Federal Register Vol. 82, No.214,

Federal Register Volume 82, Issue 214 (November 7, 2017)

Page Range51549-51752
FR Document

82_FR_214
Current View
Page and SubjectPDF
82 FR 51628 - Sunshine Act MeetingsPDF
82 FR 51668 - Sunshine Act MeetingsPDF
82 FR 51662 - Sunshine Act MeetingsPDF
82 FR 51665 - Princeton Fund Advisors, LLC. et al.PDF
82 FR 51666 - Brandes Investment Trust, et al.PDF
82 FR 51597 - Submission for OMB Review; Comment RequestPDF
82 FR 51614 - United States Global Change Research Program (USGCRP) To Announce the Availability of a Draft Fourth National Climate Assessment Report for Public CommentPDF
82 FR 51577 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coastal Migratory Pelagic Resources of the Gulf of Mexico and Atlantic Region; Commercial Closure for Spanish MackerelPDF
82 FR 51670 - Twenty First RTCA SC-227 Standards of Navigation Performance PlenaryPDF
82 FR 51615 - Authorization of Subgrants for the High School Career and Technical Education Teacher Pathway InitiativePDF
82 FR 51628 - Clean Air Act Operating Permit Program; Petition To Object to Title V Permit for Wheelabrator Frackville Energy; PennsylvaniaPDF
82 FR 51639 - 30-Day Notice of Proposed Information Collection: Transfer and Consolidation of Public Housing Programs and Public Housing AgenciesPDF
82 FR 51646 - Office of the Assistant Secretary for Administration and Management; Request for Comments on the Draft DOL FY 2018-2022 Strategic PlanPDF
82 FR 51629 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
82 FR 51629 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
82 FR 51600 - Proposed Information Collection; Comment Request; Current Population Survey (CPS) Basic Demographic ItemsPDF
82 FR 51643 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection-CJIS Name Check Form (1-791)PDF
82 FR 51667 - 60-Day Notice of Proposed Information Collection: Supplemental SIV Chief of Mission ApplicationPDF
82 FR 51670 - Pipeline Safety: Meetings of the Gas Pipeline Advisory Committee and the Liquid Pipeline Advisory CommitteePDF
82 FR 51594 - Fisheries of the Northeastern United States; Scup Fishery; 2018 and Projected 2019 SpecificationsPDF
82 FR 51582 - Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered OrganismsPDF
82 FR 51642 - Bulk Manufacturer of Controlled Substances Application: Cambrex Charles CityPDF
82 FR 51602 - Uncovered Innerspring Units From the People's Republic of China: Preliminary Results and Rescission, in Part, of the Antidumping Duty Administrative Review; 2016-2017PDF
82 FR 51636 - Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Guidance for Industry; AvailabilityPDF
82 FR 51554 - Listing of Color Additives Exempt From Certification; Calcium CarbonatePDF
82 FR 51621 - Combined Notice of FilingsPDF
82 FR 51631 - Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery; Guidance for Industry; AvailabilityPDF
82 FR 51585 - General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction DevicePDF
82 FR 51570 - Rule on Attorney-Client Privilege for Trials Before the Patent Trial and Appeal BoardPDF
82 FR 51635 - Agency Information Collection Activities; Announcement of Office of Management and Budget ApprovalsPDF
82 FR 51604 - Large Power Transformers From the Republic of Korea: Final Results of the Expedited First Sunset Review of the Antidumping Duty OrderPDF
82 FR 51616 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Corrective Action Plan (CAP)PDF
82 FR 51607 - Certain Activated Carbon From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016PDF
82 FR 51605 - Diamond Sawblades and Parts Thereof From the People's Republic of China: Initiation and Preliminary Results of Antidumping Duty Changed Circumstances ReviewPDF
82 FR 51616 - Proposed Agency Information Collection ExtensionPDF
82 FR 51597 - Information Collection; Outreach Opportunity QuestionnairePDF
82 FR 51611 - Certain Steel Threaded Rod From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016PDF
82 FR 51644 - Federal-State Unemployment Compensation Program: Certifications for 2017 Under the Federal Unemployment Tax ActPDF
82 FR 51645 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Report on Current Employment StatisticsPDF
82 FR 51613 - Carbon and Alloy Steel Wire Rod From Italy, the Republic of Korea, Spain, Turkey, and the United Kingdom: Postponement of Final Determinations of Less-Than-Fair-Value Investigation and Extension of Provisional MeasuresPDF
82 FR 51642 - Lined Paper School Supplies From China and India; Amended Schedule for Expedited ReviewsPDF
82 FR 51601 - Stainless Steel Bar From India: Preliminary Determination of No Shipments and Partial Rescission of the Antidumping Duty Administrative Review; 2016-2017PDF
82 FR 51638 - Annual Indexing of Basic Statutory Mortgage Limits for Multifamily Housing ProgramsPDF
82 FR 51639 - 30-Day Notice of Proposed Information Collection: Housing Opportunities for Persons With AIDS (HOPWA) ProgramPDF
82 FR 51673 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board Amended Notice of MeetingsPDF
82 FR 51672 - Privacy Act of 1974; Matching ProgramPDF
82 FR 51598 - Notice of Intent To Request To Conduct a New Information CollectionPDF
82 FR 51669 - Petition for Exemption; Summary of Petition Received; Auburn UniversityPDF
82 FR 51633 - Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for CommentsPDF
82 FR 51567 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection SystemPDF
82 FR 51558 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Total 25-Hydroxyvitamin D Mass Spectrometry Test SystemPDF
82 FR 51668 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Paper Promises: Early American Photography” ExhibitionPDF
82 FR 51560 - Medical Devices; Immunology and Microbiology Devices; Classification of the Genetic Health Risk Assessment SystemPDF
82 FR 51669 - Twenty Fifth RTCA SC-223 IPS and AeroMACS PlenaryPDF
82 FR 51628 - Federal Advisory Committee Act; Meeting of Technological Advisory CouncilPDF
82 FR 51550 - Airworthiness Directives; Rolls-Royce plc Turbofan EnginesPDF
82 FR 51629 - Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee (STAC)PDF
82 FR 51623 - Notice of Petition for Declaratory Order; Permian Express Terminal LLC; Permian Express Partners LLCPDF
82 FR 51617 - Notice of Application Accepted for Filing, Soliciting Comments, Protests and Motions To Intervene; Sappi Cloquet LLCPDF
82 FR 51625 - Notice of Petition for Declaratory Order; BridgeTex Pipeline Company, LLCPDF
82 FR 51623 - EDF Renewable Energy, Inc. v. Midcontinent Independent System Operator, Inc.; Southwest Power Pool, Inc.; PJM Interconnection, L.L.C.; Notice of ComplaintPDF
82 FR 51625 - Combined Notice of Filings #2PDF
82 FR 51617 - Combined Notice of FilingsPDF
82 FR 51626 - Combined Notice of Filings #1PDF
82 FR 51627 - Combined Notice of FilingsPDF
82 FR 51624 - Notice of Application; Texas Eastern Transmission, LPPDF
82 FR 51618 - Combined Notice of Filings #1PDF
82 FR 51637 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
82 FR 51637 - Center for Scientific Review; Notice of Closed MeetingsPDF
82 FR 51618 - Crown Hydro, LLC; Notice of Teleconference To Discuss Section 106 Consultation for an Application To Amend the Crown Mill ProjectPDF
82 FR 51620 - Records Governing Off-the-Record Communications; Public NoticePDF
82 FR 51671 - Notice of Performance Review Board MembersPDF
82 FR 51660 - Reinhart Partners, Inc., et al.PDF
82 FR 51599 - Notice of Public Meeting of the Alaska Advisory CommitteePDF
82 FR 51578 - Fisheries of the Northeastern United States; Golden Tilefish Fishery; 2018 and Projected 2019-2020 SpecificationsPDF
82 FR 51630 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
82 FR 51661 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Annual Listing Fees for Common Stocks and WarrantsPDF
82 FR 51658 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Establish Fees for the New TRACE Security Activity Report and End-of-Day TRACE Transaction FilePDF
82 FR 51663 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change, Security-Based Swap Submission or Advance Notice Relating to the ICE Clear Europe Procyclicality FrameworkPDF
82 FR 51655 - Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres®PDF
82 FR 51552 - Airworthiness Directives; IPECO Pilot and Co-Pilot SeatsPDF
82 FR 51643 - Notice of Lodging of Proposed Consent Decree Under the Clean Air ActPDF
82 FR 51549 - Airworthiness Criteria: Glider Design Criteria for Alexander Schleicher GmbH & Co. Models ASG 32 & ASG 32 Mi GlidersPDF
82 FR 51583 - Airworthiness Directives; Piper Aircraft, Inc. AirplanesPDF
82 FR 51589 - Determination of Rates and Terms for Public Broadcasting (PB III)PDF
82 FR 51676 - Medicare and Medicaid Programs; CY 2018 Home Health Prospective Payment System Rate Update and CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting RequirementsPDF
82 FR 51646 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards ConsiderationsPDF
82 FR 51594 - Air Plan Approval; Wisconsin; 2017 Revisions to NR 400 and 406PDF
82 FR 51575 - Air Plan Approval; Wisconsin; 2017 Revisions to NR 400 and 406PDF

Issue

82 214 Tuesday, November 7, 2017 Contents Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

See

Forest Service

See

National Agricultural Statistics Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 51597 2017-24223
Animal Animal and Plant Health Inspection Service PROPOSED RULES Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms; Withdrawal, 51582-51583 2017-24202 Census Bureau Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Current Population Survey Basic Demographic Items, 51600-51601 2017-24209 Centers Disease Centers for Disease Control and Prevention NOTICES Requests for Nominations: World Trade Center Health Program Scientific/Technical Advisory Committee, 51629-51630 2017-24155 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare and Medicaid Programs: CY 2018 Home Health Prospective Payment System Rate Update and CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements, 51676-51752 2017-23935 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 51630-51631 2017-24134 Civil Rights Civil Rights Commission NOTICES Meetings: Alaska Advisory Committee, 51599-51600 2017-24136 2017-24137 Commerce Commerce Department See

Census Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

Copyright Royalty Board Copyright Royalty Board PROPOSED RULES Determinations of Rates and Terms for Public Broadcasting (PB III), 51589-51594 2017-23991 Drug Drug Enforcement Administration NOTICES Manufacturers of Controlled Substances; Applications: Cambrex Charles City, 51642-51643 2017-24201 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Corrective Action Plan, 51616 2017-24185 Authorization of Subgrants for High School Career and Technical Education Teacher Pathway Initiative, 51615-51616 2017-24218 Employment and Training Employment and Training Administration NOTICES Federal-State Unemployment Compensation Program: Certifications for 2017 under Federal Unemployment Tax Act, 51644-51645 2017-24177 Energy Department Energy Department See

Energy Efficiency and Renewable Energy Office

See

Federal Energy Regulatory Commission

Energy Efficiency Energy Efficiency and Renewable Energy Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 51616-51617 2017-24180 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Wisconsin; 2017 Revisions to NR 400 and 406, 51575-51577 2017-23048 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Wisconsin; 2017 Revision to NR 400 and 406, 51594 2017-23448 NOTICES Clean Air Act Operating Permit Program: Petition to Object to Title V Permit for Wheelabrator Frackville Energy; Pennsylvania, 51628 2017-24215 Federal Aviation Federal Aviation Administration RULES Airworthiness Criteria: Glider Design Criteria for Alexander Schleicher GmbH and Co. Models ASG 32 and ASG 32 Mi Gliders, 51549 2017-24102 Airworthiness Directives: IPECO Pilot and Co-pilot Seats, 51552-51554 2017-24127 Rolls-Royce plc Turbofan Engines, 51550-51552 2017-24156 PROPOSED RULES Airworthiness Directives: Piper Aircraft, Inc. Airplanes, 51583-51585 2017-24083 NOTICES Meetings: Twenty Fifth RTCA SC-223 IPS and AeroMACS Plenary, 51669-51670 2017-24158 Twenty First RTCA SC-227 Standards of Navigation Performance Plenary, 51670 2017-24219 Petitions for Exemptions; Summaries: Auburn University, 51669 2017-24165 Federal Communications Federal Communications Commission NOTICES Meetings: Federal Advisory Committee Act; Technological Advisory Council, 51628 2017-24157 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 51628 2017-24338 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Texas Eastern Transmission, LP, 51624 2017-24146 Combined Filings, 51617-51623, 51625-51628 2017-24145 2017-24147 2017-24148 2017-24149 2017-24150 2017-24193 Complaints: EDF Renewable Energy, Inc. v. Midcontinent Independent System Operator, Inc., Southwest Power Pool, Inc., and PJM Interconnection, LLC, 51623-51624 2017-24151 Hydroelectric Applications: Sappi Cloquet, LLC, 51617-51618 2017-24153 Meetings: Crown Hydro, LLC; Crown Mill Hydroelectric Project; Teleconference, 51618 2017-24142 Petitions for Declaratory Orders: BridgeTex Pipeline Co., LLC, 51625-51626 2017-24152 Permian Express Terminal, LLC and Permian Express Partners, LLC, 51623 2017-24154 Records Governing Off-the-Record Communications, 51620-51621 2017-24141 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 51629 2017-24210 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 51629 2017-24211 Food and Drug Food and Drug Administration RULES Immunology and Microbiology Devices: Classification of Genetic Health Risk Assessment System, 51560-51567 2017-24159 Listing of Color Additives Exempt from Certification; Calcium Carbonate, 51554-51558 2017-24194 Medical Devices: Clinical Chemistry and Clinical Toxicology Devices; Classification of Total 25-hydroxyvitamin D Mass Spectrometry Test System, 51558-51560 2017-24161 Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System, 51567-51570 2017-24162 PROPOSED RULES General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device, 51585-51589 2017-24191 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 51635 2017-24189 Guidance: Chronic Hepatitis C Virus Infection; Developing Direct-Acting Antiviral Drugs for Treatment, 51636-51637 2017-24195 Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled with Cardiovascular-Related Imagery, 51631-51633 2017-24192 Medical Devices: Exemptions from Premarket Notification: Class II Devices, 51633-51635 2017-24163 Forest Forest Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Outreach Opportunity Questionnaire, 51597-51598 2017-24179 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

National Institutes of Health

Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Housing Opportunities for Persons with AIDS Program, 51639-51641 2017-24170 Transfer and Consolidation of Public Housing Programs and Public Housing Agencies, 51639 2017-24213 Annual Indexing of Basic Statutory Mortgage Limits for Multifamily Housing Programs, 51638 2017-24171 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Carbon and Alloy Steel Wire Rod from Italy, Republic of Korea, Spain, Turkey, and United Kingdom, 51613-51614 2017-24175 Certain Activated Carbon from the People's Republic of China, 51607-51611 2017-24184 Certain Steel Threaded Rod from the People's Republic of China, 51611-51613 2017-24178 Diamond Sawblades and Parts Thereof from the People's Republic of China, 51605-51607 2017-24183 Large Power Transformers from Republic of Korea, 51604-51605 2017-24187 Stainless Steel Bar from India, 51601-51602 2017-24172 Uncovered Innerspring Units from the People's Republic of China, 51602-51604 2017-24199 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Lined Paper School Supplies from China and India, 51642 2017-24174 Justice Department Justice Department See

Drug Enforcement Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 51643 2017-24208 Proposed Consent Decrees: Clean Air Act, 51643-51644 2017-24125
Labor Department Labor Department See

Employment and Training Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Report on Current Employment Statistics, 51645-51646 2017-24176 Draft FY 2018-2022 Strategic Plan, 51646 2017-24212
Library Library of Congress See

Copyright Royalty Board

National Agricultural National Agricultural Statistics Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Water Use Survey, 51598-51599 2017-24167 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 51637-51638 2017-24143 National Heart, Lung, and Blood Institute, 51637 2017-24144 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Coastal Migratory Pelagic Resources of the Gulf of Mexico and Atlantic Region; Commercial Closure for Spanish Mackerel, 51577-51578 2017-24220 Fisheries of the Northeastern United States: Golden Tilefish Fishery; 2018 and Projected 2019-2020 Specifications, 51578-51581 2017-24135 PROPOSED RULES Fisheries of the Northeastern United States: Scup Fishery; 2018 and Projected 2019 Specifications, 51594-51596 2017-24205 NOTICES United States Global Change Research Program Fourth National Climate Assessment Report, 51614-51615 2017-24221 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Facility Operating and Combined Licenses: Applications and Amendments Involving No Significant Hazards Considerations; Biweekly Notice, 51646-51655 2017-23749 Guidance: Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere and SIR-Spheres, 51655-51657 2017-24129 Patent Patent and Trademark Office RULES Attorney-Client Privilege for Trials before Patent Trial and Appeal Board, 51570-51575 2017-24190 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Meetings: Gas Pipeline Advisory Committee and Liquid Pipeline Advisory Committee, 51670-51671 2017-24206 Securities Securities and Exchange Commission NOTICES Applications: Brandes Investment Trust, et al., 51666-51667 2017-24224 Princeton Fund Advisors, LLC. et al., 51665-51666 2017-24225 Reinhart Partners, Inc., et al., 51660-51661 2017-24138 Meetings; Sunshine Act, 51662-51663 2017-24260 Self-Regulatory Organizations; Proposed Rule Changes: Financial Industry Regulatory Authority, Inc., 51658-51660 2017-24131 ICE Clear Europe, Ltd., 51663-51665 2017-24130 NYSE American, LLC, 51661-51662 2017-24132 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Supplemental SIV Chief of Mission Application, 51667-51668 2017-24207 Culturally Significant Objects Imported for Exhibition: Paper Promises: Early American Photography, 51668 2017-24160 Tennessee Tennessee Valley Authority NOTICES Meetings; Sunshine Act, 51668 2017-24298 Transportation Department Transportation Department See

Federal Aviation Administration

See

Pipeline and Hazardous Materials Safety Administration

Veteran Affairs Veterans Affairs Department NOTICES Meetings: Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board, 51673-51674 2017-24169 Performance Review Board Membership, 51671-51672 2017-24139 Privacy Act; Matching Program, 51672-51673 2017-24168 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 51676-51752 2017-23935 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.

To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.

82 214 Tuesday, November 7, 2017 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 21 [Docket No. FAA-2017-0863] Airworthiness Criteria: Glider Design Criteria for Alexander Schleicher GmbH & Co. Models ASG 32 & ASG 32 Mi Gliders AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Airworthiness design criteria.

SUMMARY:

These airworthiness design criteria for the Alexander Schleicher GmbH & Co. models ASG 32 & ASG 32 Mi gliders. The administrator finds the design criteria, which make up the certification basis for the ASG 32 & ASG 32 Mi gliders, acceptable.

DATES:

These airworthiness design criteria are effective December 7, 2017.

FOR FURTHER INFORMATION CONTACT:

Mr. Jim Rutherford, AIR-692, Federal Aviation Administration, Policy & Innovation Division, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City, MO 64106, telephone (816) 329-4165, facsimile (816) 329-4090.

SUPPLEMENTARY INFORMATION:

Background

On August 23, 2016, Alexander Schleicher GmbH & Co. submitted an application for type validation of the ASG 32 glider and ASG 32 Mi powered glider in accordance with the Technical Implementation Procedures for Airworthiness and Environmental Certification Between the FAA and the European Aviation Safety Agency (EASA), Revision 5, dated September 15, 2015. Both models will be documented on a single type certificate. The model ASG 32 is a two-seat, mid-wing, glider constructed from carbon-, glass-, and synthetic-fiber reinforced plastic and features a 65.6 foot (20 meter) wingspan with flaps, double-panel Schempp-Hirth airbrakes on the upper wing surface, winglets, water ballast tanks in the wing, and optional tanks in the fuselage. The glider also features a retractable landing gear with hydraulic disc brakes and a conventional T-type tailplane. The model ASG 32 Mi adds a retractable engine and fixed pitch propeller mounted in the center fuselage behind the cockpit which allows the glider to be self-launching. Both glider versions have a maximum weight of 1,874 pounds (850 kilograms). The EASA type certificated the ASG 32 and ASG 32 Mi gliders under Type Certificate Number (No.) EASA.A.599 on February 11, 2016. The associated EASA Type Certificate Data Sheet (TCDS) No. EASA.A.599 defined the certification basis Alexander Schleicher GmbH & Co. submitted to the FAA for review and acceptance.

The applicable requirements for glider certification in the United States can be found in FAA Advisory Circular (AC) 21.17-2A, “Type Certification—Fixed-Wing Gliders (Sailplanes), Including Powered Gliders,” dated February 10, 1993. AC 21.17-2A has been the basis for certification of gliders and powered gliders in the United States for many years. AC 21.17-2A states that applicants may utilize the Joint Aviation Requirements (JAR)-22, “Sailplanes and Powered Sailplanes,” or another accepted airworthiness criteria, or a combination of both, as the accepted means for showing compliance for glider type certification.

Type Certification Basis

The certification basis is based on EASA Certification Specification (CS)-22, “Sailplanes and Powered Sailplanes”, amendment 2, dated March 05, 2009. In addition to CS-22 requirements, the applicant will comply with other requirements from the certification basis referenced in EASA TCDS No. EASA.A.599, including special conditions and equivalent safety findings.

Discussion of Comments

Notice of proposed airworthiness design criteria for the Alexander Schleicher GmbH & Co. models ASG 32 & ASG 32 Mi gliders was published in the Federal Register on September 6, 2017 (82 FR 42049). No comments were received; therefore, these airworthiness design criteria are adopted as proposed.

The Airworthiness Design Criteria

Applicable Airworthiness Criteria under § 21.17(b).

Based on the Special Class provisions of § 21.17(b), the following airworthiness requirements form the FAA Certification Basis for this design:

1. 14 CFR part 21, effective February 1, 1965, including amendments 21-1 through 21-98 as applicable.

2. EASA CS-22, amendment 2, dated March 05, 2009.

3. EASA Special Condition No. SC-A.22.1.01, “Increase in maximum mass for sailplanes and powered sailplanes.”

4. EASA Equivalent Safety Finding to CS-22.335(f)—Alternate method to calculate the Design Maximum Speed (VD) using the Organisation Scientifique et Technique Internationale du Vol á Voile (OSTIV), Airworthiness Standards for Sailplanes, dated July 1997.

5. EASA Equivalent Safety Finding to CS-22.585(a)—Alternate basis for lower towing loads and subsequent lower lauching hook attachment loads.

6. “Standards for Structural Substantiation of Sailplane and Powered Sailplane Parts Consisting of Glass or Carbon Fiber Reinforced Plastics,” Luftfahrt-Bundesamt (LBA) document no. I4-FVK/91, issued July 1991.

7. “Guideline for the analysis of the electrical system for powered sailplanes,” LBA document no. I334-MS 92, issued September 15, 1992.

8. Operations allowed: VFR-Day

9. EASA Type Certificate Data Sheet No. EASA.A.599, Issue 02, dated March 17, 2016.

10. Date of application for FAA Type Certificate: August 23, 2016.

Issued in Kansas City, Missouri on October 31, 2017. Pat Mullen, Manager, Small Airplane Standards Branch, Aircraft Certification Service.
[FR Doc. 2017-24102 Filed 11-6-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-0816; Product Identifier 2017-NE-29-AD; Amendment 39-19093; AD 2017-22-13] RIN 2120-AA64 Airworthiness Directives; Rolls-Royce plc Turbofan Engines AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; request for comments.

SUMMARY:

We are adopting a new airworthiness directive (AD) for all Rolls-Royce plc (RR) RB211-Trent 970-84 and RB211-Trent 972-84 turbofan engines. This AD requires an inspection of the drains mast. This AD was prompted by cracks found in the transition duct area of the drains mast. We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD becomes effective November 22, 2017.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of November 22, 2017.

We must receive comments on this AD by December 22, 2017.

ADDRESSES:

You may send comments by any of the following methods:

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

Mail: U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001.

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

Fax: 202-493-2251.

For service information identified in this AD, contact Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby, England, DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-249936; email: http://www.rolls-royce.com/contact/civil_team.jsp; Internet: https://customers.rolls-royce.com/public/rollsroycecare. You may view this service information at the FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7125. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0816.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0816; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the mandatory continuing airworthiness information (MCAI), regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT:

Eugene Triozzi, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7148; fax: 781-238-7199; email: [email protected]

SUPPLEMENTARY INFORMATION:

Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-0816; Product Identifier 2017-NE-29-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

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

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2017-0075R1, dated May 5, 2017 (referred to hereinafter as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

RB211 Trent 900 engines have been found in service with cracks in the transition duct area of the drains mast, which is part of the fire wall in Zone 1. Cracks were found on both pre-Mod 72-H499 drains masts, Part Number (P/N) FW29847, and post-Mod 72-H499 drains masts, P/N KH31996. This condition, if not detected and corrected, could, in combination with a fire in the surrounding area, lead to a breach of the fire wall, possibly resulting in an uncontrolled fire and consequent reduced control of the aeroplane. To address this potential unsafe condition, RR published Alert Non-Modification Service Bulletin (NMSB) RB.211-71-AJ576 to provide inspection instructions for engines with drains mast P/N KH31996 and post-Mod 80-H632 vent ejector installed, which have been determined as more susceptible to cracking.

You may obtain further information by examining the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0816.

Related Service Information Under 1 CFR Part 51

RR has issued Alert Non-Modification Service Bulletin No. RB.211-71-AJ576, Initial Issue, dated March 17, 2017. The Alert NMSB describes procedures for inspection, repair, and replacement of the drains mast. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This AD

This product has been approved by the aviation authority of the United Kingdom, and is approved for operation in the United States. Pursuant to our bilateral agreement with the European Community, EASA has notified us of the unsafe condition described in the MCAI. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. This AD requires inspection and if necessary, replacement of the drains mast.

FAA's Determination of the Effective Date

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

Costs of Compliance

We estimate that this AD affects no engines installed on airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Inspection 2 work-hours × $85 per hour = $170 $10,000 $10,170 $0
    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

    For the reasons discussed above, I certify this AD:

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2017-22-13 Rolls-Royce plc: Amendment 39-19093; Docket No. FAA-2017-0816; Product Identifier 2017-NE-29-AD. (a) Effective Date

    This AD is effective November 22, 2017.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Rolls-Royce plc (RR) RB211-Trent 970-84 and RB211-Trent 972-84 turbofan engines with a drains mast, part number (P/N) KH31996, installed.

    (d) Subject

    Joint Aircraft System Component (JASC) 7170, Powerplant/Engine Drains.

    (e) Reason

    This AD was prompted by cracks found in the transition duct area of the drains mast. We are issuing this AD to prevent failure of the drains mast, engine fire, and damage to the airplane.

    (f) Compliance

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

    (g) Required Actions

    Within 12 months time since new (TSN) or within 12 months after the effective date of this AD, whichever occurs later, visually inspect the external areas of the transition duct area of the drains mast for a crack, as depicted in Figure 1 of RR Alert Non-Modification Service Bulletin (NMSB) RB.211-71-AJ576, Initial Issue, dated March 17, 2017. If there is a crack:

    (1) Before further flight, replace the drains mast with a part eligible for installation, or

    (2) Before further flight, seal the crack using the Accomplishment Instructions, paragraph 3.B. of RR Alert NMSB RB.211-71-AJ576, Initial Issue, dated March 17, 2017, and within 100 flight cycles, remove and replace the drains mast with a part eligible for installation.

    (h) Definition

    (1) For the purposes of this AD, a part eligible for installation is a part not listed in this AD, or a part that has passed the inspection required by this AD.

    (2) For the purposes of this AD, a flight cycle is a take-off and landing.

    (i) Alternative Methods of Compliance (AMOCs)

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

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

    (j) Related Information

    (1) For more information about this AD, contact Eugene Triozzi, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7148; fax: 781-238-7199; email: [email protected]

    (2) Refer to MCAI EASA AD 2017-0075R1, dated May 5, 2017, for more information. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2017-0816.

    (k) Material Incorporated by Reference

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

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

    (i) Rolls-Royce plc (RR) Alert Non-Modification Service Bulletin RB.211-71-AJ576, Initial Issue, dated March 17, 2017.

    (ii) Reserved.

    (3) For RR service information identified in this AD, contact Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby, England, DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-249936; email: http://www.rolls-royce.com/contact/civil_team.jsp; Internet: https://customers.rolls-royce.com/public/rollsroycecare.

    (4) You may view this service information at FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7125.

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

    Issued in Burlington, Massachusetts, on November 1, 2017. Karen M. Grant, Acting Manager, Engine and Propeller Standards Branch, Aircraft Certification Service.
    [FR Doc. 2017-24156 Filed 11-6-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-0490; Product Identifier 2017-NE-13-AD; Amendment 39-19082; AD 2017-22-02] RIN 2120-AA64 Airworthiness Directives; IPECO Pilot and Co-Pilot Seats AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Ipeco Holdings Ltd. (Ipeco) pilot and co-pilot seats. This AD requires modification and reidentification of the affected seats. This AD was prompted by reports of unexpected movement of pilot and co-pilot seats on takeoff and landing. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD becomes effective December 12, 2017.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 12, 2017.

    ADDRESSES:

    For service information identified in this final rule, contact Ipeco Holdings Ltd., Aviation Way, Southend on Sea, SS2 6UN, United Kingdom; phone: 44 1702 549371; fax: 44 1702 540782; email: [email protected] You may view this service information at the FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0490.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0490; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the mandatory continuing airworthiness information (MCAI), the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Neil Doh, Aerospace Engineer, Boston ACO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7757; fax: 781-238-7199; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to the specified products. The NPRM was published in the Federal Register on June 16, 2017 (82 FR 27629). The NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

    Occurrences have been reported of pilot/co-pilot unexpected rearward movement during take-off and landing. Investigations determined that horizontal guide block wear, presence of burrs on horizontal centre track, and horizontal track lock system weakness (spring tension too low) were various causes which contributed to the seat not being correctly locked.

    This condition, if not corrected, could lead to further cases of unwanted flight crew seat movement, possibly resulting in reduced control of the aeroplane.

    You may obtain further information by examining the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0490.

    Comments

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

    Request To Shorten Compliance Time

    The Air Line Pilots Association (ALPA) requested that the FAA work with EASA to reevaluate the compliance time for this AD. ALPA indicated that the requirements of this AD could be accomplished in a shorter timeframe that would enhance safety.

    ALPA did not provide data or a detailed explanation with respect to its request for a shorter time frame. Consequently, upon further review of the risk analysis with EASA, we determined the proposed time frame for accomplishment of this AD is appropriate.

    Miscellaneous Comments

    We received miscellaneous comments not relevant to this AD. No further response is required.

    Conclusion

    We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting this AD as proposed.

    Related Service Information Under 1 CFR Part 51

    Ipeco has issued Service Bulletin (SB) Number 063-25-08, Revision 00; SB Number 063-25-09, Revision 00; and SB Number 063-25-10, Revision 00; all dated May 31, 2016. These SBs provide instructions, differentiated by the part numbers of the affected pilot and co-pilot seats, for the modification and reidentification of these seats. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    Costs of Compliance

    We estimate that this AD affects an unknown number of pilot and co-pilot seats installed on 55 airplanes of U.S. registry.

    We estimate the following costs to comply with this AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Modify crew seats 2 work-hours × $85 per hour = $170 $125 $295 $16,225
    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

    For the reasons discussed above, I certify this AD:

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2017-22-02 Ipeco Holdings Ltd.: Amendment 39-19082; Docket No. FAA-2017-0490; Product Identifier 2017-NE-13-AD. (a) Effective Date

    This AD becomes effective December 12, 2017.

    (b) Affected ADs

    None.

    (c) Applicability

    (1) This AD applies to Ipeco Holdings Ltd. (Ipeco) pilot and co-pilot seats with a part number listed in the Planning Information section of Ipeco Service Bulletins (SBs) Number 063-25-08, Revision 00; Number 063-25-09, Revision 00; and Number 063-25-10, Revision 00; all dated May 31, 2016.

    (2) These seats are installed on, but not limited to, ATR-GIE Avions de Transport Regional ATR 42 and ATR 72 airplanes.

    (d) Subject

    Joint Aircraft System Component (JASC) Code 2510, Flight Compartment Equipment.

    (e) Reason

    This AD was prompted by reports of unexpected movement of pilot and co-pilot seats on takeoff and landing. We are issuing this AD to prevent unexpected movement of pilot and co-pilot seats on takeoff and landing. The unsafe condition, if not corrected, could result in reduced control of the airplane.

    (f) Compliance

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

    (2) Within 2 years after the effective date of this AD, modify and re-identify affected each pilot and co-pilot seat. Use the Accomplishment Instructions of Ipeco SB Number 063-25-08, Revision 00; Ipeco SB 063-25-09, Revision 00; or Ipeco SB 063-25-10, Revision 00; all dated May 31, 2016; as appropriate, to do the modification and reidentification.

    (g) Installation Prohibition

    Do not install any pilot or co-pilot seat identified in paragraph (c) of this AD unless the seat is modified and reidentified as specified in paragraph (f)(2) of this AD.

    (h) Alternative Methods of Compliance (AMOCs)

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

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

    (i) Related Information

    (1) For more information about this AD, contact Neil Doh, Aerospace Engineer, Boston ACO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7757; fax: 781-238-7199; email: [email protected]

    (2) Refer to MCAI European Aviation Safety Agency AD 2016-0256, dated December 16, 2016, for more information. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2017-0490.

    (j) Material Incorporated by Reference

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

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

    (i) Ipeco Service Bulletin (SB) Number 063-25-08, Revision 00; dated May 31, 2016.

    (ii) Ipeco SB Number 063-25-09, Revision 00; dated May 31, 2016.

    (iii) Ipeco SB Number 063-25-10, Revision 00; dated May 31, 2016.

    (3) For Ipeco service information identified in this AD, contact Ipeco Holdings Ltd., Aviation Way, Southend on Sea, SS2 6UN, United Kingdom; phone: 44 1702 549371; fax: 44 1702 540782; email: [email protected]

    (4) You may view this service information at FAA, Engine and Propeller Standards Branch, Policy and Innovation Division, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.

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

    Issued in Burlington, Massachusetts, on October 19, 2017. Karen M. Grant, Acting Manager, Engine and Propeller Standards Branch, Aircraft Certification Service.
    [FR Doc. 2017-24127 Filed 11-6-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket No. FDA-2016-C-2767] Listing of Color Additives Exempt From Certification; Calcium Carbonate AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. We are taking this action in response to a color additive petition submitted by the Wm. Wrigley Jr. Company.

    DATES:

    This rule is effective December 8, 2017. See section X for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by December 7, 2017. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of December 7, 2017.

    ADDRESSES:

    You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. Electronic objections must be submitted on or before December 7, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 7, 2017. Objections 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 objections in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection 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 objection, that information will be posted on https://www.regulations.gov.

    • If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection 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 objections submitted to the Dockets Management Staff, FDA will post your objection, 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-C-2767 for “Listing of Color Additives Exempt from Certification; Calcium Carbonate.” Received objections, 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 with the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Judith Kidwell, Center for Food Safety and Applied Nutrition (CFSAN) (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1071.

    SUPPLEMENTARY INFORMATION:

    I. Introduction

    In the Federal Register on October 7, 2016 (81 FR 69740), we announced that we filed a color additive petition (CAP 6C0307) submitted by Wm. Wrigley Jr. Company (petitioner), c/o Exponent, 1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20036. The petition proposed to amend the color additive regulations in part 73 (21 CFR part 73) Listing of Color Additives Exempt from Certification to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. The proposed use excludes chocolate or the chocolate portion of candy, as the current standards of identity for chocolate do not allow for the addition of color additives (see 21 CFR 163.123, 163.124, 163.130, 163.135, 163.140, 163.145, 163.153, 163.155). After the petition was filed, the petitioner clarified that calcium carbonate is intended for use only in ink applied to the surface of the chewing gum.

    II. Background

    Calcium carbonate is obtained from ground limestone or produced synthetically through a precipitation process using calcium oxide, water, and carbon dioxide. Calcium is abundant in the human body and is an integral component of bones, teeth, and other biological structures. Calcium constantly diffuses in and out of the bone and is resorbed by the kidney. Excess intake of calcium may result in hypercalcemia, hypercalciuria, gastrointestinal issues, kidney stones, interference with iron and zinc absorption, possible vascular and soft tissue calcification, and renal and cardiovascular damage. Carbonate is present in the human body as a critical component of the pH buffering system. The components of carbonate (carbon and oxygen) are ubiquitous in the human diet and body, and carbonate itself does not belong to a class of structures that is associated with any adverse effects or toxicity.

    Calcium carbonate that is pharmaceutical grade is currently approved under § 73.1070 for use as a color additive in drugs in amounts consistent with good manufacturing practices (GMP). Additionally, food grade calcium carbonate and ground limestone (consisting of not less than 94 percent calcium carbonate) are affirmed as generally recognized as safe in § 184.1191 and § 184.1409 (21 CFR 184.1191 and 184.1409), respectively. These regulations do not include limitations for use in food other than current GMP. The petitioner proposed that to ensure that only food grade calcium carbonate is used to color hard and soft candy, mints, and chewing gum, the substance must meet the specifications of the Food Chemicals Codex, 10th edition (FCC 10). We have reviewed these specifications and agree that they should be incorporated into the regulation as set forth in this document. The petitioner proposed to use calcium carbonate to color soft and hard candy, mints, and chewing gum in amounts consistent with GMP. The maximum GMP use level for calcium carbonate in hard and soft candy, mints, and chewing gum will be determined by the desired coloring effect. We have determined that the amount of calcium carbonate used in these foods is self-limiting because the addition of the color additive above a certain level will not achieve the desired coloring effect and negatively interferes with organoleptic properties, such as taste and texture. Because the amount of the color additive used in these foods is self-limiting, we have determined that there is no need for a specific upper limit on the percent by weight of calcium carbonate in hard and soft candy, mints, and chewing gum (Ref. 1).

    III. Safety Evaluation

    Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be listed for a particular use unless the data and information available to FDA establish that the color additive is safe for that use. Furthermore, under section 721(b)(4) of the FD&C Act, a color additive is deemed to be suitable and safe for the purpose of listing for use generally in or on food, while there is in effect a published finding declaring such substance exempt from the term “food additive” because of its being generally recognized by qualified experts as safe for its intended use, as provided in section 201(s) of the FD&C Act (21 U.S.C. 321(s)). FDA's color additive regulations in 21 CFR 70.3(i) define “safe” to mean that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.

    To establish with reasonable certainty that a color additive intended for use in foods is not harmful under its intended conditions of use, we consider the projected human dietary exposure to the color additive, the additive's toxicological data, and other relevant information (such as published literature) available to us. We compare an individual's estimated exposure, or estimated daily intake (EDI), of the color additive from all food sources to an acceptable daily intake level established by toxicological data. The EDI is determined by projections based on the amount of the color additive proposed for use in particular foods or drugs and on data regarding the amount consumed from all sources of the color additive. We commonly use the EDI for the 90th percentile consumer of a color additive as a measure of high chronic exposure.

    A. Estimated Dietary Exposure

    The petitioner indicated that, given the types of candies to be colored and the variable conditions under which calcium carbonate would be used, the use of the assumption that all candies would contain calcium carbonate at the maximum GMP level would lead to an overestimate of exposure. However, because only hard and soft candy, mints, and chewing gum that are colored white would result in a potential exposure to calcium carbonate from the proposed use, the petitioner reviewed the 2009-2012 National Health and Examination Survey (NHANES) food codes and identified 51 food codes in which calcium carbonate could potentially be used as a color additive that represent the intended use in hard and soft candy, mints, and chewing gum. Although we identified additional food codes that could contain calcium carbonate, these codes were intentionally excluded by the petitioner because there were no associated eating occasions for these additional food codes over the survey years. We agree with the selected 51 food codes and the exclusion of the other food codes (Ref. 2). Furthermore, the petitioner used market data to refine their exposure estimate; however, these data were limited to those products that were introduced in the last 5 years and may not fully represent the market. Therefore, to be conservative, we estimated exposure to calcium carbonate using 2-day food consumption data from the 2009-2012 NHANES for the identified 51 food codes at the GMP use levels and made no adjustment for market data. Exposure to calcium carbonate and to calcium was estimated for the U.S. population 2 years of age and older and children 2 to 5 years of age (Ref. 2).

    For the U.S. population 2 years of age and older, exposure estimates for calcium carbonate at the mean and 90th percentile from the proposed uses were 170 milligrams/person/day (mg/p/d) and 400 mg/p/d, respectively. For children 2 to 5 years of age, exposure estimates for calcium carbonate at the mean and 90th percentile were 125 mg/p/d and 270 mg/p/d, respectively.

    Calcium carbonate is a source of calcium for the consumer once ingested and metabolized by the body. Therefore, as part of our evaluation, we also estimated exposure to calcium from the petitioned uses of calcium carbonate by assuming that the amount of calcium provided by calcium carbonate as a color additive is 40 percent of the total weight of calcium carbonate. For the U.S. population 2 years of age and older, estimated exposure to calcium from the proposed uses of calcium carbonate at the mean and 90th percentile were 70 mg/p/d and 160 mg/p/d, respectively. For children 2 to 5 years of age, estimated exposure to calcium at the mean and 90th percentile were 50 mg/p/d and 110 mg/p/d, respectively.

    Additionally, we estimated exposure to calcium from background dietary sources, drugs, and dietary supplements using 2-day food consumption data for all foods and nutrient data for calcium in those foods based on the U.S. Department of Agriculture's National Nutrient Database for Standard Reference. This estimate also included exposure to calcium from dietary supplements (including non-prescription antacids that contain calcium) based on NHANES 2-day survey data (Ref. 2).

    For the U.S. population 2 years of age and older, exposure to calcium from background dietary sources, drugs, and dietary supplements at the mean and 90th percentile were estimated to be 1,125 mg/p/d and 1,900 mg/p/d, respectively. For children 2 to 5 years of age, exposure estimates at the mean and 90th percentile were 1,000 mg/p/d and 1,600 mg/p/d, respectively. Because our exposure estimates for dietary supplements include calcium from all sources, not just calcium carbonate, we believe that this exposure estimate is sufficiently conservative to include any exposure to calcium from the use of calcium carbonate to color drugs (Ref. 2).

    We estimated exposure to calcium from background dietary sources, drugs, dietary supplements and the proposed uses of calcium carbonate at the mean and 90th percentile for the U.S. population 2 years of age and older and children 2 to 5 years of age. Based on these calculations, exposure estimates for calcium for the U.S. population 2 years of age and older at the mean and 90th percentile were 1,150 mg/p/d and 1,925 mg/p/d, respectively. For children 2 to 5 years of age, exposure estimates for calcium at the mean and 90th percentile were 1,025 mg/p/d and 1,625 mg/p/d, respectively (Ref. 2).

    B. Safety of the Petitioned Uses of Calcium Carbonate

    To support the safety of the petitioned use of calcium carbonate, the petitioner referenced safety information on calcium from the 2011 Institute of Medicine (IOM) Report on Dietary Reference Intakes for Calcium and Vitamin D (Ref. 3) and the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies' reevaluation of the safety of calcium (Ref. 4). In 2011, the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board of the IOM conducted an extensive review of relevant published scientific literature on calcium to update current dietary reference intakes and Upper Tolerable Intake Levels (UL). In their 2011 assessment of calcium, the IOM established a UL of 1,000 mg/p/d for infants 0 to 6 months of age and 1,500 mg/p/d for infants 6 to 12 months of age. For children 1 to 8 years of age, IOM did not change the UL of 2,500 mg/p/d from the previous IOM report in 1997. For children 9 to 18 years of age, IOM increased the UL to 3,000 mg/p/d. For adults 19 to 50 years of age, the IOM established a UL of 2,500 mg/p/d; for adults 51 years and older, the IOM established a UL of 2,000 mg/p/d.

    The IOM considers the UL as the highest average daily intake level of a nutrient that poses no risk of adverse effects when the nutrient is consumed over long periods of time. The UL is determined using a risk assessment model developed specifically for nutrients. The dose-response assessment, which concludes with an estimate of the UL, is built upon three toxicological concepts commonly used in assessing the risk of exposures to chemical substances: No-observed-adverse-effect level, lowest-observed-effect level, and application of an uncertainty factor. We considered the ULs established by the IOM relative to the exposure estimates for calcium as the primary basis for assessing the safety of the petitioned uses of calcium carbonate.

    The estimated dietary exposure to calcium from the petitioned uses, dietary sources, and dietary supplements at the 90th percentile for the U.S. population 2 years of age and older is estimated to be 1,925 mg/p/d, which is below the IOM's UL of 2,000-3,000 mg/p/d. For children 2 to 5 years of age, the exposure estimate at the 90th percentile is 1,625 mg/p/d, which also is below the IOM's UL of 2,500 mg/p/d for this age group. Additionally, the body of literature on calcium carbonate and calcium does not present evidence of safety concerns at the expected dietary exposures discussed above. Thus, we conclude that the petitioned use of calcium carbonate as a color additive in soft and hard candy, mints, and chewing gum is safe (Ref. 5).

    IV. Incorporation by Reference

    FDA is incorporating by reference the Food Chemicals Codex, 10th ed. (2016), pp. 213-214 (calcium carbonate) and p. 754 (limestone, ground), which was approved by the Office of the Federal Register. You may purchase a copy of the material from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (http://www.usp.org). Copies also may be examined at FDA's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039.

    The FCC is a compendium of internationally recognized standards for the purity and identity of food ingredients. To ensure that only food grade calcium carbonate and ground limestone (consisting of not less than 94 percent calcium carbonate) are used in hard and soft candy, mints, and chewing gum, the additive must meet the specifications and identity in the appropriate FCC monograph.

    V. Conclusion

    FDA reviewed the data and information in the petition and other available relevant material and determined the use of calcium carbonate to color hard and soft candy, mints, and chewing gum at GMP levels is safe. We further conclude that the additive will achieve its intended technical effect and is suitable for the petitioned uses. We note that these uses do not extend to chocolate or the chocolate portion of candy because the standards of identity for chocolate do not allow for the addition of color additives (see 21 CFR 163.123, 163.124, 163.130, 163.135, 163.140, 163.145, 163.153, 163.155). Based on the available information, we are amending the color additive regulations in part 73 as set forth in this document. In addition, based on the factors listed in 21 CFR 71.20(b), we conclude that certification of calcium carbonate to color hard and soft candy, mints, and chewing gum is not necessary for the protection of public health (Ref. 1).

    VI. Public Disclosure

    In accordance with § 71.15 (21 CFR 71.15), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in § 71.15, we will delete from the documents any materials that are not available for public disclosure.

    VII. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as stated in the October 7, 2016, Federal Register notice of petition for CAP 6C0307 (81 FR 69740). We stated that we had determined, under 21 CFR 25.32(k), that this action “is of a type that does not individually or cumulatively have a significant effect on the human environment” such that neither an environmental assessment nor an environmental impact statement is required. We have not received any new information or comments that would affect our previous determination.

    VIII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

    IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    Our review of this petition was limited to section 721 of the FD&C Act. This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (ll)(4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this color additive. Accordingly, this final rule should not be construed to be a statement that a food containing this color additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all color additive final rules that pertain to food and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

    X. Objections

    This rule is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see ADDRESSES) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

    Any objections received in response to the regulation may be seen at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register.

    XI. References

    The following references are on display with the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References that are published articles and books are not on display.

    1. Memorandum from N. Hepp, Color Technology Team, Office of Cosmetics and Colors (OCAC), CFSAN, FDA to C. Johnston, Division of Petition Review, Office of Food Additive Safety (OFAS), CFSAN, FDA, October 27, 2016. 2. Memorandum from D. Doell, Division of Petition Review, OFAS, CFSAN, FDA to J. Kidwell, Division of Petition Review, OFAS, CFSAN, FDA, February 16, 2017. 3. Committee to Review Dietary Reference Intakes for Vitamin D and Calcium, Food and Nutrition Board, Institute of Medicine, “Dietary Reference Intakes for Calcium and Vitamin D,” National Academies Press, Washington, DC, 2011. 4. European Food Safety Authority (EFSA). “Scientific Opinion on the Tolerable Upper Intake Level of Calcium.” EFSA Journal, vol. 10(7), p. 2814, 2012. 5. Memorandum from T. Thurmond, Division of Petition Review, OFAS, CFSAN, FDA to J. Kidwell, Division of Petition Review, OFAS, CFSAN, FDA, February 17, 2017. List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Incorporation by reference, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 73 is amended as follows:

    PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION 1. The authority citation for part 73 continues to read as follows: Authority:

    21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

    2. Section 73.70 is added to subpart A to read as follows:
    § 73.70 Calcium carbonate.

    (a) Identity. (1) The color additive calcium carbonate is a fine, white powder consisting essentially of calcium carbonate (CaCO3) prepared either by grinding naturally occurring limestone or synthetically, by precipitation.

    (2) Color additive mixtures for food use made with calcium carbonate may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods.

    (b) Specifications. The color additive meets the specifications of the Food Chemicals Codex, 10th ed. (2016), pp. 213-214 (calcium carbonate) and p. 754 (limestone, ground), which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/cfr/ibr_locations.html.

    (c) Uses and restrictions. Calcium carbonate may be safely used in amounts consistent with good manufacturing practice to color soft and hard candies and mints, and in inks used on the surface of chewing gum, except that it may not be used to color chocolate for which standards of identity have been promulgated under section 401 of the Federal Food, Drug, and Cosmetic Act unless added color is authorized by such standards.

    (d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter.

    (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and, therefore, batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

    Dated: November 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-24194 Filed 11-6-17; 8:45 am] BILLING CODE 4164-01-P7N O
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2017-N-4394] Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Total 25-Hydroxyvitamin D Mass Spectrometry Test System AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is classifying the total 25-hydroxyvitamin D mass spectrometry 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 total 25-hydroxyvitamin D mass spectrometry 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 November 7, 2017. The classification was applicable on May 18, 2017.

    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 total 25-hydroxyvitamin D mass spectrometry 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 within class III, the De Novo classification is considered to be the initial classification of the device.

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

    II. De Novo Classification

    On March 20, 2017, AB Sciex LLC submitted a request for De Novo classification of the Vitamin D 200M Assay for the Topaz 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 generals controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on May 18, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 862.1840. We have named the generic type of device total 25-hydroxyvitamin D mass spectrometry test system, and it is identified as a device intended for use in clinical laboratories for the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) in serum or plasma to be used in the assessment of vitamin D sufficiency.

    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—Total 25-hydroxyvitamin D Mass Spectrometry Test System Risks and Mitigation Measures Identified risk Mitigation measures Clinical action based on falsely elevated inaccurate Vitamin D results may lead to unnecessary supplementation of Vitamin D General controls; Special control (1) (21 CFR 862.1840(b)(1)); and, Special control (2) (21 CFR 862.1840(b)(2)). Clinical action based on falsely low inaccurate Vitamin D results may lead to a delay in supplementation of Vitamin D General controls; Special control (1) (21 CFR 862.1840(b)(1)); and, Special control (2) (21 CFR 862.1840(b)(2)). Clinical action based on uninterpretable results due to lack of established device specific reference range values for the representative population General controls; and, Special control (3) (21 CFR 862.1840(b)(3)). Clinical action based on the misinterpretation of Vitamin D2 or Vitamin D3 results as total Vitamin D results General controls; and, Special control (4) (21 CFR 862.1840(b)(4)).

    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).

    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if, after notice of our intent to exempt and consideration of comments, we determine by order that premarket notification is not necessary to provide reasonable assurance of safety and effectiveness of the device. We believe this may be such a device. The notice of intent to exempt the device from premarket notification requirements is published elsewhere in this issue of the Federal Register.

    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 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 § 862.1840 to subpart B to read as follows:
    § 862.1840 Total 25-hydroxyvitamin D mass spectrometry test system.

    (a) Identification. A total 25-hydroxyvitamin D mass spectrometry test system is a device intended for use in clinical laboratories for the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) in serum or plasma to be used in the assessment of vitamin D sufficiency.

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

    (1) The device must have initial and annual standardization verification by a certifying vitamin D standardization organization deemed acceptable by FDA.

    (2) The 21 CFR 809.10(b) compliant labeling must include detailed descriptions of performance testing conducted to evaluate precision, accuracy, linearity, interference, including the following:

    (i) Performance testing of device precision must, at a minimum, use intended sample type with Vitamin D concentrations at medically relevant decision points. At least one sample in the precision studies must be an unmodified patient sample. This testing must evaluate repeatability and reproducibility using a protocol from an FDA-recognized standard.

    (ii) Performance testing of device accuracy must include a minimum of 115 serum or plasma samples that span the measuring interval of the device and compare results of the new device to results of a reference method or a legally marketed standardized mass spectrometry based vitamin D assay. The results must be described in the 21 CFR 809.10(b)(12) compliant labeling of the device.

    (iii) Interference from vitamin D analogs and metabolites including vitamin D2, vitamin D3, 1-hydroxyvitamin D2, 1-hydroxyvitamin D3, 3-Epi-25-Hydroxyvitamin D2, 3-Epi-25-Hydroxyvitamin D3, 1,25-Dihydroxyvitamin D2, 1,25-Dihydroxyvitamin D3, 3-Epi-1,25-Dihydroxyvitamin D2, and 3-Epi-1,25-Dihydroxyvitamin D3, 25, 26-Dihydroxyvitamin-D3, 24 (R), 25-dihydroxyvitamin-D3, 23 (R), 25-dihydroxyvitamin-D3 must be described in the 21 CFR 809.10(b)(7) compliant labeling of the device.

    (3) The 21 CFR 809.10(b) compliant labeling must be supported by a reference range study representative of the performance of the device. The study must be conducted using samples collected from apparently healthy male and female adults at least 21 years of age and older from at least 3 distinct climatic regions within the United States in different weather seasons. The ethnic, racial, and gender background of this study population must be representative of the U.S. population demographics.

    (4) The results of the device as provided in the 21 CFR 809.10(b) compliant labeling and any test report generated must be reported as only total 25-hydroxyvitamin D.

    Dated: October 31, 2017. Lauren Silvis, Chief of Staff.
    [FR Doc. 2017-24161 Filed 11-6-17; 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-4341] Medical Devices; Immunology and Microbiology Devices; Classification of the Genetic Health Risk Assessment System AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment 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 genetic health risk assessment 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 November 7, 2017. The classification was applicable on April 6, 2017.

    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 genetic health risk assessment 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 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, which amended 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. 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 within class III, the De Novo classification is considered to be the initial classification of the device.

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

    II. De Novo Classification

    On June 28, 2016, 23andMe, Inc. submitted a request for De Novo classification of the 23andMe Personal Genome Service (PGS) Test. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

    Therefore, on April 6, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.5950. We have named the generic type of device genetic health risk assessment system, and it is identified as a qualitative in vitro molecular diagnostic system used for detecting variants in genomic deoxyribonucleic acid (DNA) isolated from human specimens that will provide information to users about their genetic risk of developing a disease to inform lifestyle choices and/or conversations with a health care professional. This assessment system is for over-the-counter use. This device does not determine the person's overall risk of developing a 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—Genetic Health Risk Assessment System Risks and Mitigation Measures Identified risk Mitigation measures Incorrect understanding of the device and test system General controls, Special control (1) (21 CFR 866.5950(b)(1)), Special control (3) (21 CFR 866.5950(b)(3)), and Special control (4) (21 CFR 866.5950 (b)(4)). Incorrect test results (false positives, false negatives) General controls, Special control (2) (21 CFR 866.5950(b)(2)), and Special control (3) (21 CFR 866.5950(b)(3)). Incorrect interpretation of test results General controls, Special control (1) (21 CFR 866.5950(b)(1)), Special control (3) (21 CFR 866.5950(b)(3)), and Special control (4) (21 CFR 866.5950(b)(4)).

    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.

    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if, after notice of our intent to exempt and consideration of comments, we determine by order that premarket notification is not necessary to provide reasonable assurance of safety and effectiveness of the device. We believe this may be such a device. The notice of intent to exempt the device from premarket notification requirements is published elsewhere in this issue of the Federal Register.

    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 § 866.5950 to subpart F to read as follows:
    § 866.5950 Genetic health risk assessment system.

    (a) Identification. A genetic health risk assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in genomic deoxyribonucleic acid (DNA) isolated from human specimens that will provide information to users about their genetic risk of developing a disease to inform lifestyle choices and/or conversations with a health care professional. This assessment system is for over-the-counter use. This device does not determine the person's overall risk of developing a disease.

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

    (1) The 21 CFR 809.10 compliant labeling and any prepurchase page and test report generated, unless otherwise specified, must include:

    (i) A section addressed to users with the following information:

    (A) The limiting statement explaining that this test provides genetic risk information based on assessment of specific genetic variants but does not report on a user's entire genetic profile. This test [does not/may not, as appropriate] detect all genetic variants related to a given disease, and the absence of a variant tested does not rule out the presence of other genetic variants that may be related to the disease.

    (B) The limiting statement explaining that other companies offering a genetic risk test may be detecting different genetic variants for the same disease, so the user may get different results using a test from a different company.

    (C) The limiting statement explaining that other factors such as environmental and lifestyle risk factors may affect the risk of developing a given disease.

    (D) The limiting statement explaining that some people may feel anxious about getting genetic test health results. This is normal. If the potential user feels very anxious, such user should speak to his or her doctor or other health care professional prior to collection of a sample for testing. This test is not a substitute for visits to a doctor or other health care professional. Users should consult with their doctor or other health care professional if they have any questions or concerns about the results of their test or their current state of health.

    (E) Information about how to obtain access to a genetic counselor, board-certified clinical molecular geneticist, or equivalent health care professional about the results of a user's test.

    (F) The limiting statement explaining that this test is not intended to diagnose a disease, tell you anything about your current state of health, or be used to make medical decisions, including whether or not you should take a medication or how much of a medication you should take.

    (G) A limiting statement explaining that the laboratory may not be able to process a sample, and a description of the next steps to be taken by the manufacturer and/or the customer, as applicable.

    (ii) A section in your 21 CFR 809.10 labeling and any test report generated that is for health care professionals who may receive the test results from their patients with the following information:

    (A) The limiting statement explaining that this test is not intended to diagnose a disease, determine medical treatment, or tell the user anything about their current state of health.

    (B) The limiting statement explaining that this test is intended to provide users with their genetic information to inform lifestyle decisions and conversations with their doctor or other health care professional.

    (C) The limiting statement explaining that any diagnostic or treatment decisions should be based on testing and/or other information that you determine to be appropriate for your patient.

    (2) The genetic test must use a sample collection device that is FDA-cleared, -approved, or -classified as 510(k) exempt, with an indication for in vitro diagnostic use in over-the-counter DNA testing.

    (3) The device's labeling must include a hyperlink to the manufacturer's public Web site where the manufacturer shall make the information identified in paragraph (b)(3) of this section publicly available. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a hyperlink to the Web page containing this information and must allow unrestricted viewing access. If the device can be purchased from the Web site or testing using the device can be ordered from the Web site, the same information must be found on the Web page for ordering the device or provided in a publicly accessible hyperlink on the Web page for ordering the device. Any changes to the device that could significantly affect safety or effectiveness would require new data or information in support of such changes, which would also have to be posted on the manufacturer's Web site. The information must include:

    (i) An index of the material being provided to meet the requirements in paragraph (b)(3) of this section and its location.

    (ii) A section that highlights summary information that allows the user to understand how the test works and how to interpret the results of the test. This section must, at a minimum, be written in plain language understandable to a lay user and include:

    (A) Consistent explanations of the risk of disease associated with all variants included in the test. If there are different categories of risk, the manufacturer must provide literature references that support the different risk categories. If there will be multiple test reports and multiple variants, the risk categories must be defined similarly among them. For example, “increased risk” must be defined similarly between different test reports and different variant combinations.

    (B) Clear context for the user to understand the context in which the cited clinical performance data support the risk reported. This includes, but is not limited to, any risks that are influenced by ethnicity, age, gender, environment, and lifestyle choices.

    (C) Materials that explain the main concepts and terminology used in the test that include:

    (1) Definitions: Scientific terms that are used in the test reports.

    (2) Prepurchase page: This page must contain information that informs the user about what information the test will provide. This includes, but is not limited to, variant information, the condition or disease associated with the variant(s), professional guideline recommendations for general genetic risk testing, the limitations associated with the test (e.g., test does not detect all variants related to the disease) and any precautionary information about the test the user should be aware of before purchase. When the test reports the risk of a life-threatening or irreversibly debilitating disease or condition for which there are few or no options to prevent, treat, or cure the disease, a user opt-in section must be provided. This opt-in page must be provided for each disease that falls into this category and must provide specific information relevant to each test result. The opt-in page must include:

    (i) An option to accept or decline to receive this specific test result;

    (ii) Specification of the risk involved if the user is found to have the specific genetic test result;

    (iii) Professional guidelines that recommend when genetic testing for the associated target condition is or is not recommended; and

    (iv) A recommendation to speak with a health care professional, genetic counselor, or equivalent professional before getting the results of the test.

    (3) Frequently asked questions (FAQ) page: This page must provide information that is specific for each variant/disease pair that is reported. Information provided in this section must be scientifically valid and supported by corresponding publications. The FAQ page must explain the health condition/disease being tested, the purpose of the test, the information the test will and will not provide, the relevance of race and ethnicity to the test results, information about the population to which the variants in the test is most applicable, the meaning of the result(s), other risk factors that contribute to disease, appropriate followup procedures, how the results of the test may affect the user's family, including children, and links to resources that provide additional information.

    (iii) A technical information section containing the following information:

    (A) Gene(s) and variant(s) the test detects using standardized nomenclature, Human Genome Organization nomenclature and coordinates as well as Single Nucleotide Polymorphism Database (dbSNP) reference SNP numbers (rs#).

    (B) Scientifically established disease-risk association of each variant detected and reported by the test. This risk association information must include:

    (1) Genotype-phenotype information for the reported variants.

    (2) Table of expected frequency and risks of developing the disease in relevant ethnic populations and the general population.

    (3) A statement about the current professional guidelines for testing these specific gene(s) and variant(s).

    (i) If professional guidelines are available, provide the recommendations in the professional guideline for the gene, variant, and disease, for when genetic testing should or should not be performed, and cautionary information that should be communicated when a particular gene and variant is detected.

    (ii) If professional guidelines are not available, provide a statement that the professional guidelines are not available for these specific gene(s) and variant(s).

    (C) The specimen type (e.g., saliva, capillary whole blood).

    (D) Assay steps and technology used.

    (E) Specification of required ancillary reagents, instrumentation, and equipment.

    (F) Specification of the specimen collection, processing, storage, and preparation methods.

    (G) Specification of risk mitigation elements and description of all additional procedures, methods, and practices incorporated into the directions for use that mitigate risks associated with testing.

    (H) Information pertaining to the probability of test failure (i.e., percentage of tests that failed quality control) based on data from clinical samples, a description of scenarios in which a test can fail (i.e., low sample volume, low DNA concentration, etc.), how users will be notified of a test failure, and the nature of followup actions on a failed test to be taken by the user and the manufacturer.

    (I) Specification of the criteria for test result interpretation and reporting.

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

    (1) Accuracy of study results for each claimed specimen type.

    (i) Accuracy of the test shall be evaluated with fresh clinical specimens collected and processed in a manner consistent with the test's instructions for use. If this is impractical, fresh clinical samples may be substituted or supplemented with archived clinical samples. Archived samples shall have been collected previously in accordance with the instructions for use, stored appropriately, and randomly selected. In some limited circumstances, use of contrived samples or human cell line samples may also be appropriate and used as an acceptable alternative. The contrived or human cell line samples shall mimic clinical specimens as much as is feasible and provide an unbiased evaluation of the device accuracy.

    (ii) Accuracy must be evaluated by comparison to bidirectional Sanger sequencing or other methods identified as appropriate by FDA. Performance criteria for both the comparator method and the device must be predefined and appropriate to the device's intended use. Detailed study protocols must be provided.

