Federal Register Vol. 82, No.208,

Federal Register Volume 82, Issue 208 (October 30, 2017)

Page Range50059-50304
FR Document

82_FR_208
Current View
Page and SubjectPDF
82 FR 50301 - Unmanned Aircraft Systems Integration Pilot ProgramPDF
82 FR 50169 - Sunshine Act MeetingsPDF
82 FR 50122 - Expanded Collaborative Search Pilot ProgramPDF
82 FR 50129 - Sunshine Act MeetingsPDF
82 FR 50162 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; DOL-Only Performance Accountability, Information, and Reporting SystemPDF
82 FR 50131 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
82 FR 50070 - Removing the Prohibition on the Importation of Jadeite or Rubies Mined or Extracted From Burma, and Articles of Jewelry Containing Jadeite or Rubies Mined or Extracted From BurmaPDF
82 FR 50082 - Drawbridge Operation Regulation; Nanticoke River, Seaford, DEPDF
82 FR 50148 - National Vaccine Injury Compensation Program; List of Petitions ReceivedPDF
82 FR 50150 - National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance PolicyPDF
82 FR 50159 - Bulk Manufacturer of Controlled Substances Application: Euticals Inc.PDF
82 FR 50126 - 54KR 8ME LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
82 FR 50126 - AL Solar A, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
82 FR 50125 - Combined Notice of Filings #1PDF
82 FR 50161 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Examinations and Testing of Electrical Equipment, Including Examination, Testing, and Maintenance of High Voltage LongwallsPDF
82 FR 50166 - Proposed Collection of Information; Comment RequestPDF
82 FR 50161 - President's Committee on the International Labor Organization Charter RenewalPDF
82 FR 50220 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “The Silver Caesars: A Renaissance Mystery” ExhibitionPDF
82 FR 50164 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Sealing of Abandoned Areas StandardPDF
82 FR 50165 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Request for Assistance From the Department of Labor, Employee Benefits Security AdministrationPDF
82 FR 50163 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Rehabilitation Plan and AwardPDF
82 FR 50152 - The President's National Security Telecommunications Advisory CommitteePDF
82 FR 50157 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
82 FR 50158 - Certain Shaving Cartridges, Components Thereof and Products Containing Same Institution of InvestigationPDF
82 FR 50156 - Certain Amorphous Metal and Products Containing Same; Institution of InvestigationPDF
82 FR 50117 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Plants for Planting; Establishing a Category for Plants for Planting Not Authorized for Importation Pending Pest Risk AnalysisPDF
82 FR 50116 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Tomatoes From France, Morocco, Western Sahara, Chile, and SpainPDF
82 FR 50225 - Agency Information Collection Activity Under OMB Review: Claim, Authorization & Invoice for Prosthetic Items & ServicesPDF
82 FR 50120 - Certain Paper Clips From the People's Republic of China: Continuation of Antidumping Duty OrderPDF
82 FR 50093 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Ocean Perch in the Western Regulatory Area of the Gulf of AlaskaPDF
82 FR 50169 - Submission for Review: OPM Form 1654-B, Combined Federal Campaign Federal Retiree Pledge FormPDF
82 FR 50128 - Appraisal Subcommittee Notice of MeetingPDF
82 FR 50155 - Notice of Public Meeting, BLM Alaska Resource Advisory CouncilPDF
82 FR 50089 - Motor Vehicle Safety Standards; Electronic Stability Control Systems for Heavy VehiclesPDF
82 FR 50121 - North Pacific Fishery Management Council; Public MeetingPDF
82 FR 50222 - Notice of OFAC Sanctions ActionsPDF
82 FR 50151 - Advisory Committee on Infant Mortality; Notice of Charter RenewalPDF
82 FR 50221 - Release of Waybill DataPDF
82 FR 50142 - Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Draft Guidance for Industry; AvailabilityPDF
82 FR 50160 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Previously Approved Collection: Red Ribbon Week PatchPDF
82 FR 50209 - Cost-of-Living Increase and Other Determinations for 2018PDF
82 FR 50214 - Social Security Disability Program Demonstration Project: Promoting Opportunity Demonstration (POD)PDF
82 FR 50138 - Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
82 FR 50139 - Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by the Food and Drug Administration; Request for InformationPDF
82 FR 50141 - Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission RequirementsPDF
82 FR 50134 - Manufacturers Sharing Patient-Specific Information From Medical Devices With Patients Upon Request; Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
82 FR 50080 - Medical Devices; Neurological Devices; Classification of the Non-Electroencephalogram Physiological Signal Based Seizure Monitoring SystemPDF
82 FR 50145 - Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Alumni Commissioner's Fellowship Program FellowsPDF
82 FR 50129 - Victory Media, Inc.; Analysis To Aid Public CommentPDF
82 FR 50073 - Medical Devices; Immunology and Microbiology Devices; Classification of the Streptococcus SPP. Nucleic Acid-Based AssayPDF
82 FR 50121 - Marine Mammals; File No. 21431PDF
82 FR 50159 - Agency Information Collection Activities; Proposed eCollection; eComments Requested InfraGard Membership Application and ProfilePDF
82 FR 50127 - Update to Notice of Financial Institutions for Which the Federal Deposit Insurance Corporation Has Been Appointed Either Receiver, Liquidator, or ManagerPDF
82 FR 50126 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
82 FR 50208 - Presidential Declaration Amendment of a Major Disaster for the State of FloridaPDF
82 FR 50059 - Covered Securities Pursuant to Section 18 of the Securities Act of 1933PDF
82 FR 50208 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of FloridaPDF
82 FR 50119 - Submission for OMB Review; Comment RequestPDF
82 FR 50152 - Endangered Species Recovery Permit ApplicationsPDF
82 FR 50128 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
82 FR 50135 - Acceptance Review for De Novo Classification Requests; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
82 FR 50208 - Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of Interest: Propel Venture Partners US Fund I, L.P.PDF
82 FR 50147 - Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments; Reopening of Comment PeriodPDF
82 FR 50077 - Medical Devices; Immunology and Microbiology Devices; Classification of the Newborn Screening Test for Severe Combined Immunodeficiency DisorderPDF
82 FR 50224 - Advisory Council to the Internal Revenue Service; MeetingPDF
82 FR 50224 - Proposed Information Collection; Comment RequestPDF
82 FR 50223 - Proposed Collection; Comment Request for Form 1041-NPDF
82 FR 50144 - De Novo Classification Process (Evaluation of Automatic Class III Designation); Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
82 FR 50071 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Acute Kidney Injury Test SystemPDF
82 FR 50080 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight LossPDF
82 FR 50075 - Medical Devices; Immunology and Microbiology Devices; Classification of the Aquaporin-4 Autoantibody Immunological Test SystemPDF
82 FR 50185 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to the Exchange's Name ChangePDF
82 FR 50203 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Make Technical Corrections to Its Second Amended and Restated Certificate of IncorporationPDF
82 FR 50221 - Petition for Exemption; Summary of Petition Received; Airlines for AmericaPDF
82 FR 50175 - Self-Regulatory Organizations; Bats EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Make Technical Corrections to Its Second Amended and Restated Certificate of IncorporationPDF
82 FR 50196 - Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 723 To Remove Obsolete Rule TextPDF
82 FR 50201 - Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 723 To Remove Obsolete Rule TextPDF
82 FR 50171 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Its Fee SchedulePDF
82 FR 50186 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Provide Users With Access to Five Additional Third Party Systems and Connectivity to Two Additional Third Party Data FeedsPDF
82 FR 50181 - Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the MIAX PEARL Fee SchedulePDF
82 FR 50194 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Make Permanent an Exception to TRACE Reporting for Certain Bond Transactions Effected on the New York Stock ExchangePDF
82 FR 50198 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Nasdaq Closing Cross RulesPDF
82 FR 50129 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
82 FR 50177 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Provide Users With Access to Five Additional Third Party Systems and Connectivity to Two Additional Third Party Data FeedsPDF
82 FR 50205 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Rule 964.2NY Regarding the Participation Entitlement Formula for Specialists and e-SpecialistsPDF
82 FR 50190 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Provide Users With Access to Five Additional Third Party Systems and Connectivity to Two Additional Third Party Data FeedsPDF
82 FR 50170 - New Postal ProductsPDF
82 FR 50170 - Submission for OMB Review; Comment RequestPDF
82 FR 50133 - Submission for OMB Review; Comment RequestPDF
82 FR 50167 - Agency Information Collection Activities; Proposals, Submissions, and ApprovalsPDF
82 FR 50118 - Notice of Public Meeting of the West Virginia Advisory CommitteePDF
82 FR 50117 - Notice of Public Meeting of the Virginia Advisory CommitteePDF
82 FR 50119 - Notice of Public Meeting of the Alabama Advisory Committee for Orientation and To Discuss Voting in the State of Alabama as a Topic of SAC StudyPDF
82 FR 50104 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Modifications to the Number of Unrigged Hooks Carried On Board Bottom Longline VesselsPDF
82 FR 50151 - National Center for Complementary & Integrative Health; Notice of MeetingPDF
82 FR 50151 - National Center for Complementary and Integrative Health; Notice of MeetingPDF
82 FR 50112 - Pacific Island Fisheries; 2017 Annual Catch Limits and Accountability MeasuresPDF
82 FR 50106 - Magnuson-Stevens Act Provisions; Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Pacific Whiting; Pacific Coast Groundfish Fishery Management Plan; Amendment 21-3; Trawl Rationalization ProgramPDF
82 FR 50167 - NASA Advisory Council; Ad Hoc Task Force on STEM Education; MeetingPDF
82 FR 50220 - Release of Waybill DataPDF
82 FR 50101 - Snapper-Grouper Fishery of the South Atlantic Region; Temporary Measures To Reduce Overfishing of Golden TilefishPDF
82 FR 50084 - Hexythiazox; Pesticide TolerancesPDF
82 FR 50166 - NASA Advisory Council; Aeronautics Committee; MeetingPDF
82 FR 50167 - NASA Advisory Council; Charter RenewalPDF
82 FR 50220 - BNSF Railway Company-Abandonment Exemption-in Larimer County, CO.PDF
82 FR 50208 - National Small Business Development Centers Advisory BoardPDF
82 FR 50221 - Fee Schedule for the Transfer of U.S. Treasury Book-Entry Securities Held on the National Book-Entry SystemPDF
82 FR 50270 - Supervisory Review Committee; Procedures for Appealing Material Supervisory DeterminationsPDF
82 FR 50094 - Capital Planning and Supervisory Stress TestingPDF
82 FR 50288 - Appeals ProceduresPDF
82 FR 50228 - Restrictions on Qualified Financial Contracts of Certain FDIC-Supervised Institutions; Revisions to the Definition of Qualifying Master Netting Agreement and Related DefinitionsPDF

Issue

82 208 Monday, October 30, 2017 Contents Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

Animal Animal and Plant Health Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Importation of Plants for Planting; Establishing Category for Plants for Planting Not Authorized for Importation Pending Pest Risk Analysis, 50117 2017-23540 Importation of Tomatoes from France, Morocco, Western Sahara, Chile, and Spain, 50116-50117 2017-23539 Fiscal Bureau of the Fiscal Service NOTICES Fee Schedule for Transfer of U.S. Treasury Book-Entry Securities Held on National Book-Entry System, 50221-50222 2017-23311 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50131-50133 2017-23561 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50133-50134 2017-23467 Civil Rights Civil Rights Commission NOTICES Meetings: Alabama Advisory Committee, 50119 2017-23463 Virginia Advisory Committee, 50117-50118 2017-23464 West Virginia Advisory Committee, 50118-50119 2017-23465 Coast Guard Coast Guard RULES Drawbridge Operations: Nanticoke River, Seaford, DE, 50082-50084 2017-23559 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50119-50120 2017-23504 2017-23505
Drug Drug Enforcement Administration NOTICES Manufacturers of Controlled Substances; Applications: Euticals, Inc., 50159 2017-23556 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Pesticide Tolerances: Hexythiazox, 50084-50089 2017-23439 Federal Aviation Federal Aviation Administration NOTICES Petitions for Exemptions: Airlines for America, 50221 2017-23486 Federal Deposit Federal Deposit Insurance Corporation RULES Restrictions on Qualified Financial Contracts of Certain FDIC-Supervised Institutions: Revisions to Definition of Qualifying Master Netting Agreement and Related Definitions, 50228-50268 2017-21951 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50126-50127 2017-23509 Financial Institutions for Which Federal Deposit Insurance Corporation has been Appointed Either Receiver, Liquidator, or Manager, 50127-50128 2017-23510 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 50125-50126 2017-23553 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: 54KR 8ME, LLC, 50126 2017-23555 AL Solar A, LLC, 50126 2017-23554 Federal Financial Federal Financial Institutions Examination Council NOTICES Meetings: Appraisal Subcommittee, 50128 2017-23533 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 50129 2017-23477 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 50128-50129 2017-23472 2017-23501 Federal Retirement Federal Retirement Thrift Investment Board NOTICES Meetings; Sunshine Act, 50129 2017-23619 Federal Trade Federal Trade Commission NOTICES Proposed Consent Agreements: Victory Media, Inc., 50129-50131 2017-23514 Fish Fish and Wildlife Service NOTICES Permit Applications: Endangered Species Recovery, 50152-50155 2017-23502 Food and Drug Food and Drug Administration RULES Medical Devices: Clinical Chemistry and Clinical Toxicology Devices; Classification of Acute Kidney Injury Test System, 50071-50073 2017-23491 Gastroenterology-Urology Devices; Classification of Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss, 50080 2017-23490 Immunology and Microbiology Devices; Classification of Aquaporin-4 Autoantibody Immunological Test System, 50075-50077 2017-23489 Immunology and Microbiology Devices; Classification of Newborn Screening Test for Severe Combined Immunodeficiency Disorder, 50077-50080 2017-23496 Immunology and Microbiology Devices; Classification of Streptococcus SPP. Nucleic Acid-Based Assay, 50073-50074 2017-23513 Neurological Devices; Classification of Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System, 50080-50082 2017-23516 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Postmarketing Safety Reports for Human Drug and Biological Products, 50141-50142 2017-23518 Survey of Alumni Commissioner's Fellowship Program Fellows, 50145-50147 2017-23515 Guidance: Acceptance Review for De Novo Classification Requests, 50135-50138 2017-23500 Assessing User Fees under Generic Drug User Fee Amendments of 2017, 50142-50144 2017-23526 De Novo Classification Process (Evaluation of Automatic Class III Designation), 50144-50145 2017-23492 Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients upon Request, 50134-50135 2017-23517 Product Labeling for Certain Ultrasonic Surgical Aspirator Devices, 50138-50139 2017-23520 Meetings: Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop, 50147-50148 2017-23498 Requests for Information: Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by Food and Drug Administration, 50139-50141 2017-23519 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 50222-50223 2017-23529 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Children and Families Administration

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

Health Resources Health Resources and Services Administration NOTICES Charter Renewals: Advisory Committee on Infant Mortality, 50151 2017-23528 National Vaccine Injury Compensation Program Petitions, 50148-50150 2017-23558 National Vaccine Injury Compensation Program: Revised Amount of Average Cost of Health Insurance Policy, 50150-50151 2017-23557 Homeland Homeland Security Department See

Coast Guard

See

U.S. Customs and Border Protection

NOTICES Meetings: President's National Security Telecommunications Advisory Committee; Teleconference, 50152 2017-23544
Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50223-50225 2017-23493 2017-23494 Meetings: Advisory Council to Internal Revenue Service, 50224 2017-23495 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Paper Clips from the People's Republic of China, 50120-50121 2017-23537 International Trade Com International Trade Commission NOTICES Complaints: Certain Mounting Apparatuses for Holding Portable Electronic Devices and Components Thereof, 50157-50158 2017-23543 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Amorphous Metal and Products Containing Same, 50156-50157 2017-23541 Certain Shaving Cartridges, Components Thereof and Products Containing Same, 50158-50159 2017-23542 Justice Department Justice Department See

Drug Enforcement Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: InfraGard Membership Application and Profile, 50159-50160 2017-23511 Red Ribbon Week Patch, 50160-50161 2017-23524
Labor Department Labor Department See

Workers Compensation Programs Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: DOL-Only Performance Accountability, Information, and Reporting System, 50162-50163 2017-23569 Examinations and Testing of Electrical Equipment, Including Examination, Testing, and Maintenance of High Voltage Longwalls, 50161-50162 2017-23552 Rehabilitation Plan and Award, 50163-50164 2017-23546 Request for Assistance from Department of Labor, Employee Benefits Security Administration, 50165-50166 2017-23547 Sealing of Abandoned Areas Standard, 50164-50165 2017-23548 Charter Renewals: President's Committee on International Labor Organization, 50161 2017-23550
Land Land Management Bureau NOTICES Meetings: Alaska Resource Advisory Council, 50155-50156 2017-23532 NASA National Aeronautics and Space Administration NOTICES Charter Renewals: Advisory Council, 50167 2017-23408 Meetings: Advisory Council; Ad Hoc Task Force on STEM Education, 50167 2017-23455 Aeronautics Committee of NASA Advisory Council, 50166-50167 2017-23409 National Credit National Credit Union Administration RULES Appeals Procedures, 50288-50297 2017-23211 Supervisory Review Committee; Procedures for Appealing Material Supervisory Determinations, 50270-50285 2017-23213 PROPOSED RULES Capital Planning and Supervisory Stress Testing, 50094-50101 2017-23212 National Highway National Highway Traffic Safety Administration RULES Motor Vehicle Safety Standards: Electronic Stability Control Systems for Heavy Vehicles, 50089-50093 2017-23531 National Institute National Institutes of Health NOTICES Meetings: National Center for Complementary and Integrative Health, 50151 2017-23458 2017-23459 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Pacific Ocean Perch in Western Regulatory Area of Gulf of Alaska, 50093 2017-23536 PROPOSED RULES Fisheries of Caribbean, Gulf of Mexico, and South Atlantic: Reef Fish Fishery of Gulf of Mexico; Modifications to Number of Unrigged Hooks Carried on Board Bottom Longline Vessels, 50104-50106 2017-23460 Fisheries off West Coast States: Pacific Coast Groundfish Fishery; Pacific whiting; Pacific Coast Groundfish Fishery Management Plan; Amendment 21-3; Trawl Rationalization Program, 50106-50112 2017-23456 Pacific Island Fisheries: 2017 Annual Catch Limits and Accountability Measures, 50112-50115 2017-23457 Snapper-Grouper Fishery of South Atlantic Region: Temporary Measures to Reduce Overfishing of Golden Tilefish, 50101-50104 2017-23453 NOTICES Meetings: North Pacific Fishery Management Council, 50121 2017-23530 Permit Applications: Marine Mammals; File No. 21431, 50121-50122 2017-23512 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50167-50169 2017-23466 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Meetings; Sunshine Act, 50169 2017-23664 Patent Patent and Trademark Office NOTICES Expanded Collaborative Search Pilot Program, 50122-50125 2017-23661 Personnel Personnel Management Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Combined Federal Campaign Federal Retiree Pledge Form, 50169-50170 2017-23534 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 50170 2017-23473 Presidential Documents Presidential Documents ADMINISTRATIVE ORDERS Aircraft: Unmanned Aircraft Systems Integration Pilot Program; Establishment (Memorandum of October 25, 2017), 50299-50304 2017-23746 Securities Securities and Exchange Commission RULES Covered Securities Pursuant to Section 18 of Securities Act of 1933, 50059-50069 2017-23507 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50170-50171 2017-23471 Self-Regulatory Organizations; Proposed Rule Changes: Bats EDGA Exchange, Inc., 50175-50176 2017-23485 Bats EDGX Exchange, Inc., 50203-50205 2017-23487 Financial Industry Regulatory Authority, Inc., 50194-50196 2017-23479 Miami International Securities Exchange, LLC, 50171-50175 2017-23482 MIAX PEARL, LLC, 50181-50185 2017-23480 Nasdaq GEMX, LLC, 50196-50198 2017-23484 Nasdaq MRX, LLC, 50201-50203 2017-23483 NASDAQ PHLX, LLC, 50185-50186 2017-23488 NASDAQ Stock Market, LLC, 50198-50201 2017-23478 New York Stock Exchange, LLC, 50186-50190 2017-23481 NYSE American, LLC, 50190-50194, 50205-50207 2017-23474 2017-23475 NYSE Arca, Inc, 50177-50181 2017-23476 Small Business Small Business Administration NOTICES Conflicts of Interest; Exemptions: Propel Venture Partners US Fund I, L.P., 50208-50209 2017-23499 Disaster Declarations: Florida; Amendment 3, 50208 2017-23506 Major Disaster Declarations: Florida; Amendment 6, 50208 2017-23508 Meetings: National Small Business Development Centers Advisory Board, 50208 2017-23337 Social Social Security Administration NOTICES Cost-of-Living Increase and Other Determinations for 2018, 50209-50214 2017-23522 Social Security Disability Program Demonstration Project: Promoting Opportunity Demonstration, 50214-50219 2017-23521 State Department State Department NOTICES Culturally Significant Objects Imported for Exhibition: The Silver Caesars: A Renaissance Mystery, 50220 2017-23549 Surface Transportation Surface Transportation Board NOTICES Abandonment Exemptions: BNSF Railway Co.; Larimer County, CO, 50220-50221 2017-23356 Releases of Waybill Data, 50220-50221 2017-23454 2017-23527 Transportation Department Transportation Department See

Federal Aviation Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Bureau of the Fiscal Service

See

Foreign Assets Control Office

See

Internal Revenue Service

RULES Jadeite or Rubies Mined or Extracted from Burma: Removal of Prohibition on Importation, 50070-50071 2017-23560
Customs U.S. Customs and Border Protection RULES Jadeite or Rubies Mined or Extracted from Burma: Removal of Prohibition on Importation, 50070-50071 2017-23560 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Claim, Authorization and Invoice for Prosthetic Items and Services, 50225 2017-23538 Workers' Workers Compensation Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50166 2017-23551 Separate Parts In This Issue Part II Federal Deposit Insurance Corporation, 50228-50268 2017-21951 Part III National Credit Union Administration, 50270-50285 2017-23213 Part IV National Credit Union Administration, 50288-50297 2017-23211 Part V Presidential Documents, 50299-50304 2017-23746 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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82 208 Monday, October 30, 2017 Rules and Regulations SECURITIES AND EXCHANGE COMMISSION 17 CFR Part 230 [Release No. 33-10428; File No. S7-06-17] RIN 3235-AM07 Covered Securities Pursuant to Section 18 of the Securities Act of 1933 AGENCY:

Securities and Exchange Commission.

ACTION:

Final rule.

SUMMARY:

The Securities and Exchange Commission (“SEC” or “Commission”) is adopting an amendment to Rule 146 under Section 18 of the Securities Act of 1933, as amended (“Securities Act”), to designate certain securities listed, or authorized for listing, on Investors Exchange LLC (“IEX” or “Exchange”) as covered securities for purposes of Section 18(b) of the Securities Act. Covered securities under Section 18(b) of the Securities Act are exempt from state law registration requirements. The Commission also is amending Rule 146 to reflect name changes of certain exchanges referenced in the Rule.

DATES:

Effective Date: November 29, 2017.

FOR FURTHER INFORMATION CONTACT:

Richard Holley III, Assistant Director; Edward Cho, Special Counsel; or Michael Ogershok, Attorney-Adviser, Office of Market Supervision, at (202) 551-5777, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-7010.

SUPPLEMENTARY INFORMATION: I. Introduction

In 1996, Congress amended Section 18 of the Securities Act to exempt from state registration requirements securities listed, or authorized for listing, on the New York Stock Exchange LLC (“NYSE”), the American Stock Exchange LLC (“Amex”) (now known as NYSE American LLC),1 or the National Market System of The NASDAQ Stock Market LLC (“Nasdaq/NGM”) 2 (collectively, the “Named Markets”), or any national securities exchange designated by the Commission to have substantially similar listing standards to those of the Named Markets (“Designated Markets”).3 More specifically, Section 18(a) of the Securities Act provides that “no law, rule, regulation, or order, or other administrative action of any State . . . requiring, or with respect to, registration or qualification of securities . . . shall directly or indirectly apply to a security that—(A) is a covered security.” 4 Covered securities are defined in Section 18(b)(1) of the Securities Act to include those securities listed, or authorized for listing, on the Named Markets, or securities listed, or authorized for listing, on a national securities exchange (or tier or segment thereof) that has listing standards that the Commission determines by rule are “substantially similar” to those of the Named Markets (“Covered Securities”).5

1 On October 1, 2008, NYSE Euronext acquired The Amex Membership Corporation (“AMC”) pursuant to an Agreement and Plan of Merger, dated January 17, 2008 (“Merger”). In connection with the Merger, NYSE Amex's predecessor, Amex, a subsidiary of AMC, became a subsidiary of NYSE Euronext called NYSE Alternext US LLC (“NYSE Alternext”). See Securities Exchange Act Release No. 58673 (September 29, 2008), 73 FR 57707 (October 3, 2008) (SR-NYSE-2008-60 and SR-Amex 2008-62) (approving the Merger). In 2009, NYSE Alternext changed its name to NYSE Amex LLC (“NYSE Amex”). See Securities Exchange Act Release No. 59575 (March 13, 2009), 74 FR 11803 (March 19, 2009) (SR-NYSEALTR-2009-24) (approving the name change). In 2012, NYSE Amex changed its name from NYSE Amex LLC to NYSE MKT LLC (“NYSE MKT”). See Securities Exchange Act Release No. 67037 (May 21, 2012), 77 FR 31415 (May 25, 2012) (SR-NYSEAmex-2012-32) (publishing notice of the name change to NYSE MKT LLC). As of July 24, 2017, NYSE MKT changed its name from NYSE MKT LLC to NYSE American LLC (“NYSE American”). See Securities Exchange Act Release No. 80283 (March 21, 2017), 82 FR 15244 (March 27, 2017) (SR-NYSEMKT-2017-14).

2 As of July 1, 2006, the National Market System of The NASDAQ Stock Market LLC is known as the Nasdaq Global Market (“NGM”). See Securities Exchange Act Release Nos. 53799 (May 12, 2006), 71 FR 29195 (May 19, 2006) and 54071 (June 29, 2006), 71 FR 38922 (July 10, 2006).

3See National Securities Markets Improvement Act of 1996, Public Law 104-290, 110 Stat. 3416 (October 11, 1996).

4 15 U.S.C. 77r(a).

5 15 U.S.C. 77r(b)(1)(A) and (B). In addition, securities of the same issuer that are equal in seniority or senior to a security listed on a Named Market or national securities exchange designated by the Commission as having substantially similar listing standards to a Named Market are Covered Securities for purposes of Section 18(b) of the Securities Act. See 15 U.S.C. 77r(b)(1)(C).

Pursuant to Section 18(b)(1)(B) of the Securities Act, the Commission adopted Rule 146.6 Rule 146(b) lists those national securities exchanges, or segments or tiers thereof, that the Commission has determined to have listing standards substantially similar to those of the Named Markets and thus securities listed on such exchanges are deemed Covered Securities.7 IEX has petitioned the Commission to amend Rule 146(b) to designate certain securities listed, or authorized for listing, on IEX as Covered Securities for purposes of Section 18(b) of the Securities Act.8

6See Securities Exchange Act Release No. 39542 (January 13, 1998), 63 FR 3032 (January 21, 1998) (determining that the listing standards of the Chicago Board Options Exchange, Incorporated (“CBOE”), the Pacific Exchange, Inc. (now known as NYSE Arca, Inc.), and the Philadelphia Stock Exchange, Inc. (“Phlx”) (now known as NASDAQ PHLX LLC) were substantially similar to those of the Named Markets). The Commission notes that, on July 24, 2008, The NASDAQ OMX Group, Inc. acquired Phlx and renamed it “NASDAQ OMX PHLX LLC,” and NASDAQ OMX PHLX LLC subsequently changed its name to “NASDAQ PHLX LLC.” See Securities Exchange Act Release Nos. 58179 (July 17, 2008), 73 FR 42874 (July 23, 2008) (SR-Phlx-2008-31); 58183 (July 17, 2008), 73 FR 42850 (July 23, 2008) (SR-NASDAQ-2008-035); 62783 (August 27, 2010), 75 FR 54204 (September 3, 2010) (SR-Phlx-2010-104); and 76654 (December 15, 2015), 80 FR 79396 (December 21, 2015) (SR-Phlx-2015-105). In 2004, the Commission amended Rule 146(b) to designate options listed on the International Securities Exchange, Inc. (“ISE”) as Covered Securities for purposes of Section 18(b) of the Securities Act. See Securities Act Release No. 8442 (July 14, 2004), 69 FR 43295 (July 20, 2004). The Commission notes that, in March 2017, ISE changed its name from International Securities Exchange, LLC to “Nasdaq ISE, LLC.” See Securities Exchange Act Release No. 80325 (March 29, 2017), 82 FR 16445 (April 4, 2017) (SR-ISE-2017-25) (publishing notice of the name change to Nasdaq ISE, LLC). In 2007, the Commission amended Rule 146(b) to designate securities listed on the Nasdaq Capital Market (“NCM”) as Covered Securities for purposes of Section 18(b) of the Securities Act. See Securities Act Release No. 8791 (April 18, 2007), 72 FR 20410 (April 24, 2007) (File No. S7-18-06). In 2012, the Commission amended Rule 146(b) to designate securities listed on Tiers I and II of BATS Exchange, Inc. (“BATS”) as Covered Securities for purposes of Section 18(b) of the Securities Act. See Securities Act Release No. 9295 (January 20, 2012), 77 FR 3590 (January 25, 2012). The Commission notes that, in March 2016, BATS changed its name from BATS Exchange, Inc. to “Bats BZX Exchange, Inc.” See Securities Exchange Act Release No. 77307 (March 7, 2016), 81 FR 12996 (March 11, 2016) (SR-BATS-2016-25) (publishing notice of the name change to Bats BZX Exchange, Inc.).

7 17 CFR 230.146(b).

8See Letter from Sophia Lee, General Counsel, IEX, to Brent J. Fields, Secretary, Commission, dated September 22, 2016 (“IEX Petition”).

In July 2017, the Commission proposed to amend Rule 146(b) to designate certain securities listed, or authorized for listing, on IEX as Covered Securities for purposes of Section 18(b) of the Securities Act.9 The Commission also proposed to amend Rule 146 to reflect name changes of certain exchanges referenced in the Rule. The Commission received one comment letter,10 which supported amending Rule 146(b) to designate certain securities listed, or authorized for listing, on IEX as Covered Securities.

9See Securities Act Release No. 10390 (July 14, 2017), 82 FR 33839 (July 21, 2017) (“Proposing Release”).

10See Letter from Karl T. Muth, Lecturer in Economics and Public Policy, Northwestern University, and Lecturer in Law, Pritzker School of Law, Northwestern University, to Commission, dated July 21, 2017 (“Muth Letter”).

The Commission has determined that IEX's listing standards are substantially similar to the listing standards of the Named Markets. Accordingly, the Commission today is amending Rule 146(b) to designate securities listed, or authorized for listing, on IEX as Covered Securities under Section 18(b)(1) of the Securities Act.11 Amending Rule 146(b) to include these securities as Covered Securities will exempt those securities from state registration requirements as set forth under Section 18(a) of the Securities Act.12 The Commission also is adopting, as proposed, updated references in the Rule.

11 15 U.S.C. 77r(b)(1).

12 15 U.S.C. 77r(a).

II. Amendment to Rule 146(b) To Include IEX Securities

Under Section 18(b)(1)(B) of the Securities Act,13 the Commission has the authority to determine that the listing standards of an exchange, or tier or segment thereof, are substantially similar with those of the NYSE, NYSE American, or Nasdaq/NGM. The Commission initially compared IEX's listing standards with those of Nasdaq/NGM.14 Where the listing standards in a particular category were not substantially similar to the standards of Nasdaq/NGM, the Commission compared IEX's standards to NYSE and NYSE American.15 In addition, as it has done previously, the Commission interpreted the “substantially similar” standard to require listing standards at least as comprehensive as those of the Named Markets.16 If IEX's listing standards were higher than those of the Named Markets, then the Commission would still determine that IEX's listing standards are substantially similar to those of the Named Markets.17 Finally, the Commission notes that differences in language or approach would not necessarily lead to a determination that IEX's listing standards are not substantially similar to those of any Named Market.18

13 15 U.S.C. 77r(b)(1)(B).

14See infra note 20.

15 This approach is consistent with the approach that the Commission has previously taken. See, e.g., Securities Act Release No. 7494 (January 13, 1998), 63 FR 3032 (January 21, 1998) (File No. S7-17-97).

16See id.

17See Securities Act Release No. 8791, supra note 6.

18See id.

The Commission included in the Proposing Release its preliminary view that IEX's quantitative and qualitative listing standards were substantially similar to the listing standards for a Named Market. The Commission received no comments on its views.19 The Commission has reviewed IEX's listing standards for securities to be listed and traded on IEX and, for the reasons discussed below, has determined that IEX's listing standards are substantially similar to those of a Named Market as required by Section 18(b)(1)(B).20 Accordingly, the Commission is amending Rule 146(b) to include securities listed, or authorized for listing, on IEX.

19See Proposing Release, supra note 9, at 33841-42. See also id. at 33842 (discussing various other types of securities and exchange-traded derivative securities products).

20See infra notes 21-29 and accompanying text (discussing the quantitative and qualitative listing standards); and infra notes 30-31 and accompanying text (discussing various other types of securities and exchange-traded derivative securities products). See also generally IEX Rules Chapters 14 (IEX Listing Rules) and 16 (Other Securities). See also Securities Exchange Act Release No. 75925 (September 15, 2015), 80 FR 57261 (September 22, 2015) (File No. 10-222) (Notice of Filing of Application of IEX). In making its determination of substantial similarity, as discussed below, the Commission compared IEX's quantitative listing standards with Nasdaq/NGM's quantitative listing standards; IEX's qualitative listing standards with Nasdaq/NGM's qualitative listing standards and, with respect to the rules relating to the listing application process and internal audit function, with NYSE's and NYSE American's applicable qualitative listing standards; and IEX's listing standards for other securities, including portfolio depository receipts, index fund shares, and managed fund shares, with Nasdaq/NGM's corresponding listing standards.

A. IEX Quantitative Listing Standards

The Commission continues to believe that IEX's initial and continued quantitative listing standards for its securities are substantively identical to, and thus substantially similar to, the initial and continued quantitative listing standards for securities listed on Nasdaq/NGM.21 Accordingly, because IEX's initial and continued quantitative listing standards are substantively identical to those of Nasdaq/NGM, the Commission has determined that IEX's initial and continued quantitative listing standards are substantially similar to those of a Named Market.22

21See Proposing Release, supra note 9, at 33841. Quantitative listing standards relate to, among other things, the requirements for bid price, number of publicly held shares, number of shareholders, market value of publicly held shares, and market capitalization.

22Compare IEX Rules 14.300 series with Nasdaq/NGM Rule 5300 and 5400 series (providing for identical rules concerning initial listing and maintenance standards for units, primary equity securities, preferred stock and secondary classes of common stock, rights, warrants, and convertible debt on IEX and Nasdaq/NGM).

B. IEX Qualitative Listing Standards

The Commission continues to believe that IEX's initial and continued qualitative listing standards for its securities are substantively identical to, and thus substantially similar to, the qualitative listing standards for securities listed on Nasdaq/NGM,23 with the exception of IEX Rule 14.201 (Confidential Pre-Application Review of Eligibility) (which the Commission preliminarily believed was substantially similar to rules of NYSE and NYSE American) and IEX Rule 14.414 (Internal Audit Function) (which the Commission preliminarily believed was substantially similar to a rule of NYSE).24

23 Qualitative listing standards relate to, among other things, the number of independent directors required, conflicts of interest, composition of the audit committee, executive compensation, shareholder meeting requirements, voting rights, quorum, code of conduct, proxies, shareholder approval of certain corporate actions, and the annual and interim reports requirements.

24See Proposing Release, supra note 9, at 33841-42.

Accordingly, because IEX's initial and continued qualitative listing standards are substantively identical to those of Nasdaq/NGM, the Commission has determined that IEX's initial and continued qualitative listing standards are substantially similar to the qualitative listing standards for securities listed on Nasdaq/NGM, which is a Named Market,25 with the exception of (a) IEX Rule 14.201 (Confidential Pre-Application Review of Eligibility), discussed below, which is substantially similar to rules of other Named Markets, namely NYSE and NYSE American, and (b) IEX Rule 14.414 (Internal Audit Function), also discussed below, which is substantially similar to a rule of NYSE.

25Compare IEX Rules 14.200 and 14.400 series with Nasdaq/NGM Rules 5200 and 5600 series (providing for virtually identical rules concerning procedures and prerequisites for initial and continued listing, obligations of security issuers, the application and qualification process, and corporate governance standards on IEX and Nasdaq/NGM).

With respect to the standards relating to the listing and delisting of companies, including prerequisites for initial and continued listing on IEX, obligations of security issuers listed on IEX, as well as rules describing the application and qualification process, IEX's listing rules for securities are virtually identical to, and thus substantially similar to, those of Nasdaq/NGM.26 IEX Rule 14.201, which specifically relates to confidential pre-application review for listing eligibility, is substantially similar to the corresponding rules of NYSE and NYSE American.27

26Compare IEX Rule 14.200 series with Nasdaq/NGM Rule 5200 series (providing for virtually identical rules concerning procedures and prerequisites for initial and continued listing, obligations of security issuers, and the application and qualification process).

27See IEX Rule 14.201; NYSE Listed Company Manual Sections 101 and 104; and NYSE American Company Guide Section 201. IEX Rule 14.201 requires a company seeking the initial listing of one or more classes of securities to participate in a free, confidential pre-application eligibility review to determine whether the company meets the applicable listing criteria and, if, upon completion of this review, IEX determines that a company is eligible for listing, IEX will notify that company in writing that it has been cleared to submit an original listing application. The Commission notes that, while IEX Rule 14.201 is substantially similar to the equivalent NYSE and NYSE American rules (all of which relate to the confidential pre-application review for eligibility for companies seeking to list on the Exchange), IEX's rule contains an additional, heightened provision stating that a company deemed eligible for listing will be provided with written notification valid for nine months that it has been cleared to submit an original listing application. See IEX Rule 14.201. See also NYSE Listed Company Manual Sections 101 and 104; NYSE American Company Guide Section 201. IEX represents that an issuer that does not clear the pre-application eligibility review process or receive a timely response as part of that process on IEX after the confidential pre-application eligibility review would be permitted to appeal such determination under the procedures set forth in IEX Rule series 9.500. See IEX Petition, supra note 8, at 5.

The Commission also notes that IEX's corporate governance standards in connection with securities to be listed and traded on IEX are virtually identical to, and thus substantially similar to, the current rules of Nasdaq/NGM and NYSE.28 IEX Rule 14.414, specifically concerning the internal audit function for a listed issuer, is substantially similar to the corresponding rule of NYSE.29 Therefore, the Commission has determined that IEX's qualitative listing standards are substantially similar to those of a Named Market.

28Compare IEX Rule 14.400 series (Corporate Governance Requirements) with Nasdaq/NGM Rule 5600 series (Corporate Governance Requirements).

29Compare NYSE Listed Company Manual Section 303A.07(c) (requiring listed companies to maintain an internal audit function to provide management and the audit committee with ongoing assessments of the listed company's risk management processes and system of internal control) with IEX Rule 14.414.

C. Other Securities, Including Securities of Exchange-Traded Funds and Other Exchange-Traded Derivative Securities Products

The Commission compared IEX's listing standards for other types of securities, including, for example, portfolio depository receipts; index fund shares; securities linked to the performance of indexes, commodities, and currencies; index-linked exchangeable notes; partnership units; trust units; and managed fund shares,30 to Nasdaq/NGM's standards. The Commission continues to believe that IEX's standards for these other types of securities are virtually identical to the corresponding Nasdaq/NGM standards.31 Accordingly, because IEX's initial and continued listing standards for these other securities are substantively identical to those of Nasdaq/NGM, the Commission has determined that IEX's standards for these other securities are substantially similar to those of a Named Market.

30Compare IEX Rules Chapter 16 (Other Securities) with Nasdaq/NGM Rule 5700 series (Other Securities). See also IEX Rule 16.105(a) (Portfolio Depository Receipts); Rule 16.105(b) (Index Fund Shares); Rule 16.110 (Securities Linked to the Performance of Indexes and Commodities (Including Currencies)); Rule 16.111(a) (Index-Linked Exchangeable Notes); Rule 16.111(b) (Equity Gold Shares); Rule 16.111(c) (Trust Certificates); Rule 16.111(d) (Commodity-Based Trust Shares); Rule 16.111(e) (Currency Trust Shares); Rule 16.111(f) (Commodity Index Trust Shares); Rule 16.111(g) (Commodity Futures Trust Shares); Rule 16.111(h) (Partnership Units); Rule 16.111(i) (Trust Units); Rule 16.111(j) (Managed Trust Securities); Rule 16.113 (Paired Class Shares); Rule 16.115 (Selected Equity-linked Debt Securities (“SEEDS”)); Rule 16.120 (Trust Issued Receipts); Rule 16.125 (Index Warrants); Rule 16.130 (Listing Requirements for Securities Not Otherwise Specified (Other Securities)); and Rule 16.135 (Managed Funds Shares).

31See Proposing Release, supra note 9, at 33842.

D. Other Amendments

Finally, the Commission is amending Rule 146(b) as proposed to reflect the following name changes, on which the Commission did not receive any comments:

• Paragraphs (b)(1) and (b)(2) of Rule 146 use the term “NYSE Amex” to refer to the national securities exchange formerly known as the American Stock Exchange LLC. As noted above, in 2012, NYSE Amex changed its name from NYSE Amex LLC to NYSE MKT LLC, and, in July 2017, NYSE MKT LLC changed its name to NYSE American LLC.32 Accordingly, the Commission is making a conforming change to Rule 146(b).

32See supra note 1.

• Paragraph (b)(1) of Rule 146 refers to “Tier I of the NASDAQ OMX PHLX LLC.” As noted above, in December 2015, NASDAQ OMX PHLX LLC changed its name to NASDAQ PHLX LLC.33 Accordingly, the Commission is making a conforming change to Rule 146(b).

33See supra note 6.

• Paragraph (b)(1) of Rule 146 refers to “Tier I and Tier II of BATS Exchange, Inc.” As noted above, in March 2016, BATS Exchange, Inc. changed its name to Bats BZX Exchange, Inc.34 Accordingly, the Commission is making a conforming change to Rule 146(b).

34See id.

• Paragraph (b)(1) of Rule 146 refers to “Options listed on the International Securities Exchange, LLC.” As noted above, in March 2017, the International Securities Exchange, LLC changed its name to Nasdaq ISE, LLC.35 Accordingly, the Commission is making a conforming change to Rule 146(b).

35See id.

III. Paperwork Reduction Act

The Paperwork Reduction Act of 1995 does not apply because the amendment to Rule 146(b) does not impose recordkeeping or information collection requirements or other collection of information, which require the approval of the Office of Management and Budget under 44 U.S.C. 3501 et seq.

IV. Economic Analysis

The Commission is sensitive to the economic consequences of its rules, including the benefits, costs, and effects on efficiency, competition, and capital formation. As noted above, the Commission has determined that the overall listing standards for securities to be listed and traded on IEX are substantially similar to those of a Named Market. As such, the Commission is adopting amendments to Rule 146 under Section 18 of the Securities Act, to designate securities listed, or authorized for listing, on IEX as Covered Securities. The following analysis considers the economic effects that may result from the amendment.

Where possible, the Commission has quantified the economic effects of the amendment; however, as explained further below, the Commission is unable to quantify all of the economic effects because it lacks the information necessary to provide reasonable estimates. In some cases, quantification depends heavily on factors outside of the control of the Commission, particularly due to the flexibility that an issuer has when choosing if and where to list its securities and the flexibility of a registered national securities exchange to tailor its policies and rules to the nature of its business and technology. These factors make it difficult to quantify the changes in market share of Named and Designated Markets that may result from the amendment. In addition, the incumbent Named and Designated Markets and IEX each may react to the amendments with respect to listing fees and services. These reactions are also difficult to quantify or predict, which further complicates quantification of changes to market share, and also makes quantification of the economic effects of the amendment difficult. Therefore, some of the discussions below are qualitative in nature. In the Proposing Release the Commission solicited comment on its economic analysis, including costs and benefits and potential impacts on efficiency, competition, and capital formation, and encouraged commenters to provide specific estimates or data. The Commission did not receive any comment on, or data regarding, its estimates. The Commission received one comment letter that was generally supportive of the proposed rule amendment.36

36See Muth Letter, supra note 10 (“The removal of state-by-state heterogeneity, including through 18(b) inclusion, is one way to decrease friction both at the offering stage and on the secondary market. That IEX securities would enjoy this freedom from the encumbrances of state-level registration requirements is unobjectionable in the short-term and likely beneficial to both securities issuers and consumers in the long-term (and, indirectly, beneficial to brokers in securities of this kind).”).

A. Baseline

The Commission compared the economic effects of the amendment, including benefits, costs, and effects on efficiency, competition, and capital formation, to a baseline that consists of the existing regulatory framework and market structure.

1. Regulatory Framework and Affected Parties

The listing standards of Named and Designated Markets are quantitative and qualitative requirements that issuers must satisfy before they may list on these markets. Securities listed on a Named or Designated Market are Covered Securities, which are exempt from complying with state securities law registration and qualification requirements. As mentioned above,37 subsequent to its exchange registration, IEX petitioned the Commission to amend Rule 146(b) to provide that the listing standards for securities listed, or authorized for listing, on IEX are substantially similar to those of the Named Markets.

37See supra note 8 and accompanying text.

Pursuant to unlisted trading privileges, a national securities exchange such as IEX currently can trade securities that are listed on other exchanges.38 While IEX may offer to list securities for trading, currently, those securities would not be Covered Securities if they chose to list on IEX in the absence of this amendment to Rule 146. Issuers of securities that are not Covered Securities must comply with state securities law registration and qualification requirements, which generally require the issuer to register such securities in each state or jurisdiction in which the issuer will offer or sell its securities. State registration and qualification requirements generally vary across the 54 U.S. jurisdictions, comprising the 50 states, the District of Columbia, and the three U.S. territories of Puerto Rico, the Virgin Islands, and Guam.39 These requirements typically include: (i) Filing state administrative forms and other paperwork necessary for compliance with state registration requirements; (ii) adherence to disclosure standards; and (iii) in some states, requirements based upon the merits of the offering or issuer.40

38See 15 U.S.C. 781(f) and Rule 12f-2.

39See Office of Investor Education and Advocacy, “Blue Sky Laws” (2014), available at https://www.sec.gov/fast-answers/answers-blueskyhtm.html.

40See, e.g., Stuart R. Cohn, Securities Counseling for Small and Emerging Companies § 12:8 (2016) (describing merit review as “the authority of state administrators to deny, suspend or revoke an offering because the administrator believes that the offering has substantive weaknesses in structure, financial strength or fairness to investors”). Typical elements of merit review include: Offering expenses, including underwriter's compensation, issuer capitalization requirements, dilution, financial condition of the issuer, cheap stock held by insiders, types of offering (e.g., blind pool offerings), the quantity of securities subject to options and warrants, loans to insiders, and the price at which the securities will be offered. See id. The North American Securities Administrators Association (NASAA), an association of state and provincial securities regulators composed of the securities administrators from each state, Mexico, and 13 Canadian provinces, has issued guidelines intended to provide uniformity among state merit review standards. See NASAA Statements of Policy, available at http://www.nasaa.org/regulatory-activity/statements-of-policy/. Some exchange listing standards impose merit regulation on issuers.

The Commission lacks comprehensive, independent data to precisely estimate the total time, registration, and compliance costs associated with state registration and qualification. Moreover, those total costs may vary widely for issuers depending upon the number of states in which an issuer elects to register. To provide some information about potential costs for state registration, Table 1 below lists examples of Blue Sky registration filing fees for several states.

Table 1—Examples of Blue Sky Registration Filing Fees 41 State Filing fee California $200 plus 1/5 of 1 percent of the aggregate value of the securities proposed to be sold, with a maximum fee of $2,500. Florida $1,000. Illinois 1/20 of 1 percent of the aggregate offering in Illinois, with a minimum fee of $500 and a maximum fee of $2,500. New York Based on total offerings:
  • $500,000 or less: $300.
  • More than $500,000: $1,200.
  • Texas $100 filing fee, plus examination fee of 1/10 of 1 percent of the aggregate amount of securities sold in Texas.

    The issuer of a non-Covered Security in multiple jurisdictions would have more compliance obligations than the issuer of a Covered Security, including the potential for considerable additional costs and legal fees associated with reviews of offering-related materials at the state level.42 Additionally, as discussed above, many state securities regulators also review securities offerings based upon the merits of the offering and/or the issuer of the securities, which can further increase an issuer's compliance obligations and associated costs.43 In addition, the Commission notes that on a separate matter, the Commission received an estimate that an issuer seeking state registration in 50 states would incur $50,000 to $70,000 in filing fees and $80,000 to $100,000 in legal fees.44

    41See CA Corp Code § 25608(e) for California filing fees; http://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0500-0599/0517/Sections/0517.081.html for Florida filing fees; http://www.cyberdriveillinois.com/departments/securities/sellingsec.html for Illinois filing fees; https://ag.ny.gov/investor-protection/broker-dealer-and-securities-registration-information-sheet for New York filing fees; and https://www.ssb.texas.gov/texas-securities-act-board-rules/fee-schedule#one for Texas filing fees.

    42See Proposing Release, supra note 9, at 33843 (citing Securities Act Release No. 9741 (March 25, 2015), 80 FR 21806 (April 20, 2015) (Amendments for Small and Additional Issues Exemptions under the Securities Act (Regulation A)), at Section II.H.3 (“Regulation A Release”)).

    43See id.

    44See id. at 33843 & n.43 (citing Regulation A Release, supra note 42; Letter from Michael L. Zuppone, Paul Hastings LLP, to Commission, dated November 26, 2013, at 2 (further noting the “significant costs and uncertainties associated with `Blue Sky' law compliance”); and Regulation A Release, supra note 42, at n.1024 and accompanying text). As noted in the Proposing Release, the commenter did not address whether these estimated costs vary by the size of the offering. Also, the Commission notes that the estimate concerns the initial costs associated with registration. The Commission believes that the ongoing costs of compliance that the issuer bears will be lower than these initial costs. See id.

    In addition, the Commission believes that the state registration and qualification requirements applicable to non-Covered Securities also impose costs on broker-dealers. Specifically, broker-dealers may incur costs to ensure that they are complying with applicable state laws governing non-Covered Securities in each state in which they are transacting in those securities on behalf of their customers or providing advice or other information to customers related to those securities. For example, broker-dealers can incur costs associated with maintaining a compliance program to verify an issuer's state registration status and comply with any state requirements applicable to broker-dealers that transact in non-Covered Securities, which could vary depending on where the customer resides and where the transaction occurs. In addition, the types and content of communications broker-dealers may have with their customers regarding non-Covered securities may be subject to regulation under Blue Sky laws, thus broker-dealers may incur costs to ensure they are compliant with such requirements in each state in which they advise customers.45 While some portion of these costs may be passed on to a broker-dealer's customers—i.e., the investors that transact through the broker-dealer in non-Covered Securities—through commissions or transaction fees, the Commission believes that the compliance costs associated with Blue Sky requirements may lead some broker-dealers to only offer their services for Covered Securities.46 However, the Commission lacks the data necessary to quantify the costs that broker-dealers and their customers face.

    45See id. at 33844 & n.45 (citing Letter from Daniel Zinn, General Counsel, OTC Markets Group Inc., to Elizabeth M. Murphy, Secretary, Commission, dated March 24, 2014, at 4 (describing the commenter's views of the impact of Blue Sky laws on broker-dealers)).

    46 As noted in the Proposing Release, a commenter also stated that broker-dealers may have increased “rescission risk” for failing to comply with each jurisdiction's Blue Sky requirements, which OTC Markets argues “may chill some broker-dealers' willingness to allow their customers to transact in those securities at all, including securities of SEC reporting companies.” See id. at 33844 & n.46.

    The amendment to Rule 146 that the Commission is adopting to make IEX a Designated Market will impact several parties, including (i) issuers that currently list their securities on a Named or Designated Market; (ii) issuers with securities not currently listed on any incumbent Named or Designated Market but who might list on IEX, or on an incumbent Named or Designated Market, as a result of the competition from IEX if IEX enters the listing market; and (iii) issuers with securities not currently listed on any incumbent Named or Designated Market and that would eventually list on a Named or Designated Market, regardless of IEX's entry into the market. Given that issuers that meet the listing standards of IEX are likely to meet the listing standards of other Named or Designated Markets, the number of issuers that will list on a Named or Designated Market solely as a result of the amendment (i.e., those in category (ii) above) may be small. In addition, the amendment will affect IEX, as it will now be able to list Covered Securities, as can the Named and Designated Markets with which IEX now will be able to compete for listings.47 The impacts on each of these affected parties are discussed in more detail below.

    47 The Commission believes that the amendment also may indirectly impact exchanges that are not Named or Designated Markets as well as other trading venues for both covered and non-covered securities as explained below.

    2. Current Practices in the Market for Listings

    Issuers of public securities make several considerations when deciding on which exchange to list their securities. These considerations include, among other things, the visibility and publicity provided by the exchange, the exchange's listing services and fees, and the exchange's listing standards. The Named and Designated Markets may provide issuers of Covered Securities with additional visibility over that of securities traded over the counter, which may, in turn, increase the pool of potential investors for an issuer and thereby improve an issuer's access to capital. In addition, the Named and Designated Markets provide listing services for their listed issuers, which can include monitoring, communication, and regulatory compliance services. These services may help issuers by reducing the cost of raising capital and the costs associated with going or remaining public. However, many issuers that list for the first time do so as part of an initial public offering, which can include considerations not related to listing on an exchange, such as SEC reporting obligations, as well as legal, accounting, and other expenses (both for the initial offering and the ongoing requirements of remaining public). In addition, issuers also consider the benefits of going public, such as increased access to capital and providing investors with a signal of an issuer's ability to meet obligations that apply to public companies (e.g., reporting requirements). Commonly, the decision of which exchange to list on is made concurrently with the decision about whether or not to go public.

    Issuers must pay listing fees and meet listing standards to list on a Named or Designated Market. Listing fees may include an initial application fee, as well as an ongoing annual fee, and may vary by the number of shares in the initial offering or be fixed. However, listing fees typically represent a small portion of the overall cost of an initial public offering or the ongoing costs of remaining public,48 and thus may not be a significant factor that issuers consider when deciding (i) whether to list on a Named or Designated Market, and (ii) if so, on which Named or Designated market to list. Listing exchanges also impose listing standards on issuers, which can include corporate governance standards as well as quantitative requirements, such as minimum income, market capitalization, and operating history requirements.49 While an exchange's listing standards may prevent potential issuers who do not meet those standards from listing on the exchange, the stringency of an exchange's listing standards may provide a valuable signal to investors about the quality of issuers that are able to list, which may improve the issuers' access to capital.50

    48 Listing fees for equity securities can range from $55,000 (NYSE American) to $295,000 (NYSE). See NYSE MKT Company Guide at Sec. 140, available at http://wallstreet.cch.com/MKTtools/PlatformViewer.asp?SelectedNode=chp_1_1_1&manual=/MKT/CompanyGuide/mkt-company-guide/; and NYSE Listed Company Manual at 902.02, available at http://nysemanual.nyse.com/LCMTools/bookmark.asp?id=sx-ruling-nyse-policymanual_902.02&manual=/lcm/sections/lcm-sections/. See also supra notes 41-46 and accompanying text (discussing the overall costs of state securities registration). See also Proskauer Rose LLP, 2016 IPO Study, at 52, available at http://www.proskauer.com/files/uploads/Proskauer-2016-IPO-Study.pdf (examining 258 IPOs from 2013 to 2015 and finding that the average total IPO expense, excluding underwriting fees, was $4.15 million).

    49 The Commission views the term “listing exchange” as equivalent to the term “Named or Designated Market” for purposes of this release.

    50 See infra Section IV.A.3, for further discussion of listing standards and signaling to investors.

    3. Competitive Landscape

    The amendment to Rule 146 will affect the market for listing services, in which the Named and Designated Markets compete to provide listing services to issuers, or potential issuers, of Covered Securities because, as explained in detail below, the amendment will permit IEX to compete in this market. In addition, the Commission believes that the amendment can also affect the market for trading services because the listing status and listing designation of securities (i.e., whether a security is a Covered Security and where it is listed) are related to where and how the securities trade. In this section, the Commission discusses competition among Named and Designated Markets for listings, as well as competition among the various trading platforms (including Named and Designated Markets) for trading services.

    (a) Competition for Listings

    Listing exchanges compete with each other for listings in many ways, including, but not limited to, listing fees, listing standards, and listing services. When issuers select a listing exchange, they consider the listing fees and the costs of compliance with listing standards on any given exchange, as well as the quality of listing services and any relevant reputational benefits, among other things, each exchange may offer. Although issuers may incur costs to meet an exchange's listing standards, high listing standards may also yield benefits as they may serve as a positive signal to investors of an issuer's ability to satisfy high qualitative and quantitative listing requirements. Investors may interpret the reputation of a listing exchange and high listing standards as a credible signal of the quality of the listed securities on that exchange.51

    51See, e.g., Thomas J. Chemmanur & Paolo Fulghieri, Competition and Cooperation Among Exchanges: A Theory of Cross-listing and Endogenous Listing Standards, 82 J. Fin. Econ. 455-89 (2006), available at http://www.sciencedirect.com/science/article/pii/S0304405X06001139.

    Currently, there are three Named Markets under Section 18(b)(1)(A) of the Securities Act: NYSE, NYSE American, and Nasdaq/NGM. In addition, there are currently six Designated Markets: (i) Tier I of the NYSE Arca, Inc.; (ii) Tier I of the NASDAQ OMX PHLX LLC; (iii) CBOE; (iv) options listed on ISE; (v) The Nasdaq Capital Market; and (vi) Tier I and Tier II of BATS. As of June 2, 2017, the Commission estimates that NYSE listed 3,172 equity securities, Nasdaq listed 3,183 equity securities, NYSE Arca listed 1,529 equity securities, NYSE American listed 359 equity securities, and BATS listed 176 equity securities.52

    52 These figures of listed equities include equity securities reported to a securities information processor. The estimates also include multiple securities from the same issuer, which means the total number of securities may differ from the total number of issuers potentially affected by this rulemaking. Listing information is from the master files of the daily trade and quotation data (“TAQ Data”).

    While the number of equities listed on each exchange relative to the total number of equities listed on all exchanges is informative about overall competition for listings among the exchanges, the market shares for recent equity issue listings may provide a better picture of the nature of competition between exchanges and the size of the new listings market. Table 2 identifies the number of new equity issue listings from 2008 to 2016.53

    53 The listings data for NYSE, Nasdaq, NYSE American, and NYSE Arca were taken from Compustat Merged © 2016 Center for Research in Securities Prices (“CRSP”), The University of Chicago Booth School of Business. As CRSP does not have BATS listings data, BATS listings are from TAQ Data. See supra note 52.

    Table 2—New Equity Listings in Named and Designated Markets, 2008-2016 NYSE Nasdaq NYSE
  • American
  • NYSE ARCA BATS
    2008 68 142 53 68 0 2009 76 115 33 20 0 2010 141 156 31 12 0 2011 130 132 34 14 0 2012 148 135 19 9 17 2013 178 201 26 13 6 2014 178 278 23 12 5 2015 101 220 15 13 31 2016 81 163 5 12 85

    As shown in Table 2, two listing exchanges—NYSE and Nasdaq—captured 71% of all new equity listings on Named and Designated Markets in 2016, which is evidence of a highly concentrated listing market.54 In addition, when BATS entered the market in 2012, it gained only 17 new listings, which was 5.2% of all new equity listings in 2012. This small number of new listings suggests that the number of currently unlisted issuers that would list with a new Designated Market is likely to be small.55

    54 The Herfindahl-Hirschman Index (HHI) measure for listing exchanges is 0.321, calculated as the sum of squared market shares, or (2,552/7,217)^2 + (2,863/7,217)^2 + (1,377/7,217)^2 + (339/7,217)^2 + (86/7,217)^2 = 0.321. See Campbell McConnell, Stanley Brue & Sean Flynn, Microeconomics: Principles, Problems, & Policies 218, 219, 225, 226 (2014). An HHI close to 0 indicates low concentration while an HHI of 1 indicates total concentration or monopoly.

    55 See infra Section IV.B.2, for further discussion about how this may affect currently unlisted issuers.

    A highly concentrated market may be the result of barriers to entry, which limit competition, and can include economies of scale, reputation, legal barriers to entry, and network externalities. These barriers to entry may adversely affect a new listing exchange's ability to compete with incumbent exchanges for listings. New listing exchanges do not enjoy the economies of scale of large listing exchanges. Listing exchanges may exhibit economies of scale because an exchange with a large number of listings can spread the fixed costs of listing equities over a greater number of issuers. The larger these fixed costs are, the greater will be the scale economies of larger listing exchanges. New listing exchanges face reputational barriers to entry because they may not be able to quickly establish a strong reputation for high quality listings. This lack of reputation may discourage issuers from listing on an entrant exchange, as well as discourage investors from investing in an issuer that lists on an entrant exchange, which may further reinforce the reputational barriers to entry.

    Legal barriers to entry also can apply because exchanges are self-regulatory organizations overseen by the Commission. The governing statute and regulations establish legal barriers to entry for an entity that seeks to register as an exchange, as well as additional legal barriers for an exchange to become a Designated Market. Specifically, the process by which the Commission designates an exchange as a Designated Market imposes a legal barrier to entry on the ability of an exchange to effectively compete for the listing business of Covered Securities.

    In addition, the market for listings exhibits positive network externalities: Issuers may prefer to be listed on exchanges where other similar issuers are listed because of increased visibility. This indicates that, all else being equal, issuers may tend to favor listing their securities on large exchanges (in terms of listings) over smaller ones.

