise conditionally or unconditionally exempts 33 the system from the definition.

    29See 17 CFR 240.3b-16. See generally Regulation ATS Adopting Release, supra note 3. See also Proposal, supra note 2, at 81004 (discussing the current exemption from the definition of exchange available to ATSs).

    30See 15 U.S.C. 78f.

    31See 17 CFR 240.3b-16(a).

    32See Regulation ATS Adopting Release, supra note 3, at 70852. Specifically, Rule 3b-16(b) excludes from the definition of exchange systems that perform only traditional broker-dealer activities, including: (1) systems that route orders to a national securities exchange, a market operated by a national securities association, or a broker-dealer for execution, or (2) systems that allow persons to enter orders for execution against the bids and offers of a single dealer if certain additional conditions are met.

    33See 17 CFR 240.3b-16(e).

    Section 5 of the Exchange Act 34 requires an organization, association, or group of persons that meets the definition of “exchange” under Section 3(a)(1) of the Exchange Act,35 unless otherwise exempt, to register with the Commission as a national securities exchange pursuant to Section 6 of the Exchange Act.36 Registered national securities exchanges are also SROs,37 and must comply with regulatory requirements applicable to both national securities exchanges and SROs.38 Before a national securities exchange may commence operations, the Commission must approve the national securities exchange's application for registration filed on Form 1. Section 6(b) of the Exchange Act requires, among other things, that the national securities exchange be so organized and have the capacity to carry out the purposes of the Exchange Act and to comply, and enforce compliance by its members and persons associated with its members, with the federal securities laws and the rules of the exchange.39 Both a national securities exchange's registration application and the Commission's order approving the application are public. After registering, a national securities exchange must file with the Commission any proposed changes to its rules.40 The initial application on Form 1, amendments thereto, and filings for proposed rule changes, in combination, publicly disclose important information about national securities exchanges, such as the trading services they offer and fees they charge for those services.

    34 15 U.S.C. 78e.

    35 Pursuant to Section 3(a)(1) of the Exchange Act, the statutory definition of “exchange” means “any organization, association, or group of persons, whether incorporated or unincorporated, which constitutes, maintains, or provides a market place or facilities for bringing together purchasers and sellers of securities or for otherwise performing with respect to securities the functions commonly performed by a stock exchange. . . .” 15 U.S.C. 78c(a)(1).

    36 15 U.S.C. 78f. A “national securities exchange” is an exchange registered as such under Section 6 of the Exchange Act.

    A trading platform that meets the definition of “exchange” under Section 3(a)(1) of the Exchange and fails to register with the Commission as a national securities exchange pursuant to Section 6 of the Exchange Act, unless exempt, risks operating as an unregistered exchange in violation of Section 5 of the Exchange Act. See, e.g., Report of Investigation Pursuant to Section 21(a) of the Securities Exchange Act of 1934: The DAO, Securities Exchange Act Release No. 81207 (July 25, 2017) https://www.sec.gov/litigation/investreport/34-81207.pdf (“DAO Report”) (finding that certain tokens offered and sold by a “virtual” organization were securities, and confirming that issuers of distributed ledger or blockchain technology-based securities must register offers and sales of such securities unless a valid exemption applies, and that securities exchanges providing for trading in these securities must register unless they are exempt). Specifically, we confirmed that a system that meets the criteria of Rule 3b-16(a), and is not excluded under Rule 3b-16(b), must register as a national securities exchange pursuant to Sections 5 and 6 of the Exchange Act or operate pursuant to an appropriate exemption. See id. at Section III.D. See also In the Matter of BTC Trading, Corp. and Ethan Burnside, Respondents, Securities Exchange Act Release No. 73783 (December 8, 2014), https://www.sec.gov/litigation/admin/2014/33-9685.pdf (order instituting administrative and cease-and-desist proceedings, making findings, and imposing remedial sanctions and a cease-and-desist order and alleging, among other things, that an operator of two online venues through which account holders could trade securities using virtual currencies violated Section 5 of the Exchange Act by failing to register the trading venues as exchanges).

    37 Section 3(a)(26) of the Exchange Act defines a self-regulatory organization as any national securities exchange, registered securities association, registered clearing agency, or (with limitations) the Municipal Securities Rulemaking Board. See 15 U.S.C. 78c(a)(26). See also Proposal, supra note 2, at 81000-81001 nn. 20-26 and accompanying text (discussing certain differences between certain obligations and benefits applicable to national securities exchanges and those applicable to ATSs).

    38See, e.g., 15 U.S.C. 78f and 78s.

    39See Section 6(b)(1) of the Exchange Act, 15 U.S.C. 78f(b)(1). The Commission must also find that the national securities exchange has rules that meet certain criteria. See generally Exchange Act Section 6(b)(2) through (10), 15 U.S.C. 78f(b)(2) through (10).

    40See generally Section 19(b) of the Exchange Act, 15 U.S.C. 78s(b), and Exchange Act Rule 19b-4, 17 CFR 240.19b-4.

    Exchange Act Rule 3a1-1(a)(2) 41 exempts from the Exchange Act Section 3(a)(1) definition of “exchange” an organization, association, or group of persons that complies with Regulation ATS,42 which requires, among other things, meeting the definition of an ATS and registering as a broker-dealer.43 As a result of the exemption, an organization, association, or group of persons that meets the definition of an exchange and complies with Regulation ATS is not required by Section 5 of the Exchange Act to register as a national securities exchange pursuant to Section 6 of the Exchange Act, is not an SRO, and, therefore, is not required to comply with regulatory requirements applicable to national securities exchanges and SROs.44 An ATS that fails to comply with the requirements of Regulation ATS would no longer qualify for the exemption provided under Rule 3a1-1(a)(2), and thus, risks operating as an unregistered exchange in violation of Section 5 of the Exchange Act.45

    41See 17 CFR 240.3a1-1(a)(2).

    42See id. Rule 3a1-1 also provides two other exemptions from the definition of “exchange” for any ATS operated by a national securities association and any ATS not required to comply with Regulation ATS pursuant to Rule 301(a) of Regulation ATS. See 17 CFR 240.3a1-1(a)(1) and (3).

    Rule 3a1-1(b) provides an exception to the Rule 3a1-1(a) exemptions pursuant to which the Commission may require a trading system that is a substantial market to register as a national securities exchange, if the Commission finds doing so is necessary or appropriate in the public interest or consistent with the protection of investors. See 17 CFR 240.3a1-1(b). See also Regulation ATS Adopting Release, supra note 3, at 70857-70858.

    43See 17 CFR 242.300(a); 17 CFR 242.301(a); and 242.301(b)(1). In addition to the other requirements of Regulation ATS, to qualify for the Rule 3a1-1(a) exemption, an organization, association, or group of persons must otherwise meet the definition of “exchange.”

    44See generally Sections 5, 6, and 19 of the Exchange Act, 15 U.S.C. 78e, 78f, and 78s.

    45See 15 U.S.C. 78e.

    C. Conditions to the ATS Exemption; Confidential Notice Regime

    Rule 300(a) of Regulation ATS defines an ATS as: “any organization, association, person, group of persons, or system: (1) [t]hat constitutes, maintains, or provides a market place or facilities for bringing together purchasers and sellers of securities or for otherwise performing with respect to securities the functions commonly performed by a stock exchange within the meaning of [Rule 3b-16]; and (2) [t]hat does not: (i) [s]et rules governing the conduct of subscribers other than the conduct of such subscribers' trading on such organization, association, person, group of persons, or system; or (ii) [d]iscipline subscribers other than by exclusion from trading.” 46 Governing the conduct of or disciplining subscribers are functions performed by an SRO that we believe should be regulated as such.47 Accordingly, pursuant to the definition in Rule 300(a), a trading system that performs SRO functions, or performs functions common to national securities exchanges, such as establishing listing standards, is precluded from the definition of ATS and would be required to register as a national securities exchange or be operated by a national securities association (or seek another exemption).48

    46See 17 CFR 242.300(a).

    47See Regulation ATS Adopting Release, supra note 3, at 70859. As we noted when we adopted Regulation ATS, any system that uses its market power to regulate its participants should be regulated as an SRO. We stated that it would consider a trading system to be “governing the conduct of subscribers” outside the trading system if it imposed on subscribers, as conditions of participation in trading, any requirements for which the trading system had to examine subscribers for compliance. In addition, we stated our belief that if a trading system imposed as conditions of participation, directly or indirectly, restrictions on subscribers' activities outside of the trading system, such a trading system should be a registered exchange or operated by a national securities association, but that the limitation would not preclude an ATS from imposing credit conditions on subscribers or requiring subscribers to submit financial information to the ATS. See id.

    48See id.

    Rule 301(b)(1) of Regulation ATS requires that every ATS that is subject to Regulation ATS, pursuant to paragraph (a) of Rule 301,49 be registered as a broker-dealer under Section 15 of the Exchange Act.50 As a registered broker-dealer, an ATS must also, in addition to complying with Regulation ATS, comply with broker-dealer filing and conduct obligations, including becoming a member of an SRO, such as the Financial Industry Regulatory Authority (“FINRA”), and comply with SRO rules.51 An ATS must also comply with Rule 301(b)(2) of Regulation ATS, which currently requires all ATSs to file an initial operation report with the Commission on Form ATS 52 at least 20 days before commencing operations.53 Form ATS requirements include that an ATS provide information about: Classes of subscribers and differences in access to the services offered by the ATS to different groups or classes of subscribers; securities the ATS expects to trade; any entity other than the ATS involved in its operations; the manner in which the system operates; how subscribers access the trading system; procedures governing order entry; and procedures governing execution, reporting, clearance, and settlement of transactions effected through the ATS.54 Regulation ATS states that information filed by an ATS on Form ATS is “deemed confidential when filed” 55 and ATSs are not otherwise required to publicly disclose such information.56

    49 Pursuant to Rule 301(a), certain ATSs that are subject to other appropriate regulations are not required to comply with Regulation ATS. These ATSs include those that are: Registered as a national securities exchange under Section 6 of the Exchange Act; exempt from national securities exchange registration based on the limited volume of transactions effected; operated by a national securities association; Registered as a broker-dealer under Sections 15(b) or 15C of the Exchange Act, or are banks, that limits their activities to certain instruments; or exempted, conditionally or unconditionally, by Commission order, after application by such ATS. See 17 CFR 242.301(a).

    50See 17 CFR 242.301(b)(1).

    51 Section 15(b)(8) of the Exchange Act requires a broker or dealer to become a member of a registered national securities association, unless it effects transactions in securities solely on an exchange of which it is a member. 15 U.S.C. 78o(b)(8). See also Regulation ATS Adopting Release, supra note 3, at 70903 (discussing some of the regulatory obligations of registered broker-dealers, such as membership in an SRO and compliance with that SRO's rules). For example, a broker-dealer that is a FINRA member must file an application for approval of a material change to its business operations (as defined in FINRA Rule 1011(k)). See FINRA Rule 1017(a). Among other obligations, a broker-dealer operator of an NMS Stock ATS that is a FINRA member is subject to trade reporting requirements pursuant to FINRA rules. See, e.g., supra note 15 (discussing FINRA trade reporting requirements applicable to NMS Stock ATSs).