    (iii) Test specimens must include all genotypes that will be included in the tests and reports. The number of samples tested in the accuracy study for each variant reported must be based on the variant frequency using either the minimum numbers of samples identified in this paragraph or, when determined appropriate and identified by FDA, a minimum number of samples determined using an alternative method. When appropriate, the same samples may be used in testing to demonstrate the accuracy of testing for multiple genotypes by generating sequence information at multiple relevant genetic locations. At least 20 unique samples representing the wild-type genotype must be tested. To test samples that are heterozygous for the reported variant(s), common variants (>0.1 percent variant frequency in the relevant population) must be tested with at least 20 unique samples. Rare variants (≤0.1 percent variant frequency in the relevant population) must be tested with at least three unique samples. To test samples that are homozygous for the reported variant(s), variants with ≥2 percent variant frequency in a relevant population must be tested with at least 20 unique samples. Variants with a frequency in the relevant population <2 percent and ≥0.5 percent must be tested with at least 10 unique samples. Variants with a frequency in the relevant population <0.5 percent must be tested with at least three unique samples. If variants with a frequency of <0.5 percent are not found within the relevant population and homozygous samples are not tested, then the test results for this homozygous rare variant must not be reported to the user.

    (iv) Information about the accuracy study shall include the number and type of samples that were compared to bidirectional Sanger sequencing or other methods identified as appropriate by FDA. This information must either be reported in tabular format and arranged by clinically relevant variants or reported using another method identified as appropriate by FDA. As an example, for samples with different genotypes DD, Dd, and dd, the following table represents data from the accuracy study presented in tabular format:

    ER07NO17.001

    (v) The accuracy represents the degrees of agreement between the device results and the comparator results. The accuracy must be evaluated by measuring different percent agreements (PA) of device results with the comparator results and percent of `no calls' or `invalid calls.' Calculate the rate of `no calls' and `invalid calls' for each comparator output as %Inv(DD) = A4/NDD, %Inv(Dd) = B4/NDd, %Inv(dd) = C4/Ndd. If `no calls' or `invalid calls' are required to be retested according to the device instructions for use, the percent of final `no calls' or `invalid calls' must be provided. In the table presenting the results of the accuracy study, use only the final results (i.e., after retesting the initial `no calls' or `invalid calls', if required according to the instructions for use). Samples that resulted in a `no call' or `invalid call' after retesting must not be included in the final calculations of agreement. If the percentages of `no calls' or `invalid calls' for each comparator output are similar, combine these estimates as (A4 + B4 + C4)/(NDD + NDd + Ndd) and provide a 95 percent two-sided confidence interval. The percent of final `no calls' or `invalid calls' must be clinically acceptable.

    (vi) Point estimates of percent agreement for each genotype must be calculated as the number of correct calls for that genotype divided by the number of samples known to contain that genotype excluding `no calls' or `invalid calls'. The calculations must be performed as follows:

    ER07NO17.002

    (vii) For percent agreements for DD, Dd and dd (PA(DD|DD), PA(Dd|Dd) and PA(dd|dd)) as described in paragraph (b)(3)(iii)(J)(1)(vi) of this section, the 95 percent two-sided confidence intervals must be provided. The accuracy point estimates for percent agreements for DD, Dd and dd must be ≥99 percent per reported variant and overall. Any variants that have a point estimate for either PA(DD|DD), PA(Dd|Dd), or PA(dd|dd) of <99 percent compared to bidirectional sequencing or other methods identified as appropriate by FDA must not be incorporated into test claims and reports. Accuracy results generated from clinical specimens versus contrived samples or cell lines must be presented separately. Results must be summarized and presented in tabular format by sample type and by genotype or must be reported using another method identified as appropriate by FDA (see paragraph (b)(3)(iii)(J)(1)(iv) of this section).

    (viii) Information must be reported on the Technical Positive Predictive Value (TPPV) related to the analytical (technical) performance of the device for genotypes in each relevant subpopulation (e.g., ethnicity, gender, age, geographical location, etc.). TPPV is the percentage of individuals with the genotype truly present among individuals whose test reports indicate that this genotype is present. The TPPV depends on the accuracy measures of percent agreements and on the frequency of the genotypes in the subpopulation being studied. The f(DD) is the frequency of DD and f(Dd) is the frequency of Dd in the subpopulation being studied; TPPV must be calculated as described in paragraphs (b)(3)(iii)(J)(1)(ix) through (xi) of this section.

    (ix) For variants where the point estimates of PA(DD|DD), PA(Dd|Dd) and PA(dd|dd) are less than 100 percent, use these point estimates in TPPV calculations.

    (x) Point estimates of 100 percent in the accuracy study may have high uncertainty about performance of the test in the population. If these variants are measured using highly multiplexed technology, calculate the random error rate for the overall device. The accuracy study described in paragraph (b)(3)(iii)(J) of this section in those cases is more to determine that there is no systematic error in such devices. In those cases, incorporate that rate in the estimation of the percent agreements as calculated in paragraph (b)(3)(iii)(J)(1)(vi) of this section and include it in TPPV calculations.

    (xi) The TPPV for subpopulations with genotype frequencies of f(dd), f(Dd) and f(DD) = 1−f(dd)−f(Dd) in the subpopulation is calculated as:

    ER07NO17.003

    (2) Precision and reproducibility data must be provided using multiple instruments and multiple operators, on multiple non-consecutive days, and using multiple reagent lots. The sample panel must either include specimens from the claimed sample type (e.g., saliva) representing all genotypes for each variant (e.g., wild type, heterozygous, and homozygous) or, if an alternative panel composition of specimens is identified by FDA as appropriate, a panel composed of those specimens FDA identified as appropriate. A detailed study protocol must be created in advance of the study and must include predetermined acceptance criteria for performance results. The percentage of samples that failed quality control must be indicated (i.e., the total number of sample replicates for which a sequence variant cannot be called (no calls) or that fail sequencing quality control criteria divided by the total number of replicates tested). It must be clearly documented whether results were generated from clinical specimens, contrived samples, or cell lines. The study results shall report the variants tested in the study and the number of replicates for each variant, and what conditions were tested (i.e., number of runs, days, instruments, reagent lots, operators, specimens/type, etc.). Results must be evaluated and presented in tabular format and stratified by study parameter (e.g., by site, instrument(s), reagent lot, operator, and sample variant). The study must include all extraction steps from the claimed specimen type or matrix, unless a separate extraction reproducibility study for the claimed sample type is performed. If the device is to be used at more than one laboratory, different laboratories must be included in the reproducibility study and reproducibility across sites must be evaluated. Any no calls or invalid calls in the study must be listed as a part of the precision and reproducibility study results.

    (3) Analytical specificity data: Data must be provided that evaluates the effect of potential endogenous and exogenous interferents on test performance, including specimen extraction and variant detection. Interferents tested must include those reasonably likely to be potentially relevant to the sample type used for the device.

    (4) Interfering variant data: Nucleotide mutations that can interfere with the technology must be cited and evaluated. Data must be provided to demonstrate the effect of the interfering variant(s) on the performance of the correct calls. Alternatively, for each suspected interfering mutation for which data is not provided demonstrating the effect of the interfering variant, the manufacturer must identify the suspected interfering variants in the labeling and indicate that the impact that the interfering variants may have on the assay's performance has not been studied by providing a statement that reads “It is possible that the presence of [insert clearly identifying information for the suspected interfering variant] in a sample may interfere with the performance of this test. However, its effect on the performance of this test has not been studied.”

    (5) Analytical sensitivity data: Data must be provided demonstrating the minimum amount of DNA that will enable the test to perform correctly in 95 percent of runs.

    (6) Reagent stability: The manufacturer must evaluate reagent stability using wild-type, heterozygous, and homozygous samples. Reagent stability data must demonstrate that the reagents maintain the claimed accuracy and reproducibility. Data supporting such claims must be provided.

    (7) Specimen type and matrix comparison data: Specimen type and matrix comparison data must be generated if more than one specimen type can be tested with this device, including failure rates for the different specimens.

    (K) Clinical performance summary.

    (1) Information to support the clinical performance of each variant reported by the test must be provided.

    (2) Manufacturers must organize information by the specific variant combination as appropriate (e.g., wild type, heterozygous, homozygous, compound heterozygous, hemizygous genotypes). For each variant combination, information must be provided in the clinical performance section to support clinical performance for the risk category (e.g., not at risk, increased risk). For each variant combination, a summary of key results must be provided in tabular format or using another method identified as appropriate by FDA to include the appropriate information regarding variant type, data source, definition of the target condition (e.g., disease), clinical criteria for determining whether the target disease is present or absent, description of subjects with the target disease present and target disease absent (exclusion or inclusion criteria), and technical method for genotyping. When available, information on the effect of the variant on risk must be provided as the risk of a disease (lifetime risk or lifetime incidences) for an individual compared with the general population risk.

    (i) If odds ratios are available, using information about the genotype distribution either among individuals with the target disease absent, or in the general population, or information about the risk variant frequency and odds ratios, the likelihood ratios for the corresponding device results along with 95 percent confidence intervals must be calculated. Using information about pretest risk (π), an estimate of likelihood ratio (LR), and a relationship between post-test risk R as R/(1−R) = LR·π/(1−π), the post-test risk R must be calculated.

    (ii) When available, likelihood ratios (LR) for different test results must be presented in a tabular format along with references to the source data or using another method identified as appropriate by FDA as stated in paragraph (b)(3)(iii)(K)(2) of this section. When these values are not directly available in published literature, likelihood ratios can be separately calculated along with the 95 percent confidence interval with references to the source data. Note that a minimum requirement for the presence of the variant's effect on the risk is that a corresponding LR is statistically higher than 1 (a lower bound of 95 percent two-sided confidence interval is larger than 1). It means that the post-test risk is statistically higher than the pretest risk (an observed value of the difference between the post-test and pretest risks).

    (L) Materials that explain the main concepts and terminology used in the test that includes, but is not limited to:

    (1) Definitions: Scientific terms that are used in the test reports.

    (2) Prepurchase page: This page must contain information that informs the user about what the test will provide. This includes, but is not limited to, variant information, the condition or disease associated with the variant(s), professional guideline recommendations for general genetic risk testing, the limitations associated with the test (e.g., test does not detect all variants related to the disease) and any precautionary information about the test the user should be aware of before purchase. When the test reports the risk of a life-threatening or irreversibly debilitating disease or condition for which there are few or no options to prevent, treat, or cure the disease, a user opt-in section must be provided. This opt-in page must be provided for each disease that falls into this category and must provide specific information relevant to each test result. The opt-in page must include:

    (i) An option to accept or decline to receive this specific test result;

    (ii) Specification of the risk involved if the user is found to have the specific genetic test result;

    (iii) Professional guidelines that recommend when genetic testing for the associated target condition is or is not recommended; and

    (iv) A recommendation to speak with a health care professional, genetic counselor, or equivalent professional before getting the results of the test.

    (3) Frequently asked questions (FAQ) page: This page must provide information that is specific for each variant/disease pair that is reported. Information provided in this section must be scientifically valid and supported by corresponding publications. The FAQ page must explain the health condition/disease being tested, the purpose of the test, the information the test will and will not provide, the relevance of race and ethnicity on the test results, information about the population to which the variants in the test is most applicable, the meaning of the result(s), other risks factors that contribute to disease, appropriate followup procedures, how the results of the test may affect the user's family, including children, and links to resources that provide additional information.

    (M) User comprehension study: Information on a study that assesses comprehension of the test process and results by potential users of the test must be provided.

    (1) The test manufacturer must provide a genetic risk education module to naïve user comprehension study participants prior to their participation in the user comprehension study. The module must define terms that are used in the test reports and explain the significance of genetic risk reports.

    (2) The test manufacturer must perform pre- and post-test user comprehension studies. The comprehension test questions must include directly evaluating a representative sample of the material being presented to the user as described in paragraph (b)(3)(ii) of this section.

    (3) The manufacturer must provide a justification from a physician and/or genetic counselor that identifies the appropriate general and variant-specific concepts contained within the material being tested in the user comprehension study to ensure that all relevant concepts are incorporated in the study.

    (4) The user study must meet the following criteria:

    (i) The study participants must comprise a statistically sufficient sample size and demographically diverse population (determined using methods such as quota-based sampling) that is representative of the intended user population. Furthermore, the study participants must comprise a diverse range of age and educational levels and have no prior experience with the test or its manufacturer. These factors shall be well defined in the inclusion and exclusion criteria.

    (ii) All sources of bias must be predefined and accounted for in the study results with regard to both responders and non-responders.

    (iii) The testing must follow a format where users have limited time to complete the studies (such as an onsite survey format and a one-time visit with a cap on the maximum amount of time that a participant has to complete the tests).

    (iv) Users must be randomly assigned to study arms. Test reports in the user comprehension study given to users must define the target condition being tested and related symptoms, explain the intended use and limitations of the test, explain the relevant ethnicities in regard to the variant tested, explain genetic health risks and relevance to the user's ethnicity, and assess participants' ability to understand the following comprehension concepts: The test's limitations, purpose, appropriate action, test results, and other factors that may have an impact on the test results.

    (v) Study participants must be untrained, be naïve to the test subject of the study, and be provided the labeling prior to the start of the user comprehension study.

    (vi) The user comprehension study must meet the predefined primary endpoint criteria, including a minimum of a 90 percent or greater overall comprehension rate (i.e., selection of the correct answer) for each comprehension concept. Other acceptance criteria may be acceptable depending on the concept being tested. Meeting or exceeding this overall comprehension rate demonstrates that the materials presented to the user are adequate for over-the-counter use.

    (vii) The analysis of the user comprehension results must include results regarding reports that are provided for each gene/variant/ethnicity tested, statistical methods used to analyze all data sets, and completion rate, non-responder rate, and reasons for nonresponse/data exclusion. A summary table of comprehension rates regarding comprehension concepts (e.g., purpose of test, test results, test limitations, ethnicity relevance for the test results, etc.) for each study report must be included.

    (4) The intended use of the device must not include the following indications for use:

    (i) Prenatal testing;

    (ii) Determining predisposition for cancer where the result of the test may lead to prophylactic screening, confirmatory procedures, or treatments that may incur morbidity or mortality to the patient;

    (iii) Assessing the presence of genetic variants that impact the metabolism, exposure, response, risk of adverse events, dosing, or mechanisms of prescription or over-the-counter medications; or

    (iv) Assessing the presence of deterministic autosomal dominant variants.

    Dated: November 1, 2017. Lauren Silvis, Chief of Staff.
    [FR Doc. 2017-24159 Filed 11-6-17; 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-2015-N-3455] Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is publishing an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for autosomal recessive carrier screening gene mutation detection systems. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the autosomal recessive carrier screening gene mutation detection system devices classification regulation to reflect this final determination.

    DATES:

    This order is effective November 7, 2017.

    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.

    SUPPLEMENTARY INFORMATION: I. Statutory Background

    Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)) and the implementing regulations, 21 CFR part 807 subpart E, require persons who intend to market a device to submit and obtain FDA clearance of a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a legally marketed device that does not require premarket approval.

    On December 13, 2016, the 21st Century Cures Act (Pub. L. 114-255) (Cures Act) was signed into law. Section 3054 of the Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(2) provides that, 1 calendar day after the date of publication of the final list under paragraph (1)(B), FDA may exempt a class II device from the requirement to submit a report under section 510(k) of the FD&C Act, upon its own initiative or a petition of an interested person, if FDA determines that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of the device. This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 60-calendar-day comment period. Within 120 days of publication of such notice, FDA must publish an order in the Federal Register that sets forth its final determination regarding the exemption of the device that was the subject of the notice. If FDA fails to respond to a petition under this section within 180 days of receiving it, the petition shall be deemed granted.

    II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, Federal Register notice (63 FR 3142) and subsequently in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (referred to herein as the Class II 510(k) Exemption Guidance) (Ref. 1).

    III. Device Description

    On February 19, 2015, FDA completed its review of a De Novo request for classification of the 23andMe Personal Genome Service (PGS) Carrier Screening Test for Bloom syndrome. FDA classified the 23andMe PGS Carrier Screening Test for Bloom syndrome, and substantially equivalent devices of this generic type, into class II (special controls) under the generic name “Autosomal recessive carrier screening gene mutation detection system.” This type of device is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human specimens intended for prescription use or over-the-counter (OTC) use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.

    FDA believes that 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 determining substantial equivalence for future devices within that type (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 a 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.

    In the Federal Register of October 27, 2015 (80 FR 65774), FDA published a notice (“October 2015 notice”) announcing its intent to exempt autosomal recessive carrier screening gene mutation detection system devices from premarket notification requirements, subject to certain limitations, and provided opportunity for interested persons to submit comments by November 27, 2015. After reviewing comments received (summarized in section IV), FDA is now providing its final determination for autosomal recessive carrier screening gene mutation detection system devices by exempting this type of device from premarket notification requirements, subject to certain limitations as identified in this notice. FDA is also amending the codified language for the autosomal recessive carrier screening gene mutation detection system devices classification regulation to reflect this final determination. Persons with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitations, should withdraw their submissions.

    IV. Comments on the Proposed Exemption and FDA Response

    In response to the October 2015 notice announcing FDA's intent to exempt autosomal recessive carrier screening gene mutation detection system devices from premarket notification requirements, FDA received submissions from three commenters—a device industry manufacturer, a professional organization, and a health care organization—supporting an exemption from premarket notification for this type of device.

    To make it easier to identify comments and our responses, the word “Comment” and a comment number appear in parentheses before each comment's description, and the word “Response” in parentheses precedes each response. Similar comments are grouped together under the same number. Specific issues raised by the comments and the Agency's responses follow.

    (Comment 1) Two commenters requested that FDA clarify that the list of autosomal recessive carrier diseases included in the October 2015 notice is not exhaustive or expand the list of diseases and conditions covered by the exemption to include all diseases and conditions described in the scientific literature as inherited in an autosomal recessive manner. One commenter further requested that FDA clarify that the determination of the applicability of § 866.5940 (21 CFR 866.5940) should be based upon scientific and clinical literature as to the autosomal recessive nature of the disease or condition.

    (Response) The diseases and conditions listed in table 1 of the October 2015 notice were based upon a limited review of the scientific and clinical literature at that time. After consideration of the public comments, FDA agrees that the autosomal recessive diseases and conditions listed in that table should be treated as illustrative, and not an exhaustive list. Based on FDA's review of current scientific and clinical literature, FDA would not consider screening for autosomal recessive carrier status by detection of clinically relevant gene mutations associated with a large variety of diseases and conditions, in addition to those listed in table 1 of the October 2015 notice, to constitute a different intended use from that of a legally marketed device in the generic type under § 866.5940 for purposes of § 866.9 (21 CFR 866.9). Because FDA agrees that the list of diseases and conditions provided in the October 2015 notice is not comprehensive, and that applicability of § 866.5940 should be based upon scientific and clinical literature as to the autosomal recessive nature of a particular disease or condition, we are not providing a revised list in this final order.

    (Comment 2) One commenter requested clarification that § 866.5940 applies to OTC carrier detection devices for the determination of carrier status by detection of clinically relevant gene mutations associated with cystic fibrosis.

    (Response) In the October 2015 notice, FDA stated “[a] gene mutation detection system indicated for the determination of carrier status by detection of clinically relevant gene mutations associated with Cystic Fibrosis is not 510(k)-exempt since it is a class II device subject to premarket notification and special controls under 21 CFR 866.5900—Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.” Similarly, in the final order announcing the classification of an autosomal recessive carrier screening gene mutation detection system into class II (80 FR 65626, October 27, 2015), FDA stated “A gene mutation detection system indicated for the determination of carrier status by detection of clinically relevant gene mutations associated with cystic fibrosis is separately classified under 21 CFR 866.5900—Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system (class II, special controls), and is thus not included in the de novo classification.”

    However, after considering the comments regarding this exemption action, and after reviewing the devices that are classified as CTFR gene mutation detection systems under § 866.5900 (21 CFR 866.5900), FDA is now clarifying that an OTC gene mutation detection system indicated for the determination of autosomal recessive carrier status by detection of clinically relevant gene mutations associated with cystic fibrosis (“OTC Cystic Fibrosis carrier screening test”) is included within the scope of the classification regulation for an autosomal recessive carrier screening gene mutation detection system (§ 866.5940) and this exemption action.

    At the time FDA classified a CFTR gene mutation detection system under § 866.5900, we were not aware of any OTC Cystic Fibrosis carrier screening tests, and it was not our intent at the time to classify this test for OTC use. We also note that, to date, the only Cystic Fibrosis carrier screening tests that have been cleared by FDA under § 866.5900 are for prescription use only. Finally, FDA does not believe that the special controls under § 866.5900(b) would reasonably assure the safety and effectiveness of OTC Cystic Fibrosis carrier screening tests, as such special controls were developed to be applicable to prescription use only tests. For example, when classifying a CFTR gene mutation detection system into class II, FDA determined that the special controls under § 866.5900(b), in conjunction with general controls, provided a reasonable assurance of the safety and effectiveness of the device. One risk to health that FDA identified was that “errors in interpretation of results may lead to improper clinical recommendations and medical patient management.” The special controls concerning generation of test results, interpretation of test results, and precautions for interpretation of the test results were developed only for prescription use only tests with health care providers in mind (see Section 6—Device Description; Test Results/Reporting, Section 10—Labeling; Interpretation of Results, and Section 10—Labeling; Precautions for interpretations of the “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems” (October 26, 2005) (Ref. 2).

    Therefore, FDA is clarifying that with regard to gene mutation detection systems indicated for the determination of carrier status by detection of clinically relevant gene mutations associated with cystic fibrosis, the classification regulation § 866.5900 is only applicable to prescription use only tests. FDA is further clarifying that we would not consider a gene mutation detection system indicated for use as an OTC device for the determination of carrier status by detection of clinically relevant gene mutations associated with cystic fibrosis to constitute a different intended use from that of a legally marketed device in the generic type § 866.5940 for purposes of § 866.9(a). As such, OTC Cystic Fibrosis carrier screening tests are within the scope of the classification regulation for an autosomal recessive carrier screening gene mutation detection system (§ 866.5940) and are included within the scope of this action.

    (Comment 3) One commenter requested that the exemption be expanded to include carrier screening for X-linked conditions. The commenter further requested that the exemption be expanded to allow for the reporting of diagnostic results.

    (Response) The October 2015 notice and this final order concern the exemption from premarket notification of autosomal recessive carrier screening gene mutation detection systems in the generic type § 866.5940. Devices within the scope of the § 866.5940 regulation for autosomal recessive carrier screening gene mutation detection systems are intended for autosomal recessive carrier screening in adults of reproductive age. The requested indications for carrier screening for X-linked conditions and for reporting of diagnostic results are outside the scope of the § 866.5940 regulation. As this final order concerns only exemption of devices within the § 866.5940 regulation, the request to expand the exemption to include carrier screening for X-linked conditions or for the reporting of diagnostic results is outside the scope of this action.

    (Comment 4) The three commenters were generally supportive of the regulation and special controls established for the device type, including for the special controls that relate to genetic counseling (e.g., § 866.5940(b)(1) and (b)(4)(iii)(A)). Two commenters requested FDA provide additional recommendations that relate to the special control requirements related to genetic counseling.

    (Response) FDA appreciates the comments supporting the regulation and special controls established for the device type. FDA believes that the class II special controls established for the device type, along with the applicable general controls, provides reasonable assurance of the safety and effectiveness of the device type. FDA notes that while the comments received did not propose specific amendments to the special control requirements, such discussion is outside the scope of the October 2015 notice and this final order, which concerns the exemption from premarket notification of autosomal recessive carrier screening gene mutation detection systems in the generic type § 866.5940.

    V. Exemption for Autosomal Recessive Carrier Screening Gene Mutation Detection System Devices

    FDA has assessed the need for 510(k) clearance for this type of device by considering the factors discussed in the January 21, 1998, Federal Register notice (63 FR 3142) and subsequently in the Class II 510(k) Exemption Guidance, as previously discussed in the October 2015 notice, and has determined they weigh in favor of 510(k) exemption, subject to certain limitations discussed later in this order. Therefore, for the reasons set forth in the Federal Register of October 27, 2015, and as informed by the comments received and FDA's understanding and experience with autosomal recessive carrier screening gene detection systems, FDA has determined that premarket notification is not necessary to assure the safety and effectiveness of autosomal recessive carrier screening gene detection systems, so long as the limitations on exemption described later in this document are not met.

    VI. Limitations on Exemption

    This exemption from 510(k) for an autosomal recessive carrier screening gene mutation detection system applies only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type, or, in the case of in vitro diagnostic devices, for which a misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality. Therefore, a manufacturer of an autosomal recessive carrier screening gene mutation detection system would still be required to submit a premarket notification to FDA before introducing a device or delivering it for introduction into commercial distribution when the device meets any of the conditions described in § 866.9, except § 866.9(c)(2) to the extent it may include an autosomal recessive carrier screening gene mutation detection system, for the reasons explained in the October 2015 notice.

    Specifically, an autosomal recessive carrier screening gene mutation detection system is not exempt from the premarket notification requirement if such device: (1) Has an intended use that is different from the intended use of a legally marketed device in that generic type; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; or (2) operates using a different fundamental scientific technology than that used by a legally marketed device in that generic type; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using a DNA probe or nucleic acid hybridization or amplification technology rather than culture or immunoassay technology; or (3) is an in vitro device that is intended: for use in the diagnosis, monitoring or screening of neoplastic diseases with the exception of immunohistochemical devices; for measuring an analyte which serves as a surrogate marker for screening, diagnosis, or monitoring of life threatening diseases, such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction, or to monitor therapy; for assessing the risk of cardiovascular diseases; for use in diabetes management; for identifying or inferring the identity of a microorganism directly from clinical material; for detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; for noninvasive testing; or for near-patient testing (point of care).

    Exemption from the requirement of premarket notification does not exempt a device from other applicable regulatory controls under the FD&C Act, including the applicable general and special controls. Indeed, FDA's decision to grant 510(k) exemption for these devices is based, in part, on the special controls, in combination with general controls, providing sufficiently rigorous mitigations for the risks identified for this generic type.

    This exemption from 510(k), subject to the limitations described above, is immediately in effect for autosomal recessive carrier screening gene mutation detection systems. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review for devices in this exempted type.

    VII. Analysis of Environmental Impact

    We have 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.

    VIII. Paperwork Reduction Act of 1995

    This notice 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 parts 801 and 809 have been approved under OMB control number 0910-0485.

    IX. References

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

    1. FDA Guidance, “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,” February 19, 1998, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf. 2. FDA Guidance for Industry and FDA Staff “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems,” October 26, 2005, available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071104.pdf. 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. In § 866.5940, revise paragraph (b) introductory text to read as follows:
    § 866.5940 Autosomal recessive carrier screening gene mutation detection system.

    (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9, except § 866.9(c)(2). Autosomal recessive carrier screening gene mutation detection system must comply with the following special controls:

    Dated: November 1, 2017. Lauren Silvis, Chief of Staff.
    [FR Doc. 2017-24162 Filed 11-6-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF COMMERCE United States Patent and Trademark Office 37 CFR Part 42 [Docket No. PTO-P-2016-0029] RIN 0651-AD10 Rule on Attorney-Client Privilege for Trials Before the Patent Trial and Appeal Board AGENCY:

    Patent Trial and Appeal Board, United States Patent and Trademark Office, U.S. Department of Commerce.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule on attorney-client privilege amends the existing rules relating to the United States Patent and Trademark Office (Office or USPTO) trial practice for inter partes review, post-grant review, the transitional program for covered business method patents, and derivation proceedings that implemented provisions of the Leahy-Smith America Invents Act (“AIA”) providing for trials before the Office.

    DATES:

    This rule is effective on December 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Edward Elliott, Attorney Advisor, by telephone at (571) 272-7024 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Executive Summary: Purpose: This final rule clarifies situations where privilege is recognized for communications between clients and their domestic or foreign patent attorneys and patent agents.

    Background

    In February 2015, the USPTO held a roundtable and solicited comments on attorney-client privilege issues. See Notice of Roundtable and Request for Comments on Domestic and International Issues Related to Privileged Communications Between Patent Practitioners and Their Clients, 80 FR 3953 (Jan. 26, 2015). As part of that process, the USPTO requested comments on whether communications between patent applicants or owners with their U.S. patent agents or foreign patent practitioners should be recognized as privileged to the same extent as communications with U.S. patent attorneys. Respondents unanimously supported a rule recognizing such privilege in courts. See USPTO, Summary of Roundtable and Written Comments, available at http://www.uspto.gov/sites/default/files/documents/Summary%20of%20Privileged%20Communication%20Roundtable.pdf (“Privilege Report”).

    Some roundtable participants noted that rules regarding privilege for U.S. patent agents and foreign practitioners in PTAB discovery proceedings were difficult to discern, as there has been no explicit rule on privilege. When the issue arises before PTAB, Administrative Law Judges make legal determinations as to which communications may be protected from disclosure on a case-by-case basis, based on the Federal Rules of Evidence and common law. See 37 CFR 42.62(a); see also GEA Process Engineering, Inc. v. Steuben Foods, Inc., IPR2014-00041, Paper 117 (PTAB 2014). U.S. courts have devised several different approaches to determine under what circumstances communications with these practitioners are privileged. As the Privilege Report notes, the common law on privilege for domestic and foreign patent practitioners varies across jurisdictions. Different approaches are taken, and results sometimes conflict. This may lead to administrative inefficiencies and inconsistencies in outcomes, as PTAB must select which set of common law rules to follow.

    Administrative Law Judges in other agencies have treated certain confidential communications with a patent agent as privileged. See, e.g., USITC Inv. No. 337-TA-339, slip op. at 2, 1992 WL 811804 (ITC 1992) (finding that confidential communications between a U.S. patent agent and his client in connection with a patent prosecution are privileged). In 2016, the Federal Circuit recognized that attorney-client privilege applies to U.S. patent agents acting within the scope of their authorized practice. See In re Queen's University at Kingston, 820 F.3d 1287 (Fed. Cir. 2016).

    To address the aforementioned issues with privilege rules, the USPTO put forth a proposed PTAB rule for public comment in October 2016. See Rule Recognizing Privileged Communications Between Clients and Patent Practitioners at the Patent Trial and Appeal Board, 81 FR 71653 (Oct. 18, 2016). The Office received eighteen comments from bar associations, trade groups, law firms, and individuals. The Office expresses its gratitude for the thoughtful and comprehensive comments provided by the public, which are available online at https://www.regulations.gov/docket?D=PTO-P-2016-0029.

    The vast majority of commenters expressed support for this rule, echoing the need for clarity and certainty in this area. The policy arguments they raised in favor are already covered extensively in the Privilege Report. Several commenters raised additional issues about specific language in the proposed rule, which are addressed herein. A few commenters opposed the rule based on misunderstandings of the scope and purpose of the rule, which are clarified herein as well. Based on the feedback, the Office presents the following final rule on recognizing privilege for patent attorneys and agents.

    Responses to Comments Nature of Privilege

    Comments: Some comments expressed concern over the scope and interpretation of the proposed rule. One commenter objected to expanding those eligible to practice before PTAB to include agents. Others characterized the rule as primarily to protect communications between clients and counsel involved in PTAB proceedings.

    Response: Attorney-client privilege exists to protect clients. It allows them to have full and frank discussions with attorneys when seeking legal advice, without fear that those discussions will be used against them in legal proceedings. The privilege vests with the client, not the attorney, and does not confer authorization to practice law, but rather flows from those already having such authorization. Because of this, recognizing privilege for patent agents does not determine what types of work they are authorized to perform. The authorized functions of patents agents, including representing clients before PTAB, are established in 37 CFR 11.5(b). Likewise, privilege does not confer additional power to patent agents because it vests in the client, not the agent or attorney. Applying the privilege to agents simply recognizes that they perform legal services and that clients deserve the same protections regardless of which type of authorized legal provider they choose. Further, some foreign jurisdictions rely entirely or almost entirely on non-attorney patent agents. In such jurisdictions, hiring an attorney to handle patent matters can be difficult or impossible. See the Privilege Report for further discussion of the policy considerations supporting privilege for patent agents.

    More fundamentally, this rule is not intended primarily to protect communications between clients and their counsel for purposes of PTAB proceedings. Rather, it is primarily intended to protect communications made when seeking patents at the USPTO or foreign IP offices, such as when prosecuting applications or contemplating whether to file. The counsel on those communications may not be involved in any PTAB proceedings. Communications about prosecution are much more commonly implicated in PTAB discovery proceedings than communications about the PTAB proceeding itself. Perhaps this reflects the inherent asymmetry of privilege protections: Both parties are affected if their communications seeking legal advice about the PTAB proceeding are discoverable, whereas only the patent holder is affected by discovery of communications from prosecution. Regardless, the purpose of the rule is to protect any communications with authorized counsel from discovery in PTAB, not just communications about the instant proceeding.

    Similarly, this privilege rule does not affect an attorney, agent, or applicant's duty to disclose material information to the USPTO at any time, as the duty of disclosure under 37 CFR 1.56 continues to be controlling. This duty is not at odds with privilege protections; the duty of disclosure governs all information known by a party and establishes whether information must be provided to the USPTO, while privilege governs material available to third party adversaries in adjudicated proceedings under part 42. For instance, the privilege rule does not apply in the filing and prosecution of a patent application. Further, the privilege only protects information exchanged for purposes of obtaining legal opinions or services, not underlying facts or business documents. The precise metes and bounds of what types of communications are protected by privilege are determined according to Federal law. Finally, this rule does not nullify privilege for others who are not covered by the rule, such as attorneys not admitted to practice before the USPTO or a foreign patent office. Other sources of privilege under Federal law remain unaffected.

    Scope of Activities

    Comments: Some commenters requested clarity on the scope of covered activities. One commenter asked the USPTO to clarify whether a communication with a registered patent agent about claim interpretation of an issued patent would qualify as privileged. Others asked for general clarification of what activities by patent agents would be covered, with one requesting examples of activities that would qualify for the privilege. One commenter noted that 37 CFR 11.5(b)(1) may not provide an exhaustive list of authorized activities.

    Response: We understand the commenters' desire for clarity on these issues. The USPTO has described the functions agents are authorized to perform before the Office in 37 CFR 11.5(b)(1). Whether a particular scenario falls within the bounds of an agent's authorization is subject to determination by an appropriate authority.

    More precisely defining what types of work patent agents are and are not authorized to perform is a much larger issue that goes far beyond privilege considerations. This rulemaking is not the proper forum to address that issue. If the public feels that the general definition of authorized functions put forth by the USPTO in § 11.5(b)(1) should be updated, they should contact the USPTO to express interest in a more comprehensive process to consider that issue, which accounts for the numerous equities involved. We also note that regardless of any clarifications made to the scope of authorized duties for U.S. patent agents, the USPTO cannot alter or clarify the authorized functions of foreign patent agents in their home jurisdiction, which are established by foreign laws and regulations.

    Federal Privilege

    Comments: One comment suggested clarifying that the “same protections of privilege” refers to Federal privilege, since state courts have their own separate sources of privilege.

    Response: We concur and have adjusted the rule to specify “privilege under Federal law” in paragraph (a).

    Direct Communications

    Comments: One comment suggested that the rule as written may only cover communications directly between a client and a foreign practitioner, and not communications made by the client's U.S. attorney with the foreign practitioner. According to the comment, communications made between a client's representatives in the absence of the client could be inadvertently excluded by the current phrasing of the rule.

    Response: Under U.S. Federal law, attorney-client privilege generally encompasses communications with an attorney made by the client's representatives as well as the client. Similarly, privilege generally encompasses communications made with an attorney's employee or assistant, as well as communications between multiple attorneys working for a client. That is not to say such communications are necessarily privileged; they must still meet the other requirements for privilege, such as appropriate subject matter. However, these parties are generally regarded as parties that fall within the scope of privilege, rather than as third parties who break privilege.

    Under the new rule, communications with such parties should similarly be entitled to privilege under the same circumstances as when the practitioner is an attorney. However, we recognize that there is potential for a narrower reading of the proposed rule that does not cover communications with such parties and therefore affords lesser protection to non-attorney practitioners. We have added paragraph (c) to the rule to clarify that the scope of coverage will be the same for practitioners as for attorneys under these types of scenarios and any other situations. For instance, privilege will extend to communications with the aforementioned parties under appropriate circumstances, not just to communications directly between the practitioner and the client.

    Limitations and Exceptions

    Comments: One comment suggested explicitly defining which “limitations and exceptions” should apply to the privilege.

    Response: Exceptions to attorney-client privilege such as crime/fraud are based on longstanding common law, which continues to evolve. Our purpose here is not to redefine those exceptions. This may lead to growing discrepancies as the common law changes, which could lead to disparate treatment of privilege for patent attorneys and agents compared with other attorneys. Rather, this rule codifies who is eligible for the privilege, while leaving questions about exceptions and limitations for general jurisprudence to address in a broader manner.

    Practitioners With Limited Recognition

    Comments: A couple of commenters noted that the rule does not extend to all categories of practitioners, namely, those granted limited recognition under 37 CFR 11.9.

    Response: The rule has been amended to cover USPTO practitioners meeting the registration requirements of 37 CFR 11.7. This includes practitioners under both §§ 11.6 and 11.9(b), who have demonstrated the requisite legal, scientific, and technical qualifications and moral character. Foreign practitioners practicing at the USPTO under § 11.9(c) can qualify for privilege under paragraph (b) of the new rule through their admittance to practice in a foreign jurisdiction. Students in the USPTO law school clinic program practicing under § 11.16 can qualify for privilege under paragraph (c) of the new rule since they work under the supervision of a registered practitioner. At this time, we are not convinced an extension to other categories of practitioners is necessary or appropriate. It is not clear that recognizing privilege for these individuals furthers any of the policy reasons for applying privilege to patent agents, or that these individuals play a significant role in providing legal services for applicants.

    Relation to In re Queen's

    Comments: A few commenters noted the parallels between this rule and the Federal Circuit's decision in In re Queen's University, wondering if a USPTO rule is still necessary and whether there would be any distinction between our rule and the Federal Circuit's. One commenter mentioned a supposed difference in coverage for third-party patent validity opinions by agents.

    Response: The USPTO supports the Federal Circuit's finding of privilege for patent agents as a matter of public policy. The Privilege Report catalogs the many reasons that privilege for patent agents is warranted. A USPTO rule on privilege is still needed, for at least several reasons. The Queen's decision was a 2-1 panel result, which may be revisited in future cases either en banc at the Federal Circuit or at the Supreme Court. There are clarity benefits to having a rule explicitly codified rather than only in common law.

    Also, the Federal Circuit decision only addresses domestic patent agents, not foreign attorneys and agents. Without comparable protections in U.S. tribunals for foreign practitioners, privileged communications with U.S. patent attorneys may effectively lose that protection through parallel communications with foreign practitioners prosecuting corresponding foreign applications, which often raise very similar legal issues. Having a U.S. attorney supervise communications with foreign practitioners is not only an undesirable policy, but may not be enough to preserve privilege in all circumstances. Because the U.S. attorney is generally not authorized to practice law in foreign jurisdictions, the foreign attorney might not be considered as working “under the supervision” of the U.S. attorney in all instances. Further, some jurisdictions use non-attorney patent agents exclusively or predominantly, so it may not be possible for applicants to rely on privilege afforded by U.S. courts to foreign attorneys. The new privilege rule protects eligible communications with qualified foreign attorneys and agents from discovery at PTAB, preventing such back door exposure. The rule does not have extraterritorial effects; how communications with U.S. and foreign practitioners are treated by foreign courts is entirely up to the foreign jurisdiction.

    Another reason for the USPTO's rule is administrative economy and judicial efficiency, as explained by commenter John Cross of the University of Louisville. The typical approach to privilege for foreign practitioners examines whether the foreign jurisdiction affords something like privilege for attorneys and agents. However, this inquiry can be intensive, difficult, and lead to inconsistent results, because many jurisdictions do not need a comparable protection when their constrained discovery system prevents communications with patent practitioners from even being discoverable. Similarly, U.S. courts that use a “touch base” standard often make complex inquiries into a foreign communication's nexus with the United States, which can lead to uncertain and inconsistent results. The USPTO rule simplifies such inquiries by instead considering whether the foreign practitioner was authorized to practice within their home jurisdiction by satisfying their jurisdiction's professional requirements, and whether the communications fall within their authorized scope of practice in that jurisdiction. These criteria are simpler to adjudicate and lead to more predictable and consistent results, helping applicants understand where privilege applies long before they appear at a tribunal.

    Also, the USPTO rule applies regardless of the source of privilege for agents. Whether there is a separate agent-client privilege or agents are afforded attorney-client privilege on the basis of practicing patent law does not matter for purposes of this rule. The rule simply recognizes that privilege issues will be treated the same for agents as for attorneys within their scope of authorized practice.

    Practice of Law

    Comments: Two commenters suggested that the rule would promote the “unauthorized practice of law” by U.S. patent agents. It was suggested that participation by patent agents in PTAB proceedings would constitute unauthorized practice, and that agents participating in PTAB proceedings held concurrently with patent litigation on the same patents would constitute unauthorized litigation practice by those agents. One of these commenters also said that state bar rules may conflict with this PTAB rule.

    Response: As previously mentioned, the rule does not grant additional powers to patent agents. Privilege is a protection that vests with the client, not the practitioner. Agents are already authorized to practice before PTAB in any USPTO proceedings. Practice before PTAB cannot be unauthorized practice of law because U.S. patent agents are authorized to do so.

    The second objection suggests that practicing before PTAB is tantamount to practicing before Federal courts when there is concurrent litigation on the same patents. Because they are separate venues with separate practices and practitioners, this argument is not persuasive. Agents are authorized to advise and represent clients in PTAB proceedings because the issues are restricted to patent law matters they are authorized to perform. Federal courts have different jurisdiction than PTAB and consider a range of non-patent issues. The fact that certain patent issues, such as validity, may arise before both tribunals does not equate practice before both venues. Just because a practitioner is authorized to address the issue in one forum does not mean they are authorized to address it in other forums. This is true regardless of whether the practitioner is an agent or an attorney and whether the two forums are, for instance, PTAB and a Federal court, or a Federal court and a foreign court.

    Finally, state bar rules generally are not germane to USPTO rules. The USPTO may properly regulate the conduct of practitioners before the Office, including PTAB proceedings, as authorized by Congress. Similarly, states can properly regulate the practice of law within their borders, subject to federalism principles and rules established by the Supreme Court. The USPTO and states have separate jurisdiction. States may of course consider the policy issues the USPTO has documented when deciding privilege matters within their own courts for domestic and foreign patent agents and attorneys.

    Changes From the Proposed Rule

    In response to comments received from the public, the USPTO makes the following changes from the proposed rule. The terms for types of practitioners (domestic and foreign) were adjusted slightly for uniformity with other rules. The application of Federal law was clarified. The USPTO registration requirement now points to 37 CFR 11.7 for more precision. Paragraph (c) was added to clarify that non-attorney practitioners are afforded privilege in all the same situations as attorneys, not just for direct communications between practitioner and client.

    Rulemaking Considerations

    A. Administrative Procedure Act (APA): This final rule revises the rules relating to Office trial practice for inter partes review, post-grant review, the transitional program for covered business method patents, and derivation proceedings. The changes being adopted in this notice do not change the substantive criteria of patentability. These changes involve rules of agency practice. See, e.g., 35 U.S.C. 316(a)(5), as amended. These rules are procedural and/or interpretive rules. See Bachow Commc'ns Inc. v. F.C.C., 237 F.3d 683, 690 (D.C. Cir. 2001) (Rules governing an application process are procedural under the Administrative Procedure Act.); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (Rules for handling appeals were procedural where they did not change the substantive requirements for reviewing claims.); Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (Rule that clarifies interpretation of a statute is interpretive.); JEM Broad. Co. v. F.C.C., 22 F.3d 320, 328 (D.C. Cir. 1994) (Rules are not legislative because they do not “foreclose effective opportunity to make one's case on the merits.”).

    Accordingly, prior notice and opportunity for public comment are not required pursuant to 5 U.S.C. 553(b) or (c) (or any other law). See Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), do not require notice and comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice” (quoting 5 U.S.C. 553(b)(A))). However, the Office chose to seek public comment before implementing the rule to benefit from the public's input.

    B. Regulatory Flexibility Act: As prior notice and an opportunity for public comment are not required pursuant to 5 U.S.C. 553 or any other law, neither a regulatory flexibility analysis nor a certification under the Regulatory Flexibility Act (5 U.S.C. 601-612) is required. See 5 U.S.C. 603. Nonetheless, for the reasons set forth herein, the Senior Counsel for Regulatory and Legislative Affairs in the Office of General Law of the USPTO has certified to the Chief Counsel for Advocacy of the Small Business Administration that this rule will not have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 605(b). This rule revises the rules of practice before PTAB to explicitly recognize that communications between non-attorney or foreign patent practitioners and their clients that pertain to authorized practice before the USPTO or foreign patent offices are privileged, and to define those persons who may avail themselves of this privilege. These changes are expected to create no additional burden to those practicing before the Board as this rule merely clarifies rights and protections for the practitioner and client and does not impose a change in practice or requirements. In fact, this rule may produce a small benefit from a reduction in uncertainty and mitigation of discovery costs. For the above reasons, the changes in this rule will not have a significant economic impact on a substantial number of small entities.

    C. Executive Order 12866 (Regulatory Planning and Review): This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).

    D. Executive Order 13563 (Improving Regulation and Regulatory Review): The Office has complied with Executive Order 13563. Specifically, the Office has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole, and provided on-line access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.

    E. Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs): This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.

    F. Executive Order 13132 (Federalism): This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).

    G. Executive Order 13175 (Tribal Consultation): This rulemaking will not: (1) Have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (Nov. 6, 2000).

    H. Executive Order 13211 (Energy Effects): This rulemaking is not a significant energy action under Executive Order 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).

    I. Executive Order 12988 (Civil Justice Reform): This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).

    J. Executive Order 13045 (Protection of Children): This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997).

    K. Executive Order 12630 (Taking of Private Property): This rulemaking will not affect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).

    L. Congressional Review Act: Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), prior to issuing any final rule, the United States Patent and Trademark Office will submit a report containing the rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this final rule are not expected to result in an annual effect on the economy of 100 million dollars or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this final rule is not a “major rule” as defined in 5 U.S.C. 804(2).

    M. Unfunded Mandates Reform Act of 1995: The changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of 100 million dollars (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of 100 million dollars (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

    N. National Environmental Policy Act: This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

    O. National Technology Transfer and Advancement Act: The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions which involve the use of technical standards.

    P. Paperwork Reduction Act: The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549) requires that the Office consider the impact of paperwork and other information collection burdens imposed on the public. This final rule involves information collection requirements which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549). This rulemaking does not add any additional information requirements or fees for parties before the Board. Therefore, the Office is not resubmitting information collection packages to OMB for its review and approval because the revisions in this rulemaking do not materially change the information collections approved under OMB control number 0651-0069.

    Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to, a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB control number.

    List of Subjects in 37 CFR Part 42

    Administrative practice and procedure, Inventions and patents.

    For the reasons set forth in the preamble, 37 CFR part 42 is amended as follows.

    PART 42—TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD 1. The authority citation for 37 CFR part 42 continues to read as follows: Authority:

    35 U.S.C. 2(b)(2), 6, 21, 23, 41, 135, 311, 312, 316, 321-326; Public Law 112-29, 125 Stat. 284; and Pub. L. 112-274, 126 Stat. 2456.

    2. Add § 42.57 to read as follows:
    § 42.57 Privilege for patent practitioners.

    (a) Privileged communications. A communication between a client and a USPTO patent practitioner or a foreign jurisdiction patent practitioner that is reasonably necessary and incident to the scope of the practitioner's authority shall receive the same protections of privilege under Federal law as if that communication were between a client and an attorney authorized to practice in the United States, including all limitations and exceptions.

    (b) Definitions. The term “USPTO patent practitioner” means a person who has fulfilled the requirements to practice patent matters before the United States Patent and Trademark Office under § 11.7 of this chapter. “Foreign jurisdiction patent practitioner” means a person who is authorized to provide legal advice on patent matters in a foreign jurisdiction, provided that the jurisdiction establishes professional qualifications and the practitioner satisfies them. For foreign jurisdiction practitioners, this rule applies regardless of whether that jurisdiction provides privilege or an equivalent under its laws.

    (c) Scope of coverage. USPTO patent practitioners and foreign jurisdiction patent practitioners shall receive the same treatment as attorneys on all issues affecting privilege or waiver, such as communications with employees or assistants of the practitioner and communications between multiple practitioners.

    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. 2017-24190 Filed 11-6-17; 8:45 am] BILLING CODE 3510-16-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2017-0280; FRL-9969-89-Region 5] Air Plan Approval; Wisconsin; 2017 Revisions to NR 400 and 406 AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking direct final action to approve a revision to the Wisconsin State Implementation Plan (SIP) submitted by the Wisconsin Department of Natural Resources (WDNR) to EPA on May 16, 2017. The revision replaces the definition of “emergency electric generator” with a broader definition of “restricted internal combustion engine”. In addition, the revision makes amendments to procedures for revoking construction permits as well as language changes and other administrative updates. Lastly, WDNR is removing from the SIP two Wisconsin Administrative Code provisions that affect eligibility of coverage under general and construction permits.

    DATES:

    This direct final rule will be effective January 8, 2018, unless EPA receives adverse comments by December 7, 2017. If adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the Federal Register informing the public that the rule will not take effect.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R05-OAR-2017-0280 at http://www.regulations.gov or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the official comment (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Radhica Kanniganti, Environmental Engineer, Air Permits Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-8097, [email protected]

    SUPPLEMENTARY INFORMATION:

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

    I. Review of State Submittals II. What action is EPA taking? III. Incorporation by Reference IV. Statutory and Executive Order Reviews I. Review of State Submittals

    This final rulemaking addresses the May 16, 2017, WDNR submittal for SIP revision, revising the rules in the Wisconsin SIP to align them with Federal requirements. WDNR's submittal includes changes to the term “electric generator”, replacing it with “restricted internal combustion engine” as well as other minor language and administrative changes. Specifically, NR 400.02(136m) replaces the existing definition of emergency “electric generator” with a broader definition of “restricted internal combustion engine” and NR 406.04(1)(w) amends the exemption language for “emergency electric generators”, replacing it with exemption for “restricted use reciprocating internal combustion engines”. NR 406.08(1) and NR 406.10 involve minor changes to language, and NR 406.11(1) amends procedures for revoking construction permits. These changes serve the purpose of aligning the state and Federal regulations and are consistent with the Federal program. WDNR is also requesting the removal of two provisions from the SIP. NR 406.16(2)(d) and NR 406.17(3)(e) affect the eligibility of coverage under general and registration construction permits based on whether the project constituted a Type 2 action under the previous ch. NR 150. However, the current ch. NR 150 was amended and no longer defines or sets requirements for Type 2 actions. Removing these provisions from Wisconsin's SIP ensures consistency with Wisconsin Environmental Protection Act (WEPA) laws and does not affect consistency with the CAA. It is also consistent with Section 110(l) of the CAA. Sources covered under registration and general permits are still subject to all emission caps and applicable requirements set out in those permits.

    II. What action is EPA taking?

    EPA is approving revisions to Wisconsin's rules NR 400 and NR 406. EPA finds WDNR's submittal to be consistent with the CAA and applicable Federal requirements. WDNR's May 16, 2017, submittal requests that EPA approve the following rules into Wisconsin's SIP: (1) NR 400.02(136m), NR 406.04(1)(w), NR 406.08(1), NR 406.10 and NR 406.11(1). The submittal also requests removal of NR 406.16(2)(d) and NR 406.17(3)(e) from the SIP.

    We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the state plan if relevant adverse written comments are filed. This rule will be effective January 8, 2018 without further notice unless we receive relevant adverse written comments by December 7, 2017. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. If we do not receive any comments, this action will be effective January 8, 2018.

    III. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Wisconsin Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov, and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

    IV. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

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

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

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

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 8, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements.

    Dated: October 6, 2017. Robert A. Kaplan, Acting Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    2. Section 52.2570 is amended by revising paragraph (c)(113)(i)(D) and by adding paragraph (c)(137) to read as follows:
    § 52.2570 Identification of plan.

    (c) * * *

    (113) * * *

    (i) * * *

    (D) NR 400.02(73m) and (131m), 406.02(1) and (2), 406.04(2m), NR 406.11(1)(g)(1), 406.11(3), 406.16, 406.17, 406.18, 407.02(3m), 407.105, 407.107, 407.14 Note, 407.14(4)(c), 407.15(8)(a) and 410.03(1)(a)(6) and (7) as created and published in the (Wisconsin) Register, August 2005, No. 596, effective September 1, 2005. Sections NR 406.16(2)(d) and NR 406.17(3)(e) were repealed in 2015 and are removed without replacement; see paragraph (c)(137) of this section.

    (137) On May 16, 2017, the Wisconsin Department of Natural Resources submitted a request to revise Wisconsin's air permitting rules NR 400.02(136m), NR 406.04(1)(w), NR 406.08(1), NR 406.10 and NR 406.11(1). These revisions replace the existing definition of “emergency electric generator” with a broader definition of “restricted internal combustion engine”, amend procedures for revoking construction permits and include minor language changes and other administrative updates to ensure consistency with State and Federal regulations. Wisconsin has also requested to remove from the SIP NR 406.16(2)(d) and NR 406.17(3)(e), provisions affecting eligibility of coverage under general and registration construction permits, previously approved in paragraph (c)(113) of this section. This action ensures consistency with Wisconsin Environmental Protection Act (WEPA) laws.

    (i) Incorporation by reference.

    (A) Wisconsin Administrative Code, NR 400.02(136m) as published in the Wisconsin Administrative Register November 2015 No. 719A1, effective December 1, 2015.

    (B) Wisconsin Administrative Code, NR 406.04(1)(w), NR 406.08(1), NR 406.10 and NR 406.11(1) as published in the Wisconsin Administrative Register November 2015 No. 719A1, effective December 1, 2015.

    (ii) [Reserved]

    [FR Doc. 2017-23048 Filed 11-6-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 140722613-4908-02] RIN 0648-XF765 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coastal Migratory Pelagic Resources of the Gulf of Mexico and Atlantic Region; Commercial Closure for Spanish Mackerel AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS implements an accountability measure (AM) for commercial Spanish mackerel in the northern zone of the Atlantic exclusive economic zone (EEZ) through this temporary rule. NMFS has determined that the revised commercial quota for Spanish mackerel in the northern zone of the Atlantic EEZ will be reached by November 7, 2017. Therefore, NMFS closes the northern zone of the Atlantic EEZ to commercial harvest of Spanish mackerel on November 7, 2017. This closure is necessary to protect the Spanish mackerel resource in the Atlantic.

    DATES:

    The closure is effective at 12:01 a.m., local time, November 7, 2017, until 12:01 a.m., local time, March 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Mary Vara, NMFS Southeast Regional Office, telephone: 727-824-5305, or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The fishery for coastal migratory pelagic fish includes king mackerel, Spanish mackerel, and cobia, and is managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and Atlantic Region (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. All weights described for Spanish mackerel in the Atlantic EEZ apply as either round or gutted weight.

    On November 20, 2014, NMFS published a final rule in the Federal Register to implement Framework Amendment 1 to the FMP (79 FR 69058). That final rule implemented a commercial annual catch limit (equal to the commercial quota) of 3.33 million lb (1.51 million kg) for the Atlantic migratory group of Spanish mackerel (Atlantic Spanish mackerel). Atlantic Spanish mackerel are divided into northern and southern zones for management purposes. The northern zone commercial quota for Atlantic Spanish mackerel is 662,670 lb (300,582 kg) for the current fishing year, March 1, 2017, through February 28, 2018 (50 CFR 622.384(c)(2)(i)).

    Regulations at 50 CFR 622.384(c)(2)(iii) allow for quota transfers between the northern and southern zones with the approval from the Regional Administrator (RA) of the NMFS Southeast Region. North Carolina or Florida, in consultation with the other states in the respective zones, may request approval from the RA to transfer part or all of a respective zone's annual commercial quota to the other zone. For the purposes of quota closures as described in 50 CFR 622.8, the receiving zone's quota will be the original quota plus any transferred amount, for that fishing year only. Landings associated with any transferred quota will be included in the total landings for the Atlantic migratory group, which will be evaluated relative to the total ACL.

    In a letter dated October 30, 2017, the State of Florida requested the transfer of 100,000 lb (45,359 kg) of Atlantic Spanish mackerel commercial quota from the southern zone to the northern zone to allow the commercial quota for both zones to be fully harvested. NMFS approved the transfer of commercial quota, and therefore, the revised northern zone commercial quota for Spanish mackerel is 762,670 lb (345,941 kg) and the revised southern zone commercial quota is 2,567,330 lb (1,164,521 kg) in the current fishing year, March 1, 2017, through February 28, 2018.

    The northern zone for Atlantic Spanish mackerel extends in Federal waters off New York, New Jersey, Delaware, Maryland, Virginia, and North Carolina. The northern boundary of the northern zone extends from an intersection point off New York, Connecticut, and Rhode Island at 41°18′16.249″ N. lat., 71°54′28.477″ W. long. and proceeds southeast to 37°22′32.75″ N. lat. and the intersection point with the outward boundary of the EEZ. The southern boundary of the northern zone extends from the North Carolina and South Carolina state border, along a line extending in a direction of 135°34′55″ from true north beginning at 33°51′07.9″ N. lat., 78°32′32.6″ W. long. to the intersection point with the outward boundary of the EEZ.

    Regulations at 50 CFR 622.388(d)(1)(i) require NMFS to close the commercial sector for Atlantic Spanish mackerel in the northern zone when the commercial quota is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined the revised commercial quota of 762,670 lb (345,941 kg) for Atlantic Spanish mackerel in the northern zone will be reached by November 7, 2017. Accordingly, the commercial sector for Atlantic Spanish mackerel in the northern zone is closed effective at 12:01 a.m., local time, November 7, 2017, through February 28, 2018, the end of the current fishing year.

    During the commercial closure, a person on board a vessel that has been issued a valid Federal permit to harvest Atlantic Spanish mackerel may continue to retain this species in the northern zone under the recreational bag and possession limits specified in 50 CFR 622.382(a)(1)(iii) and (a)(2), as long as the recreational sector for Atlantic Spanish mackerel is open (50 CFR 622.384(e)(1)).

    Also during the closure, Atlantic Spanish mackerel from the closed zone, including those harvested under the bag and possession limits, may not be purchased or sold. This prohibition does not apply to Atlantic Spanish mackerel from the closed zone that were harvested, landed ashore, and sold prior to the closure and were held in cold storage by a dealer or processor (50 CFR 622.384(e)(2)).

    Classification

    The RA for the NMFS Southeast Region has determined this temporary rule is necessary for the conservation and management of Atlantic Spanish mackerel and is consistent with the Magnuson-Stevens Act and other applicable laws.

    This action is taken under 50 CFR 622.8, 622.384(e), and 622.388(d)(1)(i) and is exempt from review under Executive Order 12866.

    These measures are exempt from the procedures of the Regulatory Flexibility Act, because the temporary rule is issued without opportunity for prior notice and opportunity for comment.

    This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA) finds good cause to waive the requirements 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 procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the commercial quota and the associated AM has already been subject to notice and public comment, and all that remains is to notify the public of the closure. Additionally, allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action to protect the Atlantic Spanish mackerel stock, because the capacity of the fishing fleet allows for rapid harvest of the commercial quota. Prior notice and opportunity for public comment would require time and could potentially result in a harvest well in excess of the established commercial quota.

    For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in effectiveness of this action under 5 U.S.C. 553(d)(3).

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: November 2, 2017. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-24220 Filed 11-2-17; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 170717675-7999-02] RIN 0648-XF571 Fisheries of the Northeastern United States; Golden Tilefish Fishery; 2018 and Projected 2019-2020 Specifications AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    NMFS issues final specifications for the 2018 commercial golden tilefish fishery and projected specifications for 2019 and 2020. This action establishes allowable harvest levels and other management measures to prevent overfishing while allowing optimum yield, consistent with the Magnuson-Stevens Fishery Conservation and Management Act and the Tilefish Fishery Management Plan. It is also intended to inform the public of these specifications for the 2018 fishing year and projected specifications for 2019-2020.

    DATES:

    Effective November 2, 2017 through October 31, 2018.

    ADDRESSES:

    Copies of these specifications, including the Environmental Assessment, Regulatory Flexibility Act Analyses, and other supporting documents for the action, are available upon request from Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 N. State Street, Dover, DE 19901. The specifications document is also accessible via the Internet at: http://www.greateratlantic.fisheries.noaa.gov.

    FOR FURTHER INFORMATION CONTACT:

    Cynthia Hanson, Fishery Management Specialist, (978) 281-9180.

    SUPPLEMENTARY INFORMATION:

    Background

    The golden tilefish fishery is managed by the Mid-Atlantic Fishery Management Council under the Tilefish Fishery Management Plan (FMP), which outlines the Council's process for establishing annual specifications. Regulations implementing the Tilefish FMP appear at 50 CFR part 648, subparts A and N, which require the Council to recommend acceptable biological catch (ABC), annual catch limit (ACL), annual catch target (ACT), total allowable landings (TAL), and other management measures, for up to three years at a time. On September 7, 2017, NMFS proposed 2018-2020 specifications for the golden tilefish fishery (82 FR 42266) based on Council recommendations, and accepted public comment through September 22, 2017. Additional background information regarding the development of these specifications was provided in the proposed rule and is not repeated here.

    Final Specifications

    This action implements the approved ABCs, catch limits, and quota limits for the commercial golden tilefish fishery for the 2018 fishing year (Table 1), and projects specifications for fishing years 2019 and 2020 (Table 2), as outlined in the proposed rule. By providing projected quotas for 2019 and 2020, NMFS hopes to assist fishery participants in planning ahead. The Council will review these specifications annually, and NMFS will provide notice prior to each fishing year to announce any necessary changes for 2019 and 2020. These specifications are approximately 14 percent lower than the 2017 ABC and overall commercial quota to ensure overfishing does not occur. For more information on the Council's recommendations and decisionmaking process, please see the proposed rule (82 FR 42266).

    As explained in the proposed rule, the Mid-Atlantic Council developed these specifications in parallel with Framework Adjustment 2 to the Tilefish FMP. Framework 2 would revise how assumed discards are deducted in the specifications setting process, and the Council developed these specifications based on that new method. However, implementation of Framework 2 was delayed, and a proposed rule to implement Framework 2 is pending. Because the revision to the specification process has not been finalized, this action implements the 2018 golden tilefish specifications based on current regulations. For clarity, we also provide details of how the 2018 specifications would be changed under the process proposed by Framework 2 (Table 1). If Framework 2 is implemented as proposed, the 2018 specifications would be adjusted accordingly during the fishing year. This would result in a slight decrease in the incidental TAL and a slight increase to the IFQ TAL and by extension to individual IFQ allocations. The proposed 2019 and 2020 specifications in Table 2 anticipate the implementation of Framework 2.

    Table 1—2018 Golden Tilefish Specifications as Implemented by This Action, and Potential Revisions Under Tilefish Framework Adjustment 2 As implemented million lb mt Under framework 2 million lb mt Overfishing Limit 2.332 1,058 2.332 1,058 ABC 1.636 742 1.636 742 ACL 1.636 742 1.636 742 IFQ ACT NA NA 1.554 705 Incidental ACT NA NA 0.082 37 TAL 1.627 738 NA NA IFQ TAL 1.546 701 1.554 705 Incidental TAL 0.081 37 0.072 33 Table 2—Proposed 2019 and 2020 Golden Tilefish Specifications 2019 million lb mt 2020 million lb mt Overfishing Limit 2.421 1,098 2.291 1,039 ABC 1.636 742 1.636 742 ACL 1.636 742 1.636 742 IFQ ACT 1.554 705 1.554 705 Incidental ACT 0.082 37 0.082 37 IFQ TAL 1.554 705 1.554 705 Incidental TAL 0.072 33 0.072 33

    As in previous years, no golden tilefish quota has been allocated for research set-aside. All other management measures in the golden tilefish fishery will remain unchanged for the 2018-2020 fishing years. The incidental trip limit will stay 500 lb (226.8 kg) (live weight), and the recreational catch limit will remain eight fish per-angler, per-trip. Annual IFQ allocations will be issued to individual quota shareholders in mid-October, before the November 1 start of the fishing year.