    Issuers also may face costs associated with moving their listing from one exchange to another. These switching costs will not only include the fixed costs associated with listing on a new exchange (such as the exchange's application fee, and the legal and accounting expenses associated with ensuring that the issuer satisfies the listing standards of the new exchange) but also will include the costs associated with communicating with investors about the move to the new exchange. Thus, an issuer that is considering moving from one exchange to another would compare the relatively lower annual listing fee of its current exchange with the relatively high costs of moving its listing to a new exchange, which places the new exchange at a disadvantage and creates a barrier to entry for a potential entrant. Even if an entrant exchange prices its listing fees and services for new issuers competitively compared to the incumbent exchanges, the costs for an issuer to switch its listing to a new exchange may dissuade an issuer from switching and thereby prevent the entrant from gaining market share.

    Table 3 shows estimates of the probability that an issuer would change its listing exchange in a given year, based on issuer switching behavior for equities over the period 2008 to 2016. As an example, if an equity security was listed on NYSE in a given year, there was a 99.33% chance that it would still be listed on NYSE the following year, but a 0.04% chance it would be listed on Amex the following year, a 0.34% chance it would be listed on Nasdaq the following year, and a 0.08% chance it would be listed on NYSE Arca the following year. More generally, equities listed on NYSE and Nasdaq in a given year had a greater than 99% chance of remaining listed on that exchange the following year. This result suggests that issuers are unlikely to switch their listings away from the two exchanges with the highest market shares.

    56 The listings data for NYSE, Nasdaq, NYSE American, and NYSE Arca were taken from CRSP. BATS listings are from TAQ Data. See supra note 52.

    57 For the exchanges in the CRSP data (NYSE, NYSE American, Nasdaq, and NYSE Arca), this category (Not Trading) includes listings that were halted, suspended, not trading, or whose listing status was not known in the following year. For the exchange from the TAQ data (BATS), this column includes listings that were not in the TAQ master file in the following year.

    Table 3—Conditional Probability of Transition for Listings, 2008-2016 56 Original exchange NYSE
  • (%)
  • NYSE
  • American
  • (%)
  • Nasdaq
  • (%)
  • NYSE
  • Arca
  • (%)
  • BATS
  • (%)
  • Not trading 57
    Status in the Following Year NYSE 99.33 0.04 0.34 0.08 0.00 0.20 NYSE Amer 1.80 93.47 2.80 1.39 0.00 0.54 Nasdaq 0.38 0.07 99.11 0.01 0.00 0.42 NYSE Arca 1.50 0.47 1.13 90.81 0.00 6.10 BATS 0.00 0.00 0.00 0.00 94.40 5.60
    (b) Competition for Trading Services

    Trading in Covered Securities is segmented from trading in those securities that are not listed on a Named or Designated Market (i.e., non-Covered Securities). Non-Covered Securities trade only on over-the-counter (“OTC”) markets, which consist of alternative trading systems (“ATSs”) that trade unlisted securities and broker-dealers who internalize orders. Covered Securities, on the other hand, may trade on the registered national securities exchanges or off-exchange either on the 35 ATSs or through broker-dealers that internalize orders. The market to trade Covered Securities on either the Named and Designated Markets or the other trading platforms is more liquid than the OTC trading of non-Covered Securities because, among other things, OTC markets have higher search costs associated with finding buyers and sellers.58 Further, because Covered Securities are exempt from state securities registration laws, the costs associated with complying with state securities registration laws are lower for broker-dealers that trade Covered Securities on behalf of their customers, as compared to trading non-covered securities.

    58See, e.g., Ulff Brüggemann, Aditya Kaul, Christian Leuz & Ingrid M. Werner, The Twilight Zone: OTC Regulatory Regimes and Market Quality, (Nat'l Bureau of Econ. Research, Working Paper No. 19358, 2013), available at https://ideas.repec.org/p/nbr/nberwo/19358.html.

    Exchanges, ATSs, and broker-dealers compete to attract order flow in Covered Securities by offering better trading services or innovative trading mechanisms. Attracting order flow can generate revenue in the form of transaction fees or data revenue.59

    59 For example, market data fees collected by the three industry networks are allocated proportionally among the exchanges based, in part, on each exchange's share of the overall transaction volume. See Securities Exchange Act Release No. 61358 (January 14, 2010), 75 FR 3594, 3600-01 (January 21, 2010) (Concept Release on Equity Market Structure) (Commission concept release discussing the revenues and expenses from data fees at that point in time).

    The ability of listing exchanges, however, to successfully use innovative trading services to attract listings has declined over the past decade.60 During this time, the number of competitors in the market for trading services has increased, resulting in fragmentation in the market and a decline in the market share of trading at listing exchanges. For example, since the third quarter of 2009, the number of ATSs that reported transactions in NMS stocks has increased from 32 to 34,61 while the share volume of Covered Securities executed on ATSs has increased from 7.9% to 13.0%.62 In contrast, the two listing exchanges with the greatest number of issues listed, NYSE and Nasdaq, each experienced a sharp decline in the market share of trading volume in the securities they list. The market share of the NYSE in NYSE-listed stocks fell from approximately 80% in 2005 to 20% in 2013; Nasdaq's market share of Nasdaq-listed stocks fell by approximately half, from 50% in 2005 to 25% in 2013.63 Despite these changes, listing exchanges still currently enjoy a larger trading market share in their listed securities.64

    60See James Angel, Lawrence Harris & Chester Spatt, Equity Trading in the 21st Century: An Update (2013), available at http://www.q-group.org/wp-content/uploads/2014/01/Equity-Trading-in-the-21st-Century-An-Update-FINAL1.pdf.

    61 Data compiled from Forms ATS and Form ATS-R submitted to the Commission as of June 2017 show that 35 ATSs have noted that they expect to trade NMS stocks. However, only 34 ATSs had observable transactions in NMS stocks since the third quarter of 2009.

    62See 17 CFR 242.600(b)(47) (definition of NMS Stock) (“NMS stock means any NMS security other than an option.”) and 17 CFR 242.600(46) (definition of NMS security) (“NMS security means any security or class of securities for which transaction reports are collected, processed, and made available pursuant to an effective transaction reporting plan, or an effective national market system plan for reporting transactions in listed options.”). The estimates of ATSs that trade NMS stocks and ATS trade volume share was developed using weekly summaries of trade volume collected from ATSs pursuant to FINRA Rule 4552. See also Securities Exchange Act Release No. 76474 (November 18, 2015), 80 FR 80998, 81109 (December 28, 2015) (Regulation of NMS Stock Alternative Trading Systems). The estimates in this release were developed in the same manner as in the cited release. See also OTC (ATS & Non-ATS) Transparency, FINRA, http://www.finra.org/Industry/Compliance/MarketTransparency/ATS/.

    63See Angel, Harris & Spatt, supra note 60, at 20-21.

    64 For the purposes of this rulemaking, staff examined TAQ Data for the time period of November through December 2014. Staff observed that exchanges tend to enjoy more than 15% higher market share in the securities they list compared to the securities they do not list, on average, and they tend to enjoy about 20% higher market share in the securities they list compared to the market share of others' trading in those securities, on average.

    B. Impact on Efficiency, Competition, and Capital Formation

    Securities Act Section 2(b) 65 requires the Commission, when engaging in rulemaking that requires it to consider or determine whether an action is necessary or appropriate in the public interest, to consider, in addition to the protection of investors, whether the action will promote efficiency, competition, and capital formation.

    65See 15 U.S.C. 77b(b).

    1. Efficiency

    By listing on IEX, security issuers that otherwise would have not listed their securities on a Named or Designated Market will be able to avoid the duplicative costs of securities registration in multiple jurisdictions. In this way, the amendment will reduce the impediments to listing on exchanges, which in turn can improve market efficiency. To the extent that the amendment results in increased listing activity, then it may improve the allocative efficiency of securities markets by allowing investors to better diversify financial risks by investing in newly-listed securities.

    However, these two impacts may be mitigated by the extent to which issuers are unable to list on a Named or Designated Market because, for example, they do not satisfy listing standards or cannot afford the attendant costs of doing so. An issuer must be an SEC reporting company to list on a national securities exchange.66 Therefore, to the extent that an issuer is not already an SEC reporting company, it may face increased disclosure costs in order to be eligible to be listed on a national securities exchange. Moreover, issuers that are able to meet the listing standards of IEX are likely to be able to meet the listing standards of other Named or Designated Markets; accordingly, the entry of IEX will not necessarily increase the pool of securities eligible for listing. As a result, the Commission believes that the number of issuers that would not have listed at all in the absence of an amendment, but will now list on IEX, is likely to be small.67

    66See 15 U.S.C. 78l(b).

    67See supra Section IV.A.3.a (for further discussion).

    2. Capital Formation

    Whether IEX entering the listing market promotes capital formation depends on the extent to which issuers previously unable or unwilling to list on a Named or Designated Market subsequently do so. Some issuers may, as a result of improved services and/or decreased fees stemming from the increased competition between listing exchanges, be induced to list on an exchange where, in the absence of the amendment, they would not have done so. If so, then the entrance of IEX can provide issuers with lower cost access to capital.

    As noted in Section IV.A, one reason issuers list on a Named or Designated Market is improved access to capital. Listing on a Named or Designated Market may improve access to capital in several ways, which can promote capital formation. First, listing on a Named or Designated Market may credibly signal to investors that a firm is of higher quality because firms that list on these exchanges must meet the exchange's minimum standards for governance and disclosure. Like listed issuers on the Named and Designated Markets, IEX's listed issuers might benefit from the signal of quality that comes from listing on a Named or Designated Market. The reputational benefits that come from listing on a Named or Designated Market may make investors more willing to invest in such issuers, which may improve the issuers' access to capital, and promote capital formation.

    Second, an issuer listing on a Named or Designated Market may experience enhanced liquidity that facilitates capital formation. Investors may demand a liquidity premium (greater returns) when investing in illiquid securities to compensate for the risks associated with the lack of liquidity. Any liquidity risk premium raises the costs issuers incur when issuing new securities. Listing on a Named or Designated Market may result in more liquid trading relative to OTC trading because of potential frictions to liquidity imposed by OTC search costs.68 Therefore, if the amendment induces additional issuers to list, the enhanced liquidity can facilitate capital formation by reducing the cost that the issuers of those securities would otherwise incur (e.g., through their ability to issue securities at a higher offering price compared to a non-listed issuance) when issuing new securities. Additionally, listing on a Named or Designated Market may enhance liquidity and promote access to capital (and thereby promote capital formation) by reducing the costs of trading incurred by broker-dealers, which potentially are shared with investors. Broker-dealers incur costs to trade non-Covered Securities when ensuring their compliance with state securities laws in multiple jurisdictions,69 which are potentially shared with investors. Thus, the amendment may reduce investors' transaction costs to trade securities that list on a Named or Designated Market as a result of the amendment.70 Consequently, investors in securities that list on IEX as a result of the amendment will have easier access to invest in those securities and to further diversify their investment portfolios, which may promote capital formation by improving allocative efficiency.71

    68See supra Section IV.A.3.b. See also Darrell Duffie, Nicolae Garleanu & Lasse Heje Pedersen, Over-the-Counter Markets, 73 Econometrica 1815 (2005).

    69See supra Section IV.A.3.b.

    70See supra Section IV.A.1.

    71See, e.g., John Heaton & Deborah J. Lucas, Evaluating the Effects of Incomplete Markets on Risk Sharing and Asset Pricing, 104 J. Pol. Econ. 443 (1996).

    3. Competition

    The amendment to Rule 146(b) will likely increase competition among the Named and Designated Markets that compete to list securities. By determining that IEX has “substantially similar” listing standards to the Named and other Designated Markets, the amendment permits IEX to compete with other Named and Designated Markets to list securities that are exempt from state registration requirements. As discussed above, the Named and Designated Markets compete with each other in many ways, including listing standards, listing fees, and listing services. In addition to permitting IEX to compete to list securities as a Designated Market, the additional competition from IEX's entry into the listing market will also provide incumbent listing markets with incentives to change how they compete with each other.72

    72See, e.g., Thierry Foucault & Christine A. Parlour, Competition for Listing, 35 Rand J. Econ. 329 (2004) (describing how, in equilibrium, competing exchanges obtain positive expected profits by offering different execution costs and different listing fees). See also supra note 60 and accompanying text.

    Generally, there are two ways that increased competition can affect how listing markets compete with each other. First, it can affect how Named or Designated Markets compete to provide better services and value for listing issuers. If an additional entrant competes by providing better listing and monitoring services or lower costs for issuers, incumbent listing exchanges may decide to follow suit. For example, listing markets could reduce fees, improve services, or reduce compliance burdens associated with their listing standards.73

    73See infra note 75 (discussing the filing requirements under the Securities Exchange Act of 1934 (“Exchange Act”) necessary for any revision to exchange listing standards and noting that such listing standards and changes to such listing standards are subject to the requirements of the Exchange Act and the rules and regulations thereunder).

    The Named and Designated Markets also may compete to provide better services by increasing their level of specialization with respect to securities listings. As noted below, as in the case of BATS, some Named and Designated Markets may develop reputations for specializing in specific types of issues by catering to specific types of issuers. An increase in competitive pressures may cause the Named and Designated Markets to increase the degree to which they cater to specific types of issuers. Specialization may reduce the cost of providing listing services or may promote innovation in the provision of listing services. To the extent that specialization improves the services provided to issuers or reduces the costs of these services, this competitive response may improve the efficiency of the market for listing services.

    Second, the reputation of a Named or Designated Market for strict listing standards may be informative to an investor and serve as a signal of the quality of an issuer.74 Issuers that are able to meet the listing standards of a Named or Designated Market can signal their ability to do so by listing on those exchanges. However, because complying with these listing standards may be costly for issuers, issuers weigh the benefits of signaling their higher quality (through their ability to meet the stronger listing standards of the Named or Designated Market) against the costs of compliance with these standards.

    74 See Stewart C. Myers & Nicholas S. Majluf, Corporate Financing and Investment Decisions When Firms Have Information That Investors Do Not Have, 13 J. Fin. Econ. 187 (1984), available at http://www.sciencedirect.com/science/article/pii/0304405X84900230, for a discussion of the role of asymmetric information in corporate finance. See also Nathalie Dierkens, Information Asymmetry and Equity Issues, 26 J. Fin. & Quantitative Analysis 181 (1991), available at www.jstor.org/stable/2331264, for empirical evidence of asymmetric information in the equity issue process.

    The impact of increased competition on listing standards is uncertain. The Named and Designated Markets may respond to increased competition by strengthening listing standards to provide additional signaling and attract investors to the issuers the exchanges list. Alternatively, the Named and Designated Markets can instead respond to increased competition by proposing to weaken their listing standards to attract additional listings. The exchanges' opposing incentives to cater to these two groups of market participants make predicting the impact of increased competition on listing standards difficult.

    The Named and Designated Markets' ability to lower listing standards is constrained by two factors (1) any proposed listing standards or proposed changes to existing listing standards must be filed with the Commission pursuant to Section 19(b) of the Exchange Act and must meet statutory and rule requirements to become effective;75 and (2) an exchange with listing standards that are not substantially similar to those of a Named Market may lose its status as a Designated Market.76 The requirement that the listing standards of a Designated Market be substantially similar to those of a Named Market means that the listing standards of the Named Markets serve as a lower bound for the extent to which competition may pressure listing exchanges to attempt to weaken their listing standards.

    75 Any revision to exchange listing standards must be filed in accordance with Section 19(b) of the Exchange Act and Rule 19b-4 thereunder and is subject to the requirements of the Exchange Act and the rules and regulations thereunder. See 15 U.S.C. 78s(b) and 17 CFR 240.19b-4.

    76See 17 CFR 230.146(b)(2).

    Some of the features of the market for listings that currently inhibit competition may mitigate the effects of the amendment on competition. Specifically, some of the barriers to entry discussed in the baseline—economies of scale and network externalities—may make it difficult for IEX to effectively compete with incumbent exchanges for listings.77 For example, if a new entrant does not attract enough initial listings, the fixed cost of operations may make it difficult to keep its listing fees competitive. In addition, a new entrant may not have established a sufficient reputation as a listing exchange to credibly certify the quality of its new issues. Thus, the structure of the market for listings may mitigate some of the potential effects of increased competition between Named and Designated Markets.

    77See supra Section IV.A.

    The most recent example of an entrant into the market for listings is BATS, which became a Designated Market in 2012.78 Table 2 in Section IV.A.3.a shows that the number of new listings on BATS decreased each year until 2015 but has increased recently. While the growth in new listings by BATS may be indicative of the barriers to entry that entrants such as IEX will face, circumstances specific to BATS may have impacted its ability during that period to attract listings.79

    78See Securities Act Release No. 9295 (January 20, 2012), 77 FR 3590 (January 25, 2012).

    79 As BATS noted in its registration statement filed with the Commission on December 15, 2015, “[O]n March 23, 2012, we experienced a serious technical failure on BZX, forcing us to cancel our planned IPO. . . . These technical failures damaged our reputation and resulted in increased regulatory scrutiny of the event by the SEC and other governmental authorities.”

    Table 3 in Section IV.A.3.a shows that almost none of the new listings on BATS arrived as transfers from another exchange; rather most of those listings were the initial listing for each issuer. This evidence could indicate that switching costs may also have had an impact on BATS' ability to gain market share, and may be a factor for IEX, as well. Moreover, the vast majority of BATS-listed securities are exchange-traded products, which is consistent with the idea that, despite barriers to entry, BATS was able to enter the market by competing for one segment of the market and specializing in listing exchange-traded products.

    C. Analysis of Benefits and Costs

    The amendment to Rule 146(b) making IEX a Designated Market allows securities listed, or authorized for listing, on IEX to be designated as Covered Securities under Rule 146(b)(1) under the Securities Act. As described above, Covered Securities are exempt from state law registration requirements.80 In this section, the Commission discusses the benefits and costs of the amendment, which stem from: (i) The exemption from Blue Sky laws provided to any issuers that would not list in the absence of the amendment; and (ii) the entry of IEX into the market for listings as a Designated Market.

    80 Rule 146 and Section 18 have no effect on Federal registration requirements, which are addressed by Section 5 of the Exchange Act. See 15 U.S.C. 78e. Section 18 of the Securities Act states that no law, rule, regulation, or order, or other administrative action of any State or any political subdivision thereof requiring, or with respect to, registration or qualification of securities, or registration or qualification of securities transactions, shall directly or indirectly apply to a covered security. See 15 U.S.C. 77r(a)(1)(A).

    As noted above, the Commission is unable to quantify all of the economic effects of the amendment because it lacks the information necessary to provide reasonable estimates.

    1. Benefits of the Amendment

    The amendment will provide benefits, flowing from the exemption from Blue Sky laws, to issuers that do not currently list on an existing Named or Designated Market but choose to list on IEX.81 Specifically, the amendment will permit these issuers to avoid the potentially duplicative costs of complying with multiple state securities regulations. As noted above, these duplicative costs can include both a fixed cost of registration and ongoing compliance costs. Because an unlisted issuer needs to register in each of the jurisdictions in which its securities will be bought or sold, any issuers that list as a result of the amendment will save these registration costs. To the extent that IEX attracts previously unlisted issuers, IEX will benefit as a result of revenue from listing fees, trading fees, and data fees generated by additional issuers. In addition, absent the amendment, the heterogeneity in state securities regulations generates ongoing costs for broker-dealers and investors transacting in multiple jurisdictions.82 However, the overall magnitude of these benefits depends on the number of currently unlisted issuers that choose to list on IEX as a result of the amendment, and the Commission believes this number is likely to be small because any unlisted issuer able to meet the listing standards of IEX is likely to be able to meet the listing standards of the other Named and Designated Markets.83

    81 Data to estimate the number of such issuers does not exist, but the Commission believes that the numbers of such issuers is likely to be small, as any issuers that can meet the listing standards of IEX are likely to be able to meet the listing standards of the incumbent Named or Designated Markets.

    82See supra Sections IV.A.1 and IV.B.1.

    83See Table 2, supra Section IV.A.3.a, and accompanying text.

    More generally, by making IEX a Designated Market, the amendment will benefit IEX by allowing it to compete in the listing market for Covered Securities on a more level playing field with similarly situated national securities exchanges.84 Specifically, being able to list Covered Securities will allow IEX more effectively to compete with the incumbent Named and Designated Markets that also are able to offer Covered Securities status. This will also benefit issuers that choose to list securities on a Named or Designated Market by providing them with another alternative venue on which to list. Furthermore, adding IEX as an entrant into this market will increase the number of competitors in the market for listings. To the extent that the existing Named and Designated Markets respond to this increased competition by reducing listing fees or improving listing services, as discussed above, currently listed issuers and their investors may benefit from the improved quality of listing services, reduced listing fees or reduced compliance costs. In addition, to the extent that the entry of IEX increases the specialization of incumbent Named and Designated Markets, issuers may benefit from listing services that are more tailored to their needs.85

    84 The Commission acknowledges that this benefit to IEX may come at the expense of the existing Named and Designated Markets, who may lose a portion of their current share to a new entrant. See infra Section IV.D.

    85See supra Section IV.B.3.

    Last, if issuers list on a Named or Designated Market as a result of the amendment, this listing may impact the trading of those issuers' securities on markets that are not Named or Designated Markets. As noted in the baseline, securities that list on a Named or Designated Market may also trade on exchanges that are not Named or Designated Markets, which may bring those exchanges additional revenue from trades.86 To the extent IEX's entry into the market increases the number of issuers listing on a Named or Designated Market, exchanges that are not Named or Designated Markets may benefit from trading revenue from trading more Covered Securities, even though these exchanges do not directly compete with IEX or the Named or Designated Markets for listings business.

    86See supra Section IV.A.1.

    2. Costs of the Amendment

    For unlisted issuers that choose to list on IEX as a result of the amendment, listing on IEX may entail compliance costs arising from new reporting obligations from IEX's listing standards. In addition, if unlisted issuers choose to list on IEX as a result of the amendment, investors may also face costs from the loss of state oversight for the securities listed by these issuers. The Commission notes that the overall magnitude of costs associated with the loss of state oversight depends on the number of unlisted issuers that choose to list as a result of the amendment. The Commission believes this number is likely to be small, or non-existent, for the reasons noted above.87 Furthermore, the Commission notes that these issuers would only choose to list on IEX and bear these costs if they decided that the benefits of listing on IEX justified the costs.

    87See Table 2, supra Section IV.A.3.a, and accompanying text.

    The Commission believes that any costs to investors from a loss of state oversight for such issuers will be mitigated by (i) federal regulations and oversight of IEX and the other Named and Designated Markets, and (ii) the requirement for issuers to meet the exchanges' listing standards. Indeed, Congress, in Section 18 of the Securities Act, has already determined that federal regulation is sufficient for those issuers that meet the high listing standards of a Named or Designated Market. Furthermore, the Commission believes that regulatory protections offered by exchanges for trading in Covered Securities conducted on their facilities (e.g., market surveillance, investigation and enforcement) will mitigate the potential costs of a loss of state oversight for unlisted issuers that list on IEX.

    Issuers that currently list on an existing Named or Designated Market that would switch to IEX would not experience potential costs from a loss of state oversight or compliance costs arising from new reporting obligations, because they currently are not subject to state oversight and are subject to the reporting requirements by virtue of being an SEC reporting company (a condition to their listing on a current Named or Designated Market). However, any previously listed issuers that decide to change their listing from another Named or Designated Market to IEX will incur costs to switch their listing.88 Still, the Commission notes that issuers can choose whether or not to incur this cost and likely would do so only if the benefits of switching their listing exceed their switching costs.

    88See supra Section IV.A.3.a, for a discussion of the sources of switching costs.

    D. Other Effects of the Amendment

    Some of the effects of the amendment to Rule 146 on IEX, incumbent Named and Designated Markets, and issuers involve transfers from one party to another. For example, the listing fees collected by IEX from previously-listed issuers may come from a reduction in the listing fees collected by other Named or Designated Markets. Issuers that list on Named and Designated Markets may also enjoy savings from listing fee reductions as a result of increased listing exchange competition, which would also come from a reduction in listing fees collected by Named or Designated Markets.

    Additionally, as a result of changes to competition in the market for listings, the volume of trading across trading venues may shift, to the advantage of some venues and to the detriment of others. Changes to the Named or Designated Markets' shares of the market for listings may affect the distribution of trading volumes across Named and Designated Markets, as well as other trading venues. Commission staff estimates that an exchange captures an average share of volume in the securities listed by that exchange that is about 20% higher than the market share of other exchanges trading the same securities.89 This result suggests that even if the number of listed securities does not change, changes to listings driven by increased competition may alter the market share of trading distributed across each venue by about 20% of the volume in such securities. Any shifts in the market share of trading can result in gains and losses in transaction fees collected and the share of data fees split between exchanges. Although these gains and losses are relevant potential economic effects of the amendment, the Commission does not consider these transfers to be a benefit or cost of the amendment, but rather a consequence of increased competition.90

    89See supra note 64. Using TAQ data, Commission staff estimates that listing exchanges have around 28.8% of the dollar volume in the securities they list compared to other exchanges' average of about 3.3% of the dollar volume. Staff observed that each listing exchange enjoys a higher market share of dollar volume in its listed securities than any other exchange trading the listing exchange's listed securities. Staff also observed that these differences were not only economically large, but that they were also statistically significant.

    90 In light of the relevant statutory language and in the context of this particular rulemaking, the Commission does not believe that there are reasonable alternatives to this proposal to designate securities listed on IEX as Covered Securities.

    V. Regulatory Flexibility Act Certification

    The Commission certified, pursuant to Section 605(b) of the Regulatory Flexibility Act,91 that the amendment to Rule 146 would not have a significant economic impact on a substantial number of small entities. This certification was included in the Proposing Release.92 The Commission solicited comments on the certification. No comments on the certification were received.

    91 5 U.S.C. 605(b).

    92See Proposing Release, supra note 9, at 33850-51.

    VI. Statutory Authority and Text of the Rule

    The Commission is adopting an amendment to Rule 146 pursuant to the Securities Act of 1933,93 particularly Sections 18(b)(1)(B) and 19(a).94

    93 15 U.S.C. 77a et seq.

    94 15 U.S.C. 77r(b)(1)(B) and 77s(a).

    List of Subjects in 17 CFR Part 230

    Securities.

    For the reasons set forth in the preamble, Title 17, Chapter II of the Code of Federal Regulations is amended as follows:

    PART 230—GENERAL RULES AND REGULATIONS, SECURITIES ACT OF 1933 1. The authority citation for part 230 continues to read, in part, as follows: Authority:

    15 U.S.C. 77b, 77b note, 77c, 77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z-3, 77sss, 78c, 78d, 78j, 78l, 78m, 78n, 78o, 78o-7 note, 78t, 78w, 78ll(d), 78mm, 80a-8, 80a-24, 80a-28, 80a-29, 80a-30, and 80a-37, and Pub. L. 112-106, sec. 201(a), sec. 401, 126 Stat. 313 (2012), unless otherwise noted.

    2. Section 230.146 is amended by revising paragraphs (b)(1) and (b)(2) to read as follows:
    § 230.146 Rules under section 18 of the Act.

    (b) * * *

    (1) For purposes of Section 18(b) of the Act (15 U.S.C. 77r), the Commission finds that the following national securities exchanges, or segments or tiers thereof, have listing standards that are substantially similar to those of the New York Stock Exchange (“NYSE”), the NYSE American LLC (“NYSE American”), or the National Market System of the Nasdaq Stock Market (“Nasdaq/NGM”), and that securities listed, or authorized for listing, on such exchanges shall be deemed covered securities:

    (i) Tier I of the NYSE Arca, Inc.;

    (ii) Tier I of the NASDAQ PHLX LLC;

    (iii) The Chicago Board Options Exchange, Incorporated;

    (iv) Options listed on Nasdaq ISE, LLC;

    (v) The Nasdaq Capital Market;

    (vi) Tier I and Tier II of Bats BZX Exchange, Inc.; and

    (vii) Investors Exchange LLC.

    (2) The designation of securities in paragraphs (b)(1)(i) through (vii) of this section as covered securities is conditioned on such exchanges' listing standards (or segments or tiers thereof) continuing to be substantially similar to those of the NYSE, NYSE American, or Nasdaq/NGM.

    By the Commission.

    Dated: October 24, 2017. Lynn M. Powalski, Deputy Secretary.
    [FR Doc. 2017-23507 Filed 10-27-17; 8:45 am] BILLING CODE 8011-01-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection DEPARTMENT OF THE TREASURY 19 CFR Part 12 [CBP Dec. 17-15] RIN 1515-AE27 Removing the Prohibition on the Importation of Jadeite or Rubies Mined or Extracted From Burma, and Articles of Jewelry Containing Jadeite or Rubies Mined or Extracted From Burma AGENCY:

    U.S. Customs and Border Protection, Department of Homeland Security; Department of Treasury.

    ACTION:

    Final rule.

    SUMMARY:

    This document amends the U.S. Customs and Border Protection (CBP) regulations to remove the provision relating to the prohibition on the importation of jadeite or rubies mined or extracted from Burma, and articles of jewelry containing jadeite or rubies mined or extracted from Burma. This reflects the termination of all Burmese sanctions by Executive Order 13742, of October 7, 2016.

    DATES:

    This final rule is effective on October 30, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Daniel Collier, Partner Government Agency Branch, Trade Policy and Programs, Office of Trade, (202) 863-6225, [email protected]; or William Scopa, Branch Chief, Partner Government Agency Branch, Trade Policy and Programs, Office of Trade, (202) 863-6554, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    On July 28, 2003, the President signed into law the Burmese Freedom and Democracy Act of 2003 (Pub. L. 108-61) (the “BFDA”) to sanction the military junta then ruling Burma. Among other provisions, the BFDA required the imposition, subject to annual renewal, of a ban on the importation into the United States of any article that is a product of Burma. To implement the BFDA, the President issued Executive Order (“E.O.”) 13310 (68 FR 44853, July 30, 2003), which prohibited, among other things, the importation into the United States of any article that is a product of Burma.

    On July 29, 2008, the President signed into law the Tom Lantos Block Burmese JADE (Junta's Anti-Democratic Efforts) Act of 2008 (Pub. L. 110-286) (the “JADE Act”), which, among other things, amended the BFDA to require a prohibition on the importation into the United States of jadeite or rubies mined or extracted from Burma and articles of jewelry containing such jadeite or rubies. Section 12.151 of the CBP regulations (Title 19, Code of Federal Regulations (“CFR”) section 12.151) reflects this prohibition on the importation of jadeite or rubies mined or extracted from Burma and articles of jewelry containing such jadeite or rubies.

    The BFDA, as amended by the JADE Act, required annual renewal, which did not occur in 2013. As a result, the prohibition on the importation of jadeite or rubies mined or extracted from Burma and articles of jewelry containing jadeite or rubies mined or extracted from Burma expired on July 28, 2013. On August 6, 2013, the President signed E.O. 13651, titled “Prohibiting Certain Imports of Burmese Jadeite and Rubies” (78 FR 48793), which revoked the sections of E.O. 13310 imposing a prohibition on the importation into the United States of any article that is a product of Burma. As a result, there was no longer a general ban on importing into the United States any article that is a product of Burma; however, the specific ban of jadeite and rubies mined or extracted from Burma as well as articles of jewelry containing jadeite or rubies mined or extracted from Burma was reinstituted by E.O. 13651. Consequently, on August 23, 2016, CBP published a final rule in the Federal Register (81 FR 57456) amending the CBP regulations to update the relevant provisions to reflect the import prohibitions set forth in E.O. 13651.

    II. Termination of the Burmese Sanctions

    On October 7, 2016, the President signed E.O. 13742, titled “Termination of Emergency With Respect to the Actions and Policies of the Government of Burma” (81 FR 70593), which revoked, among others, E.O. 13310 and 13651. The President found that the situation that gave rise to the declaration of a national emergency with respect to the actions and policies of the Government of Burma has been significantly altered by Burma's substantial advances in promoting democracy, including historic elections that resulted in the formation of a democratically elected, civilian-led government; the release of many political prisoners; and greater enjoyment of human rights and fundamental freedoms, including freedom of expression and freedom of association and peaceful assembly. As a result, President Obama revoked all the Burmese sanctions. This was accomplished by revoking, among others, E.O. 13651, which prohibited the importation of any jadeite or rubies mined or extracted from Burma as well as any articles of jewelry containing jadeite or rubies mined or extracted from Burma. As of October 7, 2016, CBP is no longer enforcing this import prohibition. To reflect this, CBP is removing the relevant provision, 19 CFR 12.151, from the CBP regulations.

    III. Statutory and Regulatory Requirements A. Inapplicability of Public Notice and Delayed Effective Date Requirements

    Under section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553), rulemaking generally requires prior notice and comment, and a 30-day delayed effective date, subject to specified exceptions. This document amends the regulations to remove 19 CFR 12.151 to reflect Executive Order 13742 of October 7, 2016, which terminated the import prohibitions on Burmese articles. Since this document removes a regulation that is no longer applicable or enforced by CBP in light of the Executive Order, CBP has determined it is a nondiscretionary action and that, pursuant to the provisions of 5 U.S.C. 553(b)(B), prior public notice and comment procedures on this regulation are impracticable, unnecessary, and contrary to the public interest and that there is good cause for this rule to become effective immediately upon publication. For these reasons, pursuant to the provision of 5 U.S.C. 553(d)(3), CBP finds that there is good cause for dispensing with a delayed effective date.

    B. Executive Orders 13563 and 12866: Regulatory Planning and Review

    Executive Orders 13563 and 12866 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 (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule is not a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget has not reviewed this regulation.

    C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996, requires an agency to prepare and make available to the public a regulatory flexibility analysis that describes the effect of a proposed rule on small entities (i.e., small businesses, small organizations, and small governmental jurisdictions) when the agency is required to publish a general notice of proposed rulemaking for a rule. As a notice of proposed rulemaking is not necessary for this rule, CBP is not required to prepare a regulatory flexibility analysis for this rule.

    D. Signing Authority

    This regulation is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or that of his delegate) to approve regulations related to certain customs revenue functions.

    List of Subjects in 19 CFR Part 12

    Customs duties and inspection, Reporting and recordkeeping requirements.

    Amendments to the Regulations

    For the reasons set forth in the preamble, part 12 of title 19 of the Code of Federal Regulations (19 CFR part 12) is amended as set forth below.

    PART 12—SPECIAL CLASSES OF MERCHANDISE 1. The general authority citation for part 12 continues to read as follows: Authority:

    5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States (HTSUS)), 1624.

    2. The specific authority citation for § 12.151 is removed.
    § 12.151 [Removed and Reserved]
    3. Remove and reserve § 12.151. Dated: October 25, 2017. Kevin K. McAleenan, Acting Commissioner, U.S. Customs and Border Protection. Approved: Timothy E. Skud, Deputy Assistant Secretary of the Treasury.
    [FR Doc. 2017-23560 Filed 10-27-17; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2017-N-5685] Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Acute Kidney Injury Test System AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

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

    DATES:

    This order is effective October 30, 2017. The classification was applicable on September 5, 2014.

    FOR FURTHER INFORMATION CONTACT:

    Seth Olson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4561, Silver Spring, MD 20993-0002, 301-796-4364, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

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

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

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

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

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

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

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

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

    II. De Novo Classification

    On June 5, 2013, Astute Medical, Incorporated submitted a request for De Novo classification of the NEPHROCHECK® Test System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on September 5, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 862.1220. We have named the generic type of device acute kidney injury test system, and it is identified as a device intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods.

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

    Table 1—Acute Kidney Injury Test System Risks and Mitigation Measures Identified risks Mitigation measures/21 CFR section Incorrect interpretation of test results Special controls (1), (2), and (3) (21 CFR 862.1220(b)(1), 21 CFR 862.1220(b)(2), and 21 CFR 862.1220(b)(3)). Incorrect test results Special control (3) (21 CFR 862.1220(b)(3)).

    FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

    III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 820, regarding the Quality System Regulation have been approved under OMB control number 0910-0073.

    List of Subjects in 21 CFR Part 862

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 862 is amended as follows:

    PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 1. The authority citation for part 862 continues to read as follows: Authority:

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

    2. Add § 862.1220 to subpart B to read as follows:
    § 862.1220 Acute kidney injury test system.

    (a) Identification. An acute kidney injury test system is a device that is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods.

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

    (1) Premarket notification submissions must detail an appropriate end user device training program that will be offered while marketing the device as part of your efforts to mitigate the risk of incorrect interpretation of test results.

    (2) As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document the appropriate end user device training program provided in your premarket notification submission to satisfy special control 21 CFR 862.1220(b)(1) that will be offered while marketing the device as part of your efforts to mitigate the risk of incorrect interpretation of test results.

    (3) Robust clinical data demonstrating the positive predictive value, negative predictive value, sensitivity and specificity of the test in the intended use population must be submitted as part of the premarket notification submission.

    Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-23491 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2017-N-5719] Medical Devices; Immunology and Microbiology Devices; Classification of the Streptococcus SPP. Nucleic Acid-Based Assay AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

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

    DATES:

    This order is effective October 30, 2017. The classification was applicable on April 16, 2014.

    FOR FURTHER INFORMATION CONTACT:

    Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Upon request, FDA has classified the Streptococcus spp. nucleic acid-based assay as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

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

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

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

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

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

    Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.

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

    II. De Novo Classification

    For this device, FDA issued an order on March 20, 2014, finding the Lyra Direct Strep Assay not substantially equivalent to a predicate not subject to a premarket application approval (PMA). Thus, the device remained in class III in accordance with section 513(f)(1) of the FD&C Act when we issued the order.

    On March 28, 2014, Quidel Corp. submitted a request for De Novo classification of the Lyra Direct Strep Assay. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on April 16, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.2680. We have named the generic type of device Streptococcus spp. nucleic acid-based assay, and it is identified as a qualitative in vitro diagnostic device that is intended to simultaneously detect and identify various Streptococcus spp. nucleic acids extracted directly from clinical specimens. The device detects specific nucleic acid sequences for organism identification. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.

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

    Table 1—Streptococcus SPP. Nucleic Acid-Based Assay Risks and Mitigation Measures Identified risks Mitigation measures Incorrect identification of a pathogenic microorganism by the device can lead to improper patient management Special controls (1), (2), (3), (4), (5) and (6) (21 CFR 866.2680(b)(1); 21 CFR 866.2680(b)(2); 21 CFR 866.2680(b)(3); 21 CFR 866.2680(b)(4); 21 CFR 866.2680(b)(5); and 21 CFR 866.2680(b)(6)). Failure to correctly interpret test results Special control (7) (21 CFR 866.2680(b)(7)). Failure to correctly operate the instrument Special control (8) (21 CFR 866.2680(b)(8)).

    FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k).

    III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR parts 801 and 809, regarding labeling have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

    PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES 1. The authority citation for part 866 continues to read as follows: Authority:

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

    2. Add § 866.2680 to subpart C to read as follows:
    § 866.2680 Streptococcus spp. nucleic acid-based assay.

    (a) Identification. A Streptococcus spp. nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify various Streptococcus spp. nucleic acids extracted directly from clinical specimens. The device detects specific nucleic acid sequences for organism identification. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.

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

    (1) Premarket notification submissions must include detailed device description documentation, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology including primer/probe sequence, design, and rationale for sequence selection.

    (2) Premarket notification submissions must include detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (Limit of Detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carry-over, and cross contamination.

    (3) Premarket notification submissions must include detailed documentation from a clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted reference methods.

    (4) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, software applications and hardware-based devices that incorporate software.

    (5) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols, as appropriate.

    (6) The device labeling must include limitations regarding the need for culture confirmation of negative specimens, as appropriate.

    (7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.

    (8) Premarket notification submissions must include details on an end user device training program that will be offered while marketing the device, as appropriate.

    Dated: October 25, 2017. Lauren Silvis, Chief of Staff.
    [FR Doc. 2017-23513 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2017-N-5870] Medical Devices; Immunology and Microbiology Devices; Classification of the Aquaporin-4 Autoantibody Immunological Test System AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is classifying the Aquaporin-4 autoantibody immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Aquaporin-4 autoantibody immunological test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

    DATES:

    This order is effective October 30, 2017. The classification was applicable on April 25, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Upon request, FDA has classified the Aquaporin-4 autoantibody immunological test system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

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

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

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

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

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

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

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

    II. De Novo Classification

    On July 2, 2015, KRONUS, Inc. submitted a request for De Novo classification of the KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on April 25, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.5665. We have named the generic type of device Aquaporin-4 autoantibody immunological test system, and it is identified as a device that consists of reagents used to measure by immunochemical techniques autoantibodies in human serum samples that react with Aquaporin-4 (AQP4Ab). The measurements aid in the diagnosis of neuromyelitis optica and neuromyelitis optica spectrum disorders, in conjunction with other clinical, laboratory, and radiological (e.g., magnetic resonance imaging) findings.

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

    Table 1—Aquaporin-4 Autoantibody Immunological Test System Risks and Mitigation Measures Identified risks Mitigation measures/21 CFR section Inaccurate test results that provide false positive or false negative results can lead to improper patient management Special controls (1), (2), and (3) (21 CFR 866.5665(b)(1); 21 CFR 866.5665(b)(2); and 21 CFR 866.5665(b)(3)). Failure to correctly interpret test results can lead to false positive or false negative results Special controls (1)(iii), (2), and (3) (21 CFR 866.5665(b)(1)(iii); 21 CFR 866.5665(b)(2); and 21 CFR 866.5665(b)(3)).

    FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

    III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, the collections of information in part 820 have been approved under OMB control number 0910-0073, and the collections of information in 21 CFR parts 801 and 809, regarding labeling have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

    PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES 1. The authority citation for part 866 continues to read as follows: Authority:

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

    2. Add § 866.5665 to subpart F to read as follows:
    § 866.5665 Aquaporin-4 autoantibody immunological test system.

    (a) Identification. An Aquaporin-4 autoantibody immunological test system is a device that consists of reagents used to measure by immunochemical techniques autoantibodies in human serum samples that react with Aquaporin-4 (AQP4Ab). The measurements aid in the diagnosis of neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorders (NMOSD) in conjunction with other clinical, laboratory, and radiological (e.g., magnetic resonance imaging) findings.

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

    (1) Premarket notification submissions must include the following information:

    (i) A detailed device description including:

    (A) A detailed description of all components including all required ancillary reagents in the test;

    (B) If applicable, a detailed description of instrumentation and equipment, including illustrations or photographs of non-standard equipment or manuals;

    (C) If applicable, detailed documentation of the device software, including, but not limited to, standalone software applications and hardware-based devices that incorporate software;

    (D) A detailed description of appropriate internal and external quality controls that are recommended or provided. The description must identify those control elements that are incorporated into the specified testing procedures;

    (E) Detailed specifications for sample collection, processing, and storage;

    (F) A detailed description of methodology and assay procedure;

    (G) A description of how the assay cutoff (the medical decision point between positive and negative) was established and validated as well as supporting data; and

    (H) Detailed specification of the criteria for test results interpretation and reporting.

    (ii) Detailed information demonstrating the performance characteristics of the device, including:

    (A) Device precision/reproducibility data generated from within-run, between-run, between-day, between-lot, between-site, and total precision for multiple nonconsecutive days, as applicable. A well characterized panel of patient samples or pools from the indicated population that covers the device measuring range must be used.

    (B) Device linearity data generated from samples covering the device measuring range, if applicable.

    (C) Information on traceability to a reference material and description of value assignment of calibrators and controls, if applicable.

    (D) Device analytical sensitivity data, including limit of blank, limit of detection, and limit of quantitation, if applicable.

    (E) Device analytical specificity data, including interference by endogenous and exogenous substances, as well as cross-reactivity with samples derived from patients with other autoimmune diseases or conditions.

    (F) Device instrument carryover data, when applicable.

    (G) Device stability data, including real-time stability under various storage times and temperatures.

    (H) Specimen stability data, including stability under various storage times, temperatures, freeze-thaw, and transport conditions, where appropriate.

    (I) Method comparison data generated by comparison of the results obtained with the device to those obtained with a legally marketed predicate device with similar indications of use. A well-characterized panel of patient samples from the indicated population covering the device measuring range must be used.

    (J) Specimen matrix comparison data, if more than one specimen type or anticoagulant can be tested with the device. Samples used for comparison must be from well-characterized patient samples covering the device measuring range.

    (K) Clinical performance must be established by comparing data generated by testing samples from the indicated population and the differential diagnosis or non-target disease groups with the device to the clinical diagnostic standard.

    (1) The diagnosis of NMO and NMOSD must be based on clinical findings, laboratory tests (e.g., serological tests), and radiological tests (e.g., magnetic resonance imaging).

    (2) The differential diagnosis or non-target disease group must include the applicable diseases or conditions, including but not be limited to the following: Multiple sclerosis, stroke, Lyme disease, shingles, syphilis, human immunodeficiency virus, hepatitis B, tuberculosis, Srgen's syndrome, systemic lupus erythematous, systemic vasculitis, sarcoidosis, Graves' disease, Hashimoto's disease, Type I diabetes, rheumatoid arthritis, Addison's disease, and myasthenia gravis.

    (3) Diagnosis of diseases or conditions for the differential or non-target disease groups must be based on established diagnostic criteria and clinical evaluation.

    (4) For all samples, the diagnostic clinical criteria and the demographic information must be collected and provided.

    (5) The clinical validation results must demonstrate clinical sensitivity and clinical specificity for the test values based on the presence or absence of NMO and NMOSD.

    (6) The data must be summarized in tabular format comparing the interpretation of results to the disease status.

    (L) Expected/reference values generated by testing an adequate number of samples from apparently healthy normal individuals.

    (iii) Identification of risk mitigation elements used by the device, including description of all additional procedures, methods, and practices incorporated into the directions for use that mitigate risks associated with testing.

    (2) The device's 21 CFR 809.10(b) compliant labeling must include warnings relevant to the device including:

    (i) A warning statement that reads “The device is for use by laboratory professionals in a clinical laboratory setting”; and

    (ii) A warning statement that reads “The device is not to be used as a stand-alone device but as an adjunct to other clinical information. A diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD) should not be made on a single test result. The clinical symptoms, results from physical examination, laboratory tests (e.g., serological tests), and radiological tests (e.g. Magnetic Resonance Imaging), when appropriate, should always be taken into account when considering the diagnosis of NMO and NMOSD.”

    (3) The device's 21 CFR 809.10(b) compliant labeling must include a detailed description of the protocol and performance studies performed in accordance with paragraph (b)(1)(ii) of this section and a summary of the results.

    Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-23489 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2017-N-5924] Medical Devices; Immunology and Microbiology Devices; Classification of the Newborn Screening Test for Severe Combined Immunodeficiency Disorder AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

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

    DATES:

    This order is effective October 30, 2017. The classification was applicable on December 15, 2014.

    FOR FURTHER INFORMATION CONTACT:

    Caryl Giuliano, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5664, Silver Spring, MD 20993-0002, 301-796-2478, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

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

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

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

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

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

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

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

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

    II. De Novo Classification

    On October 14, 2014, Wallac Oy, a subsidiary of PerkinElmer, Inc., submitted a request for De Novo classification of the EnLite Neonatal TREC Kit. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on December 15, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.5930. We have named the generic type of device newborn screening test for SCID, and it is identified as a prescription device intended to measure T-cell receptor excision circle (TREC) DNA obtained from dried blood spot specimens on filter paper using a polymerase chain reaction based test as an aid in screening newborns for SCID. Presumptive positive results must be followed up by diagnostic confirmatory testing. This test is not intended for use as a diagnostic test, or for screening of SCID-like syndromes, such as DiGeorge syndrome or Omenn syndrome. It is also not intended to screen for less acute SCID syndromes, such as leaky SCID or variant SCID.

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

    Table 1—Newborn Screening Test for SCID Risks and Mitigation Measures Identified risks Mitigation measures/21 CFR section False negative results due to device or user error Special controls (1) and (2) (21 CFR 866.5930(b)(1) and 21 CFR 866.5930(b)(2)). False positive results due to device or user error Special controls (1) and (2) (21 CFR 866.5930(b)(1) and 21 CFR 866.5930(b)(2)).

    FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

    III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

    PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES 1. The authority citation for part 866 continues to read as follows: Authority:

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

    2. Add § 866.5930 to subpart F to read as follows:
    § 866.5930 Newborn screening test for severe combined immunodeficiency disorder (SCID).

    (a) Identification. A newborn screening test for SCID is a prescription device intended to measure T-cell receptor excision circle (TREC) DNA obtained from dried blood spot specimens on filter paper using a polymerase chain reaction based test as an aid in screening newborns for SCID. Presumptive positive results must be followed up by diagnostic confirmatory testing. This test is not intended for use as a diagnostic test, or for screening of SCID-like syndromes, such as DiGeorge syndrome or Omenn syndrome. It is also not intended to screen for less acute SCID syndromes, such as leaky SCID or variant SCID.

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

    (1) Premarket notification submissions must include the following information:

    (i) The intended use must indicate:

    (A) The test is not intended for diagnostic use, or for screening of SCID-like syndromes, such as DiGeorge syndrome or Omenn syndrome; and

    (B) The test is not intended to screen for less acute SCID syndromes, such as leaky SCID or variant SCID.

    (ii) A detailed description of all components in the test that includes:

    (A) A detailed description of the test components, all required reagents, instrumentation and equipment, including illustrations or photographs of nonstandard equipment or methods;

    (B) Detailed documentation of the device software including, but not limited to, standalone software applications and hardware-based devices that incorporate software;

    (C) Specifications for the filter paper, which must be appropriately labeled for in vitro diagnostic use, to be used in specimen collection and how it will be used in specimen collection validation. These specifications must include: descriptive characteristics of the filter paper, instructions on how a lab should choose the appropriate filter paper, chemical properties of the filter paper, interference concerns associated with the chemicals in the filter paper, absorption properties of the filter paper, punch size, absorption capacity, testing for homogeneity of punches, diameter of the circle for the dried blood spot aliquot, absorption time, physical composition, and number and size of punches to be tested;

    (D) Methodology and protocols for detection of T-cell receptor excision circles and methods for determination of results. The cutoff must be selected before conducting clinical and analytical studies;

    (E) A description of the result outputs along with sample reports. Sample reports must include the scale used in reporting of results (e.g., TREC copies/μL) and the range of values that will be reported out; and

    (F) A description of appropriate internal and external controls that are recommended or provided. The description must identify those control elements that are incorporated into the testing procedure.

    (iii) Information that demonstrates the performance characteristics of the test, including:

    (A) Data that demonstrates the clinical validity of the device, using well characterized prospectively or retrospectively obtained clinical specimens representative of the intended use population. A minimum of 10 to 15 confirmed positive specimens must be obtained from more than 1 site, including relevant annotation, and, at 1 year or beyond, a SCID diagnosis by flow cytometry or clinically meaningful information regarding the status of the subject must be obtained. Additional specimens should have been obtained that are characterized by other disorders that can be found by screening specimens that have low or absent TREC (e.g., other T-cell lymphopenic disorders) to supplement the range of results. The clinical validation study must have a pre-specified clinical decision point (i.e., cutoff to distinguish positive and negative results). Results must be summarized in tabular format comparing interpretation of results to the reference method. Point estimates together with two-sided 95 percent confidence intervals must be provided for the positive percent agreement, negative percent agreement, and overall percent agreement. Data must include the retest rate, the false positive rate before retest, the final false positive rate, and the false negative rate;

    (B) Device reproducibility data generated, using a minimum of three sites of which at least two must be external sites, with two operators at each site. Each site must conduct a minimum of five runs per operator over five nonconsecutive days evaluating a minimum of six different relevant TREC concentrations that span and are well distributed over the measuring range and include the clinical cutoff. Specimens must include cord blood and cord blood diluted with ABO matched adult blood specimens. Identical specimens from the same sample panel must be tested at each site. Each specimen must be run in triplicate and include controls run in triplicate. Results must be reported as the standard deviation and percentage coefficient of variation for each level tested. Results must also be displayed as a dichotomous variable around the cutoff. Total variation must be partitioned into the sum of within-lab and between-lab variations with pre-specified acceptance criteria and 95 percent confidence intervals for all data. Pre-specified acceptance criteria must be provided and followed;

    (C) Device precision data using clinical samples to evaluate the within-lot, between-lot, within-run, between run, and total variation. A range of TREC levels of the specimen must include samples within the measuring range, samples above and below the measuring range, as well as with samples very near above and below the cutoff value. At least three replicates of each specimen must be tested with controls and calibrator(s) according to the device instructions for use. The precision study must use well characterized samples using different lots, instruments, and operators. Results must be summarized in tabular format. Pre-specified acceptance criteria must be provided and followed;

    (D) Linearity of the test must be demonstrated using a dilution panel from clinical samples. The range of dilution samples must include samples within the measuring range, samples above and below the measuring range, as well as with samples very near above and below the cutoff value. Results of the regression analysis must be summarized in tabular format and fitted into a linear regression model with the individual measurement results against the dilution factors. Pre-specified acceptance criteria must be provided and followed;

    (E) Device analytic sensitivity data, including limit of blank, limit of detection, and limit of quantification;

    (F) Device specificity data, including interference, carryover, cross-contamination, and in silico analysis of potential off-target genomic sequences;

    (G) Device stability data, including real-time stability of samples under various storage times, temperatures, and freeze-thaw conditions. A separate shipping stability study must be performed;

    (H) Lot-to-lot reproducibility study of each filter paper that will be validated with the test. The lot-to-lot study must include a minimum of three lots of each blood spot card that will be validated with the test and be conducted over five nonconsecutive days. The sample panel must consist of specimens with a range of TREC levels and include samples within the measuring range, samples above and below the measuring range, and samples very near above and below the cutoff value. Multiple punches must be obtained from each card for demonstration of homogeneity of the analyte across the dried blood spot. Comparability of the test performance for each filter paper must be demonstrated. Stability and storage of TREC DNA on each blood spot card must be demonstrated. Results of the lot-to-lot study must be summarized providing the mean, standard deviation, and percentage coefficient of variation in a tabular format. Data must be calculated for within-run, between-run, within-lot, and between-lot. Data demonstrating the concordance between results across different filter papers must be provided. Study acceptance criteria must be provided and followed; and

    (I) If applicable, a thermocycler reproducibility study must be performed using thermocyclers from three independent thermocyler manufacturers. The sample panel must consist of specimens with a range of TREC levels and must include samples within the measuring range, samples above and below the measuring range, and samples very near above and below the cutoff value. The study must be done using three filter paper lots and conducted over five nonconsecutive days. Results of the thermocycler reproducibility study must be summarized providing the mean, standard deviation, and percentage coefficient of variance in a tabular format. Data must be calculated for the within-run, between-run, within-lot, between-lot, and between thermocycler manufacturer study results. Study acceptance criteria must be provided and followed.

    (iv) Identification of risk mitigation elements used by your device, including a description of all additional procedures, methods, and practices incorporated into the directions for use that mitigate risks associated with testing.

    (2) Your § 809.10 compliant labeling must include:

    (i) A warning statement that reads “This test is not intended for diagnostic use, preimplantation or prenatal testing, or for screening of SCID-like syndromes, such as DiGeorge syndrome or Omenn syndrome. It is also not intended to screen for less acute SCID syndromes, such as leaky SCID or variant SCID.”;

    (ii) A warning statement that reads “Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods and clinical evaluation, as appropriate.”;

    (iii) A description of the performance studies listed in paragraph (b)(1)(iii) and a summary of the results; and

    (iv) A description of the filter paper specifications required for the test.

    Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-23496 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 876 [Docket No. FDA-2017-N-1609] Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order; correction.

    SUMMARY:

    The Food and Drug Administration (FDA) is correcting a final order entitled “Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss” that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.

    DATES:

    Effective October 30, 2017

    FOR FURTHER INFORMATION CONTACT:

    Mark Antonino, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G208, Silver Spring, MD 20993-0002, 240-402-9980, mark.anto[email protected]

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of July 28, 2017 (82 FR 35067), FDA published the final order “Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss.” The final order published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements under section 510(k) of the FD&C Act.

    In the Federal Register of July 28, 2017, (82 FR 35067), the following correction is made: On page 35069, in the first column, the first paragraph is corrected as follows:

    “Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the oral removable palatal space occupying device for weight management and/or weight loss they intend to market.”

    Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-23490 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2017-N-5934] Medical Devices; Neurological Devices; Classification of the Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

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

    DATES:

    This order is effective October 30, 2017. The classification was applicable on February 16, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Xiaorui Tang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2609, Silver Spring, MD 20993-0002, 301-796-6500, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Upon request, FDA has classified the non-EEG physiological signal based seizure monitoring system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

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

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

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

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

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

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

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

    II. De Novo Classification

    On November 10, 2014, Brain Sentinel, Inc., submitted a request for De Novo classification of the Brain Sentinel Monitoring and Alerting System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on February 16, 2017, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 882.1580. We have named the generic type of device non-EEG physiological signal based seizure monitoring system, and it is identified as a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure.

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

    Table 1—Non-EEG Physiological Signal Based Seizure Monitoring System Risks and Mitigation Measures Identified risks Mitigation measures Adverse tissue reaction Biocompatibility evaluation. Equipment malfunction leading to injury to users (shock, burn) Electrical safety, thermal, and mechanical testing; Electromagnetic compatibility testing; and
  • Labeling.
  • Interference with or from other electrical devices Electromagnetic compatibility testing. Incorrect alerts, including: • Missing a seizure—device fails to identify physiological signal that is associated with a seizure; or
  • • False alarm—device mistakenly identifies a physiological signal as being associated with a seizure
  • Clinical performance testing;
  • Non-clinical performance testing;
  • Software verification, validation, and hazard analysis;
  • Labeling; and
  • Training.
  • FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

    At the time of classification, non-EEG physiological signal based seizure monitoring systems are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

    III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 882

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:

    PART 882—NEUROLOGICAL DEVICES 1. The authority citation for part 882 continues to read as follows: Authority:

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

    2. Add § 882.1580 to subpart B to read as follows:
    § 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.

    (a) Identification. A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure.

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

    (1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:

    (i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.

    (ii) Software, including any proprietary algorithm(s) used by the device to achieve its intended use, must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.

    (2) The patient-contacting components of the device must be demonstrated to be biocompatible.

    (3) The device must be designed and tested for electrical, thermal, and mechanical safety and electromagnetic compatibility (EMC).

    (4) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for monitoring for seizure-related activity in the intended population and for the intended use setting. Performance measurements must include positive percent agreement and false alarm rate.

    (5) Training must be provided for intended users that includes information regarding the proper use of the device and factors that may affect the collection of the physiologic data.

    (6) The labeling must include health care professional labeling and patient-caregiver labeling. The health care professional and the patient-caregiver labeling must include the following information:

    (i) A detailed summary of the clinical performance testing, including any adverse events and complications.

    (ii) Any instructions technicians and clinicians should convey to patients and caregivers regarding the proper use of the device and factors that may affect the collection of the physiologic data.

    (iii) Instructions to technicians and clinicians regarding how to set the device threshold to achieve the intended performance of the device.

    Dated: October 24, 2017. Lauren Silvis, Chief of Staff.
    [FR Doc. 2017-23516 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG 2017-0162] RIN 1625-AA09 Drawbridge Operation Regulation; Nanticoke River, Seaford, DE AGENCY:

    Coast Guard, DHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Coast Guard is modifying the operating schedule that governs the SR 13 Bridge across the Nanticoke River, mile 39.6, in Seaford, Delaware (DE). This modification will require the bridge to open on signal every Saturday and Sunday during the winter season, if at least 24 hours notice is given. This action is necessary to balance bridge operations and maintenance with the existing needs of navigation.

    DATES:

    This rule is effective November 29, 2017.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov. Type USCG-2017-0162 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email Mr. Martin A. Bridges, Fifth Coast Guard District (dpb), at (757) 398-6422, email [email protected].

    SUPPLEMENTARY INFORMATION section below for instructions on submitting comments.

    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 July 5, 2017, we published a notice of proposed rulemaking entitled, “Drawbridge Regulation; Nanticoke River, Seaford, DE” in the Federal Register (see 82 FR 127). We did not receive any comments on the proposed rule.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority 33 U.S.C. 499. The US 13 Bridge across the Nanticoke River, Mile 39.6, in Seaford, DE, owned and operated by the Delaware Department of Transportation, has a vertical clearance of 3 feet above mean high water in the closed-to-navigation position. There is a monthly average of three bridge openings on Saturdays and Sundays, from 7:30 a.m. to 3:30 p.m., from November 1 through March 31, which allow one or more vessels to transit through the bridge during each opening. The bridge is normally maintained in the closed position, due to the volume of vehicular traffic crossing the bridge. The current operating schedule is published in 33 CFR 117.243(b). The Coast Guard's authority to make a permanent change to a drawbridge operating schedule is contained in 33 CFR 117.8.

    The Nanticoke River is used predominately by recreational vessels and pleasure craft. The three-year average number of bridge openings, maximum number of bridge openings, and weekend bridge openings between 7:30 a.m. and 3:30 p.m., by month and overall for 2014 through 2016, as drawn from the data contained in the bridge tender logs provided by the Delaware Department of Transportation, is presented below.

    Month Average
  • openings
  • Maximum
  • openings
  • Proposed weekends—
  • average openings
  • 7:30 a.m.-3:30 p.m.
  • January 11 31 3 February 1 3 1 March 21 53 4 April 72 91 N/A May 138 192 N/A June 150 168 N/A July 280 175 N/A August 198 223 N/A September 144 214 N/A October 51 66 N/A November 8 13 5 December 1 4 1 Monthly 89 223 3 Daily 3 7 <1
    IV. Discussion of Comments, Changes and the Final Rule

    The Delaware Department of Transportation has requested to modify the operating regulation for the bridge, due to the limited number of requested openings of the bridge on Saturday and Sunday, from 7:30 a.m. to 3:30 p.m., from November 1 through March 31, over a period of approximately the past three years. The data presented in the table above demonstrate that the requested modification may be implemented with minimal impact to navigation. The modification requested will require the bridge to open on signal on Saturday and Sunday; from 7:31 a.m. to 3:29 p.m., from November 1 through March 31, if at least 24 hours notice is given. All other provisions of 33 CFR 117.243 (b) will remain the same.