    52 Form ATS and the Form ATS Instructions are available at http://www.sec.gov/about/forms/formats.pdf.

    53See 17 CFR 242.301(b)(2)(i). The Commission stated in the Regulation ATS Adopting Release that Form ATS would provide the Commission the opportunity to identify problems that might impact investors before the system begins to operate. See Regulation ATS Adopting Release, supra note 3, at 70864; Proposal, supra note 2, at 81005 n.70 and accompanying text. Unlike a Form 1 filed by a national securities exchange, Form ATS is not approved by the Commission. Instead, Form ATS provides the Commission with notice about an ATS's operations prior to commencing operations. See Regulation ATS Adopting Release, supra note 3, at 70864.

    54See Proposal, supra note 2, at 81005.

    55 17 CFR 242.301(b)(2)(vii). See Form ATS.

    56 As we noted in the Proposal, some ATSs may currently make voluntary public disclosures. See Proposal, supra note 2, at 81011, n.156. See also infra note 559 and accompanying text (discussing comments regarding voluntary postings of Form ATS by NMS Stock ATSs).

    ATSs must notify the Commission of any changes in their operations by filing an amendment to its Form ATS initial operation report. There are three types of amendments to an initial operation report.57 First, if any material change is made to its operations, the ATS must file an amendment on Form ATS at least 20 calendar days before implementing such change.58 Second, if any information contained in the initial operation report becomes inaccurate for any reason and has not been previously reported to the Commission as an amendment on Form ATS, the ATS must file an amendment on Form ATS correcting the information within 30 calendar days after the end of the calendar quarter in which the system has operated.59 Third, an ATS must promptly file an amendment on Form ATS correcting information that it previously reported on Form ATS after discovery that any information was inaccurate when filed.60 Also, upon ceasing to operate as an ATS, an ATS is required to promptly file a cessation of operations report on Form ATS.61 As is the case with respect to initial operation reports, Form ATS amendments and cessation of operations reports serve as notice to the Commission of changes to the ATS's operations,62 and Rule 301(b)(2)(vii) and the Instructions to the form state that Form ATS is “deemed confidential.” 63

    57 Form ATS is used for three types of submissions: Initial operation reports; amendments to initial operation reports; and cessation of operations reports. An ATS designates the type of submission on the form. See Form ATS.

    58See 17 CFR 242.301(b)(2)(ii). A “material change,” includes, but is not limited to, any change to the operating platform, the types of securities traded, or the types of subscribers. In addition, the Commission has stated that ATSs implicitly make materiality decisions in determining when to notify their subscribers of changes. See Regulation ATS Adopting Release, supra note 3, at 70864. See also infra Section IV.B.1.a.ii (discussing the materiality standard that would apply to the filing of amendments on Form ATS-N).

    59See 17 CFR 242.301(b)(2)(iii).

    60See 17 CFR 242.301(b)(2)(iv).

    61See 17 CFR 242.301(b)(2)(v).

    62See Regulation ATS Adopting Release, supra note 3, at 70864.

    63See 17 CFR 242.301(b)(2)(vii); Form ATS at 3, General Instructions A.7. Under the final rules, NMS Stock ATSs that trade only NMS stocks will not be required to file Form ATS in accordance with Rules 301(b)(2)(i) through (vii), but instead will be required to comply with the requirements of new Rule 304 and file Form ATS-N. See infra Section III.B.4. See also infra Sections IV.A, B, and C.

    Rule 301(b)(9) of Regulation ATS also requires an ATS to periodically report certain information about transactions on the ATS and information about certain activities on Form ATS-R within 30 calendar days after the end of each calendar quarter in which the market has operated.64 Form ATS-R requires quarterly volume information for specified categories of securities, as well as a list of all securities traded on the ATS during the quarter and a list of all subscribers that were participants during the quarter.65 As with respect to Form ATS, Rule 301(b)(2)(vii) and the instructions to Form ATS-R state that Form ATS-R is “deemed confidential.” 66 Under the amendments we are adopting, the requirements of Rule 301(b)(9) will continue to apply to all ATSs, including NMS Stock ATSs, as will the other requirements of Regulation ATS other than the Form ATS reporting requirements of Rule 301(b)(2).67

    64See 17 CFR 242.301(b)(9)(i). Form ATS-R and the Form ATS-R Instructions are available at https://www.sec.gov/about/forms/formats-r.pdf. In the Regulation ATS Adopting Release, the Commission stated that the information provided on Form ATS-R would permit the Commission to monitor the trading on ATSs. See Regulation ATS Adopting Release, supra note 3, at 70878.

    65See Form ATS-R at 4, Items 1 and 2 (describing the requirements for Exhibit A and Exhibit B of Form ATS-R). Form ATS-R also requires an ATS that is subject to the fair access obligations under Rule 301(b)(5) of Regulation ATS to provide as Exhibit C, a list of all persons granted, denied, or limited access to the ATS during the period covered by the Form ATS-R and designate for each person (a) whether it was granted, denied, or limited access; (b) the date the ATS took such action; (c) the effective date of such action; and (d) the nature of any denial or limitation of access. ATSs must also complete and file Form ATS-R within 10 calendar days after ceasing to operate. See 17 CFR 242.301(b)(9)(ii); Form ATS-R at 2, General Instructions A.2 to Form ATS-R.

    66See 17 CFR 242.301(b)(2)(vii); Form ATS-R at 2, General Instruction A.7.

    67See generally infra Section III. See also Section III.B.5.

    Under Rule 301(b)(3), an ATS that (1) displays subscriber orders in an NMS stock to any person (other than an employee of the ATS) and (2) during at least four of the preceding six calendar months, had an average daily trading volume of 5% or more of the aggregate average daily share volume for that NMS stock, as reported by an effective transaction reporting plan, must comply with certain order display and execution access obligations.68 An ATS that meets these criteria must comply with Rule 301(b)(3)(ii), which requires the ATS to provide to a national securities exchange or national securities association (each an SRO), for inclusion in the quotation data made available by the SRO to vendors, the prices and sizes of its orders at the highest buy price and lowest sell price for that NMS stock that are displayed to more than one subscriber.69 An ATS that meets the volume threshold also is required to comply with Rule 301(b)(3)(iii), which sets forth certain access standards regarding the orders that the ATS is required to provide to an SRO pursuant to Rule 301(b)(3)(ii).70 Under Rule 301(b)(4), an ATS must not charge any fee to broker-dealers that access the ATS through a national securities exchange or national securities association that is inconsistent with the equivalent access to the ATS that is required under Rule 301(b)(3)(iii).71

    68See 17 CFR 242.301(b)(3)(i).

    69See 17 CFR 242.301(b)(3)(ii).

    70See 17 CFR 242.301(b)(3)(iii).

    71See 17 CFR 242.301(b)(4). In addition, if the national securities exchange or national securities association to which an ATS provides the prices and sizes of orders under Rules 301(b)(3)(ii) and 301(b)(3)(iii) establishes rules designed to assure consistency with standards for access to quotations displayed on such national securities exchange, or the market operated by such national securities association, the ATS shall not charge any fee to members that is contrary to, that is not disclosed in the manner required by, or that is inconsistent with any standard of equivalent access established by such rules. See id.

    Under Rule 301(b)(5)—and even if the ATS does not display subscribers' orders to any person (other than an ATS employee)—an ATS with 5% or more of the average daily volume in an NMS stock during at least four of the preceding six calendar months, as reported by an effective transaction reporting plan, must: 72 Establish written standards for granting access to trading on its system; not unreasonably prohibit or limit any person in respect to access to services offered by such ATS by applying the above standards in an unfair or discriminatory manner; make and keep records of all grants of access including, for all subscribers, the reasons for granting such access, and all denials or limitations of access and reasons, for each applicant, for denying or limiting access; and report the information required in Exhibit C of Form ATS-R regarding grants, denials, and limitations of access.73 These requirements are referred to as the “fair access” requirements and apply on a security-by-security basis.74 A denial of access to a market participant after an ATS reaches the 5% fair access threshold in an NMS stock would be reasonable if it is based on objective standards.75

    72 17 CFR 242.301(b)(5)(i).

    73See 17 CFR 242.301(b)(5)(ii). Regulation ATS does not mandate compliance with these requirements when an ATS reaches the 5% trading threshold in an NMS stock if the following conditions are met: The ATS matches customer orders for a security with other customer orders; such customers' orders are not displayed to any person, other than employees of the ATS; and such orders are executed at a price for such security disseminated by an effective transaction reporting plan, or derived from such prices. See 17 CFR 242.301(b)(5)(iii).

    74 The fair access requirements also apply for non-NMS stocks when an ATS reaches a 5% trading threshold in certain securities other than NMS stocks, including certain equity securities, municipal securities, and corporate debt securities. See 17 CFR 242.301(b)(5)(i).

    75See Regulation ATS Adopting Release, supra note 3, at 70874.

    Prior to the Commission's adoption of Regulation SCI,76 NMS Stock ATSs were required to comply with Rule 301(b)(6), which requires certain ATSs trading 20% or more of the volume in any equity security or debt securities to comply with standards regarding the capacity, integrity, and security of their automated systems.77 Regulation SCI superseded and replaced Rule 301(b)(6)'s requirements with regard to ATSs that trade NMS stocks and equity securities that are not NMS stocks 78 and requires SCI entities,79 including NMS Stock ATSs that meet the definition of an “SCI ATS,” 80 to establish written policies and procedures reasonably designed to ensure that their systems have levels of capacity, integrity, resiliency, availability, and security adequate to maintain their operational capability and promote the maintenance of fair and orderly markets, and that they operate in a manner that complies with the Exchange Act.81

    76See Securities Exchange Act Release No. 73639 (November 19, 2014), 79 FR 72251 (December 5, 2014) (adopting final rules for systems compliance and integrity) (“SCI Adopting Release”).

    77See 17 CFR 242.301(b)(6).

    78 Regulation SCI does not apply to ATSs that trade municipal securities or corporate debt securities. See SCI Adopting Release, supra note 76, at 72262.

    79 Regulation SCI defines “SCI entity” to mean “an SCI self-regulatory organization, SCI alternative trading system, plan processor, or exempt clearing agency subject to [the Commission's Automation Review Policies].” See 17 CFR 242.1000.