    Comments and Responses

    The public comment period for the proposed rule ended on September 22, 2017. Five comments were received from the public on this rule.

    Comment 1: Three commenters wrote in support of this action and the reduction in quotas. They mentioned the importance of preemptive measures to preserve fish populations and ecosystems from overfishing while maintaining sustainable fishing practices.

    Response 1: NMFS agrees. It is important to use the best available science to maintain healthy fish stocks and sustainable fishing practices. The Council's risk policy was applied to the most recent assessment outputs in the development of these specifications consistent with National Standard 2 and the Magnuson-Stevens Act. This resulted in a recommended reduction in quota even though golden tilefish are not currently overfished or experiencing overfishing.

    Comment 2: One commenter questioned the necessity of quota reductions when overfishing is not occurring, and requested more information about Tilefish Framework Adjustment 2.

    Response 2: As explained in the proposed rule and the response to Comment 1, catch limits and quotas are being reduced a result of the application of the Council's risk policy to the best available science to prevent overfishing from occurring in the golden tilefish fishery. The commenter is correct, the golden tilefish stock is not considered overfished or subject to overfishing; but this action is working to maintain that status into the future. Framework Adjustment 2 is currently in development through a separate rulemaking process, and does have more background information on the topics in question. The proposed rule is expected to publish in October; however, in the interim, more information can be found on the Council Web site at http://www.mafmc.org/tilefish/.

    Comment 3: The commenter recommended a more drastic cut in quotas and claimed widespread corruption and collusion between NMFS and the commercial fishing industry for unregulated profit.

    Response 3: The commenter presented no rationale or evidence supporting the claims. The most recent assessment determined that the golden tilefish stock is neither overfished, nor subject to overfishing. The Council's recommended quotas were set below the overfishing limit from the stock assessment in order to account for any scientific uncertainty. NMFS used the best scientific information available and is approving specifications for the golden tilefish fishery that are consistent with the FMP, all applicable legal requirements, and the recommendations of the Council.

    Changes From the Proposed Rule

    As explained above, the proposed rule anticipated the implementation of Framework 2 before these specifications were finalized. Because that has not happened, the specifications must be implemented under current regulations, but will be adjusted when Framework 2 is finalized near the end of December 2017.

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the Tilefish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.

    This final rule is exempt from review under Executive Order 12866 because this action contains no implementing regulations.

    This final rule does not duplicate, conflict, or overlap with any existing Federal rules.

    This action does not contain a collection of information requirement for purposes of the Paperwork Reduction Act.

    The Assistant Administrator for Fisheries, NOAA, finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness period for this rule, to ensure that the final specifications are in place as close to the start of the 2018 golden tilefish fishing year as possible, which began on November 1, 2017. A delay in effectiveness past the start of the 2018 fishing year would be contrary to the public interest, as it could create confusion, added burden, and potential economic harm to the commercial golden tilefish industry. If new specifications are not effective on that date, the regulations at § 648.292(a) state the current harvest quotas would automatically continue into the new fishing year. Therefore, NMFS would be required to issue initial IFQ permits using the 2017 quota amount, and then reissue those permits using the lower 2018 quota implemented by this rule after the start of the fishing year. Representatives of the commercial golden tilefish industry have been active participants in the Council's development of these specifications, and are anticipating the 2018 quota amount implemented by this action. Issuing two sets of IFQ allocations based on different quota amounts in a short period of time would cause unnecessary confusion and paperwork for the commercial golden tilefish industry. If IFQ shareholders fished or leased their initial allocation in the interim, they could be responsible for a quota overage once the new 2018 quotas became effective. Under the regulations, such an overage would need to be paid back in the following fishing year, which would decrease fishing opportunities in 2019.

    Because the Council did not submit these specifications recommendations and the accompanying environmental assessment until early July, NMFS was unable to prepare this action early enough to allow for both an appropriate public comment period and full delay in effectiveness period. As noted above, the commercial tilefish industry has been a participant in the Council's process of developing these specifications and is anticipating these measures. Therefore, there is good cause to implement these quota specifications on November 2, 2017.

    Final Regulatory Flexibility Analysis

    The final regulatory flexibility analysis (FRFA) included in this final rule was prepared pursuant to 5 U.S.C. 604(a), and incorporates the initial regulatory flexibility analysis (IRFA) and a summary of analyses completed to support the action. A public copy of the environmental assessment/IRFA is available from the Council (see ADDRESSES). The preamble to the proposed rule included a detailed summary of the analyses contained in the IRFA, and that discussion is not repeated here.

    A Summary of the Significant Issues Raised by the Public in Response to the IRFA, a Summary of the Agency's Assessment of Such Issues, and a Statement of Any Changes Made in the Final Rule as a Result of Such Comments

    The comments NMFS received did not raise specific issues regarding the economic analyses summarized in the IRFA. Refer to the “Comments and Responses” section of this preamble for more detail. No changes to the proposed rule were required to be made as a result of public comment.

    Description and Estimate of Number of Small Entities To Which the Rule Would Apply

    This final rule affects small entities engaged in commercial fishing operations with Federal golden tilefish permits. For the purposes of the regulatory flexibility analysis (RFA) analysis, the ownership entities (or firms), not the individual vessels, are considered to be the regulated entities. Because of this, some vessels with golden tilefish permits may be considered to be part of the same firm because they may have the same owners. In terms of RFA, a business primarily engaged in commercial fishing is classified as a small business if it has combined annual receipts not in excess of $11 million, for all its affiliated operations worldwide. The current ownership data set used for this analysis is based on calendar year 2016 (the most recent complete year available) and contains average gross sales associated with those permits for calendar years 2014 through 2016. According to the commercial ownership database, 148 affiliate firms landed golden tilefish during the 2014-2016 period, with 145 of those business affiliates categorized as small, and 3 as large businesses.

    Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements

    No additional reporting, recordkeeping, or other compliance requirements are included in this final rule.

    Description of the Steps the Agency Has Taken To Minimize the Significant Economic Impact on Small Entities Consistent With the Stated Objectives of Applicable Statutes

    Specification of commercial quota is constrained by the conservation objectives set forth in the FMP and implemented at 50 CFR part 648 under the authority of the Magnuson-Stevens Act. The 2018-2020 catch limits and quotas contained in this final rule are 14 percent lower than those currently in place for 2017. However, this is the result of the Council's risk policy, which requires a formulaic buffer between the OFL and ABC that, in turn, lowers the TAL and quotas. Therefore, these lower catch levels in 2018 and projected for 2019 and 2020 are consistent with the best available scientific information, the Council's tolerance for overfishing risk, and are intended to prevent overfishing from occurring.

    As described in the proposed rule for this action, two other alternatives to the approved these specifications were considered. The status quo specifications (Alternative 2) were not consistent with the Council's risk policy. Alternative 3 would have had a comparable quota decrease over the three years with the approved specifications (Alternative 1), but fluctuating quotas and catch limits year to year. This was not selected because it did not support the annual consistency of quota/landings that the tilefish industry considers important to maintaining price and supply stability in this fishery.

    All affected IFQ shareholders will receive decreases in their tilefish 2018 IFQ allocations in comparison to their respective tilefish 2017 IFQ allocations. However, the magnitude of the decrease varies depending on the shareholder's relative percentage of the total IFQ quota. Shareholders may also seek leases to offset individual quota decreases. NMFS does not anticipate this decrease will create a significant impact on the entities affected by this action.

    Small Entity Compliance Guide

    Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a letter to permit holders that also serves as small entity compliance guide was prepared and will be sent to all holders of Federal permits issued for the golden tilefish fishery. In addition, copies of this final rule and guide (i.e., permit holder letter) are available from NMFS (see ADDRESSES) and at the following Web site: www.greateratlantic.fisheries.noaa.gov.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: November 1, 2017. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
    [FR Doc. 2017-24135 Filed 11-2-17; 4:15 pm] BILLING CODE 3510-22-P
    82 214 Tuesday, November 7, 2017 Proposed Rules DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 340 [Docket No. APHIS-2015-0057] RIN 0579-AE15 Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Proposed rule; withdrawal.

    SUMMARY:

    We are withdrawing a proposed rule that would have revised our regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms. We are taking this action after considering the comments we received following the publication of the proposed rule.

    DATES:

    We are withdrawing the proposed rule published January 19, 2017 (82 FR 7008) as of November 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Sidney Abel, Assistant Deputy Administrator, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1238; (301) 851-3896.

    SUPPLEMENTARY INFORMATION:

    On January 19, 2017, we published in the Federal Register (82 FR 7008-7039, Docket No. APHIS-2015-0057) a proposal 1 to amend the regulations in 7 CFR part 340 regarding the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms.

    1 To view the proposed rule, supporting documents, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0057.

    We solicited comments concerning our proposal for 120 days ending May 19, 2017. We extended the deadline for comments until June 19, 2017, in a document published in the Federal Register on February 10, 2017 (Docket No. APHIS-2015-0057, 82 FR 10312-10313). We received 203 comments by that date. They were from GE developers, growers of GE crops, GE industry and agricultural trade associations, universities and academic researchers, organic producers and trade associations, consumer safety and environmental advocacy groups, a Federal agency, and private citizens.

    Many commenters objected to the scope of the proposed rule. Some thought that our criteria for designating GE organisms as regulated organisms were too expansive, potentially resulting in our regulating a wider range of GE organisms than necessary and thereby increasing, rather than reducing, the regulatory burden for the biotechnology industry. Other commenters, however, thought that certain exemptions and exclusions contained in the proposed rule would effectively narrow the scope of our regulatory authority over GE organisms and increase the risk of the unintended presence of GE crops in organic and other non-GE crops.

    The January 2017 proposed rule represented a major change from our existing “regulate first/analyze later” approach to one that entailed assessing new GE organisms to determine if they posed plant pest or noxious weed risks and then regulating only organisms that did present risks. Some commenters expressed concern that the proposed risk assessment process could prove lengthy, cumbersome, and confusing, thereby hindering innovation and preventing GE products from getting to market in a timely manner. Though we did provide exclusions that would have allowed GE organisms with certain plant/trait combinations to bypass the risk assessment process, these commenters viewed the exclusions as too narrow. Other commenters, however, took the opposite view. These commenters objected to our proposed exemption from the risk assessment process of products having plant/trait combinations corresponding to specific organisms that had been granted nonregulated status based on previous risk assessments. A number of these commenters also thought the proposed process as a whole would be insufficiently rigorous, with some objecting specifically to our proposal to no longer require the submission of field test data as part of the assessment process.

    Another issue that drew many comments was our proposal to incorporate our noxious weed authority into the biotechnology regulations in part 340. Noting that noxious weeds are also regulated under the Plant Protection and Quarantine regulations in 7 CFR part 360, commenters expressed concern that this proposal could result in the creation of two parallel but inconsistent regulatory systems and thus more regulatory uncertainty.

    Finally, many commenters expressed opposition to genetic engineering in general, as well as concerns about a wide range of issues, many of which were outside the scope of the proposed rule. For example, commenters stated that the Animal and Plant Health Inspection Service (APHIS) should consider non-safety-based risks, such as economic and social impacts, including impacts on the marketability of non-GE products. Other commenters requested that APHIS regulations include provisions related to the labeling of GE products and raised concerns regarding health effects of GE products and increased pesticide use.

    Based on the scope of comments received on the January 2017 proposed rule, we have decided to withdraw the rule and to begin a fresh stakeholder engagement aimed at exploring alternative policy approaches. Because of rules limiting ex parte communications with respect to active rulemakings, publication of the 2017 proposed rule has constrained our ability to talk about alternatives with stakeholders. Withdrawing the proposed rule will lift this constraint and provide for a more open and robust policy dialogue.

    Therefore, we are withdrawing the January 19, 2017, proposed rule referenced above. As we explore a full range of policy alternatives, we will consider the comments we received on the proposed rule, as well as new scientific knowledge, and continue to seek the active and open input of stakeholders.

    Authority:

    7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 1st day of November 2017. Michael C. Gregoire, Acting Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2017-24202 Filed 11-6-17; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-1059; Product Identifier 2017-CE-035-AD] RIN 2120-AA64 Airworthiness Directives; Piper Aircraft, Inc. Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Piper Aircraft, Inc. Models PA-28-140, PA-28-150, PA-28-160, PA-28-180, PA-28-235, PA-32-260, and PA-32-300 airplanes. This proposed AD was prompted by reports of corrosion found in an area of the main wing spar not easily accessible for inspection. This proposed AD would require installing an inspection access panel in the lower wing skin near the left and the right main wing spars if not already there, inspecting the left and the right main wing spars for corrosion, and taking all necessary corrective actions. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by December 22, 2017.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Piper Aircraft, Inc., 2926 Piper Drive, Vero Beach, Florida 32960; telephone: (772) 567-4361; Internet: www.piper.com. You may review this referenced service information at the FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1059 or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Dan McCully, Aerospace Engineer, FAA, Atlanta ACO Branch, 1701 Columbia Avenue, College Park, Georgia 30337; telephone: (404) 474-5548; fax: (404) 474-5606; email: [email protected].

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-1059; Product Identifier 2017-CE-035-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

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

    Discussion

    We received two reports of significant corrosion found on the main wing spars on certain Piper Aircraft, Inc. Models PA-28-140, PA-28-150, PA-28-160, PA-28-180, PA-28-235, PA-32-260, and PA-32-300 airplanes. The corrosion was found during maintenance in an area that is not easily accessible for inspection. This condition, if not detected and corrected, could cause the main wing spar to fail. This failure could result in loss of control.

    Related Service Information Under 1 CFR Part 51

    We reviewed Piper Aircraft, Inc. Service Bulletin No. 1304, dated August 23, 2017. The service bulletin describes procedures for installing an inspection access panel in the lower wing skin near the left and the right main wing spars, if not already there, inspect for corrosion, and, if corrosion is found, taking all necessary corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination

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

    Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified in the service information described previously.

    Costs of Compliance

    We estimate that this proposed AD affects 11,476 airplanes of U.S. registry.

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

    Estimated costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S. operators
    Main wing spar inspection 2 work-hours × $85 per hour = $170 to inspect both wings Not Applicable $170 $1,950,920
    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Install inspection access panel in the lower wing skin near the left and the right main wing spars 6 work-hours × $85 per hour = $510 to install the inspection access panel on both wings $175 for the kit that contains provisions for installing inspections access panels on both wings $685

    The scope of damage found in the required inspection could vary significantly from airplane to airplane. We have no way of determining how much damage may be found on each airplane or the cost to repair damaged parts on each airplane or the number of airplanes that may require repair.

    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Piper Aircraft, Inc.: Docket No. FAA-2017-1059; Product Identifier 2017-CE-035-AD. (a) Comments Due Date

    We must receive comments by December 22, 2017.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to the following Piper Aircraft, Inc. model airplanes that are certificated in any category:

    Table 1 to Paragraph (c) of This AD—Affected Models and Serial Numbers Model Serial Nos. PA-28-140 28-20001 through 28-26946, and 28-7125001 through 28-7725290. PA-28-150 and PA-28-160 28-1 through 28-4377, and 28-1760A. PA-28-180 28-671 through 28-5859, 28-7105001 through 28-7205318, and 28-7305001 through 28-7505261. PA-28-235 28-10001 through 28-11378, 28-7110001 through 28-7710089, and 28E-11. PA-32-260 32-04, 32-1 through 32-1297, and 32-7100001 through 32-7800008. PA-32-300 32-15, 32-21, 32-40000 through 32-40974, and 32-7140001 through 32-7840222. (d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 5711, Wing Spar.

    (e) Unsafe Condition

    This AD was prompted by reports of corrosion found in an area of the main wing spar not easily accessible for inspection. We are issuing this AD to detect and correct corrosion in the wing root area of the left and the right main wing spars. The unsafe condition, if not detected and corrected, could cause the main wing spar to fail, which could result in loss of control.

    (f) Compliance

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

    (g) Determine if Inspection Access Panels Are Already Present

    Within the next 100 hours time-in-service (TIS) after the effective date of this AD or within the next 12 months after the effective date of this AD, whichever occurs first, inspect the lower wing skin near the main wing spar on both wings for the presence of an inspection access panel using Part I of the Instructions section of Piper Aircraft, Inc. (Piper) Service Bulletin (SB) No. 1304, dated August 23, 2017.

    (h) Install Inspection Access Panels

    If it is determined that no inspection access panels are present during the inspection required in paragraph (g) of this AD, within the next 100 hours TIS after the effective date of this AD or within the next 12 months after the effective date of this AD, whichever occurs first install inspection access panels on the lower skin of the left wing and the right wing using Piper SB No. 1304, dated August 23, 2017.

    (i) Inspect for Corrosion

    Within the next 100 hours TIS after the effective date of this AD or within the next 12 months after the effective date of this AD, whichever occurs first, inspect the left and the right main wing spar for any evidence of corrosion using Part I of the Instructions section of Piper SB No. 1304, dated August 23, 2017.

    (j) Corrective Actions

    Before further flight after the inspection required in paragraph (i) of this AD, if evidence of corrosion is found, take all necessary corrective actions to remove the corrosion using Part I of the Instructions section of Piper SB No. 1304, dated August 23, 2017, and/or make all necessary repairs using Part II of the Instructions section of Piper SB No. 1304, dated August 23, 2017.

    (k) Alternative Methods of Compliance (AMOCs)

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

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

    (3) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (g) through (j) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

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

    (l) Related Information

    (1) For more information about this AD, contact Dan McCully, Aerospace Engineer, FAA, Atlanta ACO Branch, 1701 Columbia Avenue, College Park, Georgia 30337; telephone: (404) 474-5548; fax: (404) 474-5606; email: [email protected].

    (2) For service information identified in this AD, contact Piper Aircraft, Inc., 2926 Piper Drive, Vero Beach, Florida 32960; telephone: (772) 567-4361; Internet: www.piper.com. You may review this referenced service information at the FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    Issued in Kansas City, Missouri, on October 30, 2017. Melvin J. Johnson, Acting Deputy Director, Policy & Innovation Division, Aircraft Certification Service.
    [FR Doc. 2017-24083 Filed 11-6-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 880 [Docket No. FDA-2017-N-6216] General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed order.

    SUMMARY:

    The Food and Drug Administration (FDA) is issuing this proposed order to reclassify the needle destruction device, renaming the device to “sharps needle destruction device,” a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. If finalized, this order will reclassify these types of devices from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.

    DATES:

    Submit either electronic or written comments on the proposed order by January 8, 2018. Please see section XI of this document for the proposed effective date when the new requirements apply and for the proposed effective date of a final order based on this proposed order.

    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 January 8, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 8, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal Rulemaking 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-6216 for “General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device.” 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:

    Christopher K. Dugard, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2561, Silver Spring, MD 20993, 240-402-6031, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background—Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

    Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f)(1) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807.

    A postamendments device that has been initially classified in class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or class II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) of the FD&C Act provides that FDA acting by order can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.

    Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of newly available regulatory authority (see Bell v. Goddard, 366 F.2d 177, 181 (7th Cir. 1966); Ethicon, Inc. v. FDA, 762 F. Supp. 382, 388-391 (D.D.C. 1991)) or in light of changes in “medical science” (Upjohn v. Finch, 422 F.2d 944, 951 (6th Cir. 1970)). Whether data before the Agency are old or new, the “new information” to support reclassification under 513(f)(3) must be “valid scientific evidence”, as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.1985), cert. denied, 474 U.S. 1062 (1986)).

    FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)). Section 520(h)(4) of the FD&C Act provides that FDA may use, for reclassification of a device, certain information in a PMA 6 years after the application has been approved. This includes information from clinical and preclinical tests or studies that demonstrate the safety or effectiveness of the device, but does not include descriptions of methods of manufacture or product composition and other trade secrets.

    Section 510(m) of the FD&C Act provides that a class II device may be exempted from the 510(k) premarket notification requirements, if the Agency determines that premarket notification is not necessary to reasonably assure the safety and effectiveness of the device.

    II. Regulatory History of the Devices

    On February 3, 1994, FDA issued a Memorandum to manufacturers and initial distributors of sharps containers and destroyers used by health care manufacturers to clarify the regulatory status of sharps destroyer devices (Ref. 1).

    On March 6, 1997, FDA approved its first needle destruction device through its PMA process under section 515 of the FD&C Act (21 U.S.C. 360e). In the June 11, 1997, Federal Register notice (62 FR 31831), FDA announced a PMA approval order for Millenium Medical Supply's Incorporated Needle-EaseTM 25011 device and the availability of the Summary of Safety and Effectiveness Data for the Device (SSED) (Ref. 2). As of the date of issuance of this proposed order, FDA has approved 18 original PMAs for this device type.2

    1 FDA approved a modified needle destruction device on February 11, 1998. The device, as modified, is marketed under the trade name Needle-Ease®3500.

    2 See PMA database for original PMAs regulated under the product code MTV: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm.

    On March 2, 2001, FDA finalized guidance entitled, “Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices,” describing the Agency's recommendations for information to include in PMA applications for sharps needle destruction devices intended for use in health care settings (Ref. 3).

    III. Device Description

    A sharps needle destruction device is a postamendments device classified into class III under section 513(f)(1) of the FD&C Act. A sharps needle destruction device is a prescription device intended for home use or in professional health care facilities to destroy sharps or needles used for medical purposes by incineration or mechanical means. Sharps needle destruction devices are typically electrical devices that can destruct sharps and/or needles in a variety of methods (grinding, incinerating, etc.) that can be either portable or stationary. Some of these devices may also employ software to provide the user with greater control. Please note these devices were originally identified as needle destruction devices (product code MTV) in FDA SSEDs and product code database; however, FDA believes the identification of sharps needle destruction device more accurately describes this device type as it can be used to destroy devices other than needles (e.g., sharps).

    IV. Proposed Reclassification

    As part of the Center for Devices and Radiological Health's 2014-2015 strategic priority “Strike the Right Balance Between Premarket and Postmarket Data Collection,” a retrospective review of class III devices subject to PMA was completed to determine whether or not, based on our current understanding of the technology, reclassification may be appropriate. On August 8, 2016, FDA published a document in the Federal Register entitled “Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection” in which FDA announced plans to reclassify sharps needle destruction devices identified with the MTV product code from class III to class II (81 FR 52445). FDA has found that sufficient information exists to establish special controls that, together with general controls, can provide a reasonable assurance of safety and effectiveness for sharps needle destruction devices.

    In accordance with section 513(f)(3) of the FD&C Act and 21 CFR part 860, subpart C, FDA is proposing to reclassify this postamendments class III device into class II. FDA believes that there is sufficient information available to FDA through FDA's accumulated experience with these devices from review submissions, peer-reviewed literature, and knowledge of similar devices to establish special controls that effectively mitigate the risks to health identified in section V. Absent the special controls identified in this proposed order, general controls applicable to the device are insufficient to provide reasonable assurance of the safety and effectiveness of the device.

    FDA is proposing to create a separate classification regulation for sharps needle destruction devices that will be reclassified from class III to II. Under this proposed order, if finalized, the sharps needle destruction devices will be identified as a prescription device. As such, the prescription device must satisfy prescription labeling requirements (see § 801.109 (21 CFR 801.109), Prescription devices). 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 § 801.5 (21 CFR 801.5), as long as the conditions of § 801.109 are met. In this proposed order, if finalized, the Agency has identified the special controls under section 513(a)(1)(B) of the FD&C Act that, together with general controls, will provide a reasonable assurance of the safety and effectiveness for sharps needle destruction devices.

    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) of the FD&C Act 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 for sharps needle destruction devices to provide reasonable assurance of the safety and effectiveness. Therefore, the Agency does not intend to exempt these proposed class II devices from 510(k) requirements. Persons who intend to market this type of device must submit to FDA a 510(k) and receive clearance prior to marketing the device.

    V. Risks to Health

    After considering the information available to FDA through review submissions, peer-reviewed literature, and knowledge of similar devices, FDA determined the probable risks to health associated with the use of sharps needle destruction devices are as follows:

    Patient/user exposure to environmental contaminants. Destroying a used sharp or needle may generate hazardous emissions from the device that may result in infection or respiratory problems for the patient and/or user. Contamination of the patient environment can occur through emission of toxic fumes or infectious aerosol when the device destroys a sharp by incineration or mechanical means, and may result from device malfunction (mechanical and/or software). The device may also become contaminated through regular usage and may cause cross-contamination.

    Patient/user burns as a result of excessive heat discharge or spark formation. Excessive heat or sparks may be generated and discharged from the device during destruction of sharps that may burn the user.

    Electromagnetic interference. While in operation, the device may interfere with other electrically powered devices, causing them to malfunction.

    Electrical shock. While in operation, the device may discharge electricity that could shock the user.

    Sharps injury. Incompletely destroyed sharps, physical device instability, device malfunctions, or use error may pose a risk for a sharps injury to the user.

    VI. Summary of Reasons for Reclassification

    FDA believes that the sharps needle destruction devices intended for home use or in professional health care facilities to reduce the incidence of needlesticks by destroying sharps and/or needles in a variety of methods (grinding, incinerating, etc.) should be reclassified from class III to class II in light of new information about the effectiveness of these devices. There is sufficient information to establish special controls for sharps needle destruction devices, in addition to general controls, which can provide reasonable assurance of safety and effectiveness of the device, as general controls themselves are insufficient to provide reasonable assurance of its safety and effectiveness. FDA believes that the risks to health associated with sharps needle destruction devices intended for home use or in professional health care facilities to reduce the incidence of needlesticks can be mitigated with special controls and that these mitigations will provide a reasonable assurance of its safety and effectiveness.

    Based on a reconsideration of the available information and data, FDA believes that there is valid scientific evidence of effectiveness for sharps needle destruction devices to reduce the incidence of needlesticks.

    VII. Summary of Data Upon Which the Reclassification Is Based

    FDA believes that the identified special controls, in addition to general controls, are necessary to provide reasonable assurance of safety and effectiveness of these devices. Taking into account the probable health benefits of the use of the device and the nature and known incidence of the risks of the device, FDA, on its own initiative, is proposing to reclassify this postamendments class III device into class II. FDA has considered and analyzed the following information: An inclusive search of the Agency's Manufacturer and User Facility Device Experience (MAUDE) database, which shows no adverse events for sharps needle destruction devices; data contained in PMAs approved 6 or more years before the date of this proposal (reviewed under section 520(h)(4) of the FD&C Act, also known as the 6-year rule); a review of sharps containers regulated under 21 CFR 880.5570, which have similar intended uses, but different technology, and are currently regulated as class II devices; and one relevant article found from a literature search that discussed the benefits and the probable risks of these devices (Ref. 4).

    VIII. Proposed Special Controls

    FDA believes that the following special controls, together with general controls, are sufficient to mitigate the risks to health described in section V and provide a reasonable assurance of safety and effectiveness for sharps needle destruction devices.

    • Performance testing will demonstrate:

    ○ The device's ability to contain or ventilate aerosols or fumes from device operation that may result in environmental contamination and cross-contamination. Performance testing will demonstrate that harmful fumes, such as ozone, are not emitted by the device during destruction of sharps needles.

    ○ Excessive heat or sparks are not generated during device operation that may injure users or patients through characterization of the heat dissipation profile from the heat source to the enclosure surface, and the point of contact between the held syringe and the user. Performance testing will ensure the heat generated through normal operation of the device will not harm users or patients or affect circuit performance and useful life of the device.

    ○ Complete destruction of sharps intended to be destructed to mitigate user injuries from incomplete sharps destruction by conducting performance testing such as simulated use demonstrating complete destruction of the sharps and/or needles intended to be destroyed.

    ○ Mitigation of injuries from device instability through characterization of the vibrations and movement generated by the device to ensure device stability in the use environment.

    • Validation of cleaning and disinfection instructions to demonstrate that the device can be safely and effectively reprocessed after use to minimize the risk of patient/user cross-contamination.

    • Performance testing ensures electromagnetic compatibility with other devices under conditions which are consistent with the intended environment of device use.

    • Electrical safety testing ensures the risk of shock to the patient/user is minimized.

    • Software hazard analysis, as well as software verification and validation, ensures that software performs as intended and potential software malfunctions do not impact the performance of the device.

    • Labeling to ensure proper use of the device, including warnings of the generation of excessive heat, potential for needle stick injuries, instructions for reprocessing, and instructions for installation (e.g., on a stable surface, adequate ventilation).

    Table 1 shows how FDA believes these special controls will mitigate each risk to health described in section V.

    Table 1—Risks to Health and Mitigation Measures for Sharps Needle Destruction Devices Identified risk to health Mitigation measures Patient/user exposure to environmental contaminants Performance testing.
  • Reprocessing validation.
  • Software verification, validation, and hazard analysis.
  • Labeling.
  • Patient/user burns Performance testing.
  • Labeling.
  • Electrical shock Electrical Safety Testing.
  • Labeling.
  • Electromagnetic interference Electromagnetic Compatibility (EMC) Testing.
  • Labeling.
  • Sharps injury Performance testing.
  • Software verification, validation, and hazard analysis.
  • Labeling.
  • In addition, FDA is proposing to limit these devices to prescription use under § 801.109. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act and § 801.5, as long as the conditions of § 801.109 are met (referring to 21 U.S.C. 352(f)(1)). Under 21 CFR 807.81, the device would continue to be subject to 510(k) notification requirements. FDA does not believe that clinical data is necessary to mitigate the identified risks to health for sharps needle destruction devices. FDA may request clinical data to evaluate substantial equivalence when a manufacturer includes new indications for use, such as indications for disease prevention or organism destruction.

    This reclassification order and the identified special controls, if finalized, would provide sufficient detail regarding FDA's requirements to reasonably assure safety and effectiveness of sharps needle destruction devices. FDA intends to withdraw the final guidance entitled, “Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA” issued in 2001 upon finalization of this proposed reclassification order (Ref. 3).

    IX. 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.

    X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed order contains no new collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520) is not required. This proposed order refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. 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 under 21 CFR part 801 have been approved under OMB control number 0910-0485.

    XI. Proposed Effective Date

    FDA proposes that any final order based on this proposal become effective 30 days after the date of its publication in the Federal Register.

    XII. References

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

    1. FDA memorandum “To Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care Professionals,” February 3, 1994, available at: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070679.pdf.

    2. FDA “Premarket Approval of Millenium Medical Supply Incorporated Needle-EaseTM 2501-ACTION,” March 6, 1997, available at: https://www.accessdata.fda.gov/cdrh_docs/pdf/p960044.pdf.

    3. “Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA,” March 2, 2001, available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073601.pdf.

    4. Tamplin S.A., D. Davidson, B. Powis, and Z. O'Leary, “Issues and Options for the Safe Destruction and Disposal of Used Injection Materials,” Waste Management, vol. 25, pp. 655-665, 2005.

    List of Subjects in 21 CFR Part 880

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq., as amended) and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 880 be amended as follows:

    PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES 1. The authority citation for part 880 continues to read as follows: Authority:

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

    2. Add § 880.6210 to subpart G to read as follows:
    § 880.6210 Sharps needle destruction device.

    (a) Identification. A sharps needle destruction device is a prescription device that is intended to destroy needles or sharps used for medical purposes by incineration or mechanical means.

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

    (1) Performance testing must demonstrate the following during operation of the device:

    (i) The device safely contains or ventilates aerosols or fumes from device operation.

    (ii) Excessive heat or sparks are not generated that may injure users or patients.

    (iii) Simulated use testing must demonstrate sharps and/or needles are completely destroyed using a range of types and sizes of sharps sufficient to represent actual use.

    (iv) Simulated use testing must demonstrate that the device is physically stable on the surface for which it is intended to be mounted to ensure the risk of harm to the patient/user as a result of the device falling is minimized.

    (2) Validation of cleaning and disinfection instructions must demonstrate that the device can be safely and effectively reprocessed after use per the recommended cleaning and disinfection protocol in the instructions for use.

    (3) Analysis and/or testing must validate electromagnetic compatibility (EMC) and electrical safety, including the safety of any battery used in the device, under conditions which are consistent with the intended environment of device use.

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

    (5) Labeling must include:

    (i) A clear description of the device and its technological features;

    (ii) How the device is to be used, including validated cleaning and disinfection instructions;

    (iii) Relevant precautions and warnings based on performance and in-use testing to ensure proper use of the device; and

    (iv) Instructions to install device in adequately ventilated area and stable area.

    Dated: November 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-24191 Filed 11-6-17; 8:45 am] BILLING CODE 4164-01-P
    LIBRARY OF CONGRESS Copyright Royalty Board 37 CFR Part 381 [Docket No. 16-CRB-0002-PBR (2018-2022)] Determination of Rates and Terms for Public Broadcasting (PB III) AGENCY:

    Copyright Royalty Board (CRB), Library of Congress.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Copyright Royalty Judges solicit comments on proposed rates and terms for use of certain works in connection with noncommercial broadcasting for the period commencing January 1, 2018, and ending on December 31, 2022.

    DATES:

    Comments and objections, if any, are due on or before November 27, 2017.

    ADDRESSES:

    You may submit comments and objections, identified by docket number 16-CRB-0002-PBR (2018-2022), by any of the following methods:

    CRB's electronic filing application: Submit comments online in eCRB at https://app.crb.gov/.

    U.S. mail: Copyright Royalty Board, P.O. Box 70977, Washington, DC 20024-0977; or

    Overnight service (only USPS Express Mail is acceptable): Copyright Royalty Board, P.O. Box 70977, Washington, DC 20024-0977; or

    Commercial courier: Address package to: Copyright Royalty Board, Library of Congress, James Madison Memorial Building, LM-403, 101 Independence Avenue SE., Washington, DC 20559-6000. Deliver to: Congressional Courier Acceptance Site, 2nd Street NE. and D Street NE., Washington, DC; or

    Hand delivery: Library of Congress, James Madison Memorial Building, LM-401, 101 Independence Avenue SE., Washington, DC 20559-6000.

    Instructions: Unless submitting online, commenters must submit an original, five paper copies, and an electronic version on a CD. All submissions must include the CRB's name and docket number. All submissions will be posted without change to eCRB on https://www.crb.gov including any personal information provided.

    Docket: For access to the docket to read background documents or comments received, go to eCRB, the Copyright Royalty Board's electronic filing and case management system, at https://app.crb.gov/ and search for docket number 16-CRB-0002-PBR (2018-2022). For documents not yet uploaded to eCRB (because it is a new system), go to the agency Web site at https://www.crb.gov/ or contact the CRB Program Specialist.

    FOR FURTHER INFORMATION CONTACT:

    Anita Blaine, CRB Program Specialist, by telephone at (202) 707-7658 or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    Section 118 of the Copyright Act, title 17 of the United States Code, establishes a statutory license for the use of certain copyrighted works in connection with noncommercial television and radio broadcasting. Chapter 8 of the Copyright Act requires the Copyright Royalty Judges (“Judges”) to conduct proceedings every five years to determine the rates and terms for the section 118 license. 17 U.S.C. 801(b)(1), 804(b)(6). In accordance with section 804(b)(6), the Judges commenced the proceeding to set rates and terms for the period 2018-2022 on January 5, 2016. 77 FR 71104.

    In the Federal Register notice, the Judges requested interested parties to submit petitions to participate. 81 FR 256 (January 5, 2016). Petitions to Participate (“PTP”s) were received from: The American Society of Authors, Composers and Publishers (“ASCAP”); SESAC, Inc.; Broadcast Music, Inc. (“BMI”); Educational Media Foundation (“EMF”); National Public Radio (“NPR”) and the Public Broadcasting Service (“PBS”), jointly; National Religious Broadcasters Noncommercial Music License Committee (“NRBNMLC”); the Church Music Publishers' Association (“CMPA”); 1 the National Music Publishers' Association (“NMPA”), The Harry Fox Agency (“HFA”), National Association of College and University Business Officers (“NACUBO”), and David Powell.2

    1 CMPA's PTP was filed late with permission of the Judges. See Order Granting Church Music Publishers' Motion to Accept Late Petition to Participate (May 6, 2016). The Judges received no written direct statement from and no notice of settlement from or regarding CMPA.

    2 Mr. Powell's Petition to Participate was dismissed on August 16, 2016. Order Dismissing Petition to Participate of David Powell.

    The Judges set the timetable for the three-month negotiation period, see 17 U.S.C. 803(b)(3), and directed the participants to submit written direct statements no later than November 7, 2016. Notice of Participants, Commencement of Voluntary Negotiation Period, and Case Scheduling Order (Mar. 25, 2016). The Judges amended the case schedule twice to accommodate ongoing negotiations. See Order for Further Proceedings and Modified Case Schedule (Aug. 12, 2016). In July and September 2016, several participants filed notices of settlement and proposed rates and terms for adoption. No participant filed a written direct statement. See Order Requiring Submission of Proposed Regulations by National Public Radio and Public Broadcasting System at 1 (Oct. 19, 2017).

    There are two ways copyright owners and public broadcasting entities 3 may negotiate rates and terms under the section 118 statutory license. First, copyright owners may negotiate rates and terms with specific public broadcasting entities for the use of all of the copyright owners' works covered by the license. Section 118(b)(2) provides that such license agreements “shall be given effect in lieu of any determination by the * * * Copyright Royalty Judges,” provided that copies of the agreement are submitted to the Judges “within 30 days of execution.” 17 U.S.C. 118(b)(2). The Judges received one agreement in this category for which no further action is required.4

    3 A “public broadcasting entity” is defined as a “noncommercial educational broadcast station as defined in section 397 of title 47 and any nonprofit institution or organization engaged in the activities described in paragraph (2) of subsection (c)” of section 118. 17 U.S.C. 118(f).

    4 The Judges received an agreement from BMI on October 24, 2017. They anticipate receiving two others (from ASCAP and SESAC). Submission of NPR and PBS at 1 (Oct. 25, 2017).

    Second, copyright owners and public broadcasting entities may negotiate rates and terms for categories of copyrighted works and uses that would be binding on all owners and entities using the same license and submit them to the Judges for approval. Section 801(b)(7)(A) provides that the Copyright Royalty Judges shall provide to those that would be bound by the terms, rates, or other determination set by any agreement in a proceeding to determine royalty rates an opportunity to comment on the agreement and shall provide to participants in the proceeding under section 803(b)(2) that would be bound by the terms, rates, or other determination set by the agreement an opportunity to comment on the agreement and object to its adoption as a basis for statutory terms and rates; and that the Copyright Royalty Judges may decline to adopt the agreement as a basis for statutory terms and rates for participants that are not parties to the agreement, if any participant described in clause (i) objects to the agreement and the Copyright Royalty Judges conclude, based on the record before them if one exists, that the agreement does not provide a reasonable basis for setting statutory terms and rates.

    17 U.S.C. 801(b)(7)(A).

    On or about September 1, 2017, the Judges received a joint submission from ASCAP, BMI, HFA, NACUBO, NMPA, NRBNMLC, and SESAC containing proposed regulations that integrated the several separately filed proposals within this category. On October 25, 2017, the Judges received two more proposals within this category, one from NPR and PBS and a joint proposal from HFA, NMPA, PBS, NPR, and CPB.5

    5 The PTP from NPR and PBS covers CPB (the Corporation for Public Broadcasting).

    NACUBO Joint Proposals

    The joint proposals of NACUBO and each of ASCAP, BMI, and SESAC propose to modify the royalty rates set forth in § 381.5. The rates proposed in the NACUBO/BMI and NACUBO/ASCAP submissions reflect a modification of the fees in different rate tiers. NACUBO/BMI Joint Proposal at 5, App. A. NACUBO/ASCAP Joint Proposal at 5, App. A. The NACUBO/SESAC submission retains a flat rate which they propose adjusting, starting in 2018, by the change in the Consumer Price Index or one-and-a-half percent, whichever is greater. NACUBO/SESAC Joint Proposal App. A.

    NRBNMLC Joint Proposals

    The joint proposals entered into by NRBNMLC and each of HFA/NMPA, ASCAP, BMI, and SESAC propose carrying forward unchanged the current provisions set forth in §§ 381.1 (except to replace “January 1, 2013” with “January 1, 2018” and “December 31, 2017” with “December 31, 2022”), 381.2, 381.9, and 381.11.

    The joint proposal between NMPA/HFA and NRBNMLC states that the rates in § 381.7(b)(4) should be modified. NMPA/HFA and NRBNMLC Joint Proposal at 2-3.

    Each of the joint proposals between NRBNMLC and ASCAP, BMI and SESAC propose modifications to § 381.6. ASCAP and NRBNMLC Joint proposal at 3; BMI and NRBNMLC Joint proposal at 5; SESAC and NRBNMLC Joint proposal at 3.

    NPR/PBS Joint Proposals

    NPR and PBS filed a joint proposal with NMPA and HFA to modify fees in § 381.7, a change that reflects the same percentage increase made in the prior rate period because such increase “is fair and reasonable.” HFA/NMPA and NPR/PBS Joint Proposal at 2.

    NPR and PBS filed proposed changes to fees in § 381.4 pursuant to negotiated license agreements with ASCAP, BMI, and SESAC. The changes conform to analogous changes in §§ 381.5 and 381.6.

    As noted above, the members of the public and participants in this rate proceeding may comment and object to any or all of the proposed regulations contained in this notice.

    List of Subjects in 37 CFR Part 381

    Copyright, Music, Radio, Television, Rates.

    Proposed Regulations

    For the reasons set forth in the preamble, the Copyright Royalty Judges propose to amend part 381 to chapter III of title 37 of the Code of Federal Regulations as set forth below:

    PART 381—USE OF CERTAIN COPYRIGHTED WORKS IN CONNECTION WITH NONCOMMERCIAL EDUCATIONAL BROADCASTING 1. The authority citation for part 381 continues to read as follows: Authority:

    17 U.S.C. 118, 801(b)(1) and 803.

    § 381.1 [Amended]
    2. In § 381.1 remove “2013” and, in its place, add “2018”, and remove “2017” and, in its place, add “2022”. 3. Amend § 381.4 as follows: a. Revise paragraph (a); b. In paragraph (c) remove “2013” and, in its place, add “2018”, and remove “2017” and, in its place, add “2022”; and c. Remove paragraph (d).

    The revision reads as follows:

    § 381.4 Performance of musical compositions by PBS, NPR and other public broadcasting entities engaged in the activities set forth in 17 U.S.C. 118(c).

    (a) Determination of royalty rate. The following rates and terms shall apply to the performance by PBS, NPR and other public broadcasting entities engaged in activities set forth in 17 U.S.C. 118(c) of copyrighted published nondramatic musical compositions, except for public broadcasting entities covered by §§ 381.5 and 381.6, and except for compositions which are the subject of voluntary license agreements: The royalty shall be $1.

    4. Amend § 381.5 by revising paragraph (c) to read as follows:
    § 381.5 Performance of musical compositions by public broadcasting entities licensed to colleges and universities.

    (c) Royalty rate. A public broadcasting entity within the scope of this section may perform published nondramatic musical compositions subject to the following schedule of royalty rates:

    (1) For all such compositions in the repertory of ASCAP, the royalty rates shall be as follows:

    (i)

    Number of full-time students 2018 2019 2020 2021 2022 Level 1 <1,000 $352 $359 $366 $373 $380 Level 2 1,000-4,999 407 415 423 431 440 Level 3 5,000-9,999 557 568 579 591 603 Level 4 10,000-19,999 722 736 751 766 781 Level 5 20,000 + 908 926 945 964 983

    (ii) Level 1 rates as set forth in paragraph (c)(1)(i) of this section, shall also apply to College Radio Stations with an authorized effective radiated power (ERP), as that term is defined in 47 CFR 73.310(a), of 100 Watts or less, as specified on its current FCC license, regardless of the size of the student population.

    (2) For all such compositions in the repertory of BMI, the royalty rates shall be as follows:

    (i)

    Number of full-time students 2018 2019 2020 2021 2022 Level 1 <1,000 $352 $359 $366 $373 $380 Level 2 1,000-4,999 407 415 423 431 440 Level 3 5,000-9,999 557 568 579 591 603 Level 4 10,000-19,999 722 736 751 766 781 Level 5 20,000 + 908 926 945 964 983

    (ii) Level 1 rates, as set forth in paragraph (c)(2)(i) of this section, shall also apply to College Radio Stations with an authorized effective radiated power (ERP), as that term is defined in 47 CFR 73.310(a), of 100 Watts or less, as specified on its current FCC license, regardless of the size of the student population.

    (3) For all such compositions in the repertory of SESAC, the royalty rates shall be as follows:

    (i) 2018: The 2017 rate, subject to an annual cost of living adjustment in accordance with paragraph (c)(3)(vi) of this section.

    (ii) 2019: The 2018 rate, subject to an annual cost of living adjustment in accordance with paragraph (c)(3)(vi) of this section.

    (iii) 2020: The 2019 rate, subject to an annual cost of living adjustment in accordance with paragraph (c)(3)(vi) of this section.

    (iv) 2021: The 2020 rate, subject to an annual cost of living adjustment in accordance with paragraph (c)(3)(vi) of this section.

    (v) 2022: The 2021 rate, subject to an annual cost of living adjustment in accordance with paragraph (c)(3)(vi) of this section.

    (vi) Such cost of living adjustment to be made in accordance with the greater of

    (A) The change, if any, in the Consumer Price Index (all consumers, all items) published by the U.S. Department of Labor, Bureau of Labor Statistics during the twelve (12) month period from the most recent Index, published before December 1 of the year immediately prior to the applicable year, or

    (B) One and one-half percent (1.5%).

    (4) For the performance of any other such compositions: $1.

    5. Amend § 381.6 as follows: a. Remove from the first sentence of paragraph (a) the words “which are”; and b. Revise paragraph (d).

    The revision reads as follows:

    § 381.6 Performance of musical compositions by other public broadcasting entities.

    (d) Royalty rate. A public broadcasting entity within the scope of this section may perform published nondramatic musical compositions subject to the following schedule of royalty rates:

    (1) For all such compositions in the repertory of ASCAP, the royalty rates shall be as follows:

    (i) Music Fees (Stations with 20% or more programming containing Feature Music):

    Population count Calendar years 2018 2019 2020 2021 2022 Level 1 0-249,999 $697 $711 $725 $739 $754 Level 2 250,000-499,999 1,243 1,268 1,294 1,319 1,346 Level 3 500,000-999,999 1,864 1,901 1,939 1,978 2,017 Level 4 1,000,000-1,499,999 2,486 2,535 2,586 2,638 2,691 Level 5 1,500,000-1,999,999 3,107 3,169 3,232 3,297 3,363 Level 6 2,000,000-2,499,999 3,728 3,803 3,879 3,956 4,035 Level 7 2,500,000-2,999,999 4,349 4,436 4,525 4,615 4,708 Level 8 3,000,000 and above 6,214 6,338 6,465 6,594 6,726

    (ii) Talk Format Station Fees (Stations with <20% Feature Music programming):

    Population count Calendar years 2018 2019 2020 2021 2022 Level 1 0-249,999 $697 $711 $725 $739 $754 Level 2 250,000-499,999 697 711 725 739 754 Level 3 500,000-999,999 697 711 725 739 754 Level 4 1,000,000-1,499,999 870 887 905 923 942 Level 5 1,500,000-1,999,999 1,087 1,109 1,131 1,154 1,177 Level 6 2,000,000-2,499,999 1,305 1,331 1,357 1,384 1,412 Level 7 2,500,000-2,999,999 1,522 1,552 1,583 1,615 1,647 Level 8 3,000,000 and above 2,175 2,218 2,262 2,308 2,354

    (2) For all such compositions in the repertory of BMI, the royalty rates shall be as follows:

    (i) Music Fees (Stations with 20% or more programming containing Feature Music):

    Population count Calendar years 2018 2019 2020 2021 2022 Level 1 0-249,999 $697 $711 $725 $739 $754 Level 2 250,000-499,999 1,243 1,268 1,294 1,319 1,346 Level 3 500,000-999,999 1,864 1,901 1,939 1,978 2,017 Level 4 1,000,000-1,499,999 2,486 2,535 2,586 2,638 2,691 Level 5 1,500,000-1,999,999 3,107 3,169 3,232 3,297 3,363 Level 6 2,000,000-2,499,999 3,728 3,803 3,879 3,956 4,035 Level 7 2,500,000-2,999,999 4,349 4,436 4,525 4,615 4,708 Level 8 3,000,000 and above 6,214 6,338 6,465 6,594 6,726

    (ii) Talk Format Station Fees (Stations with <20% Feature Music programming):

    Population count Calendar years 2018 2019 2020 2021 2022 Level 1 0-249,999 $697 $711 $725 $739 $754 Level 2 250,000-499,999 697 711 725 739 754 Level 3 500,000-999,999 697 711 725 739 754 Level 4 1,000,000-1,499,999 870 887 905 923 942 Level 5 1,500,000-1,999,999 1,087 1,109 1,131 1,154 1,177 Level 6 2,000,000-2,499,999 1,305 1,331 1,357 1,384 1,412 Level 7 2,500,000-2,999,999 1,522 1,552 1,583 1,615 1,647 Level 8 3,000,000 and above 2,175 2,218 2,262 2,308 2,354

    (3) For all such compositions in the repertory of SESAC, the royalty rates shall be as follows:

    (i) Music fees for stations with > = 20% Feature Music programming:

    Population count Calendar years 2018 2019 2020 2021 2022 Level 1 0-249,999 $152 $155 $158 $161 $164 Level 2 250,000-499,999 253 258 263 268 274 Level 3 500,000-999,999 380 388 396 403 411 Level 4 1,000,000-1,499,999 507 517 527 538 548 Level 5 1,500,000-1,999,999 634 647 660 673 686 Level 6 2,000,000-2,499,999 760 775 790 806 822 Level 7 2,500,000-2,999,999 887 905 923 941 960 Level 8 3,000,000 and above 1,268 1,293 1,318 1,344 1,371

    (ii) Talk fees for stations with <20% Feature Music programming:

    Population count Calendar years 2018 2019 2020 2021 2022 Level 1 0-249,999 $152 $155 $158 $161 $164 Level 2 250,000-499,999 152 155 158 161 164 Level 3 500,000-999,999 152 155 158 161 164 Level 4 1,000,000-1,499,999 177 181 185 188 192 Level 5 1,500,000-1,999,999 222 227 231 236 240 Level 6 2,000,000-2,499,999 266 271 277 282 288 Level 7 2,500,000-2,999,999 311 317 323 330 336 Level 8 3,000,000 and above 444 452 461 470 480

    (4) For the performance of any other such compositions, in 2018 through 2022, $1.

    6. Amend § 381.7 as follows: a. Revise paragraphs (b)(1)(i)(A) through (D) and (b)(1)(ii)(A) through (D); b. Revise paragraph (b)(2)(i) through (iv); and c. Revise paragraph (b)(4)(i) through (iii).

    The revisions read as follows:

    § 381.7 Recording rights, rates and terms.

    (b) * * *

    (1)(i) * * *

    2018-2022 (A) Feature $118.70 (B) Concert feature (per minute) 35.65 (C) Background 59.99 (D) Theme: (1) Single program or first series program 59.99 (2) Other series program 24.36

    (ii) * * *

    2018-2022 (A) Feature $9.81 (B) Concert feature (per minute) 2.58 (C) Background 4.26 (D) Theme: (1) Single program or first series of program 4.26 (2) Other series program 1.69

    (2) * * *

    2018-2022 (i) Feature $12.85 (ii) Concert feature (per minute) 18.86 (iii) Background 6.44 (iv) Theme: (A) Single program or first series program 6.44 (B) Other series program 2.57

    (4) * * *

    2018-2022 (i) Feature $.81 (ii) Feature (concert) (per half hour) 1.69 (iii) Background .41
    7. Amend § 381.10 as follows: a. In paragraph (a), remove “2013” and, in its place, add “2018”, and remove “2017” and, in its place, add “2022”; b. Revise paragraph (b);

    The revision reads as follows:

    § 381.10 Cost of living adjustment.

    (b) On the same date of the notices published pursuant to paragraph (a) of this section, the Copyright Royalty Judges shall publish in the Federal Register a revised schedule of the rates for § 381.5(c)(3), the rate to be charged for compositions in the repertory of SESAC, which shall adjust the royalty amounts established in a dollar amount according to the greater of

    (1) The change in the cost of living determined as provided in paragraph (a) of this section, or

    (2) One-and-a-half percent (1.5%).

    (3) Such royalty rates shall be fixed at the nearest dollar.

    Dated: October 31, 2017. Suzanne M. Barnett, Chief U.S. Copyright Royalty Judge.
    [FR Doc. 2017-23991 Filed 11-3-17; 11:15 am] BILLING CODE 1410-72-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2017-0280; FRL-9969-88-Region 5] Air Plan Approval; Wisconsin; 2017 Revisions to NR 400 and 406 AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve a revision to the Wisconsin State Implementation Plan (SIP) submitted by the Wisconsin Department of Natural Resources (WDNR) to EPA on May 16, 2017. The revision replaces the definition of “emergency electric generator” with a broader definition of “restricted internal combustion engine”. In addition, the revision makes amendments to procedures for revoking construction permits as well as language changes and other administrative updates. Lastly, WDNR is withdrawing two Wisconsin Administrative Code provisions that affect eligibility under general and construction permits. WDNR requested these changes to align state and Federal requirements and ensure consistency. EPA is proposing approval of Wisconsin's May 16, 2017, request because the Agency has made the preliminary determination that this SIP revision is consistent with the Clean Air Act and applicable EPA regulations regarding PSD.

    DATES:

    Comments must be received on or before December 7, 2017.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R05-OAR-2017-0280 at http://www.regulations.gov or via email to [email protected]. For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include a discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the Web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Radhica Kanniganti, Environmental Engineer, Air Permits Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-8097, [email protected].

    SUPPLEMENTARY INFORMATION:

    In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, this rule will be effective on January 8, 2018. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the Rules section of this Federal Register.

    Dated: October 6, 2017. Robert A. Kaplan, Acting Regional Administrator, Region 5.
    [FR Doc. 2017-23448 Filed 11-6-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 170828822-7822-01] RIN 0648-XF669 Fisheries of the Northeastern United States; Scup Fishery; 2018 and Projected 2019 Specifications AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS proposes revised scup specifications for the 2018 fishing year and projected specifications for 2019. Updated scientific information regarding the scup stock indicates that higher catch limits may be implemented to achieve optimum yield. This action is intended to inform the public of the proposed specifications for the 2018 fishing year and projected specifications for 2019.

    DATES:

    Comments must be received by 5 p.m. local time, on November 22, 2017.

    ADDRESSES:

    An environmental assessment (EA) was prepared for this action and describes the proposed measures and other considered alternatives, and provides an analysis of the impacts of the proposed measures and alternatives. Copies of the Specifications Document, including the EA, are available on request from Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 North State Street, Dover, DE 19901. These documents are also accessible via the Internet at http://www.mafmc.org.

    You may submit comments on this document, identified by NOAA-NMFS-2017-0121, by either of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal.

    1. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0121,

    2. Click the “Comment Now!” icon, complete the required fields, and

    3. Enter or attach your comments.

    —OR—

    Mail: Submit written comments to John Bullard, Regional Administrator, National Marine Fisheries Service, 55 Great Republic Drive, Gloucester, MA 01930. Mark the outside of the envelope, “Comments on the Proposed Rule for Revised Scup Specifications.”

    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 part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    FOR FURTHER INFORMATION CONTACT:

    Emily Gilbert, Fishery Policy Analyst, (978) 281-9244.

    SUPPLEMENTARY INFORMATION:

    General Background

    The Mid-Atlantic Fishery Management Council and the Atlantic States Marine Fisheries Commission cooperatively manage the summer flounder, scup, and black sea bass fisheries. The Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP) and its implementing regulations outline the Council's process for establishing specifications. Specifications in these fisheries include various catch and landing subdivisions, such as the commercial and recreational sector annual catch limits (ACLs), annual catch targets (ACTs), and sector-specific landing limits (i.e., the commercial fishery quota and recreational harvest limit). Annual specifications may be proposed for three-year periods, with the Council reviewing the specifications each year to ensure that previously established multi-year specifications remain appropriate. Following review, NMFS announces the final annual specifications in the Federal Register. The FMP also contains formulas to divide the specification catch limits into commercial and recreational fishery allocations, state-by-state quotas, and quota periods, depending on the species in question. Rulemaking for measures used to manage the recreational fisheries (minimum fish sizes, open seasons, and bag limits) for these three species occurs separately, and typically takes place in the spring of each year. The summer flounder and black sea bass specifications implemented through previous rulemaking remain unchanged by this action.

    On December 28, 2015, NMFS published a final rule implementing the Council's recommended 2016-2018 specifications for the scup fishery (80 FR 80689). The Council intended to reconsider the specifications set for fishing year 2018 following the review of a scup assessment update provided in July 2017.

    The assessment update indicated the scup stock is not overfished and overfishing did not occur in 2016, the most recent year for which information is available. The update estimated that the scup spawning stock biomass (SSB) is 2.1 times the proxy reference point for SSB at maximum sustainable yield (MSY), and fishing mortality (F) in 2016 was about 63 percent of the FMSY proxy reference point. In addition, the update estimated that the 2015 year class was about 2.1 times the average recruitment (i.e., number of age 0 scup) from 1984-2016. The 2016 year class was 46 percent below the 1984-2016 recruitment average. Although the 2016 year class was estimated to be below average, the 2015 year class was so large that the assessment update provided higher revised overfishing limit (OFL) recommendations for 2018 and 2019. Compared to the previously implemented 2018 OFL (29.68 million lb, 13,462 mt), the 2018 recommendation is a 52-percent increase.

    Proposed Specifications

    The Council's Scientific and Statistical Committee (SSC) met on July 19-20, 2017, to discuss the assessment update results and resulting OFL estimates, to identify an updated acceptable biological catch (ABC) level for 2018, and to project an ABC for the 2019 fishing year. To derive the ABC recommendations, the SSC applied the Council's standard risk policy for a species with a typical life history, which produces ABCs estimated to result in a 60-percent probability of not overfishing the stock. The process resulted in ABCs of 39.14 million lb (17,755 metric tons (mt)) for 2018 and 36.43 million lb (16,525 mt) for 2019 (Table 1). The revised 2018 ABC is approximately 45 percent higher than the previously established 2018 ABC. Under the FMP, 22 percent of the ABC is allocated to the recreational fishery, while 78 percent is allocation to the commercial fishery.

    Following the SSC meeting, the Monitoring Committee met on July 24, 2017, to discuss ACLs, ACTs, commercial quotas, and recreational harvest limits for the 2018 and 2019 fishing years. In light of the substantial increase in the ABC, the Monitoring Committee recommended a moderate increase for the fishery and suggested setting the 2018 commercial ACT at 25.85 million lb (11,725 mt) and the recreational ACT at 7.29 million lb (3,307 mt). These recommended ACTs were 15 percent lower than those formulaically resulting from the SSC's ABC recommendation, but 22.5 percent higher than what is currently in place for 2018. The Monitoring Committee also recommended setting the 2019 ACTs at the same level as the 2018 ACTs. The Monitoring Committee decided that there was enough management uncertainty around the upcoming adjustments to the commercial quota periods in 2018 and the outcome of the upcoming recreational harvest estimate revisions through the Marine Recreational Information Program to warrant the inclusion of a buffer between the ACLs and ACTs, which would provide for more stability in the fishery by using constant ACTs for both years.

    The Council and Commission's Scup Management Board meet jointly on August 8, 2017, to review the SSC's and Monitoring Committee's recommendations. They found merit in the idea of offering stability in the fishery by allowing for a buffer between the ACLs and ACTs, but did not accept the Monitoring Committee's specific recommendations. Instead, the Council and Commission recommended constant sector-specific ACTs across 2018 and 2019, based on the 2019 ABC and setting the ACLs for 2019 equal to the ACTs (i.e., 8.01 million lb (3,636 mt) for the recreational fishery and 23.98 million lb (10,879 mt) for the commercial fishery).

    After removing the sector-specific estimated discards from the ACTs, the scup commercial quotas and recreational harvest limits would be those shown in Table 1. These values are approximately 40 percent higher than the current 2018 commercial quota and recreational harvest limit. The Monitoring Committee did not recommend any changes to the current commercial measures, including the 9-inch (22.9-cm) minimum fish size, the mesh size requirements and seasonal possession limit thresholds, and the pot/trap gear requirements.

    The Council will revisit its decision on the projected 2019 specifications following the SSC's review next summer. By providing projected specifications for 2019, NMFS hopes to assist fishery participants in planning ahead. Final 2019 specifications will be published in the Federal Register before the start of the 2019 fishing year (January 1, 2019) based on the Council's review.

    Table 1—Council-Recommended Scup Specifications for 2018 and Projected for 2019 Scup specifications 2018
  • (current)
  • million lb mt 2018
  • (revised)
  • million lb mt 2019
  • (projected)
  • million lb mt
    OFL 29.68 13,462 45.05 20,433 41.03 18,612 ABC 27.05 12,270 39.14 17,755 36.43 16,525 Commercial ACL 21.10 9,571 30.53 13,849 28.42 12,890 Commercial ACT 21.10 9,571 28.42 12,890 28.42 12,890 Commercial Discards 3.76 1,705 4.43 2,011 4.43 2,011 Commercial Quota 17.34 7,866 23.98 10,879 23.98 10,879 Recreational ACL 5.95 2,699 8.61 3,906 8.01 3,636 Recreational ACT 5.95 2,699 8.01 3,636 8.01 3,636 Recreational Discards 0.75 338 0.65 293 0.65 293 Recreational Harvest Limit 5.21 2,361 7.37 3,342 7.37 3,342
    Classification

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

    This action is exempt from review under E.O. 12866.

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The Mid-Atlantic Fishery Management Council conducted an evaluation of the potential socioeconomic impacts of the proposed measures in conjunction with an EA. According to the commercial ownership database, 517 affiliate firms landed scup during the 2014-2016 period, with 513 of those business affiliates categorized as small businesses and 4 categorized as large businesses. Scup represented approximately 3.94 percent of the average receipts of the small entities considered and 0.11 percent of the average receipts of the large entities considered over this time period.

    The ownership data for the for-hire fleet indicate that there were 359 for-hire affiliate firms generating revenues from fishing recreationally for various species during the 2014-2016 period, all of which are categorized as small businesses. Although it is not possible to derive what proportion of the overall revenues came from specific fishing activities, given the popularity of scup as a recreational species it is likely that revenues generated from scup are important for some, if not all, of these firms.

    The proposed measure would increase both the 2018 commercial quota and the 2018 recreational harvest limit by around 40 percent. However, the scup fishery is a market-limited fishery (i.e., market conditions are typically the limiting factor, not allowable landings) and it is expected that, unless market conditions change drastically, commercial and recreational landings will likely be similar to current landings. As a result, this action is not expected to adversely impact revenues for vessels that fish for scup commercially. The increase in the recreational harvest limit does not directly impact the party/charter fishery. Future regulatory action may be needed to adjust current scup recreational management measures (i.e., bag limits, seasons, and minimum sizes), and consideration of the impact of those potential future measures on small entities engaged in the for-hire fishery will be evaluated at that time, should such a regulatory action become necessary. Because this rule will not have a significant economic impact on a substantial number of small entities, an initial regulatory flexibility analysis is not required and none has been prepared.

    There are no new reporting or recordkeeping requirements contained in any of the alternatives considered for this action.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: November 2, 2017. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
    [FR Doc. 2017-24205 Filed 11-6-17; 8:45 am] BILLING CODE 3510-22-P
    82 214 Tuesday, November 7, 2017 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request November 2, 2017.

    The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by December 7, 2017 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Rural Utilities Service

    Title: Electric System Emergency Restoration Plan.

    OMB Control Number: 0572-0140.

    Summary of Collection: Electric power systems have been identified in Presidential Decision Directive 63, May 1998, as one of the critical infrastructures of the United States. The term “critical infrastructure” is defined in section 1016(e) of the USA Patriot Act of 2001 (42 U.S.C. 5195c(e)). To ensure that the electric infrastructure in rural America is adequately protected, Rural Utilities Service (RUS) requires that all current electric borrowers conduct a Vulnerability and Risk Assessment (VRA) of their respective systems and utilize the results of this assessment to enhance an existing Emergency Restoration Plan (ERP) or, create an ERP.