    The Coast Guard provided a comment period of 60 days and received zero comments on the proposed rule.

    V. Regulatory Analysis

    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 protesters.

    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, it 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 is not considered a significant regulatory action. This determination is based on the findings that: (1) The potential impact is small, given the limited number of vessels requiring a bridge opening during the time frame of the proposed modification, and (2) vessels will be able to transit through the bridge during the time frame of the proposed modification, given the bridge will open on signal, if at least 24 hours notice is given.

    B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 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 zero comments from the Small Business Administration on this rule. 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 bridge 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, above.

    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 calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

    D. Federalism and Indian Tribal Government

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

    Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. We received zero comments on this rule.

    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 will not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble. We received zero comments on this rule.

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This action is categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction. A preliminary Record of Environmental Consideration and a Memorandum for the Record are not required for this 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.

    List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:

    PART 117—DRAWBRIDGE OPERATION REGULATIONS 1. The authority citation for part 117 continues to read as follows: Authority:

    33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.

    2. Revise § 117.243(b) to read as follows:
    § 117.243 Nanticoke River.

    (b) The draw of the SR 13 Bridge, mile 39.6, in Seaford shall:

    (1) Open on signal, except from 6 p.m. to 8 a.m., from April 1 through October 31; from November 1 through March 31, Monday to Friday and on Saturday and Sunday from 3:30 p.m. to 7:30 a.m., if at least four hours notice is given.

    (2) Open on signal, on Saturday and Sunday, from 7:31 a.m. through 3:29 p.m., from November 1 through March 31, if at least 24 hours notice is given.

    Dated: October 10, 2017. M.L. Austin, Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District.
    [FR Doc. 2017-23559 Filed 10-27-17; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0155; FRL-9968-12] Hexythiazox; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation amends an existing tolerance for residues of the ovicide/miticide hexythiazox in/on hop, dried cones, by increasing the current tolerance from 2.0 parts per million (ppm) to 20 ppm. Gowan Company requested modification of this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective October 30, 2017. Objections and requests for hearings must be received on or before December 29, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0155, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001.The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    Michael L. Goodis, P.E., Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

    C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0155 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 29, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0155, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9961-14), EPA issued a document pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP #6F8489) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366-5569. This petition requested that 40 CFR 180.448 be amended by establishing a tolerance for residues of hexythiazox in or on hop, dried cones at 20 ppm. This document referenced a summary of the petition prepared by Gowan Company, the registrant, which is available in the docket, http://www.regulations.gov. No comments were received in response to the referenced notice of filing.

    III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

    Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for hexythiazox including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with hexythiazox follows.

    A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

    Hexythiazox has low acute toxicity by the oral, dermal, and inhalation routes of exposure. It produces mild eye irritation and is not a skin irritant or skin sensitizer. Hexythiazox is associated with toxicity of the liver and adrenals following subchronic and chronic exposure to dogs, rats, and mice, with the dog being the most sensitive species. The prenatal developmental studies in rabbits and rats and the two-generation reproduction study in rats showed no indication of increased susceptibility to in utero or postnatal exposure to hexythiazox. Reproductive toxicity was not observed. There is no concern for immunotoxicity or neurotoxicity following exposure to hexythiazox. The toxicology database for hexythiazox does not show any evidence of treatment-related effects on the immune system.

    Hexythiazox is classified as “Likely to be Carcinogenic to Humans” based on a treatment-related increase in benign and malignant liver tumors in female mice and the presence of mammary gland tumors (fibroadenomas) in male rats; however, the evidence as a whole was not strong enough to warrant the use of a linear low dose extrapolation model applied to the animal data (Q1*) for a quantitative estimation of human risk because the common liver tumors (benign and malignant) were only observed in high-dose female mice, and benign mammary gland tumors were only observed in high-dose male rats. Since the effects seen in the study that serves as the basis for the chronic reference dose (cRfD) occurred at doses substantially below the lowest dose that induced tumors (and there is no mutagenic concern for hexythiazox), the cRfD is considered protective of all chronic effects, including potential carcinogenicity.

    Specific information on the studies received and the nature of the adverse effects caused by hexythiazox as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov within the document entitled “Hexythiazox. Human Health Risk Assessment for Amended Use on Hops,” dated September 5, 2017, which can be found in docket ID number EPA-HQ-OPP-2017-0155.

    B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for hexythiazox used for human risk assessment is shown in the Table of this unit.

    Table—Summary of Toxicological Doses and Endpoints for Hexythiazox for Use in Human Health Risk Assessment Exposure/scenario Point of departure
  • and uncertainty/
  • safety factors
  • RfD, PAD, LOC for
  • risk assessment
  • Study and toxicological effects
    Acute Dietary (All populations) No risk is expected from this exposure scenario as no hazard was identified in any toxicity study for this duration of exposure. Chronic Dietary (All populations) NOAEL= 2.5 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Chronic RfD = 0.025 mg/kg/day
  • cPAD = 0.025
  • One-Year Feeding Toxicity Study—Dogs.
  • LOAEL = 12.5 mg/kg/day based on increased absolute and relative adrenal weights, and associated adrenal histopathology.
  • Incidental Oral Short-Term (1 to 30 days) and Intermediate-Term (1 to 6 months) NOAEL= 30 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Residential LOC for MOE = 100 2-Generation Reproduction Study—Rat.
  • LOAEL = 180 mg/kg/day, based on decreased pup body weight during lactation and delayed hair growth and/or eye opening, and decreased parental body-weight gain and increased absolute and relative liver, kidney, and adrenal weights.
  • Dermal Short- and Intermediate-term A quantitative dermal risk assessment is not necessary since no dermal hazard is anticipated. There is no evidence of increased quantitative or qualitative susceptibility of the young following in utero and pre-and post-natal exposure to hexythiazox. Inhalation Short-Term (1 to 30 days) and Intermediate-Term (1 to 6 months) Oral NOAEL= 30 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Residential LOC for MOE = 100 2-Generation Reproduction Study—Rat.
  • LOAEL = 180 mg/kg/day, based on decreased pup body weight during lactation and delayed hair growth and/or eye opening, and decreased parental body-weight gain and increased absolute and relative liver, kidney, and adrenal weights.
  • Cancer (oral, dermal, and inhalation) Classification: “Likely to be Carcinogenic to Humans.” A quantification of risk using a non-linear approach; i.e., RfD, for hexythiazox will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to hexythiazox. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to hexythiazox, EPA considered exposure under the petitioned-for tolerances as well as all existing hexythiazox tolerances in 40 CFR 180.448. EPA assessed dietary exposures from hexythiazox in food as follows:

    i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No toxic effects attributable to a single dose of hexythiazox were observed in the toxicology database; therefore, a quantitative acute dietary exposure and risk assessment is unnecessary.

    ii. Chronic exposure. In conducting the chronic dietary (food and drinking water) exposure assessment, EPA used the Dietary Exposure Evaluation Model (DEEM-FCID), Version 3.16, which uses food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003-2008. As to residue levels in food, EPA used tolerance-level residues, assumed 100 percent crop treated (PCT), and incorporated DEEM 7.81 default processing factors when processing data were not available.

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to hexythiazox. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., Chronic exposure.

    iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for hexythiazox. Tolerance-level residues and/or 100 PCT were assumed for all food commodities.

    2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for hexythiazox in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of hexythiazox. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Surface water and groundwater estimated drinking water concentrations (EDWCs) do not result in any change to the existing EDWCs determined from a recent drinking water assessment derived on hops. Specifically, since hops is already a registered use that was recently assessed during registration review, no new drinking water scenarios were identified with this proposed increase in application rates that would require a new drinking water assessment to be conducted. In fact, the highest EDWCs associated with all uses of hexythiazox continue to be from use on sorghum in the Western U.S., using the Pesticide Root Zone Model (PRZM) surface water modeling scenario. Furthermore, based on the Agency's previous assessment, the EDWCs of hexythiazox for chronic exposures are estimated to be 4.3 parts per billion (ppb) for surface water and 2.4 ppb for ground water (DP 433290, 5/9/2016; DP 404023, 1/17/2012), and the higher of these values was used in the dietary exposure model to assess chronic dietary risk.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Hexythiazox is currently registered for the following residential uses, including ornamental landscape plantings, turf, and fruit and nut trees in residential sites.

    EPA assessed residential exposure using the following assumptions: Residential handler exposures are expected to be short-term (1 to 30 days) via either the dermal or inhalation routes of exposures. Since a quantitative dermal risk assessment is not needed for hexythiazox, handler MOEs were calculated for the inhalation route of exposure only. EPA uses the term “post-application” to describe exposure to individuals that occur as a result of being in an environment that has been previously treated with a pesticide. There is potential for post-application for individuals exposed as a result of being in an environment that has been previously treated with hexythiazox. Adult residential post-application dermal exposures were not assessed since no dermal hazard was identified for hexythiazox. The residential post-application exposure assessment for children included incidental oral exposure resulting from transfer of residues from the hand-to-mouth, object to- mouth, and from incidental ingestion of soil.

    Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.

    4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

    EPA has not found hexythiazox to share a common mechanism of toxicity with any other substances, and hexythiazox does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action; therefore, EPA has assumed that hexythiazox does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

    D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

    2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicology data base indicates no increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to hexythiazox.

    3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings:

    i. The toxicity database for hexythiazox is complete.

    ii. There is no indication that hexythiazox is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

    iii. There is no evidence that hexythiazox results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

    iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to hexythiazox in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by hexythiazox.

    E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

    1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No toxic effects attributable to a single dose of hexythiazox were observed in the toxicology database; therefore, a quantitative acute aggregate risk assessment for hexythiazox is not required.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to hexythiazox from food and water will utilize 93% of the cPAD for children 1-2 years of age, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of hexythiazox is not expected.

    3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

    Hexythiazox is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to hexythiazox. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, drinking water, and residential inhalation exposures result in an aggregate MOE for adults (7,500) that greatly exceeds the LOC of 100, and is not of concern.

    4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

    Hexythiazox is currently registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to hexythiazox. Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded the combined intermediate-term food, drinking water, and residential oral exposures result in an aggregate MOE for children (1,150) that greatly exceeds the LOC of 100, and is not of concern.

    5. Aggregate cancer risk for U.S. population. As discussed in Unit III. C.1.iii., EPA concluded that regulation based on the cRfD will be protective for both chronic and carcinogenic risks. As noted in this unit, there are no chronic risks of concern; therefore, the Agency concludes that aggregate exposure to hexythiazox will not pose a cancer risk.

    6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. general population, or to infants and children from aggregate exposure to hexythiazox residues.

    IV. Other Considerations A. Analytical Enforcement Methodology

    An adequate High performance liquid chromatography using ultra-violet detection (HPLC/UV) analytical method is available for the enforcement of tolerances for residues of hexythiazox and its metabolites containing the PT-1-3 moiety in crop and livestock commodities. This method is listed in the U.S. EPA Index of Residue Analytical Methods under hexythiazox as method AMR-985-87. The limit of quantification (LOQ) for hexythiazox residues is 0.02 ppm.

    B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by Federal Food, Drug and Cosmetic Act (FFDCA) section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

    Codex has established an MRL for residues of hexythiazox on hops at 3 ppm. The U.S. tolerance for residues of hexythiazox on hops cannot be harmonized based on approved label instructions. Based on available residue data, compliance with label instructions would result in exceedances of a tolerance harmonized with the Codex MRL.

    V. Conclusion

    Therefore, the existing tolerance for residues of the ovicide/miticide hexythiazox and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety in/on hop, dried cones is increased from 2.0 ppm to 20 ppm.

    VI. Statutory and Executive Order Reviews

    This action amends an existing tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

    This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

    VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: October 6, 2017. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority:

    21 U.S.C. 321(q), 346a and 371.

    2. Section 180.448 is amended by revising the entry “Hop, dried cones” in the table in paragraph (a) to read as follows:
    § 180.448 Hexythiazox; tolerances for residues.

    (a) * * *

    Commodity Parts per million *    *    *    *    * Hop, dried cones 20 *    *    *    *    *
    [FR Doc. 2017-23439 Filed 10-27-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 571 [Docket No. NHTSA-2015-0056] RIN 2127-AL78 Motor Vehicle Safety Standards; Electronic Stability Control Systems for Heavy Vehicles AGENCY:

    National Highway Traffic Safety Administration (NHTSA), Department of Transportation.

    ACTION:

    Final rule; response to petition for reconsideration.

    SUMMARY:

    This final rule addresses a petition for reconsideration of the final rule for FMVSS No. 136, Electronic stability control systems for heavy vehicles. The petitioner, Truck and Engine Manufacturers Association (EMA), requested that NHTSA amend the test conditions for the agency's performance test by allowing a larger lane width for long wheelbase truck tractors. After a careful technical review of the petition and the issues raised by the petitioner, the agency has decided to grant the petition because there is sufficient evidence to indicate that a larger lane width is needed for testing of long wheelbase truck tractors.

    DATES:

    The effective date of this final rule is November 29, 2017.

    Petitions for reconsideration: Petitions for reconsideration of this final rule must be received not later than December 14, 2017.

    ADDRESSES:

    Petitions for reconsideration of this final rule must refer to the docket and notice number set forth above and be submitted to the Administrator, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    For technical issues, you may contact Patrick Hallan, Office of Crash Avoidance Standards, by telephone at (202) 366-9146, and by fax at (202) 493-2990. For legal issues, you may contact David Jasinski, Office of the Chief Counsel, by telephone at (202) 366-2992, and by fax at (202) 366-3820. You may send mail to both of these officials at the National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590.

    SUPPLEMENTARY INFORMATION:

    I. FMVSS No. 136 and J-Turn Test Maneuver

    On June 23, 2015, NHTSA published a final rule establishing Federal Motor Vehicle Safety Standard (FMVSS) No. 136, Electronic stability control systems for heavy vehicles, requiring electronic stability control (ESC) systems on truck tractors and certain buses with a gross vehicle weight rating greater than 11,793 kilograms (26,000 pounds).1 ESC systems in truck tractors and large buses are designed to reduce untripped rollovers and mitigate severe understeer or oversteer conditions that lead to loss of control using automatic computer-controlled braking and reducing engine torque output.

    1 80 FR 36049.

    To test the performance of ESC systems, NHTSA included a 150-foot radius J-turn test maneuver. The test course for the test maneuver is shown in Figure 1. This maneuver involves accelerating to a constant speed on a straight stretch of high-friction track before entering into a 150-foot radius curve. After entering the curve, the driver attempts to maintain the lane. At a speed that is up to 1.3 times the lowest entrance speed at which the ESC system activates, but no less than 48.3 km/h (30 mph), an ESC system must activate the vehicle's service brakes to slow the vehicle to 46.7 km/h (29 mph) within 3 seconds after entering the curve and 45.1 km/h (28 mph) within 4 seconds after entering the curve. The test vehicle must also remain within the lane.

    ER30OC17.002

    For truck tractors, the lane width is 3.7 meters (12 feet) for both the straight section and the curved section of the course. However, after testing large buses, the agency determined that large buses require additional lane width on the curved section of the course because buses have longer wheelbases, which make it substantially more difficult to maintain a narrower lane within the curve. During testing of buses on a 3.7 meter (12 foot) width lane, the bus could not maintain the lane because of the geometry of the vehicle, not because of lack of stability. NHTSA determined that 4.3 meters (14 feet) was an appropriate lane width for testing large buses.

    As described in the final rule, the nature of the J-turn test provides two criteria for ensuring vehicle responsiveness: Maintaining the lane within the fixed radius curve and a minimum test speed. These criteria for vehicle responsiveness are needed because there is a possibility of a manufacturer designing a vehicle that responds poorly to the operator's speed and steering inputs, which would mask the actual performance of the ESC system.

    The first responsiveness criterion is the requirement that the vehicle maintain the lane during at least six of eight runs in the roll stability performance test series or at least two of four runs in the engine torque reduction test. This requirement ensures that, during J-turn test runs at increasing speeds, the ESC system activates before the vehicle becomes unstable. We allowed multiple test runs, instead of a single test run, to account for driver variability and possible driver error in conducting the maneuver. Absent driver error, we do not expect any vehicle equipped with a properly functioning ESC system to exceed the lane width during any of the tests using the J-turn maneuver.

    The other responsiveness criterion in the final rule is the minimum vehicle entry speed, which is 48 km/h (30 mph) for the roll performance test. The reason for this requirement is to discourage a manufacturer from designing a system that unnecessarily intervenes at very low speeds, thus artificially decreasing the speed at which the vehicle will enter the curve during the roll performance test.

    II. EMA Petition

    On August 7, 2015, the Truck and Engine Manufacturers Association (EMA) submitted a petition to NHTSA, pursuant to 49 CFR 553.35, requesting that the agency reconsider its June 2015 final rule establishing FMVSS No. 136. EMA is a trade association representing manufacturers of commercial motor vehicles, including medium- and heavy-duty truck tractors. EMA's petition indicated that the 3.7 meter (12 foot) lane width used in the FMVSS No. 136 test procedure presents difficulty in successfully completing the J-turn test for a small subset of truck tractors to achieve certification. According to EMA, long wheelbase truck tractors, such as specialty tractors and severe service tractors, cannot navigate the curve of the test course for the J-turn test maneuver because the radius paths of the trucks are dimensionally too large. This physical limitation does not allow the rear wheels to stay inside the 12-foot-wide lane. The petitioner states that this issue only affects certain long wheelbase truck tractors, which make up about one percent of the annual sales of the new truck tractor market.

    EMA asserted that the curved section of the 12-foot-wide lane is too narrow, and therefore, it is impracticable for the testing of a long wheelbase truck tractor with a wheelbase equal to or greater than 7112 millimeters (280 inches). EMA stated that it was challenging for the drivers of tractors with wheelbases larger than 280 inches to complete the maneuver in the 12-foot-wide lane, because there was not an adequate margin of physical space to account for test variability. EMA listed factors that contribute to the variability of its test results which included: (i) The length of the tractor's wheelbase, (ii) the experience level of the test driver, (iii) whether the maneuver is conducted in the clockwise or counter-clockwise direction, and (iv) other vehicle attributes such as steering system, suspensions, axles, and tires. EMA has shown that there are dimensional limitations for certain long wheelbase truck tractors to conduct the J-turn test maneuver within 12-foot-wide lane and a larger lane width is needed to adequately test the ESC systems.

    In support of the petition for reconsideration, on June 30, 2016, EMA submitted data from testing and computer simulations indicating that a lane width of 4.3 meters (14 feet) was necessary for these long wheelbase truck tractors. EMA tested three truck tractors with three test drivers of varying degrees of experience in conducting the J-turn maneuver in both directions (clockwise and counterclockwise). EMA also performed computer simulations on three example tractors to do a static analysis showing the clearance of the truck tractor within the lane. Based on engineering recommendations from all of the major heavy-duty tractor manufacturers using the results of the computer simulations and the vehicle testing, EMA requests that truck tractors with a wheelbase equal to or greater than 7112 mm (280 inches) be conducted on a J-turn test course with a lane width of 4.3 meters (14 feet).

    III. Agency Decision

    Pursuant to the process established under 49 CFR 553.37, after carefully considering all aspects of the petition and its subsequent data submission, the agency has decided to grant the petition without further proceedings. EMA's vehicle testing and computer simulation data support its position that truck tractors with a wheelbase equal to or greater than 7112 millimeters (280 inches) should be conducted on a test course with a wider lane, and we believe the suggested width of 4.3 meters (14 feet) is appropriate. The agency had made similar provisions for large buses by allowing a 14-foot-wide lane after first considering a 12-foot-wide lane.2 During bus testing, NHTSA observed a decrease in clearance between a vehicle and the lane boundaries as wheelbase length increases. EMA's submission further reinforces this work and applies it to truck tractors. NHTSA agrees that there are dimensional limitations for long wheelbase vehicles that potentially make it impractical to conduct the J-turn test maneuver within 12-foot-wide lane, and a larger lane width is needed to adequately test the ESC systems.

    2 See Stability Control System Test Track Research with a 2014 Prevost X3-45 Passenger Motorcoach, Docket No. NHTSA-2012-0065-0063.

    In order to ensure that the J-turn test maneuver tests the ESC system and not a test driver's ability to maintain a narrow lane, NHTSA will adopt EMA's suggested 4.3 meter (14 foot) lane width for testing longer wheelbase truck tractors. Despite the increased lane width requirement for these long wheelbase truck tractors, NHTSA is confident that the ESC systems in these long wheelbase truck tractors will be adequately tested for minimum performance using the J-turn test maneuver because the driver must maintain the lane within the same fixed radius curve and travel at the same minimum test speed as all other truck tractors.

    This change requires two clarifications. First, as with buses, the wider lane is used only in the curved section of the test course. The lane width of the straight section will remain 3.7 meters (12 feet). The dimensional considerations that require a wider lane width for long wheelbase vehicles do not apply to straight sections of the test course.

    Second, NHTSA is clarifying the definition of wheelbase by including the definition in the regulatory text. For two-axle vehicles, the wheelbase is generally clear—the distance between the center of the front axle and the center of the rear axle. Moreover, for typical 6x4 truck tractors, which have tandem rear axles, we believe the definition of wheelbase is also clear—the distance between the center of the front axle and the center of the rear tandem axles. However, to clarify wheelbase for all vehicles, including those with liftable axles or tag axles, NHTSA is specifying that the wheelbase is the longitudinal distance between the center of the front axle and the center of the rear axle. For vehicles with tandem axles, the center of the axle is considered to be the midpoint between the centers of the most forward and most rearward of the tandem axles, measured with any liftable axles down. This definition is designed to directly reflect the geometrical concerns raised in the petition. Because all testing is done with any liftable axles in the lowered position, the wheelbase will be measured with liftable axles down so the wheelbase measurement accurately reflects the turning radius of the truck tractor. The term “tandem axle” is defined as it is in FMVSS Nos. 105 and 121 as a group or set of two or more axles placed in close arrangement, one behind the other, with the centerlines of adjacent axles not more than 72 inches apart.

    IV. Rulemaking Analyses and Notices A. Executive Order 12866, Executive Order 13563, and DOT Regulatory Policies and Procedures

    The agency has considered the impact of this rulemaking action under Executive Orders 12866 and 13563 and the DOT's regulatory policies and procedures. This action was not reviewed by the Office of Management and Budget under Executive Order 12866. The agency has considered the impact of this action under the Department of Transportation's regulatory policies and procedures (44 FR 11034; February 26, 1979), and has determined that it is not “significant” under them.

    This action addresses a petition for reconsideration of the June 2015 final rule requiring ESC on truck tractors and certain large buses. However, the petition only addresses one test condition applicable to approximately one percent of truck tractors. This final rule amends the standard to allow long wheelbase truck tractors to be tested in a wider lane to account for the geometry of a turning vehicle and to ensure that the J-turn remains a test of the vehicle's stability and not the test driver. This final rule imposes no costs and adjusts FMVSS No. 136 to give more flexibility to manufacturers testing long wheelbase trucks. This action will not have any safety impacts.

    B. Executive Order 13771

    Executive Order 13771 titled “Reducing Regulation and Controlling Regulatory Costs,” directs that, unless prohibited by law, whenever an executive department or agency publicly proposes for notice and comment or otherwise promulgates a new regulation, it shall identify at least two existing regulations to be repealed. In addition, any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs. Only those rules deemed significant under section 3(f) of Executive Order 12866, “Regulatory Planning and Review,” are subject to these requirements. As discussed above, this rule is not a significant rule under Executive Order 12866 and, accordingly, is not subject to the offset requirements of Executive Order 13771.

    NHTSA has determined that this rulemaking is a deregulatory action under Executive Order 13771, as it imposes no costs and, instead, amends FMVSS No. 136 to give more flexibility to manufacturers of long wheelbase truck tractors by allowing a wider lane in the test course. Although NHTSA was not able to quantify any cost savings for this rule, in adopting an optional wider lane width for the testing of long wheelbase truck tractors, this final rule adjusts the standard to accommodate the larger physical size of certain truck tractors and improves the efficiency of testing. This issue only affects long wheelbase truck tractors, which make up about one percent of the annual sales of truck tractors. The optional wider lane width will remove the difficulties cited by the petitioner associated with navigating the test course for long wheelbase truck tractors under the current test conditions in the standard.

    C. Regulatory Flexibility Act

    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small governmental jurisdictions). The Small Business Administration's regulations at 13 CFR part 121 define a small business, in part, as a business entity “which operates primarily within the United States.” (13 CFR 121.105(a)). No regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities.

    NHTSA has considered the effects of this final rule under the Regulatory Flexibility Act. I certify that this final rule will not have a significant economic impact on a substantial number of small entities. NHTSA does not believe that any truck tractor manufacturers affected by this rule qualify as small entities. To the extent any business entities affected by this final rule do qualify as small entities, this final rule will not have a significant economic impact. This final rule addresses one test condition applicable to only one percent of truck tractors. This action will not result in added expenses for those manufacturers.

    D. Privacy Act

    Anyone is able to search the electronic form of all documents received into any of our dockets by the name of the individual submitting the document (or signing the document, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78) or you may visit http://www.transportation.gov/privacy.

    E. Other Rulemaking Analyses and Notices

    In the June 2015 final rule, the agency discussed relevant requirements related to Executive Order 13132 (Federalism), Executive Order 12988 (Civil Justice Reform); Executive Order 13045 (Protection of Children from Environmental Health and Safety Risks); the Paperwork Reduction Act, the National Technology Transfer and Advancement Act, the Unfunded Mandates Reform Act, and the National Environmental Policy Act. As today's final rule merely adjusts one test condition in FMVSS No. 136 for approximately one percent of truck tractors subject to the standard, it will not have any effect on the agency's analyses in those areas.

    List of Subjects in 49 CFR Parts 571

    Imports, Incorporation by reference, Motor vehicle safety, Reporting and recordkeeping requirements, Tires.

    In consideration of the foregoing, NHTSA amends 49 CFR part 571 as follows:

    PART 571—FEDERAL MOTOR VEHICLE SAFETY STANDARDS 1. The authority citation for part 571 continues to read as follows: Authority:

    49 U.S.C. 322, 30111, 30115, 30117, and 30166; delegation of authority at 49 CFR 1.95.

    2. In § 571.136, amend S4 by adding in alphabetical order the definitions of “tandem axle” and “wheelbase” and by revising S6.2.4.2 to read as follows:
    § 571.136 Standard No. 136; Electronic stability control systems for heavy vehicles.

    S4 Definitions.

    Tandem axle means a group or set of two or more axles placed in close arrangement, one behind the other, with the centerlines of adjacent axles not more than 72 inches apart.

    Wheelbase means the longitudinal distance between the center of the front axle and the center of the rear axle. For vehicles with tandem axles, the center of the axle is the midpoint between the centers of the most forward and most rearward tandem axles, measured when all liftable axles are in the lowered position.

    S6.2.4.2 For truck tractors, the lane width of the test course is 3.7 meters (12 feet). At the manufacturer's option, for truck tractors with a wheelbase equal to or greater than 7112 mm (280 inches) the lane width of the test course is 3.7 meters (12 feet) for the straight section and is 4.3 meters (14 feet) for the curved section. For buses, the lane width of the test course is 3.7 meters (12 feet) for the straight section and is 4.3 meters (14 feet) for the curved section.

    Issued on October 20, 2017 in Washington, DC, under authority delegated in 49 CFR 1.95 and 501.5. Heidi R. King, Deputy Administrator.
    [FR Doc. 2017-23531 Filed 10-27-17; 8:45 am] BILLING CODE 4910-59-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 160920866-7167-02] RIN 0648-XF798 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Ocean Perch in the Western Regulatory Area of the Gulf of Alaska AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is prohibiting directed fishing for Pacific ocean perch in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2017 total allowable catch of Pacific ocean perch in the Western Regulatory Area of the GOA.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), October 25, 2017, through 2400 hours, A.l.t., December 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

    The 2017 total allowable catch (TAC) of Pacific ocean perch in the Western Regulatory Area of the GOA is 2,679 metric tons (mt) as established by the final 2017 and 2018 harvest specifications for groundfish of the Gulf of Alaska (82 FR 12032, February 27, 2017).

    In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2017 TAC of Pacific ocean perch in the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 2,579 mt, and is setting aside 100 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the Western Regulatory Area of the GOA.

    After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for Pacific ocean perch in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 23, 2017.

    The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

    This action is required by § 679.20 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: October 25, 2017. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-23536 Filed 10-25-17; 4:15 pm] BILLING CODE 3510-22-P
    82 208 Monday, October 30, 2017 Proposed Rules NATIONAL CREDIT UNION ADMINISTRATION 12 CFR Part 702 RIN 3133-AE80 Capital Planning and Supervisory Stress Testing AGENCY:

    National Credit Union Administration (NCUA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The NCUA Board (“Board”) proposes to amend its regulations regarding capital planning and stress testing for federally insured credit unions with $10 billion or more in assets (covered credit unions). The proposal would reduce regulatory burden by removing some of the capital planning and stress testing requirements currently applicable to certain covered credit unions. The proposal would also make the NCUA's capital planning and stress testing requirements more efficient for covered credit unions and the NCUA by, among other things, authorizing credit unions to conduct their own stress tests in accordance with the NCUA's requirements and allowing those credit unions to incorporate the stress test results into their capital plan submissions.

    DATES:

    Comments must be received on or before December 29, 2017.

    ADDRESSES:

    You may submit comments by any of the following methods, but please send comments by one method only:

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

    NCUA Web site: https://www.ncua.gov/regulation-supervision/Pages/rules/proposed.aspx. Follow the instructions for submitting comments.

    Email: Address to [email protected]. Include “[Your name]—Comments on Proposed Rule—Capital Planning and Supervisory Stress Testing” in the email subject line.

    Fax: (703) 518-6319. Use the subject line described above for email.

    Mail: Address to Gerard Poliquin, Secretary of the Board, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314-3428.

    Hand Delivery/Courier: Same as mail address.

    FOR FURTHER INFORMATION CONTACT:

    Technical information: Dale Klein, Senior Financial Analyst—CPST, Office of National Examinations and Supervision, at the above address or telephone (703) 518-6629; or legal information: John H. Brolin, Senior Staff Attorney, Office of General Counsel, at the above address or telephone (703) 518-6540.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In April 2014, the Board issued a final rule requiring capital planning and stress testing for FICUs with assets of $10 billion or more (covered credit unions).1 The NCUA recognizes that covered credit unions present a systemic risk to the National Credit Union Share Insurance Fund (NCUSIF) thereby necessitating that they be subject to more stringent prudential standards than apply to other federally insured credit unions. This approach is consistent with that taken by the Board of Governors of the Federal Reserve System, the Federal Deposit Insurance Corporation, and the Office of the Comptroller of the Currency (the other banking agencies). Capital planning requires covered credit unions to assess their financial condition and risks over the planning horizon under both expected and more adverse conditions. Annual supervisory stress testing has allowed the NCUA to obtain an independent test of these credit unions under stress scenarios. By setting a regulatory minimum stress test capital ratio, the April 2014 final rule requires a covered credit union to take corrective action before it becomes undercapitalized to an extent that it may cause a risk of loss to the NCUSIF.

    1 12 CFR part 702, subpart E; 79 FR 24311 (Apr. 30, 2014).

    In July 2015, the Board amended the NCUA's capital planning and stress testing regulation to align its annual planning and testing schedule with the timelines being adopted by the other banking agencies. Among the reasons for this schedule change was that the NCUA's stress test scenarios are based on the supervisory stress test scenarios developed by the other banking agencies for their regulated institutions. The other banking agencies changed their schedule for publishing scenarios, which precipitated the modification of the NCUA's supervisory stress testing schedule.

    Based on the other banking agencies' experiences implementing the annual Dodd-Frank Act stress tests (DFAST), the NCUA tiered its own capital planning expectations for covered credit unions during the first three years of its program. By “tiered,” we mean that the NCUA aligned its capital planning and analysis expectations based on the size, complexity, and financial condition of each covered credit union. As the Board expected, credit union capital planning practices have evolved over the three-year period since 2014. Covered credit unions, consistent with their size, complexity, financial condition, have operated under the NCUA's tiered supervisory expectations. The Board believes that taking a graduated supervisory approach to capital planning has been beneficial for credit unions, and is consistent with the NCUA's overall supervisory objectives.

    When the NCUA's current capital planning and stress testing rule was adopted in April 2014, the Board believed it was important for the agency to initially conduct all stress tests to ensure the NCUA had an independent assessment of risk for covered credit unions.2 Current § 702.506(c) provides, however, that after the NCUA has completed three consecutive supervisory stress tests of a covered credit union, the covered credit union may, with the NCUA's approval, conduct the tests described in subpart E of part 702. The preamble to the April 2014 final rule also states that the April 2014 final rule was not the end of the process on stress testing, but just the beginning.3 Accordingly, after three productive and informative years of practical experience implementing the current capital planning and stress testing regulations, the Board now believes it is appropriate for the NCUA to revisit those regulations.

    2 79 FR 24311, 24312 (Apr. 30, 2014).

    3Id.

    II. Summary of the Proposed Rule

    The Board is proposing to amend the NCUA's capital planning and stress testing regulations. The proposed changes reflect the NCUA's experiences in implementing the current rule's requirements, while also taking into consideration the systemic risk that covered credit unions pose to the NCUSIF. As explained in more detail below, these proposed changes are intended to reduce regulatory burdens by removing some of the more onerous capital planning and stress testing requirements currently applicable to covered credit unions.

    The proposed changes to the NCUA's capital planning requirements would more closely align the agency's regulatory requirements with its current supervisory expectations for covered credit unions. Under the proposal, covered credit unions would be subject to new tiered regulatory requirements that would further ensure their capital plans are tailored to reflect their size, complexity, and financial condition. For a tier I credit union, which is a covered credit union that has completed fewer than three capital planning cycles and has less than $20 billion in total assets, review of its capital plan would be incorporated into the NCUA's supervisory oversight of that covered credit union. For a tier II credit union, which is a covered credit union that has completed three or more capital planning cycles and has less than $20 billion in total assets, or is otherwise designated as a tier II credit union by the NCUA, review of its capital plan also would be incorporated into its supervisory oversight from the NCUA. For a tier III credit union, which is a covered credit union that has $20 billion or more in total assets, or is otherwise designated as a tier III credit union by the NCUA, review of its capital plan would continue to be subject to the current requirement that the NCUA formally approve or reject it.

    Stress testing requirements under the proposal also would be tiered. Tier I credit unions would not be subject to any stress testing requirements. Once a tier I credit union satisfies the criteria for becoming a tier II credit union, which generally would be three years after it reaches total assets of $10 billion or more, that covered credit union would be required to conduct stress testing. Unlike their larger counterparts in tier III, however, tier II credit unions would not be subject to a 5% minimum stress test capital threshold. Further, under the proposal, the NCUA would no longer conduct the annual supervisory stress tests on applicable covered credit unions. Rather, the covered credit unions themselves would conduct the stress tests. Since stress testing standards were first adopted in 2014, the NCUA has conducted annual supervisory stress tests on all covered credit unions.

    While the Board recognizes that all covered credit unions are of systemic importance to the NCUSIF, the Board it is appropriate to differentiate the capital planning requirements applicable to such institutions based on their individual characteristics. Specifically, size, complexity, and financial condition are significant determinants regarding each covered credit union's risk to the NCUSIF, as well as to each covered credit union's ability to support sound capital planning and supervisory stress testing expectations. The application of the NCUA's capital planning and stress testing requirements defined by size, complexity, and financial condition would provide certain covered credit unions with a more reasonable period of time over which they can develop the policies and processes necessary to develop sound capital plans and analyses. However, the Board seeks comments on whether these characteristics are the appropriate factors, or whether other considerations should also be taken into account in assessing risk for purposes of differentiating capital planning and stress testing requirements.

    As noted above, all covered credit unions pose a degree of systemic risk to the NCUSIF and the credit union industry. This proposal, however, seeks to balance the higher risk that the larger, more complex covered credit unions may pose to the NCUSIF, with the time and resources these institutions need to prepare themselves to meet the NCUA's capital planning and supervisory stress testing expectations. The Board also seeks to tailor the NCUA's capital planning and stress testing requirements in such a manner as to reduce the regulatory burden imposed on those smaller covered credit unions which pose less risk to the NCUSIF.

    Proposed Tiers of Covered Credit Unions

    The proposal identifies three tiers of covered credit unions and would impose varying levels of regulatory requirements based on those tiers. In brief, the tier comprised of the smallest covered credit unions would have the least regulatory requirements, with a concomitant increase in requirements for each tier as the size and complexity of those covered credit unions increases. The three tiers are as follows:

    • A tier I credit union would be a covered credit union that has completed fewer than three capital planning cycles and has less than $20 billion in total assets;

    • A tier II credit union would be a covered credit union that has completed three or more capital planning cycles and has less than $20 billion in total assets, or is otherwise designated as a tier II credit union by the NCUA; and

    • A tier III credit union would be a covered credit union that has $20 billion or more in total assets, or is otherwise designated as a tier III credit union by the NCUA.

    Under the proposal, the level of the NCUA's capital planning requirements for tier I and tier II credit unions would generally decrease from the current regulatory requirements, but would generally remain the same for tier III credit unions. This proposed approach would reduce regulatory burdens on tier I and tier II credit unions while allowing them to focus on establishing sound capital planning and capital adequacy assessment processes. The tier III credit unions, on the other hand, which may pose the greatest systemic risk to the NCUSIF and which are most capable of complying with the current requirements, would remain subject to most of the current requirements. The Board seeks specific comments on whether this approach is appropriate and whether it sufficiently balances regulatory relief for covered credit unions with the NCUA's objective of managing risk to the NCUSIF.

    Under the proposal, the NCUA's capital planning and stress testing rule would distinguish between a tier II and a tier III credit union at the threshold level of $20 billion in total assets. Setting the threshold level at $20 billion would mean that a covered credit union would generally not be subject to the regulation's most rigorous requirements until it had doubled in size from the time it was first classified as a covered credit union. Setting the threshold at this level should help ensure that covered credit unions have adequate time to plan and prepare for compliance. The Board specifically requests comment, however, on whether the threshold level should be set higher, at $25 billion in total assets, to provide covered credit unions with even more time to plan and prepare for compliance. In addition, the Board requests comment on whether setting the threshold at this higher level would be reasonable and why.

    Proposed Revisions to the NCUA's Capital Planning Requirements

    This proposal would retain the current requirement that all covered credit unions submit capital plans to the NCUA no later than May 31st of each year. Tier 1 and tier II credit unions, however, would no longer be required to have their capital plans formally approved by the NCUA. Capital plan reviews for tier I and tier II credit unions would be conducted as part of the NCUA's supervision of the credit union, with any deficiencies addressed as part of the supervisory process. This approach would provide the NCUA greater latitude when reviewing capital plan submissions. This proposed change is also intended to provide the NCUA with additional flexibility to use the supervisory process to address plan deficiencies, especially for credit unions newly covered by the NCUA's capital planning requirements. The Board believes that any increased risk to the NCUSIF that may occur as a result of providing regulatory relief can be addressed through the supervisory process.

    This proposal would retain the current requirement for the NCUA to formally approve or reject a tier III credit union's capital plan. Because the failure of a tier III credit union poses the most significant risk to the NCUSIF, the Board believes it is prudent to retain the current, more formal requirements for tier III credit unions.

    The NCUA's formal rejection of a capital plan would be subject to the Supervisory Review Committee process. The Board specifically requests comment on this aspect of the proposal.

    Proposed Revisions to the NCUA's Supervisory Stress Testing Requirements

    Credit Union-Conducted Stress Tests. Under the current rule, the NCUA is required to conduct supervisory stress tests for all covered credit unions. When the Board approved the current regulation in 2014, it believed the agency should initially conduct all stress tests to ensure the NCUA had an independent assessment of risk for covered credit unions. The preamble to the final rule acknowledged, however, that it might be appropriate in the future for certain covered credit unions to conduct their own supervisory stress tests, and the Board adopted a provision in the final rule to allow for that. In particular, current § 702.506(c) provides that after the NCUA has completed three consecutive supervisory stress tests of a covered credit union, the covered credit union may, with the NCUA's approval, conduct the tests described in subpart E of part 702 on its own. Having now completed three annual stress testing cycles, the Board believes that changing the NCUA's regulations to have covered credit unions conduct their own supervisory stress tests, without needing to obtain approval from the NCUA, is appropriate. Accordingly, under the proposal, the requirement that the NCUA conduct supervisory stress tests would be eliminated.

    The Board believes that credit unions are better informed of risk when they perform their own capital analyses. Having covered credit unions conduct their own supervisory stress tests also eliminates any unintentional, negative consequences that could result from the NCUA conducting those tests, namely concerns that a covered credit union might abdicate its responsibility to perform rigorous capital analyses to the NCUA. As a safeguard, however, the proposal would retain the provision in the current rule that reserves the NCUA's right to conduct the stress tests on any covered credit union at any time, and to request qualitative and quantitative information from the covered credit unions that pertains to supervisory stress testing.

    Incremental Approach. Running a supervisory stress test requires internal controls that enable the credit union to effectively challenge all material aspects of its capital planning and analysis. For a covered credit union to develop the ability to obtain, cleanse, and manage internal and external data, and perform adequate capital analyses, it must possess a level of experience and operational scale that is unlikely to be in place or quickly developed by a credit union when it first reaches the $10 billion threshold. Accordingly, the Board is proposing to adopt an incremental regulatory approach to supervisory stress testing that would gradually increase regulatory requirements on a covered credit union over time without making the requirements too burdensome too soon.

    Table 1—Incremental Approach Tier Description Stress test Capital plan review I First three years Not required Incorporated as part of the NCUA's supervisory oversight. II 3 years or more, but less than $20 billion in total assets Credit unions run stress tests using the NCUA stress-test scenarios and NCUA guidance, but are not subject to the 5% minimum stress-test ratio Incorporated as part of the NCUA's supervisory oversight. III $20 billion or more in total assets Credit unions run stress tests using the NCUA stress-test scenarios and NCUA guidance, and are subject to the 5% minimum stress-test ratio The NCUA accepts or rejects credit union capital plans—qualitative and quantitative assessment.

    Tier I. Under the proposal, a tier I credit union would not be subject to any supervisory stress testing requirements, nor would it be required to incorporate the NCUA's stress test scenarios within its capital plan. This proposed approach would allow a tier I credit union time after it reaches the $10 billion threshold level to obtain the policies and processes necessary to develop sound capital plans and analyses prior to incorporating supervisory stress testing. Once the tier I credit union satisfies the tier II criteria, which generally would be three years after reaching the $10 billion threshold, it would then be required to comply with all tier II requirements described below.

    Tier II. This proposal would require a tier II credit union to incorporate the NCUA's annual stress test scenarios into its capital plan submissions. The Board does not believe this particular requirement imposes additional regulatory burden on a tier II credit union because, as the NCUA has observed over the last three years of implementing the stress testing regulations, covered credit unions already incorporate the NCUA's supervisory stress testing scenarios into their capital plans even though they are not required to do so under the current rule.

    Tier III. The proposal would require a tier III credit union to incorporate the NCUA's stress test scenarios into its capital plan. Because a tier III credit union poses the greatest level of systemic risk to the NCUSIF, it must also submit a plan to build capital or mitigate the risk if the credit union shows that its stress test capital ratio would fall below the 5% minimum stress test capital threshold. This is consistent with the supervisory stress testing requirements in current § 702.506(c).

    The proposal would apply the tier III threshold of $20 billion as of the March 31 measurement date of each year, and the threshold would be effective at the beginning of the next capital planning cycle. The capital planning cycle would begin on June 1 of that year and run through the capital plan submission date of May 31 of the following year.

    Web site Instructions. If the Board adopts a final rule on this matter, the NCUA will publish on its Web site instructions for tier II and tier III credit unions on how to administer their own supervisory stress tests. The Board believes that a covered credit union's ability to maintain independence and flexibility is essential to the overall success of the NCUA's supervisory stress testing program. Accordingly, under the proposal, tier II and tier III credit unions would be required to conduct their own stress tests in accordance with the instructions provided by the NCUA. The standards for conducting the tests would differ for tier II and tier III credit unions and would be commensurate with their level of systemic risk to the NCUSIF.

    Conforming and Clarifying Amendments. Finally, the proposal would also make a number of minor conforming and clarifying amendments to the current rule. These conforming and clarifying amendments would include removing, changing, and adding certain definitions, and making other small amendments to various provisions in subpart E to part 702.

    The proposed changes outlined above are discussed in more detail in the Section-by-Section Analysis below.

    III. Legal Authority

    The NCUA is issuing this proposal pursuant to its authority under the Federal Credit Union Act (FCUA).4 Section 120(a) of the FCUA authorizes the Board to “prescribe rules and regulations for the administration of” the FCUA.5 Section 204 of the FCUA authorizes the Board, through its examiners, “to examine any [federally] insured credit union . . . to determine the condition of any such credit union for insurance purposes.” 6 Section 206(e) of the FCUA authorizes the Board to take certain actions against a federally insured credit union, if, in the opinion of the Board, the credit union “is engaging or has engaged, or the Board has reasonable cause to believe that the credit union or any institution affiliated party is about to engage, in any unsafe or unsound practice in conducting the business of such credit union.” 7

    4 12 U.S.C. 1751 et seq.

    5 12 U.S.C. 1766(a).

    6 12 U.S.C. 1784(a).

    7 12 U.S.C. 1786(e).

    IV. Section-by-Section Analysis

    This proposed rule would retain most of the current language in subpart E of part 702. In particular, current §§ 702.501, and 702.503 would remain unchanged under this proposal. The proposed changes to §§ 702. 502, 702.504, 702.505, and 702.506 are described and explained in more detail below.

    Section 702.502 Definitions

    The proposal would retain most of the definitions from current § 702.502, without change, with the following exceptions.

    Adverse Scenario

    The proposal would remove the definition of “adverse scenario” from § 702.502 and replace this term throughout subpart E with terms more commonly used within the financial services industry. This change is intended to reduce confusion for covered credit unions. No substantive changes to the requirements of subpart E are intended by this change.

    Capital Planning Cycle

    The proposal would add a definition for the new term “capital planning cycle” to § 702.502. The proposal would provide that “capital planning cycle” means a complete round of capital planning over a one year period. The definition would provide further that the capital planning cycle begins on June 1st of a given year and ends on May 31st of the following year when the capital plan submission is due. This change is intended to reduce confusion for covered credit unions regarding when they would be subject to certain stress testing and other requirements, which are discussed in more detail below.

    Covered Credit Union

    The proposal would make conforming amendments to the current definition of “covered credit union” in § 702.502. In particular, the proposed definition would remove the words “capital planning and stress testing” from the second sentence in the definition and add in their place the word “applicable.” The proposed definition would provide that “covered credit union” means a federally insured credit union whose assets are $10 billion or more. The definition would provide further that a credit union that crosses that asset threshold as of March 31st of a given calendar year is subject to the applicable requirements of subpart E in the capital planning cycle that begins on June 1st of that calendar year. As explained in more detail below, this change would help clarify that a covered credit union is only subject to the applicable requirements of subpart E.

    Scenarios

    The proposal would make conforming amendments to the current definition of “scenarios” in § 702.502. In particular, the proposal would remove the words “adverse, and severely adverse” from the current definition and add in their place the words “scenarios, and stress.” The revised definition would provide that “scenarios” are those sets of conditions that affect the U.S. economy or the financial condition of a covered credit union that serve as the basis for stress testing, including, but not limited to, NCUA-established baseline scenarios, and stress scenarios.

    Severely Adverse Scenario

    The proposal would delete the definition of “severely adverse scenario” from § 702.502 and replace this term throughout subpart E with terms more commonly used within the financial services industry. This change is intended to reduce confusion for covered credit unions. No substantive changes to the requirements of subpart E are intended by this change.

    Stress Scenario

    The proposal would add the definition “stress scenario” to § 702.502. The definition would provide that “stress scenario” means a scenario that is more adverse than that associated with the baseline scenario.

    Tier I Credit Union

    The proposal would add the definition of “tier I credit union” to § 702.502. The definition would provide that “tier I credit union” means a covered credit union that has completed fewer than three capital planning cycles and has less than $20 billion in total assets. Generally, a covered credit union would be categorized as a tier I credit union for the first three years after its total assets reached $10 billion or more. After three years, a tier I credit union would become a tier II credit union with the corresponding requirements.

    The definition of a tier I credit union would provide regulatory relief for qualifying covered credit unions. The Board believes it is appropriate to adjust the expectations for credit unions that newly meet the criteria for covered credit unions. As noted earlier, the NCUA has conducted the review and assessment of covered credit union capital planning activities in a phased manner since inception of the final rule in 2014. The proposed creation of the tier I distinction would allow the NCUA to better align regulatory expectations based on the size, complexity, and financial condition of each covered credit union.

    Tier II Credit Union

    The proposal would add the definition of “tier II credit union” to § 702.502. The definition would provide that “tier II credit union” means a covered credit union that has completed three or more capital planning cycles and has less than $20 billion in total assets, or is otherwise designated as a tier II credit union by NCUA. The tier II credit union definition would recognize the iterative nature of the NCUA's capital planning and stress testing processes, and acknowledge that covered credit unions get better at developing and implementing their capital plans over time and through repetition. The Board believes these proposed changes would provide regulatory relief for tier II credit unions.

    Tier III Credit Union

    The proposal would add the definition of “tier III credit union” to § 702.502. The definition would provide that “tier III credit union” means a covered credit union that has $20 billion or more in total assets, or is otherwise designated as a tier III credit union by NCUA. The proposal identifies credit unions with total assets of $20 billion or more as posing the highest degree of risk to the NCUSIF. While the Board considers qualitative and quantitative capital plan supervision and credit union-run stress test review to be appropriate for covered credit unions with less than $20 billion in total assets, it does not for larger covered credit unions. For covered credit unions with total assets of $20 billion or more, the Board believes it is prudent, given the size of the NCUSIF and the potential loss associated with the failure of a credit union that large, to establish formal triggers requiring the NCUA and credit union actions to further mitigate NCUSIF risk exposure.

    Unless otherwise delegated to the NCUA's staff, the Board would retain the authority to designate a covered credit union as a tier II credit union or tier III credit union, respectively. The Board invites comment on what criteria would be appropriate to apply when considering such a designation.

    Section 702.504 Capital Planning (a) Annual Capital Planning (a)(1)

    The proposal would retain most of current § 702.504 without change, with the following exceptions. Proposed § 702.504(a)(1) would no longer include the last sentence in current § 702.504(a)(1), which provides that the NCUA will assess whether the capital planning and analysis process is sufficiently robust in determining whether to accept a credit union's capital plan. Given the other changes in this proposal, this sentence would no longer be necessary. Proposed § 702.504(a)(1) would provide that a covered credit union must develop and maintain a capital plan. It also would provide that a covered credit union must submit this plan and its capital policy to the NCUA by May 31 each year, or such later date as directed by the NCUA. It also would provide that the plan must be based on the covered credit union's financial data as of December 31 of the preceding calendar year, or such other date as directed by the NCUA.

    (b) Mandatory Elements (b)(4)

    The proposal would delete current § 702.504(b)(4) from the regulation. Current § 702.504(b)(4) provides that if a credit union conducts its own stress test under § 702.506(c), its capital plan must include a discussion of how the credit union will maintain a stress test capital ratio of 5 percent or more under baseline, adverse, and severely adverse conditions in each quarter of the 9-quarter horizon. This sentence would no longer be necessary in this section because it would be fully addressed in proposed § 702.506(f).

    Section 702.505 NCUA Action on Capital Plans (a) Timing

    The proposal would amend current § 702.505(a) by dividing paragraph (a) into two subparts. Proposed § 702.505(a)(1) would provide that the NCUA will address any deficiencies in the capital plans submitted by tier I and tier II credit unions through the supervisory process. The intent of this change is to provide regulatory relief to tier I and tier II credit unions by removing the regulatory review and regulatory “accept or reject” assessment of their capital plans. It also provides the NCUA with additional flexibility in addressing plan deficiencies.

    Proposed § 702.505(a)(2) would continue to require that the NCUA accept or reject tier III credit unions' capital plans. The Board is not proposing to remove this requirement for Tier III credit unions at this time for the reasons discussed above. Accordingly, proposed § 702.505(a)(2) would provide that the NCUA will notify tier III credit unions of the acceptance or rejection of their capital plans by August 31 of the year in which their plan is submitted.

    The proposal also would make additional conforming changes throughout § 702.505 to clarify that only tier III credit unions would be required to operate under a capital plan formally accepted by the NCUA. No substantive changes, other than those discussed above, are intended.

    Section 702.506 Annual Supervisory Stress Testing

    Much of the substance of current § 702.506 would remain unchanged under the proposal. Each of the proposed substantive amendments are discussed in detail below. The proposal also would make a number of non-substantive conforming amendments to address certain changes in terminology.

    (a) General Requirements

    The proposal would amend current § 702.506(a) by adding a new clarifying sentence to the beginning of proposed paragraph (a). The new sentence would provide that only tier II and tier III credit unions are required to conduct supervisory stress tests. The Board believes that exempting tier I credit unions from supervisory stress testing provides prudent regulatory relief and enables tier I credit union time to develop their own capital adequacy assessments. The Board considers the supervisory stress testing exemption for tier I credit unions, which generally would be three years, after which the tier I credit union becomes a tier II credit union, to be sufficient time to develop internal capabilities to perform credit union-run supervisory stress tests.

    NCUA-Run Tests

    The proposal would delete current § 702.506(b), which, because of the other changes being proposed to part 702, would be overridden. The NCUA already reserves, in proposed § 702.506(b)(3), the right to conduct stress tests on covered credit unions if it deems such action necessary.

    (b) Credit Union-Run Supervisory Stress Tests

    The proposal would make significant revisions to current § 702.506(c) to require tier II and tier III credit unions to conduct their own stress tests instead of first having to get approval from the NCUA. Proposal § 702.506(b) would be split into three new subparagraphs, each of which is described in more detail below.

    (b)(1) General

    Proposed § 702.506(b)(1) would provide that all supervisory stress tests must be conducted according to the NCUA's instructions. The Board is proposing to add this requirement to ensure that supervisory stress tests performed by tier II and tier III credit unions are conducted in a manner that promotes consistency and comparability. Credit union-run stress tests must adhere to these principles in order for the NCUA to assess inherent risk in the portfolios of covered credit unions and establish supervisory benchmarks. The NCUA will publish credit union-run supervisory stress test instructions each year on its Web site. The instructions will contain general directives, and where appropriate, differentiate between tier II and tier III requirements.

    (b)(2) Tier III Credit Unions

    Proposed § 702.506(b)(2) would provide that when conducting its stress test, a tier III credit union must apply the minimum stress test capital ratio to all time periods in the planning horizon. The Board believes this requirement of the current remains pertinent, but only for tier III credit unions.

    (b)(3) NCUA Tests

    Proposed § 702.506(b)(3) would retain the last two sentences in current § 702.506(c), without change. Proposed § 702.506(b)(3) would provide that the NCUA reserves the right to conduct the tests described in this section on any covered credit union at any time. Proposed paragraph (b)(3) would provide further that where both the NCUA and a covered credit union have conducted the tests, the results of the NCUA's tests will determine whether the covered credit union has met the requirements of part 702. No substantive changes are being proposed with regard to these two sentences.

    (f) Supervisory Actions

    The proposal would retain much of the language in current § 702.506(g), but would insert some additional language. The section would also be broken into three subsections, each of which is discussed in more detail below.

    (f)(1)

    Proposed § 702.506(f)(1) would provide that if a credit union-run stress test shows a tier III credit union does not have the ability to maintain a stress test capital ratio of 5 percent or more under expected and stressed conditions in each quarter of the planning horizon, the credit union must incorporate into its capital plan a stress test capital enhancement plan showing how it will meet that target.

    (f)(2)

    This section of the proposal would retain the language from the first sentence in current § 702.506(g) and limit the application of paragraph (f)(2) to tier III credit unions. Proposed paragraph (f)(2) would provide that if an NCUA-run stress test shows that a tier III credit union does not have the ability to maintain a stress test capital ratio of 5 percent or more under expected and stressed conditions in each quarter of the planning horizon, the credit union must provide the NCUA, by November 30 of the calendar year in which the NCUA conducted the tests, a stress test capital enhancement plan showing how it will meet that target. As explained above, the NCUSIF risk exposure to a tier I and tier II credit union is sufficiently mitigated through qualitative and quantitative supervision of the credit union's capital planning and capital adequacy analysis. Accordingly, the proposed rule offers regulatory relief as tier 1 and tier II credit unions would no longer be subject to the minimum stress test capital ratio.

    (f)(3)

    This section of the proposal would retain the language in the last sentence in current § 702.506(g) and move it to proposed § 702.506(f)(3). The proposal also would limit the application of this section to only tier III credit unions. Proposed § 702.506(f)(3) would provide that a tier III credit union operating without an NCUA-approved stress test capital enhancement plan required under this section may be subject to supervisory action. A tier III credit union operating without an accepted capital plan or an approved stress test capital enhancement plan will be considered poorly managed and/or operating with insufficient capital to support the credit union's risk profile. The Board believes it is prudent to subject a tier III credit union to heightened regulatory scrutiny under such circumstances.

    IV. Regulatory Procedures 1. Regulatory Flexibility Act

    The Regulatory Flexibility Act requires the NCUA to prepare an analysis of any significant economic impact any proposed regulation may have on a substantial number of small entities (primarily those under $100 million in assets).8 The proposed rule and its requirements will apply to only the largest credit unions, those with $10 billion or more in total assets. Accordingly, the Board certifies that it will not have a significant economic impact on a substantial number of small entities.

    8 5 U.S.C. 603(a); 12 U.S.C. 1787(c)(1).

    2. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (PRA) applies to rulemakings in which an agency by rule creates a new paperwork burden on regulated entities or modifies an existing burden (44 U.S.C. 3507(d)). For purposes of the PRA, a paperwork burden may take the form of a reporting, recordkeeping, or a third-party disclosure requirement, referred to as information collections.

    The NCUA is seeking comments on proposed revisions to the information collection requirements contained in Subpart E of part 702, which has been submitted to the Office of Management and Budget (OMB) for review and approval OMB control number 3133-0199. The information collection requirements are found in § 702.504, that requires FICUs with assets of at least $10 billion (covered credit unions) to develop, maintain, and submit capital plans annually to NCUA. Proposed change amend § 702.506 to require tier 2 and 3 credit unions to conduct stress tests in a manner prescribed by NCUA. This reporting requirement will have an effect on five credit unions by increasing the information collection burden by an estimated 100 hours for each.

    Estimated number of respondents: 7.

    Estimated number of responses per respondent: 1.

    Estimated total annual responses: 7.

    Estimated burden per response: 393 hours.

    Total annual burden: 2,750 hours.

    Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) 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 on the proposed information collection requirements may be sent to the 1. Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for NCUA, New Executive Office Building, Room 10235, Washington, DC 20503, or email at [email protected] and 2. NCUA PRA Clearance Officer, 1775 Duke Street, Alexandria, VA 22314, Suite 5067, or email at [email protected]

    3. Executive Order 13132

    Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. The NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order to adhere to fundamental federalism principles. The proposed rule does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. The Board has, therefore, determined that this proposal does not constitute a policy that has federalism implications for purposes of the executive order.

    4. Assessment of Federal Regulations and Policies on Families

    The Board has determined that this proposed rule will not affect family well-being within the meaning of § 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, 112 Stat. 2681 (1998).

    List of Subjects in 12 CFR Part 702

    Credit unions, Reporting and record keeping requirements.

    By the National Credit Union Administration Board, on October 19, 2017. Gerard Poliquin, Secretary of the Board.

    For the reasons discussed above, the National Credit Union Administration proposes to amend 12 CFR part 702 as follows:

    PART 702—CAPITAL ADEQUACY 1. Revise the authority citation for part 702 to read as follows: Authority:

    12 U.S.C. 1766(a), 1784(a), 1786(e), 1790d.

    Subpart E—Capital Planning and Stress Testing 2. Amend § 702.502 as follows: a. Remove the definition of “adverse scenario”; b. Add the definition of “capital planning cycle”; c. Remove from the definition of “covered credit union” the words “capital planning and stress testing” and add in their place the word “applicable”; d. Remove from the definition of “scenarios” the words “adverse and severely adverse” and add in their place the words “scenarios and stress”; e. Remove the definition of “severely adverse scenario”; f. Add the definition of “stress scenario”; and g. Add the definitions of “tier I credit union”, “tier II credit union”, and “tier III credit union”.

    The additions and revisions read as follows:

    § 702.502 Definitions.

    Capital planning cycle means a complete round of capital planning over a one year period. The capital planning cycle begins on June 1 of a calendar year and ends on May 31, the capital plan submission date, of the following calendar year.

    Stress scenario means a scenario that is more adverse than that associated with the baseline scenario.

    Tier I credit union means a covered credit union that has completed fewer than three capital planning cycles and has less than $20 billion in total assets.

    Tier II credit union means a covered credit union that has completed three or more capital planning cycles and has less than $20 billion in total assets, or is otherwise designated as a tier II credit union by NCUA.

    Tier III credit union means a covered credit union that has $20 billion or more in total assets, or is otherwise designated as a tier III credit union by NCUA.

    § 702.504 [Amended]
    3. Amend § 702.504 as follows: a. Remove the last sentence in paragraph (a)(1); b. Remove paragraph (b)(4); and c. Redesignate paragraphs (b)(5) and (6) as paragraphs (b)(4) and (5), respectively. 4. Amend § 702.505 as follows: a. Revise paragraph (a); b. In paragraph (d) introductory text, add the words “tier III” before the words “credit union's capital plan,”; and c. In paragraph (e), remove the word “covered” and add in its place the words “tier III”.

    The revision reads as follows:

    § 702.505 NCUA action on capital gains.

    (a) Timing—(1) Tier I & tier II credit unions. NCUA will address any deficiencies in the capital plans submitted by tier I and tier II credit unions through the supervisory process.

    (2) Tier III credit unions. NCUA will notify tier III credit unions of the acceptance or rejection of their capital plans by August 31 of the year in which their plan is submitted.