    80 Regulation SCI defines “SCI alternative trading system” or “SCI ATS” to mean an ATS, which during at least four of the preceding six calendar months: (1) Had with respect to NMS stocks (a) five percent (5%) or more in any single NMS stock, and one-quarter percent (0.25%) or more in all NMS stocks, of the average daily dollar volume reported by applicable transaction reporting plans, or (b) one percent (1%) or more in all NMS stocks of the average daily dollar volume reported by applicable transaction reporting plans; or (2) had with respect to equity securities that are not NMS stocks and for which transactions are reported to a self-regulatory organization, five percent (5%) or more of the average daily dollar volume as calculated by the self-regulatory organization to which such transactions are reported. However, an SCI ATS is not required to comply with the requirements of Regulation SCI until six months after satisfying the aforementioned criteria. See 17 CFR 242.1000.

    81See SCI Adopting Release, supra note 76, 79 FR at 72252.

    Rule 301(b)(7) 82 requires all ATSs, regardless of the volume traded on their systems, to permit the examination and inspection of their premises, systems, and records, and cooperate with the examination, inspection, or investigation of subscribers, whether such examination is being conducted by the Commission or by an SRO of which such subscriber is a member. Rule 301(b)(8) 83 requires all ATSs to make and keep current the records specified in Rule 302 of Regulation ATS 84 and preserve the records specified in Rule 303 of Regulation ATS.85

    82See 17 CFR 242.301(b)(7).

    83See 17 CFR 242.301(b)(8).

    84See 17 CFR 242.302.

    85See 17 CFR 242.303. In the Regulation ATS Adopting Release, the Commission stated that these requirements to make, keep, and preserve records are necessary to create a meaningful audit trail and to permit surveillance and examination to help ensure fair and orderly markets. See Regulation ATS Adopting Release, supra note 3, at 70877-78.

    Under Rule 301(b)(10), all ATSs must establish adequate safeguards and procedures to protect subscribers' confidential trading information, which includes limiting access to the confidential trading information of subscribers to those employees of the ATS who are operating the system or responsible for its compliance with Regulation ATS or any other applicable rules; and implementing standards controlling employees of the ATS trading for their own accounts.86

    86See 17 CFR 242.301(b)(10)(i).

    Furthermore, all ATSs must adopt and implement adequate oversight procedures to ensure that the above safeguards and procedures are followed.87 Finally, Rule 301(b)(11) 88 expressly prohibits any ATS from using the word “exchange” or derivations of the word “exchange,” such as the term “stock market,” in its name.89

    87See 17 CFR 242.301(b)(10)(ii).

    88See 17 CFR 240.301(b)(11).

    89 When we proposed Regulation ATS, we said that “it is important that the investing public not be confused about the market role [ATSs] have chosen to assume.” See Regulation ATS Proposing Release, supra note 7 at 23523. We expressed concern that “use of the term `exchange' by a system not regulated as an exchange would be deceptive and could mislead investors that such alternative trading system is registered as a national securities exchange.” See id.

    D. Concerns Regarding the Lack of Operational Transparency

    Despite their role in the equity markets and complexity of their operations, NMS Stock ATSs are not required under Regulation ATS to publicly disclose information about their operations. We are concerned that little information is widely available to market participants about NMS Stock ATSs, and that the lack of, or differential access to, information about operations of NMS Stock ATSs inhibits the ability of market participants to assess NMS Stock ATSs as potential trading venues. These concerns are shared by several commenters.90 Commenters also concur with our belief that NMS Stock ATSs today play a significant role in equity market structure, and that their role has changed since Regulation ATS was adopted in 1998.91 In addition, commenters reinforce our belief that NMS Stock ATSs have become more operationally complex, that the potential for conflicts of interest has risen as a result of that complexity, and that the conditions to the exemption for NMS Stock ATSs should be modified.92 Commenters also express concern about the lack of operational transparency for NMS Stock ATSs.93 Given the complexities of NMS Stock ATS operations, the lack of information about the ATS's order types, priority rules, segmentation procedures, use of market data, and fees, for example, may impede the ability of market participants to adequately understand how their orders in NMS stocks would interact, match, and execute.

    90See, e.g., CFA Institute Letter at 2; ICI Letter at 3; Better Markets Letter at 2; Investor Advocate Letter at 14; Luminex Letter at 1.

    91See, e.g., SIFMA Letter at 2; Investor Advocate Letter at 4; LeveL ATS Letter at 2. Other commenters also recognized that the role of NMS Stock ATSs has changed since the adoption of Regulation ATS. See, e.g., Schneiderman Letter at 1; Virtu Letter at 2; UBS Letter at 1; Fidelity Letter at 1; ICI Letter at 2-3; STANY Letter at 2-3.

    92See, e.g., Consumer Federation of America Letter at 4; ICI Letter at 2; HMA Letter at 18; Schneiderman Letter at 1-2; Better Markets Letter at 2; CFA Institute Letter at 2; SIFMA Letter at 8. See also infra Section V.D (describing comments on proposed disclosures required by Form ATS-N).

    93See, e.g., CBOE Letter at 1; CFA Institute Letter at 3; Consumer Federation of America Letter at 2; ICI Letter at 3. See also Investor Advocate Letter at 14; Luminex Letter at 1; Consumer Federation of America Letter at 4; UBS Letter at 5-7; AI Letter at 2. One commenter critiques both the current regulatory regime for ATSs, as well as the Proposal, but describes issues with the lack of transparency and states that the Proposal represents an important enhancement in the oversight of ATSs. See Better Markets Letter at 1-2.

    We are also concerned that the lack of available information about the ATS-related activities of the broker-dealer operator and its affiliates may hinder the ability of market participants to evaluate potential conflicts of interest, and thus limit their ability to protect their interests. Because of overlap between a broker-dealer's ATS operations and its other operations, there is a risk of information leakage of subscribers' confidential trading information to other business units of the broker-dealer operator or its affiliates.94 Several commenters describe NMS Stock ATS operational structures that exemplify the kinds of relationships about which the Commission expressed concern, or otherwise reinforce our belief that the complex relationship between an NMS Stock ATS and its broker-dealer operator, or its affiliates, creates potential conflicts of interest.95 Further, in recognizing the current potential for conflicts of interest that exist as a result of the complexity of the operations of NMS Stock ATSs, the relationship many have with their broker-dealer operator or its affiliates, and the lack of transparency about those operations and potential conflicts, many commenters also highlight recent enforcement actions brought by the Commission.96

    94 In the Regulation ATS Adopting Release, the Commission recognized the potential for abuse involving a broker-dealer that operates an ATS and offers other traditional brokerage services, and expressed concern about the potential for the misuse of confidential trading information. See Regulation ATS Adopting Release, supra note 3, at 70879. See also Proposal, supra note 2, at 81041-81042 n.367 and accompanying text.

    95See, e.g., Consumer Federation of America Letter at 4; LeveL ATS Letter at 3; Fidelity Letter at 2 n.4. See also KCG Letter at 2; Luminex Letter at 3-4; Liquidnet Letter at 11.

    Not all NMS Stock ATSs, however, are operated by multi-service broker-dealers. See, e.g., BIDS Letter at 1. This commenter describes itself as the owner and broker-dealer operator of an NMS Stock ATS that does not engage in any proprietary trading and does not have any trading affiliates.

    The rules being adopted today would not require a broker-dealer that operates an NMS Stock ATSs to limit it business only to operating the ATS. We believe that the Form ATS-N disclosures will inform market participants about the ATS-related activities of the broker-dealer operator and its affiliates that give rise to potential conflicts between the interests of the broker-dealer operator and subscribers that use the services of the NMS Stock ATS. See infra Sections X.D.7 (discussing the alternative of requiring NMS Stock ATSs to operate as limited purpose entities) and V.C.8 (discussing comments stating that the Commission should prohibit conflicts of interest arising from the other business activities of the broker-dealer operator of an NMS Stock ATS, and those of its affiliates, and the Commission's response to those comments).

    See also HMA Letter at 3 and attachment The Dark Side of the Pools: What Investors Should Learn from Regulator's Action, September 15, 2015, at 10; Investor Advocate Letter at 8; Better Markets Letter at 2; infra Section V.C (discussing comments related to disclosures about the activities of an NMS Stock ATS's broker-dealer affiliate and those of its affiliates).

    96See, e.g., Schneiderman Letter at 2; Better Markets Letter at 2-3; Consumer Federation of America Letter at 5; and HMA Letter at 12, 16-17. See also CFA Institute Letter at 2; Fidelity Letter at 4; Investor Advocate Letter at 5; Citadel Letter at 1-7.

    One commenter, however, observes that in the recent settlements cited in the Proposal, there were conflicts of interest related to commercial relationships that had nothing to do with affiliates, and believes that all differential treatment of subscribers should be disclosed and recommends limiting disclosures regarding affiliate relationships. See Markit Letter at 8. Under the requirements we are adopting today, NMS Stock ATSs must disclose on Form ATS-N differences in treatment of subscribers and the broker-dealer operator and affiliate, and we have, in response to commenters, revised questions of Form ATS-N to narrow the scope of information related to affiliates to be disclosed. See infra Sections V.C and D.

    See also Proposal, supra note 2, at 81042-81043 n.374 (citing prior settled enforcement actions against ATSs that trade NMS stocks). Since the Proposal, we have entered additional settlements regarding NMS Stock ATSs. See In the Matter of Barclays Capital Inc., Securities Exchange Act Release No. 77001 (Jan. 31, 2016), https://www.sec.gov/litigation/admin/2016/33-10010.pdf (order instituting administrative and cease-and-desist proceedings, making findings, and imposing remedial sanctions and a cease-and-desist order); In the Matter of Credit Suisse Securities (USA) LLC, Securities Act Release No. 77002 (Jan. 31, 2016), https://www.sec.gov/litigation/admin/2016/33-10013.pdf (order instituting administrative and cease-and-desist proceedings, making findings, and imposing remedial sanctions and a cease-and-desist order) (“Crossfinder Settlement”); In the Matter of Credit Suisse Securities (USA) LLC, Securities Act Release No. 77003 (Jan. 31, 2016), https://www.sec.gov/litigation/admin/2016/33-10014.pdf (order instituting administrative and cease-and-desist proceedings, making findings, and imposing remedial sanctions and a cease-and-desist order); In the Matter of Deutsche Bank Securities Inc., Securities Exchange Act Release No. 79576 (Dec. 16, 2016), https://www.sec.gov/litigation/admin/2016/33-10272.pdf (order instituting administrative and cease-and-desist proceedings, making findings, and imposing remedial sanctions and a cease-and-desist order).

    NMS Stock ATSs, which meet the definition of “exchange” but are not required to register with the Commission as national securities exchanges, compete with national securities exchanges and operate with similar complexity. Unlike national securities exchanges, NMS Stock ATSs are not required to, among other things, publicly disclose their operations and fees.97 In addition, because we review the rules of national securities exchanges, a process which requires, among other things, that to approve certain rule changes, the Commission find 98 that the national securities exchange's proposed rule changes are consistent with the Exchange Act,99 each existing national securities exchange has implemented rules that restrict affiliation between the national securities exchange and its members to mitigate the potential for conflicts of interest. We believe that the regulatory differences between NMS Stock ATSs and national securities exchanges with regard to disclosure obligations may create a competitive imbalance between two functionally similar trading centers that trade the same security.