    Need and Use of the Information: The ERP provides written procedures detailing response and restoration efforts in the event of a major system outage resulting from a natural or man made disaster. RUS requires each electric borrower to provide annually a self-certification, in writing, that an ERP exists and that an initial VRA has been performed. If this information were not collected, vulnerabilities may exist in the electric system infrastructure. The result would be increased risk to public safety and may affect the Government loan security.

    Description of Respondents: Not-for-profit institutions.

    Number of Respondents: 625.

    Frequency of Responses: Reporting: Annually.

    Total Burden Hours: 313.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2017-24223 Filed 11-6-17; 8:45 am] BILLING CODE 3410-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Information Collection; Outreach Opportunity Questionnaire AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension with revision of a currently approved information collection, Outreach Opportunity Questionnaire (0596-0207).

    DATES:

    Comments must be received in writing on or before January 8, 2018 to be assured of consideration. Comments received after that date will be considered to the extent practicable.

    ADDRESSES:

    Comments concerning this notice should be addressed to the Northern Research Station, Attention: Judy Terrell, Forest Service, USDA, 11 Campus Boulevard, Suite 200, Newtown Square, PA 19073.

    Comments also may be submitted via email to: [email protected] The public may inspect comments received at USDA Forest Service, 11 Campus Boulevard, Suite 200, Newtown Square, PA 19073 during normal business hours. Visitors are encouraged to call ahead to 610-557-4057 to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Judy Terrell, 610-557-4057. Individuals who use telecommunications devices for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339, between 8 a.m. and 8 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    Title: Outreach Opportunity Questionnaire.

    OMB Number: 0596-0207.

    Expiration Date of Approval: February 28, 2018.

    Type of Request: Extension with revision.

    Abstract: This information collection is proposing to extend the collection of information from students attending local college and university career fairs regarding the effectiveness of the information provided by the Forest Service personnel on career opportunities in the Forest Service. The collection is necessary to evaluate and determine the effectiveness of the Forest Service Civil Rights Northeastern Service Center (NESC) Outreach Program.

    Forest Service, Civil Rights personnel, have utilized the Outreach Opportunity Questionnaire to collect evaluation information from students regarding presentations at career day events as well as at colleges and universities. Data received has appeared in reports provided to the Department of Agriculture, senior Forest Service officials, the Northern Research Station Director, and the Northern Research Station Civil Rights Diversity Committee. This information is a vital component in the analysis of Agency outreach efforts.

    Estimate of Annual Burden: 20 hours/year.

    Type of Respondents: University/College students.

    Estimated Annual Number of Respondents: 675.

    Estimated Annual Number of Responses per Respondent: 1.

    Estimated Total Annual Burden on Respondents: 20 hours.

    Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency's estimate of the burden of the 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 the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the request for Office of Management and Budget approval.

    Dated: October 30, 2017. J. Lenise Lago, Acting Associate Chief, Forest Service.
    [FR Doc. 2017-24179 Filed 11-6-17; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE National Agricultural Statistics Service Notice of Intent To Request To Conduct a New Information Collection AGENCY:

    National Agricultural Statistics Service, USDA.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 this notice announces the intention of the National Agricultural Statistics Service (NASS) to seek approval to conduct a new information collection to gather data related to water usage for North Carolina agricultural operations that likely use between 10,000 and 1,000,000 gallons per day.

    DATES:

    Comments on this notice must be received by January 8, 2018 to be assured of consideration.

    ADDRESSES:

    You may submit comments, identified by docket number 0535-NEW, by any of the following methods:

    Email: [email protected] Include docket number above in the subject line of the message.

    E-fax: (855) 838-6382.

    Mail: Mail any paper, disk, or CD-ROM submissions to: David Hancock, NASS Clearance Officer, U.S. Department of Agriculture, Room 5336 South Building, 1400 Independence Avenue SW., Washington, DC 20250-2024.

    Hand Delivery/Courier: Hand deliver to: David Hancock, NASS Clearance Officer, U.S. Department of Agriculture, Room 5336 South Building, 1400 Independence Avenue SW., Washington, DC 20250-2024.

    FOR FURTHER INFORMATION CONTACT:

    R. Renee Picanso, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720-4333. Copies of this information collection and related instructions can be obtained without charge from David Hancock, NASS—OMB Clearance Officer, at (202) 690-2388 or at [email protected]

    SUPPLEMENTARY INFORMATION:

    Title: Water Use Survey.

    OMB Control Number: 0535-NEW.

    Type of Request: Intent to seek approval to conduct a new information collection for a period of three years.

    Abstract: The primary objective of the National Agricultural Statistics Service (NASS) is to collect, prepare and issue State and national estimates of crop and livestock production, prices, and disposition; as well as economic statistics, environmental statistics related to agriculture and also to conduct the Census of Agriculture.

    The Water Use survey program will collect information on water usage for North Carolina agricultural operations that likely use between 10,000 and 1,000,000 gallons per day. Agricultural operations who use over 1,000,000 gallons in any one day are required to report their water usage directly to North Carolina Department of Environmental Quality (NCDEQ) and are not included in this survey. The program will help the North Carolina Department of Agriculture and Consumer Services (NCDACS) and NCDEQ fulfill the requirements of North Carolina state legislation enacted in 2008 (SL2008-0143). All questionnaires included in this information collection will be voluntary. This project is conducted as a cooperative effort with the North Carolina Department of Agriculture and Consumer Services. Funding for this pilot survey is being provided by NCDACS.

    Authority: These data will be collected under authority of 7 U.S.C. 2204(a). Individually identifiable data collected under this authority are governed by Section 1770 of the Food Security Act of 1985 as amended, 7 U.S.C. 2276, which requires USDA to afford strict confidentiality to non-aggregated data provided by respondents. This Notice is submitted in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-113, 44 U.S.C. 3501, et seq.) and Office of Management and Budget regulations at 5 CFR part 1320.

    NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),” Federal Register, Vol. 72, No. 115, June 15, 2007, p. 33362.

    Estimate of Burden: Public reporting burden for this information collection is based on similar surveys with expected response time of 30 minutes. The estimated sample size will be approximately 3,300. The frequency of data collection for the different surveys is annual. Estimated number of responses per respondent is 1. Publicity materials and instruction sheets will account for approximately 5 minutes of additional burden per respondent. Respondents who refuse to complete a survey will be allotted 2 minutes of burden per attempt to collect the data.

    Respondents: North Carolina operations that likely use between 10,000 and 1,000,000 gallons annually.

    Estimated Number of Respondents: 3,300.

    Estimated Total Annual Burden on Respondents: 1,614 hours.

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

    All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.

    Signed at Washington, DC, October 25, 2017. R. Renee Picanso, Associate Administrator.
    [FR Doc. 2017-24167 Filed 11-6-17; 8:45 am] BILLING CODE 3410-20-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Alaska Advisory Committee AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Alaska Advisory Committee (Committee) to the Commission will be held on December 14, 2017 at 1:00 p.m. (Alaska Time). On Thursday, January 18, 2018; Thursday, February 8, 2018 and Thursday, March 8, 2018 at 12:00 p.m. (Alaska Time). The purpose of the meeting is for the Committee to discuss findings that will be included in an advisory memorandum on Alaska Native voting rights.

    DATES:

    The meeting will be held on Thursday, December 14, 2017 at 1:00 p.m. (AKT) and on Thursday, January 18, 2018; Thursday, February 8, 2018 and Thursday, March 8, 2018 at 12:00 p.m. (AKT).

    Public Call Information: Dial: 888-609-5689; Conference ID: 3574845.

    FOR FURTHER INFORMATION CONTACT:

    Ana Victoria Fortes (DFO) at [email protected] or (213) 894-3437.

    SUPPLEMENTARY INFORMATION:

    This meeting is available to the public through the following toll-free call-in number: 888-609-5689, conference ID number: 3574845. Any interested member of the public may call this number and listen to the meeting. 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 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 entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at [email protected] Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https://facadatabase.gov/committee/meetings.aspx?cid=234. Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

    Agenda I. Welcome II. Discuss Advisory Memorandum III. Public Comment IV. Next Steps V. Adjournment Dated: November 1, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-24136 Filed 11-6-17; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Alaska Advisory Committee AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Alaska Advisory Committee (Committee) to the Commission will be held at 1:00 p.m. (Alaska Time) Thursday, November 9, 2017. The purpose of the meeting is for the Committee to discuss findings that will be included in an advisory memorandum on Alaska Native voting rights.

    DATES:

    The meeting will be held on Thursday, November 9, 2017, at 1:00 p.m. AKT.

    Public Call Information: Dial: 888-609-5689; Conference ID: 3574845.

    FOR FURTHER INFORMATION CONTACT:

    Ana Victoria Fortes (DFO) at [email protected] or (213) 894-3437.

    SUPPLEMENTARY INFORMATION:

    This meeting is available to the public through the following toll-free call-in number: 888-609-5689, conference ID number: 3574845. Any interested member of the public may call this number and listen to the meeting. 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 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 entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at [email protected] Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https://facadatabase.gov/committee/meetings.aspx?cid=234. Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

    Agenda I. Welcome II. Discuss Advisory Memorandum III. Public Comment IV. Next Steps V. Adjournment

    Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstance of the committee needing to discuss and draft an advisory memorandum focused on Alaska Native voting rights that will be included in the 2018 Statutory Enforcement report.

    Dated: November 1, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-24137 Filed 11-6-17; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Census Bureau Proposed Information Collection; Comment Request; Current Population Survey (CPS) Basic Demographic Items AGENCY:

    U.S. Census Bureau, Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    DATES:

    To ensure consideration, written comments must be submitted on or before January 8, 2018.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at [email protected]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Karen Woods, U.S. Census Bureau, 7H140F, Washington, DC 20133-8400 at (301) 763-3806.

    SUPPLEMENTARY INFORMATION: I. Abstract

    The Census Bureau plans to request clearance from the Office of Management and Budget (OMB) for the collection of basic demographic information on the Current Population Survey (CPS) beginning in August 2018. The current clearance expires July 31, 2018.

    The CPS has been the source of official government statistics on employment and unemployment for over 60 years. The Bureau of Labor Statistics (BLS) and the Census Bureau jointly sponsor the basic monthly survey. The Census Bureau also prepares and conducts all the field work. At the OMB's request, the Census Bureau and the BLS divide the clearance request in order to reflect the joint sponsorship and funding of the CPS program. The BLS submits a separate clearance request for the portion of the CPS that collects labor force information for the civilian noninstitutional population. Some of the information within that portion includes employment status, number of hours worked, job search activities, earnings, duration of unemployment, and the industry and occupation classification of the job held the previous week. The justification that follows is in support of the demographic data.

    The demographic information collected in the CPS provides a unique set of data on selected characteristics for the civilian noninstitutional population. Some of the demographic information we collect are age, marital status, sex, Armed Forces status, education, race, origin, and family income. We use these data in conjunction with other data, particularly the monthly labor force data, as well as periodic supplement data. We also use these data independently for internal analytic research and for evaluation of other surveys. In addition, we use these data as a control to produce accurate estimates of other personal characteristics.

    II. Method of Collection

    The CPS basic demographic information is collected from individual households by both personal visit and telephone interviews each month. All interviews are conducted using computer-assisted interviewing. Households in the CPS are in sample for four consecutive months, and for the same four months the following year. This is called a 4-8-4 rotation pattern; households are in sample for four months, in a resting period for eight months, and then in sample again for four months.

    III. Data

    OMB Control Number: 0607-0049.

    Form Number(s): There are no forms. All interviews are conducted on computers.

    Type of Review: Regular submission.

    Affected Public: Households.

    Estimated Number of Respondents: 59,000 per month.

    Estimated Time per Response: 1.5 minutes.

    Estimated Total Annual Burden Hours: 17,700.

    Estimated Total Annual Cost to Public: There is no cost to the respondents other than their time.

    Respondent's Obligation: Voluntary.

    Legal Authority: Title 13 U.S.C. Sections 8(b), 141, and 182.

    IV. Request for Comments

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Sheleen Dumas, Departmental PRA Lead, Office of the Chief Information Officer.
    [FR Doc. 2017-24209 Filed 11-6-17; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-533-810] Stainless Steel Bar From India: Preliminary Determination of No Shipments and Partial Rescission of the Antidumping Duty Administrative Review; 2016-2017 AGENCY:

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

    SUMMARY:

    In response to requests from interested parties, the Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on stainless steel bar (SSB) from India. The period of review (POR) is February 1, 2016, through January 31, 2017. This review covers two producers or exporters of the subject merchandise: Ambica Steels Limited (Ambica), and Bhansali Bright Bars Pvt. Ltd. (Bhansali). We preliminarily determine that Bhansali and Ambica had no shipments of subject merchandise during the POR. Interested parties are invited to comment on these preliminary results.

    DATES:

    Applicable: November 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Mark Kennedy, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington DC 20230; telephone: (202) 482-7883.

    SUPPLEMENTARY INFORMATION:

    Scope of the Order

    The merchandise subject to the order is SSB. SSB means articles of stainless steel in straight lengths that have been either hot-rolled, forged, turned, cold-drawn, cold-rolled or otherwise cold-finished, or ground, having a uniform solid cross section along their whole length in the shape of circles, segments of circles, ovals, rectangles (including squares), triangles, hexagons, octagons, or other convex polygons. SSB includes cold-finished SSBs that are turned or ground in straight lengths, whether produced from hot-rolled bar or from straightened and cut rod or wire, and reinforcing bars that have indentations, ribs, grooves, or other deformations produced during the rolling process.

    Except as specified above, the term does not include stainless steel semi-finished products, cut-to-length flat-rolled products (i.e., cut-to-length rolled products which if less than 4.75 mm in thickness have a width measuring at least 10 times the thickness, or if 4.75 mm or more in thickness having a width which exceeds 150 mm and measures at least twice the thickness), wire (i.e., cold-formed products in coils, of any uniform solid cross section along their whole length, which do not conform to the definition of flat-rolled products), and angles, shapes, and sections.

    Imports of these products are currently classifiable under subheadings 7222.10.00, 7222.11.00, 7222.19.00, 7222.20.00, 7222.30.00 of the Harmonized Tariff Schedule (HTS). Although the HTS subheadings are provided for convenience and customs purposes, our written description of the scope of the Order is dispositive.

    Background

    Carpenter Technology Corporation, Crucible Industries LLC, Electralloy, a Division of G,O, Carlson, Inc., North American Stainless, Universal Stainless & Alloy Products, Inc., and Valbruna Slater Stainless, Inc. (the petitioners) timely requested an administrative review of Ambica, Bhansali, and Ambica Stainless Steel Limited (now known as Aamor Inox Limited) (ASSL).1 As such, the Department published in the Federal Register a notice of initiation of this administrative review of the antidumping duty order on SSB from India for Ambica and Bhansali.2

    1See Letter to the Department from the petitioners, “Stainless Steel Bar from India: Petitioners' Request for 2016/17 Administrative Review,” dated February 28, 2017. Although the petitioners stated that “Ambica Stainless Steel Limited” is “now known as Aamor Inox Limited,” the Department has not determined that Aamor Inox Limited is the successor in interest to Ambica Stainless Steel Limited.

    2See “Initiation of Antidumping and Countervailing Duty Administrative Reviews,” 82 FR 17188 (April 10, 2017) (Initiation Notice).

    Partial Rescission of Administrative Review

    Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation. The petitioners timely withdrew their request for review of ASSL.3 No other party requested a review of this producer/exporter. Therefore, in accordance with 19 CFR 351.213(d)(1), the Department is rescinding this review of the AD order on SSB from the PRC with respect to ASSL.

    3See Letter from the petitioners, “Stainless Steel Bar from India—Petitioners' Request to Withdraw Request for Administrative Review of Ambica Stainless Steel Limited/Aamor Inox Limited,” dated April 24, 2017.

    Preliminary Determination of No Shipments

    We received timely certifications from Bhansali and Ambica reporting that they had no shipments of the subject merchandise to the United States during the POR and requested that the Department rescind the review with respect to it.4 As detailed in the Preliminary Decision Memorandum, the Department preliminarily determines that both Bhansali and Ambica had no shipments during the POR.5

    4See Letter from Bhansali, “Stainless Steel Bar products from India: Request for No Shipment letter during the Period of Review (POR),” dated March 9, 2017; see also Letter from Ambica Steels Limited, “Stainless Steel Bar—No Shipments In Period of Review (POR),” dated May 1, 2017.

    5 For additional information and analysis, see the Preliminary Decision Memorandum.

    Consistent with our practice, we will complete the review and issue appropriate instructions to CBP based on the final results of this review.6

    6See, e.g., Certain Frozen Warmwater Shrimp from Thailand; Preliminary Results of Antidumping Duty Administrative Review, Partial Rescission of Review, Preliminary Determination of No Shipments; 2012-2013, 79 FR 15951, 15952 (March 24, 2014), unchanged in Certain Frozen Warmwater Shrimp from Thailand: Final Results of Antidumping Duty Administrative Review, Final Determination of No Shipments, and Partial Rescission of Review; 2012-2013, 79 FR 51306, 51306-307 (August 28, 2014).

    Public Comment

    Interested parties may submit case briefs no later than 30 days after the date of publication of the preliminary results.7 Rebuttal briefs, limited to the issues raised in the case briefs, may be filed no later than five days after the submission of case briefs.8 Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.9

    7See 19 CFR 351.309(c)(1)(ii); see also 19 CFR 351.303 (for general filing requirements).

    8See 19 CFR 351.309(d)(1).

    9See 19 CFR 351.309(c)(2) and (d)(2).

    All submissions to the Department must be filed electronically using ACCESS, and must also be served on interested parties.10 An electronically filed document must be received successfully in its entirety by the Department's electronic records system, ACCESS, by 5:00 p.m. Eastern Time on the date that the document is due.

    10See 19 CFR 351.303(f).

    Interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, using Enforcement and Compliance's ACCESS system within 30 days of publication of this notice.11 Requests should contain (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs.

    11See 19 CFR 351.310(c).

    Unless the deadline is extended pursuant to section 751(a)(2)(B)(iv) of the Tariff Act of 1930 (the Act) and 19 CFR 351.213(h)(2), the Department intends to issue the final results of this administrative review, including the results of our analysis of the issues raised by the parties in their case and rebuttal briefs, within 120 days after the publication of these preliminary results, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).

    Assessment of Antidumping Duties

    We are rescinding this review for ASSL; in accordance with Department practice, we will instruct CBP to assess antidumping duties at the rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse for consumption, in accordance with 19 CFR 351.212(c)(1)(i).

    Upon issuance of the final results of this review, in accordance with the Department's practice, for entries of subject merchandise during the POR for which Ambica or Bhansali did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate such entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. We intend to issue instructions to CBP 15 days after the publication date of the final results of this review.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Ambica and Bhansali will remain unchanged from the rate assigned to each company in the completed segment for the most recent period for each company; (2) for other producers and exporters covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the completed segment for the most recent period of this proceeding in which that producer or exporter participated; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation, but the producer is, then the cash deposit rate will be the rate established for the completed segment for the most recent period of this proceeding for the producer of subject merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 12.45 percent, the all-others rate established in the investigation.12 These cash deposit requirements, when imposed, shall remain in effect until further notice.

    12See Notice of Final Determination of Sales at Less Than Fair Value: Stainless Steel Bar from India, 59 FR 66915, 66921 (December 28, 1994).

    Notification to Importers

    This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Notification to Interested Parties

    We are issuing and publishing these preliminary results of administrative review in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: October 31, 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. 2017-24172 Filed 11-6-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-928] Uncovered Innerspring Units From the People's Republic of China: Preliminary Results and Rescission, in Part, of the Antidumping Duty Administrative Review; 2016-2017 AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on uncovered innerspring units (innerspring units) from the People's Republic of China (PRC). The period of review (POR) is February 1, 2016, through January 31, 2017. The Department preliminarily determines that PT Sunhere Buana International (PT Sunhere) failed to cooperate to the best of its ability and is, therefore, basing its margin on facts otherwise available with an adverse inference (AFA). The Department is also rescinding the administrative review with respect to Jietai Machinery Ltd. (HK) (Jietai Machinery). Interested parties are invited to comment on these preliminary results.

    FOR FURTHER INFORMATION CONTACT:

    Kenneth Hawkins, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-6491.

    SUPPLEMENTARY INFORMATION:

    Background

    On February 19, 2009, the Department published an antidumping duty order on innerspring units from the PRC (the Order).1 On February 28, 2017, Leggett & Platt, Inc. (the petitioner) submitted a request for the Department to conduct an administrative review of the Order that examines Jietai Machinery and PT Sunhere's exports of subject merchandise made during the POR.2 On April 10, 2016, the Department published in the Federal Register a notice of initiation of this administrative review of the Order concerning Jietai Machinery and PT Sunhere's POR exports of subject merchandise.3 4 On May 1, 2017 the Department issued its questionnaire to Jietai Machinery and PT Sunhere.5 The Department's questionnaire to Jietai Machinery was returned as undeliverable.6 The Department confirmed delivery of its questionnaire to PT Sunhere.7 On September 6, 2017, based on guidance from U.S. Customs and Border Protection (CBP), we added harmonized tariff schedule (HTS) number 7326.20.0090 to the Scope of the Order.8

    1See Uncovered Innerspring Units from the People's Republic of China: Notice of Antidumping Duty Order, 74 FR 7661 (February 19, 2009).

    2See Uncovered Innerspring Units from the People's Republic of China: Request for Antidumping Administrative Review, dated February 28, 2017.

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 82 FR 17188 (April 10, 2017) (Initiation Notice).

    4 PT Sunhere is located in Indonesia, a market economy country. The Department is examining PT Sunhere's exports of subject merchandise for this administrative review.

    5See the Department's Letter to Jietai Machinery, dated May 1, 2017; see also, the Department's Letter to PT Sunhere, dated May 1, 2017 (Questionnaires).

    6See Memorandum to the File, re: “Antidumping Duty Administrative Questionnaire Not Delivered,” dated August 2, 2017.

    7See Memorandum to the File, re: 2016-2017 Administrative Review of Uncovered Innerspring Units from the People's Republic of China: Delivery Notification of Antidumping Duty Questionnaire to PT Sunhere Buana International, dated August 15, 2017.

    8See Memorandum to the File, through Paul Walker, Program Manager, Antidumping and Countervailing Duty Operations, Office V, from Kenneth Hawkins, Case Analyst, Antidumping and Countervailing Duty Operations, Office V, re: “Uncovered Innersprings from the People's Republic of China (A-570-928) and South Africa (A-791-821,” dated September 6, 2017 (Additional HTS Memo).

    Scope of the Order

    The merchandise subject to the order is uncovered innerspring units composed of a series of individual metal springs joined together in sizes corresponding to the sizes of adult mattresses (e.g., twin, twin long, full, full long, queen, California king and king) and units used in smaller constructions, such as crib and youth mattresses. The product is currently classified under subheading 9404.29.9010 and has also been classified under subheadings 9404.10.0000, 9404.29.9005, 9404.29.9011, 7326.20.0070, 7326.20.0090, 7320.20.5010, 7320.90.5010, or 7326.20.0071 of the Harmonized Tariff Schedule of the United States (HTSUS).9 The HTSUS subheadings are provided for convenience and customs purposes only; the written description of the scope of the order is dispositive.10

    9 On September 6, 2017, the Department added HTS 7326.20.0090 to the scope based on a request from CBP. See Additional HTS Memo.

    10 For a full description of the scope of the order, see the Department Memorandum, “Decision Memorandum for Preliminary Results of 2016-2017 Antidumping Duty Administrative Review: Uncovered Innerspring Units from the People's Republic of China,” dated concurrently with and hereby adopted by this notice (Preliminary Decision Memorandum).

    Methodology

    The Department is conducting this review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). With respect to PT Sunhere, we relied on facts available and, because PT Sunhere did not act to the best of its ability to respond to the Department's requests for information, we drew an adverse inference in selecting from among the facts otherwise available.11

    11See sections 776(a) and (b) of the Act.

    For a full description of the methodology underlying our conclusions, please see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    Partial Rescission of Administrative Review

    The Department issued its questionnaire to Jietai Machinery but the questionnaire was returned as undeliverable. Despite our request to the petitioner, we received no alternative addresses for Jietai Machinery. Accordingly, consistent with the Department's practice in similar circumstances,12 the Department is rescinding the administrative review with respect to Jietai Machinery.

    12See, e.g., Certain Frozen Warmwater Shrimp from Thailand; Partial Rescission of Antidumping Duty Administrative Review, 72 FR 50931 (September 5, 2007).

    Preliminary Results of Review

    The Department preliminarily determines that a dumping margin of 234.51 percent exists for PT Sunhere for the period February 1, 2016, through January 31, 2017.

    Public Comment 13

    13 Normally, the Department discloses to interested parties the calculations performed in connection with the preliminary results of review within five days of the date of publication of the notice of preliminary results in the Federal Register, in accordance with 19 CFR 351.224(b). However, because PT Sunhere did not participate and its rate is based solely on AFA, there are no calculations to disclose.

    Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs not later than 30 days after the date of publication of this notice in the Federal Register. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.14 Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.15 Case and rebuttal briefs should be filed using ACCESS.16

    14See 19 CFR 351.309(d)(1).

    15See 19 CFR 351.309(c)(2) and (d)(2).

    16See 19 CFR 351.303.

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days of the date of publication of this notice. Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a date and time to be determined.17 Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    17See 19 CFR 351.310(d).

    Unless extended, the Department intends to issue the final results of this administrative review, which will include the results of our analysis of all issues raised in the case briefs, within 120 days of publication of these preliminary results in the Federal Register, pursuant to section 751(a)(3)(A) of the Act.

    Assessment Rates

    As noted above, we are rescinding the review with respect to Jietai Machinery. As such, the Department intends to issue appropriate assessment instructions to U.S. Customs and Border Protection (CBP) 15 days after the date of publication of this notice for Jietai Machinery. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption in accordance with 19 CFR 351.212(c)(1)(i).

    Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.18 The Department intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review. We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review if any assessment rate calculated in the final results of this review is above de minimis. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable. Assessment of duties resulting from the final results of this review will pertain only to entries of subject merchandise (i.e., innerspring units from the PRC).

    18See 19 CFR 351.212(b)(1).

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this administrative review for shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date of this notice, as provided by section 751(a)(2)(C) of the Act: (1) For PT Sunhere, the cash deposit rate will be that established in the final results of this review (except, if the rate is zero or de minimis, then zero cash deposit will be required) and the Department will collect cash deposits only on PT Sunhere's PRC-origin merchandise; (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate published for the most recently completed period; (3) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the PRC-wide rate of 234.51 percent; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213.

    Dated: October 31, 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. Appendix List of Topics Discussed in the Preliminary Decision Memorandum 1. Summary 2. Background 3. Scope of the Order 4. Partial Rescission of Administrative Review 5. Discussion of the Methodology a. Application of Facts Otherwise Available b. Use of Adverse Inference c. Selection of the Adverse Facts Available Rate 6. Recommendation
    [FR Doc. 2017-24199 Filed 11-6-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-580-867] Large Power Transformers From the Republic of Korea: Final Results of the Expedited First Sunset Review of the Antidumping Duty Order AGENCY:

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

    SUMMARY:

    As a result of this sunset review, the Department of Commerce (the Department) finds that revocation of the antidumping duty order on large power transformers (LPTs) from the Republic of Korea (Korea) would be likely to lead to continuation or recurrence of dumping at the levels indicated in the “Final Results of Sunset Review” section of this notice.

    DATES:

    Applicable November 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Moses Song, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5041.

    SUPPLEMENTARY INFORMATION:

    Background

    On July 3, 2017, the Department published the notice of initiation of the first sunset review of the antidumping duty order on LPTs from Korea, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).1 On July 18, 2017, the Department received a notice of intent to participate in this review from ABB Inc., (ABB) within the deadline specified in 19 CFR 351.218(d)(1)(i). ABB claimed interested party status under section 771(9)(C) of the Act, as a manufacturer of a domestic like product in the United States.

    1See Initiation of Five-Year (“Sunset”) Reviews, 82 FR 30844 (July 3, 2017).

    On August 2, 2017, we received a complete substantive response for this review from ABB within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). We received no substantive responses from any other interested parties, nor was a hearing requested. As a result, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), the Department conducted an expedited (120-day) sunset review of the order.

    Scope of the Order

    The scope of this order covers large liquid dielectric power transformers (LPTs) having a top power handling capacity greater than or equal to 60,000 kilovolt amperes (60 megavolt amperes), whether assembled or unassembled, complete or incomplete.

    Incomplete LPTs are subassemblies consisting of the active part and any other parts attached to, imported with or invoiced with the active parts of LPTs. The “active part” of the transformer consists of one or more of the following when attached to or otherwise assembled with one another: The steel core or shell, the windings, electrical insulation between the windings, the mechanical frame for an LPT.

    The product definition encompasses all such LPTs regardless of name designation, including but not limited to step-up transformers, step-down transformers, autotransformers, interconnection transformers, voltage regulator transformers, rectifier transformers, and power rectifier transformers.

    The LPTs subject to this order are currently classifiable under subheadings 8504.23.0040, 8504.23.0080 and 8504.90.9540 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 this order is dispositive.

    Analysis of Comments Received

    All issues raised in this review, including the likelihood of continuation or recurrence of dumping in the event of revocation and the magnitude of the margins likely to prevail if the order were revoked, are addressed in the accompanying Issues and Decision Memorandum, which is hereby adopted by this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the Internet at http://enforcement.trade.gov/frn/. The signed Issues and Decision Memorandum and the electronic version of the Issues and Decision Memorandum are identical in content.

    Final Results of Sunset Review

    Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, we determine that revocation of the antidumping duty order on LPTs from Korea would be likely to lead to continuation or recurrence of dumping, and that the magnitude of the dumping margins likely to prevail would be weighted-average dumping margins up to 29.04 percent.

    Notification to Interested Parties

    This notice serves as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    We are issuing and publishing these results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CFR 351.218.

    Dated: October 31, 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. Appendix List of Topics Discussed in the Issues and Decision Memorandum I. Summary II. Background III. Scope of the Order IV. History of the Order V. Legal Framework VI. Discussion of the Issues 1. Likelihood of Continuation or Recurrence of Dumping 2. Magnitude of the Margins Likely to Prevail VII. Final Results of Sunset Review VIII. Recommendation
    [FR Doc. 2017-24187 Filed 11-6-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-900] Diamond Sawblades and Parts Thereof From the People's Republic of China: Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review AGENCY:

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

    SUMMARY:

    The Department of Commerce is simultaneously initiating and issuing the preliminary results of a changed circumstances review of the antidumping duty order on diamond sawblades and parts thereof from the People's Republic of China to determine whether Chengdu Huifeng New Material Technology Co., Ltd. is the successor-in-interest to Chengdu Huifeng Diamond Tools Co., Ltd. Based on the information on the record, we preliminarily determine that Chengdu Huifeng New Material Technology Co., Ltd. is the successor-in-interest to Chengdu Huifeng Diamond Tools Co., Ltd. for purposes of determining antidumping duty liability. We invite interested parties to comment on these preliminary results.

    DATES:

    Applicable November 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Yang Jin Chun, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5760.

    SUPPLEMENTARY INFORMATION:

    Background

    The Department published the antidumping duty order on diamond sawblades and parts thereof from the People's Republic of China on November 4, 2009.1 In its September 20, 2017, request for a changed circumstances review, Chengdu Huifeng New Material Technology Co., Ltd., informed the Department that, effective August 16, 2016, Chengdu Huifeng Diamond Tools Co., Ltd. (1) changed its legal status from a limited liability company to a joint-stock limited company and (2) changed its name to Chengdu Huifeng New Material Technology Co., Ltd.2 Chengdu Huifeng Diamond Tools Co., Ltd., is a respondent in the ongoing administrative review of the same order covering the period November 1, 2015, through October 31, 2016.3 Pursuant to section 751(b) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.216(c) and 19 CFR 351.221(c)(3), Chengdu Huifeng New Material Technology Co., Ltd. requested that the Department initiate an expedited changed circumstances review and determine that Chengdu Huifeng New Material Technology Co., Ltd. is the successor-in-interest to Chengdu Huifeng Diamond Tools Co., Ltd.

    1See Diamond Sawblades and Parts Thereof from the People's Republic of China and the Republic of Korea: Antidumping Duty Orders, 74 FR 57145 (November 4, 2009).

    2See Chengdu Huifeng New Material Technology Co., Ltd.'s request for a changed circumstances review dated September 20, 2017 (CCR Request).

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 82 FR 4294 (January 13, 2017) (Initiation Notice).

    Scope of the Order

    The products covered by the order are all finished circular sawblades, whether slotted or not, with a working part that is comprised of a diamond segment or segments, and parts thereof, regardless of specification or size, except as specifically excluded below. Within the scope of the order are semifinished diamond sawblades, including diamond sawblade cores and diamond sawblade segments. Diamond sawblade cores are circular steel plates, whether or not attached to non-steel plates, with slots. Diamond sawblade cores are manufactured principally, but not exclusively, from alloy steel. A diamond sawblade segment consists of a mixture of diamonds (whether natural or synthetic, and regardless of the quantity of diamonds) and metal powders (including, but not limited to, iron, cobalt, nickel, tungsten carbide) that are formed together into a solid shape (from generally, but not limited to, a heating and pressing process).

    Sawblades with diamonds directly attached to the core with a resin or electroplated bond, which thereby do not contain a diamond segment, are not included within the scope of the order. Diamond sawblades and/or sawblade cores with a thickness of less than 0.025 inches, or with a thickness greater than 1.1 inches, are excluded from the scope of the order. Circular steel plates that have a cutting edge of non-diamond material, such as external teeth that protrude from the outer diameter of the plate, whether or not finished, are excluded from the scope of the order. Diamond sawblade cores with a Rockwell C hardness of less than 25 are excluded from the scope of the order. Diamond sawblades and/or diamond segment(s) with diamonds that predominantly have a mesh size number greater than 240 (such as 250 or 260) are excluded from the scope of the order. Merchandise subject to the order is typically imported under heading 8202.39.00.00 of the Harmonized Tariff Schedule of the United States (HTSUS). When packaged together as a set for retail sale with an item that is separately classified under headings 8202 to 8205 of the HTSUS, diamond sawblades or parts thereof may be imported under heading 8206.00.00.00 of the HTSUS. On October 11, 2011, the Department included the 6804.21.00.00 HTSUS classification number to the customs case reference file, pursuant to a request by U.S. Customs and Border Protection (CBP).4 The tariff classification is provided for convenience and customs purposes; however, the written description of the scope of the order is dispositive.

    4See Diamond Sawblades and Parts Thereof from the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review, 76 FR 76128, 76130 (December 6, 2011).

    Initiation of Changed Circumstances Review

    Pursuant to section 751(b)(1) of the Act and 19 CFR 351.216(d), the Department will conduct a changed circumstances review upon receipt of a request from an interested party or receipt of information concerning an antidumping duty order which shows changed circumstances sufficient to warrant a review of the order. In the past, the Department has used changed circumstances reviews to address the applicability of cash deposit rates after there have been changes in the name or structure of a respondent, such as a merger or spinoff (“successor-in-interest,” or “successorship,” determinations).5 Based on the request from Chengdu Huifeng New Material Technology Co., Ltd., and in accordance with section 751(b)(1) of Act and 19 CFR 351.216(b), we are initiating a changed circumstances review to determine whether Chengdu Huifeng New Material Technology Co., Ltd. is the successor-in-interest to Chengdu Huifeng Diamond Tools Co., Ltd. for purposes of antidumping duty liability.

    5See, e.g., Crystalline Silicon Photovoltaic Celols, Whether or Not Assembled Into Modules, from the People's Republic of China: Final Results of Changed Circumstances Review, 81 FR 91909 (December 19, 2016).

    Preliminary Results of Changed Circumstances Review

    If we conclude that an expedited action is warranted, we may combine the notices of initiation and preliminary results of a changed circumstances review under 19 CFR 351.221(c)(3)(ii). The Department has combined the notice of initiation and preliminary results in successor-in-interest cases when sufficient documentation has been provided supporting the request to make a preliminary determination.6 In this instance, we have on the record the information necessary to make a preliminary finding. Thus, we find that expedited action is warranted and have combined the notices of initiation and preliminary results pursuant to 19 CFR 351.221(c)(3)(ii).

    6See, e.g., Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review: Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, from the People's Republic of China, 81 FR 76561 (November 3, 2016).

    In making a successor-in-interest determination for purposes of antidumping duty liability, the Department examines several factors including, but not limited to, changes in management, production facilities, supplier relationships, and customer base.7 While no single factor or combination of these factors will necessarily provide a dispositive indication of a successor-in-interest relationship, the Department will generally consider the new company to be the successor to the previous company if the new company's operations are not materially dissimilar to those of its predecessor.8 Thus, if the evidence demonstrates that, with respect to the production and sales of the subject merchandise, the new company operates as essentially the same business entity as the former company, the Department will accord the new company the same antidumping treatment as its predecessor.9

    7See, e.g., Pressure Sensitive Plastic Tape from Italy: Preliminary Results of Antidumping Duty Changed Circumstances Review, 75 FR 8925 (February 26, 2010), unchanged in Pressure Sensitive Plastic Tape from Italy: Final Results of Antidumping Duty Changed Circumstances Review, 75 FR 27706 (May 18, 2010); and Brake Rotors from the People's Republic of China: Final Results of Changed Circumstances Antidumping Duty Administrative Review, 70 FR 69941 (November 18, 2005) (Brake Rotors), citing Brass Sheet and Strip from Canada; Final Results of Antidumping Duty Administrative Review, 57 FR 20460 (May 13, 1992).

    8See, e.g., Brake Rotors.

    9Id. See also, e.g., Notice of Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review: Certain Frozen Warmwater Shrimp from India, 77 FR 64953 (October 24, 2012), unchanged in Final Results of Antidumping Duty Changed Circumstances Review: Certain Frozen Warmwater Shrimp from India, 77 FR 73619 (December 11, 2012).

    In its CCR Request and Supplemental Response,10 Chengdu Huifeng New Material Technology Co., Ltd. has provided evidence for us to preliminarily determine that it is the successor-in-interest to Chengdu Huifeng Diamond Tools Co., Ltd. Chengdu Huifeng New Material Technology Co., Ltd. states that its management, production facilities, and customer/supplier relationships have not changed as a result of changes to the legal status and name of the company.11 Chengdu Huifeng New Material Technology Co., Ltd., provided documents showing changes to the legal status and name of the company.12 Further, Chengdu Huifeng New Material Technology Co., Ltd., provided documents demonstrating that its production facilities and their location and domestic and overseas customers and suppliers were the same before and after the changes to the company's legal status and name.13 Chengdu Huifeng New Material Technology Co., Ltd. also provided a list of members of the management team and supporting documentation indicating that Chengdu Huifeng Diamond Tools Co., Ltd.'s managers hold the same positions in Chengdu Huifeng New Material Technology Co., Ltd., as well as documentation showing nominal changes to the members of the board of directors made as a result of internal shifts among existing management and board members.14

    10See CCR Request and Chengdu Huifeng New Material Technology Co., Ltd.'s supplemental response dated October 10, 2017 (Supplemental Response).

    11Id.

    12See, e.g., CCR Request at Exhibits 1, 2, 8, and 9.

    13See CCR Request at Exhibits 1 through 6, and Supplemental Response at 1 and Exhibits S1-1, S1-2, S1-3, and S1-5.

    14See CCR Request at Exhibit 3, 7, and 8, and Supplemental Response at Exhibit S1-4.

    Based on record evidence, we preliminarily determine that Chengdu Huifeng New Material Technology Co., Ltd. is the successor-in-interest to Chengdu Huifeng Diamond Tools Co., Ltd. for purposes of antidumping duty liability because the changes to the legal status and name of the company resulted in no significant changes to management, production facilities, supplier relationships, or customers. As a result, we preliminarily determine that Chengdu Huifeng New Material Technology Co., Ltd. operates as essentially the same business entity as Chengdu Huifeng Diamond Tools Co., Ltd. Thus, we preliminarily determine that Chengdu Huifeng New Material Technology Co., Ltd. should receive the same antidumping duty cash deposit rate with respect to the subject merchandise as Chengdu Huifeng Diamond Tools Co., Ltd., its predecessor company.

    If these preliminary results are adopted in our final results of this changed circumstances review, effective on the publication date of our final results, we will instruct CBP to suspend liquidation of entries of subject merchandise exported by Chengdu Huifeng New Material Technology Co., Ltd. at Chengdu Huifeng Diamond Tools Co., Ltd.'s cash deposit rate.

    Public Comment

    Interested parties may submit case briefs no later than 14 days after the publication of this notice.15 Rebuttal briefs, which must be limited to issues raised in case briefs, may be filed not later than five days after the deadline for filing case briefs.16 Parties who submit case briefs or rebuttal briefs in this changed circumstance review are requested to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities. Interested parties that wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS, within 14 days of publication of this notice.17 The hearing request should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing to be held at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230 in a room to be determined. Parties will be notified of the time and date of any hearing, if requested.18

    15See 19 CFR 351.309(c)(1)(ii). (“Any interested party may submit a `case brief ' within . . . 30 days after the date of publication of the preliminary results of {a changed circumstances} review, unless the Secretary alters the time limit. . . .”) (Emphasis added).

    16See 19 CFR 351.309(d).

    17See 19 CFR 351.310(c) (“Any interested party may request that the Secretary hold a public hearing on arguments to be raised in case or rebuttal briefs within 30 days after the date of publication of the . . . preliminary results of review, unless the Secretary alters this time limit. . . .”) (Emphasis added). See also 19 CFR 351.303 for general filing requirements.

    18See 19 CFR 351.310.

    All submissions, with limited exceptions, must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov. An electronically-filed document must be received successfully in its entirety by no later than 5:00 p.m. Eastern Time on the date the document is due.

    Notifications to Interested Parties

    Consistent with 19 CFR 351.216(e), we intend to issue the final results of this changed circumstances review no later than 270 days after the date on which this review was initiated, or within 45 days after the publication of the preliminary results if all parties in this review agree to our preliminary results. The final results will include the Department's analysis of issues raised in any written comments.

    We are issuing and publishing this initiation and preliminary results notice in accordance with sections 751(b)(1) and 777(i)(1) of the Act, 19 CFR 351.216(b) and (d), and 19 CFR 351.221(c)(3).

    Dated: November 1, 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. 2017-24183 Filed 11-6-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-904] Certain Activated Carbon From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016 AGENCY:

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

    SUMMARY:

    On May 5, 2017 the Department of Commerce (the Department) published the preliminary results of the 9th administrative review of the antidumping duty order on certain activated carbon from the People's Republic of China (PRC). We gave interested parties an opportunity to comment on the preliminary results. Based on our analysis of the comments received, we made changes to the margin calculations for these final results of the antidumping duty administrative review. The final weighted-average dumping margins are listed below in the “Final Results of the Review” section of this notice. The period of review (POR) is April 1, 2015, through March 31, 2016. The two mandatory respondents in this administrative review are Jacobi Carbons AB (Jacobi) and Datong Juqiang Activated Carbon Co. Ltd. (Datong Juqiang).

    DATES:

    Applicable November 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Robert Palmer or John Anwesen, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-9068, or (202) 482-0131, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    The Department published the Preliminary Results1 on May 5, 2017. For events subsequent to the Preliminary Results, see the Department's Issues and Decision Memorandum.2 On July 24, 2017,3 in accordance with section 751(a)(3)(A) of the Tariff Act of 1930, as amended (Act), the Department extended the deadline for issuing the final results by 60 days until November 1, 2017.

    1See Certain Activated Carbon from the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review; 2015-2016, 82 FR 21195 (May 5, 2017), and accompanying Preliminary Decision Memorandum (Preliminary Results).

    2See Memorandum,”Certain Activated Carbon from the People's Republic of China: Issues and Decision Memorandum for the Final Results of the Ninth Antidumping Duty Administrative Review,” dated concurrently with, and hereby adopted by, this notice (Issues and Decision Memorandum).

    3See Memorandum, “Activated Carbon from the People's Republic of China: Extension of Deadline for Final Results of 2015-2016 Antidumping Duty Administrative Review,” dated June 13, 2016.

    Scope of the Order

    The merchandise subject to the Order4 is certain activated carbon. The products are currently classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) subheading 3802.1000. Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the scope of the order remains dispositive.5

    4See Notice of Antidumping Duty Order: Certain Activated Carbon from the People's Republic of China, 72 FR 20988 (April 27, 2007) (Order).

    5See Issues and Decision Memorandum for a complete description of the scope of the Order.

    Analysis of Comments Received

    In the Issues and Decision Memorandum, we addressed all issues raised in parties' case and rebuttal briefs. In Appendix I to this notice, we provided a list of the issues raised by parties. The Issues and Decision Memorandum is a public document and is on file in the Central Records Unit (CRU), Room B8024 of the main Department of Commerce building, as well as electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov and it is available to all parties in the CRU. In addition, parties can directly access a complete version of the Issues and Decision Memorandum on the internet at http://enforcement.trade.gov/frn/index.html. The signed Issues and Decision Memorandum and the electronic version of the Issues and Decision Memorandum are identical in content.

    Verification

    Pursuant to section 782(i) of the Act, and 19 CFR 351.307(b)(iv), from May 9-23, 2017, we conducted verification of the questionnaire responses of Datong Juqiang and Jacobi.6

    6See Memorandum, “Verification of the Questionnaire Responses of Datong Juqiang Activated Carbon Co., Ltd. in the Antidumping Administrative Review of Certain Activated Carbon from the People's Republic of China,” dated June 30, 2017; Memorandum, “Verification of Questionnaire Responses of Datong Juqiang Activated Carbon Co., Ltd.'s Supplier in the Antidumping Administrative Review of Certain Activated Carbon from the People's Republic of China,” dated June 30, 2017; Memorandum, “Verification of the Questionnaire Responses of Ningxia Huahui Activated Carbon Co., Ltd. in the Antidumping Administrative Review of Certain activated Carbon form the People's Republic of China,” dated June 30, 2017; Memorandum, “Verification of the Questionnaire Responses of Ningxia Guanghua Activated Carbon Co., Ltd. in the Antidumping Administrative Review of Certain Activated Carbon from the People's Republic of China,” dated June 30, 2017; and Memorandum, “Verification of the Questionnaire Responses of Jacobi Carbons Industry (Tianjin) Company Limited in the Antidumping Administrative Review of Certain Activated Carbon from the People's Republic of China,” dated June 30, 2017.

    Changes Since the Preliminary Results

    Based on our review of the record and comments received from interested parties regarding our Preliminary Results, we made certain revisions to the margin calculations for Jacobi, Datong Juqiang, and the non-examined, separate rate respondents.7 Further, the Issues and Decision Memorandum contains descriptions of these revisions.8

    7See Memoranda, “Antidumping Duty Administrative Review of Certain Activated Carbon from the People's Republic of China: Final Determination Calculation Memorandum for Jacobi Carbons AB,” and “Antidumping Duty Administrative Review of Certain Activated Carbon the People's Republic of China: Final Determination Calculation Memorandum for Datong Juqiang Activated Carbon Co., Ltd., ” dated concurrently with this memorandum.

    8See Issues and Decisions Memorandum at 4-5 for a summary of these revisions.

    Final Determination of No Shipments

    In the Preliminary Results, the Department preliminarily determined that Calgon Carbon (Tianjin) Co., Ltd., Sinoacarbon International Trading Co., Ltd., and Shanxi Dapu International Trade Co., Ltd. had no shipments during the period of review (POR).9 We received no information to contradict this determination. Therefore, the Department continues to determine that Calgon Carbon (Tianjin) Co., Ltd., Sinoacarbon International Trading Co., Ltd., and Shanxi Dapu International Trade Co., Ltd. had no shipments of subject merchandise during the POR, and will issue appropriate liquidation instructions that are consistent with our “automatic assessment” clarification, for these final results.10

    9See Preliminary Results at 21195.

    10See Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 4, 2011) (Assessment Practice Refinement).

    Separate Rate Respondents

    In our Preliminary Results, we determined that Jacobi, Datong Juqiang, and 13 other companies demonstrated their eligibility for separate rates.11 We have received no comments or argument since the issuance of the Preliminary Results that provides a basis for reconsideration of these determinations. Therefore, for these final results, we continue to find that the 13 companies listed in the table in the “Final Results” section of this notice are eligible for a separate rate.

    11See Preliminary Results, 82 FR 21196, and accompanying Preliminary Decision Memorandum at 7-9.

    Rate for Non-Examined Separate Rate Respondents

    The statute and the Department's regulations do not address the establishment of a rate to be assigned to respondents not selected for individual examination when the Department limits its examination of companies subject to the administrative review pursuant to section 777A(c)(2)(B) of the Act. Generally, the Department looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the rate for respondents not individually examined in an administrative review. Section 735(c)(5)(A) of the Act articulates a preference for not calculating an all-others rate using rates which are zero, de minimis, or based entirely on facts available.12 Accordingly, the Department's usual practice has been to determine the dumping margin for companies not individually examined by averaging the weighted-average dumping margins for the individually examined respondents, excluding rates that are zero, de minimis, or based entirely on facts available.13

    12See Ball Bearings and Parts Thereof from France, Germany, Italy, Japan, and the United Kingdom: Final Results of Antidumping Duty Administrative Reviews and Rescission of Reviews in Part, 73 FR 52823, 52824 (September 11, 2008), and accompanying Issues and Decision Memorandum(IDM) at Comment 16.

    13See, e.g., Preliminary Determination of Sales at Less Than Fair Value and Partial Affirmative Determination of Critical Circumstances: Certain Polyester Staple Fiber from the People's Republic of China, 71 FR 77373, 77377 (December 26, 2006), unchanged in Final Determination of Sales at Less Than Fair Value and Partial Affirmative Determination of Critical Circumstances: Certain Polyester Staple Fiber from the People's Republic of China, 72 FR 19690 (April 19, 2007).

    In the Preliminary Results, 14 the Department calculated rates for Datong Juqiang and Jacobi that were not zero, de minimis, or based entirely on facts available. However, for these final results, the calculated rate for Datong Juqiang is zero, and the calculated rate for Jacobi continues to be above de minimis. Therefore, the Department has assigned to the companies that have not been individually examined, but have demonstrated their eligibility for a separate rate, Jacobi's calculated rate for these final results.

    14See Preliminary Decision Memorandum at 10-11.

    Final Results of the Review

    For companies subject to this review, which established their eligibility for a separate rate, the Department determines that the following weighted-average dumping margins exist for the POR from April 1, 2015, through March 31, 2016:

    Exporter Weighted-
  • average dumping
  • margin
  • (USD/kg) 15
  • Jacobi Carbons AB 16 0.22 Datong Juqiang Activated Carbon Co., Ltd. 0.00 Beijing Pacific Activated Carbon Products Co., Ltd. 0.22 Carbon Activated Tianjin Co., Ltd. 0.22 Datong Municipal Yunguang Activated Carbon Co., Ltd. 0.22 Jilin Bright Future Chemicals Company, Ltd. 0.22 Ningxia Guanghua Cherishmet Activated Carbon Co., Ltd. 0.22 Ningxia Huahui Activated Carbon Co., Ltd. 0.22 Ningxia Mineral and Chemical Limited 0.22 Shanxi Industry Technology Trading Co., Ltd. 0.22 Shanxi Sincere Industrial Co., Ltd. 0.22 Shanxi Tianxi Purification Filter Co., Ltd. 0.22 Tancarb Activated Carbon Co., Ltd. 0.22 Tianjin Channel Filters Co., Ltd. 0.22 Tianjin Maijin Industries Co., Ltd. 0.22

    In the Preliminary Results, the Department found that 186 companies for which a review was requested did not establish eligibility for a separate rate because they did not file a separate rate application or a separate rate certification, as appropriate. No interested party commented on the Department's preliminary determination with respect to these 186 companies. Therefore, for these final results we determine these companies, listed in Appendix II of this notice, to be part of the PRC-wide entity. Because no party requested a review of the PRC-wide entity, and the Department no longer considers the PRC-wide entity as an exporter conditionally subject to administrative reviews,17 we did not conduct a review of the PRC-wide entity. Thus, the weighted-average dumping margin for the PRC-wide entity (i.e., 2.42 USD/kg) 18 is not subject to change as a result of this review.

    15 In the second administrative review of the Order, the Department determined that it would calculate per-unit weighted-average dumping margins and assessment rates for all future reviews. See Certain Activated Carbon from the People's Republic of China: Final Results and Partial Rescission of Second Antidumping Duty Administrative Review, 75 FR 70208, 70211 (November 17, 2010) (AR2 Carbon), and accompanying IDM at Comment 3.

    16 In the third administrative review of the Order, the Department found that Jacobi Carbons AB, Tianjin Jacobi International Trading Co. Ltd., and Jacobi Carbons Industry (Tianjin) are a single entity and, because there were no facts presented on the record of this review which would call into question our prior finding, we continue to treat these companies as part of a single entity for this administrative review, pursuant to sections 771(33)(E), (F), and (G) of the Act and 19 CFR 351.401(f). See Certain Activated Carbon from the People's Republic of China: Final Results and Partial Rescission of Third Antidumping Duty Administrative Review, 76 FR 67142, 67145 n.25 (October 31, 2011); See also Preliminary Decision Memorandum at n.8.

    17See Antidumping Proceedings: Announcement of Change in Department Practice for Respondent Selection in Antidumping Duty Proceedings and Conditional Review of the Nonmarket Economy Entity in NME Antidumping Duty Proceedings, 78 FR 65963, 65969-70 (November 4, 2013).

    18See, e.g., Certain Activated Carbon from the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2012-2013, 79 FR 70163, 70165 (November 25, 2014).

    Assessment Rates

    Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), the Department has determined, and U.S Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. The Department intends to issue assessment instructions to CBP 15 days after the publication date of these final results of review.

    For each individually-examined respondent in this review which has a final weighted-average dumping margin that is not zero or de minimis (i.e., less than 0.5 percent), we will calculate importer- (or customer-) specific per-unit duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's (or customer's) examined sales to the total sales quantity associated with those sales, in accordance with 19 CFR 351.212(b)(1).19 The Department will also calculate (estimated) ad valorem importer-specific assessment rates with which to assess whether the per-unit assessment rates are de minimis. Where either the respondent's weighted-average dumping margin is zero or de minimis, or an importer- (or cus-tomer-) specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.20

    19See AR2 Carbon, and accompanying IDM at Comment 3.

    20See 19 CFR 351.106(c)(2).

    For the respondents which were not selected for individual examination in this administrative review and which qualified for a separate rate, the assessment rate will be equal to the rate assigned to them for the final results (i.e. the 0.22 USD/kg rate for Jacobi).

    For the companies identified in Appendix II as part of the PRC-wide entity, we will instruct CBP to apply a per-unit assessment rate of 2.42 USD/kg to all entries of subject merchandise during the POR which were produced or exported by those companies.

    Pursuant to a refinement in the Department's non-market economy practice, for sales that were not reported in the U.S. sales data submitted by companies individually examined during this review, the Department will instruct CBP to liquidate entries associated with those sales at the rate for the PRC-wide entity. Furthermore, where the Department found that an exporter under review had no shipments of the subject merchandise, any suspended entries that entered under that exporter's case number (i.e., at that exporter's cash deposit rate) will be liquidated at the rate for the PRC-wide entity.21

    21 For a full discussion of this practice, see Assessment Practice Refinement, 76 FR at 65694.

    Cash Deposit Requirements

    The following per-unit cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) For Jacobi, Datong Juqiang, and the non-examined, separate rate respondents, the cash deposit rate will be equal to their weighted-average dumping margins established in the final results of this review; (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recently completed segment of this proceeding in which they were reviewed; (3) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be equal to the weighted-average dumping margin for the PRC-wide entity (i.e., 2.42 USD/kg); and (4) for all non-PRC exporters of subject merchandise which have not received their own separate rate, the cash deposit rate will be the rate applicable to the PRC exporter(s) that supplied that non-PRC exporter. These per-unit cash deposit requirements, when imposed, shall remain in effect until further notice.

    Disclosure

    We intend to disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).

    Notification to Importers Regarding the Reimbursement of Duties

    This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties has occurred and the subsequent assessment of double antidumping duties.

    Notification Regarding Administrative Protective Order

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    We are issuing and publishing these final results of administrative review and notice in accordance with sections 751(a)(1) and 777(i) of the Act.

    Dated: November 1, 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. Appendix I Issues and Decision Memorandum Summary Background Scope of the Order Changes Since the Preliminary Results Discussion of the Issues Comment 1: Value Added Tax and Entered Value Comment 2: Inflator Calculation Comment 3: Anthracite Coal Surrogate Value Comment 4: Coal Tar Surrogate Value Comment 5: Carbonized Material Surrogate Value Comment 6: Hydrochloric Acid Surrogate Value Comment 7: Whether To Use IndustrySpecific Thai Labor Data Comment 8: Whether To Continue to Use the Thai Financial Statements Comment 9: Whether To Apply Partial Adverse Facts Available for Datong Juqiang's Wood Input Comment 10: Whether To Revise Ningxia Guanghua Activated Carbon Co., Ltd.'s Water Consumption Comment 11: Jacobi Tianjin New Packing Variable Comment 12: Whether To Adjust Jacobi Tianjin's Packing Variance Comment 13: Jacobi Tianjin's Fiberboard Consumption Comment 14: Whether To Apply Adverse Facts Available to Jacobi Tianjin's Factors of Production Allocation Recommendation Appendix II Companies Not Eligible for a Separate Rate and To Be Treated as Part of PRC-Wide Entity Company 1. AmeriAsia Advanced Activated Carbon Products Co., Ltd. 2. Anhui Handfull International Trading (Group) Co., Ltd. 3. Anhui Hengyuan Trade Co. Ltd. 4. Anyang Sino-Shon International Trading Co., Ltd. 5. Baoding Activated Carbon Factory 6. Beijing Broad Activated Carbon Co., Ltd. 7. Beijing Embrace Technology Co., Ltd. 8. Beijing Haijian Jiechang Environmental Protection Chemicals 9. Beijing Hibridge Trading Co., Ltd, 10. Bengbu Jiutong Trade Co, Ltd. 11. Changji Hongke Activated Carbon Co., Ltd. 12. Chengde Jiayu Activated Carbon Factory 13. China National Building Materials and Equipment Import and Export Corp. 14. China National Nuclear General Company Ningxia Activated Carbon Factory 15. China Nuclear Ningxia Activated Carbon Plant 16. China SDIC International Trade Co., Ltd. 17. Chongqing Feiyang Active Carbon Manufacture Co., Ltd. 18. Da Neng Zheng Da Activated Carbon Co., Ltd. 19. Datong Carbon Corporation 20. Datong Changtai Activated Carbon Co., Ltd. 21. Datong City Zuoyun County Activated Carbon Co., Ltd. 22. Datong Fenghua Activated Carbon 23. Datong Forward Activated Carbon Co., Ltd. 24. Datong Fuping Activated Carbon Co. Ltd. 25. Datong Guanghua Activated Co., Ltd. 26. Datong Hongtai Activated Carbon Co., Ltd. 27. Datong Huanqing Activated Carbon Co., Ltd. 28. Datong Huaxin Activated Carbon 29. Datong Huibao Active Carbon Co., Ltd. 30. Datong Huibao Activated Carbon Co., Ltd. 31. Datong Huiyuan Cooperative Activated Carbon Plant 32. Datong Kaneng Carbon Co. Ltd. 33. Datong Locomotive Coal & Chemicals Co., Ltd. 34. Datong Tianzhao Activated Carbon Co., Ltd. 35. DaTong Tri-Star & Power Carbon Plant 36. Datong Weidu Activated Carbon Co., Ltd. 37. Datong Xuanyang Activated Carbon Co., Ltd. 38. Datong Zuoyun Biyun Activated Carbon Co., Ltd. 39. Datong Zuoyun Fu Ping Activated Carbon Co., Ltd. 40. Dezhou Jiayu Activated Carbon Factory 41. Dongguan Baofu Activated Carbon 42. Dongguan SYS Hitek Co., Ltd. 43. Dushanzi Chemical Factory 44. Fu Yuan Activated Carbon Co., Ltd. 45. Fujian Jianyang Carbon Plant 46. Fujian Nanping Yuanli Activated Carbon Co., Ltd. 47. Fujian Xinsen Carbon Co., Ltd. 48. Fujian Yuanli Active Carbon Co., Ltd. 49. Fujian Active Carbon Industrial Co., Ltd. 50. Fujian Yuanli Active Carbon Industrial Co., Ltd. 51. Fujian Zhixing Activated Carbon Co., Ltd. 52. Fuzhou Taking Chemical 53. Fuzhou Yihuan Carbon 54. Great Bright Industrial 55. Hangzhou Hengxing Activated Carbon 56. Hangzhou Hengxing Activated Carbon Co., Ltd. 57. Hangzhou Linan Tianbo Material (HSLATB) 58. Hangzhou Nature Technology 59. Hangzhou Waterland Environmental Technologies Co., Ltd. 60. Hebei Foreign Trade and Advertising Corporation 61. Hebei Luna Trading Co., Ltd. 62. Hebei Shenglun Import & Export Group Company 63. Hegongye Ninxia Activated Carbon Factory 64. Heilongjiang Provincial Hechang Import & Export Co., Ltd. 65. Hongke Activated Carbon Co., Ltd. 66. Huaibei Environment Protection Material Plant 67. Huairen Huanyu Purification Material Co., Ltd. 68. Huairen Jinbei Chemical Co., Ltd. 69. Huaiyushan Activated Carbon Group 70. Huatai Activated Carbon 71. Huzhou Zhonglin Activated Carbon 72. Inner Mongolia Taixi Coal Chemical Industry Limited Company 73. Itigi Corp. Ltd. 74. J&D Activated Carbon Filter Co. Ltd. 75. Jiangle County Xinhua Activated Carbon Co., Ltd. 76. Jiangsu Taixing Yixin Activated Carbon Technology Co., Ltd. 77. Jiangxi Hanson Import Export Co. 78. Jiangxi Huaiyushan Activated Carbon 79. Jiangxi Huaiyushan Activated Carbon Group Co. 80. Jiangxi Huaiyushan Suntar Active Carbon Co., Ltd. 81. Jiangxi Jinma Carbon 82. Jiangxi Yuanli Huaiyushan Active Carbon Co., Ltd. 83. Jianou Zhixing Activated Carbon 84. Jiaocheng Xinxin Purifìcation Material Co., Ltd. 85. Jilin Province Bright Future Industry and Commerce Co., Ltd. 86. Jing Mao (Dongguan) Activated Carbon Co., Ltd. 87. Kaihua Xingda Chemical Co., Ltd. 88. Kemflo (Nanjing) Environmental Tech 89. Keyun Shipping (Tianjin) Agency Co., Ltd. 90. Kunshan Actview Carbon Technology Co., Ltd. 91. Langfang Winfield Filtration Co. 92. Link Shipping Limited 93. Longyan Wanan Activated Carbon 94. Meadwestvaco (China) Holding Co., Ltd. 95. Mindong Lianyi Group 96. Nanjing Mulinsen Charcoal 97. Nantong Ameriasia Advanoed Activated Carbon Product Co., Ltd. 98. Ningxia Baiyun Carbon Co., Ltd. 99. Ningxia Baota Activated Carbon Co., Ltd. 100. Ningxia Baota Active Carbon Plant 101. Ningxia Guanghua A/C Co., Ltd. 102. Ningxia Blue-White-Black Activated Carbon (BWB) 103. Ningxia Fengyuan Activated Carbon Co., Ltd. 104. Ningxia Guanghua Chemical Activated Carbon Co., Ltd. 105. Ningxia Haoqing Activated Carbon Co., Ltd. 106. Ningxia Henghui Activated Carbon 107. Ningxia Honghua Carbon Industrial Corporation 108. Ningxia Huinong Xingsheng Activated Carbon Co., Ltd. 109. Ningxia Jirui Activated Carbon 110. Ningxia Lingzhou Foreign Trade Co., Ltd. 111. Ningxia Luyuangheng Activated Carbon Co., Ltd. 112. Ningxia Pingluo County Yaofu Activated Carbon Plant 113. Ningxia Pingluo Xuanzhong Activated Carbon Co., Ltd. 114. Ningxia Pingluo Yaofu Activated Carbon Factory 115. Ningxia Taixi Activated Carbon 116. Ningxia Tianfu Activated Carbon Co., Ltd. 117. Ninxia Tongfu Coking Co., Ltd. 118. Ningxia Weining Active Carbon Co., Ltd. 119. Ningxia Xingsheng Coal and Active Carbon Co., Ltd. 120. Ningxia Xingsheng Coke & Activated Carbon Co., Ltd. 121. Ningxia Yinchuan Lanqiya Activated Carbon Co., Ltd. 122. Ningxia Yirong Alloy Iron Co., Ltd. 123. Ningxia Zhengyuan Activated 124. Nuclear Ningxia Activated Carbon Co., Ltd. 125. OEC Logistic Qingdao Co., Ltd. 126. OEC Logistics Co., Ltd. (Tianjin) 127. Panshan Import and Export Corporation 128. Pingluo Xuanzhong Activated Carbon Co., Ltd. 129. Pingluo Yu Yang Activated Carbon Co., Ltd. 130. Shanghai Activated Carbon Co., Ltd. 131. Shanghai Astronautical Science Technology Development Corporation 132. Shanghai Coking and Chemical Corporation 133. Shanghai Goldenbridge International 134. Shanghai Jiayu International Trading (DezhouJiayu and Chengde Jiayu) 135. Shanghai Jinhu Activated Carbon (Xingan Shenxin and Jiangle Xinhua) 136. Shanghai Light Industry and Textile Import & Export Co., Ltd. 137. Shanghai Mebao Activated Carbon 138. Shanghai Xingchang Activated Carbon 139. Shanxi Blue Sky Purification Material Co., Ltd. 140. Shanxi Carbon Industry Co., Ltd. 141. Shanxi DMD Corporation 142. Shanxi Newtime Co., Ltd. 143. Shanxi Qixian Foreign Trade Corporation 144. Shanxi Qixian Hongkai Active Carbon Goods 145. Shanxi Supply and Marketing Cooperative 146. Shanxi Tianli Ruihai Enterprise Co. 147. Shanxi U Rely International Trade 148. Shanxi Xiaoyi Huanyu Chemicals Co., Ltd. 149. Shanxi Xinhua Activated Carbon Co., Ltd. 150. Shanxi Xinhua Chemical Co., Ltd. (formerly Shanxi Xinhua Chemical Factory) 151. Shanxi Xinhua Protective Equipment 152. Shanxi Xinshidai Import Export Co., Ltd. 153. Shanxi Xuanzhong Chemical Industry Co., Ltd. 154. Shanxi Zuoyun Yunpeng Coal Chemistry 155. Shenzhen Sihaiweilong Technology Co. 156. Shijiazhuang Xinshuang Trade Co., Ltd. 157. Sincere Carbon Industrial Co. Ltd. 158. Taining Jinhu Carbon 159. Tangshan Solid Carbon Co., Ltd. 160. Tianchang (Tianjin) Activated Carbon 161. Tianjin Century Promote International Trade Co., Ltd. 162. Taiyuan Hengxinda Trade Co., Ltd, 163. Tonghua Bright Future Activated Carbon Plant 164. Tonghua Xinpeng Activated Carbon Factory 165. Top One International Trading Co., Ltd. 166. Triple Eagle Container Line 167. Uniclear New-Material Co., Ltd. 168. United Manufacturing International (Beijing) Ltd. 169. Valqua Seal Products (Shanghai) Co. 170. VitaPac (HK) Industrial Ltd. 171. Wellink Chemical Industry 172. Xi Li Activated Carbon Co., Ltd. 173. Xi'an Shuntong International Trade & Industrials Co., Ltd. 174. Xiamen All Carbon Corporation 175. Xingan County Shenxin Activated Carbon Factory 176. Xinhua Chemical Company Ltd. 177. Xuanzhong Chemical Industry 178. Yangyuan Hengchang Active Carbon 179. Yicheng Logistics 180. Yinchuan Lanqiya Activated Carbon Co., Ltd. 181. Zhejiang Topc Chemical Industry Co. 182. Zhejiang Quizhou Zhongsen Carbon 183. Zhejiang Xingda Activated Carbon Co., Ltd. 184. Zhejiang Yun He Tang Co., Ltd. 185. Zhuxi Activated Carbon 186. Zuoyun Bright Future Activated Carbon Plant
    [FR Doc. 2017-24184 Filed 11-6-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-932] Certain Steel Threaded Rod From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016 AGENCY:

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

    SUMMARY:

    On May 5, 2017, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on certain steel threaded rod from the People's Republic of China (PRC) for the period of review (POR), April 1, 2015, through March 31, 2016. For the final results of this review, the Department finds that Jiaxing Brother Fastener Co., Ltd., RMB Fasteners Ltd., and IFI & Morgan Ltd. (RMB/IFI) had a single shipment, and Tianjin Port Free Trade Zone and Star Pipe International Trade Co., Ltd. (Tianjin Star) is eligible for a separate rate.