    5. Section 702.506 is revised to read as follows:
    § 702.506 Annual supervisory stress testing.

    (a) General requirements. Only tier II and tier III credit unions are required to conduct supervisory stress tests. The supervisory stress tests consist of a baseline scenario, and stress scenarios, which NCUA will provide by February 28 of each year. The tests will be based on the credit union's financial data as of December 31 of the preceding calendar year, or such other date as directed by NCUA. The tests will take into account all relevant exposures and activities of the credit union to evaluate its ability to absorb losses in specified scenarios over a planning horizon. The minimum stress test capital ratio is 5 percent.

    (b) Credit union-run supervisory stress tests—(1) General. All supervisory stress tests must be conducted according to NCUA's instructions.

    (2) Tier III Credit Unions. When conducting its stress test, a tier III credit union must apply the minimum stress test capital ratio to all time periods in the planning horizon.

    (3) NCUA tests. NCUA reserves the right to conduct the tests described in this section on any covered credit union at any time. Where both NCUA and a covered credit union have conducted the tests, the results of NCUA's tests will determine whether the covered credit union has met the requirements of this subpart.

    (c) Potential impact on capital. In conducting stress tests under this subpart, NCUA or the credit union will estimate the following for each scenario during each quarter of the planning horizon:

    (1) Losses, pre-provision net revenues, loan and lease loss provisions, and net income; and

    (2) The potential impact on the stress test capital ratio, incorporating the effects of any capital action over the planning horizon and maintenance of an allowance for loan losses appropriate for credit exposures throughout the horizon. NCUA or the credit union will conduct the stress tests without assuming any risk mitigation actions on the part of the credit union, except those existing and identified as part of the credit union's balance sheet, or off-balance sheet positions, such as derivative positions, on the date of the stress test.

    (d) Information collection. Upon request, the credit union must provide NCUA with any relevant qualitative or quantitative information requested by NCUA pertinent to the stress tests under this subpart.

    (e) Stress test results. A credit union required to conduct stress tests under this section must incorporate the results of its tests in its capital plan.

    (f) Supervisory actions. (1) If a credit union-run stress test shows a tier III credit union does not have the ability to maintain a stress test capital ratio of 5 percent or more under expected and stressed conditions in each quarter of the planning horizon, the credit union must incorporate, into its capital plan, a stress test capital enhancement plan that shows how it will meet that target.

    (2) If an NCUA-run stress test shows that a tier III credit union does not have the ability to maintain a stress test capital ratio of 5 percent or more under expected and stressed conditions in each quarter of the planning horizon, the credit union must provide NCUA, by November 30 of the calendar year in which NCUA conducted the tests, a stress test capital enhancement plan showing how it will meet that target.

    (3) A tier III credit union operating without an NCUA approved stress test capital enhancement plan required under this section may be subject to supervisory actions.

    (g) Consultation on proposed action. Before taking any action under this section against a federally insured, state-chartered credit union, NCUA will consult and work cooperatively with the appropriate State official.

    [FR Doc. 2017-23212 Filed 10-27-17; 8:45 am] BILLING CODE 7535-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 170828813-7813-01] RIN 0648-BH15 Snapper-Grouper Fishery of the South Atlantic Region; Temporary Measures To Reduce Overfishing of Golden Tilefish AGENCY:

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

    ACTION:

    Proposed temporary rule; request for comments.

    SUMMARY:

    This proposed temporary rule would implement interim measures to reduce overfishing of golden tilefish in Federal waters of the South Atlantic. Beginning in 2018, this temporary rule would reduce the total annual catch limit (ACL), the commercial and recreational sector ACLs, and the quotas for the hook-and-line and longline components of the commercial sector. This proposed temporary rule would be effective for 180 days, although NMFS may extend the temporary rule's effectiveness for a maximum of an additional 186 days. The intended effect of this proposed temporary rule is to reduce overfishing of golden tilefish while the South Atlantic Fishery Management Council develops long-term management measures.

    DATES:

    Written comments must be received by November 14, 2017.

    ADDRESSES:

    You may submit comments on the proposed temporary rule, identified by “NOAA-NMFS-2017-0111,” by either of the following methods:

    Electronic submission: Submit all electronic public comments via the Federal e-Rulemaking Portal: http://www.regulations.gov. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0111 click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Karla Gore, NMFS Southeast Regional Office, 263 13th Avenue South, St. Petersburg, FL 33701.

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

    Electronic copies of an environmental assessment (EA) supporting these interim measures may be obtained from the Southeast Regional Office Web site at http://sero.nmfs.noaa.gov/sustainable_fisheries/s_atl/sg/2017/golden_tilefish_interim/index.html. The EA includes a Regulatory Flexibility Act (RFA) analysis.

    FOR FURTHER INFORMATION CONTACT:

    Karla Gore, NMFS Southeast Regional Office, telephone: 727-551-5753, or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The snapper-grouper fishery in the South Atlantic region is managed under the Fishery Management Plan for Snapper-Grouper Fishery of the South Atlantic Region (FMP) and includes golden tilefish, along with other snapper-grouper species. The FMP was prepared by the South Atlantic Fishery Management Council (Council) and is implemented by NMFS through regulations at 50 CFR part 622 under authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

    Background

    The Magnuson-Stevens Act requires that NMFS and regional fishery management councils prevent overfishing and achieve, on a continuing basis, the optimum yield from federally managed fish stocks. These mandates are intended to ensure that fishery resources are managed for the greatest overall benefit to the nation, particularly with respect to providing food production and recreational opportunities, and protecting marine ecosystems.

    Golden tilefish are harvested by both commercial and recreational fishermen throughout the South Atlantic, although total landings are dominated by the commercial sector using bottom longline gear. Golden tilefish are also harvested commercially using hook-and-line gear, while the recreational sector harvests at a much lower level than either component of the commercial sector. Using data through 2010, the golden tilefish stock was assessed in 2011 through the Southeast Data, Assessment, and Review (SEDAR) stock assessment process (SEDAR 25). SEDAR 25 results indicated that golden tilefish was not subject to overfishing, and was not overfished. Based upon the results of SEDAR 25, Amendment 18B to the FMP and its implementing final rule allocated the total ACL among the sectors and commercial gear components, and specified the ACLs based upon the allocation percentages, among other actions (78 FR 23858, April 23, 2013). For golden tilefish, 97 percent of the total ACL is allocated to the commercial sector, with 25 percent of the commercial ACL available for harvest by the hook-and-line component and 75 percent available for the longline component. The recreational sector is allocated three percent of the total ACL.

    In April 2016, an update to SEDAR 25 was completed for golden tilefish using data through 2014 (SEDAR 25 Update 2016). The SEDAR 25 Update 2016 indicated that golden tilefish is undergoing overfishing but is not overfished. NMFS notified the Council of the updated stock status determination in a letter dated January 4, 2017. As mandated by the Magnuson-Stevens Act, NMFS and the Council must prepare and implement a plan amendment and regulations to end overfishing of golden tilefish.

    In May 2016, the Council's Scientific and Statistical Committee (SSC) reviewed the SEDAR 25 Update 2016 and provided fishing level recommendations for the stock. The SSC determined that the SEDAR 25 Update 2016 was based on the best scientific information available. The Council received the results of the SEDAR 25 Update 2016 and the SSC recommendations in June 2016, and Council members stated their concern over the large differences in biological benchmarks between SEDAR 25 and the SEDAR 25 Update 2016 and the much lower fishing level recommendations in the SEDAR 25 Update 2016. The Council subsequently requested that the SSC review the SEDAR 25 Update 2016, primarily as a result of their concerns about the socio-economic consequences of the large catch level reductions suggested by the SEDAR 25 Update 2016, and the large buffer recommended between the acceptable biological catch (ABC) and the overfishing limit.

    In May 2017, the SEDAR Steering Committee considered a Council request for another golden tilefish update assessment, which was intended to address the SEDAR 25 Update 2016 concerns raised by the Council and their SSC during their earlier reviews. While an update assessment could not be included in the SEDAR schedule for 2017, the Southeast Fisheries Science Center agreed to revise the SEDAR 25 Update 2016 to address these Council concerns.

    The revised stock assessment for golden tilefish will be reviewed by the SSC at its October 2017 meeting, and the Council is scheduled to discuss the revised assessment results at their December 2017 meeting. The results of the revised assessment will be used to develop Amendment 45 to the FMP, which is intended to end overfishing of golden tilefish with long-term management measures.

    The revised ABC recommendations from the Council's SSC will not be available until late October 2017, which provides insufficient time for the Council and NMFS to develop and implement management measures, respectively, to end overfishing of golden tilefish in time for the start of the 2018 fishing year on January 1, 2018. Therefore, in a letter to NMFS dated June 27, 2017, the Council requested that NMFS implement interim measures to immediately reduce overfishing of golden tilefish while long-term measures can be developed through Amendment 45. For 2018, the Council recommended setting the total ACL at the projected yield at 75 percent of the yield produced by the fishing mortality rate at maximum sustainable yield, which would be 323,000 lb (146,510 kg), gutted weight, 361,760 lb (164,092 kg), round weight. The interim measures in a final temporary rule would be effective for 180 days after the publication date in the Federal Register and may be extended for an additional 186 days. If NMFS does not extend the proposed interim measures beyond 180 days, the total and sector ACLs, as well as the quotas for the hook-and-line and longline components of the commercial sector would revert to their current values.

    Management Measures Contained in This Proposed Temporary Rule

    During the effectiveness of this proposed temporary rule in 2018, the total ACL for golden tilefish would be 323,000 lb (146,510 kg), gutted weight, 361,760 lb (164,092 kg), round weight. This proposed temporary rule would also specify the commercial and recreational sector ACLs and component commercial quotas using the existing sector allocations of 97 percent commercial and 3 percent recreational, as well as 25 percent of the commercial ACL available for the hook-and-line component and 75 percent available for the longline component. Therefore, during the effectiveness of this proposed temporary rule in 2018, the commercial ACL would be 313,310 lb (142,115 kg), gutted weight. The commercial quota for the hook-and-line component would be 78,328 lb (35,529 kg), gutted weight, and the commercial quota for the longline component would be 234,982 lb (106,586 kg), gutted weight. The recreational ACL during the effectiveness of this proposed temporary rule in 2018 would be 2,187 fish, which is equivalent to 9,690 lb (4,395 kg), gutted weight.

    The temporary reductions in the ACLs could result in earlier in-season closures particularly for the commercial sector. The earlier closures would likely result in short-term adverse socio-economic effects. However, the temporary ACLs and quotas are expected to minimize future adverse socio-economic effects by potentially reducing future reductions in the ACLs and quotas required to end overfishing through Amendment 45. The temporary ACLs and quotas would also provide biological benefits to the golden tilefish stock by reducing the current levels of fishing mortality.

    Future Action

    NMFS has determined that this proposed temporary rule is necessary to reduce overfishing of golden tilefish in the South Atlantic. NMFS will consider all public comments received on this proposed temporary rule in determining whether to proceed with a final temporary rule and, if so, whether any revisions to the final temporary rule would be appropriate. If NMFS issues a final temporary rule, it would be effective for not more than 180 days after the date of publication in the Federal Register, as authorized by section 305(c) of the Magnuson-Stevens Act. The final temporary rule could be extended if NMFS publishes a temporary rule extension in the Federal Register for up to an additional 186 days, provided that the public has had an opportunity to comment on the rule, such as through this proposed temporary rule.

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed temporary rule is consistent with the Magnuson-Stevens Act, and other applicable laws, subject to further consideration after public comment.

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

    NMFS prepared an initial regulatory flexibility analysis (IRFA) for this proposed temporary rule, as required by section 603 of the RFA, 5 U.S.C. 603. The IRFA describes the economic impact that this proposed temporary rule, if implemented, would have on small entities. A description of this proposed temporary rule, why it is being considered, and the objectives of, and legal basis for this proposed temporary rule are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble. A copy of the full analysis is available from the NMFS (see ADDRESSES). A summary of the IRFA follows.

    The Magnuson-Stevens Act provides the statutory basis for this rule. No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this proposed temporary rule. Accordingly, this rule does not implicate the Paperwork Reduction Act.

    This proposed temporary rule, if implemented, would be expected to directly affect all commercial vessels that harvest South Atlantic golden tilefish under the FMP. The change in recreational ACL in this proposed temporary rule would not directly apply to or regulate charter vessel and headboat (for-hire) businesses. Any impact to the profitability or competitiveness of for-hire fishing businesses would be the result of changes in for-hire angler demand and would therefore be indirect in nature. The RFA does not consider recreational anglers, who would be directly affected by this proposed temporary rule, to be small entities, so they are outside the scope of this analysis and only the effects on commercial vessels were analyzed. For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide.

    As of August 10, 2017, there were 544 vessels with valid or renewable Federal South Atlantic snapper-grouper unlimited permits, 114 valid or renewable 225-lb trip limited permits, and 22 golden tilefish longline endorsements. The golden tilefish longline endorsement system started in 2013. From 2012 through 2016, an average of 23 longline vessels per year landed golden tilefish in the South Atlantic. These vessels, combined, averaged 255 trips per year in the South Atlantic on which golden tilefish were landed, and 182 trips taken in the South Atlantic on which no golden tilefish were harvested or in areas outside the South Atlantic. The average annual total dockside revenue (2016 dollars) for these vessels combined was approximately $1.56 million from golden tilefish, $0.10 million from other species co-harvested with golden tilefish (on the same trips), and $0.43 million from trips in the South Atlantic on which no golden tilefish were harvested or in areas outside the South Atlantic. Total average annual revenue from all species harvested by longline vessels harvesting golden tilefish in the South Atlantic was approximately $2.10 million, or approximately $92,000 per vessel. Longline vessels generated approximately 74 percent of their total revenues from golden tilefish. For the same period, an average of 82 vessels per year landed golden tilefish using other gear types (mostly hook-and-line) in the South Atlantic. These vessels, combined, averaged 483 trips per year in the South Atlantic on which golden tilefish were landed, and 2,862 trips taken in the South Atlantic on which no golden tilefish were harvested or in areas outside the South Atlantic. The average annual total dockside revenue (2016 dollars) for these 82 vessels was approximately $0.36 million from golden tilefish, $0.66 million from other species co-harvested with golden tilefish (on the same trips in the South Atlantic), and $4.13 million from trips in the South Atlantic on which no golden tilefish were harvested or in areas outside the South Atlantic. The total average annual revenue from all species harvested by these 82 vessels was approximately $5.16 million, or approximately $62,000 per vessel. Approximately seven percent of these vessels' total revenues came from golden tilefish. Based on the foregoing revenue information, all commercial vessels using longlines or other gear types (mostly hook-and-line) affected by the proposed temporary rule may be assumed to be small entities.

    Because all entities expected to be directly affected by this proposed temporary rule are assumed to be small entities, NMFS has determined that this proposed temporary rule would affect a substantial number of small entities. For the same reason, the issue of disproportionate effects on small versus large entities does not arise in the present case.

    Reducing the South Atlantic stock ACL for golden tilefish would reduce the specific ACLs for the commercial and recreational sectors. These ACL reductions would result in ex-vessel revenue losses of approximately $229,000 for hook-and-line vessels and $600,000 for longline vessels over the entire 2018 fishing year. Ex-vessel revenue reductions for the commercial sector would result in profit reductions, although this is more likely for longline vessels as they are more dependent on golden tilefish than hook-and-line vessels.

    The following discusses the alternatives that were not selected as preferred by the Council.

    Four alternatives, including the preferred alternative as described above, were considered for reducing the stock and sector ACLs for South Atlantic golden tilefish. The first alternative, the no action alternative, would maintain the current economic benefits to all participants in the South Atlantic golden tilefish component of the snapper-grouper fishery. This alternative, however, would not address the need to curtail continued overfishing of the stock, very likely leading into the adoption of more stringent measures in the near future. The second alternative would reduce the ACLs more than the preferred alternative, and thus would be expected to result in larger revenue (and profit) losses to the commercial sector. The third alternative would establish higher ACLs than the preferred alternative. Although this alternative would result in lower revenue losses to the commercial sector, the ACLs it would establish may not be low enough to address the overfishing status of the stock. To an extent, this alternative would leave open a greater likelihood of implementing more stringent measures when more long-term management actions are implemented in Amendment 45.

    List of Subjects in 50 CFR Part 622

    Annual catch limit, Fisheries, Fishing, Golden tilefish, South Atlantic.

    Dated: October 23, 2017. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 622 is proposed to be amended as follows:

    PART 622—FISHERIES OF THE CARIBBEAN, GULF OF MEXICO, AND SOUTH ATLANTIC 1. The authority citation for part 622 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    2. In § 622.190, suspend paragraphs (a)(2)(i) through (iii) and add paragraphs (a)(2)(iv) through (vi) to read as follows:
    § 622.190 Quotas.

    (a) * * *

    (2) * * *

    (iv) Hook-and-line and longline components combined—313,310 lb (142,115 kg).

    (v) Hook-and-line component—78,328 lb (35,529 kg).

    (vi) Longline component—234,982 lb (106,586 kg).

    3. In § 622.193, suspend paragraphs (a)(1)(i), (ii), and (iii), and (a)(2), and add paragraphs (a)(1)(iv), (v), and (vi), and (a)(3) to read as follows:
    § 622.193 Annual catch limits (ACLs), annual catch targets (ACTs), and accountability measures (AMs).

    (a) * * *

    (1) * * *

    (iv) Hook-and-line component. If commercial landings for golden tilefish, as estimated by the SRD, reach or are projected to reach the commercial ACL (commercial quota) specified in § 622.190(a)(2)(v), the AA will file a notification with the Office of the Federal Register to close the hook-and-line component of the commercial sector for the remainder of the fishing year. Applicable restrictions after a commercial quota closure are specified in § 622.190(c).

    (v) Longline component. If commercial landings for golden tilefish, as estimated by the SRD, reach or are projected to reach the commercial ACL (commercial quota) specified in § 622.190(a)(2)(vi), the AA will file a notification with the Office of the Federal Register to close the longline component of the commercial sector for the remainder of the fishing year. After the commercial ACL for the longline component is reached or projected to be reached, golden tilefish may not be fished for or possessed by a vessel with a golden tilefish longline endorsement. Applicable restrictions after a commercial quota closure are specified in § 622.190(c).

    (vi) If commercial landings of golden tilefish, as estimated by the SRD, exceed the commercial ACL (including both the hook-and-line and longline component quotas) specified in § 622.190(a)(2)(iv), and the combined commercial and recreational ACL of 323,000 lb (146,510 kg), gutted weight, 361,760 lb (164,092 kg), round weight, is exceeded during the same fishing year, and golden tilefish are overfished based on the most recent Status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register to reduce the commercial ACL for that following fishing year by the amount of the commercial ACL overage in the prior fishing year.

    (3) Recreational sector. (i) If recreational landings of golden tilefish, as estimated by the SRD, reach or are projected to reach the recreational ACL of 2,187 fish, the AA will file a notification with the Office of the Federal Register to close the recreational sector for the remainder of the fishing year regardless if the stock is overfished, unless NMFS determines that no closure is necessary based on the best scientific information available. On and after the effective date of such a notification, the bag and possession limits for golden tilefish in or from the South Atlantic EEZ are zero.

    (ii) If recreational landings of golden tilefish, as estimated by the SRD, exceed the recreational ACL, then during the following fishing year recreational landings will be monitored for a persistence in increased landings, and if necessary, the AA will file a notification with the Office of the Federal Register to reduce the length of the recreational fishing season and the recreational ACL by the amount of the recreational ACL overage, if the species is overfished based on the most recent Status of U.S. Fisheries Report to Congress, and if the combined commercial and recreational ACL of 323,000 lb (146,510 kg), gutted weight, 361,760 lb (164,092 kg), round weight, is exceeded during the same fishing year. The AA will use the best scientific information available to determine if reducing the length of the recreational fishing season and recreational ACL is necessary. When the recreational sector is closed as a result of NMFS reducing the length of the recreational fishing season and ACL, the bag and possession limits for golden tilefish in or from the South Atlantic EEZ are zero.

    [FR Doc. 2017-23453 Filed 10-27-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 170619570-7570-01] RIN 0648-BG92 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Modifications to the Number of Unrigged Hooks Carried On Board Bottom Longline Vessels AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS proposes to implement management measures described in an abbreviated framework action to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP), as prepared by the Gulf of Mexico (Gulf) Fishery Management Council (Council). This proposed rule would remove the limit on the number of unrigged hooks that a commercial reef fish vessel with a bottom longline endorsement is allowed on board when using or carrying bottom longline gear in the Federal waters of the eastern Gulf. The proposed rule would not change the limit of 750 hooks that these vessels can have rigged for fishing at any given time. The purpose of the proposed rule is to reduce the regulatory and potential economic burden to bottom longline fishers.

    DATES:

    Written comments must be received by November 14, 2017.

    ADDRESSES:

    You may submit comments on the proposed rule, identified by “NOAA-NMFS-2017-0081” by either of the following methods:

    Electronic Submission: Submit all electronic comments via the Federal Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0081, click the “Comment Now!” icon, complete the required fields, and enter your attached comments.

    Mail: Submit all written comments to Kelli O'Donnell, NMFS Southeast Regional Office (SERO), 263 13th Avenue South, St. Petersburg, FL 33701.

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

    Electronic copies of the abbreviated framework action, which includes an environmental assessment, Regulatory Flexibility Act (RFA) analysis, and a regulatory impact review, may be obtained from www.regulations.gov or the SERO Web site at http://sero.nmfs.noaa.gov/sustainable_fisheries/gulf_fisheries/reef_fish/2017/Unrigged%20hooks/Unrigged_hooks_index.html.

    FOR FURTHER INFORMATION CONTACT:

    Kelli O'Donnell, NMFS SERO, telephone: 727-824-5305, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Gulf reef fish fishery includes the commercial bottom longline component and is managed under the FMP. The Council prepared the FMP and NMFS implements the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Steven Act) through regulations at 50 CFR part 622.

    Background

    The Magnuson-Stevens Act requires NMFS and regional fishery management councils to prevent overfishing and achieve, on a continuing basis, the optimum yield from federally managed fish stocks to ensure that fishery resources are managed for the greatest overall benefit to the nation.

    In 2008, using data from Federal fishery observers, the NMFS Southeast Fisheries Science Center estimated sea turtle takes by the commercial bottom longline component of the Gulf reef fish fishery exceeded the 3-year anticipated take levels that were described in the 2005 Endangered Species Act biological opinion on the reef fish fishery. Therefore, the Council and NMFS developed management measures in Amendment 31 to the FMP to reduce sea turtle takes by the bottom longline component of the Gulf reef fish fishery (75 FR 21512; April 26, 2010). These management measures require an endorsement to the Federal commercial reef fish permit to fish for reef fish using bottom longline gear in the Gulf east of 85°30′ west longitude (near Cape San Blas, FL), and a seasonal closure for bottom longline gear use in that area. In addition, vessels in that area that have the endorsement and are fishing with bottom longline gear or have bottom longline gear on board cannot possess more than 1,000 hooks total per vessel of which no more than 750 hooks can be rigged for fishing.

    Management Measures Contained in This Proposed Rule

    This proposed rule would remove the current limitation on the number of unrigged hooks allowed per bottom longline vessel in the eastern Gulf EEZ, while retaining the limit of 750 hooks that can be rigged for fishing.

    Since the implementation of Amendment 31, bottom longline endorsement holders using bottom longline gear in the eastern Gulf EEZ have reported increases in bottom longline hook losses due to shark bite-offs and through normal fishing effort. Therefore, vessel operators that use bottom longline gear in the eastern Gulf EEZ requested that the Council increase the number of total unrigged hooks per vessel, while still keeping in place the restriction of 750 hooks rigged to fish at any one time.

    Observer data from 2010-2016 has shown the average amount of hooks lost per commercial bottom longline trip in the eastern Gulf EEZ is 300 hooks. Under the current total possession limit, if more than 250 hooks are lost, a vessel either has to fish with fewer than 750 hooks, get additional hooks from other vessels to maintain the maximum number of hooks in the water, or return to port. Based on public testimony, removing the restriction on the total number of hooks kept on board is expected to make trips more economical by allowing fishing with the maximum number of hooks to continue without having to return to port or request additional hooks from other vessels. In addition, maintaining the current limit of 750 hooks rigged for fishing would preserve the reductions in sea turtle interactions since the implementation of Amendment 31.

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the FMP, the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.

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

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this certification is as follows.

    A description of this proposed rule, why it is being considered, and the objectives of, and legal basis for this proposed rule are contained in the preamble.

    This proposed rule would directly affect commercial fishing vessels that use bottom longline gear to harvest reef fish from the Gulf EEZ east of 85°30′ west longitude, east of Cape San Blas, FL. These vessels are required to have an eastern Gulf reef fish bottom longline endorsement, and as of July 6, 2017, 62 vessels have that endorsement.

    NMFS estimates up to 62 commercial longline vessels could be directly affected annually, and that 36 to 37 businesses own these 62 vessels. These businesses represent approximately 6 percent of the 631 businesses that own at least one commercial fishing vessel with a Gulf reef fish permit. NMFS expects that most to all of the directly affected vessels make their landings in Florida, and from 2011 through 2015, an annual average of 59 longline vessels landed Gulf reef fish in the state and individually landed an average of 71,130 lb (32,264 kg), gutted weight, of reef fish annually. With an average 2015 dockside price of $4.01 per lb, gutted weight, the average longline vessel had annual dockside revenue of $285,231 from reef fish landings. That annual revenue is estimated to represent approximately 98 to 99 percent of the average longline vessel's annual revenues from all landings.

    For RFA purposes, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily involved in commercial fishing (NAICS 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and its combined annual receipts are not in excess of $11 million for all of its affiliated operations worldwide. Based on the average annual dockside revenue of a longline vessel, it is expected that most to all of the businesses that would be directly affected by the proposed rule are small.

    Since May 2010, within the Gulf EEZ east of 85°30′ west longitude, a vessel for which a valid eastern Gulf reef fish bottom longline endorsement has been issued and that is fishing bottom longline gear or has bottom longline gear on board cannot possess more than a total of 1,000 hooks, and no more than 750 hooks can be rigged for fishing at any given time.

    Industry representatives have indicated that a total of 1,000 hooks is not enough on long trips to compensate for hook losses due to sharks' biting hooks off and other general reasons. Under the current total possession limit, if more than 250 hooks are lost, a vessel either has to fish with fewer than 750 hooks or acquire additional hooks from other vessels to maintain the maximum number of hooks in the water. A third option is for the vessel to end the trip and return to port; however, that reduces the vessel landings. Observer data indicates an average of over 250 hooks were lost per trip from 2011 through 2016; however, despite the total hook limit and the average hook loss, average landings of reef fish per longline trip increased over that time.

    The proposed rule would allow a vessel with a longline endorsement to possess an unlimited number of hooks, but it would not change the maximum number that can be rigged for fishing. Any bottom longline vessel that would increase the total number of hooks it possesses beyond 1,000 would do so only if there were an economic benefit of doing so. Removing the limit on the number of unrigged hooks that can be onboard is expected to improve fishers' ability to maintain the maximum number of rigged hooks over the duration of a trip. There is insufficient information to estimate the number of vessels that may benefit from possessing more than 1,000 hooks and the magnitude of such a benefit.

    NMFS expects this proposed rule would not have a significant economic impact on a substantial number of small entities, and an initial regulatory flexibility analysis is not required and none has been prepared.

    No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this proposed rule. Accordingly, this proposed rule does not implicate the Paperwork Reduction Act.

    List of Subjects in 50 CFR Part 622

    Bottom longline gear, Fisheries, Fishing, Gulf of Mexico, Reef fish.

    Dated: October 24, 2017. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 622 is proposed to be amended as follows:

    PART 622—FISHERIES OF THE CARIBBEAN, GULF OF MEXICO, AND SOUTH ATLANTIC 1. The authority citation for part 622 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    2. In § 622.35, revise the first sentence of paragraph (b)(3) to read as follows:
    § 622.35 Gear restricted areas.

    (b) * * *

    (3) Within the Gulf EEZ east of 85°30′ W. long., a vessel for which a valid eastern Gulf reef fish bottom longline endorsement has been issued that is fishing bottom longline gear or has bottom longline gear on board cannot possess more than 750 hooks rigged for fishing at any given time. * * *

    [FR Doc. 2017-23460 Filed 10-27-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 660 [Docket No. 170627602-7602-01] RIN 0648-BG98 Magnuson-Stevens Act Provisions; Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Pacific Whiting; Pacific Coast Groundfish Fishery Management Plan; Amendment 21-3; Trawl Rationalization Program AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS proposes this interim measure to change the management of the Pacific whiting at-sea sectors' (i.e., the Mothership (MS) and Catcher/Processor (C/P) sectors) allocations for darkblotched rockfish and Pacific ocean perch (POP) by managing the allocations as set-asides rather than as total catch limits. This rule also proposes regulations in accordance with Amendment 21-3 to the Pacific Coast Groundfish Fishery Management Plan (PCGFMP) (see electronic access under SUPPLEMENTARY INFORMATION). The proposed action would revise regulations so that higher than anticipated harvest of darkblotched rockfish or POP that exceeds a sector's initial distribution of those species would not require automatic closure of one or more of the Pacific whiting at-sea sectors. This action is intended to reduce the risk of those sectors not attaining their respective Pacific whiting allocations based on the incidental catch of darkblotched rockfish or POP, when allowing the sector(s) to remain open would not exceed their respective annual catch limit (ACLs). This action would not change or increase the risk of exceeding darkblotched rockfish or POP ACL, as the proposed rule would also allow NMFS to close one or both of the MS and C/P sectors via automatic action if the species-specific set-aside amounts plus the available reserve for unforeseen catch events, known colloquially as the “buffer,” are anticipated to be exceeded.

    DATES:

    Comments on this proposed rule must be received no later than November 27, 2017.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2017-0102 by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0102, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Barry A. Thom, Regional Administrator, West Coast Region, NMFS, 7600 Sand Point Way NE., Seattle, WA 98115-0070, Attn: Miako Ushio.

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

    FOR FURTHER INFORMATION CONTACT:

    Miako Ushio, phone: 206-526-4644, or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Electronic Access

    This proposed rule is accessible via the Internet at the Office of the Federal Register Web site at https://www.federalregister.gov. Background information and documents are available at the NMFS West Coast Region Web site at http://www.westcoast.fisheries.noaa.gov/fisheries/groundfish/index.html and at the Pacific Fishery Management Council's Web site at http://www.pcouncil.org/groundfish/fishery-management-plan/groundfish-amendments-in-development/. On September 27, 2017, NMFS published a notice of availability of Amendment 21-3 to the PCGFMP (82 FR 44984). Consistent with requirements of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), NMFS must make a decision to approve, disapprove, or partially approve the amendment by December 26, 2017. Comments on the approvability of the amendment must be submitted to NMFS by November 26, 2017.

    Background: Fishery

    Bycatch of rockfish species in the Pacific whiting fishery occurs at very low rates, but sporadically and unpredictably. Regulations at 50 CFR 660.55 address the allocation of these groundfish. Darkblotched rockfish and POP are caught almost exclusively by vessels in the shorebased Individual Fishing Quota (IFQ) and at-sea Pacific whiting sectors of the groundfish fishery. NMFS declared both species overfished in 2000 and 1999, respectively, and both stocks are currently managed under rebuilding plans as a result. Populations of both species have shown dramatic improvement in recent years. Darkblotched rockfish was declared rebuilt in June 2017, and a draft 2017 stock assessment indicates that POP may be rebuilt. They are currently managed as allocations, and NMFS automatically closes a fishery sector when it has reached its allocation of either species.

    In recent years, both at-sea sectors of the Pacific whiting fishery have exceeded their initial annual allocation of darkblotched rockfish (C/P sector in 2011, and the MS sector in 2014). The latter resulted in an emergency Pacific Fishery Management Council (Council) meeting in order to re-open the fishery. The risk of an inseason closure of these sectors remains high, although the rebuilding ACLs of these rockfish are far from being reached. For example: The most recent fishing mortality estimates by NMFS' Northwest Fisheries Science Center indicate that 44 and 38 percent of the darkblotched rockfish and POP ACLs, respectively, were caught in 2015. While harvest of these species at a level below the ACL may rebuild stocks more quickly, there is a negative socioeconomic impact from preventing harvest of Pacific whiting, as intended in the PCGFMP.

    Background: Current Allocations Under Amendment 21

    The Council established allocations of darkblotched rockfish and POP for the at-sea sectors in Amendment 21 to the PCGFMP. When the Council considered allocation of these species, the analysis only incorporated data on catch through 2005, and took the overfished status of the species into account when they set up the allocation structure. Ten years of additional data on bycatch in the at-sea sectors are now available. Additionally, six full years of the Shorebased IFQ Program (which was implemented in 2011, 75 FR 60868) fishery information is available. This new information indicates that the stocks of both species are currently much healthier than they were at the time Amendment 21 was implemented.

    The Council's Amendment 21 allocation recommendation was based, in part, on the idea that the C/P and MS sectors could avoid early closures by moving to areas of lower rockfish encounter rates if they were approaching a bycatch allocation. However, experience has shown that this assumption was likely too simplistic. Despite the mitigating measures enacted by the C/P and MS coops, darkblotched rockfish bycatch remains particularly variable with the potential for rapid accumulation. The 2014 closure of the MS sector provides an illustration; closure occurred after six hauls caught 4.5 mt of darkblotched rockfish, nearly 75 percent of their 2014 allocation, with the bulk coming from three of the hauls. Some of the largest hauls were delivered to motherships so closely in time that feedback on the size of the catches from observers came too late for the MS coop to effectively respond. Prior to this “lightning strike” event, the sector had made 969 hauls and caught only 2.5 mt of darkblotched rockfish. After the sector was re-opened by an emergency meeting of the Council, the sector made 330 additional hauls that brought in over 14,500 mt of Pacific whiting and only 0.1 mt of additional darkblotched rockfish. The C/P sector has experienced even more rapid accumulations of darkblotched rockfish bycatch, and would have been closed late in the 2011 season if unused allocation had not been available from the MS sector, which had already completed fishing. These events indicate that the current management structure may be adversely impacting the at-sea sectors to a greater degree than was anticipated when the Council adopted the current allocation structure under Amendment 21, due to unpredictability and high volume of bycatch events.

    Background: Amendment 21-3

    The Council has discussed a variety of solutions to reducing the risk of closure of the Pacific whiting at-sea sectors prior to attainment of their Pacific whiting allocations, such as allowing transfer of rockfish quota between sectors, but it determined that those solutions are too complex to be analyzed and implemented in a timely manner. At its September 2016 meeting, the Council recommended the interim measure of amending the PCGFMP and implementing revised regulations, so that the amounts of darkblotched rockfish and POP allocated to the C/P and MS sectors are managed as set-asides rather than as total catch limits. The Council also recommended giving NMFS inseason authority to automatically close one or both of the C/P and MS sectors in the event the species-specific set-aside amounts plus the available reserve for unforeseen catch events, known colloquially as the “buffer,” are anticipated to be exceeded.

    This action would not revise allocations between sectors, which were set by Amendment 21 to the PCGFMP, and is intended to be an interim solution to address the immediate needs of the C/P and MS sectors. Long-term solutions are being reviewed by a Council-appointed Community Advisory Board as part of the 5-year review of the trawl rationalization program. A long-term solution to address the needs of the C/P and MS sectors will focus specifically on fairly and equitably revising the allocation between the trawl sectors, and among all the groundfish fishery sectors, while leaving any applicable stock rebuilding plans unaffected.

    Intent of the Action

    This proposed action is intended to substantially reduce the risk of the Pacific whiting at-sea sectors not attaining their respective Pacific whiting allocations based on the incidental catch of darkblotched rockfish or POP, when allowing the sector(s) to remain open would not exceed ACLs for these rebuilding stocks. It would revise regulations so that higher than anticipated harvest of darkblotched rockfish or POP that exceeds the initial distribution of those species to the at-sea sectors will not require automatic closure of one or more of the at-sea sectors.

    The proposed rule would also allow NMFS to close one or both of the C/P and MS sectors of the Pacific whiting fishery via automatic action when the set-aside for that sector, plus the available reserve for unforeseen catch events, is reached or is expected to be reached for either darkblotched rockfish or POP. Because of near real-time monitoring by the C/P and MS Coop Programs, and the ability of those programs to respond quickly to changing fishery conditions, closures would occur before allocations to other fisheries or the ACLs are reached, thus limiting the potential effects and precluding potential negative biological and socioeconomic impacts of the proposed action.

    Classification

    Pursuant to section 304 (b)(1)(A) of the Magnuson-Stevens Act, NMFS has preliminarily determined that this proposed rule is consistent with the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment. In making its final determination, NMFS will take into account the complete record, including the data, views, and comments received during the comment period.

    NMFS has determined that the proposed action would not have a significant effect, individually or cumulatively, on the human environment and does not involve any extraordinary circumstances listed in The National Oceanic and Atmospheric Administration (NOAA) Policy and Procedures for Compliance with the National Environmental Policy Act and Related Authorities (NOAA Administrative Order (NAO) 216-6A and the Companion Manual for NAO 216-6A). For purposes of review under the National Environmental Protection Act, the proposed action is not part of any larger action, and can be reviewed independently. Furthermore, NMFS determined that the proposed action may appropriately be categorically excluded from the requirement to prepare either an environmental assessment or environmental impact statement, in accordance with the Companion Manual for NAO 216-6A.

    Under the Regulatory Flexibility Act (RFA), an agency does not need to conduct an Initial Regulatory Flexibility Act Analysis or Final Regulatory Flexibility Act Analysis if a certification can be made that the proposed rule, if adopted, will not have a significant adverse economic impact on a substantial number of small entities, as defined below (5 U.S.C. 601). The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities as described in this document.

    The Small Business Administration has established the following size criteria for entities classified under North American Industry Classification System (NAICS). Standards are expressed either in number of employees or annual receipts in millions of dollars. The number of employees or annual receipts indicates the maximum allowed for a concern and its affiliates to be considered small (13 CFR 121.201). A fish and seafood merchant wholesaler primarily engaged in servicing the fishing industry is a small business if it employs 100 or fewer persons, on a full-time, part-time, temporary, or other basis, at all its affiliated operations worldwide (NAICS 424460). A business primarily engaged in seafood product preparation and packaging is a small business if it is independently owned and operated, not dominant in its field of operation, and employs 750 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide (NAICS 311710). For purposes of this action, NMFS West Coast Region is applying the seafood processor standard to C/Ps and MS processor ships, which earn the majority of their revenue from selling processed seafood product. Under SBA size standards, a nonprofit organization is determined to be a small entity if (1) it is not dominant in its field of operation; and (2) for environmental, conservation, or professional organizations if combined annual receipts are $15 million or less (NAICS 813312, 813920), and for other organizations if combined annual receipts are $7.5 million or less (NAICS 813319, 813410, 813910, 813930, 813940, 813990). For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing; a business primarily engaged in commercial fishing (NAICS 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide (50 CFR 200.2).

    For the purposes of the RFA, small governmental jurisdictions such as governments of cities, counties, towns, townships, villages, school districts, or special districts are considered small jurisdictions if their populations are less than 50,000 (5 U.S.C. 601).

    A description and estimate of the number of small entities to which the rule applies and economic impacts on small entities, by entity size and industry.

    Four companies own seven permitted mothership vessels. Each year, three to six MS vessels participate in the Pacific whiting fishery. The average number of crew on each MS vessel is 104 individuals. When considering operations in Alaska, none of the MSs would be considered small businesses.

    The 17 catcher vessels that participated in the mothership coop spend about 30 percent of their total annual fishing days processing in the Pacific whiting fishery. The majority of their time is spent in the Alaska Pollock fishery. Almost 90 percent of the overall round weight taken by these vessels is taken in Alaska, and approximately 11 percent is taken in the Pacific whiting fishery.

    Three companies own nine permitted C/P fleet vessels. C/Ps are large vessels with an average crew of 131 individuals.

    Vessels in the C/P fleet spend about 20 percent of their total days fishing in the Pacific whiting fishery and 80 percent in the Alaska Pollock fishery. About 90 percent of the total round weigh taken by the C/Ps is taken in Alaska, and approximately 10 percent is taken in the Pacific whiting fishery. When considering operations from Alaska, none of the C/Ps would be considered small businesses.

    An explanation of the criteria used to evaluate whether the rule would impose “significant impacts” on small entities.

    The proposed action is primarily administrative in nature, as it does not change the ACLs for either the Pacific whiting at-sea sectors or the allocations levels of darkblotched rockfish and POP. This action is not expected to significantly reduce profit for a substantial number of small entities, because there are no associated compliance requirements or costs.

    An explanation of the criteria used to evaluate whether the rule would impose impacts on“a substantial number” of small entities.

    Two MS permit/processor owning companies self-identified on the most recent (2016) permit renewal as small businesses, and the other two identified as not being small businesses. All three companies owning C/P permits and vessels responded as not being small entities on the most recent (2016) permit renewal form. Of the 35 MS catcher vessel permits, 34 were registered to vessels with the MS catcher vessel endorsement. 27 MS catcher vessel endorsed permits were owned by 22 companies that self-identified as small entities, and the other 8 were owned by 5 companies that self-identified as not being small entities.

    A description of, and an explanation of the basis for, assumptions used.

    Data collected from the trawl rationalization program Economic Data Collection was used for this analysis.

    No Federal rules have been identified that duplicate, overlap, or conflict with this action. There are no reporting, recordkeeping or other compliance requirements in the proposed rule.

    Pursuant to Executive Order 13175, this proposed rule was developed after meaningful consultation and collaboration with tribal officials from the area covered by the PCGFMP. Consistent with the Magnuson-Stevens Act (16 U.S.C. 1852(b)(5)), one of the voting members of the Pacific Council is a representative of an Indian tribe with Federally recognized fishing rights from the area of the Council's jurisdiction.

    This proposed rule would not alter the effects on species listed under the Endangered Species Act, or on marine mammals, over what has already been considered for the regulations governing the fishery.

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

    List of Subjects in 50 CFR Part 660

    Fisheries, Fishing, Indian Fisheries.

    Dated: October 24, 2017. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 660 is proposed to be amended as follows:

    PART 660--FISHERIES OFF WEST COAST STATES 1. The authority citation for part 660 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq., 16 U.S.C. 773 et seq., and 16 U.S.C. 7001 et seq.

    2. In § 660.55, (c)(1)(i) introductory text, and (c)(1)(i)(A) and (B) are revised to read as follows:
    § 660.55 Allocations.

    (c) * * *

    (1) * * *

    (i) Trawl fishery allocation. The allocation for the limited entry trawl fishery is derived by applying the trawl allocation percentage by species/species group and area as specified in paragraph (c) of this section and as specified during the biennial harvest specifications process to the fishery harvest guideline for that species/species group and area. For IFQ species other than-darkblotched rockfish, Pacific ocean perch, and widow rockfish, the trawl allocation will be further subdivided among the trawl sectors (MS, C/P, and IFQ) as specified in §§ 660.140, 660.150, and 660.160 of subpart D. For darkblotched rockfish, Pacific ocean perch, and widow rockfish, the trawl allocation is further subdivided among the trawl sectors (MS, C/P, and IFQ) as follows:

    (A) Darkblotched rockfish. Distribute 9 percent or 25 mt, whichever is greater, of the total trawl allocation of darkblotched rockfish to the Pacific whiting fishery (MS sector, C/P sector, and Shorebased IFQ sectors). The distribution of allocation of darkblotched rockfish to each of these sectors will be done pro rata relative to the sector's allocation of the commercial harvest guideline for Pacific whiting. Darkblotched rockfish distributed to the MS sector and C/P sector are managed as set-asides at Table 2d, subpart C. The allocation of darkblotched rockfish to the Pacific whiting IFQ fishery contributes to the Shorebased IFQ allocation. After deducting allocations for the Pacific whiting fishery, the remaining trawl allocation is allocated to the Shorebased IFQ Program.

    (B) Pacific Ocean Perch (POP). Distribute 17 percent or 30 mt, whichever is greater, of the total trawl allocation of POP to the Pacific whiting fishery (MS sector, C/P sector, and Shorebased IFQ sector). The distribution of POP to each sector will be done pro rata relative to the sector's allocation of the commercial harvest guideline for Pacific whiting. POP distributed to the MS sector and C/P sector are managed as set-asides, at Table 2d, subpart C. The allocation of POP to the Pacific whiting IFQ fishery contributes to the Shorebased IFQ allocation. After deducting allocations for the Pacific whiting fishery, the remaining trawl allocation is allocated to the Shorebased IFQ Program.

    3. In § 660.60, add paragraph (d)(1)(vii) to read as follows:
    § 660.60 Specifications and management measures.

    (d) * * *

    (1) * * *

    (vii) Close one or both the MS or C/P sector when the set-aside for that sector, described in Table 2d, subpart C, plus the available reserve for unforeseen catch events, described in Table 2a, subpart C, combined, is reached or is expected to be reached for either darkblotched rockfish or Pacific ocean perch.

    4. In § 660.150, revise paragraphs (c)(1)(i) and (ii) to read as follows:
    § 660.150 Mothership (MS) Coop Program.

    (c) * * *

    (1) * * *

    (i) Species with formal allocations to the MS Coop Program are Pacific whiting, canary rockfish and widow rockfish;

    (ii) Species with set-asides for the MS and C/P Coop Programs, as described in Table 2d, subpart C.

    5. In § 660.160, revise paragraphs (c)(1)(i) and (ii) to read as follows:
    § 660.160 Catcher/processor (C/P) Coop Program.

    (c) * * *

    (1) * * *

    (i) Species with formal allocations to the C/P Coop Program are Pacific whiting, canary rockfish, and widow rockfish;

    (ii) Species with set-asides for the MS and C/P Programs, as described in Table 2d, subpart C.

    5. In § 660 Subpart C, revise Tables 2b and 2d to read as follows: BILLING CODE 3510-22-P EP30OC17.000 EP30OC17.001
    [FR Doc. 2017-23456 Filed 10-27-17; 8:45 am] BILLING CODE 3510-22-C
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 665 [Docket No. 170120106-7999-01] RIN 0648-XF186 Pacific Island Fisheries; 2017 Annual Catch Limits and Accountability Measures AGENCY:

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

    ACTION:

    Proposed specifications; request for comments.

    SUMMARY:

    NMFS proposes annual catch limits (ACLs) for Pacific Island crustacean, precious coral, and territorial bottomfish fisheries, and accountability measures (AMs) to correct or mitigate any overages of catch limits. The proposed ACLs and AMs would be effective for fishing year 2017. The proposed ACLs and AMs support the long-term sustainability of fishery resources of the U.S. Pacific Islands.

    DATES:

    NMFS must receive comments by November 14, 2017.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2017-0012, by either of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to http://www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0012, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Send written comments to Michael D. Tosatto, Regional Administrator, NMFS Pacific Islands Region (PIR), 1845 Wasp Blvd., Bldg. 176, Honolulu, HI 96818.

    Instructions: NMFS may not consider comments sent by any other method, to any other address or individual, or received after the end of the comment period. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible.

    NMFS prepared environmental analyses that describe the potential impacts on the human environment that would result from the proposed ACLs and AMs. Copies of the environmental analyses and other supporting documents are available at www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Sarah Ellgen, NMFS PIR Sustainable Fisheries, 808-725-5173.

    SUPPLEMENTARY INFORMATION:

    Fisheries in the U.S. Exclusive Economic Zone (EEZ, or Federal waters) around the U.S. Pacific Islands are managed under archipelagic fishery ecosystem plans (FEPs) for American Samoa, Hawaii, the Pacific Remote Islands, and the Mariana Archipelago (Guam and the Commonwealth of the Northern Mariana Islands (CNMI)). A fifth FEP covers pelagic fisheries. The Western Pacific Fishery Management Council (Council) developed the FEPs, and NMFS implemented them under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

    Each FEP contains a process for the Council and NMFS to specify ACLs and AMs; that process is codified at Title 50, Code of Federal Regulations, Section 665.4 (50 CFR 665.4). The regulations require NMFS to specify, every fishing year, an ACL for each stock and stock complex of management unit species (MUS) in an FEP, as recommended by the Council and considering the best available scientific, commercial, and other information about the fishery. If a fishery exceeds an ACL, the regulations require the Council to take action, which may include reducing the ACL for the subsequent fishing year by the amount of the overage, or other appropriate action.

    NMFS proposes to specify ACLs for the crustacean and precious corals MUS in American Samoa, Guam, the CNMI, and Hawaii, and the bottomfish MUS in American Samoa, Guam, and the CNMI for fishing year 2017. The fishing year for each fishery began on January 1 and ends on December 31, except for precious coral fisheries, which began July 1 and ends on June 30 next year.

    In this action, NMFS is not proposing to specify 2017 ACLs for Hawaii Kona crab and non-Deep 7 bottomfish, or coral reef ecosystem MUS in all island areas. This is because NMFS has new information for those MUS that may require additional environmental analyses to support the Council's recommendations. NMFS would propose those ACL specifications in a separate action(s). In addition, NMFS specified the 2017-2018 ACL and AM for Hawaii Deep 7 bottomfish in June 2017 (82 FR 29778, June 30, 2017).

    NMFS based the proposed specifications for crustacean, precious coral, and territorial bottomfish MUS on recommendations from the Council at its 164th meeting held October 21-22, 2015, its 166th meeting held June 6-10, 2016, and its 170th meeting held June 19-22, 2017. For this action, the Council recommended 36 ACLs: Seven each in American Samoa, Guam, and the CNMI, and 15 in Hawaii. The Council also recommended that NMFS specify multi-year ACLs and AMs in fishing years 2015-2018. NMFS proposes to implement the specifications for each year separately, prior to each fishing year. NMFS previously implemented the 2016 specifications for bottomfish, crustacean, precious coral, and coral reef ecosystem MUS (82 FR 18716, April 21, 2017). All of the proposed 2017 ACLs in this action would be the same as those specified in 2016 (82 FR 18716, April 21, 2017). NMFS also proposes to specify the same AMs as it did in 2016.

    Data from these fisheries for fishing year 2016 indicate that catches from each fishery in 2016 did not exceed the fishery's ACL, with the exception of the CNMI slipper lobsters. NMFS proposes to specify an ACL of 60 lb for CNMI slipper lobsters, which is the same ACL that NMFS implemented in 2016, even though the average three-year catch for this fishery exceeded the ACL. For CNMI slipper lobsters, there is no OFL or maximum sustainable yield (MSY) estimate. Prior to 2016, there were only three years (2007-2009) of available catch information for slipper lobsters in the CNMI. Therefore, in 2014, at its 116th meeting, the SSC recommended a proxy for calculating the ACL for the CNMI slipper lobster stock complex. Using a catch-to-habitat-based proxy comparing data from the Hawaii slipper lobster fishery (the only area that has specifically documented harvesting of slipper lobster), the Council recommended setting an ACL for the CNMI slipper lobsters for 2016-2018 at a level equal to ABC, that is, 60 lb.

    In 2015, NOAA started a pilot program to improve commercial vendor reporting in the CNMI. The Territory Science Initiative was designed to improve the data vendors submit to commercial receipt books, which track, among other stocks, the slipper lobster fishery. NMFS staff trained vendors to complete receipt books and incorporate the process into their day-to-day business routines. The program proved to be effective, and in 2016, the CNMI commercial receipt book program documented 304 lb of slipper lobsters sold by local fishermen. In comparison, there have been no reported catches or sales of slipper lobster in the CNMI from 2010-2015.

    The Council reviewed the 2016 CNMI slipper lobster fishery performance at its 170th meeting held June 19-22, 2017. The Council noted that the 304 lb reported catch in 2016, combined with zero reported catch in the past two years, resulted in a three-year average catch of 101 lb, which exceeded the ACL by 41 lb. The Council determined that the increase in reported catch was due to the Territory Science Initiative and the associated improvements in catch reporting, and not due to actual increase in harvest. The Council also concluded that the overage was not likely to have had an impact on stock sustainability or result in overfishing based on existing stock data. Based on the status of the stock, the 2016 AM was not applied, and the Council instead recommended maintaining the 2017 CNMI slipper lobster ACL at 60 lb.

    The Final Environmental Assessment (EA) for this action supports this determination. In the EA, NMFS concluded that the current level of catch of slipper lobster in the CNMI was not likely to result in overfishing as there are no clear trends indicating that lobster stocks in the CNMI have been declining. (EA Section 3.2.3). NMFS concluded that even if no ACL were specified for this fishery, the level of slipper lobster catch would be expected to remain small. NMFS also determined that an ACL of 60 lb, even if exceeded, would not result in any changes in fishing and would not be expected to have effects on the fishery different from if no ACL were specified.

    In this proposed rule, NMFS is not proposing ACLs for MUS that are currently subject to Federal fishing moratoria or prohibitions. These MUS include all species of gold coral (78 FR 32181, May 29, 2013), the three Hawaii seamount groundfish (pelagic armorhead, alfonsin, and raftfish (75 FR 69015, November 10, 2010), and deepwater precious corals at the Westpac Bed Refugia (75 FR 2198, January 14, 2010). The current prohibitions on fishing for these MUS serve as the functional equivalent of an ACL of zero.

    Additionally, NMFS is not proposing ACLs for bottomfish, crustacean, precious coral, or coral reef ecosystem MUS identified in the Pacific Remote Islands Area (PRIA) FEP. This is because fishing is prohibited in the EEZ within 12 nm of emergent land, unless authorized by the U.S. Fish and Wildlife Service (USFWS) (78 FR 32996, June 3, 2013). To date, NMFS has not received fishery data that would support any such approvals. In addition, there is no suitable habitat for these stocks beyond the 12-nm no-fishing zone, except at Kingman Reef, where fishing for these resources does not occur. Therefore, the current prohibitions on fishing serve as the functional equivalent of an ACL of zero. However, NMFS will continue to monitor authorized fishing within the Pacific Remote Islands Monument in consultation with USFWS, and may develop additional fishing requirements, including monument-specific catch limits for species that may require them.

    NMFS is also not proposing ACLs for pelagic MUS at this time, because NMFS previously determined that pelagic species are subject to international fishery agreements or have a life cycle of approximately one year and, therefore, are statutorily excepted from the ACL requirements.

    Proposed 2017 Annual Catch Limit Specifications

    The following four tables list the proposed ACL specifications for 2017.

    Table 1—American Samoa Fishery Management unit species Proposed ACL
  • specification
  • (lb)
  • Bottomfish Bottomfish multi-species stock complex 106,000 Crustacean Deepwater shrimp 80,000 Spiny lobster 4,845 Slipper lobster 30 Kona crab 3,200 Precious Coral Black coral 790 Precious corals in the American Samoa Exploratory Area 2,205
    Table 2—Mariana Archipelago—Guam Fishery Management unit species Proposed ACL
  • specification
  • (lb)
  • Bottomfish Bottomfish multi-species stock complex 66,000 Crustaceans Deepwater shrimp 48,488 Spiny lobster 3,135 Slipper lobster 20 Kona crab 1,900 Precious Coral Black coral 700 Precious corals in the Guam Exploratory Area 2,205
    Table 3—Mariana Archipelago—CNMI Fishery Management unit species Proposed ACL
  • specification
  • (lb)
  • Bottomfish Bottomfish multi-species stock complex 228,000 Crustacean Deepwater shrimp 275,570 Spiny lobster 7,410 Slipper lobster 60 Kona crab 6,300 Precious Coral Black coral 2,100 Precious corals in the CNMI Exploratory Area 2,205
    Table 4—Hawaii Fishery Management unit species Proposed ACL
  • specification
  • (lb)
  • Crustacean Deepwater shrimp 250,773 Spiny lobster 15,000 Slipper lobster 280 Precious Coral Auau Channel black coral 5,512 Makapuu Bed—Pink coral 2,205 Makapuu Bed—Bamboo coral 551 180 Fathom Bank—Pink coral 489 180 Fathom Bank—Bamboo coral 123 Brooks Bank—Pink coral 979 Brooks Bank—Bamboo coral 245 Kaena Point Bed—Pink coral 148 Kaena Point Bed—Bamboo coral 37 Keahole Bed—Pink coral 148 Keahole Bed—Bamboo coral 37 Precious corals in the Hawaii Exploratory Area 2,205
    Accountability Measures

    Each year, NMFS and local resource management agencies in American Samoa, Guam, the CNMI, and Hawaii collect information about MUS catches and apply them toward the appropriate ACLs. Pursuant to 50 CFR 665.4, when the available information indicates that a fishery is projected to reach an ACL for a stock or stock complex, NMFS must notify permit holders that fishing for that stock or stock complex will be restricted in Federal waters on a specified date. The restriction serves as the AM to prevent an ACL from being exceeded, and may include closing the fishery, closing specific areas, changing bag limits, or restricting effort.

    However, local resource management agencies do not have the resources to process catch data in near-real time, so fisheries statistics are generally not available to NMFS until at least six months after agencies collect and analyze the data. Additionally, Federal logbook information and other reporting from fisheries in Federal waters is not sufficient to monitor and track catches for the evaluation of fishery performance against the proposed ACL specifications. This is because most fishing for bottomfish, crustacean, and precious coral MUS occurs in State or territorial waters, generally 0-3 nm from shore. For these reasons, NMFS proposes to continue to specify the Council's recommended AM, which is to apply a three-year average catch to evaluate fishery performance against the proposed ACLs. Specifically, NMFS and the Council would use the average catch of fishing years 2015, 2016, and 2017 to evaluate fishery performance against the 2017 ACL for a particular fishery. At the end of each fishing year, the Council would review catches relative to each ACL. If NMFS and the Council determine that the three-year average catch for any fishery exceeds the specified ACL, NMFS would reduce the ACL in the subsequent year for that fishery by the amount of the overage.

    Cultural Fishing in American Samoa

    On March 20, 2017, in Territory of American Samoa v. NMFS, et al. (16-cv-95, D. Haw), a Federal judge vacated and set aside a NMFS rule that amended the American Samoa Large Vessel Prohibited Area (LVPA) for eligible pelagic longliners. The Court held that the action was inconsistent with the “other applicable law” provision of the Magnuson-Stevens Act by not considering the protection and preservation of cultural fishing rights in American Samoa under the Instruments of Cession. The Instruments of Cession do not specifically mention cultural fishing rights, and the Court's decision, although recognizing the need to protect those rights, does not define them. The Council is currently reevaluating the LVPA rule, including options to define cultural fishing rights in American Samoa that are subject to preservation and protection. NMFS specifically invites public comments on this proposed action that address the impact of the proposed ACL and AM specifications on cultural fishing rights in American Samoa.

    NMFS will consider public comments on the proposed ACLs and AMs and will announce the final specifications in the Federal Register. NMFS must receive any comments by the date provided in the DATES heading, not postmarked or otherwise transmitted by that date. Regardless of the final ACL specifications and AMs, all other management measures will continue to apply in the fisheries.

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator for Fisheries has determined that these proposed specifications are consistent with the applicable FEPs, other provisions of the Magnuson-Stevens Act, and other applicable laws, subject to further consideration after public comment.

    Certification of Finding of No Significant Impact on Substantial Number of Small Entities

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that these proposed specifications, if adopted, would not have a significant economic impact on a substantial number of small entities. A description of the proposed action, why it is being considered, and the legal basis for it are contained in the preamble to these proposed specifications.

    The proposed action would specify annual catch limits (ACLs) and accountability measures (AMs) for Pacific Island crustaceans, precious coral, and territorial bottomfish fisheries in American Samoa, Guam, Hawaii, and the CNMI for 2017. The proposed 2017 ACLs for MUS covered in this proposed action are identical to those specified in 2016 (82 18716, April 21, 2017). NMFS is not proposing to specify 2017 ACLs for Kona crab or non-Deep 7 bottomfish in Hawaii or coral reef ecosystem MUS in any island area because NMFS has obtained new information for those MUS that may require the agency to conduct additional environmental analyses to support the Council's recommendations. NMFS will propose those ACL specifications in a separate action(s).

    The vessels affected by this action are federally permitted to fish under the Fishery Ecosystem Plans for American Samoa, the Marianas Archipelago (Guam and the CNMI), and Hawaii. The numbers of vessels permitted under these Fishery Ecosystem Plans permitted by this action are as follows: American Samoa (0), Marianas Archipelago (16), and Hawaii (9). For Regulatory Flexibility Act (RFA) purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide. Based on available information, NMFS has determined that all affected entities are small entities under the SBA definition of a small entity, i.e., they are engaged in the business of fish harvesting, are independently owned or operated, are not dominant in their field of operation, and have annual gross receipts not in excess of $11 million. Therefore, there would be no disproportionate economic impacts between large and small entities. Furthermore, there would be no disproportionate economic impacts among the universe of vessels based on gear, home port, or vessel length.

    Even though this proposed action would apply to a substantial number of vessels, this action should not result in significant adverse economic impact to individual vessels. NMFS and the Council are not considering in-season closures in any of the fisheries to which these ACLs apply because fishery management agencies are not able to track catch relative to the ACLs during the fishing year. As a result, fishermen would be able to fish throughout the entire year. In addition, the ACLs, as proposed, would not change the gear types, areas fished, effort, or participation of the fishery during the 2017 fishing year. A post-season review of the catch data would be required to determine whether any fishery exceeded its ACL by comparing the ACL to the most recent three-year average catch for which data is available. If an ACL is exceeded, the Council and NMFS would take action in future fishing years to correct the operational issue that caused the ACL overage. NMFS and the Council would evaluate the environmental, social, and economic impacts of future actions, such as changes to future ACLs or AMs, after the required data are available. Specifically, if NMFS and the Council determine that the three-year average catch for a fishery exceeds the specified ACL, NMFS would reduce the ACL for that fishery by the amount of the overage in the subsequent year.

    The proposed action does not duplicate, overlap, or conflict with other Federal rules and is not expected to have significant impact on small entities (as discussed above), organizations, or government jurisdictions. The proposed action also will not place a substantial number of small entities, or any segment of small entities, at a significant competitive disadvantage to large entities. For the reasons above, NMFS does not expect the proposed action to have a significant economic impact on a substantial number of small entities. As such, an initial regulatory flexibility analysis is not required and none has been prepared.