    97See infra notes 34-40 and accompanying text (discussing the regulatory framework applicable to national securities exchanges, including that national securities exchanges are self-regulatory organizations (“SROs”)). See also Regulation ATS Adopting Release, supra note 3; infra Section II.B (discussing the current requirements of Regulation ATS applicable to all ATSs).

    98See Proposal, supra note 2, at 81042 n.372 and accompanying text.

    99See 15 U.S.C. 78s(b).

    Transparency has long been a hallmark of the U.S. securities markets, and is one of the primary tools used by investors to protect their interests.100 We believe that one of the most important functions the Commission can perform for investors is to ensure that they have access to the information they need to protect and further their own interests.101 The amendments that we are adopting to Regulation ATS and Exchange Act Rule 3a1-1 are designed to address the concerns identified above and provide benefits to a wide range of market participants. Public disclosures on Form ATS-N will provide market participants with information about the operations of an NMS Stock ATS, which they can use to understand how orders interact, match, and execute in an NMS Stock ATS and compare to other NMS Stock ATSs and national securities exchanges. Form ATS-N will also provide the public with information about the ATS-related activities of the broker-dealer operator and its affiliates, which can be used by market participants to assess potential conflicts of interest and information leakage.102 Collectively, the Form ATS-N public disclosures will allow market participants to better evaluate an NMS Stock ATS as a potential trading destination for their orders and help them better protect their interests. The Form ATS-N public disclosures are also designed, in part, to bring the operational transparency requirements for NMS Stock ATSs more in line with the requirements for national securities exchanges. Finally, we believe that our process for reviewing Form ATS-N filings, which provides for Commission review of disclosures for compliance with the requirements of Rule 304 and Form ATS-N, and a potential declaration of ineffectiveness of a Form ATS-N, after notice and opportunity for hearing, will facilitate better Commission oversight of NMS Stock ATSs and thus, better protection of investors.

    100See id.

    101See Proposal, supra note 2, at 81010.

    102See id. at 81042. We believe that to understand the operations of an NMS Stock ATS, it is necessary to understand the relationship and interactions between the NMS Stock ATS and its registered broker-dealer operator as well as the relationship and interactions between the NMS Stock ATS and the affiliates of its broker-dealer operator.

    III. Heightened Regulatory Requirements for NMS Stock ATSs A. Exchange Act Rule 3a1-1(a) Exemption: New Conditions for NMS Stock ATSs

    ATSs that trade NMS stocks operate pursuant to the exemption provided by Exchange Act Rule 3a1-1(a)(2), which exempts from the definition of an “exchange” any ATS that complies with Rules 300 through 303 of Regulation ATS.103 Given our concerns regarding the lack of public transparency around the operations of NMS Stock ATSs and the ATS-related activities of the broker-dealer operator and its affiliates, we proposed to expand the conditions of the Rule 3a1-1(a)(2) exemption to enhance operational transparency and oversight for these ATSs. We are adopting this requirement as proposed.104 We proposed to require NMS Stock ATSs to comply with proposed Rule 304, in addition to existing Rules 300 through 303 of Regulation ATS (except Rule 301(b)(2)), to be eligible for the exemption.105 Proposed Rule 304(a)(1)(i) set forth two new fundamental conditions to the Rule 3a1-1(a)(2) exemption: (1) An NMS Stock ATS must file Form ATS-N with the Commission (instead of the current Form ATS), and (2) the Commission must declare the Form ATS-N effective before the NMS Stock ATS can operate pursuant to the exemption. Adopted Rule 304(a)(1)(i) deletes the proposed condition that the Commission declare the Form ATS-N effective, and provides that the Form ATS-N must be effective pursuant to Rule 304(a)(1)(iii) or Rule 304(a)(1)(iv)(A). Adopted Rule 304(a)(1)(iii) has been modified to provide that Form ATS-N will become effective if the Commission does not otherwise declare Form ATS-N ineffective—the Commission will not be declaring Form ATS-N filings effective.106

    103 17 CFR 240.3a1-1(a)(2).

    104 In Exchange Act Rules 3a1-1(a)(2) and (3), Regulation ATS is currently defined as “17 CFR 242.300 through 242.303.” We are amending the references to Regulation ATS to define Regulation ATS as “17 CFR 242.300 through 242.304.” We also proposed conforming Rule 3a1-1(a)(3) by changing the reference to Rule 303 to Rule 304 to make clear that an NMS Stock ATS that meets the requirements of Rule 301(a) is not required to comply with Regulation ATS, which would be amended to include proposed Rule 304. No changes were proposed to Rule 3a1-1(a)(1), which exempts any ATS that is operated by a national securities association.

    105 Proposed Rule 304(a) provided that, unless not required to comply with Regulation ATS pursuant to Rule 301(a) of Regulation ATS, an NMS Stock ATS must comply with Rules 300 through 304 of Regulation ATS (except Rule 301(b)(2)) to be exempt from the definition of an “exchange” pursuant to Exchange Act Rule 3a1-1(a)(2). We are adopting proposed Rule 304(a) with certain modifications. As adopted, Rule 304(a) will state, “[u]nless not required to comply with Regulation ATS pursuant to § 242.301(a), an NMS Stock ATS must comply with §§ 242.300 through 242.304 (except §§ 242.301(b)(2)(i) through (vii)) to be exempt pursuant to § 240.3a-1(a)(2)” (emphasis added). The adopted rule text specifies the subparagraphs of Rule 301(b)(2) with which an NMS Stock ATS would not be required to comply. We believe that specifying the applicable subsections of Rule 301(b)(2) provides greater clarity, because Rule 301(b)(2)(viii) will apply to NMS Stock ATSs that also trade non-NMS stocks. The reference to Rule 301(b)(2) in the proposed rule text could be confusing to market participants because it does not make clear that Rule 301(b)(2)(viii) applies to certain NMS Stock ATSs. We believe that the added specificity in the adopted rule clarifies that only Rules 301(b)(2)(i) through (vii) will not be applicable to NMS Stock ATSs. See infra Section III.B.4. In addition, to reduce any potential ambiguity and improve readability, the adopted rule text deletes the language that states that the NMS Stock ATS would need to comply with the requirements to be exempt “from the definition of an `exchange'” pursuant to Exchange Act Rule 3a1-1(a)(2).

    106See infra Section IV.A.3.

    We proposed to amend Rules 3a1-1(a)(2) and (3) to require compliance with proposed Rule 304 as a condition to operating pursuant to the Rule 3a1-1(a)(2) exemption.107 We received several comments on the proposal to expand the conditions of the Rule 3a1-1(a)(2) exemption for NMS Stock ATSs and require these ATSs to comply with Rule 304. We also received comments on the application of the Proposal to ATSs that trade securities other than NMS stocks, and, specifically, requiring these types of ATSs to file a Form ATS-N and operate pursuant to the effectiveness process. Both sets of comments are discussed below.

    107 In Exchange Act Rules 3a1-1(a)(2) and (3), Regulation ATS is currently defined as “17 CFR 242.300 through 242.303.” We proposed amending these references to Regulation ATS to define Regulation ATS as “17 CFR 242.300 through 242.304.” We also proposed conforming Rule 3a1-1(a)(3) by changing the reference to Rule 303 to final Rule 304 to make clear that an NMS Stock ATS that meets the requirements of Rule 301(a) is not required to comply with Regulation ATS, which would be amended to include proposed Rule 304. No changes were proposed to Rule 3a1-1(a)(1), which exempts any ATS that is operated by a national securities association.

    1. Comments on the Rule 304 Requirements; Effectiveness

    Nearly all commenters agree with our stated goal of enhancing operational transparency for NMS Stock ATSs.108 Several commenters agree that the Commission should adopt the heightened disclosure requirements of proposed Rule 304.109 In particular, several commenters support enhancing the disclosure and oversight regime for NMS Stock ATSs as progress toward increasing operational transparency in NMS Stock ATSs.110 Specifically, some commenters express support for NMS Stock ATSs to file Form ATS-N as a tool to improve transparency.111 Several commenters assert that more transparency regarding ATS operations could help market participants evaluate and compare trading venues so they can determine where to route orders.112 One commenter states that “it is good for investors to have access to information on how their orders are handled and with whom they are dealing.” 113 Several commenters believe that making Form ATS-N filings public would encourage competition among trading venues,114 and one commenter asserts that the proposed transparency requirements could reduce competitive imbalances between NMS Stock ATSs and national securities exchanges.115

    108See SIFMA Letter at 2; Barnard Letter at Public comment on IOSCO's Consultation Report on Issues Raised by Dark Liquidity; Anonymous Letter at 1; Luminex Letter at 1; MFA/AIMA Letter at 1-2; Fidelity Letter at 1; UBS Letter at 1; Markit Letter at 3-4; Schneiderman Letter at 1; ICI Letter at 3; CFA Institute Letter at 3, 6; CBOE Letter at 1; KCG Letter at 1; PDQ Letter at 1; STA Letter at 2; Liquidnet Letter at 1; STANY Letter at 1; FINRA Letter at 1; HMA Letter at 1, 5; Citadel Letter at 1; Better Markets Letter at 3-4; BIDS Letter at 1-2; SSGA Letter at 2; T. Rowe Price Letter at 1; AI Letter at 2-3; Consumer Federation of America Letter at 4; Morgan Stanley Letter at 1; Investor Advocate Letter at 2, 6; LeveL ATS Letter at 1; Virtu Letter at 2; MFA Letter 2 at 30. But see Morgan Stanley Letter at 1, 3 (stating that it is important to balance public disclosure with disclosure more suitable for the Commission (see discussion below and infra note 150 and accompanying text); that certain disclosure requirements, such as any disclosure around broker trading infrastructure and order handling practices beyond ATS operations, should apply to all brokers (see discussion infra note 217-218and accompanying text and infra Section III.A.2); and that the Proposal treats all ATSs like exchanges and fails to account for distinct ATS models (see discussion below and infra note 176 and accompanying text)). One commenter commented only on whether the Proposal should apply to ATSs that trade only fixed-income securities. See MarketAxcess Letter; infra Section III.A.2.

    109See generally Virtu Letter; T. Rowe Price Letter; Schneiderman Letter; ICI Letter; MFA/AIMA Letter; Consumer Federation of America Letter; CBOE Letter; Citadel Letter; Anonymous Letter; Better Markets Letter; Investor Advocate Letter. See also CFA Institute Letter at 6; SIFMA Letter at 3.

    110See SIFMA Letter at 3; Virtu Letter at 2; T. Rowe Price at 1; Schneiderman Letter at 1; MFA/AIMA Letter at 2; MFA Letter 2 at 30; CBOE Letter at 1; Citadel Letter at 1; Consumer Federation of America Letter at 6; CFA Institute Letter at 3; Anonymous Letter at 1; KCG Letter at 3; Morgan Stanley Letter at 1; Investor Advocate Letter at 6; Better Markets Letter at 1.