    DATES:

    Applicable November 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Courtney Canales or Matthew Renkey, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4997 or (202) 482-2312, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On May 5, 2017, the Department published the Preliminary Results of the antidumping duty order on certain steel threaded rod from the PRC.1 On June 12, 2017, the petitioner submitted case briefs.2 On June 16, 2017 the Department released draft U.S. Customs and Border Protection (CBP) instructions.3 On June 21, 2017, RMB/IFI and Tianjin Star submitted rebuttal briefs.4 On September 1, 2017, the Department extended the deadline for the final results to November 1, 2017.5

    1See Certain Steel Threaded Rod from the People's Republic of China: Preliminary Results of the Antidumping Duty Administrative Review, and Rescission of Antidumping Duty Administrative Review; 2014-2015, 82 FR 21189 (May 5, 2017) (Preliminary Results) and accompanying Preliminary Decision Memorandum.

    2See the petitioner's June 12, 2017 submission.

    3See Memo to the File, from Courtney Canales, International Trade Compliance Analyst, “Certain Steel Threaded Rod from the People's Republic of China: Cash Deposit and Liquidation Instructions for the Preliminary Results,” dated June 16, 2017.

    4See RMB/IFI's June 21, 2017 submission; Tianjin Star's June 21, 2017 submission.

    5See Memorandum to Scot T. Fullerton, Director, Office VI, from Courtney Canales, International Trade Compliance Analyst, “Certain Steel Threaded Rod from the People's Republic of China: Extension of Deadline for Final Results of Antidumping Duty Administrative Review,” dated September 1, 2017.

    We note that no party submitted comments on the Department's preliminary determination to treat Zhejiang New Oriental Fastener Co., Ltd. (New Oriental), Zhejiang Heiter Industries Co., Ltd. (Heiter Industries), and Zhejiang Heiter Mfg. & Trade Co. Ltd. (Heiter Mfg. as part of the PRC-wide entity. Therefore, for these final results, we continue to find that New Oriental, Heiter Industries, and Heiter Mfg. are part of the PRC-wide entity. We also note that no party submitted comments on the draft CBP instructions.

    The Department conducted this administrative review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).

    Scope of the Order

    The merchandise covered by the order includes steel threaded rod. The subject merchandise is currently classifiable under subheading 7318.15.5051, 7318.15.5056, 7318.15.5090, and 7318.15.2095 of the United States Harmonized Tariff Schedule (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of the order, which is contained in the accompanying Issues and Decision Memorandum (I&D Memo), is dispositive.6

    6 For a full description of the scope of the order, see Memorandum from James Maeder Senior Director, performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to 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, “Certain Steel Threaded Rod from the People's Republic of China: Issues and Decision Memorandum for the Final Results of the Seventh Administrative Review” (November 1, 2017) (I&D Memo).

    Analysis of Comments Received

    We addressed all issues raised in the case and rebuttal briefs by parties in this review in the I&D Memo dated concurrently with, and hereby adopted by, this notice. A list of the issues which parties raised is attached in the Appendix to this notice. The I&D Memo is a public document and is on file in the Central Records Unit (CRU), Room B8024 of the main Department of Commerce building, as well as electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and in the CRU. In addition, a complete version of the I&D Memo can be accessed directly on the internet at http://enforcement.trade.gov/frn/index.html. The signed I&D Memo and the electronic versions of the I&D Memo are identical in content.

    Final Results

    The final weighted-average dumping margins are as follows:

    Exporter/producer Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • RMB Fasteners Ltd. and IFI & Morgan Ltd. (RMB/IFI) 0.00 Tianjin Port Free Trade Zone Tianjin Star International Trade Co., Ltd 5.40

    Because no party requested a review of the PRC-wide entity, and the Department no longer considers the PRC-wide entity as an exporter conditionally subject to administrative reviews,7 we did not conduct a review of the PRC-wide entity. Thus, the weighted-average dumping margin for the PRC-wide entity (i.e., 206.00 percent) 8 is not subject to change as a result of this review.

    7See Antidumping Proceedings: Announcement of Change in Department Practice for Respondent Selection in Antidumping Duty Proceedings and Conditional Review of the Nonmarket Economy Entity in NME Antidumping Duty Proceedings, 78 FR 65963, 65969-70 (November 4, 2013).

    8 The rate for the PRC-wide entity was originally set in the original investigation, see Certain Steel Threaded Rod from the People's Republic of China: Final Determination of Sales at Less than Fair Value, 74 FR 8907 (February 27, 2009). This rate has been applied in each subsequent administrative review in which there was a party being considered as part of the PRC-wide entity.

    Assessment Rates

    Pursuant to section 751(a)(2)(A) of the Act, and 19 CFR 351.212(b), the Department has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of the final results of this administrative review.

    Where the respondent reported reliable entered values, we calculated importer (or customer)-specific ad valorem rates by aggregating the dumping margins calculated for all U.S. sales to each importer (or customer) and dividing this amount by the total entered value of the sales to each importer (or customer).9 Where the Department calculated a weighted-average dumping margin by dividing the total amount of dumping for reviewed sales to that party by the total sales quantity associated with those transactions, the Department will direct CBP to assess importer-specific assessment rates based on the resulting per-unit rates.10 Where an importer- (or customer-) specific ad valorem or per-unit rate is greater than de minimis, the Department will instruct CBP to collect the appropriate duties at the time of liquidation.11 Where an importer- (or customer-) specific ad valorem or per-unit rate is zero or de minimis, the Department will instruct CBP to liquidate appropriate entries without regard to antidumping duties.12

    9See 19 CFR 351.212(b)(1).

    10Id.

    11Id.

    12See 19 CFR 351.106(c)(2).

    Pursuant to the Department's assessment practice, for entries that were not reported in the U.S. sales data submitted by companies individually examined during this review, the Department will instruct CBP to liquidate such entries at the rate for the PRC-wide entity.13

    13See Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011) (Reseller Policy).

    For the one suspended AD/CVD entry for which RMB/IFI had knowledge of sale in the United States, the Department will direct CBP to liquidate that entry without regard to antidumping duties. For all other entries claiming RMB/IFI as the exporter or producer, the Department will direct CBP to liquidate such entries and to assess antidumping duties pursuant to the Reseller Policy, i.e., at the rate for the PRC-wide entity. For all suspended AD/CVD entries by Tianjin Star, the Department will direct CBP to liquidate such entries and to assess antidumping duties at the rate identified in the Final Results section above.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For the exporters listed above, the cash deposit rate will be the rate established in the final results of review (except, if the rate is zero or de minimis, i.e., less than 0.5 percent, a zero cash deposit rate will be required for that company); (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recent period; (3) for all PRC exporters of subject merchandise which have not been found to be entitled to a separate rate, the cash deposit rate will be the PRC-Wide rate of 206 percent; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporters that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

    Disclosure

    Normally, the Department discloses to interested parties the calculations performed in connection with the final results within five days of its public announcement, or if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). However, because the Department has not calculated a weighted-average dumping margin for either of the mandatory respondents, there are no calculations to disclose.

    Notification to Importers

    This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Administrative Protective Order

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a violation subject to sanction.

    Notification to Interested Parties

    We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h) and 351.221(b)(5).

    Dated; November 1, 2017. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties for the Assistant Secretary for Enforcement and Compliance. Appendix Issues and Decision Memorandum I. Summary II. Scope III. Background IV. Discussion of the Issues Comment 1: Circumvention Concerns and Treatment of RMB/IFI Comment 2: Proper Classification and Collection of Antidumping Duties on Tianjin Star's Entries V. Conclusion
    [FR Doc. 2017-24178 Filed 11-6-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-475-836, A-580-891, A-469-816, A-489-831, A-412-826] Carbon and Alloy Steel Wire Rod From Italy, the Republic of Korea, Spain, Turkey, and the United Kingdom: Postponement of Final Determinations of Less-Than-Fair-Value Investigation and Extension of Provisional Measures AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) is postponing the deadline for issuing the final determinations in the less-than-fair-value (LTFV) investigations of carbon and alloy steel wire rod (wire rod) from Italy, the Republic of Korea (Korea), Spain, Turkey, and the United Kingdom (the UK) until no later than March 15, 2018, and is extending the provisional measures from a four-month period to a period of not more than six months. As the deadline for the final determinations of the countervailing duty (CVD) investigations of wire rod from Italy and Turkey have been aligned with the deadline for the final determinations of the LTFV investigations, the final CVD determinations shall also be postponed.

    DATES:

    Applicable November 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Victoria Cho (Italy) at 202-482-5075, Lingjun Wang (Korea) at 202-482-2316, Davina Freidmann (Spain) at 202-482-0698, Ryan Mullen (Turkey) at 202-482-5260, or Alice Maldonado (the UK) at 202-482-4682, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.

    SUPPLEMENTARY INFORMATION:

    Background

    On April 26, 2017, the Department of Commerce (the Department) published the notice of initiation of the LTFV investigations of imports of wire rod from Italy, Korea, Spain, Turkey, and the UK in the Federal Register.1 The period of investigations is January 1, 2016, through December 31, 2016, for the CVD investigations on imports from Italy and Turkey as well as for the LTFV investigations on imports from Italy, Korea, Spain, Turkey, and the UK. On September 5, 2017, and October 31, 2017, respectively, the Department published its preliminary determinations in the CVD and LTFV investigations.2 On September 18, 2017, the Department aligned the final deadline for the CVD investigations with the final determination of the LTFV investigations.3

    1See Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, United Arab Emirates, and United Kingdom: Initiation of Less-Than-Fair-Value Investigations, 82 FR 19207 (April 26, 2017) (LTFV Initiation Notice).

    2See Carbon and Alloy Steel Wire Rod from Italy: Preliminary Affirmative Countervailing Duty Determination, 82 FR 41931 (September 5, 2017); Carbon and Alloy Steel Wire Rod from the Republic of Turkey: Preliminary Affirmative Countervailing Duty Determination and Preliminary Affirmative Critical Circumstances Determination, in Part, 82 FR 41929 (September 5, 2017) (collectively CVD Preliminary Determinations). See also, Carbon and Alloy Steel Wire Rod from Italy: Preliminary Affirmative Determination of Sales at Less Than Fair Value, 82 FR 50381 (October 31, 2017); Carbon and Alloy Steel Wire Rod from the Republic of Korea: Preliminary Affirmative Determination of Sales at Less Than Fair Value, and Preliminary Negative Determination of Critical Circumstance, 82 FR 50386 (October 31, 2017); Carbon and Alloy Steel Wire Rod from Spain: Preliminary Affirmative Determination of Sales at Less Than Fair Value and Preliminary Determination of Critical Circumstance, in Part, 82 FR 50389 (October 31, 2017); Carbon and Alloy Steel Wire Rod from Turkey: Preliminary Affirmative Determination of Sales at Less Than Fair Value, and Preliminary Negative Determination of Critical Circumstance, 82 FR 50377 (October 31, 2017); and Carbon and Alloy Steel Wire Rod from the United Kingdom: Preliminary Affirmative Determination of Sales at Less Than Fair Value and Preliminary Determination of Critical Circumstance, 82 FR 50394 (October 31, 2017).

    3See Carbon and Alloy Steel Wire Rod from Italy and Turkey: Alignment of Final Countervailing Duty Determinations With Final Antidumping Duty Determinations, 82 FR 43516 (September 18, 2017).

    Postponement of Final LTFV Determinations and Aligned Final CVD Determinations

    Section 735(a)(2) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.210(b)(2) provide that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by the exporters or producers who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioners. Further, 19 CFR 351.210(e)(2) requires that such postponement requests by exporters be accompanied by a request for extension of provisional measures from a four-month period to a period of not more than six months, in accordance with section 733(d) of the Act.

    Between September 14, 2017, and October 10, 2017, Ferriere Nord S.p.A. (Ferriere Nord); POSCO; Global Steel Wire SA (GSW), CELSA Atlantic SA (CELSA Atlantic) and Compania Espanola de Laminacion (CELSA Barcelona) (collectively, CELSA); Habas Sinai ve Tibbi Gazlar Istihsal Endustrisi A.S. (Habas); Icdas Celik Enerji Tersane ve Ulasim Sanayi A.S. (Icdas); and British Steel Limited (British Steel), mandatory respondents in these investigations, requested that the Department fully extend the deadline for the final LTFV determinations, and extend the application of the provisional measures from a four-month period to a period of not more than six months.4

    4See Letters from Ferriere Nord, POSCO, CELSA, Habas, Icdas, and British Steel dated September 19, 2017, October 10, 2017, October 10, 2017, September 28, 2017, September 14, 2017, and September 18, 2017, respectively.

    On October 27, 2017, Gerdau Ameristeel US Inc., Nucor Corporation, Keystone Consolidated Industries, Inc., and Charter Steel (collectively, the Petitioners), requested that the Department grant the requests of the respondents in these investigations and fully extend the deadline for the final LTFV determinations.5

    5See Letters from the Petitioners dated October 27.

    In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii), because: (1) The preliminary determination was affirmative; (2) the request was made by the exporters and producers who account for a significant proportion of exports of the subject merchandise; and (3) no compelling reasons for denial exist, the Department is postponing the final determinations until no later than 135 days after the date of the publication of of the LTFV Preliminary Determinations, and extend the provisional measures from a four-month period to a period of not more than six months. Because the CVD investigations covering Italy and Turkey are aligned with the LTFV investigations as noted above, the Department will issue its final determinations in the CVD and LTFV investigations no later than March 15, 2018.

    This notice is issued and published pursuant to 19 CFR 351.210(g).

    Dated: November 1, 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. 2017-24175 Filed 11-6-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration United States Global Change Research Program (USGCRP) To Announce the Availability of a Draft Fourth National Climate Assessment Report for Public Comment AGENCY:

    National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).

    ACTION:

    Notice of availability for public comment.

    SUMMARY:

    The National Oceanic and Atmospheric Administration (NOAA) is publishing this notice on behalf of the United States Global Change Research Program (USGCRP) to announce the availability of a draft Fourth National Climate Assessment report for public comment. Following revision and further review (including by the National Academy of Sciences), a revised draft will undergo final Federal interagency clearance.

    DATES:

    Comments on this draft scientific assessment must be received by January 31, 2018.

    ADDRESSES:

    The draft Fourth National Climate Assessment can be accessed via the USGCRP Open Notices page (http://www.globalchange.gov/notices) or directly at the USGCRP Review and Comment System (https://review.globalchange.gov/). Registration details can be found on the review site home page, and review instructions are located on the dedicated report page. Comments may be submitted only via this online mechanism.

    All comments received through this process will be considered by the relevant chapter authors without knowledge of the commenters' identities. When the final assessment is issued, the comments and the commenters' names, along with the authors' responses, will become part of the public record and made available on http://www.globalchange.gov. No information submitted by a commenter as part of the registration process (such as an email address) will be disclosed publicly.

    Response to this notice is voluntary. Responses to this notice may be used by the government for program planning on a non-attribution basis. NOAA therefore requests that no business proprietary information or copyrighted information be submitted in response to this notice. Please note that the U.S. Government will not pay for response preparation, or for the use of any information contained in the response.

    FOR FURTHER INFORMATION CONTACT:

    David Dokken, (202) 419-3473, [email protected], U.S. Global Change Research Program.

    SUPPLEMENTARY INFORMATION:

    The U.S. Global Change Research Program (USGCRP) is mandated under the Global Change Research Act (GCRA) of 1990 to conduct a quadrennial National Climate Assessment (NCA) to evaluate scientific findings and uncertainties related to global change, analyze the effects of global change, and analyze the current and projected trends in global change, both human-induced and natural.

    The Fourth NCA fulfills this mandate by synthesizing and assessing the science and impacts of climate change across 15 sectors and 10 regions of the United States, and considers options to reduce present and future risk, in a policy-relevant, but not policy-prescriptive manner. The Fourth NCA is a product of the USGCRP, and is overseen by an interagency Federal Steering Committee. Non-Federal Regional Chapter Leads were identified via an Open Call for nominations (https://www.federalregister.gov/d/2016-20982). The draft assessment was written by teams of Federal and non-Federal authors selected for their demonstrated subject matter expertise and publications relevant to the chapter topics outlined in the prospectus (https://www.federalregister.gov/d/2016-15807) and was informed by an array of technical inputs, many gathered through an Open Call (https://www.federalregister.gov/d/2016-20982).

    The report adheres to the Information Quality Act requirements (http://www.cio.noaa.gov/services_programs/info_quality.html) for quality, transparency, and accessibility as appropriate for a Highly Influential Scientific Assessment (HISA).

    Dan Barrie, Program Manager, Assessments Program, NOAA Climate Program Office. Dated: October 10, 2017. David Holst, Chief Financial Officer/CAO, Office of Oceanic and Atmospheric Research, National Oceanic and Atmospheric Administration
    [FR Doc. 2017-24221 Filed 11-6-17; 8:45 am] BILLING CODE P
    DEPARTMENT OF EDUCATION Authorization of Subgrants for the High School Career and Technical Education Teacher Pathway Initiative AGENCY:

    Office of Career, Technical, and Adult Education, Department of Education.

    ACTION:

    Notice.

    SUMMARY:

    Pursuant to the Education Department General Administrative Regulations, this notice authorizes grantees receiving awards under the High School Career and Technical Education (CTE) Teacher Pathway Initiative (CFDA 84.051D) to make subgrants, subject to the limitations described in this notice.

    DATES:

    Grantees may begin making subgrants on November 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Laura Messenger, U.S. Department of Education, 400 Maryland Avenue SW., Potomac Center Plaza (PCP), Room 11028, Washington, DC 20202-7241. Telephone: (202) 245-7840 or by fax at (202) 245-7170.

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    Purpose of Program: The purpose of the High School CTE Teacher Pathway Initiative is to improve CTE programs assisted under the Carl D. Perkins Career and Technical Education Act of 2006 (the Perkins Act) by increasing the supply of high school CTE teachers available to teach students in CTE programs that align to in-demand industry sectors or occupations in States and communities where shortages of such teachers exist.

    Program Authority: 20 U.S.C. 2324.

    Applicable Regulations: (a) The Education Department General Administrative Regulations in 34 CFR parts 75, 77, 79, 81, 82, 84, 86, and 99. (b) The Office of Management and Budget Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474. (d) The priorities and requirements in the notice inviting applications for this program, published June 13, 2017, in the Federal Register (82 FR 27047).

    Eligible Entities for Subgrants: The following entities are eligible to apply under this competition:

    (a) A State board designated or created consistent with State law as the sole State agency responsible for the administration of CTE in the State or for the supervision of the administration of CTE in the State;

    (b) A local educational agency (LEA) (including a public charter school that operates as an LEA), an area CTE school, an educational service agency, or a consortium of such entities, in each case, that receives assistance under section 131 of the Perkins Act; and

    (c) An eligible institution or consortium of eligible institutions that receives assistance under section 132 of the Perkins Act.

    Discussion: Recognizing that creating sustainable, new, or expanded pathways to recruit and retain CTE teachers will require collaborative approaches and coordination among several entities, the Department of Education has required that the applicants to the High School CTE Teacher Pathway Initiative create partnerships to carry out the activities proposed in the applications. The Office of Career, Technical, and Adult Education has determined that for some of the partnerships, subgranting may be appropriate and necessary to meet the purposes of the High School CTE Teacher Pathway Initiative, particularly for State eligible agencies that receive a High School CTE Teacher Pathway Initiative grant award, because many of the allowable activities are decided and implemented at the school district level. The current absence of subgranting authority limits the extent to which the program grantees and partners can most effectively collaborate to conduct the activities described in funded applications.

    Requirements: If the grantee uses this subgranting authority, the subgrants, consistent with 34 CFR 75.708(b)(2), must be used only to carry out directly those project activities described in the grantee's approved application. Consistent with 34 CFR 75.708(d), grantees must ensure that subgrants are awarded on the basis of the approved budget that is consistent with the grantee's approved application and all applicable Federal statutory, regulatory, and other requirements. Grantees have the authority to award subgrants to entities that have been identified in their applications as well as to those that are awarded a subgrant through a competitive award process. Grantees under the High School CTE Teacher Pathway Initiative must ensure that every subgrant includes any conditions required by Federal statutes and Executive orders and their implementing regulations. Grantees must ensure that subgrantees are aware of the requirements imposed upon them by Federal statutes and regulations, including the Federal anti-discrimination laws listed in 34 CFR 75.500, and enforced by the Department.

    Note: This notice does not solicit applications.

    Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site. You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Dated: November 2, 2017. Michael E. Wooten, Deputy Assistant Secretary, Delegated the Duties of the Assistant Secretary for Career, Technical, and Adult Education.
    [FR Doc. 2017-24218 Filed 11-6-17; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0111] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Corrective Action Plan (CAP) AGENCY:

    Department of Education (ED), Office of Special Education and Rehabilitative Services (OSERS).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before December 7, 2017.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2017-ICCD-0111. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 216-44, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Edward West, 202-245-6145.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Corrective Action Plan (CAP).

    OMB Control Number: 1820-0694.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 60.

    Total Estimated Number of Annual Burden Hours: 975.

    Abstract: Pursuant to the Rehabilitation Act of 1973 as amended by the Workforce Innovation and Opportunity Act, the Rehabilitation Services Administration (RSA) must conduct periodic monitoring of the Vocational Rehabilitation (VR) programs in each state. As a result of this monitoring, RSA may require that VR agencies to develop a Corrective Action Plan (CAP) in order to resolve findings of non-compliance. The CAP must contain the specific steps that the agency will take to resolve each finding, timelines for the completion of each step and methods for evaluating that the findings have been resolved. RSA requires the agency to report progress toward completion of the CAP on a quarterly basis.

    Dated: November 2, 2017. Tomakie Washington, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2017-24185 Filed 11-6-17; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy [Docket Number: EERE 2017-VT-00XX] Proposed Agency Information Collection Extension AGENCY:

    Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy (DOE).

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The Department of Energy pursuant to the Paperwork Reduction Act of 1995, intends to extend for three years an information collection request with the Office of Management and Budget.

    DATES:

    Comments regarding this proposed information collection must be received on or before January 8, 2018. If you anticipate difficulty in submitting comments within that period, contact the person listed in ADDRESSES as soon as possible.

    ADDRESSES:

    Written comments should include DOCKET # EERE-2017-VT-00XX in the subject line of the message and may be sent to: Mr. Dana V. O'Hara, Office of Energy Efficiency and Renewable Energy (EE-3V), U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585-0121, or by email at Dana.O'[email protected]

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Mr. Dana V. O'Hara, Office of Energy Efficiency and Renewable Energy (EE-3V), U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585-0121, (202) 586-8063, Dana.O'[email protected] The information collection instrument is completed online, via a password protected Web page; for review purposes, the same instrument is available online at http://www1.eere.energy.gov/vehiclesandfuels/epact/docs/reporting_spreadsheet.xls.

    SUPPLEMENTARY INFORMATION:

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

    This information collection request contains: (1) OMB No. 1910-5101; (2) Information Collection Request Title: Annual Alternative Fuel Vehicle Acquisition Report for State Government and Alternative Fuel Provider Fleets; (3) Type of Review: Renewal; (4) Purpose: The information is required so that DOE can determine whether alternative fuel provider and State government fleets are in compliance with the alternative fueled vehicle acquisition mandates of sections 501 and 507(o) of the Energy Policy Act of 1992, as amended, (EPAct), whether such fleets should be allocated credits under section 508 of EPAct, and whether fleets that opted into the alternative compliance program under section 514 of EPAct are in compliance with the applicable requirements; (5) Annual Estimated Number of Respondents: Approximately 303; (6) Annual Estimated Number of Total Responses: 335; (7) Annual Estimated Number of Burden Hours: 1,970; (8) Annual Estimated Reporting and Recordkeeping Cost Burden: $120,000.

    Statutory Authority:

    42 U.S.C. 13251 et seq.

    Issued in Washington, DC on: November 1, 2017. Michael Berube, Director, Vehicle Technologies Office, Energy Efficiency and Renewable Energy.
    [FR Doc. 2017-24180 Filed 11-6-17; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP17-808-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: Report Filing: RP17-808 Supplemental Filing.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5005.

    Comments Due: 5 p.m. ET 11/8/17.

    Docket Numbers: RP18-70-000.

    Applicants: Trunkline Gas Company, LLC.

    Description: Compliance filing Annual Interruptible Storage Revenue Credit filed 10-31-17.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5085.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-71-000.

    Applicants: Trailblazer Pipeline Company LLC.

    Description: § 4(d) Rate Filing: Neg Rate 2017-10-30 Morgan Stanley to be effective 11/1/2017.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5106.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-72-000.

    Applicants: Southern Star Central Gas Pipeline, Inc.

    Description: § 4(d) Rate Filing: Vol. 2 Negotiated and Non-Conforming PLS—Tenaska November Amendment to be effective 11/1/2017.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5135.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-73-000.

    Applicants: Rockies Express Pipeline LLC.

    Description: § 4(d) Rate Filing: Neg Rate 2017-10-30 Encana to be effective 10/28/2017.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5144.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-74-000.

    Applicants: Kern River Gas Transmission Company.

    Description: § 4(d) Rate Filing: 2018 P2/AltP2 Rates, 15-Year 2003 Expansion to be effective 5/1/2018.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5145.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-75-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: AGT FRQ 2017 Filing to be effective 12/1/2017.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5160.

    Comments Due: 5 p.m. ET 11/13/17.

    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 31, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-24149 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2363-088] Notice of Application Accepted for Filing, Soliciting Comments, Protests and Motions To Intervene; Sappi Cloquet LLC

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

    a. Type of Proceeding: Extension of License Term.

    b. Project No.: P-2363-088.

    c. Date Filed: October 23, 2017.

    d. Licensee: Sappi Cloquet LLC.

    e. Name and Location of Project: Cloquet Hydroelectric Project, located on the St. Louis River in Carlton County, Minnesota.

    f. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.

    g. Licensee Contact Information: Mr. Robert Schilling, Sappi North America, 2201 Avenue B, P.O. Box 511, Cloquet, MN 55720, Phone: (218) 879-0638, Email: [email protected] and Ms. Nancy J. Skancke, NJS Law PLC, 1025 Connecticut Avenue NW., Suite 1000, Washington, DC 20036, Phone: (202) 327-5460, Email: [email protected]

    h. FERC Contact: Mr. Ashish Desai, (202) 502-8370, [email protected].

    i. Deadline for filing comments, motions to intervene and protests, is 30 days from the issuance date of this notice by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, and recommendations, using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-2363-088.

    j. Description of Proceeding: The licensee, Sappi Cloquet LLC, requests that the Commission extend the term of the license for the Cloquet Hydroelectric Project 10 years, from June 30, 2025 to June 30, 2035. The licensee is requesting the extension to align the license expiration date of the project with that of the St. Louis River Hydroelectric Project No. 2360. The Cloquet Project is located between the Knife Falls and Scanlon developments of the St. Louis River Project. The licensee states that the extension would allow it to coordinate its relicensing efforts with those of the St. Louis River Project to increase efficiency and evaluate the operational and environment impacts of the two projects in a comprehensive manner. The licensee's request includes comments from the U.S. Fish and Wildlife Service and the National Park Service supporting the license extension.

    k. This notice is available for review and reproduction at the Commission in the Public Reference Room, Room 2A, 888 First Street NE., Washington, DC 20426. The filing may also be viewed on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the Docket number (P-2363-088) excluding the last three digits in the docket number field to access the notice. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, call toll-free 1-866-208-3676 or email [email protected] For TTY, call (202) 502-8659.

    l. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.

    m. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

    n. Filing and Service of Responsive Documents: Any filing must (1) bear in all capital letters the title COMMENTS, PROTEST, or MOTION TO INTERVENE as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). All comments, motions to intervene, or protests should relate to the request to extend the license term. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. If an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: November 1, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-24153 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 11175-025] Crown Hydro, LLC; Notice of Teleconference To Discuss Section 106 Consultation for an Application To Amend the Crown Mill Project

    a. Project Name and Number: Crown Mill Hydroelectric Project No. 11175.

    b. Project licensee: Crown Hydro, LLC.

    c. Date and Time of Teleconference: Wednesday, December 6, 2017, from 9:00 a.m. to 11:00 a.m. Central Standard Time.

    d. FERC Contact: Jennifer Polardino, (202) 502-6437 or [email protected]

    e. Purpose of Meeting: Commission staff will hold a teleconference to discuss the status of consultation under section 106 of the National Historic Preservation Act for an application to amend the license of the unconstructed Crown Mill Hydroelectric Project. Crown Mill, LLC (licensee) proposes to move the location of the project's powerhouse about 250 feet north to U.S. Army Corps of Engineers (Corps) lands within the campus of the Upper St. Anthony Falls Lock and Dam. Crown Mill, LLC also proposes to construct a new tailrace tunnel instead of connecting to an existing tunnel. The project would be located on the Mississippi River, in the downtown area of the City of Minneapolis, Hennepin County, Minnesota.

    f. All local, state, and federal agencies, Indian tribes, and other interested entities are invited to participate in the teleconference. Please call or email Jennifer Polardino at (202) 502-6437 or [email protected] by Thursday, November 30, 2017, to RSVP and to receive the teleconference call-in information.

    Dated: October 31, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-24142 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

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

    Docket Numbers: EC18-12-000.

    Applicants: Public Service Company of New Hampshire, Granite Shore Power LLC.

    Description: Joint Application of Public Service Company of NH, et al. for Approval of the Disposition of Jurisdictional Facilities Under Section 203 of the FPA, Request for Waivers, Request for Shortened Notice Period and Expedited Consideration.

    Filed Date: 10/27/17.

    Accession Number: 20171027-5272.

    Comments Due: 5 p.m. ET 12/11/17.

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

    Docket Numbers: EG18-12-000.

    Applicants: EGP Stillwater Solar PV II, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of EGP Stillwater Solar PV II, LLC.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5257.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: EG18-13-000.

    Applicants: EGP Stillwater Solar, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of EGP Stillwater Solar, LLC.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5260.

    Comments Due: 5 p.m. ET 11/21/17.

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

    Docket Numbers: ER10-3297-010.

    Applicants: Powerex Corp.

    Description: Notice of Change in Status of Powerex Corp.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5227.

    Comments Due: 5 p.m. ET 11/20/17.

    Docket Numbers: ER17-1712-002.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Tariff Amendment: 2017-10-31_Amended Compensation for Manual Redispatch Filing to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5201.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER17-2218-001.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Amendment: Response to Deficiency Letter Issued September 28, 2017 in Docket No. ER17-2218 to be effective 10/3/2017.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5208.

    Comments Due: 5 p.m. ET 11/20/17.

    Docket Numbers: ER17-2220-001.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Tariff Amendment: 2017-10-30_Deficiency response re MISO-PJM JOA pseudo-tie revisions to be effective 10/1/2017.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5193.

    Comments Due: 5 p.m. ET 11/20/17.

    Docket Numbers: ER17-2449-001.

    Applicants: Public Service Company of New Hampshire.

    Description: Tariff Amendment: Amendment ? Rate Schedule No. IA-ES-37 Interconnect Agreement PSNH and Pontook to be effective 12/16/2016.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5258.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-127-001.

    Applicants: Virginia Electric and Power Company, PJM Interconnection, L.L.C.

    Description: Tariff Amendment: VEPCO submits Amendment to WDSA, Service Agreement No. 4817 to be effective 10/1/2017.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5209.

    Comments Due: 5 p.m. ET 11/20/17.

    Docket Numbers: ER18-183-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Revisions to OATT re: Proposed Pro Forma Dynamic Schedule Agreement to be effective 12/29/2017.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5192.

    Comments Due: 5 p.m. ET 11/20/17.

    Docket Numbers: ER18-184-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: 2018 RSBAA Update Filing to be effective 1/1/2018.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5015.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-186-000.

    Applicants: New England Power Pool Participants Committee.

    Description: § 205(d) Rate Filing: Nov 2017 Membership Filing to be effective 10/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5172.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-187-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Original Cost Responsibility Agreement No. 4829—NQ155 to be effective 10/19/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5176.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-188-000.

    Applicants: Jordan Creek Wind Farm LLC.

    Description: Petition for Waiver of Jordan Creek Wind Farm LLC.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5248.

    Comments Due: 5 p.m. ET 11/20/17.

    Docket Numbers: ER18-189-000.

    Applicants: California Power Exchange Corporation.

    Description: § 205(d) Rate Filing: Rate Filing for Rate Period 32 to be effective 1/1/2018.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5213.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-190-000.

    Applicants: Duke Energy Carolinas, LLC.

    Description: § 205(d) Rate Filing: NCMPA1 RS No 318 Amendment (2018) to be effective 1/1/2018.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5223.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-191-000.

    Applicants: DATC Path 15, LLC.

    Description: § 205(d) Rate Filing: Revised Appendix I 2018 to be effective 1/1/2018.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5270.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-192-000.

    Applicants: Dynegy Oakland, LLC.

    Description: § 205(d) Rate Filing: Annual RMR Section 205 Filing and RMR Schedule F Informational Filing to be effective 1/1/2018.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5288.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-193-000.

    Applicants: Midcontinent Independent System Operator, Inc., Dairyland Power Cooperative.

    Description: § 205(d) Rate Filing: 2017-10-31_Dairyland Power Coop request for rate incentive treatment to be effective 1/1/2018.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5290.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-194-000.

    Applicants: American Electric Power Service Corporation, Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: AEP Transcos Formula Rate Revisions to be effective 1/1/2018.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5305.

    Comments Due: 5 p.m. ET 11/21/17.

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

    Docket Numbers: ES17-10-000.

    Applicants: NSTAR Electric Company.

    Description: Supplement to January 13, 2017 Application of NSTAR Electric Company under Section 204 of the FPA for Authority to Assume Short-Term Debt Obligations of its affiliate, Western Mass Electric Company.

    Filed Date: 9/19/17.

    Accession Number: 20170919-5171.

    Comments Due: 5 p.m. ET 11/13/17.

    Take notice that the Commission received the following PURPA 210(m)(3) filings:

    Docket Numbers: QM18-1-000.

    Applicants: Missouri River Energy Services.

    Description: Application to Terminate Mandatory PURPA Purchase Obligation of Missouri River Energy Services, on behalf of itself and member Marshall, Minnesota.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5298.

    Comments Due: 5 p.m. ET 11/28/17.

    Docket Numbers: QM18-2-000.

    Applicants: Missouri River Energy Services.

    Description: Application to Terminate Mandatory PURPA Purchase Obligation of Missouri River Energy Services, on behalf of itself and thirty-three members.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5300.

    Comments Due: 5 p.m. ET 11/28/17.

    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 31, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-24145 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM98-1-000] Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.

    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.

    Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.

    Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v).

    The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the eLibrary link. Enter the docket number, excluding the last three digits, in the docket number field to access the document. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659.

    Docket No. File date Presenter or requester Prohibited 1. CP17-101-000 10-16-2017 Lower Raritan Watershed Partnership. 2. CP15-554-000 10-17-2017 William S. Moore, Carol M. Moore. 3. P-2100-000 10-17-2017 Pacific Fishery Management Council. 4. P-2082-000 10-23-2017 Copco Lake Fire Protection District. 5. P-2082-000 10-23-2017 Copco Lake Fire Protection District. 6. CP15-558-000 10-25-2017 Chamber of Commerce Southern New Jersey. 7. CP15-554-000, CP16-10-000 10-27-2017 Bert Carlson. Exempt 1. CP15-93-000 10-19-2017 U.S. House Representative Alex X. Mooney. 2. CP16-38-000 10-19-2017 U.S. House Representative Alex X. Mooney. 3. CP15-514-000 10-19-2017 U.S. House Representative Alex X. Mooney. 4. CP16-10-000 10-19-2017 U.S. House Representative Alex X. Mooney. 5. CP16-357-000 10-19-2017 U.S. House Representative Alex X. Mooney. 6. CP16-22-000 10-19-2017 U.S. House Representative Alex X. Mooney. 7. CP16-361-000 10-19-2017 U.S. House Representative Alex X. Mooney. 8. CP15-555-000 10-19-2017 U.S. House Representative Alex X. Mooney. 9. CP15-138-000 10-19-2017 U.S. House Representative Alex X. Mooney. 10. P-2305-000 10-19-2017 U.S. House Representative Mike Johnson. 11. CP17-41-000 10-19-2017 FERC Staff.1 12. CP16-22-000 10-23-2017 City of Waterville, Ohio, Mayor Lori A. Brodie. 13. CP17-101-000 10-24-2017 New Jersey Senator Bob Smith. 14. CP16-38-000 10-24-2017 U.S. House Representative David B. McKinley, P.E. 1 Telephone Call Summary for call on October 18, 2017 with U.S. Fish and Wildlife Service representatives. Dated: October 31, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-24141 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP18-100-000.

    Applicants: Gulf South Pipeline Company, LP.

    Description: § 4(d) Rate Filing: Cap Rel Neg Rate Agmts (Petrohawk 41455 to various eff 11-1-2017) to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5221.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-101-000.

    Applicants: Gulf South Pipeline Company, LP.

    Description: § 4(d) Rate Filing: Cap Rel Neg Rate Agmt (Methanex 42805 to BP 48730) to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5222.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-102-000.

    Applicants: Texas Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Neg Rate Agmt Filing (Indianapolis Power & Light 34015) to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5230.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-103-000.

    Applicants: Texas Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Cap Rel Neg Rate Agmts (RE Gas 35433, 34955 to BP 36710, 36712) to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5233.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-104-000.

    Applicants: Texas Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Cap Rel Neg Rate Agmt (Kaiser 35448 to Kaiser 36730) to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5235.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-105-000.

    Applicants: Rockies Express Pipeline LLC.

    Description: § 4(d) Rate Filing: Neg Rate 2017-10-31 CP to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5245.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-106-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rate—IDT To BP—contract 795292 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5286.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-107-000.

    Applicants: Gulf South Pipeline Company, LP.

    Description: § 4(d) Rate Filing: Cap Rel Neg Rate Agmts (EOG 34687 to various eff 11-1-17) to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5294.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-108-000.

    Applicants: Tennessee Gas Pipeline Company, L.L.C.

    Description: § 4(d) Rate Filing: Volume No. 2—Connecticut Exp Project—Amendment to Gas Trans Agmt to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5297.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-109-000.

    Applicants: Transcontinental Gas Pipe Line Company.

    Description: § 4(d) Rate Filing: Negotiated Rates—Cherokee AGL—Replacement Shippers—Nov 2017 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5303.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-110-000.

    Applicants: Texas Eastern Transmission, LP.

    Description: § 4(d) Rate Filing: Negotiated Rates—Piedmont to Emera 8948562 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5307.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-111-000.

    Applicants: Kern River Gas Transmission Company.

    Description: § 4(d) Rate Filing: 2017 November Negotiated Rates to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5310.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-112-000.

    Applicants: Texas Eastern Transmission, LP.

    Description: § 4(d) Rate Filing: Negotiated Rates—EQT Releases to Pacific Summit to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5340.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-113-000.

    Applicants: Texas Eastern Transmission, LP.

    Description: § 4(d) Rate Filing: Negotiated Rates—City of Dalton to Centerpoint 8948517 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5352.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-114-000.

    Applicants: Guardian Pipeline, L.L.C.

    Description: § 4(d) Rate Filing: Update Statement of Negotiated Rates—November 2017 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5353.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-115-000.

    Applicants: Guardian Pipeline, L.L.C.

    Description: § 4(d) Rate Filing: Update Non-Conforming and Negotiated Rate Agreements—November 2017 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5354.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-116-000.

    Applicants: Texas Eastern Transmission, LP.

    Description: § 4(d) Rate Filing: TETLP ASA DEC 2017 FILING to be effective 12/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5363.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-117-000.

    Applicants: Rockies Express Pipeline LLC.

    Description: § 4(d) Rate Filing: Neg Rate (7 new) 10-31-2017 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5365.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-118-000.

    Applicants: Tennessee Gas Pipeline Company, L.L.C.

    Description: § 4(d) Rate Filing: Section 311 Filing to be effective 12/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5371.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-119-000.

    Applicants: El Paso Natural Gas Company, L.L.C.

    Description: § 4(d) Rate Filing: Pathing to Off-System Locations to be effective 12/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5372.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-120-000.

    Applicants: Wyoming Interstate Company, L.L.C.

    Description: § 4(d) Rate Filing: Firm Daily Balancing Service to be effective 12/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5374.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-76-000.

    Applicants: Equitrans, L.P.

    Description: Compliance filing Operational Purchases and Sales Report for 2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5067.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-77-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rates—Con Ed Ramapo Releases eff 11-1-2017 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5068.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-78-000.

    Applicants: Equitrans, L.P.

    Description: § 4(d) Rate Filing: Negotiated Rate Service Agreements—BP MEA J Aron to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5069.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-79-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rates—BUG Ramapo Releases eff 11-1-2017 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5074.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-80-000.

    Applicants: Texas Eastern Transmission, LP.

    Description: § 4(d) Rate Filing: Negotiated Rates—Con Ed NJNY Releases eff 11-1-2017 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5096.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-81-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rates—KeySpan Ramapo Releases eff 11-1-2017 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5099.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-82-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rate—Direct Energy—contract 795251 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5100.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-83-000.

    Applicants: Rager Mountain Storage Company LLC.

    Description: § 4(d) Rate Filing: URL Update to be effective 12/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5101.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-84-000.

    Applicants: Rover Pipeline LLC.

    Description: § 4(d) Rate Filing: Non-Conforming Agreements—1 in compliance with CP15-93 Order to be effective 12/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5102.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-85-000.

    Applicants: Rover Pipeline LLC.

    Description: § 4(d) Rate Filing: Non-Conforming Agreement List Update—1 to be effective 12/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5103.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-86-000.

    Applicants: ETC Tiger Pipeline, LLC.

    Description: § 4(d) Rate Filing: Fuel Filing on 10-31-17 to be effective 12/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5104.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-87-000.

    Applicants: Fayetteville Express Pipeline LLC.

    Description: § 4(d) Rate Filing: Fuel Filing on 10-31-17 to be effective 12/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5105.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-88-000.

    Applicants: Florida Southeast Connection, LLC.

    Description: § 4(d) Rate Filing: Re-Collation of Tariffs to be effective 10/31/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5142.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-89-000.

    Applicants: Alliance Pipeline L.P.

    Description: § 4(d) Rate Filing: Contract Extension Direct Energy to be effective 10/31/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5149.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-90-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rates—KeySpan Ramapo Releases 2 eff 11-1-2017 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5165.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-91-000.

    Applicants: Transcontinental Gas Pipe Line Company.

    Description: § 4(d) Rate Filing: Rate Schedules GSS & LSS Tracker—eff 11-1-2017 to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5174.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-92-000.

    Applicants: Wyoming Interstate Company, L.L.C.

    Description: § 4(d) Rate Filing: FLU Update Filing to be effective 12/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5180.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-93-000.

    Applicants: Northern Natural Gas Company.

    Description: § 4(d) Rate Filing: 20171031 Negotiated Rate to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5183.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-94-000.

    Applicants: Gulf Crossing Pipeline Company LLC.

    Description: § 4(d) Rate Filing: Amendment to Neg Rate Agmt (BP 37-25) to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5197.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-95-000.

    Applicants: Gulf South Pipeline Company, LP.

    Description: § 4(d) Rate Filing: Cap Rel Neg Rate Agmt (FPL 41618 to DTE 48614) to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5198.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-96-000.

    Applicants: Gulf South Pipeline Company, LP.

    Description: § 4(d) Rate Filing: Amendment to Neg Rate Agmt (Sequent 34693-41) to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5199.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-97-000.

    Applicants: Gulf South Pipeline Company, LP.

    Description: § 4(d) Rate Filing: Cap Rel Neg Rate Agmt (Atmos 45527 to CenterPoint 48643) to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5200.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-98-000.

    Applicants: Gulf South Pipeline Company, LP.

    Description: § 4(d) Rate Filing: Cap Rel Neg Rate Agmts (Atlanta 8438 to various eff 11-1-17) to be effective 11/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5202.

    Comments Due: 5 p.m. ET 11/13/17.

    Docket Numbers: RP18-99-000.

    Applicants: BNP Paribas Energy Trading GP, Morgan Stanley Capitol Group Inc.

    Description: Joint Petition of BNP Paribas Energy Trading GP, et al. for Waiver of Commission Capacity Release Regulations and Policies, Related Natural Gas Pipeline Tariff Provisions, et al.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5215.

    Comments Due: 5 p.m. ET 11/13/17.

    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: November 1, 2017. Kimberly D. Bose, Secretary.
    [FR Doc. 2017-24193 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. OR18-2-000] Notice of Petition for Declaratory Order; Permian Express Terminal LLC; Permian Express Partners LLC

    Take notice that on October 27, 2017, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2016), Permian Express Terminal LLC (PET) and Permian Express Partners LLC (PEP), filed a petition for a declaratory order seeking approval of specific rate structures, terms of service, and prorationing methodology for the proposed Permian Express 3 crude oil pipeline, as more fully explained in the petition.

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

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the eLibrary link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the 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.

    Comment Date: 5:00 p.m. Eastern time on November 20, 2017.

    Dated: October 31, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-24154 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL18-26-000] EDF Renewable Energy, Inc. v. Midcontinent Independent System Operator, Inc.; Southwest Power Pool, Inc.; PJM Interconnection, L.L.C.; Notice of Complaint

    Take notice that on October 30, 2017, pursuant to sections 206 and 306 of the Federal Power Act, 16 U.S.C. 824e and 825e and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 (2017), EDF Renewable Energy, Inc. (Complainant) filed a formal complaint against Midcontinent Independent System Operator, Inc., Southwest Power Pool, Inc., and PJM Interconnection, L.L.C. (Respondents) alleging that Respondents' current Affected System coordination procedures and practices are unjust, unreasonable and unduly discriminatory, all as more fully explained in the complaint.

    Complainant certifies that a copy of the Complaint was served on the contacts for Respondents as listed on the Commission's list of Corporate Officials.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for 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.

    Comment Date: 5:00 p.m. Eastern Time on November 20, 2017.

    Dated: November 1, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-24151 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP18-10-000] Notice of Application; Texas Eastern Transmission, LP

    Take notice that on October 19, 2017, Texas Eastern Transmission, LP (Texas Eastern), 5400 Westheimer Court, Houston, Texas 77056, filed in Docket No. CP18-10-000, an application under section 7(c) of the Natural Gas Act for the proposed Texas Industrial Market Expansion and Louisiana Market Expansion Projects (Projects). Specifically, Texas Eastern requests authorization to: (i) Construct and operate facility upgrades at its existing Gillis Compressor Station in Beauregard Parish, Louisiana; (ii) implement rolled-in rate treatment for firm service on the Projects; and (iii) charge an incremental electric power cost rate applicable to firm service on the Texas Industrial Market Expansion Project. The Projects will provide an additional 157,500 dekatherms per day of firm capacity for two customers from receipt points in Louisiana to delivery points in Louisiana and Texas, all as more fully set forth in the application which is on file with the Commission and open to public inspection. This filing may be viewed on the web at http://www.ferc.gov using the eLibrary link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC at [email protected] or call toll-free, (886) 208-3676 or TYY, (202) 502-8659.

    Any questions regarding this Application should be directed to Berk Donaldson, Director, Rates and Certificates, Texas Eastern Transmission, LP., P.O. Box 1642, Houston, Texas 77251-1642; Phone: 713-627-4488, or Fax: (713) 627-5947.

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 7 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenter's will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenter's will not be required to serve copies of filed documents on all other parties. However, the non-party commentary, will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the e-Filing link.

    Comment Date: 5:00 p.m. Eastern Time on November 21, 2017.

    Dated: October 31, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-24146 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #2

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

    Docket Numbers: EC18-12-000.

    Applicants: Public Service Company of New Hampshire, Granite Shore Power LLC.

    Description: Supplement to October 27, 2017 Joint Application of Public Service Company of New Hampshire, et al. for Approval of the Disposition of Jurisdictional Facilities Under Section 203 of the FPA.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5384.

    Comments Due: 5 p.m. ET 12/11/17.

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

    Docket Numbers: ER18-206-000.

    Applicants: Southern Partners, INC.

    Description: Baseline eTariff Filing: Southern Partners, INC MBR Application to be effective 11/1/2017.

    Filed Date: 11/1/17.

    Accession Number: 20171101-5099.

    Comments Due: 5 p.m. ET 11/22/17.

    Docket Numbers: ER18-207-000.

    Applicants: Duke Energy Progress, LLC.

    Description: § 205(d) Rate Filing: DEP-City of Camden First Amended and Restated RS No. 197 to be effective 1/1/2017.

    Filed Date: 11/1/17.

    Accession Number: 20171101-5114.

    Comments Due: 5 p.m. ET 11/22/17.

    Docket Numbers: ER18-208-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 2891R3 AECC and Entergy Arkansas Attachment AO to be effective 1/1/2018.

    Filed Date: 11/1/17.

    Accession Number: 20171101-5118.

    Comments Due: 5 p.m. ET 11/22/17.

    Docket Numbers: ER18-211-000.

    Applicants: San Diego Gas & Electric Company.

    Description: § 205(d) Rate Filing: 2018 SDGE TACBAA Update to Transmission Owner Tariff Filing to be effective 1/1/2018.

    Filed Date: 11/1/17.

    Accession Number: 20171101-5161.

    Comments Due: 5 p.m. ET 11/22/17.

    Docket Numbers: ER18-213-000.

    Applicants: Pittsfield Generating Company, L P.

    Description: Compliance filing: Re-file Baseline Tariff to be effective 12/31/9998.

    Filed Date: 11/1/17.

    Accession Number: 20171101-5168.

    Comments Due: 5 p.m. ET 11/22/17.

    Docket Numbers: ER18-214-000.

    Applicants: Consolidated Edison Company of New York, Inc.

    Description: § 205(d) Rate Filing: Con Edison VDER filing 11-1-2017 to be effective 11/1/2017.

    Filed Date: 11/1/17.

    Accession Number: 20171101-5185.

    Comments Due: 5 p.m. ET 11/22/17.

    Docket Numbers: ER18-215-000.

    Applicants: Interstate Power and Light Company.

    Description: § 205(d) Rate Filing: Interstate Power and Light Company Changes in Wholesale Formula Rates to be effective 1/1/2018.

    Filed Date: 11/1/17.

    Accession Number: 20171101-5198.

    Comments Due: 5 p.m. ET 11/22/17.

    Docket Numbers: ER18-216-000.

    Applicants: Wisconsin Power and Light Company.

    Description: § 205(d) Rate Filing: Wisconsin Power and Light Company Wholesale Formula Rate Changes to be effective 1/1/2018.

    Filed Date: 11/1/17.

    Accession Number: 20171101-5199.

    Comments Due: 5 p.m. ET 11/22/17.

    Docket Numbers: ER18-217-000.

    Applicants: New York State Electric & Gas Corporation.

    Description: § 205(d) Rate Filing: NYSEG-DCEC Attachment C Annual Update to be effective 1/1/2018.

    Filed Date: 11/1/17.

    Accession Number: 20171101-5203.

    Comments Due: 5 p.m. ET 11/22/17.

    Docket Numbers: ER18-218-000.

    Applicants: Wisconsin Public Service Corporation.

    Description: § 205(d) Rate Filing: Filing of a Wholesale Distribution Agreement w/Stratford to be effective 1/1/2018.

    Filed Date: 11/1/17.

    Accession Number: 20171101-5218.

    Comments Due: 5 p.m. ET 11/22/17.

    Docket Numbers: ER18-219-000.

    Applicants: Wisconsin Public Service Corporation.

    Description: § 205(d) Rate Filing: Filing of a Wholesale Distribution Agreement w/ WEPCo to be effective 1/1/2018.

    Filed Date: 11/1/17.

    Accession Number: 20171101-5232.

    Comments Due: 5 p.m. ET 11/22/17.

    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: November 1, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-24150 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. OR18-3-000] Notice of Petition for Declaratory Order; BridgeTex Pipeline Company, LLC

    Take notice that on October 30, 2017, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2016), BridgeTex Pipeline Company, LLC (BridgeTex), filed a petition for a declaratory order seeking approval of expansion of BridgeTex pipeline systems overall tariff rate structure and terms of service, for transportation of crude oil and condensate from new origin in Midland, Texas to Houston, Texas (to be known as the BridgeTex II Expansion Project), as more fully explained in the petition.

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

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the eLibrary link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the 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.

    Comment Date: 5:00 p.m. Eastern time on November 21, 2017.

    Dated: November 1, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-24152 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

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

    Docket Numbers: ER18-185-000.

    Applicants: Enerwise Global Technologies, Inc.

    Description: Request for Limited Waiver of ISO New England, Inc. Tariff of Enerwise Global Technologies, Inc.

    Filed Date: 10/30/17.

    Accession Number: 20171030-5220.

    Comments Due: 5 p.m. ET 11/20/17.

    Docket Numbers: ER18-195-000.

    Applicants: American Electric Power Service Corporation, Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: AEP Formula Rate Revisions to be effective 1/1/2018.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5311.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-196-000.

    Applicants: Duke Energy Carolinas, LLC.

    Description: § 205(d) Rate Filing: DEC-Central Electric Fifth Amended and Restated RS No. 336 to be effective 1/1/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5321.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-197-000.

    Applicants: Alabama Power Company.

    Description: § 205(d) Rate Filing: FPU NITSA Amendment Filing to be effective 1/1/2018.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5334.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-198-000.

    Applicants: Pacific Gas and Electric Company.

    Description: § 205(d) Rate Filing: Q3 2017 Quarterly Filing of City and County of San Francisco's WDT SA (SA 275) to be effective 9/30/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5336.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-199-000.

    Applicants: Otter Tail Power Company.

    Description: § 205(d) Rate Filing: Revisions to CASOT Service Agreement No. 4 with East River Electric Power Cooper to be effective 1/1/2018.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5362.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-200-000.

    Applicants: Otter Tail Power Company.

    Description: § 205(d) Rate Filing: Notice of Termination of Rate Schedule No. 168, East River ITSA to be effective 12/31/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5373.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-201-000.

    Applicants: Arizona Public Service Company.

    Description: § 205(d) Rate Filing: Rate Schedule No. 33—WAPA Triangle Agreement, Exhibit A Revision No. 52 to be effective 12/31/2017.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5376.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-202-000.

    Applicants: Startrans IO, LLC.

    Description: § 205(d) Rate Filing: TRBAA 2018 Update to be effective 1/1/2018.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5379.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-203-000.

    Applicants: Appalachian Power Company.

    Description: § 205(d) Rate Filing: APCo-Radford PSA Cancellation to be effective 9/30/2017.

    Filed Date: 11/1/17.

    Accession Number: 20171101-5036.

    Comments Due: 5 p.m. ET 11/22/17.

    Docket Numbers: ER18-204-000.

    Applicants: PacifiCorp.

    Description: Notice of Termination of PacifiCorp (Rate Schedule No. 607) Lease Agreement.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5387.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ER18-205-000.

    Applicants: Pacific Gas and Electric Company.

    Description: Notice of Termination of Pacific Gas and Electric Company (Rate Schedule No. 240) Lease Agreement.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5388.

    Comments Due: 5 p.m. ET 11/21/17.

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

    Docket Numbers: ES18-5-000.

    Applicants: Baltimore Gas and Electric Company.

    Description: Application of Baltimore Gas and Electric Company under Section 204 of the Federal Power Act for Authorization of the Issuance of Securities.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5382.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ES18-6-000.

    Applicants: Commonwealth Edison Company.

    Description: Application of Commonwealth Edison Company under Section 204 of the Federal Power Act for Authorization of the Issuance of Securities.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5383.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ES18-7-000.

    Applicants: PECO Energy Company.

    Description: Application of PECO Energy Company under Section 204 of the Federal Power Act for Authorization of the Issuance of Securities.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5385.

    Comments Due: 5 p.m. ET 11/21/17.

    Docket Numbers: ES18-8-000.

    Applicants: Delmarva Power & Light Company, Potomac Electric Power Company.

    Description: Joint Application of Delmarva Power & Light Company and Potomac Electric Power Company under Section 204 of the Federal Power Act for Authorization to Issue Securities.

    Filed Date: 10/31/17.

    Accession Number: 20171031-5386.

    Comments Due: 5 p.m. ET 11/21/17.

    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: November 1, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-24148 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP17-1073-000.

    Applicants: Natural Gas Pipeline Company of America.

    Description: Penalty Revenue Crediting Report of Natural Gas Pipeline Company of America LLC.

    Filed Date: 9/22/17.

    Accession Number: 20170922-5035.

    Comments Due: 5 p.m. ET 11/2/17.

    Docket Numbers: RP17-1080-000.

    Applicants: LA Storage, LLC.

    Description: Annual Penalty Disbursement Report of LA Storage, LLC.

    Filed Date: 9/22/17.

    Accession Number: 20170922-5173.

    Comments Due: 5 p.m. ET 11/3/17.

    Docket Numbers: RP17-1081-000.

    Applicants: Mississippi Hub, LLC.

    Description: Annual Penalty Disbursement Report of Mississippi Hub, LLC.

    Filed Date: 9/22/17.

    Accession Number: 20170922-5174.

    Comments Due: 5 p.m. ET 11/3/17.

    Docket Numbers: RP18-56-000.

    Applicants: Texas Eastern Transmission, LP.

    Description: § 4(d) Rate Filing: Negotiated Rates—Conoco 911441 to be effective 11/1/2017.

    Filed Date: 10/25/17.

    Accession Number: 20171025-5156.

    Comments Due: 5 p.m. ET 11/6/17.

    Docket Numbers: RP18-57-000.

    Applicants: Alliance Pipeline L.P.

    Description: § 4(d) Rate Filing: Housekeeping Sheet No. 18 to be effective 11/1/2017.

    Filed Date: 10/25/17.

    Accession Number: 20171025-5167.

    Comments Due: 5 p.m. ET 11/6/17.

    Docket Numbers: RP18-58-000.

    Applicants: Southern LNG Company, L.L.C.

    Description: § 4(d) Rate Filing: SLNG Electric Power Cost Adjustment—2017 to be effective 12/1/2017.

    Filed Date: 10/26/17.

    Accession Number: 20171026-5040.

    Comments Due: 5 p.m. ET 11/7/17.

    Docket Numbers: RP18-59-000.

    Applicants: Texas Eastern Transmission, LP.

    Description: § 4(d) Rate Filing: ConocoPhillips K910882 eff. 11-1-2017 to be effective 11/1/2017.

    Filed Date: 10/26/17.

    Accession Number: 20171026-5279.

    Comments Due: 5 p.m. ET 11/7/17.

    Docket Numbers: RP18-60-000.

    Applicants: Texas Eastern Transmission, LP.

    Description: § 4(d) Rate Filing: PCB TETLP DEC 2017 FILING to be effective 12/1/2017.

    Filed Date: 10/26/17.

    Accession Number: 20171026-5302.

    Comments Due: 5 p.m. ET 11/7/17.

    Docket Numbers: RP18-61-000.

    Applicants: Dauphin Island Gathering Partners.