    This proposed action is exempt from review under E.O. 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: October 23, 2017. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
    [FR Doc. 2017-23457 Filed 10-27-17; 8:45 am] BILLING CODE 3510-22-P
    82 208 Monday, October 30, 2017 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2017-0089] Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Tomatoes From France, Morocco, Western Sahara, Chile, and Spain ACTION:

    Revision to and extension of approval of an information collection; comment request.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of fresh tomatoes from France, Morocco, Western Sahara, Chile, and Spain.

    DATES:

    We will consider all comments that we receive on or before December 29, 2017.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0089.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2017-0089, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.

    Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0089 or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

    FOR FURTHER INFORMATION CONTACT:

    For information on the regulations related to the importation of fresh tomatoes from France, Morocco, Western Sahara, Chile, and Spain, contact Dr. Robert Baca, Assistant Director for Compliance and Environmental Coordination, Plant Health Programs, Plant Protection and Quarantine, APHIS, 4700 River Road, Unit 150, Riverdale, MD 20737-1236; (301) 851-2292. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

    SUPPLEMENTARY INFORMATION:

    Title: Importation of Tomatoes From France, Morocco, Western Sahara, Chile, and Spain.

    OMB Control Number: 0579-0131.

    Type of Request: Revision to and extension of approval of an information collection.

    Abstract: The Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) authorizes the Secretary of Agriculture to restrict the importation, entry, or interstate movement of plants, plant products, and other articles to prevent the introduction of plant pests into the United States or their dissemination within the United States. As authorized by the PPA, the Animal and Plant Health Inspection Service regulates the importation of fruits and vegetables into the United States from certain parts of the world as provided in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-80).

    In accordance with § 319.56-28, fresh tomatoes from France, Morocco, Western Sahara, Chile, and Spain may be imported into the United States under certain conditions to prevent the introduction of plant pests into the United States. These conditions require the use of certain information collection activities including greenhouse, production site, and treatment facility registration; a trust fund agreement; documented quality control program; box labeling; application for import permit; appeal of denial or revocation of a permit; notice of arrival; emergency action notification; and recordkeeping. Also, each consignment of tomatoes must be accompanied by a phytosanitary certificate issued by the national plant protection organization (NPPO) or similar agency of the country of origin with an additional declaration stating that the provisions of § 319.56-28 for that country have been met.

    We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.

    The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

    (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

    (2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

    (3) Enhance the quality, utility, and clarity of the information to be collected; and

    (4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

    Estimate of burden: The public burden for this collection of information is estimated to average 0.064 hours per response.

    Respondents: Growers and importers of tomatoes from France, Morocco, Western Sahara, Chile, and Spain; and the NPPO or similar agency for these countries.

    Estimated annual number of respondents: 20.

    Estimated annual number of responses per respondent: 2,240.

    Estimated annual number of responses: 44,809.

    Estimated total annual burden on respondents: 2,867 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

    All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

    Done in Washington, DC, this 25th day of October 2017. Michael C. Gregoire, Acting Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2017-23539 Filed 10-27-17; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2017-0092] Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Plants for Planting; Establishing a Category for Plants for Planting Not Authorized for Importation Pending Pest Risk Analysis AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Revision to and extension of approval of an information collection; comment request.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request revision to and extension of approval of an information collection associated with the category of plants for planting that are not authorized for importation pending pest risk analysis.

    DATES:

    We will consider all comments that we receive on or before December 29, 2017.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0092.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2017-0092 Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.

    Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0092 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call 202-799-7039 before coming.

    FOR FURTHER INFORMATION CONTACT:

    For information on the importation of plants for planting not authorized for importation pending pest risk analysis, contact Dr. Indira Singh, Botanist, Plants for Planting Policy, IRM, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737-1236; (301) 851-2020. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

    SUPPLEMENTARY INFORMATION:

    Title: Importation of Plants for Planting; Establishing a Category for Plants for Planting Not Authorized for Importation Pending Pest Risk Analysis.

    OMB Control Number: 0579-0380.

    Type of Request: Revision to and extension of approval of an information collection.

    Abstract: Under the Plant Protection Act (7 U.S.C. 7701 et seq.), the Secretary of Agriculture is authorized to take such actions as may be necessary to prevent the introduction and spread of plant pests and noxious weeds within the United States. The Secretary has delegated this authority to the Animal and Plant Health Inspection Service (APHIS).

    The regulations contained in “Subpart-Plants for Planting” (7 CFR 319.37 through 319.37-14) prohibit or restrict, among other things, the importation of living plants, plant parts, and seeds for propagation. These regulations are intended to ensure that imported plants for planting do not serve as a host for plant pests, such as insects or pathogens, which can cause damage to U.S. agricultural and environmental resources.

    In accordance with § 319.37-2a, the importation of certain taxa of plants for planting poses a risk of introducing quarantine pests into the United States. Therefore, the importation of these taxa is not authorized pending the completion of a pest risk analysis, except as provided in the regulations. Requests to remove a taxa from the category of plants for planting whose importation is not authorized pending the completion of a pest risk analysis must be made in accordance with § 319.5. These requests contains information collection activities that include information about the requesting party, the commodity proposed for importation into the United States, shipping information, a description of the pests and diseases associated with the commodity, current practices for risk mitigation or management, and any additional information listed in § 319.5 that may be necessary for APHIS to complete a pest risk analysis.

    We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.

    The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

    (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

    (2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

    (3) Enhance the quality, utility, and clarity of the information to be collected; and

    (4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

    Estimate of burden: The public burden for this collection of information is estimated to average 3.13 hours per response.

    Respondents: National plant protection organizations of exporting countries and importers of plants for planting into the United States.

    Estimated annual number of respondents: 16.

    Estimated annual number of responses per respondent: 1.

    Estimated annual number of responses: 16.

    Estimated total annual burden on respondents: 50 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

    All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

    Done in Washington, DC, this 25th day of October 2017. Michael C. Gregoire, Acting Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2017-23540 Filed 10-27-17; 8:45 am] BILLING CODE 3410-34-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Virginia Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a meeting of the Virginia Advisory Committee to the Commission will convene by conference call at 12:00 p.m. (EST) on: Thursday, November 9, 2017. The purpose of the meeting is to receive updates from committee workgroups and continue project planning on the topic of hate crimes.

    DATES:

    Thursday, November 9, 2017, at 12:00 p.m. EST.

    ADDRESSES:

    Public call-in information: Conference call-in number: 1-800-474-8920 and conference call 8310490.

    FOR FURTHER INFORMATION CONTACT:

    Ivy Davis at [email protected] or by phone at 202-376-7533.

    SUPPLEMENTARY INFORMATION:

    Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-800-474-8920 and conference call 8310490. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.

    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-800-474-8920 and conference call 8310490.

    Members of the public are invited to make statements during the open comment period of the meeting or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at [email protected] Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=279, click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meetings. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, www.usccr.gov, or to contact the Eastern Regional Office at the above phone numbers, email or street address.

    Agenda Thursday, November 9, 2017, 12:00 p.m. EST • Rollcall • Project Planning: Collateral Consequences • Update from Committee Workgroups • Next Steps • Other Business • Open Comment • Adjourn Dated: October 24, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-23464 Filed 10-27-17; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the West Virginia Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a meeting of the West Virginia Advisory Committee to the Commission will convene by conference call at 12:00 p.m. (EST) on: Friday, November 10, 2017. The purpose of the meeting is to receive updates from committee workgroups and continue project planning on the topic of collateral consequences.

    DATES:

    Friday, November 10, 2017, at 12:00 p.m. EST.

    ADDRESSES:

    Public call-in information: Conference call-in number: 1-877-604-9665 and conference call 5788080.

    FOR FURTHER INFORMATION CONTACT:

    Ivy Davis at [email protected] or by phone at 202-376-7533.

    SUPPLEMENTARY INFORMATION:

    Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-877-604-9665 and conference call 5788080. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.

    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-877-604-9665 and conference call 5788080.

    Members of the public are invited to make statements during the open comment period of the meeting or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at [email protected] Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=281, click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meetings. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, www.usccr.gov, or to contact the Eastern Regional Office at the above phone numbers, email or street address.

    Agenda Friday, November 10, 2017, 12:00 p.m. EST • Rollcall • Project Planning: Collateral Consequences • Update from Committee Workgroups • Next Steps • Other Business • Open Comment • Adjourn Dated: October 24, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-23465 Filed 10-27-17; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Alabama Advisory Committee for Orientation and To Discuss Voting in the State of Alabama as a Topic of SAC Study AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Alabama Advisory Committee (Committee) will hold a meeting on Tuesday, November 7, 2017, at 11:00 a.m. (Central) for the purpose of a discussion of Voting in Alabama as a topic of study for the Committee.

    DATES:

    The meeting will be held on Tuesday, November 7, 2017, at 11:00 a.m. (Central).

    Public Call Information: Dial: 888-220-8670, Conference ID: 5681163.

    FOR FURTHER INFORMATION CONTACT:

    David Barreras, DFO, at [email protected] or 312-353-8311.

    SUPPLEMENTARY INFORMATION:

    Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-220-8670, conference ID: 5681163. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to David Barreras at [email protected] Persons who desire additional information may contact the Midwestern Regional Office at (312) 353-8311.

    Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Alabama Advisory Committee link (http://www.facadatabase.gov/committee/committee.aspx?cid=233&aid=17). Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Midwestern Regional Office at the above email or street address.

    Agenda Welcome and Roll Call Voting in Alabama (Committee to narrow as topic of study) Next Steps Public Comment Adjournment

    Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 days prior to the meeting because of the exceptional circumstance of the Committee working in support of the Commission's statutory enforcement report due September 30, 2018.

    Dated: October 24, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-23463 Filed 10-27-17; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: International Trade Administration.

    Title: SABIT Program: Applications and Questionnaires.

    OMB Control Number: 0625-0225.

    Form Number(s): ITA-4143P.

    Type of Request: Regular.

    Number of Respondents: 3,500.

    Average Hours per Response: 3 hours for application; 1 hours for program exit questionnaire; 1 hour for alumni success story form.

    Burden Hours: 7,000.

    Needs and Uses: The information collected by the SABIT application for participation in the SABIT Group Program will be used by ITA staff to determine the quality of applicants for SABIT's programs and create delegations of professionals from Eurasia and other regions. The program exit questionnaire will be used to improve the program by determining what worked and what did not work well. The alumni success form will be used to track SABIT alumni to determine how well the program is meeting its foreign policy objectives.

    Affected Public: International individuals or households; International businesses or other for-profit organizations.

    Frequency: Individuals can fill out up to one of each of the three types of forms per year.

    Respondent's Obligation: All forms are collected on a strictly voluntary basis.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Sheleen Dumas, Departmental PRA Lead, Office of the Chief Information Officer.
    [FR Doc. 2017-23505 Filed 10-27-17; 8:45 am] BILLING CODE 3510-HE-P
    DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request

    The Department of Commerce has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: International Trade Administration.

    Title: Annual Report from Foreign-Trade Zones.

    OMB Control Number: 0625-0109.

    Form Number(s): ITA-359P.

    Type of Request: Regular Submission (revision/extension of a currently approved information collection).

    Burden Hours: 10,784 hours.

    Number of Respondents: 263.

    Average Hours per Response: 1 to 76 hours (depending on size and structure of the foreign-trade zone).

    Needs and Uses: The Foreign-Trade Zone Annual Report is the vehicle by which Foreign Trade Zone (FTZ) grantees report annually to the Foreign Trade Zones Board, pursuant to the requirements of the Foreign Trade Zones Act (19 U.S.C. 81a-81u). The annual reports submitted by grantees are the only complete source of compiled information on FTZ's. The data and information contained in the reports relates to international trade activity in FTZ's. The reports are used by the Congress and the Department to determine the economic effect of the FTZ program. The reports are also used by the FTZ Board and other trade policy officials to determine whether zone activity is consistent with U.S. international trade policy, and whether it is in the public interest. The public uses the information regarding activities carried on in FTZ's to evaluate their effect on industry sectors. The information contained in annual reports also helps zone grantees in their marketing efforts.

    Affected Public: State, local, or tribal governments or not-for-profit institutions.

    Frequency: Annually.

    Respondent's Obligation: Required to obtain or retain benefits.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to OIRA [email protected] or fax to (202) 395-5806.

    Sheleen Dumas, Departmental PRA Lead, Office of the Chief Information Officer.
    [FR Doc. 2017-23504 Filed 10-27-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-826] Certain Paper Clips From the People's Republic of China: Continuation of Antidumping Duty Order AGENCY:

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

    SUMMARY:

    As a result of the determinations by the Department of Commerce (Department) and the International Trade Commission (ITC) that revocation of the antidumping duty (AD) order on certain paper clips (paper clips) from the People's Republic of China (PRC) would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, the Department is publishing a notice of continuation of the AD order.

    DATES:

    Applicable October 30, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Maliha Khan or Thomas Martin, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: 202-482-0895 or 202-482-3936, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On November 25, 1994, the Department published in the Federal Register the AD order on paper clips from the PRC.1 On June 1, 2016, the Department published in the Federal Register the initiation notice for the fourth sunset review of the AD duty order on paper clips from the PRC, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).2 The Department conducted this sunset review on an expedited basis, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), because it received a complete and adequate response from a domestic interested party, but no substantive responses from respondent interested parties. As a result of its review, the Department determined that revocation of the Order would likely lead to continuation or recurrence of dumping and notified the ITC of the magnitude of the margins likely to prevail should the Order be revoked.3 On August 30, 2017, the ITC published its determination that revocation of the Order would likely lead to a continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time, pursuant to section 751(c) of the Act.4

    1See Antidumping Duty Order: Certain Paper Clips from the People's Republic of China, 59 FR 60606 (November 25, 1994) (Order).

    2See Initiation of Five-Year (“Sunset”) Review, 81 FR 34974 (June 1, 2016).

    3See Certain Paper Clips from the People's Republic of China: Final Results of the Expedited Fourth Sunset Review of the Antidumping Duty Order, 81 FR 69512 (October 6, 2016), and accompanying Issues and Decision Memorandum.

    4See Investigation No. 731-TA-663 (Fourth Review) Paper Clips from China, 82 FR 41288 (August 30, 2017), and Paper Clips from China: Investigation No. 731-TA-663 (Fourth Review), USITC Publication 4719 (August 2017).

    Scope of the Order

    The products covered by the Order are certain paper clips, wholly of wire of base metal, whether or not galvanized, whether or not plated with nickel or other base metal (e.g., copper), with a wire diameter between 0.025 inches and 0.075 inches (0.64 to 1.91 millimeters), regardless of physical configuration, except as specifically excluded. The products subject to the Order may have a rectangular or ring-like shape and include, but are not limited to, clips commercially referred to as “No. 1 clips”, “No. 3 clips”, “Jumbo” or “Giant” clips, “Gem clips”, “Frictioned clips”, “Perfect Gems”, “Marcel Gems”, “Universal clips”, “Nifty clips”, “Peerless clips”, “Ring clips”, and “Glide-On clips”.

    Specifically excluded from the scope of the Order are plastic and vinyl covered paper clips, butterfly clips, binder clips, or other paper fasteners that are not made wholly of wire of base metal and are covered under a separate subheading of the HTSUS.

    The products subject to the order are currently classifiable under subheading 8305.90.3010 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the order is dispositive.

    Continuation of the Order

    As a result of the determinations by the Department and the ITC that revocation of the Order would be likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), the Department hereby orders the continuation of the AD order on paper clips from the PRC. U.S. Customs and Border Protection will continue to collect AD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise.

    The effective date of the continuation of the Order will be the date of publication in the Federal Register of this notice of continuation. Pursuant to section 751(c)(2) of the Act, the Department intends to initiate the next five-year review of the Order not later than 30 days prior to the fifth anniversary of the effective date of continuation.

    This five-year sunset review and this notice are in accordance with section 751(c) of the Act and published pursuant to section 777(i)(1) of the Act and 19 CFR 351.218(f)(4).

    Dated: October 25, 2017. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2017-23537 Filed 10-27-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF795 North Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of telephonic meeting.

    SUMMARY:

    The North Pacific Fishery Management Council (Council) Social Science Plan Team will meet telephonically on November 14, 2017.

    DATES:

    The meeting will be held on Tuesday, November 14, 2017, from 10 a.m. to 3 p.m. Alaska Time.

    ADDRESSES:

    Teleconference only: (888) 456-5038; Participant passcode: 8480290.

    Council address: North Pacific Fishery Management Council, 605 W. 4th Ave., Suite 306, Anchorage, AK 99501-2252; telephone: (907) 271-2809.

    FOR FURTHER INFORMATION CONTACT:

    Sam Cunningham, Council staff; telephone: (907) 271-2809.

    SUPPLEMENTARY INFORMATION: Agenda Tuesday, November 14, 2017

    The Social Science Planning Team (SSPT) will hold an organizational teleconference in advance of its inaugural annual meeting that will occur in Spring 2018. SSPT will elect an executive officer, establish contributing member roles and responsibilities, and discuss processes for public participation and reporting to the North Pacific Fishery Management Council and its advisory bodies. The meeting agenda also includes time to scope discussion topics for the Spring 2018 annual meeting; those topics should further the SSPT's objective of identifying information gaps or underutilized social science data collections, and strategizing to improve information resources over the medium- to long-term.

    The Agenda is subject to change, and the latest version will be posted at http://www.npfmc.org/committees/social-science-planning-team/.

    Special Accommodations

    The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.

    Dated: October 25, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-23530 Filed 10-27-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF787 Marine Mammals; File No. 21431 AGENCY:

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

    ACTION:

    Notice; receipt of application.

    SUMMARY:

    Notice is hereby given that Gregory Bossart, V.M.D., Ph.D., Georgia Aquarium, 225 Baker Street Northwest, Atlanta, GA 30313, has applied in due form for a permit to conduct research on bottlenose dolphins (Tursiops truncatus).

    DATES:

    Written, telefaxed, or email comments must be received on or before November 29, 2017.

    ADDRESSES:

    The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page, https://apps.nmfs.noaa.gov, and then selecting File No. 21431 from the list of available applications.

    These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to [email protected] Please include File No. 21431 in the subject line of the email comment.

    Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.

    FOR FURTHER INFORMATION CONTACT:

    Shasta McClenahan or Amy Hapeman, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

    The applicant requests a five-year permit to assess individual, population, and comparative perspectives of bottlenose dolphin health in the Indian River lagoon and Mantanzas River, Florida. Up to 40 adult or juvenile bottlenose dolphins per year would be captured, sampled, and released for health assessments. Procedures for captured dolphins would include morphometrics, biological sampling (skin and blubber biopsy, blood, mucus membrane swabs, fecal, and urine), ultrasound, tooth extraction, and marking (freeze-brand or roto tag). Dolphins would only be sampled once per year. An additional 400 bottlenose dolphins may be harassed each year during vessel surveys for photography, videography, counts, and behavioral observations. Two unintentional mortalities may occur due to capture over the life of the permit.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    Concurrent with the publication of this notice in the Federal Register, NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

    Dated: October 24, 2017. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2017-23512 Filed 10-27-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No.: PTO-P-2017-0036] Expanded Collaborative Search Pilot Program AGENCY:

    United States Patent and Trademark Office, Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The United States Patent and Trademark Office (USPTO) conducted two separate Collaborative Search Pilot Programs (CSPs) during the period of 2015 through 2017. One of these programs was conducted with the Japan Patent Office (JPO) and the other with the Korean Intellectual Patent Office (KIPO). Improvements in patent quality and examination pendency were identified as positive outcomes from these two original CSPs. Building on the success of these two programs, the USPTO is participating in a new, expanded CSP (Expanded CSP) in which applicants may request that multiple partnering Intellectual Property (IP) offices exchange search results for their counterpart applications prior to formulating and issuing their office actions. In Expanded CSP, each designated partner IP office will independently conduct a prior art search for its corresponding counterpart application. The search results will then be exchanged between the designated partner IP office(s) and the USPTO before any IP office issues an office action. By this exchange of search results, the examiners in all designated partner IP offices will have a more comprehensive set of prior art references to consider when making initial patentability determinations. In addition to changing the number of IP offices that may be providing search results to the USPTO, Expanded CSP provides applicants with more flexibility by not requiring that applicants follow the procedures of the First Action Interview Pilot Program (FAI). Expanded CSP will allow the USPTO to study the impact on examination processes resulting from exchanges of search results between the USPTO and multiple partner IP offices prior to formulating and issuing office actions.

    DATES:

    Under Expanded CSP, the USPTO and partner IP offices will each accept requests to participate from November 1, 2017, through November 1, 2020, and each IP office will not grant more than 400 requests per year per partner office. The offices may extend the pilot program (with or without modification), if necessary. Each office reserves the right to withdraw from the program at any time.

    FOR FURTHER INFORMATION CONTACT:

    Inquiries regarding the handling of any specific application participating in the pilot may be directed to Daniel Hunter, Director of International Work Sharing, Planning, and Implementation, Office of International Patent Cooperation, by telephone at (571) 272-8050. Any inquiries regarding this pilot program can be emailed to [email protected] Inquiries concerning this notice may be directed to Joseph F. Weiss, Jr., Senior Legal Advisor, Office of Patent Legal Administration, by phone (571) 272-7759.

    SUPPLEMENTARY INFORMATION:

    I. Background: The USPTO is continually looking for ways to improve the quality of issued patents and to promote work sharing with other IP offices throughout the world. Work sharing benefits applicants by promoting compact prosecution, reducing pendency, and supporting patent quality by reducing the likelihood of inconsistencies in patentability determinations (not predicated upon differences in national patent laws) between IP offices. The USPTO has launched numerous work sharing pilot programs, including the recently completed CSPs with JPO and KIPO. In these completed CSPs, the participating offices implemented administrative procedures to facilitate work sharing between the USPTO and a single designated partner IP office in the form of sharing search results of related counterpart applications. Feedback from the completed CSPs showed sufficiently positive benefits to justify expanding CSP to permit work sharing between the USPTO and more than one designated partner IP office for the same U.S. application.

    The USPTO will cooperate in an Expanded CSP to determine whether exchanging the results from searches independently performed by multiple IP offices, which occur substantially simultaneously, also increases the efficiency and quality of patent examination. This Expanded CSP is designed so that this exchange of search results would occur prior to the IP offices making initial patentability determinations. The current partner IP offices for the Expanded CSP are JPO and KIPO. The USPTO will announce future partner IP offices when they are designated.

    Currently, applicants in the USPTO having U.S. applications with claims of foreign priority may have search results and prior art cited to them by the foreign IP office during pendency of their U.S. applications. Often, applicants submit the prior art after examination on the merits is already underway in their U.S. application. Upon evaluation of the search results and cited prior art, the U.S. examiner may determine that the prior art cited by the foreign office is relevant to patentability and merits being used in further examination before making a final determination on patentability of the pending claims. This delay caused by further examination results in additional cost to applicants and the USPTO that could have been avoided if the U.S. examiner was in possession of the foreign office's search results before commencing examination of the U.S. application. Furthermore, in light of the USPTO's various expedited examination programs, the possibility exists that a U.S. application may reach final disposition before the applicant is in receipt of a foreign office's search results. The exchange of search results between IP offices before an initial determination on patentability should increase efficiency and promote patent examination quality.

    In order to study the benefits of the exchange of search results between multiple IP offices, current USPTO examination practice will be modified for applications in Expanded CSP so that a search will be conducted and search results generated, without issuance of an Office action. The U.S. applications in Expanded CSP will also be “made special” pursuant to USPTO procedures to ensure that they are contemporaneously searched with their corresponding counterpart applications.

    In the original version of the CSP, the USPTO required the use of the First Action Interview Pilot Program (FAI), which bifurcated the prior art search from issuance of an Office action. The USPTO has determined that it is unnecessary to require applicants participating in Expanded CSP to use FAI procedures. Instead, applications in Expanded CSP will be accorded special status prior to first action on the merits (FAOM) and prior art references provided through the exchange of search results will be included in the FAOM.

    Expanded CSP in the U.S. requires a petition to make special for the participating application and authorization to exchange information with the designated partner IP office(s) prior to an initial determination of patentability. As this work sharing program is operating under a common framework across all agreements between the USPTO and all partner offices, it is permissible to participate in Expanded CSP with multiple partner offices simultaneously, and the program is open to adding additional partner IP offices once appropriate agreements are in place.

    II. Overview of Expanded CSP: An application must meet all the requirements set forth in section III of this notice to be accepted into Expanded CSP. Applicants must file a Petition to Make Special Under the Expanded Collaborative Search Pilot Program using form PTO/SB/437 via EFS-web in a U.S. application. Use of the form is mandatory and will assist applicants in complying with the pilot program's requirements, as well as assist the USPTO in quickly identifying participating applications. Form PTO/SB/437 is available at: http://www.uspto.gov/patents-getting-started/international-protection/collaborative-search-pilot-program-csp. The collection of information involved in this pilot program has been submitted to OMB. This collection will be available at OMB's Information Collection Review Web site, www.reginfo.gov/public/do/PRAMain.

    In addition to a petition being filed with the USPTO, a request must also be filed in the corresponding counterpart applications in each applicant-designated partner IP office, in accordance with the requirements of that office. (Partner IP offices may require a petition or a request; therefore, for purposes of this notice, usage of the term `request' refers to the initial submission that a partner IP office requires to initiate participation in Expanded CSP.) As each partner IP office's conditions for entry may differ, applicants should review the requirements of the relevant partner IP offices to ensure compliance.

    No fee for a petition to make special under 37 CFR 1.102 is required for participation in Expanded CSP.

    New patent applications are normally taken up for examination in the order of their U.S. filing date. Applications accepted into Expanded CSP will receive expedited processing by being granted special status and taken out of turn until issuance of an FAOM, but will not maintain special status thereafter. Designated partner IP offices and the USPTO will be sharing search results before issuance of an initial determination on patentability. Participants in Expanded CSP should review the references cited in each respective office's initial determination on patentability. If the references cited by any partner IP office are not already of record in the USPTO application and the applicant wants to ensure that the examiner considers the references, then the applicant should file an Information Disclosure Statement (IDS) that includes a copy of the communication along with copies of any missing or newly cited references in accordance with 37 CFR 1.97, 37 CFR 1.98, and Manual of Patent Examining Procedure (MPEP) sec. 609.04(a)-(b). See also MPEP secs. 609 and 2001.06(a).

    Each office may reevaluate the workload and resources needed to administer Expanded CSP at any time. The USPTO will provide notice of any substantive changes to the program (including early termination of the program) at least 30 days prior to implementation of any changes.

    III. Requirements for Participation in Expanded CSP: The following requirements must be satisfied for a petition under Expanded CSP to be granted:

    (1) The application must be a non-reissue, non-provisional utility application filed under 35 U.S.C. 111(a); or an international application that has entered the national stage in compliance with 35 U.S.C. 371, with an effective filing date of no earlier than March 16, 2013. For corresponding counterpart applications filed in accordance with the agreement between the USPTO and KIPO only, plant applications filed under 35 U.S.C. 161 are also eligible. The U.S. application and all corresponding counterpart applications must have a common earliest priority date that is no earlier than March 16, 2013. The disclosures of the U.S. application and all counterpart applications must support the claimed subject matter as of a common date. The U.S. application must be complete and eligible to receive a filing receipt at the time the petition is filed.

    (2) A completed petition form PTO/SB/437 must be filed in the application via EFS-Web. Form PTO/SB/437 is available at: http://www.uspto.gov/patents-getting-started/international-protection/collaborative-search-pilot-program-csp. Based upon the agreements reached between the USPTO and the partner IP offices, a separate petition to make special must be filed in the U.S. application for each partner IP office that the applicant designates.

    The petition (Form PTO/SB/437) includes:

    (A) An express written consent under 35 U.S.C. 122(c) for the USPTO to accept and consider prior art references and comments from each designated partner IP office during the examination of the U.S. application;

    (B) Written authorization for the USPTO to provide to the designated partner IP office access to the participating U.S. application's bibliographic data and search results in accordance with 35 U.S.C. 122(a) and 37 CFR 1.14(c); and

    (C) A statement that the applicant agrees not to file a request for a refund of the search fee and any excess claim fees paid in the application after the mailing of the decision on the petition to join Expanded CSP. Note: Any petition for express abandonment under 37 CFR 1.138(d) to obtain a refund of the search fee and excess claim fee filed after the mailing of a decision on the petition will be granted, but the fees will not be refunded.

    (3) Petitions must be filed before examination has commenced. Examination may commence at any time after an application has been assigned to an examiner. Petitions should preferably be filed before the application has been assigned to an examiner to ensure that the USPTO does not examine the application before recognizing the petition. Therefore, applicants should check the status of the application using the Patent Application Information and Retrieval (PAIR) system to see if the application has been assigned to an examiner. If the application has been assigned to an examiner, the applicant should contact the examiner to confirm that the application has not been taken up for examination and inform the examiner that a petition to participate in Expanded CSP is being filed. Following this guidance will minimize delays caused by remedial corrective action when a petition is not recognized before examination commences. Further, examination must not have commenced in the identified corresponding counterpart application(s) before each designated partner IP office when filing petitions requesting participation in the U.S. application.

    (4) The petition filed in the USPTO and any request filed in a designated partner IP office must be filed within 15 days of each other. If the petition and request(s) are not filed within 15 days of each other, the applicant runs the risk of one of the pending applications being acted upon by an examiner before entry into the pilot program, which will result in the applications being denied entry into Expanded CSP. The request for participation filed in the corresponding counterpart application(s) for Expanded CSP must be granted by at least one of the designated partner IP offices in order to participate in Expanded CSP.

    (5) The petition submission must include a claims correspondence table, which at a minimum must establish “substantial corresponding scope” between all independent claims present in the U.S. application and the corresponding counterpart application(s) filed in the designated partner IP office(s). The claims correspondence table must individually list the claims of the instant U.S. application and correlate them to the claims of the corresponding counterpart application having a substantially corresponding scope. Claims are considered to have a “substantially corresponding scope” where, after accounting for differences due to claim format requirements, the scope of the corresponding claims in the corresponding counterpart application(s) would either anticipate or render obvious the subject matter recited under U.S. law. Additionally, claims in the U.S. application that introduce a new/different category of claims than those presented in the corresponding counterpart application(s) are not considered to substantially correspond. For example, where the corresponding counterpart application(s) contain only claims relating to a process of manufacturing a product, any product claims in the U.S. application are not considered to substantially correspond, even if the product claims are dependent on process claims that do substantially correspond to claims in the corresponding counterpart application(s). Applicants may file a preliminary amendment in compliance with 37 CFR 1.121 to amend the claims of the U.S. application to satisfy this requirement when attempting to make the U.S. application eligible for the program. A translated copy of the claims in English for each counterpart application is required if the application in the designated partner IP office(s) is not publicly available in English. A machine translation is sufficient. Non-corresponding claims need not be listed.

    (6) The U.S. application must contain 3 or fewer independent claims and 20 or fewer total claims. The U.S. application must not contain any multiple dependent claims; the corresponding counterpart application may contain multiple dependent claims in accordance with national practice of the partner IP office where it is filed. For a U.S. application that contains more than 3 independent claims or 20 total claims, or any multiple dependent claims, applicants may file a preliminary amendment in compliance with 37 CFR 1.121 to cancel the excess claims and/or the multiple dependent claims to make the application eligible for the program.

    IV. Treatment of Petition: As discussed in section III, the number of petitions to make special filed in the U.S. application must equal the number of designated partner IP offices where a corresponding counterpart application has been filed. At least one designated partner office must grant the request in order for that application and the counterpart U.S. application to participate in Expanded CSP.

    If examination commences in either the U.S. or a given designated corresponding counterpart application before either the petition or request is filed, then that combination of U.S. application and designated corresponding counterpart application cannot participate in Expanded CSP. Applicants are advised that, even if they timely file a request with a designated partner office, if the USPTO is not informed by the designated partner office of the filing of the request in the corresponding counterpart application within 20 days of a petition filing with the USPTO, then the USPTO may initially dismiss the petition. In such situation, the applicant may request reconsideration, as discussed in Item B, below.

    A. Petition Grant by USPTO: Once a determination is made that all the requirements of Section III of this notice are satisfied, the USPTO petition will be granted and the application will be placed on the examiner's special docket until an FAOM is issued. The USPTO and the designated partner IP office(s) will then have four months to provide search results. As a result, once the USPTO grants the petition, the applicant will no longer have a right to file a preliminary amendment that amends the claims. Any preliminary amendment filed after the petition is granted and before issuance of an FAOM amending the claims will not be entered unless approved by the examiner. After the petition is granted and before issuance of the FAOM, the applicant may still submit preliminary amendments to the specification that do not affect the claims. All such submissions for the participating U.S. application must be filed via EFS-Web.

    B. Petition Dismissal by USPTO: If the applicant files an incomplete Form PTO/SB/437, or if an application accompanied by Form PTO/SB/437 does not comply with the requirements set forth in this Notice, the USPTO will notify the applicant of the deficiencies by dismissing the petition and the applicant will be given a single opportunity to correct the deficiencies. If the applicant still wishes to participate in the pilot program, the applicant must make appropriate corrections within 1 month or 30 days of the mailing date of the dismissal decision, whichever is longer. The time period for reply is not extendable under 37 CFR 1.136(a). If the applicant timely files a response to the dismissal decision correcting all the noted deficiencies without introducing any new deficiencies, the USPTO will grant the petition if a grantable request has been filed in a corresponding counterpart application.

    If the applicant fails to correct the noted deficiencies within the time period set forth, the USPTO may dismiss the petition and notify the designated partner IP office(s). The U.S. application will then be taken up for examination in accordance with standard examination procedures, unless designated special in accordance with another established procedure (e.g., Request for Prioritized Examination, Petition to Make Special Based on Applicant's Age).

    C. Withdrawal of Petition: An application can be withdrawn from the pilot program only by filing a request to withdraw the petition to participate in the pilot program prior to issuance of a decision granting the petition. Once the petition for participation in the pilot program has been granted, withdrawal from the pilot program is not permitted.

    V. Requirement for Restriction: The claims must be directed to a single invention. If the examiner determines that not all the claims presented are directed to a single invention, the telephone restriction practice set forth in MPEP sec. 812.01 will be followed. The applicant must make an election without traverse during the telephonic interview. If the applicant refuses to make an election without traverse, or if the examiner cannot reach the applicant after a reasonable effort (i.e., three business days), the examiner will treat the first claimed invention (the group of claim 1) as constructively elected without traverse for examination and include a basis for the restriction or lack of unity requirement in the FAOM. When a telephonic election is made, the examiner will provide a complete record of the telephonic interview, including the restriction or lack of unity requirement and the applicant's election, in the FAOM. Applicants are strongly encouraged to ensure that applications submitted for Expanded CSP are written such that they claim a single, independent, and distinct invention. The applicant is responsible to ensure the same invention is elected in both the U.S. and all corresponding counterpart applications for concurrent treatment in Expanded CSP.

    VI. First Action on the Merits (FAOM): During examination, the USPTO examiner will consider all exchanged search results and all references submitted by the applicant in accordance with 37 CFR 1.97 and 37 CFR 1.98. Search results that are not received by the USPTO within four months may not be included in the FAOM. The examiner will prepare and issue an Office action and notify the applicant if any designated partner IP office did not provide search results prior to the issuance of the Office action. Once an FAOM issues, the application will no longer be treated as special under Expanded CSP.

    Dated: October 25, 2017. Joseph Matal, Associate Solicitor, performing the functions and duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.
    [FR Doc. 2017-23661 Filed 10-27-17; 8:45 am] BILLING CODE 3510-16-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: EC17-184-000.

    Applicants: Puget Sound Energy, Inc., Macquarie Infrastructure Partners Inc.

    Description: Supplement to September 19, 2017 Application for Authorization Under Section 203 of the Federal Power Act of Puget Sound Energy, Inc., et al.

    Filed Date: 10/23/17.

    Accession Number: 20171023-5173.

    Comments Due: 5 p.m. ET 10/30/17.

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

    Docket Numbers: ER08-1281-013.

    Applicants: New York Independent System Operator, Inc.

    Description: Motion to Terminate the Reporting Obligation of the New York Independent System Operator, Inc.

    Filed Date: 3/27/2017.

    Accession Number: 20170327-5298.

    Comments Due: 5 p.m. ET 11/14/17.

    Docket Numbers: ER17-2027-001.

    Applicants: Southwest Power Pool, Inc.

    Description: Tariff Amendment: Deficiency Response—Integrated Transmission Planning Process Tariff Revisions to be effective 10/1/2017.

    Filed Date: 10/23/17.

    Accession Number: 20171023-5477.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: ER17-2560-001.

    Applicants: Avista Corporation.

    Description: Tariff Amendment: Avista Corp NITSA BPA Kalispel SA T-1140 Amendment to be effective 10/1/2017.

    Filed Date: 10/24/17.

    Accession Number: 20171024-5114.

    Comments Due: 5 p.m. ET 11/14/17.

    Docket Numbers: ER18-135-000.

    Applicants: AEP Texas Inc.

    Description: § 205(d) Rate Filing: AEP TX-Oncor IA Second Amended & Restated to be effective 9/26/2017.

    Filed Date: 10/23/17.

    Accession Number: 20171023-5475.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: ER18-136-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2017-10-23_Revisions to MISO-PJM JOA to address congestion overlap issues to be effective 3/1/2018.

    Filed Date: 10/23/17.

    Accession Number: 20171023-5483.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: ER18-137-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Revisions to MISO-PJM JOA re: Overlapping Congestion Charges to be effective 3/1/2018.

    Filed Date: 10/23/17.

    Accession Number: 20171023-5484.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: ER18-138-000.

    Applicants: First Solar Development, LLC.

    Description: Petition for Limited Waiver of Tariff Submission Deadline of First Solar Development, LLC.

    Filed Date: 10/23/17.

    Accession Number: 20171023-5628.

    Comments Due: 5 p.m. ET 11/6/17.

    Docket Numbers: ER18-139-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Amendment to ISA No. 3198 and CSA Nos. 2642 and 2643; Queue No. T157/W4-037 to be effective 9/1/2010.

    Filed Date: 10/24/17.

    Accession Number: 20171024-5072.

    Comments Due: 5 p.m. ET 11/14/17.

    Docket Numbers: ER18-140-000.

    Applicants: Lackawanna Energy Center LLC.

    Description: Baseline eTariff Filing: Application for Market-Based Rate Authorization to be effective 12/24/2017.

    Filed Date: 10/24/17.

    Accession Number: 20171024-5079.

    Comments Due: 5 p.m. ET 11/14/17.

    Docket Numbers: ER18-141-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: LGIA Alamitos Energy Center Project SA No 197 to be effective 10/25/2017.

    Filed Date: 10/24/17.

    Accession Number: 20171024-5080.

    Comments Due: 5 p.m. ET 11/14/17.

    Docket Numbers: ER18-142-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: LGIA Huntington Beach Energy Project SA No 196 to be effective 10/25/2017.

    Filed Date: 10/24/17.

    Accession Number: 20171024-5081.

    Comments Due: 5 p.m. ET 11/14/17.

    Docket Numbers: ER18-143-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Revisions to OATT 10.4 and OA 15.6 RE: Limitation on Claims to be effective 12/23/2017.

    Filed Date: 10/24/17.

    Accession Number: 20171024-5084.

    Comments Due: 5 p.m. ET 11/14/17.

    Docket Numbers: ER18-144-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: Interconnection Agreement Bob Switch-Eldorado 220-kV Transmission Line to be effective 10/25/2017.

    Filed Date: 10/24/17.

    Accession Number: 20171024-5112.

    Comments Due: 5 p.m. ET 11/14/17.

    Docket Numbers: ER18-145-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2017-10-24_SA 2637 Border Winds-NSP E&P (J290) Termination to be effective 10/25/2017.

    Filed Date: 10/24/17.

    Accession Number: 20171024-5127.

    Comments Due: 5 p.m. ET 11/14/17.

    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: October 24, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-23553 Filed 10-27-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-128-000] 54KR 8ME LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of 54KR 8ME 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 November 13, 2017.

    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 Web site 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: October 24, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-23555 Filed 10-27-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-126-000] AL Solar A, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of AL Solar A, 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 November 13, 2017.

    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 Web site 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: October 24, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-23554 Filed 10-27-17; 8:45 am] BILLING CODE 6717-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION [OMB No. 3064-0198] Agency Information Collection Activities: Submission for OMB Review; Comment Request 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. On August 18, 2017, the FDIC requested comment for 60 days on a proposal to renew the information collection described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.

    DATES:

    Comments must be submitted on or before November 29, 2017.

    ADDRESSES:

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

    http://www.FDIC.gov/regulations/laws/federal/notices.html.

    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, at the FDIC address above.

    SUPPLEMENTARY INFORMATION:

    On August 18, 2017, (82 FR 39430), the FDIC requested comment for 60 days on a proposal to renew the information collection described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.

    Proposal To Renew the Following Currently Approved Collections of Information

    1. Title: Information Collection for Qualitative Research.

    OMB Number: 3064-0198.

    Form Number: None.

    Affected Public: Consumers and financial services providers.

    Burden Estimate:

    2017 Summary of Annual Burden (3064-0198) Number of
  • sessions
  • Participants/
  • session
  • Hours/session
  • (incl. intake
  • form)
  • Travel time Burden
  • hours/year
  • Method: In-Person Focus Groups 50 10 1.75 1.50 1,625 In-Person Interviews 50 1 1 1.50 125 Phone Interviews 60 1 1 0 60 Virtual Collection 1 50 1.50 0 75 Cognitive Testing 4 25 2.00 1.50 350 Total Hourly Burden 2,235

    General Description of Collection: The FDIC plans to collect information from consumers and financial services providers through qualitative research methods such as focus groups, in-depth interviews, and/or qualitative virtual methods. The information collected will be used to deepen the FDIC's understanding of the knowledge, experiences, behaviors, capabilities, and preferences of consumers of financial services. These qualitative research methods will also contribute to the FDIC's understanding of how consumers, including those who are financially underserved, use a range of different types of bank and non-bank financial services. Interviews of financial services providers are intended to provide greater insight into the providers' perceptions of the opportunities and challenges of providing an array of financial services and products. These qualitative methods will also provide an opportunity to test and improve other survey efforts conducted by the FDIC. The FDIC does not intend to use qualitative research to measure or quantify results.

    Participation in this information collection will be voluntary and conducted in-person, by phone, or using other methods, such as virtual technology. The FDIC plans to retain an experienced contractor(s) to recommend the most appropriate collection method based on the objectives of each qualitative research effort. The FDIC will consult with OMB regarding each specific information collection during the approval period.

    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, this 24th day of October 2017. Federal Deposit Insurance Corporation. Valerie J. Best, Assistant Executive Secretary.
    [FR Doc. 2017-23509 Filed 10-27-17; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Update to Notice of Financial Institutions for Which the Federal Deposit Insurance Corporation Has Been Appointed Either Receiver, Liquidator, or Manager AGENCY:

    Federal Deposit Insurance Corporation.

    ACTION:

    Update Listing of Financial Institutions in Liquidation.

    SUMMARY:

    Notice is hereby given that the Federal Deposit Insurance Corporation (Corporation) has been appointed the sole receiver for the following financial institutions effective as of the Date Closed as indicated in the listing. This list (as updated from time to time in the Federal Register) may be relied upon as “of record” notice that the Corporation has been appointed receiver for purposes of the statement of policy published in the July 2, 1992, issue of the Federal Register (57 FR 29491). For further information concerning the identification of any institutions which have been placed in liquidation, please visit the Corporation Web site at www.fdic.gov/bank/individual/failed/banklist.html or contact the Manager of Receivership Oversight in the appropriate service center.

    Dated: October 24, 2017. Federal Deposit Insurance Corporation. Valerie J. Best, Assistant Executive Secretary. Institutions in Liquidation [In alphabetical order] FDIC ref. No. Bank name City State Date closed 10529 The Farmers and Merchants State Bank of Argonia Argonia KS 10/13/2017
    [FR Doc. 2017-23510 Filed 10-27-17; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL FINANCIAL INSTITUTIONS EXAMINATION COUNCIL [Docket No. AS17-08] Appraisal Subcommittee Notice of Meeting AGENCY:

    Appraisal Subcommittee of the Federal Financial Institutions Examination Council.

    ACTION:

    Notice of Meeting.

    Description: In accordance with Section 1104 (b) of Title XI of the Financial Institutions Reform, Recovery, and Enforcement Act of 1989, as amended, notice is hereby given that the Appraisal Subcommittee (ASC) will meet in open session for its regular meeting:

    Location: Federal Reserve Board—International Square location, 1850 K Street NW., Washington, DC 20006.

    Date: November 8, 2017.

    Time: 10:00 a.m.

    Status: Open.

    Reports Chairman Executive Director Delegated State Compliance Reviews Financial Report Action and Discussion Items September 13, 2017 Open Session Minutes “Reporting Requirements” Proposed Information Collection: OMB Clearance pursuant to Paperwork Reduction Act Bulletin on AMC Registry Fees Bulletin on 12-month extension of Implementation Period for AMC Programs ASC Rules of Operation—Meeting Schedule How To Attend and Observe an ASC Meeting

    If you plan to attend the ASC Meeting in person, we ask that you send an email to [email protected] You may register until close of business four business days before the meeting date. You will be contacted by the Federal Reserve Law Enforcement Unit on security requirements. You will also be asked to provide a valid government-issued ID before being admitted to the Meeting. The meeting space is intended to accommodate public attendees. However, if the space will not accommodate all requests, the ASC may refuse attendance on that reasonable basis. The use of any video or audio tape recording device, photographing device, or any other electronic or mechanical device designed for similar purposes is prohibited at ASC meetings.

    Dated: October 25, 2017. James R. Park, Executive Director.
    [FR Doc. 2017-23533 Filed 10-27-17; 8:45 am] BILLING CODE 6700-01-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 November 22, 2017.

    A. Federal Reserve Bank of Minneapolis (Brendan S. Murrin, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:

    1. NATCOM Bancshares, Inc., Superior, Wisconsin; to acquire 49 percent of the voting shares of Republic Bancshares, Inc., Duluth, Minnesota, and thereby indirectly acquire shares of Republic Bank, Inc., Duluth, Minnesota.

    Board of Governors of the Federal Reserve System, October 24, 2017. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2017-23501 Filed 10-27-17; 8:45 am] BILLING CODE 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 November 17, 2017.

    A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272:

    1. A.N.B. Holding Company, Ltd., Terrell, Texas, and The ANB Corporation, Terrell, Texas; to merge with G-6 Corporation, Mesquite, Texas, and thereby indirectly acquire First State Bank, Mesquite, Texas.

    Board of Governors of the Federal Reserve System, October 19, 2017. Ann Misback, Secretary of the Board.
    [FR Doc. 2017-23472 Filed 10-27-17; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 7, 2017.

    A. Federal Reserve Bank of Atlanta (Kathryn Haney, Director of Applications) 1000 Peachtree Street NE., Atlanta, Georgia 30309. Comments can also be sent electronically to [email protected]:

    1. Gregory W. Griffith, Silver Spring, Maryland; Beverly Franklin Hales, Peachtree City, Georgia; Ethel Stephanie Stuckey Benfield, Atlanta, Georgia; Russell D. Franklin, Tallahassee, Florida; Jay Gould Stuckey, Los Angeles, California; Scott M. Stuckey, Los Angeles, California; Marietta Bryson Stuckey, Augusta, Georgia; W. S. Stuckey IV, Augusta, Georgia; James Austin Putnam, Eastman, Georgia; Williamson Elliott Putnam, Eastman, Georgia; Christine, S. Boland, Washington, DC; Michelle S. Stuckey, Atlanta, Georgia; Andrew Stuckey, Brookline, Massachusetts; Todd Giddens as Trustee of the LSF Family Trust, Dublin, Georgia, and Gregory W. Griffith as Trustee of the WSS Family Trust, Silver Spring, Maryland; to retain voting shares of Citizens Corporation, and thereby indirectly retain voting shares of Citizens Bank & Trust Company, both of Eastman, Georgia.

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

    1. Linda Sue Baier, individually and together with James Alan Bair, both of Fort Madison, Iowa as a group acting in concert; to retain voting shares of Fort Madison Financial Company and thereby indirectly acquire voting shares of Connection Bank, both of Fort Madison, Iowa.

    C. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. Susan Schardt, Kearney, Nebraska, individually, and as co-trustee of the following trusts: Brian Schardt Trust No. 2; the Christina Nokelby Trust No. 2; the Kimberly Schardt Porter Trust No. 2; and the Rebecca Rathjen Trust No. 2, to acquire voting shares of Exchange Company, Kearney, Nebraska, and thereby indirectly acquire voting shares of Exchange Bank, Gibbon, Nebraska.

    In addition, Patricia Schardt, Deshler, Nebraska, has applied individually and as trustee of the Ronald P. Schardt Marital Trust and Ronald P. Schardt GS Exempt Marital Trust, to retain voting shares of Exchange Company, and for approval to join as a member of the Schardt Family Group acting in concert, which controls Exchange Company.

    Board of Governors of the Federal Reserve System, October 19, 2017. Ann Misback, Secretary of the Board.
    [FR Doc. 2017-23477 Filed 10-27-17; 8:45 am] BILLING CODE P
    FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Sunshine Act Meetings Employee Thrift Advisory Council Meeting

    AGENDA:

    Employee Thrift Advisory Council, November 8, 2017, 10:00 a.m. (In-Person), 77 K Street NE., Washington, DC 20002.

    1. Approval of the minutes of the May 31, 2017 Joint Board/ETAC meeting 2. Thrift Savings Plan Statistics 3. FY18 Budget 5. Blended Retirement Update 6. Participant Survey 7. Withdrawal Project Overview 9. New Business CONTACT PERSON FOR MORE INFORMATION:

    Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.

    Dated: October 25, 2017. Megan Grumbine, General Counsel, Federal Retirement Thrift Investment Board.
    [FR Doc. 2017-23619 Filed 10-26-17; 11:15 am] BILLING CODE 6760-01-P
    FEDERAL TRADE COMMISSION [File No. 162 3210] Victory Media, Inc.; Analysis To Aid Public Comment AGENCY:

    Federal Trade Commission.

    ACTION:

    Proposed Consent Agreement.

    SUMMARY:

    The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.

    DATES:

    Comments must be received on or before November 20, 2017.

    ADDRESSES:

    Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write: “In the Matter of Victory Media, Inc., File No. 1623210” on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc/victorymediaconsent/ by following the instructions on the web-based form. If you prefer to file your comment on paper, write “In the Matter of Victory Media, Inc., File No. 1623210” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024.

    FOR FURTHER INFORMATION CONTACT:

    Nikhil Singhvi (202-326-3480) and Stephanie Cox (202-326-2908), Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580.

    SUPPLEMENTARY INFORMATION:

    Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for October 19, 2017), on the World Wide Web, at https://www.ftc.gov/news-events/commission-actions.

    You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before November 20, 2017. Write “In the Matter of Victory Media, Inc., File No. 1623210” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at https://www.ftc.gov/policy/public-comments.

    Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/victorymediaconsent/ by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site.

    If you prefer to file your comment on paper, write “In the Matter of Victory Media, Inc., LLC, File No. 1623210” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street, SW., 5th Floor, Suite 5610 (Annex D), Washington, DC. 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

    Because your comment will be placed on the publicly accessible FTC Web site at https://www.ftc.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any sensitive personal information, such as your or anyone else's Social Security number; date of birth; driver's license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “trade secret or any commercial or financial information which . . . is privileged or confidential”—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

    Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on the public FTC Web site—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from the FTC Web site, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request.

    Visit the FTC Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before November 20, 2017. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

    Analysis of Proposed Consent Order To Aid Public Comment

    The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Victory Media, Inc. The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the FTC will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final agreement's proposed order.

    The respondent publishes print and online magazines and guides for servicemembers transitioning from military service to the civilian workforce. The respondent does business under the names G.I. Jobs and Military Friendly. Its Web sites include gijobs.com, militaryfriendly.com, and militaryspouse.com. Victory Media also maintains active social media accounts, including on Twitter, Facebook, YouTube, and LinkedIn, under handles such as “Military Friendly” or “G.I. Jobs” that attract military consumers.

    The respondent operates a search tool, School Matchmaker, at gijobs.com to help servicemembers find educational institutions in their fields of interest. The proposed complaint in this matter alleges that the respondent made claims that its Matchmaker tool searched schools that met respondent's “military friendly” criteria. In fact, the tool searches only schools that pay to be included, whether respondent has designated them as “military friendly” or not. Thus, several schools not designated by the respondent as “military friendly” are included in the Matchmaker search results. The proposed complaint alleges that the respondent's misrepresentations regarding the scope of the Matchmaker search tool constitute a deceptive act or practice under Section 5 of the FTC Act.

    Additionally, the FTC complaint alleges that the respondent, in certain of its articles, emails, and social media posts, misrepresented that its endorsements were independent and not paid advertising, and failed to adequately disclose that the content recommended schools that paid the respondent specifically to be promoted therein. The proposed complaint alleges that those misrepresentations and undisclosed paid recommendations constitute deceptive acts or practices under Section 5 of the FTC Act.

    The proposed order is designed to prevent the respondent from engaging in similar deceptive practices in the future.

    Part I prohibits the respondent from making any misrepresentations regarding the scope of any search tool, including whether the tool only searches “military friendly” schools. Part I further prohibits the respondent from making any misrepresentations about material connections between it and any schools, and from making any misrepresentations that paid commercial advertising is independent content.

    Part II requires the respondent, when endorsing schools (or preparing third-party endorsements of schools), to clearly and conspicuously disclose, in close proximity to the endorsement, any payments or other material connections between the respondent or the other endorser and the school. This disclosure requirement applies where consumers are likely to believe that such endorsements reflect the beliefs of the respondent or other endorser (and not the schools themselves).

    Parts III through VII of the proposed order are reporting and compliance provisions.

    Part III is an order distribution provision. Part IV requires the respondent to submit a compliance report one year after the issuance of the order, and to notify the Commission of corporate changes that may affect compliance obligations. Part V requires the respondent to create, for 10 years, accounting, personnel, complaint, and advertising records, and to maintain each of those records for 5 years. Part VI requires the respondent to submit additional compliance reports within 10 business days of a written request by the Commission, and to permit voluntary interviews with persons affiliated with the respondent. Part VII “sunsets” the order after twenty years, with certain exceptions.

    The purpose of this analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the complaint or proposed order, or to modify in any way the proposed order's terms.

    By direction of the Commission.

    Donald S. Clark, Secretary.
    [FR Doc. 2017-23514 Filed 10-27-17; 8:45 am] BILLING CODE 6750-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-18-0932; Docket No. CDC-2018-0094] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Information Collection for Evaluation of Education, Communication, and Training Activities for Mobile Populations. This data collection will enable to evaluate its mobile populations and stakeholders communication, training, and education material's effectiveness.

    DATES:

    CDC must receive written comments on or before December 29, 2017.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2018-0094 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

    Please note: Submit all Federal comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    The OMB is particularly interested in comments that will help:

    1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    3. Enhance the quality, utility, and clarity of the information to be collected; and

    4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    5. Assess information collection costs.

    Proposed Project

    Information Collection for Evaluation of Education, Communication, and Training Activities for Mobile Populations (OMB Control Number 0920-0932, Expires 7/31/2018)—Extension—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    The CDC's Division of Global Migration and Quarantine (DGMQ) seeks to request a three-year extension of a currently approved generic information collection plan to conduct evaluation research. Information gathered from this plan's associated data collections will help CDC plan and implement health communication, education, and training activities to improve health and prevent the spread of disease. These activities include communicating, educating, and training with international travelers and other mobile populations, training healthcare providers, and educating public health departments, federal partners, and other stakeholders.

    CDC proposes to change the current title of this generic plan from “Information Collection for Evaluation of Education, Communication, and Training Activities for the Division of Global Migration and Quarantine” to “Information Collection for Evaluation of Education, Communication, and Training Activities for Mobile Populations.”

    In the past three years, OMB approved two individual information collections under this generic plan, where both resulted in collaborations between multiple divisions within the NCEZID. DGMQ proposes a less exclusive project title because multiple divisions across NCEZID frequently collaborate on various activities. DGMQ does not propose any other changes for this extension request.

    DGMQ has aligned the proposed information collections with DGMQ's mission to reduce morbidity and mortality among immigrants, refugees, travelers, expatriates, and other globally mobile populations, and to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States. This mission is supported by delegated legal authorities outlined in the Public Health Service (PHS) Act (42 U.S.C. 264) and in regulations that are codified in 42 Code of Federal Regulations (CFR) parts 70 and 71, and 34.

    Approval of this extension request will enable DGMQ to continue collecting information in an expedited manner. To help improve and inform activities during both routine and emergency public health events, DGMQ seeks to collect the following information types: Knowledge, attitudes, and behaviors of key audiences (such as refugees, immigrants, migrants, international travelers, travel industry partners, healthcare providers, non-profit agencies, customs brokers and forwarders, schools, state and local health departments). This generic information collection plan will help DGMQ continue to refine efforts prove valuable for communication activities that must occur quickly in response to public health emergencies.

    DGMQ staff will use a variety of data collection methods for this proposed project: Interviews, focus groups, surveys, and pre/post-tests. Depending on the research questions and audiences involved, data may be gathered in-person, by telephone, online, or using some combination of these formats. CDC may collect data in quantitative and/or qualitative forms. CDC will assess numerous audience variables under the auspices of this generic information collection plan. These include, but are not limited to, knowledge, attitudes, beliefs, behavioral intentions, practices, behaviors, skills, self-efficacy, and information needs and sources. Insights gained from evaluation research will assist in the development, refinement, implementation, and demonstration of outcomes and impact of communication, education, and training activities.

    DGMQ estimates that 17,500 respondents and 7,982 hours of burden will be involved in evaluation research activities each year. The collected information will not impose a cost burden on the respondents beyond that associated with their time to provide the required data.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden
  • (in hours)
  • General Public Focus Groups Screening form 1,050 1 10/60 175 Healthcare Professionals Focus Groups Screening form 450 1 10/60 75 General Public Focus Groups 525 1 90/60 788 Healthcare Professionals Focus Groups 225 1 90/60 338 General Public Interview Screening Form 700 1 10/60 117 Healthcare Professionals Interview Screening Form 300 1 10/60 50 General Public Interviews 350 1 1 350 Healthcare Professionals Interviews Interviews 150 1 1 150 General Public Survey Screening Forms 5,250 1 10/60 875 Healthcare Professionals Survey Screening Forms 2,250 1 10/60 375 General Public Surveys 2,625 1 45/60 1,969 Healthcare Professionals Surveys 1,125 1 45/60 844 General Public Pre/Post Tests 1,750 1 45/60 1,313 Healthcare Professionals Pre/Post Tests 750 1 45/60 563 Total 7,982
    Leroy A. Richardson, 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. 2017-23561 Filed 10-27-17; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Proposed Projects

    Title: Multistate Financial Institution Data Match and Federally Assisted State Transmitted Levy (MSFIDM/FAST Levy).

    OMB No.: 0970-0196.

    Description: Section 466(a)(17) of the Social Security Act (the Act) requires states to establish procedures for their child support agencies to enter into agreements with financial institutions doing business in their state for the purpose of securing information leading to the enforcement of child support orders. Under 452(m) and 466(a)(17)(A)(i) of the Act, the Secretary may aid state agencies conducting data matches with financial institutions doing business in two or more states by establishing a centralized and standardized matching program through the Federal Parent Locator Service.

    To further assist states collect child support, the federal Office of Child Support Enforcement (OCSE) worked with child support agencies and financial institutions to develop the Federally Assisted State Transmitted (FAST) Levy system.

    FAST Levy is a central, standardized, and secure electronic process for child support agencies and financial institutions to exchange information about levying financial accounts to collect past-due support. OCSE picks up files created by child support agencies that contain FAST Levy requests and distributes them to financial institutions that use the FAST Levy system. Those financial institutions create response files that OCSE picks up and distributes to the child support agencies.

    The MSFIDM/FAST-Levy information collection activities are authorized by: 42 U.S.C. 652(m), which authorizes OCSE, through the Federal Parent Locator Service, to aid state child support agencies and financial institutions doing business in two or more states reach agreements regarding the receipt from financial institutions, and the transfer to the state child support agencies, of information pertaining to the location of accounts held by obligors who owe past-due support; 42 U.S.C. 666(a)(2) and (c)(1)(G)(ii), which require state child support agencies in cases in which there is an arrearage to establish procedures to secure assets to satisfy any current support obligation and the arrearage by attaching and seizing assets of the obligor held in financial institutions; 42 U.S.C. 666(a)(17)(A), which requires state child support agencies to establish procedures under which the state child support agencies shall enter into agreements with financial institutions doing business in the State to develop and operate, in coordination with financial institutions, and the Federal Parent Locator Service (in the case of financial institutions doing business in two or more States), a data match system, using automated data exchanges to the maximum extent feasible, in which a financial institution is required to quarterly provide information pertaining to a noncustodial parent owing past-due support who maintains an account at the institution and, in response to a notice of lien or levy, encumber or surrender, assets held; 42 U.S.C. 652(a)(7), which requires OCSE to provide technical assistance to state child support enforcement agencies to help them establish effective systems for collecting child and spousal support; and, 45 CFR 303.7(a)(5), which requires state child support agencies to transmit requests for information and provide requested information electronically to the greatest extent possible. To facilitate this requirement for states, OCSE developed the FAST Levy system that supports the electronic exchange of lien and levy information between child support agencies and financial institutions.

    Respondents: Multistate Financial Institutions and State Child Support Agencies.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per respondent
  • Average
  • burden hours
  • per response
  • Total burden hours
    Financial Data Match Result File-Portal 192 4 5 minutes 1 64 Election Form 30 1 0.5 15 FAST-Levy Record Specifications: Current Financial Institutions Users to Program New Codes 1 1 65 2 65 FAST-Levy Record Specifications: Current State Child Support Agencies to Program New Codes 3 1 65 195 FAST-Levy Response Withhold Record Specifications: Financial Institutions 1 1 1,716 1,716 FAST-Levy Request Withhold Record Specifications: State Child Support Agencies 2 1 1,610 3,220 1 Estimate is approximately 5 minutes per response. For calculation, use 5/60. 2 Estimate is an average based on input from OCSE's matching partners.