    111See ICI Letter at 4-6; Consumer Federation of America Letter at 6; CFA Institute Letter at 3; Citadel Letter at 3; KCG Letter at 3; STA Letter at 2; MFA/AIMA Letter at 4; CBOE Letter at 1; Investor Advocate Letter at 2, 8.

    112See Luminex Letter at 1; Fidelity Letter at 1; SSGA Letter at 2; KCG Letter at 1; Citadel Letter at 1; ICI Letter at 3; STA Letter at 2; Schneiderman Letter at 2; Consumer Federation of America Letter at 6; Investor Advocate Letter at 11.

    113See Luminex Letter at 1.

    114See STA Letter at 2; Consumer Federation of America Letter at 6; Investor Advocate Letter at 3, 11-12.

    115See Citadel Letter at 1.

    With respect to the Commission's effectiveness determination for Form ATS-N, another commenter states that “given the level of competition between exchanges and NMS Stock ATSs, this effectiveness determination would better align the Commission's oversight among different types of trading venues.” 116 One commenter, however, believes that ATSs do not add sufficient value to offset the regulatory inequity and market fragmentation they have created.117 This commenter also states that the Proposal represents “meaningful progress in the effort to increase the operational transparency of NMS Stock ATSs.” 118 The Proposal was not designed to eliminate the exemption from the definition of exchange that is currently available to all ATSs, including NMS Stock ATSs. We believe that NMS Stock ATSs play a significant role in equity market structure and provide market participants with a variety of trading models to facilitate the interaction and execution of orders in NMS stocks.

    116See Investor Advocate Letter at 12.

    117See CBOE Letter at 1.

    118Id.

    We believe that the current market for NMS stock execution services, consisting of national securities exchanges, NMS Stock ATSs, and other off-exchange venues, has resulted in an improvement to market efficiency.119 The changes to the requirements for NMS Stock ATSs that we are adopting today will increase operational transparency for these ATSs, bringing it more in line with the operational transparency for national securities exchanges, while continuing to recognize the difference in the business structure of ATSs as registered broker-dealers. We also believe that while the rules adopted today will increase the regulatory burden for NMS Stock ATSs and could result in some NMS Stock ATSs electing to no longer operate as an ATS, those NMS Stock ATSs that remain may compete more heavily with each other and with national securities exchanges, which could ultimately result in improvements to efficiency and capital formation.120

    119See infra Section X.B.6 (discussing the effects of NMS Stock ATSs on the market for NMS stock execution services, including fragmentation).

    120See infra Section X.C (discussing the expected economic effects of today's rulemaking, as well as its expected effects on efficiency, competition, and capital formation).

    Another commenter believes that increased disclosure will aid in developing industry-based standards.121 Three commenters state that increased disclosure will boost investor confidence,122 and according to one of these commenters, increased transparency and investor confidence could lead to more investors using NMS Stock ATSs, and result in greater price discovery and lower costs of capital formation.123

    121See STA Letter at 2.

    122See CFA Institute Letter at 3; Schneiderman Letter at 2; Investor Advocate Letter at 11-12.

    123See Investor Advocate Letter at 11, 12.

    We believe that a wide range of market participants will benefit from the enhanced operational transparency, including, for example, fund managers and the many brokers that subscribe to NMS Stock ATSs and route their orders, and those of their customers, to NMS Stock ATSs for execution. Five commenters observe, for example, that more transparency regarding ATS operations could assist market participants in achieving best execution.124 One commenter states that disclosure of material aspects of ATS operations that allow market participants to weigh the costs and benefits of venues is “particularly important for asset managers who are acting in a fiduciary capacity.” 125 Another commenter believes that making Form ATS-N filings publicly available would provide a “valuable tool for funds to use to assess NMS Stock ATSs, make informed routing decisions, and evaluate the performance of their brokers.” 126

    124See Citadel Letter at 1; Consumer Federation of America Letter at 6; HMA Letter at 10; Luminex at 1; SIFMA Letter at 35.

    125See SSGA Letter at 2.

    126See ICI Letter at 3.

    We believe that the information disclosed on Form ATS-N will help brokers meet their best execution obligations to their customers, as they should be better able to assess the trading venues to which they route orders.127 We also believe that asset managers and institutional investors, who subscribe to an NMS Stock ATS or whose orders may be routed to an NMS Stock ATS by their brokers, should have more information about how NMS Stock ATSs operate, including how orders and trading interest of the institutional investor may be displayed or made known outside the ATS. This information also will enable asset managers to better evaluate the routing decisions of their brokers, including whether their brokers routed their orders to a venue that best fits their trading interests.

    127See, e.g., Proposal, supra note 2, at 81002 n.36 and accompanying text, 81013 n.187 and accompanying text (discussing that the Consumer Federation of America previously commented that Form ATS should require ATSs to provide “critical details about an ATS's participants, segmentation, and fee structure” because the “information will allow market participants, regulators, and third party analysts to assess whether an ATS's terms of access and service are such that it makes sense to trade on that venue”).

    a. Comments on Form ATS-N Requirement

    Some commenters, however, believe NMS Stock ATSs should not be required to comply with new Rule 304 and the Commission should instead simply amend Regulation ATS to require making Form ATS public for NMS Stock ATSs.128 Two of these commenters assert that the Commission should mandate disclosure of current Form ATS as a first step to increase disclosure before considering implementing more burdensome disclosure requirements.129

    128See Luminex Letter at 2-3; PDQ Letter at 2; Fidelity Letter at 5; STANY Letter at 3; Morgan Stanley Letter at 2.

    129See Fidelity Letter at 5; STANY Letter at 3.

    We are not adopting commenters' suggestion to make Form ATS public rather than requiring NMS Stock ATSs to comply with Rule 304 and file Form ATS-N. First, we believe that new Form ATS-N requires important additional disclosures that are not made under existing Form ATS.130 While Form ATS-N will require NMS Stock ATSs to disclose more information than Form ATS, in response to certain comments, we have reduced the burden of completing Form ATS-N by narrowing the scope of several requests for information and, in some cases, eliminating certain requests from the form.131 We have also simplified Form ATS-N to make completing and maintaining the form less burdensome and have modified questions so as not to solicit competitively sensitive information.132 We believe that Form ATS-N disclosures will help market participants compare and evaluate NMS Stock ATSs and make better informed decisions about where to route their orders to achieve their trading or investment objectives, enhance execution quality, and improve efficiency and capital allocation.133

    130See infra Sections X.C.1 and X.C.2. We have considered any additional burden that may result from completion of Form ATS-N and the benefits of the additional information that will be made available to market participants by requiring NMS Stock ATSs to file Form ATS-N, and making Form ATS-N public. See id.

    131 For example, we have narrowed a request for information regarding trading by affiliates of the broker-dealer operator on the NMS Stock ATS by requiring only the disclosures of affiliates that can enter or direct the entry of orders and trading interest into the ATS. See infra Section V.C.1. We are not requiring NMS Stock ATSs to provide proposed Exhibit 1 to Form ATS-N. See infra Section V.B.2. Exhibit 1 would have required that NMS Stock ATSs provide a copy of any materials currently provided to subscribers or other persons related to the operations of the ATS or the disclosures on Form ATS-N, such as frequently asked questions, manuals, and marketing materials.

    132See infra Section V.C.

    133See infra Section X.C.4.

    Based on Commission staff's experience reviewing disclosures made by ATSs on Form ATS over the past 19 years and as discussed in the Proposal, we have observed that ATSs have often provided minimal, rudimentary, and summary disclosures about their operations on Form ATS. One commenter agrees with our assessment, stating that based on its review of publicly available Forms ATS, the forms “often provide minimal and often generalized information” with respect to classification and segmentation of subscribers, means of access to the ATS, matching priority, order interaction, order types, and how the NBBO is calculated, and they are often missing “critical details” about their operations.134 Further, this commenter states that “[r]arely do Form ATSs provide information relating to their fee structures and potential or actual conflicts of interest.” 135 According to another commenter, current Form ATS is “not adequate” to allow the Commission and market participants to “understand how NMS Stock ATSs operate in today's environment, given the complexity and the potential for significant conflicts of interest with the broker-dealer operator.” 136 In addition, one commenter observes that market participants currently receive “varying levels” of information about the operations of the NMS Stock ATS.137 As described in the Proposal,138 we believe that the complexity of NMS Stock ATS operations has increased substantially and in a manner that causes the current disclosure requirements of Form ATS to result in an insufficient, and inconsistent, level of detail about the operations of NMS Stock ATSs.

    134See Consumer Federation of America Letter at 3.

    135See id.

    136See Investor Advocate Letter at 8.

    137See Morgan Stanley Letter at 1.

    138See Proposal, supra note 2, at 81011.

    Two commenters argue that a new Form ATS-N is unnecessary because most of the fundamental information required in Form ATS-N is currently covered by Form ATS.139 In addition, three commenters suggest that, as an alternative to requiring NMS Stock ATSs to file and make public Form ATS-N, we should clarify the requests for information on Form ATS and mandate that the revised Form ATS be made public.140 One of these commenters believes such an approach would help achieve the Commission's goal of operational transparency, while “maintaining a regulatory structure under which NMS Stock ATSs can continue to innovate.” 141 Even if we were to “clarify” the requests for information on Form ATS to standardize disclosures and make current and past Forms ATS public, Form ATS does not require the disclosure of certain information that will be required by Form ATS-N. For example, Form ATS-N requires NMS Stock ATSs to disclose information about the ATS-related activities of the broker-dealer operator and its affiliates that will allow market participants to assess potential conflicts of interest and information about the NMS Stock ATS's safeguards and procedures to protect confidential trading information. The disclosure requirements of Form ATS are not sufficient to provide market participants with adequate information about the operational complexity of NMS Stock ATSs and the ATS-related activities of the broker-dealer operator and its affiliates that exist today. Form ATS-N is designed to provide market participants with more robust, detailed, and standardized disclosures, and to enable market participants to better understand the operations of NMS Stock ATSs and potential conflicts of interest between ATS operations and the other ATS-related activities of the broker-dealer operator and its affiliates.

    139See Luminex Letter at 2-3; STANY Letter at 3.

    140See STANY Letter at 3; PDQ Letter at 2; Fidelity Letter at 5.

    141See STANY Letter at 3.

    One commenter who suggests making Form ATS public as an alternative to requiring Form ATS-N expresses concern that the “crippling amount of detail” required to be disclosed under Form ATS-N would not be useful to market participants.142 We do not believe that Form ATS-N, as modified from the Proposal, will require a “crippling” level of detail that will only be useful to the Commission, and several commenters agree that the Form ATS-N disclosures would be useful for market participants in comparing trading venues and assessing conflicts of interest.143 While Form ATS-N will require NMS Stock ATSs to disclose more information than Form ATS, we have recognized commenters' concerns regarding the burden of completing Form ATS-N by narrowing the scope of several requests, eliminating certain requests altogether, and simplifying its format.144

    142See id. at 4.