    Description: 2017 Cash Out Report of Dauphin Island Gathering Partners.

    Filed Date: 10/26/17.

    Accession Number: 20171026-5319.

    Comments Due: 5 p.m. ET 11/7/17.

    Docket Numbers: RP18-62-000.

    Applicants: Midwestern Gas Transmission Company.

    Description: Compliance filing 2016-2017 Cashout Report.

    Filed Date: 10/27/17.

    Accession Number: 20171027-5079.

    Comments Due: 5 p.m. ET 11/8/17.

    Docket Numbers: RP18-63-000.

    Applicants: Midwestern Gas Transmission Company.

    Description: Compliance filing 2016-2017 Gas Sales and Purchases Report.

    Filed Date: 10/27/17.

    Accession Number: 20171027-5080.

    Comments Due: 5 p.m. ET 11/8/17.

    Docket Numbers: RP18-64-000.

    Applicants: Natural Gas Pipeline Company of America.

    Description: § 4(d) Rate Filing: Negotiated Rate Filing Tenaska Marketing Ventures to be effective 11/1/2017.

    Filed Date: 10/27/17.

    Accession Number: 20171027-5092.

    Comments Due: 5 p.m. ET 11/8/17.

    Docket Numbers: RP18-65-000.

    Applicants: Guardian Pipeline, L.L.C.

    Description: Compliance filing 2016-2017 Gas Sales and Purchases Report.

    Filed Date: 10/27/17.

    Accession Number: 20171027-5093.

    Comments Due: 5 p.m. ET 11/8/17.

    Docket Numbers: RP18-66-000.

    Applicants: Natural Gas Pipeline Company of America.

    Description: § 4(d) Rate Filing: Shell Energy North Negotiated Rate to be effective 11/1/2017.

    Filed Date: 10/27/17.

    Accession Number: 20171027-5096.

    Comments Due: 5 p.m. ET 11/8/17.

    Docket Numbers: RP18-67-000.

    Applicants: OkTex Pipeline Company, L.L.C.

    Description: Compliance filing 2016-2017 Gas Sales and Purchases Report.

    Filed Date: 10/27/17.

    Accession Number: 20171027-5100.

    Comments Due: 5 p.m. ET 11/8/17.

    Docket Numbers: RP18-68-000.

    Applicants: Viking Gas Transmission Company.

    Description: Compliance filing 2016-2017 Gas Sales and Purchases Report.

    Filed Date: 10/27/17.

    Accession Number: 20171027-5110.

    Comments Due: 5 p.m. ET 11/8/17.

    Docket Numbers: RP18-69-000.

    Applicants: Texas Eastern Transmission, LP.

    Description: Compliance filing TETLP OFO October 2017 Penalty Disbursement Report.

    Filed Date: 10/27/17.

    Accession Number: 20171027-5161.

    Comments Due: 5 p.m. ET 11/8/17.

    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 30, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-24147 Filed 11-6-17; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9970-30-Region 3] Clean Air Act Operating Permit Program; Petition To Object to Title V Permit for Wheelabrator Frackville Energy; Pennsylvania AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of final action.

    SUMMARY:

    Pursuant to the Clean Air Act (CAA), the Environmental Protection Agency (EPA) Administrator signed an Order, dated October 6, 2017, denying a petition to object to a title V operating permit, issued by the Pennsylvania Department of Environmental Protection (PADEP) to the Wheelabrator Frackville Energy facility in Schuylkill County, Pennsylvania. The Order responds to an October 15, 2016 petition. The petition was submitted by the Environmental Integrity Project (EIP) and the Sierra Club (Petitioners). This Order constitutes final action on that petition requesting that the Administrator object to the issuance of the proposed CAA title V permit.

    ADDRESSES:

    Copies of the final Order, the petition, and all pertinent information relating thereto are on file at the following location: EPA, Region III, Air Protection Division (APD), 1650 Arch St., Philadelphia, Pennsylvania 19103. EPA requests that if at all possible, you contact the individual listed in the FOR FURTHER INFORMATION CONTACT section to view copies of the final Order, petition, and other supporting information. You may view the hard copies Monday through Friday, from 9 a.m. to 3 p.m., excluding Federal holidays. If you wish to examine these documents, you should make an appointment at least 24 hours before the visiting day. The final Order is also available electronically at the following Web site: https://www.epa.gov/title-v-operating-permits/title-v-petition-database.

    FOR FURTHER INFORMATION CONTACT:

    David Talley, Air Protection Division, EPA Region III, telephone (215) 814-2117, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    The CAA affords EPA a 45-day period to review and object to, as appropriate, operating permits proposed by state permitting authorities. Section 505(b)(2) of the CAA authorizes any person to petition the EPA Administrator within 60 days after the expiration of this review period to object to a state operating permit if EPA has not done so. Petitions must be based only on objections raised with reasonable specificity during the public comment period, unless the petitioner demonstrates that it was impracticable to raise these issues during the comment period or that the grounds for objection or other issue arose after the comment period.

    The October 15, 2016 petition requested that the Administrator object to the proposed title V operating permit issued by PADEP (Permit No. 54-00005), on the grounds that the proposed permit did not contain adequate monitoring and testing requirements to demonstrate compliance with the particulate matter emission limits contained in the permit.

    The Order denying the petition to object to the state operating permit to the Wheelabrator Frackville Energy facility explains the reasons behind EPA's decision to deny the petition for objection.

    Dated: October 18, 2017. Cosmo Servidio, Regional Administrator, Region III.
    [FR Doc. 2017-24215 Filed 11-6-17; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Meeting of Technological Advisory Council AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (FCC) Technological Advisory Council will hold a meeting.

    DATES:

    Wednesday, December 6, 2017 in the Commission Meeting Room, from 10:00 a.m. to 4:00 p.m.

    ADDRESSES:

    Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.

    FOR FURTHER INFORMATION CONTACT:

    Walter Johnston, Chief, Electromagnetic Compatibility Division, 202-418-0807; [email protected]

    SUPPLEMENTARY INFORMATION:

    At the December 6, meeting, which is the final meeting of the calendar year, the FCC Technological Advisory Council will discuss recommendations to the FCC Chairman on its work program agreed to at its initial meeting on June 8, 2017. The FCC will attempt to accommodate as many people as possible. However, admittance will be limited to seating availability. Meetings are also broadcast live with open captioning over the Internet from the FCC Live Web page at http://www.fcc.gov/live/. The public may submit written comments before the meeting to: Walter Johnston, the FCC's Designated Federal Officer for Technological Advisory Council by email: [email protected] or U.S. Postal Service Mail (Walter Johnston, Federal Communications Commission, Room 2-A665, 445 12th Street SW., Washington, DC 20554). Open captioning will be provided for this event. Other reasonable accommodations for people with disabilities are available upon request. Requests for such accommodations should be submitted via email to [email protected] or by calling the Office of Engineering and Technology at 202-418-2470 (voice), (202) 418-1944 (fax). Such requests should include a detailed description of the accommodation needed. In addition, please include your contact information. Please allow at least five days advance notice; last minute requests will be accepted, but may not be possible to fill.

    Federal Communications Commission. Julius P. Knapp, Chief, Office of Engineering and Technology.
    [FR Doc. 2017-24157 Filed 11-6-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meetings FEDERAL REGISTER CITATION NOTICE OF PREVIOUS ANNOUNCEMENT:

    82 FR 51253.

    PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING:

    Wednesday, November 8, 2017 at 10:00 a.m.

    CHANGES IN THE MEETING:

    The following matter will also be considered: FEC Email Management Policy.

    CONTACT PERSON FOR MORE INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Dayna C. Brown, Secretary and Clerk of the Commission.
    [FR Doc. 2017-24338 Filed 11-3-17; 4:15 pm] BILLING CODE 6715-01-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 21, 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. Gaylon M. Lawrence, Nashville, Tennessee; to retain 10 percent or more of the outstanding voting shares of CapStar Financial Holdings, Inc., and thereby indirectly retain voting shares of CapStar Bank, both in Nashville, Tennessee.

    Board of Governors of the Federal Reserve System, November 1, 2017. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2017-24210 Filed 11-6-17; 8:45 am] BILLING CODE 6210-01-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 December 1, 2017.

    A. Federal Reserve Bank of Minneapolis (Brendan S. Murrin, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:

    1. Dakota Financial, Inc., Marietta, Minnesota; to acquire 63.23 percent of the voting shares of Milan Agency, Inc., and thereby indirectly acquire shares of Prairie Sun Bank, both in Milan, Minnesota.

    Board of Governors of the Federal Reserve System, November 1, 2017. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2017-24211 Filed 11-6-17; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee (STAC) ACTION:

    Notice.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the STAC. The STAC consists of 17 members including experts in fields associated with occupational medicine, environmental medicine, environmental health, industrial hygiene, epidemiology, toxicology, mental health, and representatives of World Trade Center (WTC) responders as well as representatives of certified-eligible WTC survivors. Members may be invited to serve for three-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of STAC objectives https://www.cdc.gov/wtc/stac.html.

    DATES:

    Nominations for membership on the STAC must be received no later than January 26, 2018. Packages received after this time will not be considered for the current membership cycle.

    ADDRESSES:

    All nominations should be mailed to NIOSH Docket 229-F, c/o Mia Wallace, Committee Management Specialist, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, 1600 Clifton Rd. NE., MS: E-20, Atlanta, Georgia 30333, or emailed (recommended) to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Paul Middendorf, Deputy Associate Director for Science, 1600 Clifton Rd. NE., MS: E-20, Atlanta, GA 30333; telephone (404) 498-2500 (this is not a toll-free number); email [email protected]

    SUPPLEMENTARY INFORMATION:

    The U.S. Department of Health and Human Services policy stipulates that committee membership be balanced in terms of points of view represented, and the committee's function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees, requiring the filing of financial disclosure reports at the beginning and annually during their terms. NIOSH identifies potential candidates and provides a slate of nominees for consideration to the Director of CDC for STAC membership each year, CDC reviews the proposed slate of candidates, and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment near the start of the term in October, or as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate who is not selected in one year may be reconsidered in a subsequent year.

    Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. The Administrator is seeking nominations for members fulfilling the following categories:

    • Environmental medicine or Environmental health specialist;

    • Epidemiologist;

    • Occupational physician who has experience treating WTC rescue and recovery workers;

    • Occupational physician;

    • Representative of WTC responders; and

    • Toxicologist.

    Candidates should submit the following items:

    Current curriculum vitae, including complete contact information (telephone numbers, mailing address, email address);

    The category of membership (environmental medicine or environmental health specialist, occupational physician, pulmonary physician, representative of WTC responders, certified-eligible WTC survivor representative, industrial hygienist, toxicologist, epidemiologist, or mental health professional) that the candidate is qualified to represent);

    A summary of the background, experience, and qualifications that demonstrates the nominee's suitability for the nominated membership category; and

    At least one letter of recommendation from person(s) not employed by the U.S. Department of Health and Human Services. (Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency (e.g., CDC, NIH, FDA, etc.).

    Nominations may be submitted by the candidate him- or herself, or by the person/organization recommending the candidate.

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry.

    Elaine L. Baker Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2017-24155 Filed 11-6-17; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS-10656 and CMS-10455] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments must be received by January 8, 2018.

    ADDRESSES:

    When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

    1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

    2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number _________, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    William Parham at (410) 786-4669.

    SUPPLEMENTARY INFORMATION:

    Contents

    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

    CMS-10656 Evaluation of the Partnership for Patients (PfP) 3.0 CMS-10455 Report of a Hospital Death Associated with Restraint or Seclusion

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

    Information Collection

    1. Type of Information Collection Request: New collection of information request; Title of Information Collection: Evaluation of the Partnership for Patients (PfP) 3.0; Use: In the summer of 2015, the Centers for Medicare & Medicaid Services (CMS) Administrator approved the plans for integration of the Partnership for Patients (PfP) Hospital Engagement Network (HEN) model test with the Quality Improvement Network-Quality Improvement Organization (QIN-QIO) program. This is consistent with the Agency's intention for further integration to maximize the strengths of the QIO program and PfP HENs to sustain and expand current national reductions in in-patient harm and 30-day readmissions. The alignment of the two programs permits the systematic use of innovative patient safety practices at a national scale.

    Under this initiative, CMS has awarded multiple contracts to Hospital Improvement Innovation Networks (HIINs), formerly known as HENs, to engage the hospital, provider, and broader caregiver communities to implement well-tested and measured best practices. The end result of the overall initiative is the anticipated reduction in preventable hospital-based harm and readmissions for patients.

    The PfP initiative is a public-private partnership dedicated to the improvement of health care quality, safety, and affordability. CMS, working with hospitals, providers, and the broader caregiver community, aims to implement and disseminate best practices on a national scale to reduce hospital acquired conditions (HACs) and all-cause readmissions. Through the PfP model, which was initiated in April 2011, CMS fostered rapid learning among a nationwide community of practice, resulting in major strides in patient safety and engagement by patients and families.

    A mixed methods approach to answering the PfP HIIN evaluation questions includes three primary data collection activities, as follows: Hospital Survey on Prevention of Adverse Events and Reduction of Readmissions, HIIN Data Quality Assurance (QA) Survey and Qualitative Discussions with HIIN leaders and Other Support Contractors. The data collected will provide us feedback to focus efforts to improve the effectiveness and efficiency of the HIIN initiative. As we draft future HIIN and QIO contracts, information from hospitals about HIIN influence on their care processes will be used together with follow-up input from stakeholders about the survey results. Form Number: CMS-10656 (OMB Control Number: 0938-NEW); Frequency: Annually; Affected Public: Private Sector: Business or other for-profits and Not-for-profit institutions; Number of Respondents: 835; Total Annual Responses: 854; Total Annual Hours: 392. (For policy questions regarding this collection contact Israel Cross at 410-786-0619.)

    2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Report of a Hospital Death Associated with Restraint or Seclusion; Use: The regulation that was published on May, 16, 2012 (77 FR 29074) included a reduction in the reporting requirement related to hospital deaths associated with the use of restraint or seclusion, § 482.13(g). Hospitals must use Form CMS-10455 to report those deaths associated with restraint and/or seclusion directly to the Centers for Medicare & Medicaid Services (CMS) Regional Office (RO). This requirement also applies to rehabilitation or psychiatric distinct part units (DPUs) in Critical Access Hospitals (CAHs). The RO must provide hospitals with instructions for submitting the form fax and/or email, based on RO preference. Hospitals are no longer required to report to CMS those deaths where there was no use of seclusion and the only restraint was 2-point soft wrist restraints beginning in May 9, 2014. This reporting requirement change resulted in no necessary edits to the form CMS-10455 as soft wrist restraints may be used in combination with other types of restraints. It was estimated that this would reduce the volume of reports that must be submitted by 90 percent for hospitals. In addition, the final rule replaced the previous requirement for reporting via telephone to CMS, which proved to be cumbersome for both CMS and hospitals, with a requirement that allows submission of reports via telephone, facsimile or electronically, as determined by CMS.

    Form CMS-10455 is being revised in order to obtain the necessary information for the ROs to make a determination whether or not to authorize an on-site investigation related to the details surrounding the death of individuals associated with restraint and/or seclusion. Form Number: CMS-10455 (OMB control number: 0938-1210); Frequency: Occasionally; Affected Public: Private Sector; Number of Respondents: 6,389; Number of Responses: 6,389; Total Annual Hours: 2,619. (For policy questions regarding this collection contact Karina Meushaw at 410-786-1000.)

    Dated: November 1, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2017-24134 Filed 11-6-17; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0529] Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery; 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 guidance for industry entitled “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery.” The guidance is intended to promote the safe use of nonprescription (also referred to as over-the-counter or OTC) aspirin drug products by encouraging drug manufacturers, packagers, and labelers marketing aspirin drug products with cardiovascular-related imagery to include a statement that reminds consumers to talk to their health care provider before using aspirin for their heart.

    DATES:

    The announcement of the guidance is published in the Federal Register on November 7, 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-2012-D-0529 for “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery; Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of the 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 guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Emily Baker, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51 Rm. 5203, Silver Spring, MD 20993-0002, 301-796-7524.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a guidance for industry entitled “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery.” Aspirin is a common active ingredient in many prescription and OTC drug products. Most OTC aspirin drug products are currently marketed pursuant to the Tentative Final Monograph (TFM) for Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) Drug Products (53 FR 46204, November 16, 1988) for the temporary relief of minor aches and pains associated with a cold, headache, backache, toothache, premenstrual and menstrual cramps, minor pain of arthritis, and reduction in fever.

    In addition to the OTC conditions of use in the IAAA TFM, FDA regulations at § 343.80 (21 CFR 343.80) also contain professional labeling about cardiovascular uses of aspirin directed at health care practitioners (63 FR 56802, October 23, 1998). After publication of the professional labeling regulation for aspirin, some OTC aspirin labels were modified to include cardiovascular-related imagery (e.g., heart image, electrocardiography graphic, stethoscope around a heart image). However, the final rule for IAAA products at § 343.80 authorizes labeling for cardiovascular events only in professional labeling directed to health care professionals.

    Because of the potential side effects associated with long-term aspirin therapy, FDA recommends that any cardiovascular-related imagery on OTC aspirin labels be accompanied by a statement that reminds consumers to talk to their health care provider before using aspirin for the professional indication of secondary prevention of cardiovascular events. Therefore, this guidance provides that FDA does not intend to take action against manufacturers of single-ingredient aspirin, buffered aspirin, and aspirin in combination with an antacid, marketed pursuant to the TFM for IAAA Drug Products because the product label includes cardiovascular-related imagery (e.g., heart image, electrocardiography graphic, stethoscope around a heart image) if the label also includes language as described in the guidance recommending that patients talk to a health care professional before taking aspirin for cardiovascular uses and the product is otherwise marketed in accordance with the TFM.

    In the Federal Register of January 11, 2017 (82 FR 3335), FDA published a draft guidance entitled “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery; Guidance for Industry.” We have made changes to the guidance in response to comments received and revised the recommended statement to make it more consumer friendly.

    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 “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    The recommendations in this guidance are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the labeling statements are a “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)).

    III. Electronic Access

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

    Dated: November 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-24192 Filed 11-6-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1129] Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is announcing its intent to exempt a list of class II devices from premarket notification requirements, subject to certain limitations. The Agency has determined that, based on established factors, these devices no longer require premarket notification to provide reasonable assurance of safety and effectiveness. FDA is publishing this notice to obtain comments regarding the proposed exemptions, in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

    DATES:

    Submit either electronic or written comments on the notice by January 8, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 8, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 8, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2017-N-1129 for “Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 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:

    Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, [email protected]

    SUPPLEMENTARY INFORMATION

    :

    I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing regulations, 21 CFR part 807 subpart E, require persons who intend to market a new device to submit and obtain clearance of a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval.

    The 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed into law on December 13, 2016. Section 3054 of the Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act requires FDA to publish in the Federal Register a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. FDA is required to publish this notice within 90 days of the date of enactment of the Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Additionally, FDA must provide at least a 60-day comment period for any such notice required to be published under section 510(m)(1)(A) of the FD&C Act. FDA published this notice in the Federal Register of March 14, 2017 (82 FR 13609). Under section 510(m)(1)(B) of the FD&C Act, FDA must publish in the Federal Register, within 210 days of enactment of the Cures Act, a list representing its final determination regarding the exemption of the devices that were contained in the list published under section 510(m)(1)(A). FDA published that list in the Federal Register of July 11, 2017 (82 FR 31976).

    As amended, section 510(m)(2) of the FD&C Act provides that, 1 day after the date of publication of the final list under section 510(m)(1), FDA may exempt a class II device from the requirement to submit a report under section 510(k) of the FD&C Act upon its own initiative or a petition of an interested person, if FDA determines that a report under section 510(k) is not necessary to assure the safety and effectiveness of the device. To do so, FDA must publish in the Federal Register a notice of its intent to exempt the device, or of the petition, and provide a 60-day period for public comment. Within 120 days after the issuance of this notice, FDA must publish an order in the Federal Register that sets forth its final determination regarding the exemption of the device that was the subject of the notice. If FDA fails to respond to a petition under section 510(m)(2) of the FD&C Act within 180 days of receiving it, the petition shall be deemed granted.

    II. Factors FDA May Consider for Exemption

    There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, Federal Register notice (63 FR 3142) and subsequently in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (“Class II 510(k) Exemption Guidance”) (Ref. 1). Accordingly, FDA generally considers the following factors to determine whether premarket notification is necessary for class II devices: (1) The device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) characteristics of the device necessary for its safe and effective performance are well established; (3) changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means such as routine testing, before causing harm, or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not be likely to result in a change in the device's classification. FDA may also consider that, even when exempting devices, these devices would still be subject to the limitations on exemptions.

    III. Limitations on Exemptions

    FDA has determined that premarket notification is not necessary to assure the safety and effectiveness of the class II devices listed in table 1. This determination is based, in part, on the Agency's knowledge of the device, including past experience and relevant reports or studies on device performance (as appropriate), the applicability of general and special controls, and the Agency's ability to limit an exemption.

    A. General Limitations of Exemptions

    FDA's proposal to grant an exemption from premarket notification for class II devices listed in table 1 applies only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type, or, in the case of in vitro diagnostic devices, for which a misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality. FDA proposes that a manufacturer of a listed device would still be required to submit a premarket notification to FDA before introducing a device or delivering it for introduction into commercial distribution when the device meets any of the conditions described in 21 CFR 862.9 to 21 CFR 892.9.

    B. Partial Limitations of Exemptions

    In addition to the general limitations, FDA may also partially limit an exemption from premarket notification requirements to specific devices within a listed device type when initial Agency assessment determines that the factors laid out in the Class II 510(k) Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all devices in a particular group. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices. In table 1, for example, FDA is listing the proposed exemption of the genetic health risk assessment system, but limits the exemption to such devices that have received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the genetic health risk assessment system (a “one-time FDA reviewed genetic health risk assessment system”). FDA believes that a one-time FDA review (e.g., premarket notification) of a genetic health risk assessment system is necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA believes that a one-time FDA review of a genetic health risk assessment system is necessary to mitigate the risk of false negatives and false positives by ensuring that certain information be submitted to FDA to allow the Agency to assess the safety and effectiveness of the devices and the regulatory controls necessary to address those issues as well as to ensure the devices perform to acceptable standards.

    IV. List of Class II Devices

    FDA is identifying the following list of class II devices that, if finalized, would no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in §§ 862.9 to 892.9:

    Table 1—Class II Devices 21 CFR section Device type Product
  • code
  • Partial exemption limitation
  • (if applicable)
  • 862.1840 Total 25-hydroxyvitamin D Mass Spectrometry Test System PSL 866.5950 Genetic Health Risk Assessment System PTA Exemption is limited to a genetic health risk assessment system that has received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the genetic health risk assessment system (a “one-time FDA reviewed genetic health risk assessment system”). 876.1500 Endoscopic Maintenance System PUP 880.6710 Purifier, Water, Ultraviolet, Medical KMG 884.5960 Vibrator for Therapeutic Use, Genital KXQ
    V. Reference

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

    1. FDA Guidance, “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,” February 19, 1998, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf. Dated: October 31, 2017. Lauren Silvis, Chief of Staff.
    [FR Doc. 2017-24163 Filed 11-6-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-N-0618; FDA-2013-N-1155; FDA-2010-N-0118; FDA-2011-N-0655; FDA-2014-N-0086; FDA-2011-N-0144; FDA-2016-N-2836] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

    FOR FURTHER INFORMATION CONTACT:

    Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]

    SUPPLEMENTARY INFORMATION:

    The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    Table 1—List of Information Collections Approved By OMB Title of collection OMB control No. Date approval expires Reporting and Recordkeeping for Electronic Products—General Requirements 0910-0025 7/31/2020 Food Labeling Regulations 0910-0381 7/31/2020 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 0910-0520 7/31/2020 Animal Generic Drug User Fee Act Cover Sheet 0910-0632 7/31/2020 Potential Tobacco Product Violations Reporting Form 0910-0716 7/31/2020 Voluntary Qualified Importer Program Guidance for Industry 0910-0840 7/31/2020 Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute—Sponsored Transfusion-Transmissible Infectious Monitoring System 0910-0841 7/31/2020 Dated: November 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-24189 Filed 11-6-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1170] Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; 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 guidance for industry entitled “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.” The purpose of this guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This guidance finalizes the draft guidance of the same name issued on May 4, 2016.

    DATES:

    The announcement of the guidance is published in the Federal Register on November 7, 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-2013-D-1170 for “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Guidance for Industry; 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)).

    Submit written requests for single copies of this 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 guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey Murray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6360, Silver Spring, MD 20993-0002, 301-796-1500.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a guidance for industry entitled “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.” This guidance addresses nonclinical development, early phases of clinical development, and phase 3 protocol designs. Important issues addressed in this guidance include: trial design options, choice of noninferiority margins for active-controlled phase 3 trials in the evaluation of interferon (IFN)-free regimens, and trial design options and safety evaluations for specific populations including patients with decompensated cirrhosis, patients either pre- or post-liver transplant, and patients with chronic kidney disease and clinical virology considerations. This guidance finalizes the draft guidance of the same name issued on May 4, 2016 (81 FR 26805). Changes made to the guidance took into consideration comments received. In addition to editorial changes primarily for clarification, the major changes are as follows:

    • Modification of several sections to focus on IFN-free DAA regimens.

    • Additional clarification on trial designs for combinations of investigational DAAs with or without ribavirin.

    • Additional clarification on the recommended trial population to include patients with clinical or laboratory evidence of chronic hepatitis C disease, such as the presence of fibrosis by biopsy or noninvasive tests.

    • Additional details on DAA drug development in patients with decompensated cirrhosis, including recommendations for a review by an independent adjudication committee for all serious hepatic events, deaths, liver transplantations, and changes in prespecified alanine transaminase, aspartate transaminase, and bilirubin parameters and a recommendation for long-term followup to characterize clinical outcomes such as progression or regression of liver disease, liver-related mortality, occurrence of hepatocellular carcinoma, or liver failure requiring liver transplantation.

    • Additional clarification on efficacy endpoints, specifically additional post-treatment followup (e.g., 1 year or longer) may be needed if one or more drugs in the regimen has a long plasma or intracellular half-life or prolonged antiviral activity.

    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 “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.” 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively.

    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: November 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-24195 Filed 11-6-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following Heart, Lung, & Blood Program Project Review Committee meeting.

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

    Name of Committee: Heart, Lung, and Blood Initial Review Group; Heart, Lung, and Blood Program Project Review Committee.

    Date: December 1, 2017.

    Time: 8:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sheraton BWI (Baltimore), 1100 Old Elkridge Landing Road, Baltimore, MD 21090.

    Contact Person: Jeffrey H. Hurst, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7208, Bethesda, MD 20892, 301-435-0303, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: November 1, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-24144 Filed 11-6-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

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

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

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Synthetic Psychoactive Drugs and Strategic Approaches to Counteract their Deleterious Effects.

    Date: November 30, 2017.

    Time: 1:00 p.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Jasenka Borzan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892-7814, 301-435-1787, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Neuroimmunology, Neuroinflammation and Brain Tumor.

    Date: December 6, 2017.

    Time: 10:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Nataliya Gordiyenko, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5202, MSC 7846, Bethesda, MD 20892, 301-435-1265, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Retinal Synapses and Circuitry.

    Date: December 6, 2017.

    Time: 12:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Afia Sultana, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 4189, Bethesda, MD 20892, (301) 827-7083, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: November 1, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-24143 Filed 11-6-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-6045-N-01] Annual Indexing of Basic Statutory Mortgage Limits for Multifamily Housing Programs AGENCY:

    Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.

    ACTION:

    Notice.

    SUMMARY:

    In accordance with Section 206A of the National Housing Act, HUD has adjusted the Basic Statutory Mortgage Limits for Multifamily Housing Programs for Calendar Year 2017.

    DATES:

    January 1, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Daniel J. Sullivan, Deputy Director, Office of Multifamily Development, Department of Housing and Urban Development, 451 Seventh Street SW., Washington, DC 20410-8000, telephone (202) 402-6130 (this is not a toll-free number). Hearing or speech-impaired individuals may access this number through TTY by calling the toll-free Federal Information Relay Service at (800) 877-8339.

    SUPPLEMENTARY INFORMATION:

    The FHA Down Payment Simplification Act of 2002 (Pub. L. 107-326, approved December 4, 2002) amended the National Housing Act by adding a new Section 206A (12 U.S.C. 1712a). Under Section 206A, the following are affected:

    I. Section 207(c)(3)(A) (12 U.S.C. 1713(c)(3)(A)); II. Section 213(b)(2)(A) (12 U.S.C. 1715e(b)(2)(A)); III. Section 220(d)(3)(B)(iii)(I) (12 U.S.C. 1715k(d)(3)(B)(iii)(I)); IV. Section 221(d)(4)(ii)(I) (12 U.S.C. 1715l(d)(4)(ii)(I)); V. Section 231(c)(2)(A) (12 U.S.C. 1715v(c)(2)(A)); and VI. Section 234(e)(3)(A) (12 U.S.C. 1715y(e)(3)(A)).

    The Dollar Amounts in these sections are the base per unit statutory limits for FHA's multifamily mortgage programs collectively referred to as the `Dollar Amounts.' They are adjusted annually (commencing in 2004) on the effective date of the Consumer Financial Protection Bureau's adjustment of the $400 figure in the Home Ownership and Equity Protection Act of 1994 (HOEPA) (Pub. L. 103-325, approved September 23, 1994). The adjustment of the Dollar Amounts shall be calculated using the percentage change in the Consumer Price Index for All Urban Consumers (CPI-U) as applied by the Bureau of Consumer Financial Protection for purposes of the above-described HOEPA adjustment.

    HUD has been notified of the percentage change in the CPI-U used for the HOEPA adjustment and the effective date of the HOEPA adjustment. The percentage change in the CPI-U is 2.1 percent and the effective date of the HOEPA adjustment is January 1, 2017. The Dollar Amounts have been adjusted correspondingly and have an effective date of January 1, 2017.

    These revised statutory limits, high cost areas and per unit cost thresholds for substantial rehabilitation may be applied to FHA multifamily mortgage insurance applications submitted or amended on or after July 1, 2017, so long as the loan has not been initially endorsed.

    The adjusted Dollar Amounts for Calendar Year 2017 are shown below:

    Basic Statutory Mortgage Limits for Calendar Year 2017 Multifamily Loan Program Section 207—Multifamily Housing Section 207 pursuant to Section 223(f)—Purchase or Refinance Housing Section 220—Housing in Urban Renewal Areas Bedrooms Non-elevator Elevator 0 $51,575 $60,158 1 57,133 66,657 2 68,244 81,734 3 84,116 102,368 4+ 95,228 115,749 Section 213—Cooperatives Bedrooms Non-elevator Elevator 0 $55,894 $59,515 1 64,447 67,428 2 77,725 81,993 3 99,489 106,073 4+ 110,837 116,438 Section 234—Condominium Housing Bedrooms Non-elevator Elevator 0 $57,035 $60,021 1 65,762 68,806 2 79,311 83,667 3 101,521 108,239 4+ 113,098 118,812 Section 221(d)(4)—Moderate Income Housing Bedrooms Non-elevator Elevator 0 $51,328 $55,445 1 58,266 63,562 2 70,429 77,291 3 88,400 99,988 4+ 99,890 109,758 Section 231—Housing for the Elderly Bedrooms Non-elevator Elevator 0 $48,800 $55,445 1 54,555 63,562 2 65,147 77,291 3 78,401 99,988 4+ 92,173 109,758 Section 207—Manufactured Home Parks Per Space—$23,678 Per Unit Limit for Substantial Rehabilitation for Calendar Year 2017

    The 2016 Multifamily Accelerated Processing (MAP) Guide established a base amount of $15,000 per unit to define substantial rehabilitation for FHA insured loan programs. Section 5.1.D.2 of the MAP guide requires that this base amount be adjusted periodically based on the percentage change published by the Consumer Financial Protection Bureau or other inflation cost index published by HUD. Accordingly, the 2017 base amount per dwelling unit to determine substantial rehabilitation for FHA insured loan programs is $15,315.

    Environmental Impact

    This issuance establishes mortgage and cost limits that do not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 24 CFR 50.19(c)(6), this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).

    Dated: October 31, 2017. Dana T. Wade, General Deputy Assistant Secretary for Housing.
    [FR Doc. 2017-24171 Filed 11-6-17; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5997-N-72] 30-Day Notice of Proposed Information Collection: Transfer and Consolidation of Public Housing Programs and Public Housing Agencies AGENCY:

    Office of the Chief Information Officer, HUD.

    ACTION:

    Notice.

    SUMMARY:

    HUD submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for 30 days of public comment.

    DATES:

    Comments Due Date: December 7, 2017.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806, Email: OIRA [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email [email protected], or telephone 202-402-3400. This is not a toll-free number. Person with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    Copies of available documents submitted to OMB may be obtained from Ms. Pollard.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A. The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on June 27, 2017 at 82 FR 29091.

    A. Overview of Information Collection

    Title of Information Collection: Transfer and Consolidation of Public Housing Programs and Public Housing Agencies.

    OMB Approval Number: 2577-0280.

    Type of Request: Reinstatement, without change, of a previously approved collection for which approval has expired.

    Form Number: No form is used to collect this information. Forms collected with information incidental to this collection are: HUD-52190-A, HUD-53012-A, HUD 53012-B, HUD-52722, HUD-52723, HUD-51999, SF-1199A, HUD-27056, HUD-27054A, HUD-52540.

    Description of the Need for the Information and Proposed Use: State legislatures or other local governing bodies may from time to time direct or agree that the public interest is best served if one Public Housing Agency (PHA) cedes its public housing program to another PHA, or that two or more PHAs should be combined into one multijurisdictional PHA. This proposed information collection serves to protect HUD's several interests in either transaction: (1) Insuring the continued use of the property as Public Housing; (2) that HUD's interests are secured; and (3) that the Operating and Capital subsidies that HUD pays to support the operation and maintenance of Public Housing is properly paid to the correct PHA on behalf of the correct properties. In addition to submitting documentation to HUD, PHAs are required to make conforming changes to HUD's Public Housing Information Center (PIC).

    Total Estimated Burdens:

    Total Burden Hour Estimates for PHAs Number of transfer or consolidation actions Number of
  • respondents
  • Frequency of
  • requirement *
  • × Estimated
  • average
  • time for
  • requirement
  • (hours)
  • = Estimated
  • annual burden
  • (hours)
  • 3 Transfers 6 1 120 720 2 Consolidations 4 1 200 800 Subtotals 10 320 1520 * The frequency shown assumes that the receiving or consolidated PHA makes one submission for all other PHAs involved in either the transfer or consolidation.
    B. Solicitation of Public Comment

    This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

    (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;

    (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 collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    HUD encourages interested parties to submit comment in response to these questions.

    Authority:

    Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.

    Dated: November 1, 2017. Colette Pollard, Department Reports Management Officer, Office of the Chief Information Officer.
    [FR Doc. 2017-24213 Filed 11-6-17; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5997-N-71] 30-Day Notice of Proposed Information Collection: Housing Opportunities for Persons With AIDS (HOPWA) Program AGENCY:

    Office of the Chief Information Officer, HUD.

    ACTION:

    Notice.

    SUMMARY:

    HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 30 days of public comment.

    DATES:

    Comments Due Date: December 7, 2017

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax:202-395-5806, Email: OIRA [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Anna P. Guido, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Anna P. Guido at Anna. P. [email protected] or telephone 202-402-5535. This is not a toll-free number. Person with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339. Copies of available documents submitted to OMB may be obtained from Ms. Guido.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

    The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on June 16, 2017 at 82 FR 27716.

    A. Overview of Information Collection

    Title of Information Collection: Housing Opportunities for Persons With AIDS (HOPWA) Program.

    OMB Approval Number: 2506-0133.

    Type of Request: Revision of a currently approved collection.

    Form Number: HUD-40110-B, HUD-40110-C, HUD-40110-D, SF-424, SF-LLL, and HUD-2991.

    Description of the need for the information and proposed use: The current paperwork reduction act approval under OMB Control No. 2506-0133 covers both the HOPWA formula and competitive grant programs. The competitive grant program includes new competitive grants and renewal grants. The information collection requirements pertain to grant application submission requirements which will be used to rate applications, determine eligibility, and establish grant amounts. HOPWA plans to continue using form HUD-40110-B, HOPWA Competitive Application & Renewal of Permanent Supportive Housing Project Budget Summary, as a component of determining applicant eligibility and establishing grant amounts for competitive grants. Limited technical edits are proposed for form HUD-40110-B. HOPWA competitive and renewal application submission also require submission of the following forms: SF424; SFLLL; and HUD-2991. Form HUD-2991 is currently covered under OMB approval number 2506-0112.

    The addition of narratives to address the five HUD standard rating factors will allow HUD to rate application and further determine eligibility and establish grant amounts. Applicants applying for HUD competitive funds are required to respond to these five rating factors in narrative form. These narratives will complement the currently approved budget summary form, and allow HUD to determine if applicants are proposing projects within statutory and regulatory limitations. The five HUD standard rating factors include: Factor 1: Capacity of the Applicant and Relevant Organizational Staff; Factor 2: Need/Extent of the Problem; Factor 3: Soundness of Approach; Factor 4: Leveraging Resources; and Factor 5: Achieving Results and Program Evaluation. New HOPWA competitive applicants will be required to respond to each rating factor within the page limits establish in the grant solicitation. HOPWA renewal applicants will also be required to respond with narratives, but the information will be more limited and focused on continued compliance with the HOPWA program activities originally awarded until their initial grant application.

    The reporting and recordkeeping for both HOPWA formula and competitive grant programs are also included in this approval. Technical edits are proposed for forms HUD-40110-C and HUD-40110-D, and are limited to updating outdated references and information currently contained in the forms. Grantees provide annual information on program accomplishments that supports program evaluation and the ability to measure program beneficiary outcomes related to: maintaining housing stability; preventing homelessness; and improving access to care and support. Competitive grantees report through HUD-40110-C, the HOPWA Annual Performance Report (APR); Formula grantees report through HUD-40110-D, the HOPWA Consolidated Annual Performance and Evaluation Report (CAPER). Grantees are required to report on the activities undertaken only. HUD systematically reviews and conducts data analysis in order to prepare national and individual grantee performance profiles that are not only used to measure program performance against benchmark goals and objectives, but also to communicate the program's achievement and contributions towards Departmental strategic goals.

    Completed technical edits incorporated into forms covered by this proposed information collection, as discussed above.

    I. HUD-40110-B, HOPWA Competitive Application & Renewal of Permanent Supportive Housing Project Budget Summary

    a. Cover page description. The statement, “Selections of applications for funding under the HOPWA Program are based on the rating factors set forth in the SuperNOFA for Housing and Community Development Programs and the criteria established in the annual HOPWA renewal notice for those permanent supportive housing grantee's seeking renewal funding.” changed to, “Selections of applications for funding under the HOPWA Program are based on the rating factors set forth in the published Notice of Funding Award (NOFA) and the criteria established in the annual HOPWA renewal notice for eligible permanent supportive housing grantees seeking renewal funding.” This edit reflects a change in Departmental process that now each program office releases a NOFA when funding is available to be awarded.

    b. Cover page description. The public reporting burden was updated on the budget form to show the number of hours it would take to complete the renewal grant application versus the new competitive grant application.

    c. Transparency Act Compliance. This section of the form was removed. All grantees are required to enter this information into Federal Funding Accountability and Transparency Act (FFATA) Federal Subaward Reporting System (FSRS) so it is no longer necessary to collect this information here.

    d. Applicant Certifications. Language from Appendix A of 24 CFR part 87 was added to cover the certification regarding lobbying for all applicants.

    II. HUD-40110-C, HOPWA Annual Performance Report (APR)

    a. Cover page and Overview pages.

    i. Descriptive paragraph. The number of burden hours was updated.

    ii. Recordkeeping. HMIS overview of HOPWA elements were updated to reflect current HMIS elements.

    iii. Filing Requirements. The physical address was updated to include the correct room number.

    iv. Program Income. The citation was updated to reflect new 2 CFR 200 requirements.

    b. Part 2: Grantee Narrative and Assessment

    i. E. Unmet Housing Need. This section was removed. Grantees are no longer required to report on local unmet need.

    c. Part 3: Summary Overview of Grant Activities

    i. Section 3: Households. The link to HUD-published area median income was updated.

    III. HUD-40110-D, HOPWA Consolidated Annual Performance and Evaluation Report (CAPER)

    a. Cover page and Overview pages.

    i. Descriptive paragraph. The number of burden hours was updated.

    ii. Recordkeeping. HMIS overview of HOPWA elements were updated to reflect current HMIS elements.

    iii. Filing Requirements. The physical address was updated to include the correct room number.

    iv. Program Income. The citation was updated to reflect new 2 CFR 200 requirements.

    b. Part 1: 5. Grantee Narrative and Performance Assessment

    i. d. Unmet Housing Need. This section was removed. Grantees are no longer required to report on local unmet need.

    c. Part 3. Accomplishment Data

    i. Opening paragraph. References to reporting in IDIS were removed. Grantees are no longer required to use IDIS for the reporting of Accomplishment Data.

    d. Part 7: Summary Overview of Grant Activities

    Section 3: Households. The link to HUD-published area median income was updated Respondents (i.e. affected public): HOPWA competitive and renewal grant applicants, and all HOPWA formula, competitive, and renewal grantees.

    Information collection Number of
  • respondents
  • Responses
  • per year
  • Total
  • annual
  • responses
  • Hours
  • per
  • response
  • Total
  • hours
  • Hourly
  • cost
  • Annualized
  • cost
  • HOPWA Renewal Application (including HUD-40110-B, narratives, and other requirements listed in the renewal notice) 28.00 1.00 28.00 15.00 420.00 $23.85 $10,017.00 HOPWA Competitive Application (including HUD-40110-B, narratives, and other requirements listed in the NOFA) 40.00 1.00 40.00 45.00 1,800.00 23.85 42,930.00 HUD-40110-C Annual Progress Report (APR) 99.00 1.00 99.00 55.00 5,445.00 23.85 129,863.25 HUD-40110-D Consolidated Annual Performance and Evaluation Report (CAPER) 128.00 1.00 128.00 41.00 5,248.00 23.85 125,164.80 Recordkeeping for Competitive, Renewal, and Formula Grantees 227.00 1.00 227.00 60.00 13,620.00 23.85 324,837.00 Grant Amendments (budget change, extension, or early termination) 30.00 1.00 30.00 6.00 180.00 23.85 4,293.00 Total 552.00 - 552.00 - 26,713.00 - 637,105.05

    Renewal grants are awarded for a three-year operating period. Currently, there are 82 eligible renewal grantees. The number of respondents listed for HOPWA renewal applications represents one-third of the renewal grantees, or the estimated number of grantees projected to renew HOPWA grants each year. The number of respondents listed for HOPWA competitive applications represents the number of respondents expected to submit an application if funding becomes available in the next three years. Form HUD-40110-C, the APR is submitted by all renewal and competitive grantees on an annual basis. The number of respondents for the APR include 82 renewal grantees, eight (8) current HOPWA competitive grantees, and nine (9) potential competitive grantees, if funding becomes available.

    HOPWA grantees and applicants may be required to respond to more than one piece of information collection. The total number of respondents include: 82 renewal grantees, eight (8) current HOPWA competitive grantees, 40 potential competitive applicants, and 128 current HOPWA formula grantees. The total of 552 total annual responses captures each unique response from the 258 respondents. All annualized costs reflect staff time spent on tasks in the table. The hourly rate is based on a GS-9 for Rest of United States. 26,713 hours * $23.85 = $637,105.05

    B. Solicitation of Public Comment

    This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

    (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;

    (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 collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    HUD encourages interested parties to submit comment in response to these questions.

    Authority:

    Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.

    Dated: October 31, 2017. Anna P. Guido, Department Reports Management Officer, Office of the Chief Information Officer.
    [FR Doc. 2017-24170 Filed 11-6-17; 8:45 am] BILLING CODE 4210-67-P
    INTERNATIONAL TRADE COMMISSION [Investigation Nos. 701-TA-442 and 731-TA-1095-1096 (Second Review)] Lined Paper School Supplies From China and India; Amended Schedule for Expedited Reviews AGENCY:

    United States International Trade Commission.

    ACTION:

    Notice.

    DATES:

    October 27, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Calvin Chang (202-205-3062), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (https://www.usitc.gov). The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.

    SUPPLEMENTARY INFORMATION:

    On October 6, 2017, the Commission established a schedule for conducting expedited reviews on lined paper school supplies from China and India. On October 26, 2017, the schedule was published in the Federal Register (82 FR 49659). This notice corrects several dates in the previously-published schedule. In particular, the staff report containing information concerning the subject matter of the review will be placed in the nonpublic record on January 3, 2018 and made available to persons on the Administrative Protective Order service list for this review. Comments pursuant to section 207.62(d) of the Commission's rules are due on or before January 9, 2018.

    The Commission has determined that these reviews are extraordinarily complicated and therefore has determined to exercise its authority to extend the review period by up to 90 days pursuant to 19 U.S.C. 1675(c)(5)(B).

    For further information concerning these investigations see the Commission's notice cited above.

    Authority:

    These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission's rules.

    By order of the Commission.

    Issued: November 1, 2017. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2017-24174 Filed 11-6-17; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City 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 in accordance with on or before January 8, 2018.

    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 12, 2017, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 applied to be registered as a bulk manufacturer of 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 4-Anilino-N-phenethyl-4-piperidine (ANPP) 8333 II Phenylacetone 8501 II Cocaine 9041 II Codeine 9050 II Oxycodone 9143 II Hydromorphone 9150 II Hydrocodone 9193 II Morphine 9300 II Oripavine 9330 II Thebaine 9333 II Opium extracts 9610 II Opium fluid extract 9620 II Opium tincture 9630 II Opium, powdered 9639 II Oxymorphone 9652 II Noroxymorphone 9668 II Fentanyl 9801 II

    The company plans to manufacture the listed controlled substances in bulk for sale to its customers, for dosage form development, for clinical trials, and for use in stability qualification studies.

    Dated: October 30, 2017. Demetra Ashley, Acting Assistant Administrator.
    [FR Doc. 2017-24201 Filed 11-6-17; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE [OMB Number 1110-0060] Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection—CJIS Name Check Form (1-791) AGENCY:

    Criminal Justice Information Services Division, Federal Bureau of Investigation, Department of Justice.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Criminal Justice Information Services (CJIS) Division, 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. The proposed information collection is published to obtain comments from the public and affected agencies.

    DATES:

    Comments are encouraged and will be accepted for 60 days until January 8, 2018.

    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 Gerry Lynn Brovey, Supervisory Information Liaison Specialist, FBI, CJIS, Resources Management Section, Administrative Unit, Module C-2, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306 (facsimile: 304-625-5093) or email [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. Additionally, comments may be submitted via email 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 Bureau of Justice Statistics, 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: Revision of a currently approved collection in use without an OMB control number.

    (2) The Title of the Form/Collection: CJIS Name Check Request.

    (3) The agency form number, if any, and the applicable component of the Department sponsoring the collection: 1-791.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract:

    Primary: Agencies authorized to submit applicant fingerprints into the Next Generation Identification (NGI) system for noncriminal justice purposes such as employment, benefits, and licensing. This form is completed to obtain a name check for an applicant when the fingerprints have been rejected twice for quality to ensure eligible individuals are not denied employment, benefits, or licensing.

    (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 77,816 respondents will complete each form within approximately 5 minutes.

    (6) An estimate of the total public burden (in hours) associated with the collection: There are an estimated 6,485 total annual burden hours associated with this collection.

    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.405A, Washington, DC 20530.

    Dated: November 2, 2017. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2017-24208 Filed 11-6-17; 8:45 am] BILLING CODE 4410-02-P
    DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    On October 31, 2017, the Department of Justice lodged a proposed consent decree with the United States District Court for the Southern District of Texas in the lawsuit entitled United States and the Louisiana Department of Environmental Quality v. Exxon Mobil Corp. and ExxonMobil Oil Corp., Civil Action No. 4:17-cv-03302.

    The United States and Louisiana Department of Environmental Quality filed this lawsuit under the Clean Air Act and Louisiana Environmental Quality Act. The complaint seeks injunctive relief and civil penalties based on violations of the Clean Air Act's New Source Review requirements, New Source Performance Standards, National Emissions Standards for Hazardous Air Pollutants, “Title V” program requirements and operating permits, and related Texas and Louisiana state implementation plan requirements. The alleged violations involve flares used at petrochemical manufacturing plants owned and operated by the defendants, Exxon Mobil Corp. and ExxonMobil Oil Corp., in Baytown and Beaumont, Texas, and Baton Rouge, Louisiana. The consent decree requires the defendants to perform injunctive relief, pay a $2,500,000 civil penalty, perform a Supplemental Environmental Project in Baytown, Texas, and two Beneficial Environmental Projects in Louisiana.

    The publication of this notice opens a period for public comment on the proposed consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States and the Louisiana Department of Environmental Quality v. Exxon Mobil Corp. and ExxonMobil Oil Corp., D.J. Ref. No. 90-5-2-1-10128. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail:

    To submit comments: Send them to: By email [email protected]. By mail Assistant Attorney General;
  • U.S. DOJ-ENRD;
  • P.O. Box 7611;
  • Washington, DC. 20044-7611.
  • During the public comment period, the proposed consent decree may be examined and downloaded at this Justice Department Web site: https://www.justice.gov/enrd/consent-decrees. We will provide a paper copy of the proposed consent decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ-ENRD, P.O. Box 7611, Washington, DC 20044-7611.

    Please enclose a check or money order for $36.75 (25 cents per page reproduction cost) payable to the United States Treasury. For a paper copy without the exhibits and signature pages, the cost is $23.50.

    Thomas P. Carroll, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division.
    [FR Doc. 2017-24125 Filed 11-6-17; 8:45 am] BILLING CODE 4410-15-P
    DEPARTMENT OF LABOR Employment and Training Administration Federal-State Unemployment Compensation Program: Certifications for 2017 Under the Federal Unemployment Tax Act AGENCY:

    Employment and Training Administration, DOL.

    ACTION:

    Notice.

    SUMMARY:

    The Secretary of Labor signed the annual certifications under the Federal Unemployment Tax Act, 26 U.S.C. 3301 et seq., thereby enabling employers who make contributions to state unemployment funds to obtain certain credits against their liability for the federal unemployment tax. By letter, the certifications were transmitted to the Secretary of the Treasury. The letter and certifications are printed below.

    Signed in Washington, DC, October 31, 2017. Nancy M. Rooney, Deputy Assistant Secretary, Employment and Training Administration. The Honorable Steven T. Mnuchin Secretary of the Treasury Department of the Treasury 1500 Pennsylvania Avenue NW., Washington, DC 20220 Dear Secretary Mnuchin: Transmitted herewith are an original and one copy of the certifications of the states and their unemployment compensation laws for the 12-month period ending on October 31, 2017. One certification is required with respect to the normal federal unemployment tax credit by Section 3304 of the Internal Revenue Code of 1986 (IRC), and the other certification is required with respect to the additional tax credit by Section 3303 of the IRC. Both certifications list all 53 jurisdictions. Sincerely, R. Alexander Acosta UNITED STATES DEPARTMENT OF LABOR OFFICE OF THE SECRETARY WASHINGTON, DC CERTIFICATION OF STATES TO THE SECRETARY OF THE TREASURY PURSUANT TO SECTION 3304(c) OF THE INTERNAL REVENUE CODE OF 1986

    In accordance with the provisions of Section 3304(c) of the Internal Revenue Code of 1986 (26 U.S.C. 3304(c)), I hereby certify the following named states to the Secretary of the Treasury for the 12-month period ending on October 31, 2017, in regard to the unemployment compensation laws of those states, which heretofore have been approved under the Federal Unemployment Tax Act:

    Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Virgin Islands Washington West Virginia Wisconsin Wyoming

    This certification is for the maximum normal credit allowable under Section 3302(a) of the Code.

    Signed at Washington, DC, on October 31, 2017. R. Alexander Acosta UNITED STATES DEPARTMENT OF LABOR OFFICE OF THE SECRETARY WASHINGTON, DC CERTIFICATION OF STATE UNEMPLOYMENT COMPENSATION LAWS TO THE SECRETARY OF THE TREASURY PURSUANT TO SECTION 3303(b)(1) OF THE INTERNAL REVENUE CODE OF 1986

    In accordance with the provisions of paragraph (1) of Section 3303(b) of the Internal Revenue Code of 1986 (26 U.S.C. 3303(b)(1)), I hereby certify the unemployment compensation laws of the following named states, which heretofore have been certified pursuant to paragraph (3) of Section 3303(b) of the Code, to the Secretary of the Treasury for the 12-month period ending on October 31, 2017:

    Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Virgin Islands Washington West Virginia Wisconsin Wyoming

    This certification is for the maximum additional credit allowable under Section 3302(b) of the Code, subject to the limitations of Section 3302(c) of the Code.

    Signed at Washington, DC, on October 31, 2017. R. Alexander Acosta
    [FR Doc. 2017-24177 Filed 11-6-17; 8:45 am] BILLING CODE 4510-30-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Report on Current Employment Statistics ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Bureau of Labor Statistics (BLS) sponsored information collection request (ICR) revision titled, “Report on Current Employment Statistics,” 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 December 7, 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=201706-1220-004 (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-BLS, 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 Report on Current Employment Statistics (CES) information collection. The Congress has charged the BLS with the responsibility of collecting and publishing monthly information on employment, average wages received, and the hours worked, by area and by industry. See 29 U.S.C. 2. The CES program provides current monthly statistics on employment, hours, and earnings, by industry. The statistics are fundamental inputs in economic decision processes at all levels of government, private enterprise, and organized labor. This information collection has been classified as a revision, because the agency has added additional foreign language versions of the forms. The BLS Authorizing Statute authorizes this information collection. See 29 U.S.C. 1, 2.

    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 1220-0011. The current approval is scheduled to expire on November 30, 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 June 19, 2017 (82 FR 27874).

    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 1220-0011. 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-BLS.

    Title of Collection: Report on Current Employment Statistics.

    OMB Control Number: 1220-0011.

    Affected Public: Private Sector—businesses or other for-profits and not-for-profit institutions; State, Local, and Tribal Governments; and Federal Government.

    Total Estimated Number of Respondents: 297,683.

    Total Estimated Number of Responses: 3,572,196.

    Total Estimated Annual Time Burden: 538,240 hours.

    Total Estimated Annual Other Costs Burden: $0.

    Dated: October 31, 2017. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2017-24176 Filed 11-6-17; 8:45 am] BILLING CODE 4510-24-P
    DEPARTMENT OF LABOR Office of the Secretary Office of the Assistant Secretary for Administration and Management; Request for Comments on the Draft DOL FY 2018-2022 Strategic Plan AGENCY:

    Office of the Secretary, Labor.

    ACTION:

    Request for comments on the draft DOL FY 2018-2022 strategic plan.

    SUMMARY:

    The Department of Labor (DOL) is seeking public comment on its Draft FY 2018-2022 Strategic Plan.

    DATES:

    Comments must be received by December 7, 2017.

    ADDRESSES:

    Comments can be provided by email to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Steve Richardson, Office of the Assistant Secretary for Administration and Management, Performance Management Center, (202) 693-7122.

    SUPPLEMENTARY INFORMATION:

    The Department of Labor's Draft FY 2018-2022 Strategic Plan is provided to satisfy a requirement of the Government Performance and Results Modernization Act (GPRMA) that agency stakeholders have an opportunity to comment. This plan presents the Secretary's vision, the Department's mission, and a description of how component agencies will achieve supporting goals and strategic objectives in the next four years. We look forward to receiving your comments. The text of the draft strategic plan is available in pdf on the Department of Labor Web site at https://www.dol.gov/agencies/osec/stratplan.

    Dated: November 1, 2017. Bryan Slater, Assistant Secretary for Administration and Management.
    [FR Doc. 2017-24212 Filed 11-6-17; 8:45 am] BILLING CODE 4510-04-P
    NUCLEAR REGULATORY COMMISSION [NRC-2017-0212] Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Biweekly notice.

    SUMMARY:

    Pursuant to Section 189a. (2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.

    This biweekly notice includes all notices of amendments issued, or proposed to be issued, from October 7 to October 23, 2017. The last biweekly notice was published on October 24, 2017.

    DATES:

    Comments must be filed by December 7, 2017. A request for a hearing must be filed by January 8, 2018.

    ADDRESSES:

    You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0212. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Mail comments to: May Ma, Office of Administration, Mail Stop: OWFN-2-A13, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Beverly A. Clayton, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3475, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2017-0212, facility name, unit number(s), plant docket number, application date, and subject when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0212.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in this document.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    B. Submitting Comments

    Please include Docket ID NRC-2017-0212, facility name, unit number(s), plant docket number, application date, and subject in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. Notice of Consideration of Issuance of Amendments to Facility Operating Licenses and Combined Licenses and Proposed No Significant Hazards Consideration Determination

    The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in § 50.92 of title 10 of the Code of Federal Regulations (10 CFR), this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated, or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. The basis for this proposed determination for each amendment request is shown below.

    The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.

    Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period if circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. If the Commission takes action prior to the expiration of either the comment period or the notice period, it will publish in the Federal Register a notice of issuance. If the Commission makes a final no significant hazards consideration determination, any hearing will take place after issuance. The Commission expects that the need to take this action will occur very infrequently.

    A. Opportunity To Request a Hearing and Petition for Leave To Intervene

    Within 60 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at http://www.nrc.gov/reading-rm/doc-collections/cfr/. Alternatively, a copy of the regulations is available at the NRC's Public Document Room, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. If a petition is filed, the Commission or a presiding officer will rule on the petition and, if appropriate, a notice of a hearing will be issued.

    As required by 10 CFR 2.309(d) the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest.

    In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to the specific sources and documents on which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant or licensee on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.

    Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.

    Petitions must be filed no later than 60 days from the date of publication of this notice. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii). The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document.

    If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to establish when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of the amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.

    A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission no later than 60 days from the date of publication of this notice. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions set forth in this section, except that under 10 CFR 2.309(h)(2) a State, local governmental body, or federally recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. Alternatively, a State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).

    If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.

    B. Electronic Submissions (E-Filing)

    All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities that request to participate under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562, August 3, 2012). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC Web site at http://www.nrc.gov/site-help/e-submittals.html. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.

    To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at [email protected], or by telephone at 301-415-1677, to (1) request a digital identification (ID) certificate, which allows the participant (or its counsel or representative) to digitally sign submissions and access the E-Filing system for any proceeding in which it is participating; and (2) advise the Secretary that the participant will be submitting a petition or other adjudicatory document (even in instances in which the participant, or its counsel or representative, already holds an NRC-issued digital ID certificate). Based upon this information, the Secretary will establish an electronic docket for the hearing in this proceeding if the Secretary has not already established an electronic docket.

    Information about applying for a digital ID certificate is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals/getting-started.html. Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit adjudicatory documents. Submissions must be in Portable Document Format (PDF). Additional guidance on PDF submissions is available on the NRC's public Web site at http://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the time the document is submitted through the NRC's E-Filing system. To be timely, an electronic filing must be submitted to the E-Filing system no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of a transmission, the E-Filing system time-stamps the document and sends the submitter an email notice confirming receipt of the document. The E-Filing system also distributes an email notice that provides access to the document to the NRC's Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the document on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before adjudicatory documents are filed so that they can obtain access to the documents via the E-Filing system.

    A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html, by email to [email protected], or by a toll-free call at 1-866-672-7640. The NRC Electronic Filing Help Desk is available between 9 a.m. and 6 p.m., Eastern Time, Monday through Friday, excluding government holidays.

    Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff. Participants filing adjudicatory documents in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.

    Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at https://adams.nrc.gov/ehd, unless excluded pursuant to an order of the Commission or the presiding officer. If you do not have an NRC-issued digital ID certificate as described above, click cancel when the link requests certificates and you will be automatically directed to the NRC's electronic hearing dockets where you will be able to access any publicly available documents in a particular hearing docket. Participants are requested not to include personal privacy information, such as social security numbers, home addresses, or personal phone numbers in their filings, unless an NRC regulation or other law requires submission of such information. For example, in some instances, individuals provide home addresses in order to demonstrate proximity to a facility or site. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, participants are requested not to include copyrighted materials in their submission.

    For further details with respect to these license amendment applications, see the application for amendment which is available for public inspection in ADAMS and at the NRC's PDR. For additional direction on accessing information related to this document, see the “Obtaining Information and Submitting Comments” section of this document.

    DTE Electric Company, Docket No. 50-341, Fermi 2, Monroe County, Michigan

    Date of amendment request: August 31, 2017. A publicly-available version is in ADAMS under Accession No. ML17243A422.

    Description of amendment request: The proposed amendment would replace existing technical specifications (TS) requirements related to “operations with a potential for draining the reactor vessel” (OPDRVs) with new requirements on reactor pressure vessel water inventory control (RPV WIC) to protect Safety Limit 2.1.1.3, which requires reactor vessel water level to be greater than the top of active irradiated fuel.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed change replaces existing TS requirements related to OPDRVs with new requirements on RPV WIC that will protect Safety Limit 2.1.1.3. Draining of RPV water inventory in Mode 4 (i.e., cold shutdown) and Mode 5 (i.e., refueling) is not an accident previously evaluated and, therefore, replacing the existing TS controls to prevent or mitigate such an event with a new set of controls has no effect on any accident previously evaluated. RPV water inventory control in Mode 4 or Mode 5 is not an initiator of any accident previously evaluated. The existing OPDRV controls or the proposed RPV WIC controls are not mitigating actions assumed in any accident previously evaluated.

    The proposed change reduces the probability of an unexpected draining event (which is not a previously evaluated accident) by imposing new requirements on the limiting time in which an unexpected draining event could result in the reactor vessel water level dropping to the top of the active fuel (TAF). These controls require cognizance of the plant configuration and control of configurations with unacceptably short drain times. These requirements reduce the probability of an unexpected draining event. The current TS requirements are only mitigating actions and impose no requirements that reduce the probability of an unexpected draining event.

    The proposed change reduces the consequences of an unexpected draining event (which is not a previously evaluated accident) by requiring an Emergency Core Cooling System (ECCS) subsystem to be operable at all times in Modes 4 and 5. The current TS requirements do not require any water injection systems, ECCS or otherwise, to be Operable in certain conditions in Mode 5. The change in requirement from two ECCS subsystems to one ECCS subsystem in Modes 4 and 5 does not significantly affect the consequences of an unexpected draining event because the proposed Actions ensure equipment is available within the limiting drain time that is as capable of mitigating the event as the current requirements. The proposed controls provide escalating compensatory measures to be established as calculated drain times decrease, such as verification of a second method of water injection and additional confirmations that containment and/or filtration would be available if needed.

    The proposed change reduces or eliminates some requirements that were determined to be unnecessary to manage the consequences of an unexpected draining event, such as automatic initiation of an ECCS subsystem and control room ventilation. These changes do not affect the consequences of any accident previously evaluated since a draining event in Modes 4 and 5 is not a previously evaluated accident and the requirements are not needed to adequately respond to a draining event.

    Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed change replaces existing TS requirements related to OPDRVs with new requirements on RPV WIC that will protect Safety Limit 2.1.1.3. The proposed change will not alter the design function of the equipment involved. Under the proposed change, some systems that are currently required to be operable during OPDRVs would be required to be available within the limiting drain time or to be in service depending on the limiting drain time. Should those systems be unable to be placed into service, the consequences are no different than if those systems were unable to perform their function under the current TS requirements.

    The event of concern under the current requirements and the proposed change is an unexpected draining event. The proposed change does not create new failure mechanisms, malfunctions, or accident initiators that would cause a draining event or a new or different kind of accident not previously evaluated or included in the design and licensing bases.

    Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change replaces existing TS requirements related to OPDRVs with new requirements on RPV WIC. The current requirements do not have a stated safety basis and no margin of safety is established in the licensing basis. The safety basis for the new requirements is to protect Safety Limit 2.1.1.3. New requirements are added to determine the limiting time in which the RPV water inventory could drain to the top of the active fuel in the reactor vessel should an unexpected draining event occur. Plant configurations that could result in lowering the RPV water level to the TAF within one hour are now prohibited. New escalating compensatory measures based on the limiting drain time replace the current controls. The proposed TS establish a safety margin by providing defense-in-depth to ensure that the Safety Limit is protected and to protect the public health and safety. While some less restrictive requirements are proposed for plant configurations with long calculated drain times, the overall effect of the change is to improve plant safety and to add safety margin.

    Therefore, the proposed change does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: Jon P. Christinidis, DTE Energy, Expert Attorney—Regulatory, 688 WCB, One Energy Plaza, Detroit, MI 48226-1279.

    Energy Northwest, Docket No. 50-397, Columbia Generating Station, Benton County, Washington

    Date of amendment request: July 25, 2017. A publicly-available version is in ADAMS under Accession No. ML17206A543.

    Description of amendment request: The amendment would delete the Note associated with Surveillance Requirement 3.5.1.2 to reflect the Residual Heat Removal system's design, and ensure that the system's operation is consistent with the limiting condition for operation requirements in Technical Specification 3.5.1, “ECCS [Emergency Core Cooling System]—Operating.”

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    No physical changes to the facility will occur as a result of this proposed amendment. The proposed change will not alter the physical design. The current Technical Specification Note could make Columbia susceptible to potential water hammer in the Residual Heat Removal system if in the Shutdown Cooling Mode of Residual Heat Removal in Mode 3 when swapping from the Shutdown Cooling to Low Pressure Core Injection mode of Residual Heat Removal system. The proposed License Amendment Request will eliminate the risk for cavitation of the pump and voiding in the suction piping, thereby avoiding potential to damage the Residual Heat Removal system, including water hammer.

    Therefore there is no significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously analyzed?

    Response: No.

    The proposed change does not alter the physical design, safety limits, or safety analysis assumptions associated with the operation of the plant. Accordingly, the change does not introduce any new accident initiators, nor does it reduce or adversely affect the capabilities of any plant structure, system, or component to perform their safety function. Deletion of the Technical Specification Note is appropriate because current Technical Specification could put the plant at risk for potential cavitation of the pump and voiding in the suction piping, resulting in potential to damage the Residual Heat Removal system, including water hammer.

    Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change does not alter the physical design, safety limits, or safety analysis assumptions associated with the operation of the plant. Accordingly, the change does not introduce any new accident initiators, nor does it reduce or adversely affect the capabilities of any plant structure, system, or component to perform their safety function. Deletion of the Technical Specification Note is appropriate because current Technical Specification could put the plant at risk for potential cavitation of the pump and voiding in the suction piping, resulting in potential to damage the Residual Heat Removal system, including water hammer.

    Therefore, the proposed change does not involve a significant reduction in the margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: William A. Horin, Esq., Winston & Strawn, 1700 K Street NW., Washington, DC 20006-3817.

    NRC Branch Chief: Robert J. Pascarelli.

    Entergy Nuclear Operations, Inc., Docket No. 50-255, Palisades Nuclear Plant (PNP), Van Buren County, Michigan

    Date of amendment request: March 30, 2017, as supplemented by letter dated October 17, 2017. Publicly-available versions are in ADAMS under Accession Nos. ML17089A380 and ML17290A342, respectively.

    Description of amendment request: The license amendment request was originally noticed in the Federal Register on May 23, 2017 (82 FR 23623). The notice is being reissued in its entirety to include the revised scope, description of the amendment request, and proposed no significant hazards consideration determination. The proposed amendment would revise the PNP Cyber Security Plan Milestone 8 full implementation date from December 15, 2017, to March 31, 2019.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed changes to the CSP [Cyber Security Plan] implementation schedule is administrative in nature. This change does not alter accident analysis assumptions, add any initiators, or affect the function of plant systems or the manner in which systems are operated, maintained, modified, tested, or inspected. The proposed change does not require any plant modifications which affect the performance capability of the structures, system, and components relied upon to mitigate the consequences of postulated accidents, and has no impact on the probability or consequences of an accident previously evaluated.

    Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed changes to the CSP implementation schedule is administrative in nature. This proposed change does not alter accident analysis assumptions, add any initiators, or affect the function of plant systems or the manner in which systems are operated, maintained, modified, tested, or inspected. The proposed change does not require any plant modifications which affect the performance capability of the structures, systems, and components relied upon to mitigate the consequences of postulated accidents and does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed change involve a significant reduction in a margin of safety?

    Response: No.

    Plant safety margins are established through limiting conditions for operation, limiting safety system settings, and safety limits specified in the technical specifications. The proposed changes to the CSP implementation schedule is administrative in nature. In addition, the milestone date delay for full implementation of the CSP has no substantive impact because other measures have been taken which provide adequate protection during this period of time. Because there is no change to established safety margins as a result of this change, the proposed change does not involve a significant reduction in a margin of safety.

    Therefore, the proposed change does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: William Glew, Associate General Counsel—Nuclear, Entergy Services, Inc., 440 Hamilton Ave., White Plains, NY 10601.

    NRC Branch Chief: David J. Wrona.

    Exelon Generation Company, LLC, Docket No. 50-333, James A. FitzPatrick Nuclear Power Plant, Oswego County, New York

    Date of amendment request: September 14, 2017. A publicly-available version is in ADAMS under Accession No. ML17257A193.

    Description of amendment request: The amendment would revise the James A. FitzPatrick Nuclear Power Plant Technical Specifications (TSs) to address secondary containment personnel access door openings.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed change addresses conditions during which the secondary containment SR [Surveillance Requirement] 3.6.4.1.3 is not met. The secondary containment is not an initiator of any accident previously evaluated. As a result, the probability of any accident previously evaluated is not increased. The consequences of an accident previously evaluated while utilizing the proposed changes are no different than the consequences of an accident while utilizing the existing four-hour Completion Time for an inoperable secondary containment. As a result, the consequences of an accident previously evaluated are not significantly increased.

    Therefore, the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed change does not alter the protection system design, create new failure modes, or change any modes of operation. The proposed change does not involve a physical alteration of the plant; and no new or different kind of equipment will be installed. Consequently, there are no new initiators that could result in a new or different kind of accident.

    Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change would provide an allowance for brief, inadvertent, simultaneous opening of redundant secondary containment personnel access doors during normal entry and exit conditions. The allowance for both an inner and outer secondary containment access door to be open simultaneously for entry and exit does not significantly impact the ability to maintain the required secondary containment vacuum as the doors are promptly closed after entry or exit, thereby restoring the secondary containment boundary. In addition, brief, inadvertent, simultaneous opening and closing of redundant secondary containment personnel access doors during entry and exit conditions does not significantly impact the ability of the Standby Gas Treatment (SGT) System to maintain the required secondary containment vacuum. Therefore, the safety function of the secondary containment is not affected.

    Therefore, the proposed changes do not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: Donald P. Ferraro, Assistant General Counsel, Exelon Generation Company, LLC, 200 Exelon Way, Suite 305, Kennett Square, PA 19348.

    NRC Branch Chief: James G. Danna.

    FirstEnergy Nuclear Operating Company, et al., Docket Nos. 50-334 and 50-412, Beaver Valley Power Station, Unit Nos. 1 and 2, Beaver County, Pennsylvania FirstEnergy Nuclear Operating Company, et al., Docket No. 50-346, Davis-Besse Nuclear Power Station, Unit No. 1, Ottawa County, Ohio FirstEnergy Nuclear Operating Company, et al., Docket No. 50-440, Perry Nuclear Power Plant, Unit No. 1, Lake County, Ohio

    Date of amendment request: August 11, 2017. A publicly-available version is in ADAMS under Accession No. ML17227A172.

    Description of amendment request: The proposed amendments change the respective technical specifications (TSs) as follows:

    The proposed changes revise Section 1.3, “Completion Times,” and Section 3.0, “LCO Applicability” of the TSs to clarify the use and application of the TS usage rules, as described below:

    • Section 1.3 is revised to clarify “discovery” and to discuss exceptions to starting the Completion Time at condition entry.

    • Limiting Condition for Operation (LCO) 3.0.4.b is revised to clarify that LCO 3.0.4.a, LCO 3.0.4.b, and LCO 3.0.4.c are independent options.

    • Surveillance Requirement (SR) 3.0.3 is revised to allow application of SR 3.0.3 when an SR has not been previously performed and to clarify the application of SR 3.0.3.

    The proposed changes to the TSs are consistent with Technical Specification Task Force (TSTF-529), Revision 4, “Clarify Use and Application Rules.” The NRC staff issued a safety evaluation for TSTF-529 (ADAMS Accession No. ML16060A440) provided to the Technical Specifications Task Force in a letter dated April 21, 2016 (ADAMS Package Accession No. ML16060A441). This review included a review of the NRC staff's evaluation, as well as the information provided in TSTF-529. The NRC letter dated April 21, 2016, included the model application, No Significant Hazards Consideration (NSHC) Determination, and the model safety evaluation for referencing in license amendment applications. The licensee affirmed the applicability of the model NSHC determination in its application dated August 11, 2017, which is presented below.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below, along with NRC edits in square brackets:

    1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed changes to Section 1.3 and LCO 3.0.4 have no effect on the requirement for systems to be Operable and have no effect on the application of TS actions. The proposed change to SR 3.0.3 states that the allowance may only be used when there is a reasonable expectation the surveillance will be met when performed. Since the proposed change does not significantly affect system Operability, the proposed change will have no significant effect on the initiating events for accidents previously evaluated and will have no significant effect on the ability of the systems to mitigate accidents previously evaluated.

    Therefore, it is concluded that this change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed change create the possibility of a new or different kind of accident from any previously evaluated?

    Response: No.

    The proposed change to the TS usage rules does not affect the design or function of any plant systems. The proposed change does not change the Operability requirements for plant systems or the actions taken when plant systems are not operable.

    Therefore, it is concluded that this change does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed change involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change clarifies the application of Section 1.3 and LCO 3.0.4 and does not result in changes in plant operation. SR 3.0.3 is revised to allow application of SR 3.0.3 when an SR has not been previously performed if there is reasonable expectation that the SR will be met when performed. This expands the use of SR 3.0.3 while ensuring the affected system is capable of performing its safety function. As a result, plant safety is either improved or unaffected.

    Therefore, it is concluded that this change does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: David W. Jenkins, FirstEnergy Nuclear Operating Company, FirstEnergy Corporation, 76 South Main Street, Mail Stop A-GO-15, Akron, OH 44308.

    NRC Acting Branch Chief: David J. Wrona.

    FirstEnergy Nuclear Operating Company, Docket No. 50-440, Perry Nuclear Power Plant, Unit No. 1, Lake County, Ohio

    Date of amendment request: September 11, 2017. A publicly-available version is in ADAMS under Accession No. ML17254A495.

    Description of amendment request: The proposed amendment would revise the technical specification (TS) requirements in TS 3.3.6.1, “Primary Containment and Drywell Isolation Instrumentation,” by adding an Actions note allowing intermittent opening, under administrative control, of penetration flow paths that are isolated. The proposed change is consistent with NRC-approved Technical Specifications Task Force (TSTF) traveler TSTF-306-A, Revision 2, “Add Action to [Limiting Condition for Operation (LCO)] 3.3.6.1 to Give Option to Isolate the Penetration.”

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed change to adopt TSTF-306-A allows primary containment and drywell isolation valves to be unisolated under administrative controls when the associated isolation instrumentation is not operable. The isolation function is an accident mitigating function and is not an initiator of an accident previously evaluated. Administrative controls are required to be in effect when the valves are unisolated so that the penetration can be rapidly isolated when the need is indicated.

    The addition of the note that the penetration flow paths may be unisolated under administrative control provides consistency and clarification with the intermittent opening allowances contained in LCO 3.6.1.3, “Primary Containment Isolation Valves (PCIVs),” and LCO 3.6.5.3, “Drywell Isolation Valves,” allowed elsewhere in the Technical Specifications (TS).

    Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed change does not involve any physical changes to plant equipment and does not change the method by which any safety-related system performs its function. The Perry Nuclear Power Plant TS currently allow containment and drywell isolation valves to be open under administrative control after being closed to comply with TS ACTIONS for inoperable valves.

    Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change does not affect the operation of plant equipment or the function of any equipment assumed in the accident analysis. The allowance to unisolate a penetration flow path will not have a significant effect on the margin of safety because the penetration flow path can be isolated manually, if needed. This change simply provides consistency with what is already allowed elsewhere in the TSs. There are no changes being made to safety analysis assumptions or results. When the valves are unisolated, the design basis function of containment isolation is maintained by administrative controls.

    Therefore, the proposed change does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: David W. Jenkins, Attorney, FirstEnergy Corporation, Mail Stop A-GO-15, 76 South Main Street, Akron, OH 44308.

    NRC Branch Chief: David J. Wrona.

    Florida Power & Light Company, et al., Docket Nos. 50-335 and 50-389, St. Lucie Plant Unit Nos. 1 and 2, St. Lucie County, Florida

    Date of amendment request: September 14, 2017. A publicly-available version is in ADAMS under Accession No. ML17257A300.

    Description of amendment request: The amendments would revise the Technical Specifications related to inoperable Auxiliary Feedwater pump steam supply.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The Auxiliary Feedwater (AFW) system is not an initiator of any design basis accident or event, and therefore the proposed changes do not increase the probability of any accident previously evaluated. The proposed changes to address the condition of one inoperable AFW pump due to an inoperable steam supply or one inoperable AFW pump due to an inoperable steam supply concurrent with one inoperable motor-driven AFW pump do not change the response of the plant to any accidents. The proposed changes do not adversely affect accident initiators or precursors nor alter the design assumptions, conditions, and configuration of the facility or the manner in which the plant is operated and maintained. The proposed changes do not adversely affect the ability of structures, systems, and components (SSCs) to perform their intended safety function to mitigate the consequences of an initiating event within the assumed acceptance limits. The proposed changes do not affect the source term, containment isolation, or radiological release assumptions used in evaluating the radiological consequences of any accident previously evaluated. Further, the proposed changes do not increase the types and amounts of radioactive effluent that may be released offsite, nor significantly increase individual or cumulative occupational/public radiation exposures.

    Therefore, facility operation in accordance with the proposed license amendments would not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed changes do not result in a change in the manner in which the AFW system provides plant protection. The AFW system will continue to supply water to the Steam Generators to remove decay heat and other residual heat by delivering at least the minimum required flow rate. There are no design changes associated with the proposed changes. The changes to the required actions and completion times do not change any existing accident scenarios, nor create any new or different accident scenarios. The changes do not involve a physical alteration of the plant (i.e., no new or different type of equipment will be installed) or a change in the methods governing normal plant operation. In addition, the changes do not impose any new or different requirements or eliminate any existing requirements. The changes do not alter assumptions made in the safety analysis. The proposed changes are consistent with the safety analysis assumptions and current plant operating practice.

    Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.

    3. Does the proposed change involve a significant reduction in a margin of safety?

    Response: No.

    The proposed changes do not alter the manner in which safety limits, limiting safety system settings or limiting conditions for operation are determined. The safety analysis acceptance criteria are not impacted by these changes. The proposed changes will not result in plant operation in a configuration outside the design basis.

    Therefore, operation of the facility in accordance with the proposed amendment will not involve a significant reduction in the margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: William S. Blair, Managing Attorney—Nuclear, Florida Power & Light Company, 700 Universe Boulevard, MS LAW/JB, Juno Beach, FL 33408-0420.

    NRC Branch Chief: Undine Shoop.

    Pacific Gas and Electric Company, Docket Nos. 50-275 and 50-323, Diablo Canyon Nuclear Power Plant, Units 1 and 2, San Luis Obispo County, California

    Date of amendment request: September 28, 2017. A publicly-available version is in ADAMS under Accession No. ML17271A090.

    Description of amendment request: The amendments would revise Technical Specifications (TSs) 3.1.4, “Rod Group Alignment Limits”; 3.1.5, “Shutdown Bank Insertion Limits”; 3.1.6, “Control Rod Insertion Limits”; and 3.1.7, “Rod Position Indication,” to adopt Technical Specification Task Force (TSTF) Traveler TSTF-547, Revision 1, “Clarification of Rod Position Requirements (ADAMS Accession No. ML15365A610). The NRC staff approved the TSTF and issued an associated model safety evaluation by letter dated March 4, 2016 (ADAMS Accession No. ML16012A126).

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    Control and shutdown rods are assumed to insert into the core to shut down the reactor in evaluated accidents. Rod insertion limits ensure that adequate negative reactivity is available to provide the assumed shutdown margin (SDM). Rod alignment and overlap limits maintain an appropriate power distribution and reactivity insertion profile.

    Control and shutdown rods are initiators to several accidents previously evaluated, such as rod ejection. The proposed change does not change the limiting conditions for operation for the rods or make any technical changes to the Technical Specification (TS) Surveillance Requirements (SRs) governing the rods. Therefore, the proposed change has no effect on the probability of any accident previously evaluated.

    Revising the TS Actions to provide a limited time to repair rod movement control has no effect on the SDM assumed in the accident analysis as the proposed Actions require verification that SDM is maintained. The effects on power distribution will not cause a significant increase in the consequences of any accident previously evaluated as all TS requirements on power distribution continue to be applicable.

    Revising the TS Actions to provide an alternative to frequent use of the moveable incore detector system or the Power Distribution Monitoring System to verify the position of rods with inoperable rod position indicator does not change the requirement for the rods to be aligned and within the insertion limits.

    Therefore, the assumptions used in any accidents previously evaluated are unchanged and there is no significant increase in the consequences.

    The proposed change to resolve the differences in the TS ensure that the intended Actions are followed when equipment is inoperable. Actions taken with inoperable equipment are not assumptions in the accidents previously evaluated and have no significant effect on the consequences.

    The proposed change to eliminate an unnecessary action has no effect on the consequences of accidents previously evaluated as the analysis of those accidents did not consider the use of the action.

    The proposed change to increase consistency within the TS has no effect on the consequences of accidents previously evaluated as the proposed change clarifies the application of the existing requirements and does not change the intent.

    Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed change create the possibility of a new or different accident from any accident previously evaluated?

    Response: No.

    The proposed change does not involve a physical alteration of the plant (i.e., no new or different type of equipment will be installed). The change does not alter assumptions made in the safety analyses. The proposed change does not alter the limiting conditions for operation for the rods or make any technical changes to the Surveillance Requirements governing the rods. The proposed change maintains or improves safety when equipment is inoperable and does not introduce new failure modes.

    Therefore, the proposed change does not create the possibility of a new or different accident from any accident previously evaluated.

    3. Does the proposed change involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change to allow an alternative method of verifying rod position has no effect on the safety margin as actual rod position is not affected. The proposed change to provide time to repair rods that are operable but immovable does not result in a significant reduction in the margin of safety because all rods must be verified to be operable, and all other banks must be within the insertion limits. The remaining proposed changes to make the requirements internally consistent and to eliminate unnecessary actions do not affect the margin of safety as the changes do not affect the ability of the rods to perform their specified safety function.

    Therefore, the proposed change does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment requests involve no significant hazards consideration.

    Attorney for licensee: Jennifer Post, Esq., Pacific Gas and Electric Company, P.O. Box 7442, San Francisco, California 94120.

    NRC Branch Chief: Robert J. Pascarelli.

    III. Notice of Issuance of Amendments to Facility Operating Licenses and Combined Licenses

    During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.

    A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the Federal Register as indicated.

    Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.

    For further details with respect to the action see (1) the applications for amendment, (2) the amendment, and (3) the Commission's related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items can be accessed as described in the “Obtaining Information and Submitting Comments” section of this document.

    Entergy Operations, Inc., Docket No. 50-313, Arkansas Nuclear One, Unit 1 (ANO-1), Pope County, Arkansas

    Date of amendment request: April 24, 2017.

    Brief description of amendment: The amendment revised technical specification requirements regarding steam generator tube inspections and reporting as described in Technical Specifications Task Force (TSTF) Traveler TSTF-510, Revision 2, “Revision to Steam Generator Program Inspection Frequencies and Tube Sample Selection,” using the Consolidated Line Item Improvement Process for ANO-1.

    Date of issuance: October 10, 2017.

    Effective date: As of the date of issuance and shall be implemented within 90 days from the date of issuance.

    Amendment No.: 258. A publicly-available version is in ADAMS under Accession No. ML17235A519; documents related to this amendment are listed in the Safety Evaluation enclosed with the amendment.

    Renewed Facility Operating License No. DPR-51: Amendment revised the Operating License and Technical Specifications.

    Date of initial notice in Federal Register : July 5, 2017 (82 FR 31092).

    The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 10, 2017.

    No significant hazards consideration comments received: No.

    Entergy Operations, Inc., Docket No. 50-368, Arkansas Nuclear One, Unit 2 (ANO-2), Pope County, Arkansas

    Date of amendment request: April 24, 2017.

    Brief description of amendment: The amendment revised technical specification requirements regarding steam generator tube inspections and reporting as described in Technical Specifications Task Force (TSTF) Traveler TSTF-510, Revision 2, “Revision to Steam Generator Program Inspection Frequencies and Tube Sample Selection,” using the Consolidated Line Item Improvement Process for ANO-2.

    Date of issuance: October 10, 2017.

    Effective date: As of the date of issuance and shall be implemented within 90 days from the date of issuance.

    Amendment No.: 307. A publicly-available version is in ADAMS under Accession No. ML17251A211; documents related to this amendment are listed in the Safety Evaluation enclosed with the amendment.

    Renewed Facility Operating License No. NPF-6: Amendment revised the Operating License and Technical Specifications.

    Date of initial notice in Federal Register : July 5, 2017 (82 FR 31093).

    The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 10, 2017.

    No significant hazards consideration comments received: No.

    FirstEnergy Nuclear Operating Company and FirstEnergy Nuclear Generation, LLC, Docket Nos. 50-334 and 50-412, Beaver Valley Power Station, Units 1 and 2, Beaver County, Pennsylvania

    Date of amendment request: September 28, 2016, as supplemented by letters dated May 20, 2017; September 7, 2017; and September 20, 2017.

    Brief description of amendments: The amendments revised the Beaver Valley Power Station, Units 1 and 2, emergency action level (EAL) scheme to one based on Nuclear Energy Institute (NEI) document NEI 99-01, Revision 6, “Development of Emergency Action Level for Non-Passive Reactors,” November 2012.

    Date of issuance: October 12, 2017.

    Effective date: As of the date of issuance and shall be implemented within 180 days of issuance.

    Amendment Nos.: 300 (Unit 1) and 189 (Unit 2). A publicly-available version is in ADAMS under Accession No. ML17216A570; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

    Renewed Facility Operating License Nos. DPR-66 and NPF-73: Amendments revised the Renewed Facility Operating Licenses.

    Date of initial notice in Federal Register : December 20, 2016 (81 FR 92868). The supplemental letters dated May 20, 2017; September 7, 2017; and September 20, 2017, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the NRC staff's original proposed no significant hazards consideration determination as published in the Federal Register.

    The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 12, 2017.

    No significant hazards consideration comments received: No.

    FirstEnergy Nuclear Operating Company, et al., Docket No. 50-346, Davis-Besse Nuclear Power Station, Unit No. 1, Ottawa County, Ohio

    Date of application for amendment: January 11, 2017.

    Brief description of amendment: The amendment changes Technical Specification 3.3.1, “Reactor Protection System (RPS) Instrumentation” for Davis-Besse Nuclear Power Station, Unit No. 1, by modifying the format and by providing an alternative set of required actions, with longer completion times, to be used when the ultrasonic flow meter is out of service.

    Date of issuance: October 19, 2017.

    Effective date: As of the date of issuance and shall be implemented within 60 days from the date of issuance.

    Amendment No.: 296. A publicly-available version is in ADAMS under Accession No. ML17270A112; documents related to this amendment are listed in the Safely Evaluation enclosed with the amendment.

    Renewed Facility Operating License No. NPF-3: The amendment revised the renewed facility operating license and technical specifications.

    Date of initial notice in Federal Register : March 14, 2017 (82 FR 13665).

    The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 19, 2017.

    No significant hazards consideration comments received: No.

    FirstEnergy Nuclear Operating Company, Docket No. 50-440, Perry Nuclear Power Plant (PNPP), Unit No. 1, Lake County, Ohio

    Date of amendment request: April 26, 2017.

    Brief description of amendment: The amendment revised the PNPP Environmental Protection Plan (Nonradiological) to clarify and enhance wording, to remove duplicative or outdated program information, and to relieve the burden of submitting unnecessary or duplicative information to the NRC.

    Date of issuance: October 19, 2017.

    Effective date: As of the date of issuance and shall be implemented within 60 days of issuance.

    Amendment No.: 178. A publicly-available version is in ADAMS under Accession No. ML17257A098; documents related to this amendment are listed in the Safety Evaluation enclosed with the amendment.

    Facility Operating License No. NPF-58: Amendment revised the Facility Operating License.

    Date of initial notice in Federal Register : July 5, 2017 (82 FR 31097).

    The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 19, 2017.

    No significant hazards consideration comments received: No.

    Florida Power & Light Company, et al., Docket Nos. 50-335 and 50-389, St. Lucie Plant, Unit Nos. 1 and 2, St. Lucie County, Florida

    Date of amendment request: May 2, 2017.

    Brief description of amendments: The amendments revised the Renewed Facility Operating Licenses' “Fire Protection” license conditions. The changes incorporated new references into these license conditions that approved a revision to plant modifications previously approved in the March 31, 2016, NRC issuance of National Fire Protection Association Standard 805 license amendments (ADAMS Accession No. ML15344A346).

    Date of issuance: October 23, 2017.

    Effective date: As of the date of issuance and shall be implemented within 60 days of issuance.

    Amendment Nos.: 242 (Unit No. 1) and 193 (Unit No. 2). A publicly-available version is in ADAMS under Accession No. ML17248A379; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

    Renewed Facility Operating License Nos. DPR-67 and NPF-16: Amendments revised the Renewed Facility Operating Licenses.

    Date of initial notice in Federal Register : July 5, 2017 (82 FR 31098).

    The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 23, 2017.

    No significant hazards consideration comments received: No.

    NextEra Energy Duane Arnold, LLC, Docket No. 50-331, Duane Arnold Energy Center (DAEC), Linn County, Iowa

    Date of amendment request: March 31, 2017.

    Brief description of amendment: The amendment revised the DAEC Plume Exposure Pathway Emergency Planning Zone (EPZ) in its Emergency Preparedness Plan. The DAEC Evacuation Time Estimates Study has also been revised to encompass the changes proposed to the DAEC Plume Exposure Pathway EPZ boundary.

    Date of issuance: October 18, 2017.

    Effective date: As of the date of issuance and shall be implemented within 180 days.

    Amendment No.: 301. A publicly-available version is in ADAMS under Accession No. ML17212A646; documents related to this amendment are listed in the Safety Evaluation enclosed with the amendment.

    Renewed Facility Operating License No. DPR-49: The amendment revised the Emergency Plan.

    Date of initial notice in Federal Register : June 6, 2017 (82 FR 26132).

    The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 18, 2017.

    No significant hazards consideration comments received: No.

    Tennessee Valley Authority, Docket Nos. 50-390 and 50-391, Watts Bar Nuclear Plant, Units 1 and 2, Rhea County, Tennessee

    Date of amendment request: October 20, 2016, as supplemented by letters dated May 5, 2017, and July 21, 2017.

    Brief description of amendments: The amendments revised Technical Specification 3.7.12, “Auxiliary Building Gas Treatment System (ABGTS),” to provide an action when both trains of the ABGTS are inoperable due to the auxiliary building secondary containment enclosure boundary being inoperable.

    Date of issuance: October 17, 2017.

    Effective date: As of the date of issuance and shall be implemented within 60 days of issuance.

    Amendment Nos.: 116 (Unit 1) and 16 (Unit 2). A publicly-available version is in ADAMS under Accession No. ML17236A057; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

    Facility Operating License Nos. NPF-90 and NPF-96: Amendments revised the Facility Operating Licenses and Technical Specifications.

    Date of initial notice in Federal Register : February 28, 2017 (82 FR 12137). The supplemental letters dated May 5, 2017, and July 21, 2017, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the NRC staff's original proposed no significant hazards consideration determination as published in the Federal Register.

    The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 17, 2017.

    No significant hazards consideration comments received: No.

    For the Nuclear Regulatory Commission.

    Anne T. Boland, Director, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation.
    [FR Doc. 2017-23749 Filed 11-6-17; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2017-0215] Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres® AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Draft guidance; request for comment.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is revising its licensing guidance for licenses authorizing the use of Yttrium-90 (Y-90) Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres®. The NRC is requesting public comment on the draft revision of the licensing guidance (Rev. 10). The document has been revised to significantly update the criteria for training and experience, medical event reporting, inventory requirement specifications, and waste disposal issues. The revised guidance document also provides new information regarding cremation and autopsy. This guidance is intended for use by NRC applicants, NRC licensees, and the NRC staff.

    DATES:

    Submit comments by January 8, 2018. Comments received after this date will be considered if it is practical to do so, but the NRC is only able to ensure consideration of comments received on or before this date.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0215. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Mail comments to: May Ma, Office of Administration, Mail Stop: OWFN-2-A13, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Lisa Dimmick, Office of Nuclear Material Safety and Safeguards; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-0694; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2017-0215 when contacting the NRC about the availability of information regarding this action. You may obtain publicly-available information related to this action by the following methods:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0215.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The draft Y-90 Microsphere Brachytherapy Sources and Devices Licensing Guidance, Revision 10, is available in ADAMS under Accession No. ML17107A375.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    The draft Y-90 Microsphere Brachytherapy Sources and Devices Licensing Guidance, Revision 10, is also available on the NRC's public Web site on the “Medical Uses Licensee Toolkit” page at https://www.nrc.gov/materials/miau/med-use-toolkit.html.

    B. Submitting Comments

    Please include Docket ID NRC-2017-0215 in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

    II. Background

    The NRC is requesting public comment on the draft licensing guidance entitled “Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres® Licensing Guidance.” This draft would be revision 10 to this licensing guidance. The licensing guidance provides medical use applicants with an acceptable means of satisfying the requirements for a license for the use of TheraSphere® and SIR-Spheres® and is not intended to be the only means of satisfying the requirements for a license. The licensing guidance provides the NRC with a set of standard criteria for evaluating a license application, although an applicant may submit alternative information and commitments for review by the NRC staff to make a licensing determination unless the information is specifically required by regulation. This guidance will also be available for voluntary use by Agreement States.

    The licensing guidance for Y-90 microsphere brachytherapy was initially published in October 2002 and subsequently revised in 2004, 2007, 2008, 2011, 2012, and 2016. Following years of using the current licensing guidance, the NRC staff, stakeholders, and the Advisory Committee on the Medical Uses of Isotopes (ACMUI) have identified numerous issues that need to be addressed. A working group comprised of Agreement State representatives and NRC staff was formed to address identified issues. The document has been revised to significantly update the criteria for training and experience, medical event reporting, inventory requirement specifications, and waste disposal issues. The revised guidance document also provides new information regarding cremation and autopsy.

    As described in the draft licensing guidance, the NRC is recommending removal of the alternate, manufacturer provided clinical training pathway to complete the training and experience criteria listed in Section B of the training and experience section of the licensing guidance. During an ACMUI meeting on October 7, 2016 (ML16357A688), the ACMUI recommended that the NRC leave this alternate pathway in the Y-90 microsphere licensing guidance to allow access to Y-90 microsphere brachytherapy in areas where there may not already be approved AUs to supervise new physicians. However, after licensing Y-90 microspheres under 10 CFR 35.1000 for over 10 years, there should be substantial facilities and AUs available to offer training for Y-90 microspheres, similar to other therapeutic modalities, and therefore this pathway should be removed to bring Y-90 microsphere brachytherapy training and experience (T&E) in line with other T&E requirements in 10 CFR part 35.

    The manufacturers stated, during the same ACMUI meeting, that training under the supervision of a manufacturer representative should remain as a T&E pathway because their representatives are highly knowledgeable about their devices. The NRC agrees with the manufacturers that the individual who provides the training in the operation of the device should be knowledgeable about the device, and this could include a manufacturer representative as well as the licensees' personnel. The proposed licensing guidance still requires the physician to receive training on the operation of the device. However, the clinical experience a physician received during the 3 patient cases should include more than operation of the device. At a minimum, the clinical experience should also include evaluation of dose and activity of Y-90 microspheres to be administered to each treatment site, calculating and measuring the activity and safely preparing the Y-90 microspheres to be delivered, using administrative controls to prevent a medical event, and following up and reviewing each patient's case history. During the ACMUI meeting, the ACMUI recommended that this type of training be provided by someone with defined medical experience, but left it up to the NRC to decide what medical experience would be necessary. As this T&E is specific to patient care and patient follow-up, the proposed licensing guidance recommends this type of training be provided by an AU for each type of Y-90 microsphere for which the individual is seeking AU status, similar to how other modalities are regulated in 10 CFR part 35. Additionally, changing the criteria would not preclude the manufacturer representatives from providing training, as is normally done for other therapies.

    III. Request for Comments

    The NRC is requesting comments on the proposed licensing guidance, entitled, “Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres® Licensing Guidance, Revision 10.” While the NRC is requesting comments on the entirety of the proposed guidance, the NRC is specifically seeking comments on several sections.

    (1) Recommended Minimum Clinical Experience: Due to the complexity of delivery of Y-90 microspheres, the licensing guidance historically and currently recommends that a prospective AU demonstrate he or she has clinical experience with the device. The current recommendation is that 3 patient cases for each type of microsphere should be completed for each prospective authorized user prior to approval. This recommendation is similar to requirements in other therapy modalities, such as section 35.390 of title 10 of the Code of Federal Regulations (10 CFR). The NRC is seeking specific comments on whether 3 patient cases provide adequate clinical experience for a physician to gain AU status for Y-90 microspheres.

    (2) Adding Authorization for Other Microsphere Type: The NRC is seeking comments to determine additional training needed when an AU who is already authorized to use one type of microsphere requests authorization for use of another type of microsphere. For instance, are 3 additional cases for the other type of microsphere necessary for the AU to gain the knowledge to safely administer the new microsphere, or should the number of cases be left to the discretion of the supervising AU?

    (3) Written Attestation from Preceptor: Historically, the NRC has not required a written attestation, signed by a preceptor AU, because there was not a sufficient number of AUs to supervise the training and sign the written attestation. However, given that the NRC and Agreement States have licensed Y-90 microsphere brachytherapy AUs for over 10 years, the NRC is seeking comments to determine if there is anything unique about Y-90 microsphere brachytherapy compared to other types of manual brachytherapy that would obviate the need for a written attestation.

    (4) Clinical Experience under the Supervision of a Manufacturer Representative: The proposed licensing guidance removes the alternate pathway, which allows an individual to become an AU for Y-90 microsphere brachytherapy prior to completing any patient cases if the applicant commits that the first three patient cases completed by that AU will be hands-on and supervised in the physical presence of a manufacturer representative. This alternate pathway remained in the licensing guidance for several years because there were a limited number of AUs who were authorized for each type of Y-90 microsphere, which made it difficult for physicians who were seeking authorization to complete the necessary clinical experience described in Section B under the supervision of another AU already authorized for the use of Y-90 microspheres. The NRC is seeking comments on whether completing the recommended clinical experience under the supervision of AU(s) authorized for the type of microsphere for which the new physician is seeking authorization still presents an undue burden on physicians. Further, the NRC is seeking comments on whether any unique characteristics of Y-90 microsphere brachytherapy warrant continuation of this alternate training pathway. Additionally, the NRC is seeking comments on whether finding licensed facilities at which the physicians could complete this clinical experience would be difficult.

    (5) Timeliness for Completion of In-Vivo Cases: The NRC is seeking comments on whether the proposed one in-vivo case prior to treating patients would be appropriate if 6 months has passed to ensure recentness of training or whether this proposal could potentially lower licensee's safety standards for the patients being treated.

    (6) Medical Event Definition: The NRC is seeking comments on the definition of medical events (ME) for Y-90 microspheres as provided in the proposed guidance. A primary purpose of ME reporting is to identify the cause of the event in order to correct them and prevent their recurrence. In the last 2 years there have been several MEs reported where the administration of the Y-90 results in dose or activity to the lobe opposite the lobe documented in the written directive. The working group was informed that in some instances, the AU may determine in the interventional radiology suite that they may be unable to deliver the amount of Y-90 microspheres to the intended lobe, but still wish to perform the treatment knowing some dose or activity may go to the lobe opposite the lobe documented in the written directive. The NRC is seeking specific comments on whether the delivery of Y-90 microspheres can be controlled to a specific lobe or location as described in the written directive and, if not, whether flexibility in the written directive is necessary to avoid reporting of events that cannot be controlled using the current technology. If flexibility is necessary, the NRC is seeking comments on whether the use of dose or activity ranges in the written directive or an ability to change the written directive in the interventional radiology suite prior to administering the Y-90 microspheres would be adequate. This type of revision could be made verbally by the AU, as long as the revision is documented in writing and signed by the AU within 24 hours of providing the revision verbally, consistent with other uses in 10 CFR part 35.

    Dated at Rockville, Maryland, this 1st day of November, 2017.

    For the U.S. Nuclear Regulatory Commission.

    Daniel S. Collins, Director, Division of Material Safety, State, Tribal and Rulemaking Programs, Office of Nuclear Material Safety and Safeguards.
    [FR Doc. 2017-24129 Filed 11-6-17; 8:45 am] BILLING CODE 7590-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-81995; File No. SR-FINRA-2017-033] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Establish Fees for the New TRACE Security Activity Report and End-of-Day TRACE Transaction File November 1, 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 24, 2017, Financial Industry Regulatory Authority, Inc. (“FINRA”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by FINRA. FINRA has designated the proposed rule change as “establishing or changing a due, fee or other charge” under Section 19(b)(3)(A)(ii) of the Act 3 and Rule 19b-4(f)(2) thereunder,4 which renders the proposal effective upon receipt of this filing by the Commission. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3 15 U.S.C. 78s(b)(3)(A)(ii).

    4 17 CFR 240.19b-4(f)(2).

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    FINRA is proposing to amend Rule 7730 to establish fees for the new TRACE Security Activity Report and End-of-Day TRACE Transaction File.

    The text of the proposed rule change is available on FINRA's Web site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA 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

    FINRA's TRACE data product offerings, set forth in Rule 7730 (Trade Reporting and Compliance Engine (TRACE)), include both real-time as well as historic data for most TRACE-eligible securities.5 The SEC recently approved a new (i) TRACE Security Activity Report and (ii) End-of-Day TRACE Transaction File.6 The new TRACE Security Activity Report is a monthly report that provides aggregated statistics by security for TRACE-Eligible Securities that are Corporate and Agency Bonds (“CA Bonds”). The report will contain basic descriptive security elements, aggregate par value volume information, number of transactions, number of unique market participant identifiers (“MPIDs”), and top 5 statistics for disseminated transactions in CA Bonds. The new End-of-Day TRACE Transaction File is a daily file available after the TRACE system closes that includes all transaction data disseminated as part of Real-Time TRACE transaction data on that day and is separately available for each data set for which Real-Time TRACE transaction data is available (i.e., the Corporate Bond Data Set, Agency Data Set, SP Data Set, and Rule 144A Data Set).

    5 Rule 6710 (Definitions) provides that a “TRACE-Eligible Security” is a debt security that is United States (“U.S.”) dollar-denominated and issued by a U.S. or foreign private issuer, and, if a “restricted security” as defined in Securities Act Rule 144(a)(3), sold pursuant to Securities Act Rule 144A; or is a debt security that is U.S. dollar-denominated and issued or guaranteed by an Agency as defined in paragraph (k) or a Government-Sponsored Enterprise as defined in paragraph (n); or a U.S. Treasury Security as defined in paragraph (p). “TRACE-Eligible Security” does not include a debt security that is issued by a foreign sovereign or a Money Market Instrument as defined in paragraph (o).

    6Id. [sic]

    FINRA is now proposing to amend Rule 7730 to establish fees for the TRACE Security Activity Report and the End-of-Day TRACE Transaction File. FINRA is proposing to establish a fee of $750 per month for receipt of the TRACE Security Activity Report, unless the subscriber is a qualifying tax-exempt organization, in which case FINRA would charge $250 per month. FINRA also is proposing to establish a fee of $750 per month per data set for receipt of the End-of-Day TRACE Transaction File, unless the subscriber is a qualifying tax-exempt organization, in which case FINRA would charge $250 per month per data set. However, subscribers to the Vendor Real-Time Data Feed will not be charged a fee to receive the End-of-Day TRACE Transaction File for the Vendor Real-Time data set(s) to which they have subscribed. FINRA believes that these fees are reasonable, and notes that subscribing to each product is optional for members and others.

    FINRA has filed the proposed rule change for immediate effectiveness. The effective date of the proposed rule change will be the date of effectiveness of the TRACE Security Activity Report and End-of-Day TRACE Transaction File.7

    7See Securities Exchange Act Release No. 81318 (August 4, 2017), 82 FR 37484 (August 10, 2017) (Order Approving File No. SR-FINRA-2017-021); see also Securities Exchange Act Release No. 81114 (July 11, 2017), 82 FR 32728 (July 17, 2017) (Order Approving File No. SR-FINRA-2017-015). FINRA will announce the effective date of each data product in a Regulatory Notice. The effective date will be no later than 365 days following Commission approval of each respective data product.

    2. Statutory Basis

    FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(5) of the Act,8 which requires, among other things, that FINRA rules provide for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using any facility or system that FINRA operates or controls.

    8 15 U.S.C. 78o-3(b)(5).

    Pursuant to the proposal, FINRA will establish fees for (i) the TRACE Security Activity Report that will provide interested parties with a means for receiving aggregated statistics by security for CA Bonds, and (ii) the End-of-Day TRACE Transaction File that will provide interested parties with an alternative means of receiving the transaction information disseminated each trading day as part of the Real-Time TRACE transaction data product. The TRACE Security Activity Report will be made available to subscribers for a fee of $750 per month, or $250 per month for qualifying tax-exempt organizations. FINRA believes that the proposed fees are reasonable.

    The TRACE Security Activity Report is an entirely new report and is not comparable to any current FINRA TRACE data product offering. FINRA cannot at this time estimate the number of persons that may subscribe to the product. However, as indicated by the comment letters received by the Commission on the proposal to adopt the TRACE Security Activity Report,9 FINRA believes that there will be some interest in the report, including in connection with compliance efforts with respect to regulatory obligations under the Investment Company Act of 1940.10 FINRA believes that the fee of $750 per month is reasonable given the costs to be incurred by FINRA in developing the report and providing ongoing administrative, functional and technical support to subscribers, while still being priced at an amount that should allow it to be accessible to interested parties. FINRA also notes that, for a qualifying tax-exempt organization, the fee for the TRACE Security Activity Report will be $250 per month. Where feasible, FINRA generally endeavors to provide TRACE data products to qualifying tax-exempt organizations at a reduced subscription fee to encourage access to TRACE data to facilitate bond market research.

    9See letter to Brent J. Fields, Secretary, Commission, from Bennett Golub, Chief Risk Officer, and Alexis Rosenblum, Director, BlackRock, Inc., dated July 20, 2017; and letter to Robert W. Errett, Deputy Secretary, Commission, from Sean Davy, Managing Director, Capital Markets Division, Securities Industry and Financial Markets Association, dated July 20, 2017.

    10 17 CFR 270.22e-4.

    The End-of-Day TRACE Transaction File will be made available to subscribers for a fee of $750 per month per data set, $250 per month per data set for qualifying tax-exempt organizations, or at no cost to subscribers to the Vendor Real-Time Data Feed for the Vendor Real-Time data set(s) to which they have subscribed. FINRA believes that the proposed fees are reasonable. FINRA currently charges $1,500 per month per data set for the Vendor Real-Time Data Feed. The End-of-Day TRACE Transaction File will provide access to all of the transactions that were disseminated via the Real-Time Data Feed throughout the trading day, but in a single file only available at the end of the trading day. This option not only provides a lower-priced alternative to the Vendor Real-Time Data Feed, it also requires less technological infrastructure from subscribers. Given the current fees established for this somewhat related product, FINRA believes that the proposed fee of $750 per month per data set is reasonable, which is half of the cost of the Vendor Real-Time Data Feed. FINRA also believes this fee is reasonable given the costs to be incurred by FINRA in developing the report and providing ongoing administrative, functional and technical support to subscribers. FINRA also notes that any current subscribers to Vendor Real-Time Data will not be charged a fee for receipt of the End-of-Day TRACE Transaction File for the Vendor Real-Time data set(s) to which they have subscribed. FINRA cannot at this time estimate the number of persons that may subscribe to the product; however, as stated in the Notice, some market participants have indicated that a simpler alternative that allows them to receive transaction information once a day in an end-of-day file would be useful.11 As is the case with the TRACE Security Activity Report, FINRA will make the End-of-Day TRACE Transaction File available to qualifying tax-exempt organizations at a reduced subscription fee (of $250 per month per data set) to encourage access to TRACE data to facilitate bond market research.

    11See Securities Exchange Act Release No. 80805 (May 30, 2017), 82 FR 25862 (June 5, 2017) (Notice of Filing of File No. SR-FINRA-2017-015) (“Notice”).

    FINRA believes that the proposed fees are reasonable, and notes that the fees will be applied equally to all similarly situated interested parties that choose to subscribe to either data product. Thus, FINRA believes that the proposed rule change is consistent with the Act.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA 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. The proposal to establish fees in connection with the new TRACE Security Activity Report and End-of-Day TRACE Transaction File applies only to members that choose to subscribe to these data products, and the proposed fees for each data product will apply equally to all similarly situated subscribers. Subscribers to the Vendor Real-Time Data Feed will not be charged a fee to receive the End-of-Day TRACE Transaction File for the Vendor Real-Time data set(s) to which they have subscribed.

    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 has become effective pursuant to Section 19(b)(3)(A)

    of the Act 12 and paragraph (f)(2) of Rule 19b-4 thereunder.13 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 shall institute proceedings to determine whether the proposed rule should be approved or disapproved.

    12 15 U.S.C. 78s(b)(3)(A).

    13 17 CFR 240.19b-4(f)(2).

    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-FINRA-2017-033 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Robert W. Errett, Deputy Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

    All submissions should refer to File Number SR-FINRA-2017-033. 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 such filing also will be available for inspection and copying at the principal office of FINRA. 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-FINRA-2017-033 and should be submitted on or before November 28, 2017.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.14

    14 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-24131 Filed 11-6-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Investment Company Act Release No. 32892; 812-14830] Reinhart Partners, Inc., et al. November 1, 2017. AGENCY:

    Securities and Exchange Commission (“Commission”).

    ACTION:

    Notice.

    Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and (a)(2) of the Act, and under section 12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and (B) of the Act.

    Applicants:

    Reinhart Partners, Inc. (the “Adviser”), Managed Portfolio Series (the “Trust”), and Quasar Distributors, LLC (the “Distributor”).

    Summary of Application:

    Applicants request an order (“Order”) that permits: (a) Actively managed series of certain open-end management investment companies to issue shares (“Shares”) redeemable in large aggregations only (“Creation Units”); (b) secondary market transactions in Shares to occur at the next-determined net asset value plus or minus a market-determined premium or discount that may vary during the trading day; (c) certain series to pay redemption proceeds, under certain circumstances, more than seven days from the tender of Shares for redemption; (d) certain affiliated persons of the series to deposit securities into, and receive securities from, the series in connection with the purchase and redemption of Creation Units; (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the series to acquire Shares; and (f) certain series to create and redeem Shares in kind in a master-feeder structure. The Order would incorporate by reference terms and conditions of a previous order granting the same relief sought by applicants, as that order may be amended from time to time (“Reference Order”).1

    1 Eaton Vance Management, et al., Investment Company Act Rel. Nos. 31333 (Nov. 6, 2014) (notice) and 31361 (Dec. 2, 2014) (order).

    Filing Date:

    The application was filed on October 4, 2017 and amended on October 12, 2017.

    Hearing or Notification of Hearing:

    An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on November 27, 2017, and should be accompanied by proof of service on applicants, in the form of an affidavit or, for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.

    ADDRESSES:

    Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicants: Reinhart Partners, Inc., 1500 West Market Street, Suite 100, Mequon, Wisconsin 53092; Managed Portfolio Series, 615 East Michigan Street, 4th Floor, Milwaukee, Wisconsin 53202; Quasar Distributors, LLC, 777 East Wisconsin Avenue, 6th Floor, Milwaukee, Wisconsin 53202.

    FOR FURTHER INFORMATION CONTACT:

    Courtney S. Thornton, Senior Counsel, at (202) 551-6812, or Robert H. Shapiro, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).

    SUPPLEMENTARY INFORMATION:

    The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling (202) 551-8090.

    Summary of the Application

    1. The Trust is registered as an open-end management investment company under the Act and is a statutory trust organized under the laws of Delaware. Applicants seek relief with respect to Reinhart Intermediate Bond NextShares (the “Initial Fund”). The portfolio positions of each Fund (as defined below) will consist of securities and other assets selected and managed by its Adviser or Subadviser (as defined below) to pursue the Fund's investment objective.

    2. The Adviser, a Wisconsin corporation, will be the investment adviser to the Initial Fund. An Adviser (as defined below) will serve as investment adviser to each Fund. The Adviser is, and any other Adviser will be, registered as an investment adviser under the Investment Advisers Act of 1940 (“Advisers Act”). The Adviser may retain one or more subadvisers (each a “Subadviser”) to manage the portfolios of the Funds. Any Subadviser will be registered, or not subject to registration, under the Advisers Act.

    3. The Distributor is a Delaware limited liability company and a broker-dealer registered under the Securities Exchange Act of 1934 and will act as the principal underwriter of Shares of the Funds. Applicants request that the requested relief apply to any distributor of Shares, whether affiliated or unaffiliated with the Adviser (included in the term “Distributor”). Any Distributor will comply with the terms and conditions of the Order.

    Requested Exemptive Relief

    4. Applicants seek the requested Order under section 6(c) of the Act for an exemption from sections 2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under section 12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and (B) of the Act. The requested Order would permit applicants to offer exchange-traded managed funds. Because the relief requested is the same as the relief granted by the Commission under the Reference Order and because the Adviser has entered into, or anticipates entering into, a licensing agreement with Eaton Vance Management, or an affiliate thereof in order to offer exchange-traded managed funds,2 the Order would incorporate by reference the terms and conditions of the Reference Order.

    2 Eaton Vance Management has obtained patents with respect to certain aspects of the Funds' method of operation as exchange-traded managed funds.

    5. Applicants request that the Order apply to the Initial Fund and to any other existing or future open-end management investment company or series thereof that: (a) Is advised by the Adviser or any entity controlling, controlled by, or under common control with the Adviser (any such entity included in the term “Adviser”); and (b) operates as an exchange-traded managed fund as described in the Reference Order; and (c) complies with the terms and conditions of the Order and of the Reference Order, which is incorporated by reference herein (each such company or series and Initial Fund, a “Fund”).3

    3 All entities that currently intend to rely on the Order are named as applicants. Any other entity that relies on the Order in the future will comply with the terms and conditions of the Order and of the Reference Order, which is incorporated by reference herein.

    6. Section 6(c) of the Act provides that the Commission may exempt any person, security or transaction, or any class of persons, securities or transactions, from any provisions of the Act, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 17(b) of the Act authorizes the Commission to exempt a proposed transaction from section 17(a) of the Act if evidence establishes that the terms of the transaction, including the consideration to be paid or received, are reasonable and fair and do not involve overreaching on the part of any person concerned, and the proposed transaction is consistent with the policies of the registered investment company and the general purposes of the Act. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities or transactions, from any provision of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors.

    7. Applicants submit that for the reasons stated in the Reference Order: (1) With respect to the relief requested pursuant to section 6(c) of the Act, the relief is appropriate, in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act; (2) with respect to the relief request pursuant to section 17(b) of the Act, the proposed transactions are reasonable and fair and do not involve overreaching on the part of any person concerned, are consistent with the policies of each registered investment company concerned and consistent with the general purposes of the Act; and (3) with respect to the relief requested pursuant to section 12(d)(1)(J) of the Act, the relief is consistent with the public interest and the protection of investors.

    For the Commission, by the Division of Investment Management, pursuant to delegated authority.

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-24138 Filed 11-6-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-81996; File No. SR-NYSEAMER-2017-27] Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Annual Listing Fees for Common Stocks and Warrants November 1, 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 25, 2017, NYSE American LLC (“NYSE American” or the “Exchange”) 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 proposes to amend annual listing fees for common stocks and warrants. The proposed 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 Section 141 of the NYSE American Company Guide to amend certain of its listing fee provisions. The amended fees will take effect in the 2018 calendar year. The following are the proposed fee increases:

    • The annual fee for a common stock with 50 million shares or less outstanding would increase from $35,000 to $40,000.

    • The annual fee for a common stock with more than 50 million and up to 75 million shares outstanding would increase from $45,000 to $50,000.

    • The annual fee for a common stock with more than 75 million shares outstanding would increase from $50,000 to $60,000.

    • The flat annual fee applicable to warrants would increase from $5,000 to $10,000.

    As described below, the Exchange proposes to make the aforementioned fee increases to better reflect the Exchange's costs related to listing equity securities and the corresponding value of such listing to issuers.

    The Exchange also proposes to remove a number of references in Section 141 to fees that are no longer applicable as they were superseded by new fee rates specified in the rule text.

    2. Statutory Basis

    The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,3 in general, and furthers the objectives of Section 6(b)(4) 4 of the Act, in particular, in that it is designed to provide for the equitable allocation of reasonable dues, fees, and other charges. The Exchange also believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,5 in that it is designed 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 and is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers.

    3 15 U.S.C. 78f(b).

    4 15 U.S.C. 78f(b)(4).

    5 15 U.S.C. 78f(b)(5).

    The Exchange believes that it is reasonable to increase the annual listing fees for common stocks and warrants because these fees have not been increased since 2015. In that regard, the Exchange notes that, since the fees were last amended, the Exchange has improved and increased the services it provides to listed companies. These improvements include the continued development and enhancement of an interactive web-based platform designed to improve communication between the Exchange and listed companies, the availability to listed companies of the Exchange's new state-of-the-art conference facilities at 11 Wall Street, and continued development and content in an investor relations tool available to all listed companies which provides companies with information enabling them to better understand the trading and ownership of their securities.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change is designed to ensure that the fees charged by the Exchange accurately reflect the services provided and benefits realized by listed companies. The market for listing services is extremely competitive. Each listing exchange has a different fee schedule that applies to issuers seeking to list securities on its exchange. Issuers have the option to list their securities on these alternative venues based on the fees charged and the value provided by each listing. Because issuers have a choice to list their securities on a different national securities exchange, the Exchange does not believe that the proposed fee changes impose a burden on competition.

    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 foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A) 6 of the Act and subparagraph (f)(2) of Rule 19b-4 7 thereunder, because it establishes a due, fee, or other charge imposed by the Exchange.

    6 15 U.S.C. 78s(b)(3)(A).

    7 17 CFR 240.19b-4(f)(2).

    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) 8 of the Act to determine whether the proposed rule change should be approved or disapproved.

    8 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-NYSEAMER-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-NYSEAMER-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 such 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-NYSEAMER-2017-27, and should be submitted on or before November 28, 2017.

    9 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.9

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-24132 Filed 11-6-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION Sunshine Act Meetings TIME AND DATE:

    2:00 p.m. on Thursday, November 9, 2017.

    PLACE:

    Closed Commission Hearing Room 10800.

    STATUS:

    This meeting will be closed to the public.

    MATTERS TO BE CONSIDERED:

    Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.

    The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(7), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.

    Commissioner Stein, as duty officer, voted to consider the items listed for the closed meeting in closed session.

    The subject matters of the closed meeting will be:

    Institution and settlement of injunctive actions;

    Institution and settlement of administrative proceedings; and

    Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in the scheduling of meeting items.

    CONTACT PERSON FOR MORE INFORMATION:

    For further information and to ascertain what, if any, matters have been added, deleted or postponed; please contact Brent J. Fields from the Office of the Secretary at (202) 551-5400.

    Dated: November 2, 2017. Brent J. Fields, Secretary.
    [FR Doc. 2017-24260 Filed 11-3-17; 11:15 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-81994; File No. SR-ICEEU-2017-013] Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change, Security-Based Swap Submission or Advance Notice Relating to the ICE Clear Europe Procyclicality Framework November 1, 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 23, 2017, ICE Clear Europe Limited (“ICE Clear Europe”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule changes described in Items I, II, and III below, which Items have been prepared primarily by ICE Clear Europe. 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. Clearing Agency's Statement of the Terms of Substance of the Proposed Rule Change

    The principal purpose of the changes is to adopt a new policy framework for addressing the procyclicality of its risk management policies by establishing such a framework that addresses the risk appetite, model design, monitoring and assessment and management of procyclicality in the risk models used by ICE Clear Europe to manage default risk.

    II. Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe 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. ICE Clear Europe has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of such statements.

    (A) Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change (a) Purpose

    The purpose of the Procyclicality Framework is to establish an overall framework for the risk appetite, model design, monitoring and assessment and management of procyclicality in the risk models used by ICE Clear Europe to manage default risk. The European Market Infrastructure Regulation 3 (“EMIR”) and related implementing standards require that a central counterparty (“CCP”) ensure that its margin framework provides, among other matters, stable and prudent margin requirements that limit procyclicality to the extent that the soundness and financial security of the central counterparty is not negatively affected.4 Those standards also require that central counterparties implement at least one of several specified options for mitigating procyclicality with respect to margin requirements.5

    3 Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories, as well as various implementing regulations and technical standards.

    4 Article 28 of Commission Delegated Regulation (EU) No 153/2013 of 19 December 2012 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council with regard to regulatory technical standards on requirements for central counterparties.

    5 The CPMI-IOSCO Principles for Financial Market Infrastructures (“PFMIs”) similarly provide that a clearing house should limit procyclicality for margin requirements and haircuts. See Principles 5 (Collateral) and 6 (Margin).

    Although ICE Clear Europe's current margin policies incorporate the anti-procyclicality (“APC”) measures required by EMIR (and ICE Clear Europe does not propose to change such measures at this time), it is proposing to adopt the Procyclicality Framework in order to provide a more defined framework for considering the impact of procyclicality on margining, membership, collateral haircuts, stress testing and concentration risk policies. The framework is designed to set out (1) the aspects of ICE Clear Europe risk policies relevant to procyclicality considerations, (2) how the clearing house will assess procyclicality (both as a qualitative and a quantitative matter) and (3) how the clearing house will factor considerations of procyclicality into its response to emerging risks.

    Although “procyclicality” is not expressly defined in EMIR, ICE Clear Europe considers procyclicality for purposes of the proposed framework to be the extent to which changes in market conditions can have an effect on a clearing member's ability to manage its liquidity to meet ICE Clear Europe's changing margin requirements. For example, a typical initial margin model would require increased margin in stressed margin conditions, and such increases may potentially occur rapidly and/or over-react to the change in conditions. Such margin increases, in turn, may stress a clearing member's ability to obtain liquidity to meet the increased requirements.

    The framework identifies sources of procyclicality, in particular in margin models, stress testing, and collateral haircut policies, and references existing mitigation strategies and stress testing arrangements used by the clearing house. Stress testing scenarios that are based on models similar to margin models but targeting a higher confidence quantile may also be procyclical due to changing market conditions, which may lead to increased stress shock results and therefore in default fund requirements. The framework also addresses how ICE Clear Europe intends to address procyclicality on an ongoing basis. Under the framework, ICE Clear Europe will assess procyclicality by monitoring the 95th percentile expected shortfall of the 5-day percentage change in initial margin (or other relevant risk mitigant) over a rolling 250-day window. ICE Clear Europe established this period, in consultation with Clearing Members, as an appropriate period to reflect short-term spikes in margin. ICE Clear Europe will also monitor the largest percentage changes to facilitate observation of both the maximum and a tail estimate to remove extreme outliers. A red-amber-green (“R-A-G”) escalation framework will be used with respect to implementing APC measures based on certain defined thresholds for expected 95th percentile expected shortfall metric, which are detailed in an appendix to the framework. The escalation framework specifies appropriate responses where the expected shortfall level is at an amber or green level. ICE Clear Europe will assess procyclicality both on a regular basis in monitoring model performance and making margin rate adjustments as part of risk model design.

    The framework requires that the model design process take into consideration the procyclicality characteristics of the model. This should include analysis of the performance of APC measures during periods of increasing volatility (in light of defined threshold conditions specified in the framework), in a range of market conditions, including stress periods.

    In addition to the quantitative metrics, there are a number of qualitative inputs that are given consideration under the framework. For example, ICE Clear Europe will take into consideration the periodicity of margin updates and will attempt to mitigate the effect of such updates by communicating any such updates to the cleared markets up to a week in advance. The framework also includes procedures for considering the impact of prospective margin changes on the portfolios of Clearing Members and communicating with Clearing Members that may be significantly affected by such changes. The framework also takes into account the activities of other CCPs in the relevant market (including whether they are implementing APC measures), expectations of market participants, the potential for moral hazard created by an expectation of gradual margin changes (which may not be possible in extreme situations), and the ability of the clearing house to override normal APC measures in extreme circumstances. The framework recognizes that different APC measures and thresholds may be appropriate in different markets based on their historical performance. ICE Clear Europe also takes into account the different liquidity resources and practices of different types of Clearing Members, including banks, broker-dealers and other traders, and the need for margin add-ons to mitigate particular liquidity and/or concentration risks. The framework also sets out APC considerations for new products and material changes in existing products.

    Appendices to the framework set out more specific analysis of procyclicality for F&O and CDS products. These analyses are calculated using several different measures of procyclicality, on both whole period and stressed period bases, and both taking into account price change effects and without price change effects, among other factors. The appendices also detail an ICE Clear Europe approach to back testing initial margin calculations, both with and without anti-procyclicality measures under its existing margin policies.

    Pursuant to the framework, ICE Clear Europe will disclose its APC methodology on its Web site. The framework further provides for ongoing governance, including the role of the chief risk officer, and review by the relevant product risk committees and board risk committee, as appropriate.

    (b) Statutory Basis

    ICE Clear Europe believes that the proposed APC framework is consistent with the requirements of Section 17A of the Act 6 and the regulations thereunder applicable to it, including the standards under Rule 17Ad-22.7 Section 17A(b)(3)(F) of the Act 8 requires, among other things, that the rules of a clearing agency be designed to promote the prompt and accurate clearance and settlement of securities transactions and, to the extent applicable, derivative agreements, contracts, and transactions, the safeguarding of securities and funds in the custody or control of the clearing agency or for which it is responsible, and the protection of investors and the public interest. The proposed amendments are designed to enhance and formalize the overall assessment and management of procyclicality in the clearing house's margin and haircut models, among other matters, consistent with regulatory requirements under EMIR. The model is thus intended to strengthen the risk models and procedures already used by the clearing house, particularly the margin model, and limit on an ongoing basis the risks of procyclicality for Clearing Members and the clearing house itself. The framework will also provide greater clarity and transparency for Clearing Members and others as to the clearing house's approach to managing procyclicality. As a result, ICE Clear Europe believes that the proposed changes will promote the prompt and accurate clearance and settlement of cleared transactions, and in general protect investors and the public interest, within the meaning of Section 17A(b)(3)(F).9 In addition, the changes are consistent with the requirements of Rule 17Ad-22(e)(2),10 which requires that a clearing agency have governance arrangements that are clear and transparent, prioritize the safety and efficiency of the clearing agency and support the public interest requirements of Section 17A of the Act applicable to clearing agencies and the objectives of owners and participants, among other matters. The amendments also generally strengthen the clearing house's risk management procedures, consistent with the requirements of Rule 17Ad-22(e)(3) and (6).11

    6 15 U.S.C. 78q-1.

    7 17 CFR 240.17Ad-22.

    8 15 U.S.C. 78q-1(b)(3)(F).

    9 15 U.S.C. 78q-1(b)(3)(F).