    Estimated Total Annual Burden Hours: 5,275.

    Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201, Attention Reports Clearance Officer. All requests should be identified by the information collection. Email address: [email protected]

    OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families.

    Bob Sargis, Reports Clearance Officer.
    [FR Doc. 2017-23467 Filed 10-27-17; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1264] Manufacturers Sharing Patient-Specific Information From Medical Devices With Patients Upon Request; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled “Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request.” FDA developed this guidance to clarify our position regarding manufacturers appropriately and responsibly sharing “patient-specific information”—information unique to an individual patient or unique to that patient's treatment or diagnosis that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed medical device—with that patient at that patient's request. This guidance provides information and recommendations to industry, health care providers, and FDA staff about the mechanisms and considerations for device manufacturers sharing such information with individual patients when they request it.

    DATES:

    The announcement of the guidance is published in the Federal Register on October 30, 2017.

    ADDRESSES:

    You may submit either electronic or written comments on Agency guidances at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-D-1264 for “Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Esther Bleicher, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993-0002, 301-796-8547.

    SUPPLEMENTARY INFORMATION: I. Background

    Increasingly, patients seek to play an active role in their own health care. FDA believes that sharing “patient-specific information” with patients upon their request may assist them in being more engaged with their health care providers in making sound medical decisions. For purposes of this guidance, “patient-specific information” is information unique to an individual patient or unique to that patient's treatment or diagnosis that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed medical device. This information may include, but is not limited to, recorded patient data, device usage/output statistics, health care provider inputs, incidence of alarms, and/or records of device malfunctions or failures.

    FDA developed this guidance to convey FDA's position regarding manufacturers appropriately and responsibly sharing patient-specific information with that patient at that patient's request. In general, manufacturers may do so without undergoing additional premarket review in advance. FDA generally would not consider patient-specific information to be “labeling,” as defined in section 201(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(m)). FDA is aware that when manufacturers share patient-specific information with patients, manufacturers also may provide them with supplemental information or other materials (e.g., descriptions of intended use, benefit and risk information, instructions for use) that may be considered labeling. Any labeling is subject to applicable requirements in the FD&C Act and FDA regulations.

    In the Federal Register of June 10, 2016 (81 FR 37603), FDA announced the availability of the draft guidance formerly entitled “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” and interested parties were invited to comment by August 9, 2016. FDA has considered all of the public comments received prior to finalizing this guidance.

    II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500067 to identify the guidance you are requesting.

    Dated: October 24, 2017. Lauren Silvis, Chief of Staff.
    [FR Doc. 2017-23517 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6069] Acceptance Review for De Novo Classification Requests; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Acceptance Review for De Novo Classification Requests.” The purpose of this draft guidance is to explain the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review. This draft guidance discusses De Novo acceptance review policies and procedures, “Refuse to Accept” principles, and the elements of the De Novo Acceptance Checklist and the Recommended Content Checklist and is being issued to be responsive to an explicit deliverable identified in the Medical Device User Fee Amendments of 2017 (MDUFA IV). This draft guidance is not final nor is it in effect at this time.

    DATES:

    Submit either electronic or written comments on the draft guidance by December 29, 2017 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-2017-D-6069 for “Acceptance Review for De Novo Classification Requests; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled “Acceptance Review for De Novo Classification Requests” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002 or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Sergio de del Castillo, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993-0002, 301-796-6419; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The automatic class III designation for devices of a new type occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the device. Any device that is of a new type that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976.

    FDA may classify a device through the De Novo classification process, which is the pathway authorized under section 513(f)(2) of the FD&C Act. A person may submit a De Novo request after submitting a premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and receiving a not substantially equivalent (NSE) determination (section 513(f)(2)(A)(i) of the FD&C Act). A person may also submit a De Novo request without first submitting a premarket notification under section 510(k), if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence (section 513(f)(2)(A)(ii) of the FD&C Act).

    Upon receipt of a De Novo request, FDA is required to classify the device by written order (section 513(f)(2)(A)(iii) of the FD&C Act). The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Per section 513(f)(2)(B)(i) of the FD&C Act, the classification is the initial classification of the device for the purposes of section 513(f)(1) of the FD&C Act.

    We believe De Novo classification enhances patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo classification process, the device can serve as a predicate for future devices of that type, including for 510(k)s (section 513(f)(2)(B)(i)). As a result, after a De Novo request is granted, other device sponsors do not have to submit a De Novo request or premarket application under section 515 of the FD&C Act (21 U.S.C. 360e)) in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, other device sponsors can use the less-burdensome 510(k) process, when applicable, as a pathway to market their device.

    FDA is issuing this draft guidance to provide clarity regarding the Agency's expectations for information to be submitted in a De Novo request and ensure predictability and consistency for sponsors. Focusing the Agency's review resources on complete De Novo requests will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible. Moreover, with the enactment of MDUFA IV, FDA agreed to issuance of draft (and final) guidance which includes a submission checklist to facilitate a more efficient and timely review process to assist with new performance goals. Acceptance review therefore takes on additional importance in both encouraging quality applications from De Novo requesters and allowing the Agency to appropriately concentrate resources on complete applications.

    FDA anticipates that the Agency and industry may need a period of time to operationalize the policies within this guidance, when finalized. Therefore, if all criteria necessary to meet a minimum threshold of acceptability for De Novo requests as outlined in this guidance, when finalized, are not included in a De Novo request received by FDA before or up to 60 days after the publication of this guidance, when finalized, CDRH staff does not generally intend to refuse to accept.

    II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Acceptance Review for De Novo Classification Requests.” 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 draft guidance is not subject to Executive Order 12866.

    III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of “Acceptance Review for De Novo Classification Requests” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 16055 to identify the guidance you are requesting.

    IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3502), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c) (2)(A) of the PRA (44 U.S.C. 3506 (c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    De Novo Classification Process (Evaluation of Automatic Class III Designation) OMB Control Number 0910-0844—Revision

    To aid in the acceptance review, the guidance recommends that requesters complete and submit with their De Novo request an Acceptance Checklist that identifies the location of supporting information for each acceptance element and a Recommended Content Checklist that identifies the location of supporting information for each recommended content element. Therefore, we request revision of OMB control number 0910-0844, “De Novo Classification Process (Evaluation of Automatic Class III Designation)” to include the Acceptance Checklist and the Recommended Content Checklist in the hourly burden estimate for De Novo requests.

    We previously estimated the average burden per response for a De Novo request under 21 U.S.C. 513(f)(2)(i) to be 100 hours and under 21 U.S.C. 513(f)(2)(ii) to be 180 hours. We estimate that it will take approximately 1 hour to prepare an Acceptance Checklist and 1 hour to prepare a Recommended Content Checklist. Our estimate assumes that each De Novo request will include both checklists. Therefore, we estimate the revised average burden per response for a De Novo request under 21 U.S.C. 513(f)(2)(i) to be 102 hours and under 21 U.S.C. 513(f)(2)(ii) to be 182 hours. The revision results in a 104-hour increase in the total burden estimate. The average burden per response is based on estimates by FDA administrative and technical staff that are familiar with the requirements for submission of a De Novo request (and related materials), have consulted and advised manufacturers on submissions, and have reviewed the documentation submitted.

    Approved operating and maintenance costs for a De Novo request include printing, shipping, and eCopy costs. We believe any increase of the operating and maintenance cost resulting from the addition of the Acceptance Checklist and Recommended Content Checklist to be de minimis. Therefore, we are not requesting revision of the operating and maintenance cost estimate for OMB control number 0910-0844.

    Respondents to the information collection are medical device manufacturers seeking to market medical device products through submission of a De Novo classification request under section 513(f)(2) of the FD&C Act.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total hours Total
  • operating and
  • maintenance
  • costs 2
  • De Novo Request Under 21 U.S.C. 513(f)(2)(i) CDRH 25 1 25 102 2,550 CBER 1 1 1 102 102 De Novo Request Under 21 U.S.C. 513(f)(2)(ii) CDRH 25 1 25 182 4,550 CBER 1 1 1 182 182 Total De Novo requests 52 7,384 $6,308 Request for withdrawal2 5 1 5 10 50 $5 Total 7,434 $6,313 1 There are no capital costs associated with this collection of information. 2 No change from approved information collection. This information is retained for the convenience of the reader.
    Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-23500 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-3275] Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled “Product Labeling for Certain Ultrasonic Surgical Aspirator Devices.” FDA is providing a specific labeling recommendation in this guidance to promote the safe and effective use of ultrasonic surgical aspirator devices. The labeling recommendation is being made in light of the risk of tissue dissemination and relates to use of these devices in the removal of uterine fibroids.

    DATES:

    The announcement of the guidance is published in the Federal Register on October 30, 2017.

    ADDRESSES:

    You may submit either electronic or written comments on Agency guidances at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

    • For written/paper comments submitted to 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-2016-D-3275 for “Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food and Drug Administration Staff.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at 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 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

    An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “Product Labeling for Certain Ultrasonic Surgical Aspirator Devices” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Trisha Eustaquio, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1529, Silver Spring, MD 20993-0002, 301-796-5214.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is issuing this guidance to recommend the addition of a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices. This guidance applies to ultrasonic surgical aspirator devices with indications for use in laparoscopic surgery, open surgery, or gynecologic surgery, as such surgeries can include gynecologic procedures. Ultrasonic surgical aspirator devices are surgical tools intended to fragment, emulsify, and aspirate hard and soft tissue. However, the mechanism of action of ultrasonic surgical aspirator devices creates the potential for tissue dissemination. In light of this risk, FDA is providing a specific labeling recommendation in this guidance regarding use of these devices in the removal of uterine fibroids.

    FDA is aware that ultrasonic surgical aspirator devices are sometimes used to treat advanced malignancy through cytoreduction (also known as debulking). When used in advanced cancers, the risk of adverse clinical effects from tissue dissemination may be small compared to the device's potential benefits. In certain clinical circumstances, however, the unintended dissemination of cancerous cells may have a significant adverse effect that outweighs any demonstrated benefits. Specifically, use of an ultrasonic surgical aspirator device during treatment for symptomatic uterine fibroids on a woman with an occult uterine sarcoma could result in dissemination of this cancer. Therefore, FDA recommends that manufacturers of ultrasonic surgical aspirator devices with indications for use in laparoscopic surgery, open surgery, or gynecologic surgery prominently include a specific contraindication in their product labeling that the device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

    In the Federal Register on November 10, 2016 (81 FR 79028), FDA announced the availability of the draft guidance and interested parties were invited to comment by January 9, 2017. FDA has considered all of the public comments received prior to finalizing this guidance.

    II. Significance of Guidance

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

    III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food and Drug Administration Staff” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500072 to identify the guidance you are requesting.

    IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120 and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485.

    Dated: October 25, 2017. Lauren Silvis, Chief of Staff.
    [FR Doc. 2017-23520 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5925] Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by the Food and Drug Administration; Request for Information AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Request for information.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is requesting information to assist in identifying standard development organizations (SDOs) that meet the requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act), of the 21st Century Cures Act (Cures Act), which was signed into law on December 13, 2016.

    DATES:

    Submit either electronic or written comments on the notice by November 29, 2017.

    ADDRESSES:

    You may submit comments and information as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 29, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 29, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2017-N-5925 for “Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by FDA; Request for Information.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Katherine Schumann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301-796-1182 or [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    Antimicrobial susceptibility testing is used to determine if certain microorganisms that are isolated from a patient with an infection are likely to be killed or inhibited by a particular antimicrobial drug at the concentrations of the drug that are attainable at the site of infection. Historically, susceptibility test interpretive criteria has been contained in the Microbiology subsection of antimicrobial drug labeling, and there have been significant challenges associated with ensuring that this information is up-to-date for individual antimicrobial drug labels. For some time, FDA and other stakeholders have recognized that susceptibility test interpretive criteria standards established by nationally or internationally recognized SDOs can be useful sources of information to identify and update susceptibility test interpretive criteria.

    Section 511A of the FD&C Act (21 U.S.C. 360a) was added by section 3044 of the Cures Act (Pub. L. 114-255), which was signed into law on December 13, 2016. This provision clarifies FDA's authority to identify and efficiently update susceptibility test interpretive criteria, including through the recognition by FDA of standards established by SDOs. It also clarifies that sponsors of antimicrobial susceptibility testing devices may rely upon listed susceptibility test interpretive criteria to support premarket authorization of their devices, provided they meet certain conditions, which provides for a more streamlined process for incorporating up-to-date information into such devices.

    Section 511A of the FD&C Act requires FDA to establish within 1 year after the date of enactment of the Cures Act an interpretive criteria Web site containing a list of FDA-recognized susceptibility test interpretive criteria standards, as well as other susceptibility test interpretive criteria identified by FDA. The list of standards consists of new or updated susceptibility test interpretive criteria standards with respect to legally marketed antimicrobial drugs that have been: (1) Established by nationally or internationally recognized SDOs that meet the requirements under section 511A(b)(2)(A)(i) of the FD&C Act and (2) recognized, in whole or in part, by FDA, pursuant to section 511A(c) of the FD&C Act.

    Section 511A(b)(2)(A)(i) of the FD&C Act requires that in order for FDA to recognize, in whole or in part, new or updated susceptibility test interpretive criteria standards established by an SDO, the SDO must: (1) Be a nationally or internationally recognized SDO that establishes and maintains procedures to address potential conflicts of interest and ensure transparent decision making; (2) hold meetings to ensure that there is an opportunity for public input by interested parties, and establishes and maintains processes to ensure that such input is considered in decision making; and (3) permit its standards to be made publicly available, through the National Library of Medicine or a similar source acceptable to the Secretary of Health and Human Services.

    II. Issues for Consideration and Request for Information

    FDA is currently identifying SDOs that meet the requirements under section 511A(b)(2)(A)(i) of the FD&C Act and invites submission of information relevant to this task. FDA is particularly interested in publicly available information illustrating how an SDO has national or international recognition, information illustrating an SDO's established and maintained procedures on how the SDO addresses potential conflicts of interest and ensures transparent decision-making, information illustrating that an SDO holds open meetings and has established and maintained processes to ensure that public input by interested parties is considered in decision-making, and information illustrating that an SDO's standards are made publicly available through the National Institutes of Health/National Library of Medicine or a similar source. When providing this information, please provide weblinks to where this information is publicly available. This information may assist in FDA's determination of which SDOs may fulfill the statutory requirements.

    Dated: October 25, 2017. Lauren Silvis, Chief of Staff.
    [FR Doc. 2017-23519 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0334] Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the requirements for electronic submission of postmarketing safety reports for human drug and biological products.

    DATES:

    Submit either electronic or written comments on the collection of information by December 29, 2017.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 29, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 29, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2008-N-0334 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected].

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Postmarketing Safety Reports for Human Drug and Biological Products: Waivers From Electronic Submission Requirements—OMB Control Number 0910-0770—Extension

    This information collection supports FDA regulations. In the Federal Register of June 10, 2014 (79 FR 33072), FDA published a final rule entitled “Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements.” The final rule amended FDA's postmarketing safety reporting regulations for human drug and biological products under 21 CFR parts 310, 314, and 600 and added part 329 to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. Specifically, this includes:

    • manufacturers; packers; distributors; applicants with approved new drug applications, abbreviated new drug applications, and biologics licensing applications (BLAs); and those that market prescription drugs for human use without an approved application must submit postmarketing safety reports to the Agency (§§ 310.305, 314.80, 314.98, and 600.80);

    • manufacturers, packers, or distributors whose name appears on the label of nonprescription human drug products marketed without an approved application must report serious adverse events associated with their products (section 760 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379aa)); and

    • applicants with approved BLAs must submit biological lot distribution reports to the Agency (§ 600.81).

    Under §§ 310.305(e)(2), 314.80(g)(2), 329.100(c)(2), 600.80(h)(2), and 600.81(b)(2), those who are subject to these postmarketing safety reporting requirements may request a waiver from the electronic format requirement. While FDA currently has OMB approval for the collection of postmarketing safety reports,1 this information collection supports respondents seeking waivers from submitting those reports in electronic format as required by the regulations.

    1 FDA currently has OMB approval for submission of postmarketing safety reports under parts 310, 314, and 600. The information collection for parts 310 and 314 is approved under OMB control numbers 0910-0291 and 0910-0230. The information collection for part 600 is approved under OMB control numbers 0910-0291 and 0910-0308. Submissions required by section 760 of the FD&C Act have been approved under OMB control number 0910-0636.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR section Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    310.305(e)(2) 1 1 1 1 1 314.80(g)(2) 5 1 5 1 5 329.100(c)(2) 1 1 1 1 1 600.80(h)(2) 5 1 5 1 5 600.81(b)(2) 1 1 1 1 1 Total 13 1 There are no capital or operating and maintenance costs associated with this collection of information.

    In table 1 of this document, we estimate the burden associated with the submission of waiver requests for postmarketing safety reports in electronic format under §§ 310.305(e)(2), 314.80(g)(2), 329.100(c)(2), 600.80(h)(2), and 600.81(b)(2). We expect few waiver requests. We estimate that approximately one manufacturer will request a waiver annually under §§ 310.305(e)(2), 329.100(c)(2), and 600.81(b)(2), and approximately five manufacturers will request a waiver annually under §§ 314.80(g)(2) and 600.80(h)(2). We estimate that each waiver request will take approximately 1 hour to prepare and submit.

    Dated: October 24, 2017. Lauren Silvis, Chief of Staff.
    [FR Doc. 2017-23518 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0880] Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; 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 “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.” This draft guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application.

    DATES:

    Submit either electronic or written comments on the guidance December 29, 2017 to ensure that the Agency considers your comment on this draft 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-2012-D-0880 for “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.” 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 Division of Dockets Management 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:

    Mehrban Iranshad, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 4145, Silver Spring, MD 20993, 301-796-7900, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.” GDUFA II (Pub. L. 115-52, Title III) was signed into law by the President on August 18, 2017. GDUFA II continues FDA's and industry's goal to improve the public's access to safe and effective generic drugs and to improve upon the predictability of the review process. GDUFA II extends FDA's authority to collect user fees from fiscal year (FY) 2018 to FY 2022 and introduces a number of technical revisions that affect what fees are collected and how some fees are collected. GDUFA II authorizes fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), annual facility fees, a one-time fee for original ANDAs pending with FDA on October 1, 2012 (backlog fees), and the Generic Drug Applicant Program Fee (GDUFA Program Fee).

    The draft guidance announced in this notice addresses changes in user fee assessments from GDUFA I, user fees incurred by industry under GDUFA II, payment procedures, reconsideration and appeals, and other additional information to assist industry in complying with GDUFA II. FDA will issue separate guidance documents regarding GDUFA II non-user fee requirements and processes.

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance, when finalized, will represent the Agency's current thinking on “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.” 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 contains information collection provisions 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 guidance refers to collections of information for filling out and submitting Form FDA 3913 (User Fee Payment Refund Request), previously approved under OMB control number 0910-0805, and Form FDA 3914 (User Fee Payment Transfer Request), previously approved under OMB control number 0910-0805.

    III. Electronic Access

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

    Dated: October 25, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-23526 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] De Novo Classification Process (Evaluation of Automatic Class III Designation); Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The purpose of this document is to provide guidance on the process for the submission and review of a De Novo classification request (hereafter a “De Novo request”) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the De Novo classification process. FDA is issuing this guidance to also provide updated recommendations for interactions with FDA related to the De Novo classification process, including what information to submit when seeking a path to market via the De Novo classification process. This guidance replaces “New Section 513(f)(2)—Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff,” dated February 19, 1998.

    DATES:

    The announcement of the guidance is published in the Federal Register on October 30, 2017.

    ADDRESSES:

    You may submit either electronic or written comments on Agency guidances at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2011-D-0689 for “De Novo Classification Process (Evaluation of Automatic Class III Designation); Guidance for Industry and Food and Drug Administration Staff; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation)” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002 or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Sergio de del Castillo, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993-0002, 301-796-6419; and Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 301-240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The automatic class III designation for devices of a new type occurs by operation of law and without any action by FDA, regardless of the level of risk posed. Any device that is of a new type that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device section 513(f)(1) of the FD&C Act (21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976.

    FDA may classify a device through the De Novo classification process, which is the pathway authorized under section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)). A person may submit a De Novo request after submitting a premarket notification under section 510(k) of the FD&C Act and receiving a not substantially equivalent (NSE) determination (section 513(f)(2)(A)(i) of the FD&C Act). A person may also submit a De Novo request without first submitting a premarket notification under section 510(k), if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence (section 513(f)(2)(A)(ii) of the FD&C Act).

    Upon receipt of a De Novo request, FDA is required to classify the device by written order (section 513(f)(2)(A)(iii) of the FD&C Act). The classification will be according to the criteria under section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Per section 513(f)(2)(B)(i) of the FD&C Act, the classification is the initial classification of the device for the purposes of section 513(f)(1) of the FD&C Act.

    We believe De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo classification process, the device can serve as a predicate for future devices of that type, including for 510(k)s (section 513(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or PMA in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when applicable, as a pathway to market their device.

    FDA is issuing this document to provide guidance on the process for the submission and review of a De Novo request under section 513(f)(2) of the FD&C Act, also known as the De Novo classification process. This guidance also provides updated recommendations for interactions with FDA related to the De Novo classification process, including what information to submit when seeking a path to market via the De Novo classification process. This guidance will provide clarity regarding the Agency's review process and expectations for information to be submitted in a De Novo request and ensures predictability and consistency for sponsors.

    FDA considered comments received on the draft guidance that appeared in the Federal Register (79 FR 47651) of August 14, 2014. FDA revised the guidance as appropriate in response to the comments. This document supersedes “New Section 513(f)(2)—Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff” dated February 19, 1998.

    II. Significance of Guidance

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

    III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of “De Novo Classification Process (Evaluation of Automatic Class III Designation)” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1760 to identify the guidance you are requesting.

    IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844. The collections of information in the guidance document “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” have been approved under OMB control number 0910-0756. The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485.

    Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-23492 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5975] Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Alumni Commissioner's Fellowship Program Fellows AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Survey of Alumni Commissioner's Fellowship Program Fellows.

    DATES:

    Submit either electronic or written comments on the collection of information by December 29, 2017.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 29, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 29, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2017-N-5975 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Alumni Commissioner's Fellowship Program Fellows.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected].

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Survey of Alumni Commissioner's Fellowship Program Fellows—OMB Control Number 0910—NEW

    FDA is requesting approval from OMB to gather information from Alumni Commissioner's Fellowship Program (CFP) Fellows. The information from Alumni CFP Fellows will allow FDA's Office of the Commissioner (OC) to easily and efficiently elicit and review program feedback. The online voluntary survey will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their experience with the FDA while a Commissioner's Fellow. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of surveys being misrouted within the Agency mail system. The information gathered by the survey will be used to gain insights into, and to document, impacts that the CFP has had and is having on former CFP fellows and contributions and impacts that the former fellows are making in their current work. The voluntary surveys include questions to assess the following measures: Post-fellowship employment (e.g., employment type); number of awards; number of contributions while a CFP fellow (e.g., number of publications, guidance documents authored or co-authored); and contributions in their field (e.g., list of publications).

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Fellowship Program Survey 35 1 35 * 0.50 17.5 1 There are no capital costs or operating maintenance costs associated with this collection of information. * 30 minutes.

    FDA based these estimates on the number of fellows who have graduated and left the Agency over the past 5 years.

    Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-23515 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4180] Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments; Reopening of Comment Period AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; reopening of the comment period.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is reopening the comment period provided in the notice entitled “Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments,” published in the Federal Register of July 25, 2017 (82 FR 34531). That notice announced the public workshop to be held on October 10, 2017, and requested comments by October 18, 2017. The Agency is taking this action to allow interested parties additional time to submit comments.

    DATES:

    FDA is reopening the comment period for the public workshop “Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments” published on July 25, 2017 (82 FR 34531). Submit either electronic or written comments on this public workshop by December 14, 2017.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 14, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2017-N-4180 for “Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments; Reopening of Comment Period.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Francisco Vicenty, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3426, Silver Spring, MD 20993, 301-796-5577, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of July 25, 2017 (82 FR 34531), FDA published a notice announcing the public workshop entitled “Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments” with an 85-day comment period to request comments. The public workshop was held on October 10, 2017. FDA is reopening the comment period for the public workshop until December 14, 2017. The Agency believes that this will allow adequate time for interested persons to submit comments without significantly delaying the action by the Agency.

    Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-23498 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

    FOR FURTHER INFORMATION CONTACT:

    For information about requirements for filing petitions, and the Program in general, contact Lisa L. Reyes, Acting Clerk, United States Court of Federal Claims, 717 Madison Place NW., Washington, DC 20005, (202) 357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 08N146B, Rockville, MD 20857; (301) 443-6593, or visit our Web site at: http://www.hrsa.gov/vaccinecompensation/index.html.

    SUPPLEMENTARY INFORMATION:

    The program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of HHS, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation.

    A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the table) set forth at 42 CFR 100.3. This table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.

    Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register.” Set forth below is a list of petitions received by HRSA on September 1, 2017, through September 30, 2017. This list provides the name of petitioner, city and state of vaccination (if unknown then city and state of person or attorney filing claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction.

    Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:

    1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and

    2. Any allegation in a petition that the petitioner either:

    a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the Table, or

    b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.

    In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading FOR FURTHER INFORMATION CONTACT), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, 5600 Fishers Lane, 08N146B, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of HHS) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the program.

    Dated: October 24, 2017. George Sigounas, Administrator. List of Petitions Filed 1. Jeffery Rowe, Grand Rapids, Michigan, Court of Federal Claims No: 17-1182V. 2. Clifford Reed, Dallas, Texas, Court of Federal Claims No: 17-1183V. 3. Robin Croce, Corona, California, Court of Federal Claims No: 17-1184V. 4. Matthew Jiminez, Boca Raton, Florida, Court of Federal Claims No: 17-1190V. 5. Laura Carson, Washington, District of Columbia, Court of Federal Claims No: 17-1193V. 6. Kristin Leara, Honolulu, Hawaii, Court of Federal Claims No: 17-1197V. 7. Scott Swailes, Holly Springs, North Carolina, Court of Federal Claims No: 17-1198V. 8. Ann Fly, Seattle, Washington, Court of Federal Claims No: 17-1200V. 9. Brenda Booker, Los Angeles, California, Court of Federal Claims No: 17-1201V. 10. Edwin M. Laird, Spokane, Washington, Court of Federal Claims No: 17-1203V. 11. Daniel Silver, Austin, Texas, Court of Federal Claims No: 17-1204V. 12. Kathleen Doherty-Peck, Norwich, Connecticut, Court of Federal Claims No: 17-1205V. 13. Barbara Perry, Arden, North Carolina, Court of Federal Claims No: 17-1207V. 14. Michael Napolitano, New Hyde Park, New York, Court of Federal Claims No: 17-1208V. 15. Laurence Kratzer, Walnut Creek, California, Court of Federal Claims No: 17-1209V. 16. Elizabeth McCrabb, Charleston, South Carolina, Court of Federal Claims No: 17-1210V. 17. Breanna White, Tallahassee, Florida, Court of Federal Claims No: 17-1211V. 18. Jodilyn Druery, Phoenix, Arizona, Court of Federal Claims No: 17-1213V. 19. Cherie J. Sullivan, Minneapolis, Minnesota, Court of Federal Claims No: 17-1214V. 20. Steven Ford, Chicago, Illinois, Court of Federal Claims No: 17-1217V. 21. Kelli Stricklin, Nixa, Missouri, Court of Federal Claims No: 17-1218V. 22. Ronald Brown, Naperville, Illinois, Court of Federal Claims No: 17-1219V. 23. Marlo K. Mayle, Freemont, Ohio, Court of Federal Claims No: 17-1221V. 24. Leslie K. Thompson, Murray, Utah, Court of Federal Claims No: 17-1223V. 25. Kevin Foxx, Newport News, Virginia, Court of Federal Claims No: 17-1224V. 26. Ava Cleaves, Indianapolis, Indiana, Court of Federal Claims No: 17-1225V. 27. Milan Sedlacek, Boston, Massachusetts, Court of Federal Claims No: 17-1226V. 28. James Daniel Parlette, Frankfort, Michigan, Court of Federal Claims No: 17-1227V. 29. Misti Fraser, Evansville, Indiana, Court of Federal Claims No: 17-1229V. 30. Ai Cordero, Torrance, California, Court of Federal Claims No: 17-1230V. 31. Azieb Kidane, Roseville, Minnesota, Court of Federal Claims No: 17-1231V. 32. Ofilia Arechiga, Santa Maria, California, Court of Federal Claims No: 17-1234V. 33. Elenita Alvarez-Tompkins, Washington, District of Columbia, Court of Federal Claims No: 17-1236V. 34. Theresa Cusolito, San Pedro, California, Court of Federal Claims No: 17-1237V. 35. Belinda Dawson-Savard, Salem, Oregon, Court of Federal Claims No: 17-1238V. 36. Sean Kelleher, Windsor, Connecticut, Court of Federal Claims No: 17-1239V. 37. Nick Koropatny, Washington, District of Columbia, Court of Federal Claims No: 17-1240V. 38. Carrie Schmatz, Manitowoc, Wisconsin, Court of Federal Claims No: 17-1241V. 39. Andrea Dixon on behalf of J. D., Farmington Hills, Michigan, Court of Federal Claims No: 17-1244V. 40. Correne Johnson, Blaine, Minnesota, Court of Federal Claims No: 17-1249V. 41. Stuart Weaver, Luray, Virginia, Court of Federal Claims No: 17-1251V. 42. Kehkahsan Khatoon, Farmington Hills, Michigan, Court of Federal Claims No: 17-1253V. 43. William Bartoszek, Hamburg, New York, Court of Federal Claims No: 17-1254V. 44. Breana Porcello, Medford, Massachusetts, Court of Federal Claims No: 17-1255V. 45. Lynn Johnson, Belgrade, Montana, Court of Federal Claims No: 17-1256V. 46. Glenn Reinhardt, San Antonio, Texas, Court of Federal Claims No: 17-1257V. 47. Michael O'Conner, Akron, Ohio, Court of Federal Claims No: 17-1259V. 48. Joan Smith, St. Louis, Missouri, Court of Federal Claims No: 17-1262V. 49. Judith Wilson, Madison, Wisconsin, Court of Federal Claims No: 17-1264V. 50. Sarah Stone, New York, New York, Court of Federal Claims No: 17-1265V. 51. Christine Ann Birch, Port Angeles, Washington, Court of Federal Claims No: 17-1266V. 52. Laurie Bloyer, Albuquerque, New Mexico, Court of Federal Claims No: 17-1267V. 53. Sara D'Angelo, Albuquerque, New Mexico, Court of Federal Claims No: 17-1268V. 54. Margaret DeLorenzo, Syracuse, New York, Court of Federal Claims No: 17-1269V. 55. Frances Lee, Graham, North Carolina, Court of Federal Claims No: 17-1270V. 56. Sandra Loydpierson, Charlotte, North Carolina, Court of Federal Claims No: 17-1271V. 57. Nicole Marshall, Exeter, New Hampshire, Court of Federal Claims No: 17-1272V. 58. Naomi Miller, Washington, District of Columbia, Court of Federal Claims No: 17-1273V. 59. Dolores Millican, Houston, Texas, Court of Federal Claims No: 17-1274V. 60. Jennifer Richey, North Kansas City, Missouri, Court of Federal Claims No: 17-1276V. 61. Ronald Beckman, Minneapolis, Minnesota, Court of Federal Claims No: 17-1279V. 62. Erika Hicks on behalf of A. C., Aurora, Colorado, Court of Federal Claims No: 17-1282V. 63. Larry Edge, Tavares, Florida, Court of Federal Claims No: 17-1283V. 64. Angela M. Andricks, Fostoria, Ohio, Court of Federal Claims No: 17-1284V. 65. Ralph Putnam, Putnam, Connecticut, Court of Federal Claims No: 17-1285V. 66. Marie Altema, Jersey City, New Jersey, Court of Federal Claims No: 17-1286V. 67. Barbara M. McDaniel, Washington, District of Columbia, Court of Federal Claims No: 17-1287V. 68. Larry Moranda, Eureka, California, Court of Federal Claims No: 17-1288V. 69. Caroline DiFrancesco, Reno, Nevada, Court of Federal Claims No: 17-1289V. 70. William Bartman on behalf of Angeline Bartman, Deceased, Pittsburgh, Pennsylvania, Court of Federal Claims No: 17-1290V. 71. Jon Flaig, Waverly, Iowa, Court of Federal Claims No: 17-1291V. 72. Patricia Feight, Mount Pleasant, Michigan, Court of Federal Claims No: 17-1292V. 73. Marc Barnet, Miramar, Florida, Court of Federal Claims No: 17-1293V. 74. Janet H. Stuchal, Lansdale, Pennsylvania, Court of Federal Claims No: 17-1294V. 75. Pamela M. Shaffer, Troy, Ohio, Court of Federal Claims No: 17-1295V. 76. Joan M. Douglass, Puyallup, Washington, Court of Federal Claims No: 17-1296V. 77. Cathy Mullen, Farmington Hills, Michigan, Court of Federal Claims No: 17-1297V. 78. Carrie Sadowski Ferguson, Arnold, Maryland, Court of Federal Claims No: 17-1299V. 79. Joyce Popwell, Pamona, New Jersey, Court of Federal Claims No: 17-1301V. 80. Gail Tomashefski, Indianapolis, Indiana, Court of Federal Claims No: 17-1302V. 81. Selwyn Hervey and Marylou Catoe Hervey on behalf of T. H., Rancho Santa Margarita, California, Court of Federal Claims No: 17-1305V. 82. Kristen Holmes, Houston, Texas, Court of Federal Claims No: 17-1306V. 83. Erika Colpaert on behalf of R. C., Farmington Hills, Michigan, Court of Federal Claims No: 17-1307V. 84. Elisabeth Link, Haddon Heights, New Jersey, Court of Federal Claims No: 17-1309V. 85. Rodolfo Monterroso, Inglewood, California, Court of Federal Claims No: 17-1310V. 86. Julia Wade, Lafayette, Louisiana, Court of Federal Claims No: 17-1311V. 87. Sally Jo Delpha, Liverpool, New York, Court of Federal Claims No: 17-1313V. 88. Joan Fram, Attleboro, Massachusetts, Court of Federal Claims No: 17-1314V. 89. Mindy Puckett, South Fargo, North Dakota, Court of Federal Claims No: 17-1316V. 90. Ralph Mueller, Boston, Massachusetts, Court of Federal Claims No: 17-1318V. 91. Richard Brandell, Springfield, Missouri, Court of Federal Claims No: 17-1319V. 92. Robert Malwitz, Grand Rapids, Minnesota, Court of Federal Claims No: 17-1320V. 93. David T. McDaniel, North Bend, Washington, Court of Federal Claims No: 17-1322V. 94. James Struck, Evanston, Illinois, Court of Federal Claims No: 17-1326V. 95. Angela Tavolacci on behalf of L. T., Washington, District of Columbia, Court of Federal Claims No: 17-1327V. 96. Jonathan McDougald, Fayetteville, North Carolina, Court of Federal Claims No: 17-1328V. 97. Richard Kadry, South Fargo, North Dakota, Court of Federal Claims No: 17-1330V. 98. Harry Cobb, Virginia Beach, Virginia, Court of Federal Claims No: 17-1331V. 99. Dave W. Highland, Louisville, Colorado, Court of Federal Claims No: 17-1333V. 100. Kay B. Harvey, Roanoke, Virginia, Court of Federal Claims No: 17-1334V. 101. Lindsey Denwiddie, Manchester, New Hampshire, Court of Federal Claims No: 17-1335V. 102. Barbara Kern, Gladwyne, Pennsylvania, Court of Federal Claims No: 17-1337V. 103. Cris D. Salazar, Santa Fe, New Mexico, Court of Federal Claims No: 17-1338V. 104. Geraldine Abel, Bridgeville, Delaware, Court of Federal Claims No: 17-1339V. 105. Mark Palmore, Frankfort, Indiana, Court of Federal Claims No: 17-1340V. 106. Stefanie Hoffman, Eugene, Oregon, Court of Federal Claims No: 17-1341V. 107. Timothy Flaig, Seattle, Washington, Court of Federal Claims No: 17-1342V. 108. Kathleen Purvis, Phenix City, Alabama, Court of Federal Claims No: 17-1343V. 109. Heather Russell-Lang, Naples, Florida, Court of Federal Claims No: 17-1344V. 110. Rosanna Massucci, Morristown, New Jersey, Court of Federal Claims No: 17-1345V. 111. Cristina K. Biesold on behalf of C. P. B., New York, New York, Court of Federal Claims No: 17-1346V. 112. Amber Wilson on behalf of A. W., Washington, District of Columbia, Court of Federal Claims No: 17-1349V. 113. Yukiko Boquet, Washington, District of Columbia, Court of Federal Claims No: 17-1351V. 114. Caprice Britt, Washington, District of Columbia, Court of Federal Claims No: 17-1352V. 115. Amy Dunlap, Washington, District of Columbia, Court of Federal Claims No: 17-1353V. 116. Barbara Easter, Washington, District of Columbia, Court of Federal Claims No: 17-1354V. 117. Herbert Geller, Washington, District of Columbia, Court of Federal Claims No: 17-1355V. 118. Nickol Marta, San Francisco, California, Court of Federal Claims No: 17-1356V. 119. Tracy Murray, Washington, District of Columbia, Court of Federal Claims No: 17-1357V. 120. Monika Nuon, Washington, District of Columbia, Court of Federal Claims No: 17-1358V. 121. Mary Perry, Washington, District of Columbia, Court of Federal Claims No: 17-1359V. 122. Amber Quintal, Washington, District of Columbia, Court of Federal Claims No: 17-1360V. 123. Wilma Rivers, Washington, District of Columbia, Court of Federal Claims No: 17-1361V. 124. Andrew J. Kaltenmark on behalf of Addison Judith Kaltenmark, Valdosta, Georgia, Court of Federal Claims No: 17-1362V. 125. Prentissa Rodrigue, Chalmette, Louisiana, Court of Federal Claims No: 17-1364V. 126. Robert J. Schaefer, St. Louis, Missouri, Court of Federal Claims No: 17-1365V. 127. Gayle Foshee-Naughton, Clearwater, Florida, Court of Federal Claims No: 17-1366V. 128. Benjamin S. Maxwell, Spokane, Washington, Court of Federal Claims No: 17-1367V. 129. Mechelle Head, Dresher, Pennsylvania, Court of Federal Claims No: 17-1368V. 130. Charles Gensmer, Coon Rapids, Minnesota, Court of Federal Claims No: 17-1369V. 131. Lauren Rettig, Memphis, Tennessee, Court of Federal Claims No: 17-1370V. 132. Laura Weishaar on behalf of Loretta Nordtvedt, Deceased, Seattle, Washington, Court of Federal Claims No: 17-1372V. 133. Emily Conger, Fort Worth, Texas, Court of Federal Claims No: 17-1373V. 134. Nathan Coulter, Garden City, New York, Court of Federal Claims No: 17-1376V. 135. Maria Swicki, Warwick, Rhode Island, Court of Federal Claims No: 17-1377V. 136. Jodi Fiske, Delray Beach, Florida, Court of Federal Claims No: 17-1378V. 137. John Alves and Virginia Alves on behalf of B. A., Gloucester, Massachusetts, Court of Federal Claims No: 17-1379V. 138. Jennifer Martindale, Glen Falls, New York, Court of Federal Claims No: 17-1380V. 139. James Blute, Lowell, Massachusetts, Court of Federal Claims No: 17-1381V. 140. Naomi Delgado, West Palm Beach, Florida, Court of Federal Claims No: 17-1382V. 141. John Mason, Merced, California, Court of Federal Claims No: 17-1383V. 142. Lisa Spencer, Buffalo, New York, Court of Federal Claims No: 17-1384V. 143. Toni Ragusa, White Plains, New York, Court of Federal Claims No: 17-1385V. 144. Becky Wiethorn, Independence, Kentucky, Court of Federal Claims No: 17-1386V. 145. Nichole Wagner, Boston, Massachusetts, Court of Federal Claims No: 17-1388V. 146. Teresa Stine, South Mountain, Pennsylvania, Court of Federal Claims No: 17-1389V.
    [FR Doc. 2017-23558 Filed 10-27-17; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy AGENCY:

    Health Resources and Services Administration, Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    The Health Resources and Services Administration (HRSA) is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP).

    Section 100.2 of the VICP's implementing regulation (42 CFR part 100) states that the revised amount of an average cost of a health insurance policy, as determined by the Secretary, is effective upon its delivery by the Secretary to the United States Court of Federal Claims (the Court), and will be published periodically in a notice in the Federal Register. This figure is calculated using the most recent Medical Expenditure Panel Survey-Insurance Component (MEPS-IC) data available as the baseline for the average monthly cost of a health insurance policy. This baseline is adjusted by the annual percentage increase/decrease obtained from the most recent annual Kaiser Family Foundation and Health Research and Educational Trust (KFF/HRET) Employer Health Benefits survey or other authoritative source that may be more accurate or appropriate.

    In 2017, MEPS-IC, available at www.meps.ahrq.gov, published the annual 2016 average total single premium per enrolled employee at private-sector establishments that provide health insurance. The figure published was $6,101. This figure is divided by 12-months to determine the cost per month of $508.42. The $508.42 is increased or decreased by the percentage change reported by the most recent KFF/HRET Employer Health Benefits Survey, available at www.kff.org. The percentage increase from 2016 to 2017 was 4.0 percent. By adding this percentage increase, the calculated average monthly cost of a health insurance policy for a 12-month period is $528.76.

    Therefore, the Secretary announces that the revised average cost of a health insurance policy under the VICP is $528.76 per month. In accordance with § 100.2, the revised amount was effective upon its delivery by the Secretary to the Court. Such notice was delivered to the Court on October 24, 2017.

    Dated: October 24, 2017. George Sigounas, Administrator.
    [FR Doc. 2017-23557 Filed 10-27-17; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Infant Mortality; Notice of Charter Renewal SUMMARY:

    The Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Infant Mortality (ACIM) has been rechartered. The effective date of the renewed ACIM charter is September 30, 2017.

    FOR FURTHER INFORMATION CONTACT:

    David S. de la Cruz, Ph.D., M.P.H., CAPTAIN, United States Public Health Service, Designated Federal Officer, ACIM, Health Resources and Services Administration (HRSA), HHS, Room 18N25, 5600 Fishers Lane, Rockville, MD 20857. Phone: (301) 443-0543; [email protected]

    SUPPLEMENTARY INFORMATION:

    ACIM was established under provisions of 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended. The Committee is governed by provisions of Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of Advisory Committees. ACIM advises the Secretary on Department activities and programs that are directed at reducing infant mortality and improving the health status of pregnant women and infants. The Committee represents a public and private partnership at the highest level to provide guidance and focus attention on the policies and resources required to address the reduction of infant mortality. The Committee also provides advice on how best to coordinate the myriad of federal, state, local, and private programs and efforts that are designed to deal with the health and social problems impacting infant mortality, including the Healthy Start program.

    On September 30, 2017, the ACIM charter was renewed. Renewal of the ACIM charter authorizes the Committee to operate until September 30, 2019. A copy of the ACIM charter is available on the Committee's Web site: http://www.hrsa.gov/advisorycommittees/mchbadvisory/InfantMortality/Index.html. A copy of the charter can also be obtained by accessing the Federal Advisory Committee Act (FACA) database that is maintained by the Committee Management Secretariat under the General Services Administration. The Web site address for the FACA database is http://www.facadatabase.gov/.

    Amy McNulty, Acting Director, Division of the Executive Secretariat.
    [FR Doc. 2017-23528 Filed 10-27-17; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Integrative Health; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the ZAT1 VS (07).

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

    Name of Committee: National Center for Complementary and Integrative Health Special Emphasis Panel; Research Resource for Systematic Reviews of Complementary and Integrative Health (R24).

    Date: December 5, 2017.

    Time: 1:00 p.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Viatcheslav A. Soldatenkov, MD, Ph.D., Scientific Review Officer Office of Scientific Review, Division of Extramural Activities NCCIH/NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, MD 20892, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.213, Research and Training in Complementary and Alternative Medicine, National Institutes of Health, HHS)
    Dated: October 24, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-23459 Filed 10-27-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary and Integrative Health; 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 ZAT1 AJT (05) Exploratory Clinical Trials of Mind and Body Interventions.

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

    Name of Committee: National Center for Complementary and Integrative Health Special Emphasis Panel; Exploratory Clinical Trials of Mind and Body Interventions Review Panel.

    Date: December 1, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852.

    Contact Person: Ashlee Tipton, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Center for Complementary, and Integrative Health, 6707 Democracy Boulevard, Room 401, Bethesda, MD 20892, 301-451-3849, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.213, Research and Training in Complementary and Alternative Medicine, National Institutes of Health, HHS)
    Dated: October 24, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-23458 Filed 10-27-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY [Docket ID DHS-2017-0062] The President's National Security Telecommunications Advisory Committee AGENCY:

    National Protection and Programs Directorate, Department of Homeland Security (DHS).

    ACTION:

    Committee Management; Notice of Federal Advisory Committee Meeting.

    SUMMARY:

    The President's National Security Telecommunications Advisory Committee (NSTAC) will meet via teleconference on Thursday, November 16, 2017. The meeting will be open to the public.

    DATES:

    The NSTAC will meet on November 16, 2017 from 3:30 p.m. to 4:00 p.m. Eastern Standard Time (EST). Please note that the meeting may close early if the committee has completed its business.

    ADDRESSES:

    The meeting will be held via conference call. For access to the conference call bridge, information on services for individuals with disabilities, or to request special assistance to participate, please email [email protected] by 5:00 p.m. EST on Wednesday, November 15, 2017.

    Members of the public are invited to provide comment on the issues that will be considered by the committee as listed in the SUPPLEMENTARY INFORMATION section below. The report that participants will deliberate and vote on during the meeting is available at www.dhs.gov/nstac for review as of Friday, October 6, 2017. Comments may be submitted at any time and must be identified by docket number DHS-2017-0062. Comments may be submitted by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Please follow the instructions for submitting written comments.

    Email: [email protected]. Include the docket number DHS-2017-0062 in the subject line of the email.

    Fax: (703) 705-6190, ATTN: Sandy Benevides.

    Mail: Helen Jackson, Designated Federal Officer, Stakeholder Engagement and Cyber Infrastructure Resilience Division, National Protection and Programs Directorate, Department of Homeland Security, 245 Murray Lane, Mail Stop 0612, Arlington, VA 20598-0612.

    Instructions: All submissions received must include the words “Department of Homeland Security” and the docket number for this action. Comments received will be posted without alteration at www.regulations.gov, including any personal information provided.

    Docket: For access to the docket and comments received by the NSTAC, please go to www.regulations.gov and enter docket number DHS-2017-0062.

    A public comment period will be held during the teleconference on Thursday, November 16, 2017, from 3:35 p.m. EST to 3:45 p.m. Speakers who wish to participate in the public comment period must register in advance by no later than Monday, November 13, 2017, at 5:00 p.m. EST by emailing [email protected]. Speakers are requested to limit their comments to three minutes and will speak in order of registration. Please note that the public comment period may end before the time indicated, following the last request for comments.

    FOR FURTHER INFORMATION CONTACT:

    Helen Jackson, NSTAC Designated Federal Officer, Department of Homeland Security, (703) 705-6276 (telephone) or [email protected] (email).

    SUPPLEMENTARY INFORMATION:

    Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. Appendix (Pub. L. 92-463). The NSTAC advises the President on matters related to national security and emergency preparedness (NS/EP) telecommunications and cybersecurity policy.

    Agenda: The NSTAC will hold a conference call on Thursday, November 16, 2017, to deliberate and vote on the final draft of the NSTAC Report to the President on Internet and Communications Resilience which addresses ways in which the private sector and Government, together, can improve the resilience of the Internet and communications ecosystem (e.g., against botnets). In May 2017, the National Security Council (NSC), on behalf of the President, and as part of Executive Order 13800, Strengthening the Cybersecurity of Federal Networks and Critical Infrastructure, Section 2 (d), requested that the President's NSTAC examine how the private sector and Government could improve the resilience of the Internet and communications ecosystem. The report examines threats within the Internet ecosystem and possible solutions, ranging from short-term remedies to long-term solutions. The NSTAC's goal is to inform the Administration's efforts to set cybersecurity priorities and develop policies to deepen Government and private industry cooperation. The report provides specific recommendations for the private sector and the Government. The draft NSTAC Report to the President on Internet and Communications Resilience can be found at https://www.dhs.gov/publication/2017-nstac-publications.

    Dated: October 25, 2017. Helen Jackson, Designated Federal Officer for the NSTAC.
    [FR Doc. 2017-23544 Filed 10-27-17; 8:45 am] BILLING CODE 9110-9P-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R8-ES-2017-N131; FXES11130800000-178-FF08E00000] Endangered Species Recovery Permit Applications AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of receipt of permit applications; request for comment.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (Act) prohibits activities with endangered and threatened species unless a Federal permit allows such activity. The Act also requires that we invite public comment before issuing recovery permits to conduct certain activities with endangered species.

    DATES:

    Comments on these permit applications must be received on or before November 29, 2017.

    ADDRESSES:

    Written data or comments should be submitted to the Endangered Species Program Manager, U.S. Fish and Wildlife Service, Region 8, 2800 Cottage Way, Room W-2606, Sacramento, CA 95825 (telephone: 916-414-6464; fax: 916-414-6486). Please refer to the respective permit number for each application when submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    Daniel Marquez, Fish and Wildlife Biologist; see ADDRESSES (telephone: 760-431-9440; fax: 760-431-9624; email: [email protected]).

    SUPPLEMENTARY INFORMATION:

    The following applicants have applied for scientific research permits to conduct certain activities with endangered species under section 10(a)(1)(A) of the Act (16 U.S.C. 1531 et seq.). We seek review and comment from local, State, and Federal agencies and the public on the following permit requests:

    Applicants Permit No. TE-212445 Applicant: Robert Schell, San Rafael, California

    The applicant requests a permit renewal and amendment to take (capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi); and take (capture, handle, take tissue samples, and release) the California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segments (DPS)) (Ambystoma californiense) in conjunction with survey and research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-040553 Applicant: Daniel A. Marschalek, San Diego, California

    The applicant requests a permit renewal to take the Quino checkerspot butterfly (Euphydryas editha quino) and Laguna Mountains skipper (Pyrgus ruralis lagunae) in conjunction with survey activities throughout the range of each species in California for the purpose of enhancing the species' survival.

    Permit No. TE-34126C Applicant: Francesca A. Cannizzo, Fresno, California

    The applicant requests a new permit to take (capture, handle, and release) the California tiger salamander (central California DPS (Ambystoma californiense)) and take (capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio) and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-64144A Applicant: Emily M. Mastrelli, San Diego, California

    The applicant requests a permit amendment to take the Quino checkerspot butterfly (Euphydryas editha quino) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-74377B Applicant: Shannon E. Mindeman, San Diego, California

    The applicant requests a permit amendment to take the Quino checkerspot butterfly (Euphydryas editha quino) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-021929 Applicant: Sacramento Splash, Mather, California

    The applicant requests a permit renewal to take (capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey activities in Sacramento County, California, for the purpose of enhancing the species' survival.

    Permit No. TE-34132C Applicant: U.S. Forest Service, Vallejo, California

    The applicant requests a new permit to take (capture, handle, measure, take skin swabs, clip toes, insert PIT (Passive Integrated Transponder) tags, mark with VIE (Visual Implant Elastomer), transport, translocate, emergency salvage, and release) the Sierra Nevada yellow-legged frog (Rana sierrae) and mountain yellow-legged frog (northern California DPS (Rana muscosa)) in conjunction with survey and research activities throughout the range of each species in California for the purpose of enhancing the species' survival.

    Permit No. TE-24603A Applicant: Karen J. Carter, Running Springs, California

    The applicant requests a permit renewal to take the Yuma Clapper rail (Yuma Ridgway's r.) (Rallus longirostris yumanensis) (R. obsoletus y.) in conjunction with survey activities throughout the range of the species in California and Nevada for the purpose of enhancing the species' survival.

    Permit No. TE-082233 Applicant: Marcus C. England, Los Angeles, California

    The applicant requests a permit renewal to take (locate and monitor nests; and remove brown-headed cowbird (Molothrus ater) eggs and chicks from parasitized nests) the least Bell's vireo (Vireo bellii pusillus) and take (survey for, locate and monitor nests, and remove brown-headed cowbird (Molothrus ater) eggs and chicks from parasitized nests) the southwestern willow flycatcher (Empidonax traillii extimus) in conjunction with survey and population monitoring activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-179036 Applicant: Cullen Wilkerson, Richmond, California

    The applicant requests a permit amendment to take the California Clapper rail (California Ridgway's r.) (Rallus longirostris obsoletus) (R. obsoletus o.) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-233373 Applicant: Mary Anne Flett, Point Reyes Station, California

    The applicant requests a permit amendment to take the California Clapper rail (California Ridgway's r.) (Rallus longirostris obsoletus) (R. obsoletus o.) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-798003 Applicant: North State Resources, Inc., Redding, California

    The applicant requests a permit renewal to take (capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi); take (by survey activities) the southwestern willow flycatcher (Empidonax traillii extimus); and take (capture, handle, and release) the California tiger salamander (Santa Barbara County and Sonoma County DPSs (Ambystoma californiense)) in conjunction with survey activities throughout the range of the species in California and Oregon for the purpose of enhancing the species' survival.

    Permit No. TE-59592B Applicant: Angela M. Johnson, Wauconda, Illinois

    The applicant requests a permit amendment and renewal to take (survey for, locate and monitor nests, and remove brown-headed cowbird (Molothrus ater) eggs and chicks from parasitized nests) the southwestern willow flycatcher (Empidonax traillii extimus) and take (locate and monitor nests, and remove brown-headed cowbird (Molothrus ater) eggs and chicks from parasitized nests) the least Bell's vireo (Vireo bellii pusillus) in conjunction with survey and population monitoring activities throughout the range of the species in California, Nevada, and Arizona, for the purpose of enhancing the species' survival.

    Permit No. TE-837574 Applicant: Eremico Biological Services, Weldon, California

    The applicant requests a permit renewal to take (capture, band, collect blood samples, and release) the southwestern willow flycatcher (Empidonax traillii extimus) in conjunction with survey, population monitoring, and research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-60149A Applicant: California Department of Fish and Wildlife, Arcata, California

    The applicant requests a permit renewal to take (capture, handle, and release) the tidewater goby (Eucyclogobius newberryi) in Humboldt County, Del Norte County, and Mendocino County, California, in conjunction with survey activities for the purpose of enhancing the species' survival.

    Permit No. TE-36221C Applicant: Jason R. Peters, Sacramento, California

    The applicant requests a new permit to take (capture, handle, and release) the California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment DPSs (Ambystoma californiense)) and take (capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-190303 Applicant: Daniel W.H. Shaw, Tahoma, California

    The applicant requests a permit renewal and amendment to take (capture, handle, and release) the Sierra Nevada yellow-legged frog (Rana sierrae) and California tiger salamander (Santa Barbara County and Sonoma County DPSs (Ambystoma californiense)) in conjunction with survey activities throughout the range of the species for the purpose of enhancing the species' survival.

    Permit No. TE-86811A Applicant: Southwest Resource Management Association, Riverside, California

    The applicant requests a permit amendment to take (capture, handle, release, and emergency salvage) the unarmored threespine stickleback (Gasterosteus aculeatus williamsoni) in conjunction with survey and salvage activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-797315 Applicant: Michael Morrison, College Station, Texas

    The applicant requests a permit renewal to take (capture, handle, mark, and release) the Fresno kangaroo rat (Dipodomys nitratoides exilis) and take (capture, handle, measure, mark, collect fur samples, and release) the salt marsh harvest mouse (Reithrodontomys raviventris) in conjunction with survey and research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-190302 Applicant: Mitch Siemens, Arroyo Grande, California

    The applicant requests a permit renewal to take (capture, handle, and release) the California tiger salamander (Santa Barbara County and Sonoma County DPSs (Ambystoma californiense)) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-053379 Applicant: Christine Tischer, Orange, California

    The applicant requests a permit renewal to take the Quino checkerspot butterfly (Euphydryas editha quino) and take (capture, handle, release, collect adult vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), Riverside fairy shrimp (Streptocephalus woottoni), San Diego fairy shrimp (Branchinecta sandiegonensis), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-003269 Applicant: Robert James, San Diego, California

    The applicant requests a permit renewal to take (capture, handle, and release) the Stephens' kangaroo rat (Dipodomys stephensi) and Pacific pocket mouse (Perognathus longimembris pacificus); take (capture, handle, release, collect vouchers, and collect branchiopod cysts) the San Diego fairy shrimp (Branchinecta sandiegonensis) and Riverside fairy shrimp (Streptocephalus woottoni); and take the Quino checkerspot butterfly (Euphydryas editha quino) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-811615 Applicant: Cynthia Daverin, San Diego, California

    The applicant requests a permit renewal to take (survey for, locate and monitor nests, and remove brown-headed cowbird (Molothrus ater) eggs and chicks from parasitized nests) the southwestern willow flycatcher (Empidonax traillii extimus); take (locate and monitor nests, and remove brown-headed cowbird (Molothrus ater) eggs and chicks from parasitized nests) the least Bell's vireo (Vireo bellii pusillus); and take the Quino checkerspot butterfly (Euphydryas editha quino) in conjunction with survey and population monitoring activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-074955 Applicant: Susan Scatolini, San Diego, California

    The applicant requests a permit renewal to take (capture, handle, release, collect vouchers, and collect branchiopod cysts) the San Diego fairy shrimp (Branchinecta sandiegonensis) and Riverside fairy shrimp (Streptocephalus woottoni) in conjunction with survey activities within San Diego County and Imperial County, California, for the purpose of enhancing the species' survival.

    Permit No. TE-74785A Applicant: Barry Nerhus, Costa Mesa, California

    The applicant requests a permit renewal and amendment to take (survey for and locate and monitor nests) the Light-Footed Clapper rail (light-footed Ridgway's r.) (Rallus longirostris levipes) (R. obsoletus l.) in conjunction with survey and population monitoring activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-45250C Applicant: Griffin Brungraber, Bend, Oregon

    The applicant requests a new permit to take the Quino checkerspot butterfly (Euphydryas editha quino) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-45251C Applicant: Emily Moffitt, Campbell, California

    The applicant requests a new permit to take (capture, handle, and release) the California tiger salamander (Santa Barbara County and Sonoma County DPSs (Ambystoma californiense)) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-195305 Applicant: Andres Aguilar, Los Angeles, California

    The applicant requests a permit renewal to take (capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey and research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-025732 Applicant: Samuel Sweet, Santa Barbara, California

    The applicant requests a permit renewal to take (capture, handle, measure, mark, relocate, release, attach radio tags, collect tail tissue, swab for chytrid fungus testing, collect specimens, conduct restoration activities, and remove and euthanize hybrids) the California tiger salamander (Santa Barbara County DPS (Ambystoma californiense)) and take (capture, handle, swab for chytrid fungus testing, maintain in enclosures in-stream, release, relocate, and collect dead individuals) the arroyo toad (arroyo southwestern) (Anaxyrus californicus) in conjunction with survey and scientific research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-54614A Applicant: California Department of Fish and Wildlife, Rancho Cordova, California

    The applicant requests a permit amendment and renewal to take (capture, handle, collect, photograph, tag, attach radio transmitters and radio track, mark, collect morphological data, collect parasites and tissue, conduct veterinary testing (assess reproductive condition, conduct health assessments, quarantine, test for disease and parasites), administer veterinary care, obtain genetic samples, euthanize, remove from the wild, transport, hold in captivity, captive-rear, captive-breed, release to the wild, translocate, use remote cameras, and monitor populations) the Amargosa vole (Microtus californicus scirpensis) in conjunction with survey, research, and behavior studies throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-018111 Applicant: Tenera Environmental, San Luis Obispo, California

    The applicant requests a permit renewal to take (capture, handle, and release) the tidewater goby (Eucyclogobius newberryi) in conjunction with survey activities throughout the range of the species in California for the species for the purpose of enhancing the species' survival.

    Permit No. TE-787037 Applicant: University of San Diego, San Diego, California

    The applicant requests a permit renewal to take (capture, handle, release, collect adult vouchers, collect resting eggs, conduct genetic analysis, process vernal pool soil samples for egg identification, and culturing and hatching out of branchiopod eggs) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey and genetic research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Public Comments

    We invite public review and comment on each of these recovery permit applications. Comments and materials we receive will be available for public inspection, by appointment, during normal business hours at the address listed in the ADDRESSES section of this notice.

    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.

    Angela Picco, Acting Regional Director, Pacific Southwest Region, Sacramento, California.
    [FR Doc. 2017-23502 Filed 10-27-17; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [17X LLAK980600.L1820000.XX0000.LXSIARAC0000] Notice of Public Meeting, BLM Alaska Resource Advisory Council AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In accordance with the Federal Land Policy and Management Act of 1976 as amended and the Federal Advisory Committee Act of 1972, the Bureau of Land Management (BLM) Alaska Resource Advisory Council (RAC) will meet as indicated below.

    DATES:

    The RAC will hold a public meeting on Thursday, November 16, 2017, from 8 a.m. until 5 p.m. and Friday, November 17, 2017, from 8 a.m. until noon. A public comment period will be held during Thursday's meeting from 4 to 5 p.m.

    ADDRESSES:

    The meeting will take place in the Executive Dining Room at the Federal Building, 222 W. 7th Ave., Anchorage, Alaska. The agenda will be posted online by Oct. 17, 2017, at https://www.blm.gov/site-page/get-involved-resource-advisory-council/near-you/alaska/rac.