    143See supra notes 109-123 and accompanying text.

    144See infra Section V.

    Other commenters discuss how market participants currently glean information about ATSs, and suggest that such methods could serve as alternatives to the requirements of Rule 304, or inform the Rule 304 requirements.145 One commenter states that it performs periodic due diligence on ATSs because it believes that as a fiduciary, it should only trade on venues or exchanges that further its goals of satisfying “best execution,” that protect client information, and generally support principles of fair access.146 This commenter also states that currently, market participants perform such due diligence by sending ATSs questionnaires.147 Similarly, another commenter observes that ATSs are incentivized to respond to these questionnaires to attract participants, and therefore, the Commission should not place additional disclosure burdens on ATSs.148 We do not believe that the practice of some market participants individually soliciting information about the operations of NMS Stock ATSs and conflicts of interest through questionnaires is an adequate alternative to Form ATS-N. We believe that disclosures on Form ATS-N should be easily accessible to all market participants. This is particularly important for NMS Stock ATSs given how orders in NMS stocks may be routed among various trading centers before receiving an execution. Based on the Commission's experience, responses to questionnaires are generally unavailable to non-subscribers, including potential subscribers and customers of current subscribers. Without this information, potential subscribers would be unable to fully assess an NMS Stock ATS as a trading center and customers of subscribers would be inhibited from assessing their broker's routing decisions. In addition, we believe, as indicated by comments,149 that the publicly available, standardized disclosure regime that will result from Rule 304 and Form ATS-N is critical for all market participants to receive equal information about NMS Stock ATSs.

    145See SSGA Letter at 2; PDQ Letter at 2; Morgan Stanley Letter at 2.

    146See SSGA Letter at 2. See also Fidelity Letter at 8 (discussing that, from a due diligence perspective, subscribers may require NMS Stock ATS information).

    147See SSGA Letter at 2. See also PDQ Letter at 2.

    148See PDQ Letter at 2.

    149See Virtu Letter at 2; Schneiderman Letter at 1; ICI Letter at 3; Consumer Federation of America Letter at 6; and Citadel Letter at 1.

    One commenter suggests that, as an alternative to the proposed Form ATS-N, the Commission should mandate that ATS operators publicly disclose current and historical Form ATS filings and related amendments, and responses to standardized, frequently asked questions (“FAQs”) regarding ATS operations.150 The commenter believes that this approach would be “more balanced and appropriate” and “less burdensome and faster to implement.” 151 For the reasons discussed above in this section, we believe that the requests on Form ATS are not designed to produce adequate information for market participants about the operational complexity of NMS Stock ATSs and the ATS-related activities of their broker-dealer operators and their affiliates. We also believe that making public an ATS's responses to standardized, FAQs regarding its operations would not achieve the same level of disclosure that Form ATS-N will require, and would not facilitate our oversight of NMS Stock ATSs. Based on Commission experience, the information required to be disclosed on Form ATS-N exceeds the information provided by NMS Stock ATSs in their responses to FAQs and will provide a greater benefit to market participants. In addition, NMS Stock ATSs must file Form ATS-N disclosures with the Commission, which will be subject to Commission review before they become public. As discussed in the Proposal, the public disclosures on Form ATS-N are designed to standardize the information available to all market participants about NMS Stock ATSs and facilitate their ability to compare and evaluate these trading venues.152 Finally, we believe that the burden resulting from filing a Form ATS-N would not be significant compared to requiring an NMS Stock ATS to prepare disclosures on Form ATS and responses to FAQs.

    150See Morgan Stanley Letter at 2 (asserting that “standardization is the key to concise, comparable and meaningful information regarding ATS operations”). This commenter states that while it supports the Proposal's effort to mandate transparency, it is concerned that proposed Form ATS-N “will result in more subjective, narrative responses that will not lend themselves to side-by-side comparison.” See id. at 1.

    151See id. at 2.

    152See Proposal, supra note 2, at 81123. See also infra Section V.A.1. We believe that requiring NMS Stock ATSs to provide only “yes” or “no” responses would limit ATSs, which provide diverse services and often operate uniquely, from accurately describing their operations and inhibit market participants from fully understanding the operations of the ATS or the ATS-related activities of the broker-dealer operator and its affiliates. See id. (discussing the Commission's belief that narrative responses are important for market participants to understand the operations of NMS Stock ATSs given differences across ATSs, and provide NMS Stock ATSs with the flexibility in their responses).

    We received four comments about the application of Rule 304 to some or all NMS Stock ATSs. We received three comments expressing the importance of the Commission's need to heighten the regulatory requirements for all NMS Stock ATSs.153 In particular, one commenter states that the Commission's additional disclosure requirements are important for creating a consistent and fair set of obligations for all NMS Stock ATSs while providing market participants and subscribers with complete information.154 This commenter observes that although an ATS may have a small share of volume relative to the overall equities trading marketplace, it does not necessarily follow that such ATS has a similarly small share of each subscriber's flow.155 Another commenter cautions the Commission about allowing exemptions based on metrics such as dollar volume, trading volume, or number of subscribers because allowing such exemptions could increase “incentives and opportunities” for regulatory arbitrage, and may result in unintended consequences.156 On the other hand, one commenter argues that the Commission should take a tiered regulatory approach to NMS Stock ATSs by applying certain of the enhanced requirements only to larger NMS Stock ATSs.157 This commenter suggests that to foster competitive innovations among NMS Stock ATSs, the Commission should only apply the requirement of prior Commission “approval” of changes before they are implemented to “larger ATSs with a substantial market footprint.” 158

    153See CFA Institute Letter at 3; UBS Letter at 2. See also KCG Letter at 1.

    154See UBS Letter at 2.

    155See id.

    156See CFA Institute Letter at 3.

    157See STANY Letter at 2. See also Luminex Letter at 1.

    158See STANY Letter at 2.

    We continue to believe that requiring all NMS Stock ATSs to publicly file a Form ATS-N, irrespective of the volume of NMS stocks transacted on the ATS is appropriate, and does not agree that its objectives would be achieved by applying Rule 304 on a tiered basis to NMS Stock ATSs. Given that broker-dealers can route their customers' orders to any NMS Stock ATS for execution, we do not believe that transaction volume in NMS stocks serves as a proxy for whether customers of broker-dealers or subscribers to an ATS should have information about how their orders would be prioritized, matched, or executed on an NMS Stock ATS or understand the ATS-related activities of the broker-dealer operator and its affiliates that may give rise to conflicts of interest.159 As a result, customers of broker-dealers that route their orders to NMS Stock ATSs with low volume will have the same level of information to assess their broker-dealers' routing decisions as customers of broker-dealers that may route orders to any other NMS Stock ATSs. Amending Exchange Act Rule 3a1-1(a) to apply the requirements of Rule 304 to all NMS Stock ATSs would promote efficient and effective market operations by providing information all market participants can use to evaluate all NMS Stock ATSs that could be potential destinations for their orders. We believe that these requirements, including the requirement that NMS Stock ATSs file amendments to Form ATS-N in advance of adopting material changes,160 would not place an undue burden on smaller NMS Stock ATSs or their ability to innovate.161 Smaller NMS Stock ATSs that are not operated by multi-service broker-dealer operators and do not engage in other brokerage or dealing activities in addition to their ATS operations would have a lower burden than other ATSs because certain sections of Form ATS-N (such as several items of Part II) may not be applicable to these NMS Stock ATSs.162 We believe that the reduction in costs from exempting small NMS Stock ATSs would be minimal as compared to the benefits that would result from requiring the same level of transparency from small NMS Stock ATSs as from other NMS Stock ATSs.163 Further, under Regulation ATS, every ATS must currently wait 20 calendar days from the date of filing an amendment to Form ATS-N before implementing a material change to its operations.164 In addition, we believe that the new process for NMS Stock ATSs applicable to filing material amendments is appropriate,165 and, like the other requirements of Rule 304, should be applied consistently across NMS Stock ATSs, regardless of their size or trading volume. The Commission review process for Form ATS-N amendments is designed to improve operational transparency for all market participants and not only for market participants that use NMS Stock ATSs with significant trading volume as compared to other NMS Stock ATSs.

    159 National securities exchanges are subject to the same public rule filing and registration requirements irrespective of the volume transacted on the exchange. While an NMS Stock ATS may not transact significant overall volume in NMS stocks, that ATS may transact a significant volume of orders in certain NMS stocks or orders for certain subscribers. Additionally, we also believe that applying the enhanced regulatory requirements only to larger NMS Stock ATSs could create an opportunity for arbitrage without appropriate benefit, in that an NMS Stock ATS may be incentivized to structure their operations to avoid being subject to enhanced requirements. We believe that the burden of complying with the enhanced regulatory requirements imposed on lower volume NMS Stock ATSs is justified by the benefits. See infra Section X.D.4.

    160 One commenter expresses its concern that “small and innovative ATSs will be frustrated by the requirement that changes to their technology must be approved by the Commission prior to implementation.” See STANY Letter at 2. The Commission will not “approve” material amendments, but instead, may declare amendments ineffective if the disclosures filed by an NMS Stock ATS on Form ATS-N are materially deficient with respect to their completeness or comprehensibility. See infra Section IV.B.2. In addition, we are requiring that NMS Stock ATSs publicly disclose a brief summary of a material amendment upon filing, and after the Commission has had an opportunity to review the amendment, the material amendment would be made public. This change from the Proposal is in response to commenters who believe that an ATS may be placed at a competitive disadvantage if it is required to publicly file a material change 30 calendar days before implementing the change. See infra Section IV.E.2.c.

    161See infra Section X.D.4.

    162See infra Section V.C and Section X.C.4.a.

    163See infra Section X.D.4.

    164See supra note 58 and accompanying text.