    10 17 CFR 240.17Ad-22(e)(2).

    11 17 CFR 240.17Ad-22(e)(3) and (6).

    (B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed amendments would have any impact, or impose any burden, on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes are designed to provide additional protections against the effects of procyclicality by setting forth a methodology to identify and mitigate such risks, consistent with the requirements of EMIR. As such, the changes are intended to reduce the potential liquidity burden for Clearing Members of increases in margin requirements during stressed scenarios. As a result, ICE Clear Europe does not believe the changes will adversely affect the cost to clearing members or other market participants of clearing services. The changes will otherwise not affect the terms or conditions of any cleared contract or the standards or requirements for participation in or use of the Clearing House. The changes should not, in the Clearing House's view, adversely affect competition among Clearing Members, or the ability of market participants to access clearing services generally. As a result, ICE Clear Europe believes that any impact on competition is appropriate in furtherance of the purposes of the Act.

    (C) Clearing Agency's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others

    Written comments relating to the proposed changes to the rules have not been solicited or received. ICE Clear Europe will notify the Commission of any written comments received by ICE Clear Europe.

    III. Date of Effectiveness of the Proposed Rule Change

    Within 45 days of the date of publication of this notice in the Federal Register or within such longer period up to 90 days (i) as the Commission may designate if it finds such longer period to be appropriate and publishes its reasons for so finding or (ii) as to which the self-regulatory organization consents, the Commission will:

    (A) By order approve or disapprove the proposed rule change or

    (B) institute proceedings to determine whether the proposed rule change should be disapproved.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml) or

    • Send an email to [email protected] Please include File Number SR-ICEEU-2017-013 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-ICEEU-2017-013 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, security-based swap submission or advance notice that are filed with the Commission, and all written communications relating to the proposed rule change, security-based swap submission or advance notice between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for 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 such filings will also be available for inspection and copying at the principal office of ICE Clear Europe and on ICE Clear Europe's Web site at https://www.theice.com/notices/Notices.shtml?regulatoryFilings.

    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-ICEEU-2017-013 and should be submitted on or before November 28, 2017.

    12 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.12

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-24130 Filed 11-6-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Investment Company Act Release No. 32894; File No. 812-14776] Princeton Fund Advisors, LLC. et al. November 2, 2017. AGENCY:

    Securities and Exchange Commission (“Commission”).

    ACTION:

    Notice.

    Notice of an application for an order under section 12(d)(1)(J) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 12(d)(1)(A) and (B) of the Act and under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and (2) of the Act. The requested order would permit open-end management investment companies registered under the Act to acquire shares of open-end management investment companies registered under the Act that are outside of the same group of investment companies as the acquiring companies.

    Applicants:

    Northern Lights Fund Trust, a Delaware statutory trust registered under the Act as an open-end management investment company with multiple series (the “Trust”); Princeton Fund Advisors, LLC, a Deleware limited liability company (the “Adviser”), registered as an investment adviser under the Investment Advisers Act of 1940; and Foreside Distribution Services, L.P., a Delaware limited liability company, and Northern Lights Distributors, LLC, a Nebraska limited liability company (together the “Distributors”), each registered as a broker-dealer under the Securities Exchange Act of 1934 (“Exchange Act”).

    Filing Dates:

    The application was filed on May 16, 2017 and amended on August 16, 2017.

    Hearing or Notification of Hearing:

    An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on November 28, 2017 and should be accompanied by proof of service on the applicants, in the form of an affidavit, or, for lawyers, a certificate of service. Pursuant to Rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.

    ADDRESSES:

    Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicants: Thompson Hine LLP, 41 South High Street, Suite 1700, Columbus, OH 43215.

    FOR FURTHER INFORMATION CONTACT:

    Rochelle Kauffman Plesset, Senior Counsel, at (202) 551-6840 or David Marcinkus, Branch Chief, at (202) 551-6882 (Division of Investment Management, Chief Counsel's Office).

    SUPPLEMENTARY INFORMATION:

    The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at http://www.sec.gov/search/search.htm, or by calling (202) 551-8090.

    Summary of the Application

    1. Applicants request an order to permit (a) registered open-end management investment companies (the “Investing Funds”) that are not part of the same “group of investment companies,” within the meaning of section 12(d)(1)(G)(ii) of the Act, as the Trust, to acquire shares in series of the Trust 1 advised by the Adviser in excess of the limits in sections 12(d)(1)(A) of the Act and (b) the Funds, their principal underwriters and any broker or dealer registered under the Exchange Act to sell shares of the Funds to the Investing Funds in excess of the limits in section 12(d)(1)(B) of the Act. Applicants also request an order of exemption under sections 6(c) and 17(b) of the Act from the prohibition on certain affiliated transactions in section 17(a) of the Act to the extent necessary to permit the Funds to sell their shares to, and redeem their shares from, the Investing Funds.2 Applicants state that such transactions will be consistent with the policies of each Fund and each Investing Fund and with the general purposes of the Act and will be based on the net asset values of the Funds.

    1 Applicants request that the order apply to (1) each existing series of the Trust that currently is part of the same “group of investment companes” as the Trust and is advised by the Adviser, (2) to any future series of the Trust, and any other existing or future registered open-end management investment companies and any series thereof that are, or may in the future be, advised by the Advisor and that are part of the same group of investment companies (each, a “Fund” and collectively the “Funds”), and (3) any principal underwriter and distributor for a Fund. Certain of the Funds may have obtained exemptions from the Commission necessary to permit their shares to be listed and traded on a national securities exchange at negotiated prices and, accordingly, to operate as an exchange-traded fund (“ETF”). For purposes of the request for relief, the term “group of investment companies” means any two or more registered investment companies that hold themselves out to investors as related companies for purposes of investment and investor services.

    2 An Investing Fund generally would purchase and sell shares of a Fund that operates as an ETF through secondary market transactions rather than through principal transactions with the Fund. The requested relief is intended to cover tranasactions directly between Funds and Investing Funds. Applicants are not seeking relief from Section 17(a) for, and the requested relief will not apply to, transactions where an ETF could be deemed an affiliated person, or an affiliated person of an affiliated person, of an Investing Fund because an investment adviser to the ETF or an entity controlling, controlled by or under common control with the investment adviser to the ETF is also an investment adviser to the Investing Fund.

    2. Applicants agree that any order granting the requested relief will be subject to the terms and conditions stated in the application.3 Such terms and conditions are designed to, among other things, help prevent any potential (i) undue influence over a Fund that is not in the same “group of investment companies” as the Investing Fund through control or voting power, or in connection with certain services, transactions, and underwritings, (ii) excessive layering of fees, and (iii) overly complex fund structures, which are the concerns underlying the limits in sections 12(d)(1)(A) and (B) of the Act.

    3 Applicants state that each Investing Fund that intends to invest in a Fund in excess of the limits of section 12(d)(1)(A) would be required to sign an agreement that the Investing Fund would adhere to the terms and conditions of the order.

    3. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities, or transactions, from any provision of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors. Section 17(b) of the Act authorizes the Commission to grant an order permitting a transaction otherwise prohibited by section 17(a) if it finds that (a) the terms of the proposed transaction are fair and reasonable and do not involve overreaching on the part of any person concerned; (b) the proposed transaction is consistent with the policies of each registered investment company involved; and (c) the proposed transaction is consistent with the general purposes of the Act. Section 6(c) of the Act permits the Commission to exempt any persons or transactions from any provision of the Act if such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act.

    For the Commission, by the Division of Investment Management, pursuant to delegated authority.

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-24225 Filed 11-6-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Investment Company Act Release No. 32893; File No. 812-14809] Brandes Investment Trust, et al. November 2, 2017. AGENCY:

    Securities and Exchange Commission (“Commission”).

    ACTION:

    Notice.

    SUMMARY:

    Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and (a)(2) of the Act, and under section 12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and (B) of the Act.

    Applicants:

    Brandes Investment Trust (the “Trust”), Brandes Investment Partners, L.P. (the “Adviser”) and ALPS Distributors, Inc. (the “Distributor”).

    Summary of Application:

    Applicants request an order (“Order”) that permits: (a) Actively managed series of certain open-end management investment companies to issue shares (“Shares”) redeemable in large aggregations only (“Creation Units”); (b) secondary market transactions in Shares to occur at the next-determined net asset value plus or minus a market-determined premium or discount that may vary during the trading day; (c) certain series to pay redemption proceeds, under certain circumstances, more than seven days from the tender of Shares for redemption; (d) certain affiliated persons of the series to deposit securities into, and receive securities from, the series in connection with the purchase and redemption of Creation Units; (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the series to acquire Shares; and (f) certain series to create and redeem Shares in kind in a master-feeder structure. The Order would incorporate by reference terms and conditions of a previous order granting the same relief sought by applicants, as that order may be amended from time to time (“Reference Order”).1

    1 Eaton Vance Management, et al., Investment Company Act Rel. Nos. 31333 (Nov. 6, 2014) (notice) and 31361 (Dec. 2, 2014) (order).

    DATES:

    The application was filed on August 11, 2017.

    Hearing or Notification of Hearing:

    An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on November 27, 2017, and should be accompanied by proof of service on applicants, in the form of an affidavit or, for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.

    ADDRESSES:

    Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicants: Thomas Quinlan, Esq., Brandes Investment Partners L.P., 11988 El Camino Real, Suite 600, San Diego, California 92130.

    FOR FURTHER INFORMATION CONTACT:

    Laura J. Riegel, Senior Counsel, at (202) 551-3038, or Robert H. Shapiro, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).

    SUPPLEMENTARY INFORMATION:

    The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling (202) 551-8090.

    Applicants

    1. The Trust is registered as an open-end management investment company under the Act and is a statutory trust organized under the laws of Delaware. Applicants seek relief with respect to one Fund (as defined below, and that Fund, the “Initial Fund”). The portfolio positions of each Fund will consist of securities and other assets selected and managed by its Adviser or Subadviser (as defined below) to pursue the Fund's investment objective.

    2. The Adviser, a Delaware limited partnership, will be the investment adviser to the Initial Fund. An Adviser (as defined below) will serve as investment adviser to each Fund. The Adviser is, and any other Adviser will be, registered as an investment adviser under the Investment Advisers Act of 1940 (“Advisers Act”). The Adviser may retain one or more subadvisers (each a “Subadviser”) to manage the portfolios of the Funds. Any Subadviser will be registered, or not subject to registration, under the Advisers Act.

    3. The Distributor is a Colorado corporation and a broker-dealer registered under the Securities Exchange Act of 1934 and will act as the principal underwriter of Shares of the Funds. Applicants request that the requested relief apply to any distributor of Shares, whether affiliated or unaffiliated with the Adviser (included in the term “Distributor”). Any Distributor will comply with the terms and conditions of the Order.

    Applicants' Requested Exemptive Relief

    4. Applicants seek the requested Order under section 6(c) of the Act for an exemption from sections 2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under section 12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and (B) of the Act. The requested Order would permit applicants to offer exchange-traded managed funds. Because the relief requested is the same as the relief granted by the Commission under the Reference Order and because the Adviser has entered into, or anticipates entering into, a licensing agreement with Eaton Vance Management, or an affiliate thereof in order to offer exchange-traded managed funds,2 the Order would incorporate by reference the terms and conditions of the Reference Order.

    2 Eaton Vance Management has obtained patents with respect to certain aspects of the Funds' method of operation as exchange-traded managed funds.

    5. Applicants request that the Order apply to the Initial Fund and to any other existing or future open-end management investment company or series thereof that: (a) Is advised by the Adviser or any entity controlling, controlled by, or under common control with the Adviser (any such entity included in the term “Adviser”); and (b) operates as an exchange-traded managed fund as described in the Reference Order; and (c) complies with the terms and conditions of the Order and of the Reference Order, which is incorporated by reference herein (each such company or series and Initial Fund, a “Fund”).3

    3 All entities that currently intend to rely on the Order are named as applicants. Any other entity that relies on the Order in the future will comply with the terms and conditions of the Order and of the Reference Order, which is incorporated by reference herein.

    6. Section 6(c) of the Act provides that the Commission may exempt any person, security or transaction, or any class of persons, securities or transactions, from any provisions of the Act, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 17(b) of the Act authorizes the Commission to exempt a proposed transaction from section 17(a) of the Act if evidence establishes that the terms of the transaction, including the consideration to be paid or received, are reasonable and fair and do not involve overreaching on the part of any person concerned, and the proposed transaction is consistent with the policies of the registered investment company and the general purposes of the Act. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities or transactions, from any provision of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors.

    7. Applicants submit that for the reasons stated in the Reference Order: (1) With respect to the relief requested pursuant to section 6(c) of the Act, the relief is appropriate, in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act; (2) with respect to the relief request pursuant to section 17(b) of the Act, the proposed transactions are reasonable and fair and do not involve overreaching on the part of any person concerned, are consistent with the policies of each registered investment company concerned and consistent with the general purposes of the Act; and (3) with respect to the relief requested pursuant to section 12(d)(1)(J) of the Act, the relief is consistent with the public interest and the protection of investors.

    For the Commission, by the Division of Investment Management, pursuant to delegated authority.

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-24224 Filed 11-6-17; 8:45 am] BILLING CODE 8011-01-P
    DEPARTMENT OF STATE [Public Notice: 10177] 60-Day Notice of Proposed Information Collection: Supplemental SIV Chief of Mission Application ACTION:

    Notice of request for public comment.

    SUMMARY:

    The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.

    DATES:

    The Department will accept comments from the public up to January 8, 2018.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Web: Persons with access to the Internet may comment on this notice by going to www.Regulations.gov. You can search for the document by entering “Docket Number: DOS-2017-0041” in the Search field. Then click the “Comment Now” button and complete the comment form.

    Email: [email protected].

    You must include the DS form number (if applicable), information collection title, and the OMB control number in any correspondence.

    FOR FURTHER INFORMATION CONTACT:

    Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to S. Taylor at [email protected].

    SUPPLEMENTARY INFORMATION:

    Title of Information Collection: Supplemental SIV Chief of Mission Application.

    OMB Control Number: 1405-0134.

    Type of Request: Revision of a Currently Approved Collection.

    Originating Office: Bureau of Consular Affairs, Visa Office (CA/VO/L/R).

    Form Number: DS-157.

    Respondents: Afghan Special Immigrant Visa Applicants.

    Estimated Number of Respondents: 8,700.

    Estimated Number of Responses: 8,700.

    Average Time per Response: 1 hour.

    Total Estimated Burden Time: 8,700 hours.

    Frequency: Once per respondent.

    Obligation to Respond: Required to Obtain or Retain a Benefit.

    We are soliciting public comments to permit the Department to:

    • Evaluate whether the proposed information collection is necessary for the proper functions of the Department.

    • Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.

    • Enhance the quality, utility, and clarity of the information to be collected.

    • Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

    Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.

    Abstract of Proposed Collection

    Department of State uses Form DS-157 (Supplemental SIV Chief of Mission Application) in order to facilitate the Chief of Mission approval process required for special immigrant visa (SIV) applicants under section 602(b) of the Afghan Allies Protection Act of 2009 (Pub. L. 111-8). The information requested on the form is limited to that which the Chief of Mission uses to evaluate eligibility of SIV applicants. The DS-157 is only being used by Afghan SIV applicants for Chief of Mission approval.

    Methodology

    Applicants are required to complete the DS-157, along with other required documentation, and to submit their package to the appropriate SIV email address.

    Edward Ramotowski, Deputy Assistant Secretary, Bureau of Consular Affairs, Department of State.
    [FR Doc. 2017-24207 Filed 11-6-17; 8:45 am] BILLING CODE 4710-06-P
    DEPARTMENT OF STATE [Public Notice 10194] Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Paper Promises: Early American Photography” Exhibition SUMMARY:

    Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Paper Promises: Early American Photography,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit objects at The J. Paul Getty Museum at the Getty Center, Los Angeles, California, from on or about February 27, 2018, until on or about May 27, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.

    FOR FURTHER INFORMATION CONTACT:

    Elliot Chiu in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email: [email protected]). The mailing address is U.S. Department of State, L/PD, SA-5, Suite 5H03, Washington, DC 20522-0505.

    SUPPLEMENTARY INFORMATION:

    The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257-1 of December 11, 2015). I have ordered that Public Notice of these determinations be published in the Federal Register.

    Alyson Grunder, Deputy Assistant Secretary for Policy, Bureau of Educational and Cultural Affairs, Department of State.
    [FR Doc. 2017-24160 Filed 11-6-17; 8:45 am] BILLING CODE 4710-05-P
    TENNESSEE VALLEY AUTHORITY Sunshine Act Meetings Meeting No. 17-04

    The TVA Board of Directors will hold a public meeting on November 9, 2017, at Pickwick Landing State Park Inn, 116 State Park Lane, Counce, Tennessee 38326. The public may comment on any agenda item or subject at a public listening session which begins at 9:30 a.m. (CT). Following the end of the public listening session, the meeting will be called to order to consider the agenda items listed below. On-site registration will be available until 15 minutes before the public listening session begins at 9:30 a.m. (CT). Preregistered speakers will address the Board first. TVA management will answer questions from the news media following the Board meeting.

    Status:

    Open.

    Agenda Chair's Welcome Old Business Approval of minutes of the August 23, 2017, Board Meeting New Business 1. Report from President and CEO 2. Report of the Finance, Rates, and Portfolio Committee A. Financial Performance Update B. Long Term Service Agreement for Lagoon Creek C. Large and Medium Transformers 3. Report of the People and Performance Committee A. Fiscal Year 2017 Performance and Compensation B. CEO Compensation for Fiscal Year 2018 4. Report of the Audit, Risk, and Regulation Committee 5. Report of the Nuclear Oversight Committee 6. Report of the External Relations Committee A. Direct-served power arrangements For more information:

    Please call TVA Media Relations at (865) 632-6000, Knoxville, Tennessee. People who plan to attend the meeting and have special needs should call (865) 632-6000. Anyone who wishes to comment on any of the agenda in writing may send their comments to: TVA Board of Directors, Board Agenda Comments, 400 West Summit Hill Drive, Knoxville, Tennessee 37902.

    Dated: November 2, 2017. Sherry A. Quirk, General Counsel.
    [FR Doc. 2017-24298 Filed 11-3-17; 11:15 am] BILLING CODE 8120-08-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration [Summary Notice No. 2017-82] Petition for Exemption; Summary of Petition Received; Auburn University AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice.

    SUMMARY:

    This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition. The FAA is republishing this notice to include pertinent information not contained in the previous summary posted to the Federal Docket on September 27, 2017, to clarify that the petitioner specifically requests to utilize an FAA-approved Precision Flight Controls model DCX MAX Advanced Aviation Training Device (AATD) for fifty (50) percent of the training requirements described in Part 141 Appendix G, for the Flight Instructor Instrument certification. The FAA letter of authorization for this trainer currently allows for (5) percent of the training requirements.

    DATES:

    Comments on this petition must identify the petition docket number and must be received on or before November 17, 2017.

    ADDRESSES:

    Send comments identified by docket number FAA-2017-0860 using any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your comments electronically.

    Mail: Send comments to Docket Operations, M-30; U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

    Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: Fax comments to Docket Operations at 202-493-2251.

    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to http://www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at http://www.dot.gov/privacy.

    Docket: Background documents or comments received may be read at http://www.regulations.gov at any time. Follow the online instructions for accessing the docket or go to the Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Clarence Garden (202) 267-7489, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591.

    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC.

    Lirio Liu, Director, Office of Rulemaking.
    Petition for Exemption

    Docket No.: FAA-2017-0860.

    Petitioner: Auburn University.

    Section(s) of 14 CFR Affected: 141, Appendix G 4. (4).

    Description of Relief Sought: Auburn University seeks exemption from 14 CFR part 141, Appendix G to Part 141, Flight Instructor Instrument (Airplane) Certification Course, 4. (4). Auburn University seeks an exemption to allow an increase in the Flight Simulation Training Device (FSTD) allowance to fifty (50) percent of the 15.0 hours required from five (5) percent currently allowed. More specifically, Auburn University requests to utilize an FAA-approved Precision Flight Controls model DCX MAX Advanced Aviation Training Device (AATD) for fifty (50) percent of the training requirements described in Part 141 Appendix G, for the Flight Instructor Instrument certification. The FAA letter of authorization for this trainer currently allows for (5) percent of the training requirements.

    [FR Doc. 2017-24165 Filed 11-6-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Twenty Fifth RTCA SC-223 IPS and AeroMACS Plenary AGENCY:

    Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).

    ACTION:

    Twenty Fifth RTCA SC-223 IPS and AeroMACS Plenary.

    SUMMARY:

    The FAA is issuing this notice to advise the public of a meeting of Twenty Fifth RTCA SC-223 IPS and AeroMACS Plenary.

    DATES:

    The meeting will be held December 4-8, 2017 9:00 a.m.—5:00 p.m.

    ADDRESSES:

    The meeting will be held at: RTCA Headquarters, 1150 18th Street NW., Suite 910, Washington, DC 20036.

    FOR FURTHER INFORMATION CONTACT:

    Rebecca Morrison at [email protected] or 202-330-0654, or The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington DC, 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at http://www.rtca.org.

    SUPPLEMENTARY INFORMATION:

    Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Twenty Fifth RTCA SC-223 IPS and AeroMACS Plenary. The agenda will include the following:

    Monday, December 4, 2017 9:00 a.m.-5:00 p.m. 1. Welcome, Introductions, Administrative Remarks 2. Review of previous meeting notes and action items 3. Review of Current State of Industry Standards A. ICAO WG-I B. AEEC IPS Sub Committee C. EUROCAE WG status 4. Current State of Industry Activities A. SESAR Programs B. ESA IRIS Precursor C. Any Other Activities 5. IPS Technical Discussions A. Review of IPS high level profile (working papers) B. Review of IPS RFC detail Profiles C. Prioritization of additional IETF RFCs for Profiling 6. Any Other Topics of Interest 7. Plans for Next Meetings Tuesday December 5, 2017 9:00 a.m.-5:00 p.m. 8. Continue with Plenary Agenda Wednesday, December 6, 2017 9:00 a.m.-5:00 p.m. 9. Continue with Plenary Agenda Thursday, December 7, 2017 9:00 a.m.-5:00 p.m. 10. Continue with Plenary Agenda Friday, December 8, 2017 9:00 a.m.-12:00 p.m. 11. Continue with Plenary Agenda 12. Review of Action Items and Meeting Summary 13. Adjourn

    Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the FOR FURTHER INFORMATION CONTACT section. Members of the public may present a written statement to the committee at any time.

    Issued in Washington, DC on November 2, 2017. Mohannad Dawoud, Management & Program Analyst, Partnership Contracts Branch, ANG-A17, NextGen, Procurement Services Division, Federal Aviation Administration.
    [FR Doc. 2017-24158 Filed 11-6-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Twenty First RTCA SC-227 Standards of Navigation Performance Plenary AGENCY:

    Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).

    ACTION:

    Twenty First RTCA SC-227 Standards of Navigation Performance Plenary.

    SUMMARY:

    The FAA is issuing this notice to advise the public of a meeting of Twenty First RTCA SC-227 Standards of Navigation Performance Plenary.

    DATES:

    The meeting will be held December 4-8, 2017, 9:00 a.m.-5:00 p.m.

    ADDRESSES:

    The meeting will be held at: RTCA Headquarters, 1150 18th Street NW., Suite 910, Washington, DC 20036.

    FOR FURTHER INFORMATION CONTACT:

    Rebecca Morrison at [email protected] or 202-330-0654, or The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at http://www.rtca.org.

    SUPPLEMENTARY INFORMATION:

    Pursuant to section 10(a) (2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Twenty First RTCA SC-227 Standards of Navigation Performance Plenary. The agenda will include the following:

    Monday December 4, 2017, 9:00 a.m.-5:00 p.m. 1. Welcome and Administrative Remarks 2. Introduction 3. Review of Minutes from Meeting 20. 4. Agenda Overview 5. Schedule 6. New Business 7. Review and disposition comments received from Final Review and Comment period 8. Review updated TOR Tuesday December 5, 2017, 9:00 a.m.-5:00 p.m. 9. Continue Plenary Agenda Wednesday December 8, 2017, 9:00 a.m.-5:00 p.m. 10. Continue Plenary Agenda Thursday December 7, 2017, 9:00 a.m.-5:00 p.m. 11. Continue Plenary Agenda Friday December 8, 2017, 9:00 a.m.-5:00 p.m. 12. Continue Plenary Agenda 13. Adjourn when Agenda is complete

    Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the FOR FURTHER INFORMATION CONTACT section. Members of the public may present a written statement to the committee at any time.

    Issued in Washington, DC on November 2, 2017. Mohannad Dawoud, Management & Program Analyst, Partnership Contracts Branch, ANG-A17, NextGen, Procurement Services Division, Federal Aviation Administration.
    [FR Doc. 2017-24219 Filed 11-6-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2016-0136] Pipeline Safety: Meetings of the Gas Pipeline Advisory Committee and the Liquid Pipeline Advisory Committee AGENCY:

    Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.

    ACTION:

    Notice of advisory committee meetings.

    SUMMARY:

    This notice announces both a public meeting of the Technical Pipeline Safety Standards Committee, also known as the Gas Pipeline Advisory Committee (GPAC), to discuss topics and provisions of the proposed rule titled “Safety of Gas Transmission and Gathering Pipelines,” and a joint meeting of the GPAC and the Technical Hazardous Liquid Pipeline Safety Standards Committee, also known as the Liquid Pipeline Advisory Committee (LPAC). The purpose of the joint meeting of the GPAC and LPAC is to discuss a variety of policy issues and topics relative to pipeline safety.

    DATES:

    The GPAC and LPAC will meet in a joint session on December 13, 2017, from 8:30 a.m. to 5:00 p.m., and the GPAC only will meet on December 14, 2017, from 8:30 a.m. to 5:00 p.m. and on December 15, 2017, from 8:30 a.m. to 12:00 p.m. ET. Members of the public who wish to attend in person are asked to register no later than December 3, 2017. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify PHMSA by December 3, 2017. For additional information see the ADDRESSES section.

    ADDRESSES:

    The meeting will be held at the Hilton Arlington, 950 North Stafford Street, Arlington, Virginia 22203. The agenda and any additional information for the meetings will be published on the following pipeline advisory committee meeting and registration page: https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=127.

    The meetings will not be webcast; however, presentations will be available on the meeting Web site and posted on the E-Gov Web site, https://www.regulations.gov/, under docket number PHMSA-2016-0136 within 30 days following the meeting.

    Public Participation

    These meetings will be open to the public. Members of the public who attend in person will also be provided an opportunity to make a statement during the meetings.

    Written comments: Persons who wish to submit written comments on the meetings may submit them to the docket in the following ways:

    E-Gov Web site: https://www.regulations.gov. This site allows the public to enter comments on any Federal Register notice issued by any agency.

    Fax: 1-202-493-2251.

    Mail: Docket Management Facility; U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE., West Building, Room W12-140, Washington, DC 20590-0001.

    Hand Delivery: Room W12-140 on the ground level of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC, between 9:00 a.m. and 5:00 p.m., Monday through Friday, except on Federal holidays.

    Instructions: Identify the docket number PHMSA-2016-0136 at the beginning of your comments. Note that all comments received will be posted without change to https://www.regulations.gov, including any personal information provided. Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). Therefore, consider reviewing DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000; (65 FR 19477), or view the Privacy Notice at https://www.regulations.gov before submitting comments.

    Docket: For docket access or to read background documents or comments, go to https://www.regulations.gov at any time or to Room W12-140 on the ground level of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC, between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays.

    If you wish to receive confirmation of receipt of your written comments, please include a self-addressed, stamped postcard with the following statement: “Comments on PHMSA-2016-0136.” The docket clerk will date stamp the postcard prior to returning it to you via the U.S. mail.

    Privacy Act Statement

    In accordance with 5 U.S.C. 553(c), the DOT solicits comments from the public to better inform its rulemaking process. The DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

    Services for Individuals with Disabilities: The public meeting will be physically accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Cheryl Whetsel at [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For information about the meeting, contact Cheryl Whetsel by phone at 202-366-4431 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Meeting Details and Agenda

    The GPAC and LPAC will meet in a joint session to discuss a variety of topics to keep committee members up-to-date on the pipeline safety program and policy issues.

    The GPAC will be considering the proposed rule titled “Safety of Gas Transmission and Gathering Pipelines,” which was published in the Federal Register on April 8, 2016; (81 FR 20722), and the associated regulatory analysis. Based on discussions at the previous GPAC meetings, the topics that will be discussed at this meeting are material documentation and the integrity verification process. If time permits, strengthened assessment requirements would also be discussed.

    Prior to these meetings, PHMSA will finalize the agendas and will publish them on the PHMSA meeting page at https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=127.

    II. Committee Background

    The GPAC and the LPAC are statutorily mandated advisory committees that advise PHMSA on proposed gas pipeline and hazardous liquid pipeline safety standards, respectively, and their associated risk assessments. The committees are established in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, as amended) and 49 U.S.C. 60115. The committees consist of 15 members with membership evenly divided among Federal and State governments, the regulated industry, and the general public. The committees advise PHMSA on the technical feasibility, reasonableness, cost-effectiveness, and practicability of each proposed pipeline safety standard.

    Issued in Washington, DC on November 2, 2017, under authority delegated in 49 CFR 1.97. John A. Gale, Director, Office of Standards and Rulemaking.
    [FR Doc. 2017-24206 Filed 11-6-17; 8:45 am] BILLING CODE 4910-60-P
    DEPARTMENT OF VETERANS AFFAIRS Notice of Performance Review Board Members AGENCY:

    Corporate Senior Executive Management Office, Department of Veterans Affairs.

    ACTION:

    Notice.

    SUMMARY:

    Under provisions of law agencies are required to publish a notice in the Federal Register of the appointment of Performance Review Board (PRB) members. This notice announces the appointment of individuals to serve on the PRB of the Department of Veterans Affairs.

    DATES:

    This notice is applicable October 31, 2017.

    ADDRESSES:

    Corporate Senior Executive Management Office, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420.

    FOR FURTHER INFORMATION CONTACT:

    Contact Tia N. Butler, Executive Director, Corporate Senior Executive Management Office (052), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-7865.

    SUPPLEMENTARY INFORMATION:

    The membership of the Department of Veterans Affairs Performance Review Board is as follows:

    Wright Simpson, Vivieca (Chair) Breyfogle, Cynthia Hyduke, Barbara Rivera, Fernando Frueh, Michael Rawls, Cheryl Hipolit, Richard Johnson, Harvey Sullivan, Matthew Hanson, Anita Chandler, Richard Skelly, Jonathan (Alternate) MacDonald, Edna (Alternate) Hogan, Michael (Alternate) Powers, Glenn (Alternate)

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. David J. Schulkin, Secretary of Veterans Affairs, Department of Veterans Affairs, approved this document on October 31, 2017, for publication.

    Authority:

    5 U.S.C. 4314(c)(4)

    Dated:October 31, 2017. Jeffrey Martin, Office Program Manager, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.
    [FR Doc. 2017-24139 Filed 11-6-17; 8:45 am] BILLING CODE 8320-01-P
    DEPARTMENT OF VETERANS AFFAIRS Privacy Act of 1974; Matching Program AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Notice of Modified Matching Program.

    SUMMARY:

    The Department of Veterans Affairs (VA) has a current 12 month computer matching agreement (CMA) re-establishment agreement with the Federal Bureau of Prisons (BOP) regarding Veterans who are in Federal prison and are also in receipt of compensation and pension benefits. The purpose of this CMA is to renew the agreement between VA, Veterans Benefits Administration (VBA) and the United States Department of Justice (DOJ), BOP. BOP will disclose information about individuals who are in federal prison. VBA will use this information as a match for recipients of Compensation and Pension benefits for adjustments of awards.

    DATES:

    Comments on this new system of records must be received no later than 30 days after date of publication in the Federal Register. If no public comment is received during the period allowed for comment or unless otherwise published in the Federal Register by VA, the new system will become effective 30 days after date of publication in the Federal Register. This matching program will be valid for 18 months from the effective date of this notice.

    ADDRESSES:

    Written comments may be submitted through www.Regulations.gov; by mail or hand-delivery to Director, Regulation Policy and Management (00REG), Department of Veterans Affairs, 810 Vermont Ave. NW., Room 1064, Washington, DC 20420; or by fax to (202) 273-9026 (not a toll-free number). Comments should indicate that they are submitted in response to CMA re-establishment agreement with the Federal BOP. Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call (202) 461-4902 for an appointment. (This is not a toll-free number.) In addition, comments may be viewed online at www.Regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Eric Robinson (VBA), 202-443-6016 (this is not a toll-free number).

    SUPPLEMENTARY INFORMATION:

    This agreement continues an arrangement for a periodic computer-matching program between VA (VBA as the matching recipient agency) and DOJ (BOP as the matching source agency). This agreement sets forth the responsibilities of VBA and BOP with respect to information disclosed pursuant to this agreement and takes into account both agencies' responsibilities under the Privacy Act of 1974, 5 U.S.C. 552a, as amended by the Computer Matching and Privacy Protection Act of 1988, as amended, and the regulations promulgated thereunder, including computer matching portions of a revision of OMB Circular No. A-130, 65 FR 77677 dated December 12, 2000.

    Participating Agencies: VA (VBA as the matching recipient agency) and DOJ (BOP as the matching source agency).

    Authority for Conducting the Matching Program:

    The legal authority to conduct this match is 38 U.S.C. 1505, 5106, and 5313. Section 5106 requires any Federal department or agency to provide VA such information as VA requests for the purposes of determining eligibility for, or the amount of VA benefits, or verifying other information with respect thereto. Section 1505 provides that no VA pension benefits shall be paid to or for any person eligible for such benefits, during the period of that person's incarceration as the result of conviction of a felony or misdemeanor, beginning on the 61st day of incarceration. Section 5313 provides that VA compensation or dependency and indemnity compensation above a specified amount shall not be paid to any person eligible for such benefit, during the period of that person's incarceration as the result of conviction of a felony, beginning on the 61st day of incarceration.

    Purpose(s): The purpose of this matching program between VBA and BOP is to identify those Veterans and VA beneficiaries who are in receipt of certain VA benefit payments and who are confined (see Article II.G.) for a period exceeding 60 days due to a conviction for a felony or a misdemeanor. VBA has the obligation to reduce or suspend compensation, pension, and dependency and indemnity compensation benefit payments to Veterans and VA beneficiaries on the 61st day following conviction and incarceration in a Federal, State, or Local institution for a felony or a misdemeanor. VBA will use the BOP records provided in the match to update the master records of Veterans and VA beneficiaries receiving benefits and to adjust their VA benefits, accordingly, if needed.

    Categories of Individuals: Veterans who have applied for compensation for service-connected disability under 38 U.S.C. Chapter 11; Veterans who have applied for nonservice-connected disability under 38 U.S.C. Chapter 15; Veterans entitled to burial benefits under 38 U.S.C. Chapter 23; Surviving spouses and children who have claimed pensions based on nonservice-connected death of a Veteran under 38 U.S.C. Chapter 15; Surviving spouses and children who have claimed death compensation based on service-connected death of a Veteran under 38 U.S.C. Chapter 11; Surviving spouses and children who have claimed dependency and indemnity compensation for service connected death of a Veteran under 38 U.S.C. Chapter 13; Parents who have applied for death compensation based on service connected death of a Veteran under 38 U.S.C. Chapter 11; Parents who have applied for dependency and indemnity compensation for service-connected death of a Veteran under 38 U.S.C. Chapter 13; Individuals who applied for educational assistance benefits administered by VA under title 38 of the U.S. Code; Individuals who applied for educational assistance benefits maintained by the Department of Defense under title 10 of the U.S. Code that are administered by VA; Veterans who apply for training and employers who apply for approval of their programs under the provisions of the Emergency Veterans' Job Training Act of 1983, Public Law 98-77; Any VA employee who generates or finalizes adjudicative actions using the Benefits Delivery Network (BDN) or the Veterans Service Network (VETSNET) computer processing systems; Veterans who apply for training and employers who apply for approval of their programs under the provisions of the Service Members Occupational Conversion and Training Act of 1992, Public Law 102-484; Representatives of individuals covered by the system.

    CATEGORIES OF RECORDS:

    The record, or information contained in the record, may include identifying information (e.g., name, address, social security number); military service and active duty separation information (e.g., name, service number, date of birth, rank, sex, total amount of active service, branch of service, character of service, pay grade, assigned separation reason, service period, whether Veteran was discharged with a disability, reenlisted, received a Purple Heart or other military decoration); payment information (e.g., Veteran payee name, address, dollar amount of readjustment service pay, amount of disability or pension payments, number of non-pay days, any amount of indebtedness (accounts receivable) arising from title 38 U.S.C. benefits and which are owed to the VA); medical information (e.g., medical and dental treatment in the Armed Forces including type of service-connected disability, medical facilities, or medical or dental treatment by VA health care personnel or received from private hospitals and health care personnel relating to a claim for VA disability benefits or medical or dental treatment); personal information (e.g., marital status, name and address of dependents, occupation, amount of education of a Veteran or a dependent, dependent's relationship to Veteran); education benefit information (e.g., information arising from utilization of training benefits such as a Veteran trainee's induction, reentrance or dismissal from a program or progress and attendance in an education or training program): Applications for compensation, pension, education, and vocational rehabilitation benefits and training which may contain identifying information, military service and active duty separation information, payment information, medical and dental information, personal and education benefit information relating to a Veteran or beneficiary's incarceration in a penal institution (e.g., name of incarcerated Veteran or beneficiary, claims folder number, name and address of penal institution, date of commitment, type of offense, scheduled release date, Veteran's date of birth, beneficiary relationship to Veteran and whether Veteran or beneficiary is in a work release or half-way house program, on parole or has been released from incarceration); the VA employee's BDN or VETSNET identification numbers, the number and kind of actions generated and/or finalized by each such employee, the compilation of cases returned for each employee.

    SYSTEM(S) OF RECORDS:

    Compensation, Pension, Education, and Vocational Rehabilitation and Employment Records—VA (58 VA 21/22/28)”, published at 74 FR 29275 (June 19, 2009), last amended at 77 FR 42593 on July 19, 2012. Justice/BOP-005,” published on June 7, 1984 (48 FR 2371 1), republished on May 9, 2002 (67 FR 31371), January 25, 2007 (72 FR 3410) and April 26, 2012 (77 FR 24982) and last modified on April 18, 2016 (81 FR 22639), routine use (i).

    Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on June 12, 2017 for publication.

    Dated: November 2, 2017. Kathleen M. Manwell, Program Analyst, VA Privacy Service, Office of Privacy Information and Identity Protection, Office of Quality, Privacy and Risk, Office of Information and Technology, Department of Veterans Affairs.
    [FR Doc. 2017-24168 Filed 11-6-17; 8:45 am] BILLING CODE 8320-01-P
    DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board Amended Notice of Meetings

    The Department of Veterans Affairs (VA) gives notice under Public Law 92-463; Title 5 U.S.C. App. 2 (Federal Advisory Committee Act) that the subcommittees of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board (JBL/CS SMRB) will meet from 8 a.m. to 5 p.m. on the dates indicated below (unless otherwise listed):

    Subcommittee Date Location Surgery November 15, 2017 20 F Conference Center. Pulmonary Medicine November 15, 2017 20 F Conference Center. Infectious Diseases—B November 16, 2017 20 F Conference Center. Oncology—A/D November 16, 2017 20 F Conference Center. Hematology November 17, 2017 20 F Conference Center. Oncology—C November 17, 2017 20 F Conference Center. Cellular & Molecular Medicine November 20, 2017 VA Central Office.* Oncology—B November 20, 2017 20 F Conference Center. Infectious Diseases—A November 21, 2017 VA Central Office.* Epidemiology November 28, 2017 VA Central Office.* Mental Health & Behavioral Sciences—A November 28, 2017 20 F Conference Center. Nephrology November 28, 2017 20 F Conference Center. Oncology—E November 28, 2017 20 F Conference Center. Immunology & Dermatology—A November 29, 2017 20 F Conference Center. Mental Health & Behavioral Sciences—B November 29-30, 2017 20 F Conference Center. Cardiovascular Studies—A November 30, 2017 20 F Conference Center. Endocrinology—A November 30, 2017 20 F Conference Center. Neurobiology—C November 30, 2017 20 F Conference Center. Neurobiology—A December 1, 2017 20 F Conference Center. Neurobiology—E December 1, 2017 20 F Conference Center. Endocrinology—B December 4, 2017 20 F Conference Center. Neurobiology—B December 5, 2017 20 F Conference Center. Special Panel for Sheep Review December 5, 2017 VA Central Office.* Neurobiology—F December 6, 2017 VA Central Office.* Cardiovascular Studies—B December 7, 2017 20 F Conference Center. Gastroenterology December 7, 2017 20 F Conference Center. Neurobiology—D December 8, 2017 20 F Conference Center. Gulf War Research December 8, 2017 VA Central Office.* Special Emphasis Panel on Million Veteran Prog Proj January 11-12, 2018 20 F Conference Center. Eligibility January 19, 2018 20 F Conference Center. JBL/CS SMRB January 25, 2018 VA Central Office.* * Teleconference.

    The addresses of the meeting sites are:

    20 F Conference Center, 20 F Street NW., Washington, DC VA Central Office, 1100 First Street NE., Suite 600, Washington, DC

    The purpose of the subcommittees is to provide advice on the scientific quality, budget, safety and mission relevance of investigator-initiated research proposals submitted for VA merit review evaluation. Proposals submitted for review include various medical specialties within the general areas of biomedical, behavioral and clinical science research.

    These subcommittee meetings will be closed to the public for the review, discussion, and evaluation of initial and renewal research proposals, which involve reference to staff and consultant critiques of research proposals. Discussions will deal with scientific merit of each proposal and qualifications of personnel conducting the studies, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Additionally, premature disclosure of research information could significantly obstruct implementation of proposed agency action regarding the research proposals. As provided by subsection 10(d) of Public Law 92-463, as amended by Public Law 94-409, closing the subcommittee meetings is in accordance with Title 5 U.S.C. 552b(c)(6) and (9)(B).

    Those who would like to obtain a copy of the minutes from the closed subcommittee meetings and rosters of the subcommittee members should contact Holly Krull, Ph.D., Manager, Merit Review Program (10P9B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, at (202) 632-8522 or email at [email protected]

    Dated: November 2, 2017. LaTonya L. Small, Federal Advisory Committee Management Officer.
    [FR Doc. 2017-24169 Filed 11-6-17; 8:45 am] BILLING CODE 8320-01-P
    82 214 Tuesday, November 7, 2017 Rules and Regulations Part II Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR Part 484 Medicare and Medicaid Programs; CY 2018 Home Health Prospective Payment System Rate Update and CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 484 [CMS-1672-F] RIN 0938-AT01 Medicare and Medicaid Programs; CY 2018 Home Health Prospective Payment System Rate Update and CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    This final rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2018. This rule also: Updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the third year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between calendar year (CY) 2012 and CY 2014; and discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CY 2014 through CY 2017. In addition, this rule finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model and to the Home Health Quality Reporting Program (HH QRP). We are not finalizing the implementation of the Home Health Groupings Model (HHGM) in this final rule.

    DATES:

    These regulations are effective on January 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    For general information about the Home Health Prospective Payment System (HH PPS), please send your inquiry via email to: [email protected]

    For information about the Home Health Value-Based Purchasing (HHVBP) Model, please send your inquiry via email to: [email protected]

    Contact Joan Proctor, (410) 786-0949 for information about the Home Health Quality Reporting Program (HH QRP).

    SUPPLEMENTARY INFORMATION:

    Wage index addenda will be available only through the internet on the CMS Web site at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/coding_billing.html.

    Table of Contents I. Executive Summary A. Purpose B. Summary of the Major Provisions C. Summary of Costs and Benefits II. Background A. Statutory Background B. Current System for Payment of Home Health Services C. Updates to the Home Health Prospective Payment System D. Report to Congress: Home Health Study on Access to Care for Vulnerable Patient Populations and Subsequent Research and Analyses III. Provisions of the Proposed Rule: Payment Under the Home Health Prospective Payment System (HH PPS) and Responses to Comments A. Monitoring for Potential Impacts—Affordable Care Act Rebasing Adjustments B. CY 2018 HH PPS Case-Mix Weights C. CY 2018 Home Health Payment Rate Update D. Payments for High-Cost Outliers Under the HH PPS E. Proposed Implementation of the Home Health Groupings Model (HHGM) for CY 2019 IV. Provisions of the Home Health Value-Based Purchasing (HHVBP) Model and Responses to Comments A. Background B. Quality Measures C. Quality Measures for Future Consideration V. Updates to the Home Health Care Quality Reporting Program (HH QRP) A. Background and Statutory Authority B. General Considerations Used for the Selection of Quality Measures for the HH QRP C. Accounting for Social Risk Factors in the HH QRP D. Removal From OASIS E. Collection of Standardized Patient Assessment Data Under the HH QRP F. HH QRP Quality Measures Beginning With the CY 2020 HH QRP G. HH QRP Quality Measures and Measure Concepts Under Consideration for Future Years H. Standardized Patient Assessment Data I. Form, Manner, and Timing of Data Submission Under the HH QRP J. Other Provisions for the CY 2019 HH QRP and Subsequent Years K. Policies Regarding Public Display of Quality Measure Data for the HH QRP L. Mechanism for Providing Confidential Feedback Reports to HHAs M. Home Health Care CAHPS® Survey (HHCAHPS) VI. Collection of Information Requirements A. Statutory Requirement for Solicitation of Comments B. Collection of Information Requirements for the HH QRP C. Submission of PRA-Related Comments VII. Regulatory Impact Analysis A. Statement of Need B. Overall Impact C. Detailed Economic Analysis D. Accounting Statement and Table E. Reducing Regulation and Controlling Regulatory Costs F. Conclusion VIII. Federalism Analysis Regulation Text Acronyms

    In addition, because of the many terms to which we refer by abbreviation in this final rule, we are listing these abbreviations and their corresponding terms in alphabetical order below:

    ACH LOS Acute Care Hospital Length of Stay ADL Activities of Daily Living AM-PAC Activity Measure for Post-Acute Care APR DRG All-Patient Refined Diagnosis-Related Group APU Annual Payment Update ASPE Assistant Secretary for Planning and Evaluation BBA Balanced Budget Act of 1997, Public Law 105-33 BBRA Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, (Pub. L. 106-113) BIMS Brief Interview for Mental Status BLS Bureau of Labor Statistics CAD Coronary Artery Disease CAH Critical Access Hospital CAM Confusion Assessment Method CARE Continuity Assessment Record and Evaluation CASPER Certification and Survey Provider Enhanced Reports CBSA Core-Based Statistical Area CCN CMS Certification Number CHF Congestive Heart Failure CMI Case-Mix Index CMP Civil Money Penalty CMS Centers for Medicare & Medicaid Services CoPs Conditions of Participation COPD Chronic Obstructive Pulmonary Disease CVD Cardiovascular Disease CY Calendar Year DM Diabetes Mellitus DRA Deficit Reduction Act of 2005, Public Law 109-171, enacted February 8, 2006 DRG Diagnosis-Related Group DTI Deep Tissue Injury EOC End of Care FDL Fixed Dollar Loss FI Fiscal Intermediaries FR Federal Register FY Fiscal Year HAVEN Home Assessment Validation and Entry System HCC Hierarchical Condition Categories HCIS Health Care Information System HH Home Health HHA Home Health Agency HHCAHPS Home Health Care Consumer Assessment of Healthcare Providers and Systems Survey HH PPS Home Health Prospective Payment System HHGM Home Health Groupings Model HHQRP Home Health Quality Reporting Program HHRG Home Health Resource Group HHVBP Home Health Value-Based Purchasing HIPPS Health Insurance Prospective Payment System HVBP Hospital Value-Based Purchasing IADL Instrumental Activities of Daily Living ICD-9-CM International Classification of Diseases, Ninth Revision, Clinical Modification ICD-10-CM International Classification of Diseases, Tenth Revision, Clinical Modification IH Inpatient Hospitalization IMPACT Act Improving Medicare Post-Acute Care Transformation Act of 2014 (Pub. L. 113-185) IPPS [Acute Care Hospital] Inpatient Prospective Payment System IPR Interim Performance Report IRF Inpatient Rehabilitation Facility IRF-PAI IRF Patient Assessment Instrument IV Intravenous LCDS LTCH CARE Data Set LEF Linear Exchange Function LTCH Long-Term Care Hospital LUPA Low-Utilization Payment Adjustment MACRA Medicare Access and CHIP Reauthorization Act of 2015 MAP Measure Applications Partnership MDS Minimum Data Set MFP Multifactor productivity MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, enacted December 8, 2003 MSA Metropolitan Statistical Area MSS Medical Social Services NQF National Quality Forum NQS National Quality Strategy NRS Non-Routine Supplies OASIS Outcome and Assessment Information Set OBRA Omnibus Budget Reconciliation Act of 1987, Public Law 100-2-3, enacted December 22, 1987 OCESAA Omnibus Consolidated and Emergency Supplemental Appropriations Act, Public Law 105-277, enacted October 21, 1998 OES Occupational Employment Statistics OIG Office of Inspector General OLS Ordinary Least Squares OT Occupational Therapy OMB Office of Management and Budget PAC Post-Acute Care PAC-PRD Post-Acute Care Payment Reform Demonstration PAMA Protecting Access to Medicare Act of 2014 PEP Partial Episode Payment Adjustment PHQ-2 Patient Health Questionnaire-2 PPOC Primary Point of Contact PPS Prospective Payment System PRA Paperwork Reduction Act PRRB Provider Reimbursement Review Board PT Physical Therapy PY Performance Year QAP Quality Assurance Plan QIES Quality Improvement Evaluation System QRP Quality Reporting Program RAP Request for Anticipated Payment RF Renal Failure RFA Regulatory Flexibility Act, Public Law 96—354 RHHIs Regional Home Health Intermediaries RIA Regulatory Impact Analysis ROC Resumption of Care SAF Standard Analytic File SLP Speech-Language Pathology SN Skilled Nursing SNF Skilled Nursing Facility SOC Start of Care SSI Surgical Site Infection TEP Technical Expert Panel TPS Total Performance Score UMRA Unfunded Mandates Reform Act of 1995 VAD Vascular Access Device VBP Value-Based Purchasing I. Executive Summary A. Purpose

    This final rule updates the payment rates for home health agencies (HHAs) for calendar year (CY) 2018, as required under section 1895(b) of the Social Security Act (the Act). This final rule also updates the case-mix weights under section 1895(b)(4)(A)(i) and (b)(4)(B) of the Act for CY 2018 and implements a 0.97 percent reduction to the national, standardized 60-day episode payment amount to account for case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between CY 2012 and CY 2014, under the authority of section 1895(b)(3)(B)(iv) of the Act. Additionally, this rule finalizes changes to the Home Health Value Based Purchasing (HHVBP) Model under the authority of section 1115A of the Act, and Home Health Quality Reporting Program (HH QRP) requirements under the authority of section 1895(b)(3)(B)(v) of the Act. We are not finalizing the implementation of the Home Health Groupings Model (HHGM) in this final rule. We received a number of comments from the public that we would like to take into further consideration.

    B. Summary of the Major Provisions

    In the CY 2015 HH PPS final rule (79 FR 66072), we finalized our proposal to recalibrate the case-mix weights every year with the most current and complete data available at the time of rulemaking. In section III.B. of this final rule, we are recalibrating the HH PPS case-mix weights, using the most current cost and utilization data available, in a budget-neutral manner. Also in section III.B. of this final rule, as finalized in the CY 2016 HH PPS final rule (80 FR 68624), we are implementing a reduction to the national, standardized 60-day episode payment rate for CY 2018 of 0.97 percent to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between CY 2012 and CY 2014. In section III.C. of this final rule, we update the payment rates under the HH PPS by 1 percent for CY 2018 in accordance with section 411(d) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015) which amended section 1895(b)(3)(B) of the Act. Additionally, section III.C. of this final rule, updates the CY 2018 home health wage index using FY 2014 hospital cost report data. In section III.D. of this final rule, we note that the fixed-dollar loss ratio remains 0.55 for CY 2018 to pay up to, but no more than, 2.5 percent of total payments as outlier payments, as required by section 1895(b)(5)(A) of the Act.

    In section IV of this final rule, we are finalizing changes to the Home Health Value-Based Purchasing (HHVBP) Model implemented January 1, 2016. We are amending the definition of “applicable measure” to mean a measure for which a competing HHA has provided a minimum of 40 completed surveys for Home Health Care Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) measures, beginning with Performance Year (PY) 1, for purposes of receiving a performance score for any of the HHCAHPS measures, and for PY 3 and subsequent years, we are finalizing the removal of the Outcome and Assessment Information Set (OASIS)-based measure, Drug Education on All Medications Provided to Patient/Caregiver during All Episodes of Care, from the set of applicable measures.

    In section V. of this final rule, we are finalizing updates to the Home Health Quality Reporting Program, including: The replacement of one quality measure and the adoption of two new quality measures, data submission requirements, exception and extension requirements, and reconsideration and appeals procedures. We have also finalized the removal of 235 data elements from 33 current OASIS items, effective with all HHA assessments on or after January 1, 2019. We are not finalizing the standardized patient assessment data elements that we proposed to adopt for three of the five categories under section 1899B(b)(1)(B) of the Act: Cognitive Function and Mental Status; Special Services, Treatments, and Interventions; and Impairments.

    C. Summary of Costs and Benefits Table 1—Summary of Costs and Transfers Provision description Costs Transfers CY 2018 HH PPS Payment Rate Update The overall economic impact of the HH PPS payment rate update is an estimated −$80 million (−0.4 percent) in payments to HHAs. CY 2018 HHVBP Model The overall economic impact of the HHVBP Model provision for CY 2018 through 2022 is an estimated $378 million in total savings from a reduction in unnecessary hospitalizations and SNF usage as a result of greater quality improvements in the HH industry (none of which is attributable to the changes finalized in this final rule). As for payments to HHAs, there are no aggregate increases or decreases expected to be applied to the HHAs competing in the model. CY 2019 HH QRP The overall economic impact of the HH QRP changes is a savings to HHAs of an estimated $146.0 million, beginning January 1, 2019 II. Background A. Statutory Background

    The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted August 5, 1997), significantly changed the way Medicare pays for Medicare home health services. Section 4603 of the BBA mandated the development of the HH PPS. Until the implementation of the HH PPS on October 1, 2000, HHAs received payment under a retrospective reimbursement system.

    Section 4603(a) of the BBA mandated the development of a HH PPS for all Medicare-covered home health services provided under a plan of care (POC) that were paid on a reasonable cost basis by adding section 1895 of the Act, entitled “Prospective Payment For Home Health Services.” Section 1895(b)(1) of the Act requires the Secretary to establish a HH PPS for all costs of home health services paid under Medicare. Section 1895(b)(2) of the Act requires that, in defining a prospective payment amount, the Secretary shall consider an appropriate unit of service and the number, type, and duration of visits provided within that unit, potential changes in the mix of services provided within that unit and their cost, and a general system design that provides for continued access to quality services.

    Section 1895(b)(3)(A) of the Act requires the following: (1) The computation of a standard prospective payment amount include all costs for HH services covered and paid for on a reasonable cost basis and that such amounts be initially based on the most recent audited cost report data available to the Secretary; and (2) the standardized prospective payment amount be adjusted to account for the effects of case-mix and wage levels among HHAs.

    Section 1895(b)(3)(B) of the Act addresses the annual update to the standard prospective payment amounts by the home health applicable percentage increase. Section 1895(b)(4) of the Act governs the payment computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act require the standard prospective payment amount to be adjusted for case-mix and geographic differences in wage levels. Section 1895(b)(4)(B) of the Act requires the establishment of an appropriate case-mix change adjustment factor for significant variation in costs among different units of services.

    Similarly, section 1895(b)(4)(C) of the Act requires the establishment of wage adjustment factors that reflect the relative level of wages, and wage-related costs applicable to home health services furnished in a geographic area compared to the applicable national average level. Under section 1895(b)(4)(C) of the Act, the wage-adjustment factors used by the Secretary may be the factors used under section 1886(d)(3)(E) of the Act.

    Section 1895(b)(5) of the Act gives the Secretary the option to make additions or adjustments to the payment amount otherwise paid in the case of outliers due to unusual variations in the type or amount of medically necessary care. Section 3131(b)(2) of the Affordable Care Act revised section 1895(b)(5) of the Act so that total outlier payments in a given year would not exceed 2.5 percent of total payments projected or estimated. The provision also made permanent a 10 percent agency-level outlier payment cap.

    In accordance with the statute, as amended by the BBA, we published a final rule in the July 3, 2000 Federal Register (65 FR 41128) to implement the HH PPS legislation. The July 2000 final rule established requirements for the new HH PPS for home health services as required by section 4603 of the BBA, as subsequently amended by section 5101 of the Omnibus Consolidated and Emergency Supplemental Appropriations Act for Fiscal Year 1999 (OCESAA), (Pub. L. 105-277, enacted October 21, 1998); and by sections 302, 305, and 306 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, (BBRA) (Pub. L. 106-113, enacted November 29, 1999). The requirements include the implementation of a HH PPS for home health services, consolidated billing requirements, and a number of other related changes. The HH PPS described in that rule replaced the retrospective reasonable cost-based system that was used by Medicare for the payment of home health services under Part A and Part B. For a complete and full description of the HH PPS as required by the BBA, see the July 2000 HH PPS final rule (65 FR 41128 through 41214).

    Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v) to the Act, requiring HHAs to submit data for purposes of measuring health care quality, and links the quality data submission to the annual applicable percentage increase. This data submission requirement is applicable for CY 2007 and each subsequent year. If an HHA does not submit quality data, the home health market basket percentage increase is reduced by 2 percentage points. In the November 9, 2006 Federal Register (71 FR 65884, 65935), we published a final rule to implement the pay-for-reporting requirement of the DRA, which was codified at § 484.225(h) and (i) in accordance with the statute. The pay-for-reporting requirement was implemented on January 1, 2007.

    The Affordable Care Act made additional changes to the HH PPS. One of the changes in section 3131 of the Affordable Care Act is the amendment to section 421(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 8, 2003) as amended by section 5201(b) of the DRA. Section 421(a) of the MMA, as amended by section 3131 of the Affordable Care Act, requires that the Secretary increase, by 3 percent, the payment amount otherwise made under section 1895 of the Act, for HH services furnished in a rural area (as defined in section 1886(d)(2)(D) of the Act) with respect to episodes and visits ending on or after April 1, 2010, and before January 1, 2016.

    Section 210 of the MACRA amended section 421(a) of the MMA to extend the rural add-on for 2 more years. Section 421(a) of the MMA, as amended by section 210 of the MACRA, requires that the Secretary increase, by 3 percent, the payment amount otherwise made under section 1895 of the Act, for home health services provided in a rural area (as defined in section 1886(d)(2)(D) of the Act) with respect to episodes and visits ending on or after April 1, 2010, and before January 1, 2018. Section 411(d) of MACRA amended section 1895(b)(3)(B) of the Act such that for home health payments for CY 2018, the market basket percentage increase shall be 1 percent.

    B. Current System for Payment of Home Health Services

    Generally, Medicare currently makes payment under the HH PPS on the basis of a national, standardized 60-day episode payment rate that is adjusted for the applicable case-mix and wage index. The national, standardized 60-day episode rate includes the six home health disciplines (skilled nursing, home health aide, physical therapy, speech-language pathology, occupational therapy, and medical social services). Payment for non-routine supplies (NRS) is not part of the national, standardized 60-day episode rate, but is computed by multiplying the relative weight for a particular NRS severity level by the NRS conversion factor. Payment for durable medical equipment covered under the HH benefit is made outside the HH PPS payment system. To adjust for case-mix, the HH PPS uses a 153-category case-mix classification system to assign patients to a home health resource group (HHRG). The clinical severity level, functional severity level, and service utilization are computed from responses to selected data elements in the OASIS assessment instrument and are used to place the patient in a particular HHRG. Each HHRG has an associated case-mix weight which is used in calculating the payment for an episode. Therapy service use is measured by the number of therapy visits provided during the episode and can be categorized into nine visit level categories (or thresholds): 0 to 5; 6; 7 to 9; 10; 11 to 13; 14 to 15; 16 to 17; 18 to 19; and 20 or more visits.

    For episodes with four or fewer visits, Medicare pays national per-visit rates based on the discipline(s) providing the services. An episode consisting of four or fewer visits within a 60-day period receives what is referred to as a low-utilization payment adjustment (LUPA). Medicare also adjusts the national standardized 60-day episode payment rate for certain intervening events that are subject to a partial episode payment adjustment (PEP adjustment). For certain cases that exceed a specific cost threshold, an outlier adjustment may also be available.

    C. Updates to the Home Health Prospective Payment System

    As required by section 1895(b)(3)(B) of the Act, we have historically updated the HH PPS rates annually in the Federal Register. The August 29, 2007 final rule with comment period set forth an update to the 60-day national episode rates and the national per-visit rates under the HH PPS for CY 2008. The CY 2008 HH PPS final rule included an analysis performed on CY 2005 home health claims data, which indicated a 12.78 percent increase in the observed case-mix since 2000. Case-mix represents the variations in conditions of the patient population served by the HHAs. Subsequently, a more detailed analysis was performed on the 2005 case-mix data to evaluate if any portion of the 12.78 percent increase was associated with a change in the actual clinical condition of home health patients. We identified 8.03 percent of the total case-mix change as real, and therefore, decreased the 12.78 percent of total case-mix change by 8.03 percent to get a final nominal case-mix increase measure of 11.75 percent (0.1278 * (1−0.0803) = 0.1175).

    To account for the changes in case-mix that were not related to an underlying change in patient health status, we implemented a reduction, over 4 years, to the national, standardized 60-day episode payment rates. That reduction was to be 2.75 percent per year for 3 years beginning in CY 2008 and 2.71 percent for the fourth year in CY 2011. In the CY 2011 HH PPS final rule (76 FR 68532), we updated our analyses of case-mix change and finalized a reduction of 3.79 percent, instead of 2.71 percent, for CY 2011 and deferred finalizing a payment reduction for CY 2012 until further study of the case-mix change data and methodology was completed.

    In the CY 2012 HH PPS final rule (76 FR 68526), we updated the 60-day national episode rates and the national per-visit rates. In addition, as discussed in the CY 2012 HH PPS final rule (76 FR 68528), our analysis indicated that there was a 22.59 percent increase in overall case-mix from 2000 to 2009 and that only 15.76 percent of that overall observed case-mix percentage increase was due to real case-mix change. As a result of our analysis, we identified a 19.03 percent nominal increase in case-mix. At that time, to fully account for the 19.03 percent nominal case-mix growth identified from 2000 to 2009, we finalized a 3.79 percent payment reduction in CY 2012 and a 1.32 percent payment reduction for CY 2013.

    In the CY 2013 HH PPS final rule (77 FR 67078), we implemented the 1.32 percent reduction to the payment rates for CY 2013 finalized the previous year, to account for nominal case-mix growth from 2000 through 2010. When taking into account the total measure of case-mix change (23.90 percent) and the 15.97 percent of total case-mix change estimated as real from 2000 to 2010, we obtained a final nominal case-mix change measure of 20.08 percent from 2000 to 2010 (0.2390 * (1−0.1597) = 0.2008). To fully account for the remainder of the 20.08 percent increase in nominal case-mix beyond that which was accounted for in previous payment reductions, we estimated that the percentage reduction to the national, standardized 60-day episode rates for nominal case-mix change would be 2.18 percent. Although we considered proposing a 2.18 percent reduction to account for the remaining increase in measured nominal case-mix, we finalized the 1.32 percent payment reduction to the national, standardized 60-day episode rates in the CY 2012 HH PPS final rule (76 FR 68532).

    Section 3131(a) of the Affordable Care Act requires that, beginning in CY 2014, we apply an adjustment to the national, standardized 60-day episode rate and other amounts that reflect factors such as changes in the number of visits in an episode, the mix of services in an episode, the level of intensity of services in an episode, the average cost of providing care per episode, and other relevant factors.