    FOR FURTHER INFORMATION CONTACT:

    Dave Doucet, RAC Coordinator, BLM Alaska State Office, 222 W. 7th Avenue #13, Anchorage, AK 99513; [email protected]; 907-271-4405. 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:

    The 15-member BLM Alaska RAC was chartered to provide advice to the BLM and the Secretary of the Interior on a variety of planning and management issues associated with public land management in Alaska. All RAC meetings are open to the public. If you have written comments to distribute to the RAC, please do so prior to the start of the meeting.

    Agenda items for the meeting include updates on BLM Alaska planning efforts such as the Bering Sea-Western Interior and Central Yukon Resource Management Plans, the Road to Ambler Mining District Environmental Impact Statement, the Donlin Gold Mine Right of Way, and the Alaska Stand Alone Pipeline/Alaska LNG project. In addition, the BLM will present updates on the status of Public Land Orders withdrawing land from selection or development, activities in the National Petroleum Reserve in Alaska, including the Greater Mooses Tooth Unit 2 project, and the upcoming Oil and Gas Lease Sale. The Placer Mining Subcommittee will present reports on the 2017 placer mining field season and preparations for the 2018 field season, and the Alaska Native Claims Settlement Act Subcommittee will discuss access and subsistence issues. The BLM will also encourage the RAC to provide the BLM with input on recreation, access and transportation issues including the proposed Trans-Alaska Trail along the Trans-Alaska Pipeline System corridor; the Transportation Management Plans for the Steese National Conservation Area and the White Mountains National Recreation Area; the possibilities of partnerships with the State and other agencies for access, recreation, and transportation issues; and the possibility of adjusting recreation site fees. The State of Alaska will also make a presentation on the Arctic Strategic Transportation and Resources Project. The BLM Alaska will post the meeting agenda by Oct. 17, 2017, to the BLM Alaska Web site at https://www.blm.gov/get-involved/resource-advisory-council/near-you/alaska/rac. During the public comment period, depending upon the number of people wishing to comment, time for individual oral comments may be limited. Please be prepared to submit written comments. Written comments can be submitted by email to [email protected]

    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.

    Authority:

    42 U.S.C. 15906; 43 CFR 1784.4-2.

    Karen E. Mouritsen, Acting State Director, Alaska.
    [FR Doc. 2017-23532 Filed 10-27-17; 8:45 am] BILLING CODE 4310-JA-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-1078] Certain Amorphous Metal and Products Containing Same; Institution of Investigation AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 19, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of Metglas, Inc. of Conway, South Carolina and Hitachi Metals, Ltd. of Japan. Supplements were filed on September 20, 2017, and October 6, 2017. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, or in the sale of certain amorphous metal and products containing same by reason of misappropriation of trade secrets, the threat or effect of which is to destroy or substantially injure a domestic industry in the United States.

    The complainants request that the Commission institute an investigation and, after the investigation, issue a general exclusion order, or in the alternative a limited exclusion order, and cease and desist orders.

    ADDRESSES:

    The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.

    FOR FURTHER INFORMATION CONTACT:

    Pathenia M. Proctor, The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.

    SUPPLEMENTARY INFORMATION:

    Authority:

    The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2017).

    Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on October 24, 2017, ordered that

    (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(A) of section 337 in the importation into the United States, or in the sale of certain amorphous metal and products containing same by reason of misappropriation of trade secrets, the threat or effect of which is to destroy or substantially injure a domestic injury in the United States;

    (2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:

    (a) The complainant are:

    Metglas, Inc., 440 Allied Drive, Conway, SC 29526. Hitachi Metals, Ltd., Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo 108-8224, Japan.

    (b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:

    Advanced Technology & Materials, No. 76 Xueyuan Nanlu, Haidian, Beijing 100081, China. AT&M International Trading Co., Ltd., No. 76 Xueyuan Nanlu, Haidian, Beijing 100081, China. CISRI International Trading Co., Ltd., No. 13 Gaoliangqiaoxiejie, Haidian District, Beijing 100081, China. Beijing ZLJG Amorphous Technology Co., Ltd., No. 9 Huanyu Road, Majuqiao, Tongzhou District, Beijing, 101102, China. Qingdao Yunlu Energy Technology Co., Ltd., No. 97 Yanyang Road, Chengyang District, Qingdao, China.

    (c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW., Suite 401, Washington, DC 20436; and

    (3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.

    Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.

    Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.

    By order of the Commission.

    Issued: October 25, 2017. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2017-23541 Filed 10-27-17; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Mounting Apparatuses for Holding Portable Electronic Devices and Components Thereof, DN 3268; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

    FOR FURTHER INFORMATION CONTACT:

    Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at https://edis.usitc.gov, and will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000.

    General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's Electronic Document Information System (EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

    SUPPLEMENTARY INFORMATION:

    The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of National Products, Inc. (“NPI”) on October 24, 2017. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain mounting apparatuses for holding portable electronic devices and components thereof. The complaint names as respondents Shenzhen Chengshuo Technology Co., Ltd. d/b/a WUPP of China; Foshan City Qishi Sporting Goods Technology Co., Ltd. d/b/a N-Star of China; Chengdu MWUPP Technology Co., Ltd. of China; Shenzhen Yingxue Technology Co., Ltd. d/b/a Yingxue Tech of China; Shenzhen Shunsihang Technology Co., Ltd. d/b/a BlueFire of China; Guangzhou Kean Products Co., Ltd. of China; Prolech Electronics Limited of China; Gangzhou Kaicheng Metal Produce Co., Ltd. d/b/a ZJMOTO of China; Shenzhen Smilin Electronic Technology Co., Ltd. of China; and Shenzhen New Dream Intelligent Plastic Co., Ltd. of China. The complainant requests that the Commission issue a general exclusion order, or in the alternative, a limited exclusion order, cease and desist orders, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).

    Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

    In particular, the Commission is interested in comments that:

    (i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;

    (ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

    (iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

    (iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

    (v) explain how the requested remedial orders would impact United States consumers.

    Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register. There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation.

    Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3268”) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, Electronic Filing Procedures 1 ). Persons with questions regarding filing should contact the Secretary (202-205-2000).

    1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf.

    Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel,2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.3

    2 All contract personnel will sign appropriate nondisclosure agreements.

    3 Electronic Document Information System (EDIS): https://edis.usitc.gov.

    This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

    By order of the Commission.

    Issued: October 25, 2017. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2017-23543 Filed 10-27-17; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-1079] Certain Shaving Cartridges, Components Thereof and Products Containing Same Institution of Investigation AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 25, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of The Gillette Company LLC of Boston, Massachusetts. A supplement to the complaint was filed on September 28, 2017. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain shaving cartridges, components thereof and products containing same by reason of infringement of U.S. Patent No. 9,193,077 (“the ’077 patent”). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute.

    The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

    ADDRESSES:

    The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.

    FOR FURTHER INFORMATION CONTACT:

    The Office of Docket Services, U.S. International Trade Commission, telephone (202) 205-1802.

    SUPPLEMENTARY INFORMATION:

    Authority: The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2017).

    Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on October 24, 2017, ordered that—

    (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain shaving cartridges, components thereof and products containing same by reason of infringement of one or more of claims 1-4, 11-14, and 18-20 of the ’077 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;

    (2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:

    (a) The complainant is: The Gillette Company LLC, 1 Gillette Park, Boston, MA 02127.

    (b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served: Edgewell Personal Care Company, 1350 Timberlake Manor Parkway, Chesterfield, MO 63017; Edgewell Personal Care Brands, LLC, 6 Research Drive, Shelton, CT 06484; Edgewell Personal Care, LLC, 6 Research Drive, Shelton, CT 06484; Schick Manufacturing, Inc., 6 Research Drive, Shelton, CT 06484; Schick (Guangzhou) Co., Limited, No. 3 Xia Yuan Road, Dong Ji, Industrial District, Getdd, Guangzhou 510730, China.

    (3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.

    The Office of Unfair Import Investigations will not participate as a party in the investigation.

    The Commission notes that issues regarding whether the importation requirement of section 337 is met may be present here. In instituting this investigation, the Commission has not made any determination as to whether Complainant has satisfied this requirement. Accordingly, the presiding Administrative Law Judge may wish to consider this issue at an early date. Notwithstanding any Commission Rules to the contrary, which are hereby waived, any such decision should be issued in the form of an initial determination (ID) under Rule 210.42(c), 19 CFR 210.42(c). The ID will become the Commission's final determination 45 days after the date of service of the ID unless the Commission determines to review the ID. Any such review will be conducted in accordance with Commission Rules 210.43, 210.44, and 210.45, 19 CFR 210.43, 210.44, and 210.45.

    Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.

    Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.

    By order of the Commission.

    Issued: October 25, 2017. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2017-23542 Filed 10-27-17; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Euticals Inc. ACTION:

    Notice of application.

    DATES:

    Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 29, 2017.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import raw material are not appropriate. 72 FR 3417 (January 25, 2007).

    SUPPLEMENTARY INFORMATION:

    The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

    In accordance with 21 CFR 1301.33(a), this is notice that on June 20, 2017, Euticals, Inc., 2460 W. Bennett Street, Springfield, Missouri 65807-1229 applied to be registered as a bulk manufacturer the following basic classes of controlled substances:

    Controlled substance Drug code Schedule Gamma Hydroxybutyric Acid 2010 I Amphetamine 1100 II Lisdexamfetamine 1205 II Methylphenidate 1724 II Phenylacetone 8501 II Methadone 9250 II Methadone intermediate 9254 II Tapentadol 9780 II

    The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers.

    Dated: October 17, 2017. Demetra Ashley, Acting Assistant Administrator.
    [FR Doc. 2017-23556 Filed 10-27-17; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE [OMB Number 1110-0049] Agency Information Collection Activities; Proposed eCollection; eComments Requested InfraGard Membership Application and Profile AGENCY:

    Federal Bureau of Investigation, Department of Justice.

    ACTION:

    30-day notice.

    SUMMARY:

    Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Training Division's Curriculum Management Section (CMS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the Federal Register, on August 3, 2017 allowing for a 60 day comment period.

    DATES:

    Comments are encouraged and will be accepted for an additional 30 days until November 29, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to Lisa Avery, Management and Program Analyst, Strategic Initiatives Unit, Federal Bureau of Investigation, Intelligence Branch, Office of Private Sector, FBIHQ, 1075 F Street SW., Washington DC 20024 or via email at [email protected] Written comments and/or suggestions can also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to [email protected]

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Enhance the quality, utility, and clarity of the information to be collected; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

    (1) Type of Information Collection: Personally identifiable information for vetting purposes.

    (2) Title of the Form/Collection: InfraGard Membership Application and Profile

    (3) Agency form number, if any, and the applicable component of the Department sponsoring the collection: Agency form number: Unnumbered Sponsoring component: Strategic Initiatives Unit (SIU) Office of Private Sector of the Federal Bureau of Investigation (FBI), Department of Justice (DOJ).

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Members of the public and private-sector with a nexus to critical infrastructure protection interested in being a member of the FBI's National InfraGard Program. Personal information is collected by the FBI for vetting and background information to obtain membership to the program and access to its secure portal. InfraGard is a two-way information sharing exchange between the FBI and members of the public and private sector focused on intrusion and vulnerabilities affecting 16 critical infrastructures. Members are provided access to law enforcement sensitive analytical products pertain to their area of expertise.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond/reply: It is estimated that InfraGard has approximately 50,000 members and receives approximately 7,200 new applications for membership per year. The average response time for reading and responding to membership application and profile is estimated to be 30 minutes.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total hour burden for completing the application and profile is 3,600 hours.

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Suite 3E.405B, Washington, DC 20530.

    Dated: October 25, 2017. Melody Braswell, Department Clearance Officer, PRA, U.S. Department of Justice.
    [FR Doc. 2017-23511 Filed 10-27-17; 8:45 am] BILLING CODE 4410-02-P
    DEPARTMENT OF JUSTICE [OMB Number 1117-0051] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Previously Approved Collection: Red Ribbon Week Patch AGENCY:

    Drug Enforcement Administration, Department of Justice.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Justice (DOJ), Drug Enforcement Administration, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

    DATES:

    Comments are encouraged and will be accepted for 60 days until December 29, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Gary R. Owen, Chief, Office of Congressional & Public Affairs, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152.

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

    1. Type of Information Collection: Proposed collection.

    2. The Title of the Form/Collection: DEA Red Ribbon Week Patch.

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: The agency form number is DEA-316a. The applicable component within the Department of Justice is the Drug Enforcement Administration.

    4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Boy Scout and Girl Scout Troop Leaders.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 450 respondents will complete the application in approximately 10 minutes.

    6. An estimate of the total public burden (in hours) associated with the collection: The estimated public burden associated with this collection is 75 hours. It is estimated that applicants will take 10 minutes to complete the DEA-316a. The burden hours for collecting respondent data sum to 75 hours (450 respondents × 10 minutes = 4,500 minutes. 4500/60 seconds = 75).

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.

    Dated: October 25, 2017. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2017-23524 Filed 10-27-17; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF LABOR President's Committee on the International Labor Organization Charter Renewal AGENCY:

    Bureau of International Labor Affairs, Labor.

    ACTION:

    Notice of charter renewal.

    SUMMARY:

    On September 29, 2017, President Trump continued the President's Committee on the International Labor Organization (ILO) for two years through September 30, 2019. In response, and pursuant to the Federal Advisory Committee Act (FACA), the Secretary of Labor renewed the committee's charter on October 23, 2017.

    Purpose: The President's Committee on the International Labor Organization was established in 1980 by Executive Order 12216 to monitor and assess the work of the ILO and make recommendations to the President regarding United States policy towards the ILO. The committee is chaired by the Secretary of Labor and the Department of Labor's Bureau of International Labor Affairs is responsible for providing the necessary support for the committee.

    The committee is composed of seven members: The Secretary of Labor (chair), the Secretary of State, the Secretary of Commerce, the Assistant to the President for National Security Affairs, the Assistant to the President for Economic Policy, and one representative each from organized labor and the business community, designated by the Secretary. The labor and business members are the presidents of the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) and the United States Council for International Business (USCIB), respectively, as the most representative organizations of U.S. workers and employers engaged in ILO matters.

    Authority:

    The authority for this notice is granted by the Federal Advisory Committee Act (5 U.S.C. App. 2) and Executive Order No. 13811 of September 29, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Robert B. Shepard, Director, Office of International Relations, Bureau of International Labor Affairs, U.S. Department of Labor, telephone (202) 693-4808.

    Signed at Washington, DC.

    Martha E. Newton, Deputy Undersecretary, Bureau of International Labor Affairs.
    [FR Doc. 2017-23550 Filed 10-27-17; 8:45 am] BILLING CODE 4510-28-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Examinations and Testing of Electrical Equipment, Including Examination, Testing, and Maintenance of High Voltage Longwalls ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, “Examinations and Testing of Electrical Equipment, Including Examination, Testing, and Maintenance of High Voltage Longwalls,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

    DATES:

    The OMB will consider all written comments that agency receives on or before November 29, 2017.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201708-1219-002 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-MSHA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email: [email protected] Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor—OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    Authority:

    44 U.S.C. 3507(a)(1)(D).

    SUPPLEMENTARY INFORMATION:

    This ICR seeks to extend PRA authority for the Examinations and Testing of Electrical Equipment, Including Examination, Testing, and Maintenance of High Voltage Longwalls information collection. MSHA regulations require records to be kept on the examination, testing, calibration, and maintenance of covered atmospheric monitoring systems, electric equipment, grounding off-track direct-current machines and enclosures of related detached components, circuit breakers, electrical work, and devices for overcurrent protection. The records are intended to verify that examinations and tests were conducted and give insight into the hazardous conditions that have been encountered and those that may be encountered. These records greatly assist those who use them in making decisions during accident investigations to establish root causes and to prevent similar occurrences. These decisions will ultimately affect the safety and health of miners. Federal Mine Safety and Health Act of 1977 sections 101(a) and 103(h) authorize this information collection. See 30 U.S.C. 811(a), 813(h).

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1219-0116.

    OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on October 31, 2017. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the Federal Register on June 16, 2017 (82 FR 27728).

    Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should mention OMB Control Number 1219-0116. The OMB is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-MSHA.

    Title of Collection: Examinations and Testing of Electrical Equipment, Including Examination, Testing, and Maintenance of High Voltage Longwalls.

    OMB Control Number: 1219-0116.

    Affected Public: Private Sector—businesses or other for-profits.

    Total Estimated Number of Respondents: 843.

    Total Estimated Number of Responses: 405,606.

    Total Estimated Annual Time Burden: 73,784 hours.

    Total Estimated Annual Other Costs Burden: $0.

    Dated: October 23, 2017. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2017-23552 Filed 10-27-17; 8:45 am] BILLING CODE 4510-43-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; DOL-Only Performance Accountability, Information, and Reporting System ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, “DOL-Only Performance Accountability, Information, and Reporting System,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.

    DATES:

    The OMB will consider all written comments that agency receives on or before November 29, 2017.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201710-1205-004 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to [email protected].

    Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email: [email protected]. Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor-OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected].

    FOR FURTHER INFORMATION CONTACT:

    Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to [email protected].

    SUPPLEMENTARY INFORMATION:

    This ICR seeks approval under the PRA for revisions to the DOL-Only Performance Accountability, Information, and Reporting System. The following programs will be required to report through this system: Workforce Innovation and Opportunity Act (WIOA) Adult, Dislocated Worker and Youth, Wagner Peyser Employment Service, National Farmworker Jobs, Trade Adjustment Assistance, YouthBuild, Indian and Native American, Job Corps, and Jobs for Veterans' State Grants. Requiring these programs to use a standard set of data elements, definitions, and specifications at all levels of the workforce system helps improve the quality of the performance information that is received by the DOL. While H1-B grants, the Reintegration of Ex-Offenders program, and the Trade Adjustment Assistance program are not authorized under the WIOA, these programs will be utilizing the data element definitions and reporting templates proposed in this ICR. The accuracy, reliability, and comparability of program reports submitted by states and grantees using Federal funds are fundamental elements of good public administration, and are necessary tools for maintaining and demonstrating system integrity. This ICR includes several information collection instruments—Program Performance Report, WIOA Pay-for-Performance Report, Participant Individual Record Layout, WIOA Data Element Specifications, and Job Openings Report. This ICR has been classified as a revision, because specified data elements, sub-populations, barriers to employment, and reporting templates have changed as some reporting requirements or data element definitions have been revised in an attempt to better align definitions across DOL programs, in a larger effort to reduce overall reporting burden. WIOA section 416(d) authorizes this information collection. See 29 U.S.C. 3141(d).

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1205-0521. The current approval is scheduled to expire on August 31, 2019; however, the DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. New requirements would only take effect upon OMB approval. For additional substantive information about this ICR, see the related notice published in the Federal Register on May 23, 2017 (82 FR 23604).

    Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should mention OMB Control Number 1205-0521. The OMB is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-ETA.

    Title of Collection: DOL-Only Performance Accountability, Information, and Reporting System.

    OMB Control Number: 1205-0521.

    Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Respondents: 17,532,542.

    Total Estimated Number of Responses: 35,064,970.

    Total Estimated Annual Time Burden: 8,938,029 hours.

    Total Estimated Annual Other Costs Burden: $6,791,395.

    Authority:

    44 U.S.C. 3507(a)(1)(D).

    Dated: October 25, 2017. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2017-23569 Filed 10-27-17; 8:45 am] BILLING CODE 4510-FN-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Rehabilitation Plan and Award ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, “Rehabilitation Plan and Award,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.

    DATES:

    The OMB will consider all written comments that agency receives on or before November 29, 2017.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201706-1240-002 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to [email protected].

    Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email: [email protected]. Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor-OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected].

    FOR FURTHER INFORMATION CONTACT:

    Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to [email protected].

    SUPPLEMENTARY INFORMATION:

    This ICR seeks approval under the PRA for revisions to the Rehabilitation Plan and Award (Form OWCP-16) information collection. Vocational rehabilitation counselors use Form OWCP-16 to submit an agreed upon rehabilitation plan for OWCP approval. The form also documents any OWCP payment award for approved services. This information collection has been classified as a revision, because the agency has clarified several questions and disclosures. The agency also made formatting changes intended to make the form more user friendly. The Federal Employees' Compensation Act and Longshore and Harbor Workers' Compensation Act authorizes this information collection. See 5 U.S.C. 8103, 8193; 33 U.S.C. 907.

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1240-0045. The current approval is scheduled to expire on October 31, 2017; however, the DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. New requirements would only take effect upon OMB approval. For additional substantive information about this ICR, see the related notice published in the Federal Register on August 8, 2017 (82 FR 37121).

    Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should mention OMB Control Number 1240-0045. The OMB is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-OWCP.

    Title of Collection: Rehabilitation Plan and Award.

    OMB Control Number: 1240-0045.

    Affected Public: Private Sector—businesses or other for-profits and not-for-profit institutions.

    Total Estimated Number of Respondents: 3,913.

    Total Estimated Number of Responses: 3,913.

    Total Estimated Annual Time Burden: 1,957 hours.

    Total Estimated Annual Other Costs Burden: $0.

    Authority:

    44 U.S.C. 3507(a)(1)(D).

    Dated: October 24, 2017. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2017-23546 Filed 10-27-17; 8:45 am] BILLING CODE 4510-CR-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Sealing of Abandoned Areas Standard ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, “Sealing of Abandoned Areas Standard,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

    DATES:

    The OMB will consider all written comments that agency receives on or before November 29, 2017.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201708-1219-002 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-MSHA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email: [email protected] Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor-OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    Authority:

    44 U.S.C. 3507(a)(1)(D).

    SUPPLEMENTARY INFORMATION:

    This ICR seeks to extend PRA authority for the Sealing of Abandoned Areas Standard information collection. The Standard includes reporting and recordkeeping requirements to help ensure the construction and maintenance of seals are done correctly; certified persons conducting sampling in sealed areas are adequately trained, and problems can be found and corrected. Federal Mine Safety and Health Act of 1977 sections 101(a) and 103(h) authorize this information collection. See 30 U.S.C. 811(a) and 813(h).

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1219-0116.

    OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on October 31, 2017. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the Federal Register on June 16, 2017 (82 FR 26952).

    Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should mention OMB Control Number 1219-0142. The OMB is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-MSHA.

    Title of Collection: Sealing of Abandoned Areas Standard.

    OMB Control Number: 1219-0142.

    Affected Public: Private Sector—businesses or other for-profits.

    Total Estimated Number of Respondents: 242.

    Total Estimated Number of Responses: 15,800.

    Total Estimated Annual Time Burden: 3,525 hours.

    Total Estimated Annual Other Costs Burden: $1,068,083.

    Dated: October 23, 2017. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2017-23548 Filed 10-27-17; 8:45 am] BILLING CODE 4510-43-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Request for Assistance From the Department of Labor, Employee Benefits Security Administration ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Employee Benefits Security Administration (EBSA) sponsored information collection request (ICR) titled, “Request for Assistance from the Department of Labor, Employee Benefits Security Administration,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

    DATES:

    The OMB will consider all written comments that agency receives on or before November 29, 2017.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201708-1210-002 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-EBSA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email: [email protected] Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor—OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    Authority:

    44 U.S.C. 3507(a)(1)(D).

    SUPPLEMENTARY INFORMATION:

    This ICR seeks to extend PRA authority for the Request for Assistance from Department of Labor, Employee Benefits Security Administration information collection. The EBSA assists employee benefit plan participants in understanding their rights, responsibilities, and benefits under employee benefit law and intervenes informally on behalf of beneficiaries with plan sponsors in order to assist participants in obtaining the health and retirement benefits that may have been inappropriately denied. Such informal intervention can avert the necessity for a formal investigation or a civil action. The EBSA maintains a toll-free telephone number through which inquirers can reach Benefits Advisors in ten Regional Offices. The EBSA has also made a request for assistance form available on its Web site for those wishing to obtain assistance in this manner. Employee Retirement Income Security Act of 1974 (ERISA) sections 504 and 513 authorize this information collection. See 29 U.S.C. 1134, 1143.

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1210-0146.

    OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on October 31, 2017. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the Federal Register on May 22, 2017 (82 FR 23303).

    Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should mention OMB Control Number 1210-0146. The OMB is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-EBSA.

    Title of Collection: Request for Assistance from the Department of Labor, Employee Benefits Security Administration.

    OMB Control Number: 1210-0146.

    Affected Public: Individuals or Households.

    Total Estimated Number of Respondents: 7,618.

    Total Estimated Number of Responses: 7,618.

    Total Estimated Annual Time Burden: 3,809 hours.

    Total Estimated Annual Other Costs Burden: $0.

    Dated: October 23, 2017. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2017-23547 Filed 10-27-17; 8:45 am] BILLING CODE 4510-29-P
    DEPARTMENT OF LABOR Office of Workers' Compensation Programs Proposed Collection of Information; Comment Request AGENCY:

    Division of Coal Mine Workers' Compensation, Office of Workers' Compensation Programs, Department of Labor.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation Programs (OWCP) is soliciting comments concerning the proposed collection: Application For Self-Insurance Under The Black Lung Benefits Act, 1240-0NEW (CM-2017; CM-2017a; CM-2017b). A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.

    DATES:

    Written comments must be received by the office listed in the addresses section below by December 29, 2017.

    ADDRESSES:

    You may submit comments by mail, delivery service, or by hand to Ms. Yoon Ferguson, U.S. Department of Labor, 200 Constitution Ave. NW., Room S-3323, Washington, DC 20210; by fax to (202) 354-9647; or by Email to [email protected] Please use only one method of transmission for comments (mail/delivery, fax, or Email). Please note that comments submitted after the comment period will not be considered.

    SUPPLEMENTARY INFORMATION:

    I. Background: The Department of Labor is requesting an approval of a new information collection. This information collection is essential to the mission of OWCP's Division of Coal Mine Workers' Compensation, which administers the Black Lung Benefits Act (BLBA), 30 U.S.C. 901 et seq. The statute grants the Department authority to authorize and regulate coal mine operators who wish to self-insure their BLBA liabilities. 30 U.S.C. 933. This information collection would provide OWCP with sufficient information to determine whether a coal mine operator should be (or continue to be) authorized to self-insure. The information would also allow OWCP to determine the security amount a coal mine operator must deposit to guarantee that it will be able to meet its BLBA liabilities.

    II. Review Focus: The Department is particularly interested in comments that will help it to:

    * Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    * evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    * enhance the quality, utility and clarity of the information to be collected; and

    * minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    III. Current Actions: The Department seeks the approval of this new information collection to carry out its responsibility to administer the BLBA.

    Agency: Office of Workers' Compensation Programs.

    Type of Review: New Collection (Request for New OMB Control Number).

    Title: Application For Self-Insurance Under the Black Lung Benefits Act, 1240-0NEW (CM-2017; CM-2017a; CM-2017b).

    OMB Number: 1240-0NEW.

    Agency Number: CM-2017; CM-2017a; CM-2017b.

    Affected Public: Business entities or other for-profit institutions.

    Total Respondents: 53.

    Total Annual Responses: 318.

    Average Time per Response: 20 minutes-2 hours.

    Estimated Total Burden Hours: 283.

    Frequency: Annually and quarterly.

    Total Burden Cost (operating/maintenance): $137.47.

    Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.

    Dated: October 24, 2017. Yoon Ferguson, Agency Clearance Officer, Office of Workers' Compensation Programs, U.S. Department of Labor.
    [FR Doc. 2017-23551 Filed 10-27-17; 8:45 am] BILLING CODE 4510-CK-P
    NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 17-079] NASA Advisory Council; Aeronautics Committee; Meeting AGENCY:

    National Aeronautics and Space Administration.

    ACTION:

    Notice of meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Aeronautics Committee of the NASA Advisory Council (NAC). The meeting will be held for the purpose of soliciting, from the aeronautics community and other persons, research and technical information relevant to program planning. This Committee reports to the NAC.

    DATES:

    Wednesday, November 15, 2017, 12:30-5:15 p.m.; and Thursday, November 16, 2017, 8:00-11:30 a.m., Local Time.

    ADDRESSES:

    The AERO Institute, 38256 Sierra Highway, Palmdale, CA 93550.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Irma Rodriguez, Designated Federal Officer, NAC Aeronautics Committee, NASA Headquarters, Washington, DC 20546, (202) 358-0984, or [email protected]

    SUPPLEMENTARY INFORMATION:

    The meeting will be open to the public up to the capacity of the room. This meeting is also available telephonically and WebEx. You must use a touch-tone telephone to participate in this meeting. Any interested person may dial the USA toll-free conference number 1-844-467-6272, passcode 317924, to participate in this meeting by telephone. The WebEx link is https://nasa.webex.com/, the meeting number for 11/15/17 is 998 190 104, and the password is [email protected]; and for 11/16/17 the meeting number is 999 027 064, and the password is [email protected] The agenda for the meeting includes the following topics:

    • Low Boom Flight Demonstrator (LFBD) • System Wide Safety Assurance Project Objectives and Content • Hypersonics Project Attendees will be requested to sign a register to document attendance. It is imperative that the meeting be held on these dates to accommodate the scheduling priorities of the key participants. For questions, please call Ms. Irma Rodriguez at (202) 358-0984. Patricia D. Rausch, Advisory Committee Management Officer, National Aeronautics and Space Administration.
    [FR Doc. 2017-23409 Filed 10-27-17; 8:45 am] BILLING CODE 7510-13-P
    NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 17-078] NASA Advisory Council; Charter Renewal AGENCY:

    National Aeronautics and Space Administration (NASA).

    ACTION:

    Notice of renewal of the charter of the NASA Advisory Council.

    Pursuant to sections 14(b)(1) and 9(c) of the Federal Advisory Committee Act, as amended (Pub. L. 92-463, 5 U.S.C. App.), and after consultation with the Committee Management Secretariat, General Services Administration, the NASA Acting Administrator has determined that renewal of the charter of the NASA Advisory Council is necessary and in the public interest. The renewed charter is for a two-year period ending October 20, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Marla K. King, NASA Headquarters, 300 E Street SW., Washington, DC 20546, phone: (202) 358-1148; email: [email protected]

    Patricia D. Rausch, Advisory Committee Management Officer, National Aeronautics and Space Administration.
    [FR Doc. 2017-23408 Filed 10-27-17; 8:45 am] BILLING CODE 7510-13-P
    NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 17-080] NASA Advisory Council; Ad Hoc Task Force on STEM Education; Meeting AGENCY:

    National Aeronautics and Space Administration.

    ACTION:

    Notice of meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the Ad Hoc Task Force on Science, Technology, Engineering and Mathematics (STEM) of the NASA Advisory Council (NAC). This Task Force reports to the NAC.

    DATES:

    Monday, November 13, 2017, 11:30 a.m.-3:30 p.m., Eastern Standard Time (EST).

    FOR FURTHER INFORMATION CONTACT:

    Dr. Beverly Girten, Designated Federal Officer, NAC Ad Hoc Task Force on STEM Education, NASA Headquarters, Washington, DC 20546, (202) 358-0212, or [email protected]

    SUPPLEMENTARY INFORMATION:

    This meeting will be virtual and will be available telephonically and by WebEx only. You must use a touch tone phone to participate in this meeting. Any interested person may dial the toll free access number 844-467-6272 or toll access number 720-259-6462, and then the numeric participant passcode: 634012 followed by the # sign. To join via WebEx, the link is https://nasa.webex.com/, the meeting number is 999 557 944 and the password is Education1! (Password is case sensitive.) NOTE: If dialing in, please “mute” your telephone. The agenda for the meeting will include the following:

    —Opening Remarks by Chair —Transition Update —Business Service Assessment Update —Formulation of Recommendations and Findings —Other Related Topics

    It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.

    Patricia D. Rausch, Advisory Committee Management Officer, National Aeronautics and Space Administration.
    [FR Doc. 2017-23455 Filed 10-27-17; 8:45 am] BILLING CODE 7510-13-P
    NATIONAL SCIENCE FOUNDATION Agency Information Collection Activities; Proposals, Submissions, and Approvals AGENCY:

    National Science Foundation, National Center for Science and Engineering Statistics.

    ACTION:

    Submission to OMB and Request for Comments.

    SUMMARY:

    The National Science Foundation (NSF) has submitted the following information collection requirements to OMB for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Written comments on this notice must be received by [] to be assured consideration. Comments received after that date will be considered to the extent practicable.

    FOR FURTHER INFORMATION CONTACT:

    Comments should be addressed to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for National Science Foundation, 725 17th Street NW., Room 10235, Washington, DC 20503, and to Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314; telephone (703) 292-7556; or send email to [email protected] Copies of the submission(s) may be obtained by calling 703-292-7556. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339, which is accessible 24 hours a day, 7 days a week, 365 days a year (including Federal holidays).

    SUPPLEMENTARY INFORMATION:

    Comments are invited on: (a) The proposed confidentiality pledge's fit for use by the National Center for Science and Engineering Statistics (NCSES), and (b) ways to enhance the quality, utility, and clarity of the pledge.

    Title: National Center for Science and Engineering Statistics Confidentiality Pledge.

    OMB Approval Number: 3145-0245.

    Summary of Collection: Federal statistics provide key information that the Nation uses to measure its performance and make informed choices about budgets, employment, health, investments, taxes, and a host of other significant topics. The overwhelming majority of Federal surveys are conducted on a voluntary basis. Respondents, ranging from businesses to households to institutions, may choose whether to provide the requested information. Many of the most valuable Federal statistics come from surveys that ask for highly sensitive information such as proprietary business data from companies or particularly personal information or practices from individuals. Strong and trusted confidentiality and exclusively statistical use pledges under the Confidential Information Protection and Statistical Efficiency Act (CIPSEA) and similar statistical confidentiality pledges are effective and necessary in honoring the trust that businesses, individuals, and institutions, by their responses, place in statistical agencies.

    Under CIPSEA and similar statistical confidentiality protection statutes, many Federal statistical agencies make statutory pledges that the information respondents provide will be seen only by statistical agency personnel or their sworn agents, and will be used only for statistical purposes. CIPSEA and similar statutes protect the confidentiality of information that agencies collect solely for statistical purposes and under a pledge of confidentiality. These Acts protect such statistical information from administrative, law enforcement, taxation, regulatory, or any other non-statistical use and immunize the information submitted to statistical agencies from many legal processes. Moreover, statutes like the CIPSEA carry criminal penalties of a Class E felony (fines up to $250,000, or up to five years in prison, or both) for conviction of a knowing and willful unauthorized disclosure of covered information.

    As part of the Consolidated Appropriations Act for Fiscal Year 2016 signed on December 17, 2015, the Congress enacted the Federal Cybersecurity Enhancement Act of 2015 (H.R. 2029, Division N, Title II, Subtitle B, Sec. 223). This Act, among other provisions, requires the Secretary of the Department of Homeland Security (DHS) to provide Federal civilian agencies' information technology systems with cybersecurity protection for their Internet traffic. The DHS cybersecurity program's objective is to protect Federal civilian information systems from malicious malware attacks. The Federal statistical system's objective is to ensure that the DHS Secretary performs those essential duties in a manner that honors the Government's statutory promises to the public to protect their confidential data. Given that the DHS is not a Federal statistical agency, both DHS and the Federal statistical system have been successfully engaged in finding a way to balance both objectives and achieve these mutually reinforcing objectives.

    As required by passage of the Federal Cybersecurity Enhancement Act of 2015, the Federal statistical community will implement DHS' cybersecurity protection program, called Einstein.

    The technology currently used to provide this protection against cyber malware electronically searches Internet traffic in and out of Federal civilian agencies in real time for malware signatures. When such a signature is found, the Internet packets that contain the malware signature are shunted aside for further inspection by DHS personnel. Because it is possible that such packets entering or leaving a statistical agency's information technology system may contain confidential statistical data, statistical agencies can no longer promise their respondents that their responses will be seen only by statistical agency personnel or their sworn agents. However, they can promise, in accordance with provisions of the Federal Cybersecurity Enhancement Act of 2015, that such monitoring can be used only to protect information and information systems from cybersecurity risks, thereby, in effect, providing stronger protection to the security and integrity of the respondents' submissions.

    Accordingly, DHS and Federal statistical agencies have developed a Memorandum of Agreement for the installation of Einstein cybersecurity protection technology to monitor their Internet traffic.

    On February 2, 2017, in a pair of Federal Register notices (82 FR 9599 and 82 FR 9597), the public was notified of the change to the confidentiality pledges to be used by NCSES. No comments were received in response to those notices.

    Table 1 contains a listing of the current numbers and information collection titles for those NCSES programs whose confidentiality pledges will change to reflect the statutory implementation of DHS' Einstein monitoring for cybersecurity protection purposes. For the Information Collection Requests (ICRs) listed in the table below, NCSES statistical confidentiality pledges will be modified to include one of two sentences, based on whether the collection agent is another federal agency (e.g., the U.S. Census Bureau) or a private-sector contractor. For collections by another federal agency, the following sentence will be added to the confidentiality pledge: “Per the Federal Cybersecurity Enhancement Act of 2015, your data are protected from cybersecurity risks through screening of the systems that transmit your data.” For collections by private-sector contractors, whose systems are not covered by Einstein, the following sentence will be added to the confidentiality pledge: “Per the Federal Cybersecurity Enhancement Act of 2015, your data are protected from cybersecurity risks through screening of the federal information systems that transmit your data.”

    Table 1 indicates which pledge (federal vs. private) the ICR will use.

    Table 1—Current PRA OMB Numbers, Expiration Dates, and Information Collection Titles Included in This Notice OMB control
  • no.
  • Expiration
  • date
  • Information collection title Pledge
  • version
  • 3145-0101 08/31/2018 Survey of Science and Engineering Research Facilities (Facilities) Private. 3145-0019 05/31/2018 Survey of Earned Doctorates Private. 3145-0020 08/31/2018 Survey of Doctorate Recipients Private. 3145-0100 09/30/2019 Higher Education R&D Survey Private. 3145-0141 * 05/31/2018 National Survey of College Graduates Federal. 3145-0174 07/31/2019 Generic Clearance of Survey Improvement Projects Private. 3145-0235 06/30/2017 Early Career Doctorates Survey Private. * This information collection was also named in a Federal Register Notice from the U.S. Census Bureau (81 FR 94321), since that agency collects data on NSF's behalf.
    Dated: October 24, 2017. Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation.
    [FR Doc. 2017-23466 Filed 10-27-17; 8:45 am] BILLING CODE 7555-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2017-0001] Sunshine Act Meetings DATE:

    Weeks of October 30, November 6, 13, 20, 27, December 4, 2017.

    PLACE:

    Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.

    STATUS:

    Public and Closed.

    Week of October 30, 2017 Monday, October 30, 2017

    3:50 p.m. Affirmation Session (Public Meeting) (Tentative).

    Aerotest Operations, Inc. (Aerotest Radiography and Research Reactor), Joint Motion to Terminate Proceedings (Tentative).

    Monday, October 30, 2017

    4:00 p.m. Briefing on Export Licensing (Closed—Ex. 1 & 9).

    Week of November 6, 2017—Tentative

    There are no meetings scheduled for the week of November 6, 2017.

    Week of November 13, 2017—Tentative

    There are no meetings scheduled for the week of November 13, 2017.

    Week of November 20, 2017—Tentative

    There are no meetings scheduled for the week of November 20, 2017.

    Week of November 27, 2017—Tentative Tuesday, November 28, 2017

    10:00 a.m. Briefing on Security Issues (Closed—Ex. 1).

    Thursday, November 30, 2017

    10:00 a.m. Briefing on Equal Employment Opportunity, Affirmative Employment, and Small Business (Public) (Contact: Larniece McKoy Moore: 301-415-1942).

    This meeting will be webcast live at the Web address—http://www.nrc.gov/.

    Week of December 4, 2017—Tentative

    There are no meetings scheduled for the week of December 4, 2017.

    Additional Information

    By a vote of 3-0 on October 25, 2017, the Commission determined pursuant to U.S.C. 552b(e) and § 9.107(a) of the Commission's rules that the above referenced Affirmation Session be held with less than one week notice to the public. The meeting is scheduled on October 30, 2017

    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, 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 email [email protected] or [email protected]

    Dated: October 25, 2017. Denise L. McGovern, Policy Coordinator, Office of the Secretary.
    [FR Doc. 2017-23664 Filed 10-26-17; 4:15 pm] BILLING CODE 7590-01-P
    OFFICE OF PERSONNEL MANAGEMENT Submission for Review: OPM Form 1654-B, Combined Federal Campaign Federal Retiree Pledge Form AGENCY:

    Office of Personnel Management.

    ACTION:

    30-Day notice and request for comments.

    SUMMARY:

    The Office of Combined Federal Campaign, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on an information collection request (ICR) 3206-NEW, OPM Form 1654-B, the Combined Federal Campaign Retiree Pledge Form. As required by the Paperwork Reduction Act of 1995, as amended by the Clinger-Cohen Act, OPM is soliciting comments for this collection. The information collection was previously published in the Federal Register on August 22, 2017 at 82 FR 39918 allowing for a 60-day public comment period. No comments were received for this information collection. The purpose of this notice is to allow an additional 30 days for public comments.

    DATES:

    Comments are encouraged and will be accepted until November 29, 2017. This process is conducted in accordance with 5 CFR 1320.1.

    ADDRESSES:

    Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to [email protected] or faxed to (202) 395-6974.

    FOR FURTHER INFORMATION CONTACT:

    A copy of this ICR, with applicable supporting documentation, may be obtained by contacting the Office of Information and Regulatory Affairs, Office of Management Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to [email protected] or faxed to (202) 395-6974.

    SUPPLEMENTARY INFORMATION:

    The Office of Management and Budget is particularly interested in comments that:

    1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    3. Enhance the quality, utility, and clarity of the information to be collected; and

    4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    The Combined Federal Campaign (CFC) is the world's largest and most successful annual workplace philanthropic giving campaign, with 36 CFC Zones throughout the country and overseas raising millions of dollars each year. The mission of the CFC is to promote and support philanthropy through a program that is employee focused, cost-efficient, and effective in providing all federal employees and retirees the opportunity to improve the quality of life for others.

    OPM Form 1654-B is a new information collection that collects CFC pledge information from federal annuitants and military retirees pursuant to Executive Order 13743 signed October 13, 2016. It will be available in both paper format and as an electronic form administered by the CFC's Central Campaign Administrator pursuant to 5 CFR 950.106(a).

    Analysis

    Agency: Combined Federal Campaign, Office of Personnel Management.

    Title: OPM Form 1654-B, Combined Federal Campaign Federal Retiree Pledge Form.

    OMB Number: 3206—NEW.

    Frequency: Annually.

    Affected Public: Individuals or Households.

    Number of Respondents: 250,000.

    Estimated Time per Respondent: 30 minutes.

    Total Burden Hours: 125,000 hours.

    U.S. Office of Personnel Management. Kathleen M. McGettigan, Acting Director.
    [FR Doc. 2017-23534 Filed 10-27-17; 8:45 am] BILLING CODE 6325-46-P
    POSTAL REGULATORY COMMISSION [Docket No. CP2018-28] 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 a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

    DATES:

    Comments are due: October 30, 2017.

    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 Web site (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 3010, and 39 CFR 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 3015, and 39 CFR 3020, subpart B. Comment deadline(s) for each request appear in section II.

    II. Docketed Proceeding(s)

    1. Docket No(s).: CP2018-28; 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: October 19, 2017; Filing Authority: 39 CFR 3015.5; Public Representative: Christopher C. Mohr; Comments Due: October 30, 2017.

    This notice will be published in the Federal Register.

    Stacy L. Ruble, Secretary.
    [FR Doc. 2017-23473 Filed 10-27-17; 8:45 am] BILLING CODE 7710-FW-P
    SECURITIES AND EXCHANGE COMMISSION [SEC File No. 270-399, OMB Control No. 3235-0456] Submission for OMB Review; Comment Request Upon Written Request, Copies Available From: Securities and Exchange Commission, Office of FOIA Services, 100 F Street NE., Washington, DC 20549-2736 Extension: Form 24F-2.

    Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission (the “Commission”) has submitted to the Office of Management and Budget a request for extension of the previously approved collection of information discussed below.

    Rule 24f-2 (17 CFR 270.24f-2) under the Investment Company Act of 1940 (15 U.S.C. 80a) requires any open-end management companies (“mutual funds”), unit investment trusts (“UITs”) or face-amount certificate companies (collectively, “funds”) deemed to have registered an indefinite amount of securities to file, not later than 90 days after the end of any fiscal year in which it has publicly offered such securities, Form 24F-2 (17 CFR 274.24) with the Commission. Form 24F-2 is the annual notice of securities sold by funds that accompanies the payment of registration fees with respect to the securities sold during the fiscal year.

    The Commission estimates that 7,284 funds file Form 24F-2 on the required annual basis. The average annual burden per respondent for Form 24F-2 is estimated to be two hours. The total annual burden for all respondents to Form 24F-2 is estimated to be 14,568 hours. The estimate of average burden hours is made solely for the purposes of the Paperwork Reduction Act, and is not derived from a comprehensive or even a representative survey or study of the costs of Commission rules.

    Compliance with the collection of information required by Form 24F-2 is mandatory. The Form 24F-2 filing that must be made to the Commission is available to the public. 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 control number.

    The public may view the background documentation for this information collection at the following Web site, www.reginfo.gov. Comments should be directed to: (i) Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington, DC 20503, or by sending an email to: [email protected]; and (ii) Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email to: [email protected] Comments must be submitted to OMB within 30 days of this notice.

    October 24, 2017. Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-23471 Filed 10-27-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-81933; File No. SR-MIAX-2017-42] Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Its Fee Schedule October 24, 2017.

    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 October 11, 2017, Miami International Securities Exchange LLC (“MIAX Options” or “Exchange”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. 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.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange is filing a proposal to amend the MIAX Options Fee Schedule (the “Fee Schedule”) to adopt a fee for the sale of certain historical market data.

    The text of the proposed rule change is available on the Exchange's Web site at http://www.miaxoptions.com/rule-filings, at MIAX's principal office, 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 aspects of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The Exchange proposes to amend its Fee Schedule to adopt a fee for the sale of certain historical market data.

    The historical market data that the Exchange proposes to sell provides information about the past activity of all option products traded on the Exchange for each trading session conducted during a particular calendar month. The data is intended to enhance the user's ability to analyze option trade and volume data, evaluate historical trends in the trading activity of a particular option product, and enable the testing of trading models and analytical strategies. Specifically, the historical market data that the Exchange proposes to sell includes all data that is captured and disseminated on the following proprietary MIAX Options data feeds, on a T+1 basis: MIAX Top of Market data feed (“ToM”); MIAX Order Feed (“MOR”); MIAX Administrative Information Subscriber Feed (“AIS”); and MIAX Complex Top of Market data feed (“cToM”) (“Historical Market Data”). All such proprietary MIAX Options data feeds that, on a T+1 basis, comprise the Historical Market Data are described on the Exchange's Fee Schedule.3

    3See MIAX Fee Schedule, Section 6.

    ToM provides real-time updates of the MIAX Best Bid or Offer, or MBBO,4 price with aggregate orders and quote size of contracts that can be displayed, display of Public Customer 5 interest at the MBBO, display of Priority Customer 6 interest at the MBBO, and MIAX Options last sale.7 MOR provides real-time updates of options orders, products traded on MIAX Options, MIAX Options System 8 status, and MIAX Options underlying trading status.9 AIS provides real-time updates of products traded on MIAX Options, trading status for MIAX Options and products traded on MIAX Options, and liquidity seeking event notifications.10 cToM provides real-time updates of MIAX Options strategy best bid or offer, or cMBBO,11 price with aggregated complex order sizes of a strategy that can be displayed at that price, and MIAX Options strategy last sale.12

    4 The term “MBBO” means the best bid or offer on the Exchange. See Exchange Rule 100. See also Exchange Rule 506(c)(2).

    5 The term “Public Customer” means a person that is not a broker or dealer in securities. See Exchange Rule 100.

    6 The term “Priority Customer” means a person or entity that (i) is not a broker or dealer in securities, and (ii) does not place more than 390 orders in listed options per day on average during a calendar month for its own beneficial account(s). See Exchange Rule 100.

    7See Securities Exchange Act Release No. 69007 (February 28, 2013), 78FR 14617 (March 6, 2013) (SR-MIAX-2013-05).

    8 The term “System” means the automated trading system used by the Exchange for the trading of securities. See Exchange Rule 100.

    9See Securities Exchange Act Release No. 74759 (April 17, 2015), 80 FR 22749 (April 23, 2015) (SR-MIAX-2015-28).

    10See Securities Exchange Act Release No. 73326 (October 9, 2014), 79 FR 62233 (October 16, 2014) (SR-MIAX-2014-51).

    11See Exchange Rule 506(c)(2).

    12See Securities Exchange Act Release No. 79146 (October 24, 2016), 81 FR 75171(October 28, 2016) (SR-MIAX-2016-36).

    MIAX Options will only assess the fee for Historical Market Data on a user (whether Member or Non-Member) that specifically requests such Historical Market Data. Historical Market Data will be uploaded onto an Exchange-provided device. The amount of the fee is $500, and it will be assessed on a per device basis. Each device shall have a maximum storage capacity of 8 Terabytes and will be configured to include data for both MIAX Options and MIAX PEARL. Users may request up to six months of Historical Market Data per device, subject to the device's storage capacity. Historical Market Data is available from August 1, 2017 to the present (always on a T+1 basis), however only the most recent six months of Historical Market Data shall be available for purchase from the request date. Historical Market Data usage is restricted to internal use only, and thus may not be distributed to any third-party.

    The Exchange notes that this filing is substantially similar to a companion MIAX PEARL filing establishing a fee for historical market data on its exchange.13

    13See SR-PEARL-2017-35 (filed on October 11, 2017).

    2. Statutory Basis

    The Exchange believes that its proposal to amend its fee schedule is consistent with Section 6(b) of the Act 14 in general, and furthers the objectives of Section 6(b)(4) of the Act 15 in particular, in that it is an equitable allocation of reasonable dues, fees and other charges among Exchange members and issuers and other persons using its facilities. The proposal provides for the equitable allocation of reasonable fees and other charges among Exchange members and other persons using its facilities because all persons and entities will have equal access to Historical Market Data.

    14 15 U.S.C. 78f(b).

    15 15 U.S.C. 78f(b)(4).

    The Exchange believes the proposed fees are a reasonable allocation of its costs and expenses among its Members and other persons using its facilities since it is recovering the costs associated with distributing such data. Access to the Exchange is provided on fair and non-discriminatory terms. The Exchange believes the proposed fees are equitable and not unfairly discriminatory because the fee level results in a reasonable and equitable allocation of fees amongst users for similar services. Moreover, the decision as to whether or not to purchase Historical Market Data is entirely optional to all users. Potential purchasers are not required to purchase the Historical Market Data, and the Exchange is not required to make the Historical Market Data available. Purchasers may request the data at any time or may decline to purchase such data. The allocation of fees among users is fair and reasonable because, if the market deems the proposed fees to be unfair or inequitable, firms can diminish or discontinue their use of this data.

    In adopting Regulation NMS, the Commission granted self-regulatory organizations and broker-dealers increased authority and flexibility to offer new and unique market data to the public. It was believed that this authority would expand the amount of data available to consumers, and also spur innovation and competition for the provision of market data:

    “[E]fficiency is promoted when broker-dealers who do not need the data beyond the prices, sizes, market center identifications of the NBBO and consolidated last sale information are not required to receive (and pay for) such data when broker-dealers may choose to receive (and pay for) additional market data based on their own internal analysis of the need for such data.” 16

    16See Securities Exchange Act Release No. 51808 (June 9, 2005), 70 FR 37496 (June 29, 2005).

    By removing “unnecessary regulatory restrictions” on the ability of exchanges to sell their own data, Regulation NMS advanced the goals of the Act and the principles reflected in its legislative history. If the free market should determine whether proprietary data is sold to broker-dealers at all, it follows that the price at which such data is sold should be set by the market as well.

    In July, 2010, Congress adopted H.R. 4173, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (“Dodd-Frank Act”), which amended Section 19 of the Act. Among other things, Section 916 of the Dodd-Frank Act amended paragraph (A) of Section 19(b)(3) of the Act by inserting the phrase “on any person, whether or not the person is a member of the self-regulatory organization” after “due, fee or other charge imposed by the self-regulatory organization.” As a result, all SRO rule proposals establishing or changing dues, fees or other charges are immediately effective upon filing regardless of whether such dues, fees or other charges are imposed on members of the SRO, non-members, or both. Section 916 further amended paragraph (C) of Section 19(b)(3) of the Act to read, in pertinent part, “At any time within the 60-day period beginning on the date of filing of such a proposed rule change in accordance with the provisions of paragraph (1) [of Section 19(b)], the Commission summarily may temporarily suspend the change in the rules of the self-regulatory organization made thereby, 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 this title. If the Commission takes such action, the Commission shall institute proceedings under paragraph (2)(B) [of Section 19(b)] to determine whether the proposed rule should be approved or disapproved.”

    The Exchange believes that these amendments to Section 19 of the Act reflect Congress's intent to allow the Commission to rely upon the forces of competition to ensure that fees for market data are reasonable and equitably allocated. Although Section 19(b) had formerly authorized immediate effectiveness for a “due, fee or other charge imposed by the self-regulatory organization,” the Commission adopted a policy and subsequently a rule stating that fees for data and other products available to persons that are not members of the self-regulatory organization must be approved by the Commission after first being published for comment. At the time, the Commission supported the adoption of the policy and the rule by pointing out that unlike members, whose representation in self-regulatory organization governance was mandated by the Act, non-members should be given the opportunity to comment on fees before being required to pay them, and that the Commission should specifically approve all such fees. The Exchange believes that the amendment to Section 19 reflects Congress's conclusion that the evolution of self-regulatory organization governance and competitive market structure have rendered the Commission's prior policy on non-member fees obsolete. Specifically, many exchanges have evolved from member-owned, not-for-profit corporations into for-profit, investor-owned corporations (or subsidiaries of investor-owned corporations). Accordingly, exchanges no longer have narrow incentives to manage their affairs for the exclusive benefit of their members, but rather have incentives to maximize the appeal of their products to all customers, whether members or non-members, so as to broaden distribution and grow revenues. Moreover, the Exchange believes that the change also reflects an endorsement of the Commission's determinations that reliance on competitive markets is an appropriate means to ensure equitable and reasonable prices. Simply put, the change reflects a presumption that all fee changes should be permitted to take effect immediately, since the level of all fees are constrained by competitive forces.

    Selling proprietary market data, such as Historical Market Data, is a means by which exchanges compete to attract business. To the extent that exchanges are successful in such competition, they earn trading revenues and also enhance the value of their data products by increasing the amount of data they provide. The need to compete for business places substantial pressure upon exchanges to keep their fees for both executions and data reasonable.17 The Exchange therefore believes that the fees for Historical Market Data are properly assessed on Members and Non-Member users.

    17See Sec. Indus. Fin. Mkts. Ass'n (SIFMA), Initial Decision Release No. 1015, 2016 SEC LEXIS 2278 (ALJ June 1, 2016) (finding the existence of vigorous competition with respect to non-core market data).

    The decision of the United States Court of Appeals for the District of Columbia Circuit in NetCoalition v. SEC, No. 09-1042 (D.C. Cir. 2010), although reviewing a Commission decision made prior to the effective date of the Dodd-Frank Act, upheld the Commission's reliance upon competitive markets to set reasonable and equitably allocated fees for market data:

    “In fact, the legislative history indicates that the Congress intended that the market system `evolve through the interplay of competitive forces as unnecessary regulatory restrictions are removed' and that the SEC wield its regulatory power `in those situations where competition may not be sufficient,' such as in the creation of a `consolidated transactional reporting system.' ” 18

    18NetCoalition, at 15 (quoting H.R. Rep. No. 94-229, at 92 (1975), as reprinted in 1975 U.S.C.C.A.N. 321, 323).

    The court's conclusions about Congressional intent are therefore reinforced by the Dodd-Frank Act amendments, which create a presumption that exchange fees, including market data fees, may take effect immediately, without prior Commission approval, and that the Commission should take action to suspend a fee change and institute a proceeding to determine whether the fee change should be approved or disapproved only where the Commission has concerns that the change may not be consistent with the Act.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Indeed, the Exchange believes that offering certain Historical Market Data will enhance competition by encouraging sales, which will make analytical data more readily available to investors. Notwithstanding its determination that the Commission may rely upon competition to establish fair and equitably allocated fees for market data, the NetCoalition Court found that the Commission had not, in that case, compiled a record that adequately supported its conclusion that the market for the data at issue in the case was competitive. The Exchange believes that a record may readily be established to demonstrate the competitive nature of the market in question.

    The market for data products is extremely competitive and users may freely choose alternative venues and data vendors based on the aggregate fees assessed, the data offered, and the value provided. Numerous exchanges compete with each other for listings, trades, and market data itself, providing virtually limitless opportunities for entrepreneurs who wish to produce and distribute their own market data. Transaction execution and proprietary data products are complementary in that market data is both an input and a byproduct of the execution service. In fact, market data and trade execution are a paradigmatic example of joint products with joint costs. The decision whether and on which platform to post an order will depend on the attributes of the platform where the order can be posted, including the execution fees, data quality and price, and distribution of its data products. Without trade executions, exchange data products cannot exist. Moreover, data products are valuable to many end users only insofar as they provide information that end users expect will assist them or their customers in making trading decisions.

    The costs of producing market data include not only the costs of the data distribution infrastructure, but also the costs of designing, maintaining, and operating the exchange's transaction execution platform and the cost of regulating the exchange to ensure its fair operation and maintain investor confidence. The total return that a trading platform earns reflects the revenues it receives from both products and the joint costs it incurs. Moreover, the operation of the Exchange is characterized by high fixed costs and low marginal costs. This cost structure is common in content distribution industries such as software, where developing new software typically requires a large initial investment (and continuing large investments to upgrade software), but once the software is developed, the incremental cost of providing that software to an additional user is typically small, or even zero (e.g., if the software can be downloaded over the internet after being purchased).19 In the case of any exchange, it is costly to build and maintain a trading platform, but the incremental cost of trading each additional share on an existing platform, or distributing an additional instance of data, is very low. Market information and executions are each produced jointly (in the sense that the activities of trading and placing orders are the source of the information that is distributed) and are each subject to significant scale economies.

    19See William J. Baumol and Daniel G. Swanson, “The New Economy and Ubiquitous Competitive Price Discrimination: Identifying Defensible Criteria of Market Power,” Antitrust Law Journal, Vol. 70, No. 3 (2003).

    Competition among trading platforms can be expected to constrain the aggregate return each platform earns from the sale of its joint products. The level of competition and contestability in the market is evidence in the numerous alternative venues that compete for order flow, including SRO markets, as well as internalizing BDs and various forms of alternative trading systems (“ATSs”), including dark pools and electronic communication networks (“ECNs”). Each SRO market competes to produce transaction reports via trade executions. It is common for BDs to further and exploit this competition by sending their order flow and transaction reports to multiple markets, rather than providing them all to a single market. Competitive markets for order flow, executions, and transaction reports provide pricing discipline for the inputs of proprietary data products. The large number of SROs, TRFs, BDs, and ATSs that currently produce proprietary data or are currently capable of producing it provides further pricing discipline for proprietary data products. Each SRO, TRF, ATS, and BD is currently permitted to produce proprietary data products, and many currently do or have announced plans to do so, including the Nasdaq exchanges, NYSE exchanges, and CBOE/Bats exchanges.

    In this competitive environment, an “excessive” price for one product will have to be reflected in lower prices for other products sold by the Exchange, or otherwise the Exchange may experience a loss in sales that may adversely affect its profitability. In this case, the proposed rule change enhances competition by providing Historical Market Data at a fixed price. As such, the Exchange believes that the proposed changes will enhance, not impair, competition in the financial markets.

    The market for market data products is competitive and inherently contestable because there is fierce competition for the inputs necessary to the creation of proprietary data and strict pricing discipline for the proprietary products themselves. Numerous exchanges compete with each other for listings, trades, and market data itself, providing virtually limitless opportunities for entrepreneurs who wish to produce and distribute their own market data. This proprietary data is produced by each individual exchange, as well as other entities, in a vigorously competitive market.

    Broker-dealers currently have numerous alternative venues for their order flow, including fifteen existing options markets. Each SRO market competes to produce transaction reports via trade executions. Competitive markets for order flow, executions, and transaction reports provide pricing discipline for the inputs of proprietary data products. The large number of SROs that currently produce proprietary data or are currently capable of producing it provides further pricing discipline for proprietary data products. Each SRO is currently permitted to produce proprietary data products, and many in addition to MIAX Options currently do, including NASDAQ, CBOE, Nasdaq ISE, NYSE American, and NYSE Arca. Additionally, order routers and market data vendors can facilitate single or multiple broker-dealers' production of proprietary data products. The potential sources of proprietary products are virtually limitless.

    Market data vendors provide another form of price discipline for proprietary data products because they control the primary means of access to end subscribers. Vendors impose price restraints based upon their business models. For example, vendors such as Bloomberg and Thomson Reuters that assess a surcharge on data they sell may refuse to offer proprietary products that end subscribers will not purchase in sufficient numbers. Internet portals, such as Google, impose a discipline by providing only data that will enable them to attract “eyeballs” that contribute to their advertising revenue. Retail broker-dealers, such as Schwab and Fidelity, offer their customers proprietary data only if it promotes trading and generates sufficient commission revenue. Although the business models may differ, these vendors' pricing discipline is the same: they can simply refuse to purchase any proprietary data product that fails to provide sufficient value. The Exchange and other producers of proprietary data products must understand and respond to these varying business models and pricing disciplines in order to market proprietary data products successfully.

    In addition to the competition and price discipline described above, the market for proprietary data products is also highly contestable because market entry is rapid, inexpensive, and profitable. The history of electronic trading is replete with examples of entrants that swiftly grew into some of the largest electronic trading platforms and proprietary data producers: Archipelago, BATS Trading and Direct Edge. Regulation NMS, by deregulating the market for proprietary data, has increased the contestability of that market. While broker-dealers have previously published their proprietary data individually, Regulation NMS encourages market data vendors and broker-dealers to produce proprietary products cooperatively in a manner never before possible. Multiple market data vendors already have the capability to aggregate data and disseminate it on a profitable scale, including Bloomberg, and Thomson Reuters.