    165See infra Section IV.B.1.a.

    b. Comments on Effects on ATSs Relative to National Securities Exchanges

    We received comments regarding the competitive effect of Rule 304 on ATSs relative to national securities exchanges.166 Some commenters support public disclosure of Form ATS-N on the grounds that the current differences in transparency requirements for ATSs and national securities exchanges are competitively unfair.167 On the other hand, other commenters express concern about the competitive burden that the requirements of Rule 304 could place on ATSs.168 Specifically, one commenter states that not extending the enhanced transparency requirements to national securities exchanges may “result in a competitive advantage to exchanges.” 169 We believe that the new disclosure requirements for NMS Stock ATSs are not more rigorous than the disclosure standards for national securities exchanges and will not provide national securities exchanges with a competitive advantage over NMS Stock ATSs. National securities exchanges are required to publicly file proposed rule changes with the Commission to disclose, among other things, their manner of operations and fees.170 These proposed rules changes are subject to notice and comment from the public, as well as Commission consideration, pursuant to Section 19(b) and 17 CFR 240.19b-4 (Rule 19b-4).171 This is not the case for NMS Stock ATSs. Furthermore, Form ATS-N is designed to solicit information about ATS-related activities of the broker-dealer operator and its affiliates to help market participants better understand potential conflicts of interest and information leakage. In the context of national securities exchanges, we have expressed concern that the affiliation of a national securities exchange with one of its members raises potential conflicts of interest, and the potential for unfair competitive advantage; and because the Commission reviews the rules of national securities exchanges, a process which requires, among other things, that to approve certain rule changes the Commission find that the proposed rule change is consistent with the Exchange Act, each existing national securities exchange has implemented rules that restrict affiliation between the exchange and its members to mitigate the potential for these types of conflicts of interest.172 NMS Stock ATSs are not subject to such restrictions with respect to the activities of their broker-dealer operator and its affiliates that may raise conflicts of interests.

    166See, e.g., Anonymous Letter at 1, Citadel Letter at 1; Markit Letter at 4; STANY Letter at 3.

    167See Anonymous Letter at 1; Citadel Letter at 1.

    168See Markit Letter at 4; STANY Letter at 3.

    169See Markit Letter at 4.

    170See Proposal, supra note 2, at 81011.

    171See id.

    172See Proposal, supra note 2, at 81042 n. 370-372 and accompanying text. In cases where we have approved exceptions to this prohibition, there have been limitations and conditions on the activities of the national securities exchange and its affiliated member designed to address concerns about potential conflicts of interest and unfair competitive advantage. See id. at 81042 n.372.

    Another commenter states its view that requiring public disclosure of Form ATS-N will “alter the competitive landscape . . . between NMS Stock ATSs and national securities exchanges.” 173 We continue to believe that since the adoption of Regulation ATS, the market in execution services for NMS stocks has evolved such that trading functions of NMS Stock ATSs have become more functionally similar to those of national securities exchanges.174 The enhanced transparency requirements for NMS Stock ATSs are designed to allow market participants to compare execution services of NMS Stock ATSs against national securities exchanges, to appropriately calibrate the level of transparency between NMS Stock ATSs and national securities exchanges, and to foster even greater competition for order flow of NMS stocks between those trading centers.175

    173See STANY Letter at 3.

    174See supra Section II.D.

    175See infra Section X.C.2.a (discussing the economic benefits of the new disclosure requirements). See also Section X.C.4.a.i.

    One commenter asserts that the Proposal treats all ATSs as stand-alone, exchange-like price/time priority models and fails to account for distinct ATS models (e.g. price/capacity/size priority and interval VWAP crossing) and does not consider that an ATS may be part of a broader, integrated electronic offering available to clients choosing to access the markets through a full-service broker-dealer.176 This commenter also states that while Regulation ATS recognizes the distinction between exchanges and ATS offerings, the regulatory structure specifically tailored for exchanges can be seen throughout much of the Proposal and proposed Form ATS-N, such as in the Proposal's focus on: Subscribers, in the way an exchange has members; a subscriber manual, in the way an exchange has a rule book; and fees, similar to an exchange fee schedule.177

    176See Morgan Stanley Letter at 3.

    177See id. at 2-3.

    One commenter questions why the Commission has determined that NMS Stock ATSs should be subject to “essentially similar disclosure requirements” as national securities exchanges without affording NMS Stock ATSs benefits such as limited immunity and market data revenue that national securities exchanges receive.178 NMS Stock ATSs, unlike registered national securities exchanges, are registered as broker-dealers and exempt from the requirements of, among other provisions, Sections 6 and 19(b) of the Exchange Act. However, an NMS Stock ATS that desires the benefits afforded to national securities exchanges can choose to register as a national securities exchange under Section 6 of the Exchange Act 179 and be subject to the requirements of, among other provisions, Sections 6 and 19(b) of the Exchange Act. In addition, we do not agree with the commenter's view that the disclosure requirements with which NMS Stock ATSs must comply are “essentially similar” to the disclosure requirements imposed on national securities exchanges. For example, a national securities exchange is required to file with the Commission all rule changes establishing or changing a due, fee, or other charge assessed to members, which the Commission reviews for consistency with the Exchange Act.180 In contrast, an NMS Stock ATS will be required to provide disclosure on the types of fees and charges of the NMS Stock ATS.181 Further, disclosure is only one of the requirements to which national securities exchanges are subject. Notably, the rules and changes to the rules of national securities exchanges are required to be filed with the Commission and are subject to public notice and comment.182 NMS Stock ATSs are not subject to these requirements, as well as many others, applicable to national securities exchanges.183

    178See Fidelity Letter at 4.

    179See 15 U.S.C. 78f. An ATS is not required to comply with the requirements of Rule 301(b) if it is registered as an exchange under Section 6 of the Exchange Act. See 17 CFR 242.301(a)(1).

    180See 17 CFR 240.19b-4(f)(2). Another commenter states that while Regulation ATS recognizes the distinction between national securities exchanges and ATS offerings, the regulatory structure tailored for national securities exchanges can be seen throughout much of the Proposal and proposed Form ATS-N, and included as examples the Proposal's focus on disclosures regarding subscribers, subscriber manuals, and fees, as well as the public posting upon filing of amendments to Form ATS-N. See Morgan Stanley Letter at 3-4. This commenter believes this approach is contrary to the objectives of Regulation ATS and urges the Commission to reconsider aspects of the Proposal that have the effect of not recognizing the materially different roles that ATSs and exchanges are intended to play in the U.S. marketplace. See id at 4. We agree that registered broker-dealers that operate ATSs should continue to be able to avail themselves of the exemption from the definition of “exchange” provided by Exchange Act Rule 3a1-1 and Regulation ATS, but believe that due to changes in the role and operation of NMS Stock ATSs since the adoption of Regulation ATS, it is in the public interest to update the requirements for that exemption applicable to that subset of ATSs. Also many of the disclosure items identified by this commenter are the kinds of disclosures other commenters have described as significant to their understanding of the operation of NMS Stock ATSs.

    181See infra Section V.D.19.

    182See generally 15 U.S.C. 78s(b); 17 CFR 240.19b-4.

    183See 15 U.S.C. 78f(b).

    While NMS Stock ATSs and national securities exchanges are subject to different regulatory regimes, NMS Stock ATSs are trading centers that perform similar trading functions as national securities exchanges and have evolved to become more like national securities exchanges in their operations. We believe that Form ATS-N, as adopted, accommodates the differences between the regulatory requirements for national securities exchanges and those of NMS Stock ATSs while increasing public operational transparency for NMS Stock ATSs. The Commission does not agree that NMS Stock ATSs are being treated like national securities exchanges and believes that Form ATS-N is designed in a manner that allows ATSs to explain their unique business models. For example, NMS Stock ATSs will be able to explain their trading models, and associated facilities and procedures, in Part III, Item 11 of adopted Form ATS-N (“Trading, Rules and Facilities”). In addition, Part III, Item 19 (“Fees”) requires an NMS Stock ATS to identify and describe the types of fees or charges of the ATS and any differences among subscribers, whereas national securities exchanges are required to publicly post their complete fee schedules and any changes are subject to the SRO rule filing process under Section 19 of the Exchange Act. The Commission also understands that some broker-dealer operators offer their NMS Stock ATSs along with other execution and routing services. We believe that requests on Form ATS-N are appropriately designed, and provide narrative flexibility, to elicit information about the varying NMS Stock ATS models, including those of multi-service broker-dealers.184

    184See, e.g., infra Section V.D.11 (describing Part III, Item 11 of Form ATS-N, which asks NMS Stock ATSs to provide a summary of their marketplaces and the means and facilities for bringing together the orders of multiple buyers and sellers on the NMS Stock ATS).

    c. Comments on Effectiveness Requirement

    We proposed that to qualify for the exemption from the definition of “exchange,” an NMS Stock ATS's Form ATS-N must be declared effective by the Commission; as adopted, a Form ATS-N must be effective for the ATS to qualify for the exemption.185 Several commenters express their support for requiring that Form ATS-N be subject to Commission review,186 and some commenters support the proposed requirement that Form ATS-N be declared effective by the Commission,187 while other commenters raise concerns about requiring that Form ATS-N be declared effective by the Commission.188 One commenter states that the proposed effective/ineffective process is “unnecessary” and “will have a chilling effect” on, or stifle innovation of, ATS operations.189 Another commenter similarly questions the need for the Commission to make a determination of effectiveness for Form ATS-N, and expresses concern that such a process would increase the regulatory risk for new NMS Stock ATSs and stifle innovation in the ATS marketplace by delaying the effectiveness of NMS Stock ATSs whose features, while meeting regulatory requirements, do not meet industry norms.190

    185See infra Section IV.A.1. As adopted, the Commission will not declare initial Form ATS-N filings effective under Rule 304.

    186See Citadel Letter at 3; HMA Letter at 7-8; and Investor Advocate Letter at 11-12.

    187See MFA/AIMA Letter at 4; CFA Institute Letter at 4; and PDQ Letter at 2. Two commenters do not object to the effectiveness process. See Liquidnet Letter at 3 and STANY Letter at 2.

    188See Luminex Letter at 1; Fidelity Letter at 8-9.

    189See Luminex Letter at 1.

    190See Fidelity Letter at 8-9.

    We do not believe that requiring Form ATS-N to become effective after Commission review is “unnecessary;” 191 rather, the review process will facilitate the Commission's oversight of NMS Stock ATSs and help ensure that information required by the form is disclosed in a complete and comprehensible manner. We have modified the proposed effectiveness process for initial Form ATS-N so that the Commission will not declare initial Form ATS-N effective; instead, initial Form ATS-N, as amended, will become effective, unless declared ineffective, upon the earlier of: (1) The completion of review by the Commission and publication pursuant to Rule 304(b)(2), or (2) the expiration of the Commission review period, or, if applicable, the extended review period.192 Form ATS-N will nevertheless be subject to Commission review, and, as proposed, the Commission may declare a Form ATS-N ineffective if it finds, after notice and opportunity for hearing, that such action is necessary or appropriate in the public interest, and is consistent with the protection of investors.193 We believe that requiring Form ATS-N to be effective, which would occur only after being subject to Commission review, could incentivize NMS Stock ATSs to make more detailed and informative disclosures than under current Form ATS. While requiring Form ATS-N to be effective may have some impact on innovation,194 our review of Form ATS-N is designed to mitigate any effect on innovation, and accordingly would focus on, for example, the completeness and comprehensibility of the Form ATS-N disclosures and not include a review of the merits of the disclosures or whether such trading functionalities meet industry norms.195 We do not believe that requiring Form ATS-N to be effective will unduly increase the “regulatory risk” of launching a new NMS Stock ATS as one commenter suggests.196 We understand that the Commission review process will generate some uncertainty for NMS Stock ATSs as a Form ATS-N could be declared ineffective, which is not currently the case with respect to Form ATS.197 The Commission review process, however, will not be merit based, and determinations of ineffectiveness will require the Commission to make certain findings after notice to the NMS Stock ATS and opportunity for hearing.198 In addition, the rule provides that if the Commission does not declare the Form ineffective before the end of a fixed time period, the Form ATS-N will become effective. We believe that these factors will provide NMS Stock ATSs with greater regulatory certainty regarding the effectiveness process.

    191See supra note 189 and accompanying text.

    192See infra Sections IV.A.3.c and IV.A.4.a.

    193See id.

    194See infra Section X.C.

    195See supra note 190 and accompanying text. See also infra Section IV.A.3.d.

    196See supra note 190 and accompanying text.

    197See infra Section X.C.4.

    198See infra Section IV.A.3.

    2. Comments on Extending Rule 304 to Non-NMS Stock ATSs

    Rule 304 of Regulation ATS, as proposed and adopted, would apply only to NMS Stock ATSs, as defined in Rule 300(k) of Regulation ATS. We are concerned that, given the significance of NMS Stock ATSs in equity market structure and their operational complexities, the lack of transparency around NMS Stock ATSs operations could inhibit market participants' ability to evaluate NMS Stock ATSs as potential routing destinations for their orders in NMS stocks. As discussed in the Proposal, we did not propose to apply Rule 304 to non-NMS Stock ATSs, which would include ATSs that trade corporate or municipal fixed income securities (“Fixed Income ATSs”), U.S. Government securities (“Government Securities ATSs”),199 or OTC Equity securities (“OTC Equity Securities ATSs”).200 We sought comment on whether Rule 304, in whole or in part, should apply to Fixed Income ATSs, Government Securities ATSs, and OTC Equity Securities ATSs.201 We also did not propose to apply Rule 304 to any other type of trading center besides NMS Stock ATSs,202 such as non-ATS OTC trading centers 203 or national securities exchanges.

    199 The term “U.S. Government securities” is defined under Section 3(a)(42) of the Exchange Act. See 15 U.S.C. 78c(a)(42) (defining “government securities” as, among other things, “securities which are direct obligations of, or obligations guaranteed as to principal or interest by, the United States”).

    200 For purposes of this discussion, we are using the term “OTC Equity Security” as it is defined in FINRA's 6400 rule series for quoting and trading in OTC Equity Securities. FINRA defines OTC Equity Security as “any equity security that is not an `NMS stock' as that term is defined in Rule 600(b)(47) of SEC Regulation NMS; provided, however, that the term `OTC Equity Security' shall not include any Restricted Equity Security,” which FINRA defines as “any equity security that meets the definition of `restricted security' as contained in Securities Act Rule 144(a)(3).” See FINRA Rules 6420(f), (k).

    201See Proposal, supra note 1, at 81018.

    202See Proposal, supra note 2. See also infra note 668 and accompanying text (discussing the term “trading center”).

    203 For purposes of this discussion, references to non-ATS OTC trading centers, as used herein, encompass all executions that occur off a national securities exchange and outside an ATS, including when a broker-dealer is acting as an OTC market maker, block positioner (i.e., any broker-dealer in the business of executing, as principal or agent, block size trades for its customers), or operation of an internal broker-dealer system. See 17 CFR 242.600(b)(52) (defining “OTC market maker” as any dealer that holds itself out as being willing to buy and sell to its customers, or others, in the United States, an NMS stock for its own account on a regular or continuous basis otherwise than on a national securities exchange in amounts of less than block size); 17 CFR 242.600(b)(9) (defining “block size” as an order of at least 10,000 shares or for a quantity of stock having a market value of at least $200,000); and 17 CFR 240.17a-3(a)(16)(ii)(A) (defining “internal broker-dealer system” as any facility, other than a national securities exchange, an exchange exempt from registration based on limited volume, or an alternative trading system as defined in Regulation ATS that provides a mechanism, automated in full or in part, for collecting, receiving, disseminating, or displaying system orders and facilitating agreement to the basic terms of a purchase or sale of a security between a customer and the sponsor, or between two customers of the sponsor, through use of the internal broker-dealer system or through the broker or dealer sponsor of such system). See also 2010 Equity Market Structure Release, supra note 13, at 3599-3600.

    We received several comments generally supporting operational transparency and about whether or not to apply Rule 304 to non-NMS Stock ATSs.204 Of the commenters generally supporting enhanced operational transparency, several encourage the Commission to make the current Form ATS public for all ATSs.205 Some commenters urge the Commission to amend Regulation ATS to apply Rule 304 to all ATSs.206 Two commenters explicitly support applying the Proposal solely to NMS Stock ATSs.207

    204See Better Markets Letter at 3, 8; CFA Institute Letter; Citadel Letter; Consumer Federation of America Letter at 6-7; Fidelity Letter at 6-7; HMA Letter at 5-6, 10, 12; ICI Letter at 11; Investor Advocate Letter at 2, 12-15; KCG Letter at 12-13; Liquidnet Letter at 3; Luminex Letter at 2, 4; MarketAxess Letter; Markit Letter at 2, 4, 9; MFA/AIMA Letter 2-4; MFA Letter 2 at 30; Morgan Stanley Letter at 5-6; PDQ Letter at 2; SIFMA Letter at 3, 5; STANY Letter at 5; T. Rowe Price Letter at 2; Virtu Letter at 2.

    205See Fidelity Letter at 7; ICI Letter at 11; Luminex Letter at 2; Morgan Stanley Letter 2, 5; Investor Advocate Letter at 2-3; PDQ Letter at 2; STANY Letter at 3; SIFMA Letter at 3-4.

    206See Better Markets Letter at 3, 8; CFA Institute Letter at 3-4; Consumer Federation of America Letter at 6-7; HMA Letter 5-6, 10, 12.

    207See ICI Letter at 11; Liquidnet Letter at 3.

    Several commenters specifically argue for extending Rule 304, including Form ATS-N, to Fixed Income ATSs.208 Several commenters, however, recommend against extending the Proposal requirements for NMS Stock ATSs to Fixed Income ATSs.209 Several commenters suggest that the Commission require Fixed Income ATSs to make their Forms ATS public.210

    208See Consumer Federation of America Letter at 6; Better Markets Letter at 8; CFA Institute Letter at 3-4; HMA Letter at 10; MFA/AIMA Letter at 2-3.

    209See Fidelity Letter at 6-7; KCG Letter at 12-13; Liquidnet Letter at 3; MarketAxess Letter at 3-4 ; Markit Letter at 9; SIFMA Letter at 3.

    210See Fidelity Letter at 6; SIFMA Letter at 34-35; Markit Letter at 9; Investor Advocate Letter at 12-16; ICI Letter at 11. See also Luminex Letter at 4.

    We also received several comments that specifically address enhancing operational transparency for, or extending Rule 304 to, Government Securities ATSs.211 Several commenters support applying Rule 304 requirements to Government Securities ATSs,212 while several state that Regulation ATS should be amended to include electronic platforms for U.S. Government securities.213 Other commenters believe that the Commission should gather additional information on fixed income markets, which include U.S. Government securities markets, and as an interim step, make the Form ATS filings for these ATSs public.214 We also received comments that specifically oppose applying the Proposal requirements to Government Securities ATSs,215 or more generally oppose expanding Rule 304 to non-NMS Stock ATSs.216

    211See Better Markets Letter at 8; CFA Institute Letter at 3-4; Citadel Letter at 4-5; Investor Advocate Letter at 16-17; KCG Letter; Liquidnet Letter at 3; MFA/AIMA Letter at 2-7; SIFMA Letter at 3, 5, 35-36; Virtu Letter at 2.

    212 Some commenters specifically support operational transparency and enhanced monitoring of trading activity for Government Securities ATSs. See Virtu Letter at 2; Better Markets Letter at 8; CFA Institute Letter at 3-4; Citadel Letter at 4-5; MFA/AIMA Letter at 2-7. See also Liquidnet Letter at 3 (stating that it does “not object” to the requirements of Regulation ATS applying to systems that cross trades in U.S. Government securities).

    213See Citadel Letter at 4-5; Liquidnet Letter at 3; Investor Advocate Letter at 16-19; Virtu Letter at 2. One commenter combined its support for transparency of ATSs that trade U.S. Government securities and Fixed Income ATSs. See MFA/AIMA Letter at 3-4

    214See SIFMA Letter at 34-35; Markit Letter at 9; Investor Advocate Letter, at 14. See also Fidelity Letter at 6.

    215See KCG Letter at 13; SIFMA Letter at 3, 5, 36.

    216See supra note 209 accompanying text.

    We also received comments regarding enhancing operational transparency for other non-ATS OTC trading centers—namely broker-dealers that internalize order flow.217 In general, these commenters point out the discrepancy in disclosure obligations that would result from the Proposal, or the possibility that broker-dealers would route order flow to non-ATS trading centers as a result.218

    217See ICI Letter at 12; Morgan Stanley Letter at 2-3.

    218See id. See also Fidelity Letter at 11-12. Another commenter recommends that the Commission be required to conduct a review within a designated time-period to assess the effectiveness of the new rules and determine if any refinements should be proposed. See T. Rowe Price Letter at 3. In addition, one commenter suggests that regulators periodically monitor the development of the market and technological developments, and take appropriate action as needed. See Barnard Letter at 3. In addition to the Commission's ongoing oversight responsibilities under the Exchange Act, Rule 304 provides a process for the Commission to review disclosures filed on Form ATS-N, either through an initial Form ATS-N, Form ATS-N amendment, or cessation of operations.

    Given the range of commenter views on these questions and our belief that it is appropriate to take an incremental approach by first applying the amended regime to NMS Stock ATSs before considering a further step, we are not amending Rule 3a1-1(a) and Regulation ATS for non-NMS Stock ATSs. We intend to monitor the implementation and effectiveness of Rule 304 to NMS Stock ATSs, and should we decide to take further action with respect to non-NMS Stock ATSs, we would do so in a separate rulemaking and take into account our experience with Rule 304 and NMS Stock ATSs.

    The Commission notes that the Fixed Income Market Structure Advisory Committee (“FIMSAC”) was formed in 2017 pursuant to the Commission's authority under the Federal Advisory Committee Act to provide the Commission with diverse perspectives on the structure and operations of the U.S. fixed income markets, as well as advice and recommendations on matters related to fixed income market structure.219 The FIMSAC recently issued recommendations for the Commission to review the framework for the oversight of electronic trading platforms for municipal securities and corporate bonds. Specifically, the FIMSAC recommended that the Commission form, together with FINRA and the MSRB, a joint working group to review the regulatory framework for oversight of electronic trading platforms used in the municipal securities and corporate bond markets.220 In light of recent recommendations of the FIMSAC, and comments received, we wi