    The Court in NetCoalition concluded that the Commission had failed to demonstrate that the market for market data was competitive based on the reasoning of the Commission's NetCoalition order because, in the Court's view, the Commission had not adequately demonstrated that the proprietary data at issue in the case is used to attract order flow. The Exchange believes, however, that evidence not then before the court clearly demonstrates that availability of data attracts order flow. Due to competition among platforms, the Exchange intends to improve its platform data offerings on a continuing basis, and to respond promptly to customers' data needs.

    The intensity of competition for proprietary information is significant and the Exchange believes that this proposal itself clearly evidences such competition. The Exchange is offering Historical Market Data in order to keep pace with changes in the industry and evolving customer needs. It is entirely optional and is geared towards attracting new order flow. MIAX Options competitors continue to create new market data products and innovative pricing in this space. In all cases, the Exchange expects firms and other parties to make decisions on how much and what types of data to consume on the basis of the total cost of interacting with MIAX Options or other exchanges. Of course, the explicit data fees are only one factor in a total platform analysis. Some competitors have lower transactions fees and higher data fees, and others are vice versa. The market for this proprietary information is highly competitive and continually evolves as products develop and change.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    The foregoing rule change is effective pursuant to Section 19(b)(3)(A)(ii) of the Act,20 and subparagraph (f)(2) of Rule 19b-4 21 thereunder, because it establishes a due, fee, or other charge imposed by the Exchange. 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) 22 of the Act to determine whether the proposed rule change should be approved or disapproved.

    20 15 U.S.C. 78s(b)(3)(A)(ii).

    21 17 CFR 240.19b-4(f)(2).

    22 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 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-MIAX-2017-42 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-MIAX-2017-42. 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 Web site (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 Web site 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-MIAX-2017-42 and should be submitted on or before November 20, 2017.

    23 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.23

    Robert W. Errett, Deputy Secretary.
    [FR Doc. 2017-23482 Filed 10-27-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-81936; File No. SR-BatsEDGA-2017-27] Self-Regulatory Organizations; Bats EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Make Technical Corrections to Its Second Amended and Restated Certificate of Incorporation October 24, 2017.

    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 October 13, 2017, Bats EDGA Exchange, Inc. (the “Exchange” or “EDGA”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I, II and III below, which Items have been prepared by the Exchange. 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.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange seeks to amend its Second Amended and Restated Certificate of Incorporation. The text of the proposed rule change is provided below.

    (additions are italicized; deletions are [bracketed]) Second Amended and Restated Certificate of Incorporation of Bats EDGA Exchange, Inc.

    The name of the corporation is Bats EDGA Exchange, Inc. The corporation filed its original Certificate of Incorporation with the Secretary of State of the State of Delaware on March 9, 2009 under the name EDGA Exchange, Inc. This Second Amended and Restated Certificate of Incorporation of the corporation, which restates and integrates and also further amends the provisions of the corporation's Restated Certificate of Incorporation, was duly adopted in accordance with the provisions of Sections 242 and 245 of the General Corporation Law of the State of Delaware and by the written consent of its sole stockholder in accordance with Section 228 of the General Corporation Law of the State of Delaware. The [Second Amended and] Restated Certificate of Incorporation of the corporation is hereby amended, integrated and restated to read in its entirety as follows:

    The text of the proposed rule change is available at the Exchange's Web site at www.bats.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

    EDGA recently amended its Restated Certificate of Incorporation in connection with a corporate transaction (the “Transaction”) involving, among other things, the recent acquisition of EDGA, along with Bats BYX Exchange, Inc. (“Bats BYX”), Bats BZX Exchange, Inc. (“Bats BZX”), and Bats EDGX Exchange, Inc. (“Bats EDGX” and, together with Bats EDGA, Bats BYX, and Bats BZX, the “Bats Exchanges”) by CBOE Holdings, Inc. (“CBOE Holdings”). CBOE Holdings is also the parent of Chicago Board Options Exchange, Incorporated (“CBOE”) and C2 Options Exchange, Incorporated (“C2”). Particularly, the filing proposed, among other things, to amend and restate the certificate of incorporation of the Exchange based on certificates of incorporation of CBOE and C2.3 The Exchange notes that in conforming the Exchange's Certificate to the certificates of CBOE and C2, it inadvertently (1) did not comply with a provision of Delaware law and (ii) referred to an inaccurate version of the Certificate in the introductory paragraph. The Exchange seeks to correct those errors.

    3See Securities Exchange Act Release No. 81496 (August 30, 2017), 82 FR 42206 (September 6, 2017) (SR-BatsEDGA-2017-22).

    Particularly, Section 245(c) of the Delaware General Corporation Law (DGCL) requires that a restated certificate of incorporation “shall state, either in its heading or in an introductory paragraph, the corporation's present name, and, if it has been changed, the name under which it was originally incorporated, and the date of filing of its original certificate of incorporation with the secretary of state.” The Exchange notes that the conformed Certificate did not reference the name under which the corporation was originally incorporated (i.e., “EDGA Exchange, Inc.”). In order to comply with Section 245(c) of the DGCL, the Exchange proposes to amend its Certificate to add a reference to its original name.

    The Exchange also notes that it inadvertently did not reference the correct version of the Certificate in two places in the introductory paragraph. Particularly, the Exchange notes that the third sentence of the introductory paragraph provides that the Second Amended and Restated Certificate of Incorporation of the corporation restated and integrated and also further amended the provisions of the corporation's “Certificate of Incorporation” instead of the then current (and now previous) version titled, “Restated Certificate of Incorporation”. Additionally, the last sentence of the introductory paragraph which provides that the current certificate is “amended, integrated and restated to read in its entirety as follows:” mistakenly references the new title of the amended Certificate (i.e., “Second Amended and Restated Certificate of Incorporation”) instead of the title of the then current (and now previous) Certificate (“Restated Certificate of Incorporation”). As such, the Exchange proposes to add “Restated” to the third sentence and eliminate the new title reference “Second Amended and” from the last sentence to accurately reflect the correct version of the Certificate that was amended and restated.

    The Exchange notes that the proposed changes are concerned solely with the administration of the Exchange and do not affect the meaning, administration, or enforcement of any rules of the Exchange or the rights, obligations, or privileges of Exchange members or their associated persons is [sic] any way.

    2. Statutory Basis

    The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.4 Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 5 requirements that the rules of an exchange be 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 mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 6 requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers.

    4 15 U.S.C. 78f(b).

    5 15 U.S.C. 78f(b)(5).

    6Id.

    In particular, the Exchange believes correcting inadvertent non-substantive, technical errors in its Certificate in order to comply with Delaware law and reflect the correct and accurate version of the Certificate that was amended will avoid potential confusion, thereby removing impediments to, and perfecting the mechanism for a free and open market and a national market system, and, in general, protecting investors and the public interest of market participants. As noted above, the proposed changes do not affect the meaning, administration, or enforcement of any rules of the Exchange or the rights, obligations, or privileges of Exchange members or their associated persons is any way.

    (B) Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. Rather, the proposed rule change is merely attempting to correct inadvertent technical errors in the Exchange's introductory paragraph of its Certificate. The proposed rule change has no impact on competition.

    (C) Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others

    The Exchange neither solicited nor received comments on the proposed rule change.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 7 and paragraph (f) of Rule 19b-4 8 thereunder. At any time within 60 days of the filing of the 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 will institute proceedings to determine whether the proposed rule change should be approved or disapproved.

    7 15 U.S.C. 78s(b)(3)(A).

    8 17 CFR 240.19b-4(f).

    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-BatsEDGA-2017-27 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

    All submissions should refer to File Number SR-BatsEDGA-2017-27. 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 Web site (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 Web site 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-BatsEDGA-2017-27 and should be submitted on or before November 20, 2017.

    9 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.9

    Robert W. Errett, Deputy Secretary.
    [FR Doc. 2017-23485 Filed 10-27-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-81929; File No. SR-NYSEARCA-2017-122] Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Provide Users With Access to Five Additional Third Party Systems and Connectivity to Two Additional Third Party Data Feeds October 24, 2017.

    Pursuant to Section 19(b)(1) 1 of the Securities Exchange Act of 1934 (the “Act”) 2 and Rule 19b-4 thereunder,3 notice is hereby given that, on October 11, 2017, NYSE Arca, Inc. (the “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 provide Users with access to five additional third party systems and connectivity to two additional third party data feeds. In addition, the Exchange proposes to change its NYSE Arca Options Fees and Charges (the “Options Fee Schedule”) and the NYSE Arca Equities Fees and Charges (the “Equities Fee Schedule” and, together with the Options Fee Schedule, the “Fee Schedules”) related to these co-location services. The proposed rule change is available on the Exchange's Web site 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

    The Exchange proposes to amend the co-location 4 services offered by the Exchange to provide Users 5 with access to five additional third party systems and connectivity to two additional third party data feeds. In addition the Exchange proposes to make the corresponding changes to the Exchange's Fee Schedules related to these co-location services.

    4 The Exchange initially filed rule changes relating to its co-location services with the Commission in 2010. See Securities Exchange Act Release No. 63275 (November 8, 2010), 75 FR 70048 (November 16, 2010) (SR-NYSEArca-2010-100) (the “Original Co-location Filing”). The Exchange operates a data center in Mahwah, New Jersey (the “data center”) from which it provides co-location services to Users.

    5 For purposes of the Exchange's co-location services, a “User” means any market participant that requests to receive co-location services directly from the Exchange. See Securities Exchange Act Release No. 76010 (September 29, 2015), 80 FR 60197 (October 5, 2015) (SR-NYSEArca-2015-82). As specified in the Fee Schedules, a User that incurs co-location fees for a particular co-location service pursuant thereto would not be subject to co-location fees for the same co-location service charged by the Exchange's affiliates New York Stock Exchange LLC (“NYSE LLC”) and NYSE MKT LLC (“NYSE MKT and, together with NYSE LLC, the “Affiliate SROs”). See Securities Exchange Act Release No. 70173 (August 13, 2013), 78 FR 50459 (August 19, 2013) (SR-NYSEArca-2013-80).

    As set forth in the Fee Schedules, the Exchange charges fees for connectivity to the execution systems of third party markets and other content service providers (“Third Party Systems”), and data feeds from third party markets and other content service providers (“Third Party Data Feeds”).6 The lists of Third Party Systems and Third Party Data Feeds are set forth in the Fee Schedules.

    6See Securities Exchange Act Release No. 80310 (March 24, 2017), 82 FR 15763 (March 30, 2017) (SR-NYSEArca-2016-89).

    The Exchange now proposes to make the following changes:

    • Add five content service providers to the list of Third Party Systems: Chicago Mercantile Exchange (CME Group), Chicago Stock Exchange (CHX), Investors Exchange (IEX), OneChicago and TMX Group (together, the “Additional Third Party Systems” or “ATPS”); and

    • add two feeds to the list of Third Party Data Feeds: Investors Exchange and OneChicago (together the “Additional Third Part Data Feeds” or “ATPD”).

    The Exchange would provide access to the Additional Third Party Systems (“Access”) and connectivity to the Additional Third Party Data Feeds (“Connectivity”) as conveniences to Users. Use of Access or Connectivity would be completely voluntary. The Exchange is not aware of any impediment to third parties offering Access or Connectivity.

    The Exchange does not have visibility into whether third parties currently offer, or intend to offer, Users access to the Additional Third Party Systems and connectivity to the Additional Third Party Data Feeds, as such third parties are not required to make that information public. However, if one or more third parties presently offer, or in the future opt to offer, such Access and Connectivity to Users, a User may utilize the Secure Financial Transaction Infrastructure (“SFTI”) network, a third party telecommunication network, third party wireless network, a cross connect, or a combination thereof to access such services and products through a connection to an access center outside the data center (which could be a SFTI access center, a third-party access center, or both), another User, or a third party vendor.

    The Exchange will announce the dates that each Product is available through customer notices disseminated to all Users simultaneously.

    Connectivity to Additional Third Party Systems

    The Exchange proposes to revise the Fee Schedules to provide that Users may obtain connectivity to the five Additional Third Party Systems for a fee. As with the current Third Party Systems, Users would connect to the Additional Third Party Systems over the internet protocol (“IP”) network, a local area network available in the data center.7

    7See Securities Exchange Act Release No. 74219 (February 6, 2015), 80 FR 7899 (February 12, 2015) (SR-NYSEArca-2015-03) (notice of filing and immediate effectiveness of proposed rule change to include IP network connections).

    As with the current Third Party Systems, in order to obtain access to an Additional Third Party System, the User would enter into an agreement with the relevant third party content service provider, pursuant to which the third party content service provider would charge the User for access to the Additional Third Party System. The Exchange would then establish a unicast connection between the User and the relevant third party content service provider over the IP network.8 The Exchange would charge the User for the connectivity to the Additional Third Party System. A User would only receive, and only be charged for, access to Additional Third Party Systems for which it enters into agreements with the third party content service provider.

    8 Information flows over existing network connections in two formats: “unicast” format, which is a format that allows one-to-one communication, similar to a phone line, in which information is sent to and from the Exchange; and “multicast” format, which is a format in which information is sent one-way from the Exchange to multiple recipients at once, like a radio broadcast.

    The Exchange has no ownership interest in the Additional Third Party Systems. Establishing a User's access to an Additional Third Party System would not give the Exchange any right to use the Additional Third Party Systems. Connectivity to an Additional Third Party System would not provide access or order entry to the Exchange's execution system, and a User's connection to an Additional Third Party System would not be through the Exchange's execution system.

    As with the existing connections to Third Party Systems, the Exchange proposes to charge a monthly recurring fee for connectivity to an Additional Third Party System. Specifically, when a User requests access to an Additional Third Party System, it would identify the applicable content service provider and what bandwidth connection it required.

    The Exchange proposes to modify its Fee Schedules to add the Additional Third Party Systems to its existing list of Third Party Systems. The additional items would be as follows:

    Third Party Systems Chicago Mercantile Exchange (CME Group) Chicago Stock Exchange (CHX) Investors Exchange (IEX) OneChicago TMX Group

    The Exchange does not propose to change the monthly recurring fee the Exchange charges Users for unicast connectivity to each Third Party System, including the Additional Third Party Systems.

    Connectivity to Additional Third Party Data Feeds

    The Exchange proposes to revise the Fee Schedules to provide that Users may obtain connectivity to each of the two Additional Third Party Data Feeds for a fee. The Exchange would receive the Additional Third Party Data Feeds from the content service provider, at its data center. It would then provide connectivity to that data to Users for a fee. Users would connect to the Additional Third Party Data Feeds over the IP network.9

    9See supra note 7, at 7899 (“The IP network also provides Users with access to away market data products”).

    In order to connect to an Additional Third Party Data Feed, a User would enter into a contract with the content service provider, pursuant to which the content service provider would charge the User for the Third Party Data Feed. The Exchange would receive the Third Party Data Feed over its fiber optic network and, after the content service provider and User entered into the contract and the Exchange received authorization from the content service provider, the Exchange would re-transmit the data to the User over the User's port. The Exchange would charge the User for the connectivity to the Additional Third Party Data Feed. A User would only receive, and would only be charged for, connectivity to the Additional Third Party Data Feeds for which it entered into contracts.

    The Exchange has no affiliation with the sellers of the Additional Third Party Data Feeds. It would have no right to use the Additional Third Party Data Feeds other than as a redistributor of the data. The Additional Third Party Data Feeds would not provide access or order entry to the Exchange's execution system. The Additional Third Party Data Feeds would not provide access or order entry to the execution systems of the third parties generating the feed. The Exchange would receive the Additional Third Party Data Feeds via arms-length agreements and it would have no inherent advantage over any other distributor of such data.

    As it does with the existing Third Party Data Feeds, the Exchange proposes to charge a monthly recurring fee for connectivity to each Additional Third Party Data Feed. The monthly recurring fee would be per Additional Third Party Data Feed. Depending on its needs and bandwidth, a User may opt to receive all or some of the feeds or services included in an Additional Third Party Data Feed.

    The Exchange proposes to add the connectivity fees for the Additional Third Party Data to its existing list in the Fee Schedules. The additional items would be as follows:

    Third party data feed Monthly
  • recurring connectivity fee per third party data feed
  • Investors Exchange (IEX) $1,000 OneChicago 1,000
    General

    As is the case with all Exchange co-location arrangements, (i) neither a User nor any of the User's customers would be permitted to submit orders directly to the Exchange unless such User or customer is a member organization, a Sponsored Participant or an agent thereof (e.g., a service bureau providing order entry services); (ii) use of the co-location services proposed herein would be completely voluntary and available to all Users on a non-discriminatory basis; 10 and (iii) a User would only incur one charge for the particular co-location service described herein, regardless of whether the User connects only to the Exchange or to the Exchange and one or both the Affiliate SROs.11

    10 As is currently the case, Users that receive co-location services from the Exchange will not receive any means of access to the Exchange's trading and execution systems that is separate from, or superior to, that of other Users. In this regard, all orders sent to the Exchange enter the Exchange's trading and execution systems through the same order gateway, regardless of whether the sender is co-located in the data center or not. In addition, co-located Users do not receive any market data or data service product that is not available to all Users, although Users that receive co-location services normally would expect reduced latencies in sending orders to, and receiving market data from, the Exchange.

    11See SR-NYSEArca-2013-80, supra note 5 at 50459. The Affiliate SROs have also submitted substantially the same proposed rule change to propose the changes described herein. See SR-NYSE-2017-52 and SR-NYSEAMER-2017-24.

    The proposed change is not otherwise intended to address any other issues relating to co-location services and/or related fees, and the Exchange is not aware of any problems that Users would have in complying with the proposed change.

    2. Statutory Basis

    The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,12 in general, and furthers the objectives of Sections 6(b)(5) of the Act,13 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.

    12 15 U.S.C. 78f(b).

    13 15 U.S.C. 78f(b)(5).

    The Exchange believes that the proposed changes would remove impediments to, and perfect the mechanisms of, a free and open market and a national market system and, in general, protect investors and the public interest because, by offering additional services, the Exchange would give each User additional options for addressing its access and connectivity needs, responding to User demand for access and connectivity options. Providing additional services would help each User tailor its data center operations to the requirements of its business operations by allowing it to select the form and latency of access and connectivity that best suits its needs.

    The Exchange would provide Access and Connectivity as conveniences to Users. Use of Access or Connectivity would be completely voluntary. The Exchange is not aware of any impediment to third parties offering Access or Connectivity. The Exchange does not have visibility into whether third parties currently offer, or intend to offer, Users access to the Additional Third Party Systems and connectivity to the Additional Third Party Data Feeds. However, if one or more third parties presently offer, or in the future opt to offer, such Access and Connectivity to Users, a User may utilize the SFTI network, a third party telecommunication network, third party wireless network, a cross connect, or a combination thereof to access such services and products through a connection to an access center outside the data center (which could be a SFTI access center, a third-party access center, or both), another User, or a third party vendor.

    The Exchange believes that the proposed changes would remove impediments to, and perfect the mechanisms of, a free and open market and a national market system and, in general, protect investors and the public interest because, by offering access to the Additional Third Party Systems and connectivity to the Additional Third Party Data Feeds to Users upon the effective date of this filing, the Exchange would give Users additional options for connectivity and access to new services as soon as they are available, responding to User demand for access and connectivity options.

    The Exchange also believes that the proposed rule change is consistent with Section 6(b)(4) of the Act,14 in particular, because it provides for the equitable allocation of reasonable dues, fees, and other charges among its members, issuers and other persons using its facilities and does not unfairly discriminate between customers, issuers, brokers or dealers.

    14 15 U.S.C. 78f(b)(4).

    The Exchange believes that the proposed fee changes are consistent with Section 6(b)(4) of the Act for multiple reasons. The Exchange operates in a highly competitive market in which exchanges offer co-location services as a means to facilitate the trading and other market activities of those market participants who believe that co-location enhances the efficiency of their operations. Accordingly, fees charged for co-location services are constrained by the active competition for the order flow of, and other business from, such market participants. If a particular exchange charges excessive fees for co-location services, affected market participants will opt to terminate their co-location arrangements with that exchange, and adopt a possible range of alternative strategies, including placing their servers in a physically proximate location outside the exchange's data center (which could be a competing exchange), or pursuing strategies less dependent upon the lower exchange-to-participant latency associated with co-location. Accordingly, the exchange charging excessive fees would stand to lose not only co-location revenues but also the liquidity of the formerly co-located trading firms, which could have additional follow-on effects on the market share and revenue of the affected exchange.

    The Exchange believes that the additional services and fees proposed herein would be equitably allocated and not unfairly discriminatory because, in addition to the services being completely voluntary, they would be available to all Users on an equal basis (i.e., the same products and services would be available to all Users). All Users that voluntarily selected to receive Access or Connectivity would be charged the same amount for the same services. Users that opted to use Access or Connectivity would not receive access or connectivity that is not available to all Users, as all market participants that contracted with the relevant market or content provider would receive access or connectivity.

    The Exchange believes that the proposed charges would be reasonable, equitably allocated and not unfairly discriminatory because the Exchange would offer the Access and Connectivity as conveniences to Users, but in order to do so must provide, maintain and operate the data center facility hardware and technology infrastructure. The Exchange must handle the installation, administration, monitoring, support and maintenance of such services, including by responding to any production issues. Since the inception of co-location, the Exchange has made numerous improvements to the network hardware and technology infrastructure and has established additional administrative controls. The Exchange has expanded the network infrastructure to keep pace with the increased number of services available to Users, including resilient and redundant feeds. In addition, in order to provide Access and Connectivity, the Exchange would maintain multiple connections to each ATPD and ATPS, allowing the Exchange to provide resilient and redundant connections; adapt to any changes made by the relevant third party; and cover any applicable fees charged by the relevant third party, such as port fees. In addition, Users would not be required to use any of their bandwidth for Access and Connectivity unless they wish to do so.

    The Exchange believes the proposed fees for Access and Connectivity would be reasonable because they would allow the Exchange to defray or cover the costs associated with offering Users access to Additional Third Party Systems and connectivity to Additional Third Party Data Feeds while providing Users the convenience of receiving such Access and Connectivity within co-location, helping them tailor their data center operations to the requirements of their business operations.

    For the reasons above, the proposed changes would not unfairly discriminate between or among market participants that are otherwise capable of satisfying any applicable co-location fees, requirements, terms and conditions established from time to time by the Exchange.

    For these reasons, the Exchange believes that the proposal is consistent with the Act.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,15 the Exchange believes that the proposed rule change will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act because all of the proposed services are completely voluntary.

    15 15 U.S.C. 78f(b)(8).

    The Exchange believes that providing Users with additional options for connectivity and access to new services would not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act because such proposed Access and Connectivity would satisfy User demand for access and connectivity options. The Exchange would provide Access and Connectivity as conveniences equally to all Users. The Exchange does not have visibility into whether third parties currently offer, or intend to offer, Users access to the Additional Third Party Systems and connectivity to the Additional Third Party Data Feeds, as such third parties are not required to make that information public. However, if one or more third parties presently offer, or in the future opt to offer, such Access and Connectivity to Users, a User may utilize the SFTI network, a third party telecommunication network, third party wireless network, a cross connect, or a combination thereof to access such services and products through a connection to an access center outside the data center (which could be a SFTI access center, a third-party access center, or both), another User, or a third party vendor. Users that opt to use the proposed Access or Connectivity would not receive access or connectivity that is not available to all Users, as all market participants that contract with the content provider may receive access or connectivity. In this way, the proposed changes would enhance competition by helping Users tailor their Access and Connectivity to the needs of their business operations by allowing them to select the form and latency of access and connectivity that best suits their needs.

    The Exchange operates in a highly competitive market in which exchanges offer co-location services as a means to facilitate the trading and other market activities of those market participants who believe that co-location enhances the efficiency of their operations. Accordingly, fees charged for co-location services are constrained by the active competition for the order flow of, and other business from, such market participants. If a particular exchange charges excessive fees for co-location services, affected market participants will opt to terminate their co-location arrangements with that exchange, and adopt a possible range of alternative strategies, including placing their servers in a physically proximate location outside the exchange's data center (which could be a competing exchange), or pursuing strategies less dependent upon the lower exchange-to-participant latency associated with co-location. Accordingly, the exchange charging excessive fees would stand to lose not only co-location revenues but also the liquidity of the formerly co-located trading firms, which could have additional follow-on effects on the market share and revenue of the affected exchange. For the reasons described above, the Exchange believes that the proposed rule change reflects this competitive environment.

    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

    The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act 16 and Rule 19b-4(f)(6) thereunder.17 Because the proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative prior to 30 days from the date on which it was filed, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(6)(iii) thereunder.18

    16 15 U.S.C. 78s(b)(3)(A)(iii).

    17 17 CFR 240.19b-4(f)(6).

    18 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6) requires a self-regulatory organization to give 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. The Exchange has satisfied this requirement.

    A proposed rule change filed under Rule 19b-4(f)(6) 19 normally does not become operative for 30 days after the date of the filing. However, Rule 19b-4(f)(6)(iii) 20 permits the Commission to designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange has requested that the Commission waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Exchange represents that the proposed rule changes present no new or novel issues. According to the Exchange, waiver of the operative delay would allow Users to access the Additional Third Party Systems and the Additional Third Party Data Feeds without delay, which would assist Users in tailoring their data center operations to the requirements of their business operations. The Exchange also represents that the proposed changes to the Price List would provide Users with more complete information regarding their Access and Connectivity options. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. Accordingly, the Commission waives the 30-day operative delay and designates the proposed rule change operative upon filing.21

    19 17 CFR 240.19b-4(f)(6).

    20 17 CFR 240.19b-4(f)(6)(iii).

    21 For purposes only of waiving the 30-day 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) 22 of the Act to determine whether the proposed rule change should be approved or disapproved.

    22 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 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-2017-122 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-2017-122. 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 Web site (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 Web site 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-2017-122 and should be submitted on or before November 20, 2017.

    23 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.23

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-23476 Filed 10-27-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-81932; File No. SR-PEARL-2017-35] Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the MIAX PEARL Fee Schedule October 24, 2017.

    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 October 11, 2017, MIAX PEARL, LLC (“MIAX PEARL” or “Exchange”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. 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.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange is filing a proposal to amend the MIAX PEARL Fee Schedule (the “Fee Schedule”) to adopt a fee for the sale of certain historical market data.

    The text of the proposed rule change is available on the Exchange's Web site at http://www.miaxoptions.com/rule-filings/pearl at MIAX PEARL's principal office, 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 aspects of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The Exchange proposes to amend its Fee Schedule to adopt a fee for the sale of certain historical market data.

    The historical market data that the Exchange proposes to sell provides information about the past activity of all option products traded on the Exchange for each trading session conducted during a particular calendar month. The data is intended to enhance the user's ability to analyze option trade and volume data, evaluate historical trends in the trading activity of a particular option product, and enable the testing of trading models and analytical strategies. Specifically, the historical market data that the Exchange proposes to sell includes all data that is captured and disseminated on the following proprietary MIAX PEARL data feeds, on a T+1 basis: MIAX PEARL Top of Market (“ToM”); and MIAX PEARL Liquidity Feed (“PLF”) (“Historical Market Data”). All such proprietary MIAX PEARL data feeds that, on a T+1 basis, comprise the Historical Market Data are described on the Exchange's Fee Schedule.3

    3See MIAX PEARL Fee Schedule, Section 6.

    ToM provides real-time, ultra-low latency updates of the MIAX PEARL Best Bid or Offer, or PBBO,4 the last sale with trade price, size and condition, last sale cancellations, listed series updates, system state, and underlying trading state.5 PLF provides real-time, ultra-low latency updates of new simple orders added to the MIAX PEARL order book, updates to simple orders resting on the MIAX PEARL order book, listed series updates, System 6 state, and underlying trading state.7

    4 The term “PBBO” means the best bid or offer on the PEARL Exchange. See Exchange Rule 100. See also Exchange Rule 506(d).

    5See Securities Exchange Act Release No. 79913 (February 1, 2017), 82 FR 9617 (February 7, 2017) (SR-PEARL-2017-01) (Establishing MIAX PEARL ToM and PLF Data Products).

    6 The term “System” means the automated trading system used by the Exchange for the trading of securities. See Exchange Rule 100.

    7See supra note 5.

    MIAX PEARL will only assess the fee for Historical Market Data on a user (whether Member or Non-Member) that specifically requests such Historical Market Data. Historical Market Data will be uploaded onto an Exchange-provided device. The amount of the fee is $500, and it will be assessed on a per device basis. Each device shall have a maximum storage capacity of 8 Terabytes and will be configured to include data for both MIAX Options and MIAX PEARL. Users may request up to six months of Historical Market Data per device, subject to the device's storage capacity. Historical Market Data is available from August 1, 2017 to the present (always on a T+1 basis), however only the most recent six months of Historical Market Data shall be available for purchase from the request date. Historical Market Data usage is restricted to internal use only, and thus may not be distributed to any third-party.

    The Exchange notes that this filing is substantially similar to a companion MIAX Options filing 8 establishing a fee for historical market data on its exchange.

    8See SR-MIAX-2017-42 (filed on October 11, 2017).

    2. Statutory Basis

    The Exchange believes that its proposal to amend its Fee Schedule is consistent with Section 6(b) of the Act 9 in general, and furthers the objectives of Section 6(b)(4) of the Act,10 in particular, in that it is an equitable allocation of reasonable dues, fees and other charges among Exchange members and issuers and other persons using its facilities. The proposal provides for the equitable allocation of reasonable fees and other charges among Exchange members and other persons using its facilities because all persons and entities will have equal access to Historical Market Data.

    9 15 U.S.C. 78f(b).

    10 15 U.S.C. 78f(b)(4).

    The Exchange believes the proposed fees are a reasonable allocation of its costs and expenses among its Members and other persons using its facilities since it is recovering the costs associated with distributing such data. Access to the Exchange is provided on fair and non-discriminatory terms. The Exchange believes the proposed fees are equitable and not unfairly discriminatory because the fee level results in a reasonable and equitable allocation of fees amongst users for similar services. Moreover, the decision as to whether or not to purchase Historical Market Data is entirely optional to all users. Potential purchasers are not required to purchase the Historical Market Data, and the Exchange is not required to make the Historical Market Data available. Purchasers may request the data at any time or may decline to purchase such data. The allocation of fees among users is fair and reasonable because, if the market deems the proposed fees to be unfair or inequitable, firms can diminish or discontinue their use of this data.

    In adopting Regulation NMS, the Commission granted self-regulatory organizations and broker-dealers increased authority and flexibility to offer new and unique market data to the public. It was believed that this authority would expand the amount of data available to consumers, and also spur innovation and competition for the provision of market data:

    [E]fficiency is promoted when broker-dealers who do not need the data beyond the prices, sizes, market center identifications of the NBBO and consolidated last sale information are not required to receive (and pay for) such data when broker-dealers may choose to receive (and pay for) additional market data based on their own internal analysis of the need for such data.11

    11See Securities Exchange Act Release No. 51808 (June 9, 2005), 70 FR 37496 (June 29, 2005).

    By removing “unnecessary regulatory restrictions” on the ability of exchanges to sell their own data, Regulation NMS advanced the goals of the Act and the principles reflected in its legislative history. If the free market should determine whether proprietary data is sold to broker-dealers at all, it follows that the price at which such data is sold should be set by the market as well.

    In July, 2010, Congress adopted H.R. 4173, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (“Dodd-Frank Act”), which amended Section 19 of the Act. Among other things, Section 916 of the Dodd-Frank Act amended paragraph (A) of Section 19(b)(3) of the Act by inserting the phrase “on any person, whether or not the person is a member of the self-regulatory organization” after “due, fee or other charge imposed by the self-regulatory organization.” As a result, all SRO rule proposals establishing or changing dues, fees or other charges are immediately effective upon filing regardless of whether such dues, fees or other charges are imposed on members of the SRO, non-members, or both. Section 916 further amended paragraph (C) of Section 19(b)(3) of the Act to read, in pertinent part, “At any time within the 60-day period beginning on the date of filing of such a proposed rule change in accordance with the provisions of paragraph (1) [of Section 19(b)], the Commission summarily may temporarily suspend the change in the rules of the self-regulatory organization made thereby, 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 this title. If the Commission takes such action, the Commission shall institute proceedings under paragraph (2)(B) [of Section 19(b)] to determine whether the proposed rule should be approved or disapproved.”

    The Exchange believes that these amendments to Section 19 of the Act reflect Congress's intent to allow the Commission to rely upon the forces of competition to ensure that fees for market data are reasonable and equitably allocated. Although Section 19(b) had formerly authorized immediate effectiveness for a “due, fee or other charge imposed by the self-regulatory organization,” the Commission adopted a policy and subsequently a rule stating that fees for data and other products available to persons that are not members of the self-regulatory organization must be approved by the Commission after first being published for comment. At the time, the Commission supported the adoption of the policy and the rule by pointing out that unlike members, whose representation in self-regulatory organization governance was mandated by the Act, non-members should be given the opportunity to comment on fees before being required to pay them, and that the Commission should specifically approve all such fees. The Exchange believes that the amendment to Section 19 reflects Congress's conclusion that the evolution of self-regulatory organization governance and competitive market structure have rendered the Commission's prior policy on non-member fees obsolete. Specifically, many exchanges have evolved from member-owned, not-for-profit corporations into for-profit, investor-owned corporations (or subsidiaries of investor-owned corporations). Accordingly, exchanges no longer have narrow incentives to manage their affairs for the exclusive benefit of their members, but rather have incentives to maximize the appeal of their products to all customers, whether members or non-members, so as to broaden distribution and grow revenues. Moreover, the Exchange believes that the change also reflects an endorsement of the Commission's determinations that reliance on competitive markets is an appropriate means to ensure equitable and reasonable prices. Simply put, the change reflects a presumption that all fee changes should be permitted to take effect immediately, since the level of all fees are constrained by competitive forces.

    Selling proprietary market data, such as Historical Market Data, is a means by which exchanges compete to attract business. To the extent that exchanges are successful in such competition, they earn trading revenues and also enhance the value of their data products by increasing the amount of data they provide. The need to compete for business places substantial pressure upon exchanges to keep their fees for both executions and data reasonable.12 The Exchange therefore believes that the fees for Historical Market Data are properly assessed on Members and Non-Member users.

    12See Sec. Indus. Fin. Mkts. Ass'n (SIFMA), Initial Decision Release No. 1015, 2016 SEC LEXIS 2278 (ALJ June 1, 2016) (finding the existence of vigorous competition with respect to non-core market data).

    The decision of the United States Court of Appeals for the District of Columbia Circuit in NetCoalition v. SEC, No. 09-1042 (D.C. Cir. 2010), although reviewing a Commission decision made prior to the effective date of the Dodd-Frank Act, upheld the Commission's reliance upon competitive markets to set reasonable and equitably allocated fees for market data:

    In fact, the legislative history indicates that the Congress intended that the market system `evolve through the interplay of competitive forces as unnecessary regulatory restrictions are removed' and that the SEC wield its regulatory power `in those situations where competition may not be sufficient,' such as in the creation of a `consolidated transactional reporting system.' 13

    13NetCoalition, at 15 (quoting H.R. Rep. No. 94-229, at 92 (1975), as reprinted in 1975 U.S.C.C.A.N. 321, 323).

    The court's conclusions about Congressional intent are therefore reinforced by the Dodd-Frank Act amendments, which create a presumption that exchange fees, including market data fees, may take effect immediately, without prior Commission approval, and that the Commission should take action to suspend a fee change and institute a proceeding to determine whether the fee change should be approved or disapproved only where the Commission has concerns that the change may not be consistent with the Act.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    MIAX PEARL does not believe that the proposed rule changes will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. Indeed, the Exchange believes that offering certain Historical Market Data will enhance competition by encouraging sales, which will make analytical data more readily available to investors. Notwithstanding its determination that the Commission may rely upon competition to establish fair and equitably allocated fees for market data, the NetCoalition Court found that the Commission had not, in that case, compiled a record that adequately supported its conclusion that the market for the data at issue in the case was competitive. The Exchange believes that a record may readily be established to demonstrate the competitive nature of the market in question.

    The market for data products is extremely competitive and users may freely choose alternative venues and data vendors based on the aggregate fees assessed, the data offered, and the value provided. Numerous exchanges compete with each other for listings, trades, and market data itself, providing virtually limitless opportunities for entrepreneurs who wish to produce and distribute their own market data. Transaction execution and proprietary data products are complementary in that market data is both an input and a byproduct of the execution service. In fact, market data and trade execution are a paradigmatic example of joint products with joint costs. The decision whether and on which platform to post an order will depend on the attributes of the platform where the order can be posted, including the execution fees, data quality and price, and distribution of its data products. Without trade executions, exchange data products cannot exist. Moreover, data products are valuable to many end users only insofar as they provide information that end users expect will assist them or their customers in making trading decisions.

    The costs of producing market data include not only the costs of the data distribution infrastructure, but also the costs of designing, maintaining, and operating the exchange's transaction execution platform and the cost of regulating the exchange to ensure its fair operation and maintain investor confidence. The total return that a trading platform earns reflects the revenues it receives from both products and the joint costs it incurs. Moreover, the operation of the Exchange is characterized by high fixed costs and low marginal costs. This cost structure is common in content distribution industries such as software, where developing new software typically requires a large initial investment (and continuing large investments to upgrade software), but once the software is developed, the incremental cost of providing that software to an additional user is typically small, or even zero (e.g., if the software can be downloaded over the internet after being purchased).14 In the case of any exchange, it is costly to build and maintain a trading platform, but the incremental cost of trading each additional share on an existing platform, or distributing an additional instance of data, is very low. Market information and executions are each produced jointly (in the sense that the activities of trading and placing orders are the source of the information that is distributed) and are each subject to significant scale economies.

    14See William J. Baumol and Daniel G. Swanson, “The New Economy and Ubiquitous Competitive Price Discrimination: Identifying Defensible Criteria of Market Power,” Antitrust Law Journal, Vol. 70, No. 3 (2003).

    Competition among trading platforms can be expected to constrain the aggregate return each platform earns from the sale of its joint products. The level of competition and contestability in the market is evidence in the numerous alternative venues that compete for order flow, including SRO markets, as well as internalizing BDs and various forms of alternative trading systems (“ATSs”), including dark pools and electronic communication networks (“ECNs”). Each SRO market competes to produce transaction reports via trade executions. It is common for BDs to further and exploit this competition by sending their order flow and transaction reports to multiple markets, rather than providing them all to a single market. Competitive markets for order flow, executions, and transaction reports provide pricing discipline for the inputs of proprietary data products. The large number of SROs, TRFs, BDs, and ATSs that currently produce proprietary data or are currently capable of producing it provides further pricing discipline for proprietary data products. Each SRO, TRF, ATS, and BD is currently permitted to produce proprietary data products, and many currently do or have announced plans to do so, including the Nasdaq exchanges, NYSE exchanges, and CBOE/Bats exchanges.

    In this competitive environment, an “excessive” price for one product will have to be reflected in lower prices for other products sold by the Exchange, or otherwise the Exchange may experience a loss in sales that may adversely affect its profitability. In this case, the proposed rule change enhances competition by providing Historical Market Data at a fixed price. As such, the Exchange believes that the proposed changes will enhance, not impair, competition in the financial markets.

    The market for market data products is competitive and inherently contestable because there is fierce competition for the inputs necessary to the creation of proprietary data and strict pricing discipline for the proprietary products themselves. Numerous exchanges compete with each other for listings, trades, and market data itself, providing virtually limitless opportunities for entrepreneurs who wish to produce and distribute their own market data. This proprietary data is produced by each individual exchange, as well as other entities, in a vigorously competitive market.

    Broker-dealers currently have numerous alternative venues for their order flow, including fifteen existing options markets. Each SRO market competes to produce transaction reports via trade executions. Competitive markets for order flow, executions, and transaction reports provide pricing discipline for the inputs of proprietary data products. The large number of SROs that currently produce proprietary data or are currently capable of producing it provides further pricing discipline for proprietary data products. Each SRO is currently permitted to produce proprietary data products, and many in addition to MIAX PEARL currently do, including NASDAQ, CBOE, Nasdaq ISE, NYSE American, and NYSE Arca. Additionally, order routers and market data vendors can facilitate single or multiple broker-dealers' production of proprietary data products. The potential sources of proprietary products are virtually limitless.

    Market data vendors provide another form of price discipline for proprietary data products because they control the primary means of access to end subscribers. Vendors impose price restraints based upon their business models. For example, vendors such as Bloomberg and Thomson Reuters that assess a surcharge on data they sell may refuse to offer proprietary products that end subscribers will not purchase in sufficient numbers. Internet portals, such as Google, impose a discipline by providing only data that will enable them to attract “eyeballs” that contribute to their advertising revenue. Retail broker-dealers, such as Schwab and Fidelity, offer their customers proprietary data only if it promotes trading and generates sufficient commission revenue. Although the business models may differ, these vendors' pricing discipline is the same: They can simply refuse to purchase any proprietary data product that fails to provide sufficient value. The Exchange and other producers of proprietary data products must understand and respond to these varying business models and pricing disciplines in order to market proprietary data products successfully.

    In addition to the competition and price discipline described above, the market for proprietary data products is also highly contestable because market entry is rapid, inexpensive, and profitable. The history of electronic trading is replete with examples of entrants that swiftly grew into some of the largest electronic trading platforms and proprietary data producers: Archipelago, BATS Trading and Direct Edge. Regulation NMS, by deregulating the market for proprietary data, has increased the contestability of that market. While broker-dealers have previously published their proprietary data individually, Regulation NMS encourages market data vendors and broker-dealers to produce proprietary products cooperatively in a manner never before possible. Multiple market data vendors already have the capability to aggregate data and disseminate it on a profitable scale, including Bloomberg, and Thomson Reuters.

    The Court in NetCoalition concluded that the Commission had failed to demonstrate that the market for market data was competitive based on the reasoning of the Commission's NetCoalition order because, in the Court's view, the Commission had not adequately demonstrated that the proprietary data at issue in the case is used to attract order flow. The Exchange believes, however, that evidence not then before the court clearly demonstrates that availability of data attracts order flow. Due to competition among platforms, the Exchange intends to improve its platform data offerings on a continuing basis, and to respond promptly to customers' data needs.

    The intensity of competition for proprietary information is significant and the Exchange believes that this proposal itself clearly evidences such competition. The Exchange is offering Historical Market Data in order to keep pace with changes in the industry and evolving customer needs. It is entirely optional and is geared towards attracting new order flow. MIAX PEARL competitors continue to create new market data products and innovative pricing in this space. In all cases, the Exchange expects firms and other parties to make decisions on how much and what types of data to consume on the basis of the total cost of interacting with MIAX PEARL or other exchanges. Of course, the explicit data fees are only one factor in a total platform analysis. Some competitors have lower transactions fees and higher data fees, and others are vice versa. The market for this proprietary information is highly competitive and continually evolves as products develop and change.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    The foregoing rule change is effective pursuant to Section 19(b)(3)(A)(ii) of the Act,15 and subparagraph (f)(2) of Rule 19b-416 thereunder, because it establishes a due, fee, or other charge imposed by the Exchange. 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) 17 of the Act to determine whether the proposed rule change should be approved or disapproved.

    15 15 U.S.C. 78s(b)(3)(A)(ii).

    16 17 CFR 240.19b-4(f)(2).

    17 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 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-PEARL-2017-35 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-PEARL-2017-35. 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 Web site (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 Web site 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-PEARL-2017-35 and should be submitted on or before November 20, 2017.

    18 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.18

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-23480 Filed 10-27-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-81938; File No. SR-Phlx-2017-83] Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to the Exchange's Name Change October 24, 2017.

    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),1 and Rule 19b-4 thereunder,2 notice is hereby given that on October 19, 2017, NASDAQ PHLX LLC (“Phlx” or “Exchange”) 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 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.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange proposes to amend its rules as well as certain corporate documents of the Exchange to reflect legal name changes.

    The text of the proposed rule change is available on the Exchange's Web site at http://nasdaqphlx.cchwallstreet.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 aspects 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 this filing is to reflect in the Exchange's governing documents (and the governing documents of its parent company) 3 and the Exchange's Rulebook a non-substantive corporate branding change to the Exchange's name.4 Specifically, current references will be changed as follows:

    3 The Exchange proposes to amend: (i) The Amended Certificate of Formation; (ii) Second Amended Limited Liability Company Agreement; (iii) By-Laws; (iv) Rulebook; and (v) Pricing Schedule.

    4 The NASDAQ Stock Market LLC and NASDAQ BX, Inc. will also be filing similar rule changes.

    • References to “NASDAQ” will be changed to “Nasdaq” • References to “NASDAQ PHLX LLC” or “NASDAQ PHLX” will be changed to “Nasdaq PHLX LLC” or “Nasdaq PHLX” • References to “NASDAQ OMX PSX” or “NASDAQ PSX” will be changed to “Nasdaq PSX” • References to “The NASDAQ OMX Group, Inc.” or “NASDAQ OMX Group, Inc.” will be changed to “Nasdaq, Inc.” 5

    5See Securities Exchange Act Release No. 75421 (July 10, 2015), 80 FR 42136 (July 16, 2015)(SR-BSECC-2015-001, SR-BX-2015-030, SR-NASDAQ-2015-058, SR-Phlx-2015-46, SR-SCCP-2015-01).

    • In addition to the preceding changes, all references to “OMX” will be removed from the Rulebook.6

    6Id.

    • References to “The NASDAQ Stock Market LLC” or “NASDAQ Stock Market LLC” will be changed to “The Nasdaq Stock Market LLC” • References to “NASDAQ BX, Inc.” or “NASDAQ BX” will be changed to “Nasdaq BX, Inc.” or “Nasdaq BX” • In all instances where the word “the” should have been capitalized, (e.g., Rule 1080(n)(ii)(J)(1)), the Exchange will make the appropriate correction.

    This name change proposal is a non-substantive change. No changes to the ownership or structure of the Exchange have taken place. No other changes are being proposed in this filing. The Exchange represents that these changes are concerned solely with the administration of the Exchange and do not affect the meaning, administration, or enforcement of any rules of the Exchange or the rights, obligations, or privileges of Exchange members or their associated persons in any way. Accordingly, this filing is being submitted under Rule 19b-4(f)(3). In lieu of providing a copy of the marked changes, the Exchange represents that it will make the necessary non-substantive revisions to the Amended Certificate of Formation, Second Amended Limited Liability Company Agreement, By-Laws, Rulebook, and Pricing Schedule and post updated versions of each on the Exchange's Web site pursuant to Rule 19b-4(m)(2).

    The Exchange notes that the following references are not being amended in the Exchange's governing documents and the Exchange's Rulebook:

    • Any name with a trademark (TM) or service mark (SM) attached to the name.

    • Any references in the Amended Certificate of Formation or Second Amended Limited Liability Company Agreement which references [sic] a prior name of the Exchange and reflects a historical date wherein that name was in effect.

    2. Statutory Basis

    The Exchange believes that its proposal is consistent with section 6(b) of the Act,7 in general, and furthers the objectives of section 6(b)(5) of the Act,8 in particular, in that it is designed to promote just and equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general to protect investors and the public interest by avoiding confusion with the name. The Exchange proposes to conform its name to that of its parent, Nasdaq Inc., by changing the capitalization in the word “NASDAQ” to “Nasdaq.” The Exchange also proposes to amend the names of affiliated markets in a similar manner, by changing the name “NASDAQ” to “Nasdaq.” The name change of the Exchange as well as other name changes to related entities are non-substantive changes. No changes to the ownership or structure of the Exchange have taken place.

    7 15 U.S.C. 78f(b).

    8 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 not necessary or appropriate in furtherance of the purposes of the Act. The name change will align with the parent company, Nasdaq, Inc.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    Pursuant to section 19(b)(3)(A) of the Act 9 and Rule 19b-4(f)(3) thereunder,10 the Exchange has designated this proposal as one that is concerned solely with the administration of the self-regulatory organization, and therefore has become effective.

    9 15 U.S.C. 78s(b)(3)(A).

    10 17 CFR 240.19b-4(f)(3).

    At any time within 60 days of the filing of the 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.

    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-Phlx-2017-83 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-Phlx-2017-83. 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 Web site (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 Web site 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-Phlx-2017-83 and should be submitted on or before November 20, 2017.

    11 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.11

    Robert W. Errett, Deputy Secretary.
    [FR Doc. 2017-23488 Filed 10-27-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-81926; File No. SR-NYSE-2017-52] Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Provide Users With Access to Five Additional Third Party Systems and Connectivity to Two Additional Third Party Data Feeds October 24, 2017.

    Pursuant to Section 19(b)(1) 1 of the Securities Exchange Act of 1934 (the “Act”) 2 and Rule 19b-4 thereunder,3 notice is hereby given that on October 11, 2017, New York Stock Exchange LLC (“NYSE” or the “Exchange”) 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 provide Users with access to five additional third party systems and connectivity to two additional third party data feeds. In addition, the Exchange proposes to change its Price List related to these co-location services. The proposed rule change is available on the Exchange's Web site 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

    The Exchange proposes to amend the co-location 4 services offered by the Exchange to provide Users 5 with access to five additional third party systems and connectivity to two additional third party data feeds. In addition the Exchange proposes to make the corresponding changes to the Exchange's Price List related to these co-location services.

    4 The Exchange initially filed rule changes relating to its co-location services with the Commission in 2010. See Securities Exchange Act Release No. 62960 (September 21, 2010), 75 FR 59310 (September 27, 2010) (SR-NYSE-2010-56) (the “Original Co-location Filing”). The Exchange operates a data center in Mahwah, New Jersey (the “data center”) from which it provides co-location services to Users.

    5 For purposes of the Exchange's co-location services, a “User” means any market participant that requests to receive co-location services directly from the Exchange. See Securities Exchange Act Release No. 76008 (September 29, 2015), 80 FR 60190 (October 5, 2015) (SR-NYSE-2015-40). As specified in the Price List, a User that incurs co-location fees for a particular co-location service pursuant thereto would not be subject to co-location fees for the same co-location service charged by the Exchange's affiliates NYSE American LLC (“NYSE American”) and NYSE Arca, Inc. (“NYSE Arca” and, together with NYSE American, the “Affiliate SROs”). See Securities Exchange Act Release No. 70206 (August 15, 2013), 78 FR 51765 (August 21, 2013) (SR-NYSE-2013-59).

    As set forth in the Price List, the Exchange charges fees for connectivity to the execution systems of third party markets and other content service providers (“Third Party Systems”), and data feeds from third party markets and other content service providers (“Third Party Data Feeds”).6 The lists of Third Party Systems and Third Party Data Feeds are set forth in the Price List.

    6See Securities Exchange Act Release No. 80311 (March 24, 2017), 82 FR 15741 (March 30, 2017) (SR-NYSE-2016-45).

    The Exchange now proposes to make the following changes:

    • Add five content service providers to the list of Third Party Systems: Chicago Mercantile Exchange (CME Group), Chicago Stock Exchange (CHX), Investors Exchange (IEX), OneChicago and TMX Group (together, the “Additional Third Party Systems” or “ATPS”); and

    • add two feeds to the list of Third Party Data Feeds: Investors Exchange and OneChicago (together the “Additional Third Part Data Feeds” or “ATPD”).

    The Exchange would provide access to the Additional Third Party Systems (“Access”) and connectivity to the Additional Third Party Data Feeds (“Connectivity”) as conveniences to Users. Use of Access or Connectivity would be completely voluntary. The Exchange is not aware of any impediment to third parties offering Access or Connectivity.

    The Exchange does not have visibility into whether third parties currently offer, or intend to offer, Users access to the Additional Third Party Systems and connectivity to the Additional Third Party Data Feeds, as such third parties are not required to make that information public. However, if one or more third parties presently offer, or in the future opt to offer, such Access and Connectivity to Users, a User may utilize the Secure Financial Transaction Infrastructure (“SFTI”) network, a third party telecommunication network, third party wireless network, a cross connect, or a combination thereof to access such services and products through a connection to an access center outside the data center (which could be a SFTI access center, a third-party access center, or both), another User, or a third party vendor.

    The Exchange will announce the dates that each Product is available through customer notices disseminated to all Users simultaneously.

    Connectivity to Additional Third Party Systems

    The Exchange proposes to revise the Price List to provide that Users may obtain connectivity to the five Additional Third Party Systems for a fee. As with the current Third Party Systems, Users would connect to the Additional Third Party Systems over the internet protocol (“IP”) network, a local area network available in the data center.7

    7See Securities Exchange Act Release No. 74222 (February 6, 2015), 80 FR 7888 (February 12, 2015) (SR-NYSE-2015-05) (notice of filing and immediate effectiveness of proposed rule change to include IP network connections).

    As with the current Third Party Systems, in order to obtain access to an Additional Third Party System, the User would enter into an agreement with the relevant third party content service provider, pursuant to which the third party content service provider would charge the User for access to the Additional Third Party System. The Exchange would then establish a unicast connection between the User and the relevant third party content service provider over the IP network.8 The Exchange would charge the User for the connectivity to the Additional Third Party System. A User would only receive, and only be charged for, access to Additional Third Party Systems for which it enters into agreements with the third party content service provider.

    8 Information flows over existing network connections in two formats: “unicast” format, which is a format that allows one-to-one communication, similar to a phone line, in which information is sent to and from the Exchange; and “multicast” format, which is a format in which information is sent one-way from the Exchange to multiple recipients at once, like a radio broadcast.

    The Exchange has no ownership interest in the Additional Third Party Systems. Establishing a User's access to an Additional Third Party System would not give the Exchange any right to use the Additional Third Party Systems. Connectivity to an Additional Third Party System would not provide access or order entry to the Exchange's execution system, and a User's connection to an Additional Third Party System would not be through the Exchange's execution system.

    As with the existing connections to Third Party Systems, the Exchange proposes to charge a monthly recurring fee for connectivity to an Additional Third Party System. Specifically, when a User requests access to an Additional Third Party System, it would identify the applicable content service provider and what bandwidth connection it required.

    The Exchange proposes to modify its Price List to add the Additional Third Party Systems to its existing list of Third Party Systems. The additional items would be as follows:

    Third Party Systems Chicago Mercantile Exchange (CME Group) Chicago Stock Exchange (CHX) Investors Exchange (IEX) OneChicago TMX Group

    The Exchange does not propose to change the monthly recurring fee the Exchange charges Users for unicast connectivity to each Third Party System, including the Additional Third Party Systems.

    Connectivity to Additional Third Party Data Feeds

    The Exchange proposes to revise the Price List to provide that Users may obtain connectivity to each of the two Additional Third Party Data Feeds for a fee. The Exchange would receive the Additional Third Party Data Feeds from the content service provider, at its data center. It would then provide connectivity to that data to Users for a fee. Users would connect to the Additional Third Party Data Feeds over the IP network.9

    9See supra note 7, at 7889 (“The IP network also provides Users with access to away market data products”).

    In order to connect to an Additional Third Party Data Feed, a User would enter into a contract with the content service provider, pursuant to which the content service provider would charge the User for the Third Party Data Feed. The Exchange would receive the Third Party Data Feed over its fiber optic network and, after the content service provider and User entered into the contract and the Exchange received authorization from the content service provider, the Exchange would re-transmit the data to the User over the User's port. The Exchange would charge the User for the connectivity to the Additional Third Party Data Feed. A User would only receive, and would only be charged for, connectivity to the Additional Third Party Data Feeds for which it entered into contracts.

    The Exchange has no affiliation with the sellers of the Additional Third Party Data Feeds. It would have no right to use the Additional Third Party Data Feeds other than as a redistributor of the data. The Additional Third Party Data Feeds would not provide access or order entry to the Exchange's execution system. The Additional Third Party Data Feeds would not provide access or order entry to the execution systems of the third parties generating the feed. The Exchange would receive the Additional Third Party Data Feeds via arms-length agreements and it would have no inherent advantage over any other distributor of such data.

    As it does with the existing Third Party Data Feeds, the Exchange proposes to charge a monthly recurring fee for connectivity to each Additional Third Party Data Feed. The monthly recurring fee would be per Additional Third Party Data Feed. Depending on its needs and bandwidth, a User may opt to receive all or some of the feeds or services included in an Additional Third Party Data Feed.

    The Exchange proposes to add the connectivity fees for the Additional Third Party Data to its existing list in the Price List. The additional items would be as follows:

    Third party data feed Monthly
  • recurring
  • connectivity
  • fee per
  • third party
  • data feed
  • Investors Exchange (IEX) $1,000 OneChicago 1,000
    General

    As is the case with all Exchange co-location arrangements, (i) neither a User nor any of the User's customers would be permitted to submit orders directly to the Exchange unless such User or customer is a member organization, a Sponsored Participant or an agent thereof (e.g., a service bureau providing order entry services); (ii) use of the co-location services proposed herein would be completely voluntary and available to all Users on a non-discriminatory basis; 10 and (iii) a User would only incur one charge for the particular co-location service described herein, regardless of whether the User connects only to the Exchange or to the Exchange and one or both the Affiliate SROs.11

    10 As is currently the case, Users that receive co-location services from the Exchange will not receive any means of access to the Exchange's trading and execution systems that is separate from, or superior to, that of other Users. In this regard, all orders sent to the Exchange enter the Exchange's trading and execution systems through the same order gateway, regardless of whether the sender is co-located in the data center or not. In addition, co-located Users do not receive any market data or data service product that is not available to all Users, although Users that receive co-location services normally would expect reduced latencies in sending orders to, and receiving market data from, the Exchange.

    11See SR-NYSE-2013-59, supra note 5 at 51766. The Affiliate SROs have also submitted substantially the same proposed rule change to propose the changes described herein. See SR-NYSEAMER-2017-24 and SR-NYSEArca-2017-122.

    The proposed change is not otherwise intended to address any other issues relating to co-location services and/or related fees, and the Exchange is not aware of any problems that Users would have in complying with the proposed change.

    2. Statutory Basis

    The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,12 in general, and furthers the objectives of Sections 6(b)(5) of the Act,13 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.

    12 15 U.S.C. 78f(b).

    13 15 U.S.C. 78f(b)(5).

    The Exchange believes that the proposed changes would remove impediments to, and perfect the mechanisms of, a free and open market and a national market system and, in general, protect investors and the public interest because, by offering additional services, the Exchange would give each User additional options for addressing its access and connectivity needs, responding to User demand for access and connectivity options. Providing additional services would help each User tailor its data center operations to the requirements of its business operations by allowing it to select the form and latency of access and connectivity that best suits its needs.

    The Exchange would provide Access and Connectivity as conveniences to Users. Use of Access or Connectivity would be completely voluntary. The Exchange is not aware of any impediment to third parties offering Access or Connectivity. The Exchange does not have visibility into whether third parties currently offer, or intend to offer, Users access to the Additional Third Party Systems and connectivity to the Additional Third Party Data Feeds. However, if one or more third parties presently offer, or in the future opt to offer, such Access and Connectivity to Users, a User may utilize the SFTI network, a third party telecommunication network, third party wireless network, a cross connect, or a combination thereof to access such services and products through a connection to an access center outside the data center (which could be a SFTI access center, a third-party access center, or both), another User, or a third party vendor.

    The Exchange believes that the proposed changes would remove impediments to, and perfect the mechanisms of, a free and open market and a national market system and, in general, protect investors and the public interest because, by offering access to the Additional Third Party Systems and connectivity to the Additional Third Party Data Feeds to Users upon the effective date of this filing, the Exchange would give Users additional options for connectivity and access to new services as soon as they are available, responding to User demand for access and connectivity options.

    The Exchange also believes that the proposed rule change is consistent with Section 6(b)(4) of the Act,14 in particular, because it provides for the equitable allocation of reasonable dues, fees, and other charges among its members, issuers and other persons using its facilities and does not unfairly discriminate between customers, issuers, brokers or dealers.

    14 15 U.S.C. 78f(b)(4).

    The Exchange believes that the proposed fee changes are consistent with Section 6(b)(4) of the Act for multiple reasons. The Exchange operates in a highly competitive market in which exchanges offer co-location services as a means to facilitate the trading and other market activities of those market participants who believe that co-location enhances the efficiency of their operations. Accordingly, fees charged for co-location services are constrained by the active competition for the order flow of, and other business from, such market participants. If a particular exchange charges excessive fees for co-location services, affected market participants will opt to terminate their co-location arrangements with that exchange, and adopt a possible range of alternative strategies, including placing their servers in a physically proximate location outside the exchange's data center (which could be a competing exchange), or pursuing strategies less dependent upon the lower exchange-to-participant latency associated with co-location. Accordingly, the exchange charging excessive fees would stand to lose not only co-location revenues but also the liquidity of the formerly co-located trading firms, which could have additional follow-on effects on the market share and revenue of the affected exchange.

    The Exchange believes that the additional services and fees proposed herein would be equitably allocated and not unfairly discriminatory because, in addition to the services being completely voluntary, they would be available to all Users on an equal basis (i.e., the same products and services would be available to all Users). All Users that voluntarily selected to receive Access or Connectivity would be charged the same amount for the same services. Users that opted to use Access or Connectivity would not receive access or connectivity that is not available to all Users, as all market participants that contracted with the relevant market or content provider would receive access or connectivity.

    The Exchange believes that the proposed charges would be reasonable, equitably allocated and not unfairly discriminatory because the Exchange would offer the Access and Connectivity as conveniences to Users, but in order to do so must provide, maintain and operate the data center facility hardware and technology infrastructure. The Exchange must handle the installation, administration, monitoring, support and maintenance of such services, including by responding to any production issues. Since the inception of co-location, the Exchange has made numerous improvements to the network hardware and technology infrastructure and has established additional administrative controls. The Exchange has expanded the network infrastructure to keep pace with the increased number of services available to Users, including resilient and redundant feeds. In addition, in order to provide Access and Connectivity, the Exchange would maintain multiple connections to each ATPD and ATPS, allowing the Exchange to provide resilient and redundant connections; adapt to any changes made by the relevant third party; and cover any applicable fees charged by the relevant third party, such as port fees. In addition, Users would not be required to use any of their bandwidth for Access and Connectivity unless they wish to do so.

    The Exchange believes the proposed fees for Access and Connectivity would be reasonable because they would allow th